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PROPOVEN 2% EMULSION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE

Active substance(s): PROPOFOL

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Package Insert M0xxxxx/xx UK
Propoven 1% MCT
Size

180 x 588 mm

BPZ gefalzt
45 x 98mm
2D-Matrix-Code M0xxxxx/xx UK
Smallest Fontsize

EAN-Code:
10. Korrektur

9 pt.
-

Schwarz
Stanzform

25.02.2014 | 14:10 uhr

PACKAGE LEAFLET: INFORMATION FOR THE USER

Propoven 1%

emulsion for injection/ infusion in pre-filled syringe
Active substance: Propofol

Read all of this leaflet carefully before you are
given this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
The name of this medicine is Propoven 1% emulsion for
injection/for infusion in pre-filled syringe. In the rest of this
leaflet it will be referred to as Propoven 1%.
What is in this leaflet:
1. What Propoven 1% is and what it is used for
2. What you need to know before you are given
Propoven 1%
3. How to use Propoven 1%
4. Possible side effects
5. How to store Propoven 1%
6. Contents of the pack and other information
1. What Propoven 1% is and what it is used for
Propoven 1% belongs to a group of medicines called
general anaesthetics. General anaesthetics are used
to cause unconsciousness (sleep) so that surgical
operations or other procedures can be performed. They
can also be used to sedate you (so that you are sleepy but
not completely asleep).
Propoven 1% is used to:
• induce and maintain general anaesthesia in adults,
adolescents and children older than 1 month.
• sedate patients older than 16 years of age receiving
artificial respiration in intensive care.
• sedate adults, adolescents and children older than 1
month during diagnostic and surgical procedures,
alone or in combination with local or regional
anaesthesia.
2. What you need to know before you are given
Propoven 1%
Do not use Propoven 1%
- if you are allergic to propofol, soya, peanut or to any of
the other ingredients of this medicine (listed in section 6).
- in patients of 16 years of age or younger for sedation in
intensive care.
Warnings and precautions
Talk to your doctor or pharmacist before you are given
Propoven 1% and if any of the subsequent mentioned
applies to you or applied to you in the past.
You should not receive Propoven 1%, or only under
extreme caution and intensive monitoring, if you:
- have advanced heart failure
- have any other serious disease of the heart
- are receiving electroconvulsive therapy (ECT, a
treatment for psychiatric problems)
In general, Propoven 1% should be given with caution to
elderly or weak patients.
Before receiving Propoven 1%, tell your anaesthetist or
intensive care doctor if you have:
- heart disease
- lung disease
- kidney disease
- liver disease
- seizures (epilepsy)
- a raised pressure inside the skull (raised intracranial
 pressure). In combination with low blood pressure the
amount of blood reaching the brain may be decreased.
- altered levels of fat in the blood. If you are receiving
total parenteral nutrition (feeding through a vein), the
levels of fat in your blood must be monitored.
If you have any of the following conditions, they must be
treated before you receive Propoven 1%:
- heart failure
- when there is insufficient blood reaching the tissues
(circulatory failure)
- severe breathing problems (respiratory failure)
- dehydration (hypovolaemia)
- seizures (epilepsy)
Propoven 1% may increase the risk of
- epileptic seizures
- a nervous reflex that slows the heart rate (vagotonia,
bradycardia)
- changes in the blood flow to the organs of the body
(haemodynamic effects on the cardiovascular system)
if you are overweight and receive high doses of
Propoven 1%.
Involuntary movements can occur during sedation with
Propoven 1%. The doctors will take into account how this
might affect surgical procedures being performed under
sedation and will take the necessary precautions.
Very occasionally, after anaesthesia, there may be a
period of unconsciousness associated with stiffness of the
muscles. This requires observation by the medical staff
but no other treatment. It will resolve spontaneously.
The injection of Propoven 1% can be painful. A local
anaesthetic can be used to reduce this pain but can have
its own side effects.
You will not be allowed to leave the hospital until you are
fully awake.
Children and adolescents (Propoven 1%)
The use of Propoven 1% is not recommended in newborn infants or children younger than 1 month.
Special care should also be observed when administering
Propoven 1% to children less than 3 years of age.
However, evidence now available does not suggest that
this is any less safe than in older children.
Propoven 1% must not be given to children and
adolescents younger than 16 years of age for sedation
in the intensive care unit, since its safety has not been

demonstrated in this patient group for this indication.
Other medicines and Propoven 1%
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
You must take special care if you are also taking any of
the following medicines:
- premedications (your anaesthetist will know which
medicines may interact with Propoven 1%)
- other anaesthetics, including general, regional, local
and inhalational anaesthetics (Lower doses of
Propoven 1% may be required. Your anaesthetist will
know this.)
- analgesics (painkillers)
- drugs that relax muscles, e.g. suxamethonium
- benzodiazepines (drugs for anxiety)
- drugs that affect many of the internal body functions
such as the heart rate, e.g. atropine
- strong painkillers, e.g. fentanyl
- alcohol
- neostigmine (a treatment for muscle weakness)
- cyclosporin (used to prevent transplant rejections)
Propoven 1% with food, drink and alcohol
After you have been given Propoven 1%, you should not
eat, drink or consume alcohol until fully recovered.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Propoven 1% should not be given to pregnant women
unless clearly necessary. Mothers should stop breastfeeding and discard any breast milk for 24 hours after
receiving Propoven 1%.
Driving and using machines
After you have been given Propoven 1%, you must not
drive, operate machinery, or work in dangerous situations.
You should not go home alone.
Propoven 1% contains soya-bean oil and sodium
Propoven 1% contains soya-bean oil. If you are allergic to
peanut or soya, do not use this medicinal product.
This medicinal product contains less than 1 mmol (23 mg)
sodium per 100 ml, i.e. essentially ´sodium-free`.
3. How to use Propoven 1%
Propoven 1% will only be given to you in hospitals or
suitable therapy units by your anaesthetist or by an
intensive care doctor.
Dosage
The dose you are given will vary depending on your age,
body weight and physical condition. The doctor will give
the correct dose to start and to sustain anaesthesia or
to achieve the required level of sedation, by carefully
watching your responses and vital signs (pulse, blood
pressure, breathing, etc). It can also be affected by other
medicines you may be taking.
Adults
Most people need 1.5 to 2.5mg propofol per kg body weight
to make them go to sleep (induction of anaesthesia), and
then 4 to 12 mg propofol per kg body weight per hour after
this to keep them asleep (maintenance of anaesthesia).
For sedation, doses of 0.3 to 4.0 mg propofol per kg body
weight per hour are usually sufficient.
For sedation during surgical and diagnostic procedures in
adults, most patients will require 0.5 - 1 mg propofol per
kg body weight over 1 to 5 minutes for onset of sedation.
Maintenance of sedation may be accomplished by titrating
Propoven 1% infusion to the desired level of sedation.
Most patients will require 1.5 - 4.5 mg propofol per kg
body weight per hour. The infusion may be supplemented
by bolus administration of 10 – 20 mg propofol (1 – 2
ml Propoven 1% or 0.5 - 1ml Propoven 1%) if a rapid
increase of the depth of sedation is required.
Use in children and adolescents over one month of age
The use of Propoven 1% is not recommended in children
younger than 1 month.
Special care should also be observed when administering
Propoven 1% to children less than 3 years of age.
However, evidence now available does not suggest that
this is any less safe than in children older than 3 years.
The dose should be adjusted according to age and/or
body weight. Most patients over 8 years of age require
approximately 2.5 mg/kg bodyweight Propoven 1% to
make them go to sleep (induction of anaesthesia). In
younger children, especially between the age of 1 month
and 3 years, dose requirements may be higher (2.5 – 4
mg/kg bodyweight).
Rates in the region of 9-15 mg/kg/h usually achieve
satisfactory anaesthesia to keep them asleep
(maintenance of anaesthesia). In younger children,
especially between the age of 1 month and 3 years, dose
requirements may be higher.
For sedation during surgical and diagnostic procedures
in children over 1 month of age with Propoven 1% most
paediatric patients require 1 – 2 mg/kg bodyweight
propofol for onset of sedation. Maintenance of sedation
may be accomplished by titrating Propoven 1% infusion to
the desired level of sedation. Most patients require 1.5 - 9
mg/kg/h propofol. The infusion may be supplemented by
bolus administration of up to 1 mg/kg bodyweight if a rapid
increase of depth of sedation is required.
Propoven 1% must not be given to children and
adolescents younger than 16 years of age for sedation
in the intensive care unit, since its safety has not been
demonstrated in this patient group for this indication.
Elderly and weak patients
Elderly and weak patients may require lower doses.
Method of administration
Propoven 1% is for intravenous use, usually administered
on the back of your hand or in the forearm. Your
anaesthetist may use a needle or cannula (a fine plastic
tube). Propoven 1% will be injected into a vein either
manually or by electric pumps. Your doctor will make sure
that the pump is compatible with the pre-filled syringes. 10
ml and 20 ml glass syringes are suitable for manual use
only and must not be used with a pump.
Propoven 1% is for single use only. Any unused emulsion
must be discarded. The pre-filled syringes should be

The following information is intended for medical or
healthcare professionals only:

Propoven 1% should not be administered by the same
person conducting the surgical or diagnostic procedure.

Propoven 1% should not be mixed prior to administration with injection or infusion solutions other than glucose
50 mg/ml (5%) solution for injection or sodium chloride 9
mg/ml (0.9%) solution for injection or preservative free
lidocaine 10 mg/ml (10mg/ml) solution for injection. Final
propofol concentration must not be below 2 mg/ml.

Propoven 1% may be administered undiluted or diluted
in glucose 50 mg/ml (5%) solution for injection or sodium
chloride 9 mg/ml (0.9%) solution for injection.
Propoven 1% 10 mg/ml must not be mixed with any other
solutions for infusion or injection except those mentioned
above.

For single use only. Any unused emulsion must be discarded.

Co-administration of Glucose 50 mg/ml (5%) solution for
injection, sodium chloride 9 mg/ml (0.9%) solution for
injection or sodium chloride 1.8 mg/ml (0.18%) solution for
injection and glucose 40 mg/ml (4%) solution for injection
with Propoven 1% is permitted via a Y-piece connector
close to the injection site.

Pre-filled syringes should be shaken before use.
If two layers can be seen after shaking the emulsion
should not be used.
Use only homogeneous preparations and undamaged
pre-filled syringes.
After use, tapped pre-filled syringes must be discarded.
Propoven
1%
must
only
be
given
in
hospitals or adequately equipped day therapy units by
physicians trained in anaesthesia or in the care of patients in
intensive care. Circulatory and respiratory functions
should be constantly monitored (e.g. ECG, pulse
oxymetry) and facilities for maintenance of patient
airways, artificial ventilation, and other resuscitation
facilities should be immediately available at all times.
For sedation during surgical and diagnostic procedures

Co-administration of other medicinal products or fluids added to the Propoven 1% infusion line must occur close to
the cannula site using a Y-piece connector or a three-way
valve.
Propoven 1% is a lipid containing emulsion without
antimicrobial preservatives and may support rapid growth
of microorganisms.
The emulsion must be drawn aseptically. Administration
must commence without delay.

M0xxxxx/xx UK
V002

shaken before use. If two layers can be seen after shaking
the emulsion should not be used. Use only homogeneous
preparations and undamaged pre-filled syringes.
Application of pre-filled syringes:
Sterility has to be ensured. The outer surface of the
syringe and the plunger rod are not sterile.









1) Take out the syringe from the packaging and shake it.
2) Insert the plunger rod by screwing it clock-wise into
the syringe.
3) Remove the tip cap from the syringe and connect
the infusion line, needle or cannula to the syringe.
Get rid of the air bubble (a small bubble can
remain) and the ready-to-use syringe will be
installed in the pump or administered manually.

Duration of treatment
When used for sedation, Propoven 1% must not be
administered for more than 7 days.

What Propoven 1% contains
- The active substance is propofol.
Each ml emulsion contains 10 mg propofol.
Each 10 ml syringe contains 10 mg propofol.
Each 20 ml syringe contains 200 mg propofol.
Each 50 ml syringe contains 500 mg propofol.





-




The other ingredients are soya-bean oil, refined,
medium-chain triglycerides, purified egg
phosphatides, glycerol, oleic acid, sodium
hydroxide, water for injections

What Propoven 1% looks like and contents of the
pack
Propoven 1% is a white oil-in-water emulsion for injection
or infusion in a pre-filled syringe.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Propoven 1% is
pre-filled syringes.

4. Possible side effects

Pack sizes:
Packs containing 5 pre-filled syringes with 10 ml emulsion
Packs containing 5 pre-filled syringes with 20 ml emulsion
Packs containing 1 pre-filled syringe with 50 ml emulsion

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
These side effects may occur during the induction of
anaesthesia (common may affect up to 1 in 10 people):
- spontaneous movements
- muscle jerks (myoclonus)
- muscle twitching (minimal excitation)
- low blood pressure (hypotension)
- slow heartbeat (bradycardia)
- rapid heartbeat (tachycardia)
- hot flushes
- increased breathing (hyperventilation)
- stopping breathing (temporary apnoea)
- coughing after anaesthesia
- hiccups (singultus)
If you think you have any of the below mentioned side
effects or any other side effects, please inform a physician
as soon as possible.
Very common (may affect more than 1 in 10 people):
- local pain during the injection.
Common( may affect up to 1 in 10 people):
- increase of levels of fat in the blood (hypertriglyceridemia)
Uncommon (may affect up to 1 in 100 people):
- severe low blood pressure (hypotension)
- coughing during anaesthesia
- slowing of the pulse rate (progressive bradycardia)
Rare (may affect up to 1 in 1,000 people):
- a severe allergic reaction (anaphylaxis), including:
-
swelling of the skin of the face, mouth and

throat (angioedema)
-
narrowing of the airways in the lungs that

makes it difficult to breathe (bronchospasm)
-
reddening of the skin (erythema)
-
low blood pressure (hypotension)
- headache
- dizziness (vertigo)
- epileptiform movements (involuntary movements similar
to epilepsy), including convulsions and opisthotonus (a
rigid posture with the head arched backwards)
- blood clots (thrombosis)
- inflammation of the blood vessels (phlebitis)
- discoloration of urine
- postoperative fever
These rare side effects may occur during the recovery
period (waking up):
- euphoria (feeling happy) and sexual arousal
- shivering and feeling cold
- irregular heartbeat (arrhythmia)
- coughing
- feeling sick (nausea) or vomiting
When Propoven 1% is administered in combination with
lidocaine (a local anaesthetic used to reduce the pain at
the site of injection), certain side effects may occur rarely:
- dizziness
- vomiting
- sleepiness
- fits
- a slowing of the heart rate (bradycardia)
- irregular heartbeat (cardiac arrhythmias)
- shock
Very rare (may affect up to 1 in 10,000 people):
- allergic reactions caused by soya-bean oil
- delayed epileptiform attacks (involuntary movements
similar to epilepsy after waking up)
- convulsions in epileptic patients
- unconsciousness after anaesthesia
- fluid on the lungs (pulmonary oedema)
- inflammation of the pancreas (pancreatitis)
- severe tissue responses after accidental injection into
tissues
- rhabdomyolysis (a disorder of muscle)
- a change in the acidity of the blood (metabolic acidosis)
- a high level of potassium in the blood (hyperkalaemia)
- heart failure.
If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.
5. How to store Propoven 1%
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the syringe and the outer packaging after EXP.
The expiry date refers to the last day of that month.

available

in

plastic

and

glass

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi, Cestrian Court, Eastgate Way,
Manor Park, Runcorn, Cheshire,
WA7 1NT
Manufacturer:
Fresenius Kabi Austria GmbH
A-8055 Graz, Hafnerstraße 36
Austria
This medicinal product is authorised in the Member
States of the EEA under the following names:
Country

Trade Name

Austria





Propofol „Fresenius” 1 % mit MCT
Emulsion zur Injektion oder Infusion
in einer Fertigspritze

Belgium

Propolipid 1 %

Cyprus





Propofol MCT/LCT/ Fresenius 1%
(10 mg/ml) γαλάκτωμα για έγχυση ή
ένεση σε προγεμισμένη σύριγγα

Czech Republic





Propofol MCT Fresenius 10 mg/ml
injekční/infuzní emulze v předplněné
injekční stříkačce

Denmark

Propolipid

Estonia

Propoven 1%

Germany





Propofol Fresenius MCT 10 mg/ml
Emulsion zur Injektion/Infusion
in einer Fertigspritze

Greece





Propofol MCT/LCT/ Fresenius 1%
(10mg/ml) γαλάκτωμα για έγχυση ή
ένεση σε προγεμισμένη σύριγγα

Finland





Propolipid 10 mg/ml injektio-/
infuusioneste, emulsio,
esitäytetyssä ruiskussa

Hungary





Propofol MCT Fresenius 10 mg/ml
emulzió injekcióhoz vagy infúzióhoz
előretöltött fecskendőben

Iceland



Propolidid 10 mg/ml, stungu- eða
innrennslislyf, fleyti í áfylltri sprautu

Ireland



Propoven 10 mg/ml emulsion for
injection/infusion in pre-filled syringe

Italy



Propofol Kabi

Latvia





Propoven 1 % emulsija injekcijām
vai infūzijām pilnšļircē

Lithuania



Propoven 1% injekcinė/infuzinė
emulsija užpildytame švirkšte

Luxembourg





Propofol MCT Fresenius 10 mg/ml
Emulsion zur Injektion/Infusion in
einer Fertigspritze

Netherlands



Propofol
Fresenius

Norway

Propolipid

Poland

Propofol 1% MCT/LCT Fresenius

Portugal

Propofol 1% MCT/LCT Fresenius

Slovakia





Propofol MCT Fresenius 10 mg/ml
injekční/infuzní emulze v předplněné
injekční stříkačce

Slovenia





Propoven 10 mg/ml emulzija za
injiciranje/infundiranje v napolnjeni
injekcijski brizgi

Spain



Propofol
Lipomed
Fresenius
10 mg/ml emulsión inyectable y
para perfusión en jeringa precargada





10mg/ml

MCT/LCT

Sweden

Propolipid

United Kingdom



Propoven
1%
emulsion
for
injection/infusion in pre-filled syringe

This leaflet was last revised Feb 2014

Store at or below 25 °C.
Do not freeze.
After first opening the product must be used immediately.
Administration systems with undiluted Propoven 1% 10
mg/ml should be replaced 12 hours after opening of the
syringe. Dilutions with glucose 50 mg/ml (5%) solution for
injection or sodium chloride 9 mg/ml (0.9%) solution for
injection or an admixture with preservative-free lidocaine
10 mg/ml (10mg/ml) solution for injection (at least 2 mg
propofol per ml) should be prepared aseptically (controlled
and validated conditions preserved) immediately before
administration and has to be administered within 6 hours
after preparation.
6. Contents of the pack and other information

Asepsis must be maintained for both Propoven 1% and
the infusion equipment throughout the infusion period.
Propoven 1% must not be administered through a microbiological filter.
Infusion of Propoven 1%:
The use of a burette, drop counter, syringe pump or volumetric infusion pump to control the infusion rate is recommended when Propoven 1% is infused undiluted.
As usual for fat emulsions, the infusion of Propoven 1%
via one infusion system must not exceed 12 hours. The
infusion set for Propoven 1% must be changed at least
every 12 hours.
Infusion of diluted Propoven 1% 10 mg/ml:
Burettes, drop counters or volumetric infusion pumps
should always be used to control infusion rates. The maximum dilution must not exceed 1 part of Propoven 1%
10 mg/ml to 4 parts of glucose 50 mg/ml (5%) solution for
injection or sodium chloride 9 mg/ml (0.9%) solution for
injection (minimum concentration 2 mg propofol per ml).
The mixture should be prepared aseptically and administered within 6 hours.
If the same injection system used for Propoven 1% is to
be used for the injection of muscle relaxants (e.g. atracurium and mivacurium), the injection system must first be

flushed.
To reduce pain on the injection site, Propoven 1% should
be administered in a larger vein or lidocaine injection solution may be administered before induction of anaesthesia
with Propoven 1%. Alternatively, Lidocaine may be added
to the solution (20 parts of Propoven 1% 10 mg/ml to 1
part of 10mg/ml preservative free lidocaine solution for injection) to reduce pain at the site of injection of Propoven
1% 10 mg/ml.
Intravenous lidocaine is to be avoided in patients with
acute porphyrias.

Package Insert M0xxxxx/xx UK
Propoven 2%
Size

180 x 588 mm

BPZ gefalzt
45 x 98mm
2D-Matrix-Code M0xxxxx/xx UK
Smallest Fontsize

EAN-Code:
7. Korrektur

9 pt.
-

Schwarz
Stanzform

25.02.2014 | 14:35 uhr

PACKAGE LEAFLET: INFORMATION FOR THE USER

Propoven 2%

emulsion for injection/ infusion in pre-filled syringe
Active substance: Propofol

Read all of this leaflet carefully before you are
given this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
The name of this medicine is Propoven 2% emulsion for
injection/for infusion in pre-filled syringe. In the rest of this
leaflet it will be referred to as Propoven 2%.
What is in this leaflet:
1. What Propoven 2% is and what it is used for
2. What you need to know before you are given
Propoven 2%
3. How to use Propoven 2%
4. Possible side effects
5. How to store Propoven 2%
6. Contents of the pack and other information
1. What Propoven 2% is and what it is used for
Propoven 2% belongs to a group of medicines called
general anaesthetics. General anaesthetics are used
to cause unconsciousness (sleep) so that surgical
operations or other procedures can be performed. They
can also be used to sedate you (so that you are sleepy but
not completely asleep).
Propoven 2% is used to:
• induce and maintain general anaesthesia in adults,
adolescents and children older than 3 years.
• sedate patients oldern than 16 years of age receiving
artificial respiration in intensive care.
• sedate adults, adolescents and children older than 3
years during diagnostic or surgical procedures, alone
or in combination with local or regional anaesthesia.
2. What you need to know before you are given
Propoven 2%
Do not use Propoven 2%
- if you are allergic to propofol, soya, peanut or to any of
the other ingredients of this medicine (listed in section 6).
- in patients of 16 years of age or younger for sedation in
intensive care.
Warnings and precautions
Talk to your doctor or pharmacist before you are given
Propoven 2% and if any of the subsequent mentioned
applies to you or applied to you in the past.
You should not receive Propoven 2%, or only under
extreme caution and intensive monitoring, if you:
- have advanced heart failure
- have any other serious disease of the heart
- are receiving electroconvulsive therapy (ECT, a
treatment for psychiatric problems)
In general, Propoven 2% should be given with caution to
elderly or weak patients.
Before receiving Propoven 2%, tell your anaesthetist or
intensive care doctor if you have:
- heart disease
- lung disease
- kidney disease
- liver disease
- seizures (epilepsy)
- a raised pressure inside the skull (raised intracranial
pressure). In combination with low blood pressure the
amount of blood reaching the brain may be decreased.
- altered levels of fat in the blood. If you are receiving
total parenteral nutrition (feeding through a vein), the
levels of fat in your blood must be monitored.
If you have any of the following conditions, they must be
treated before you receive Propoven 2%:
- heart failure
- when there is insufficient blood reaching the tissues
(circulatory failure)
- severe breathing problems (respiratory failure)
- dehydration (hypovolaemia)
- seizures (epilepsy)
Propoven 2% may increase the risk of
- epileptic seizures
- a nervous reflex that slows the heart rate (vagotonia,
bradycardia)
- changes in the blood flow to the organs of the body
(haemodynamic effects on the cardiovascular system)
if you are overweight and receive high doses of
Propoven 2%.
Involuntary movements can occur during sedation with
Propoven 2%. The doctors will take into account how this
might affect surgical procedures being performed under
sedation and will take the necessary precautions.
Very occasionally, after anaesthesia, there may be a
period of unconsciousness associated with stiffness of the
muscles. This requires observation by the medical staff
but no other treatment. It will resolve spontaneously.
The injection of Propoven 2%. can be painful. A local
anaesthetic can be used to reduce this pain but can have
its own side effects.
You will not be allowed to leave the hospital until you are
fully awake.
Children and adolescents (Propoven 2%)
The use of Propoven 2% is not recommended in children
younger than 3 years of age.
Propoven 2% must not be given to children and
adolescents younger than 16 years of age for sedation
in the intensive care unit, since its safety has not been
demonstrated in this patient group for this indication.
Other medicines and Propoven 2%
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

The following information is intended for medical or
healthcare professionals only:
For single use only. Any unused emulsion must be discarded.
Pre-filled syringes should be shaken before use.
If two layers can be seen after shaking the emulsion
should not be used.
Use only homogeneous preparations and undamaged
pre-filled syringes.
After use, tapped pre-filled syringes must be discarded.
Propoven 2% must only be given in hospitals or adequately equipped day therapy units by physicians trained in
anaesthesia or in the care of patients in intensive care.
Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse oxymetry) and facilities for
maintenance of patient airways, artificial ventilation, and
other resuscitation facilities should be immediately available at all times.
For sedation during surgical and diagnostic procedures
Propoven 2% should not be administered by the same
person conducting the surgical or diagnostic procedure.
Propoven 2% is administered undiluted intravenously by
continuous infusion. Propoven 2% 20 mg/ml must not be
mixed with any other solutions for infusion or injection.
Co-administration of Glucose 50 mg/ml (5%) solution for

You must take special care if you are also taking any of
the following medicines:
- premedications (your anaesthetist will know which
medicines may interact with Propoven 2%)
- other anaesthetics, including general, regional, local
and inhalational anaesthetics (Lower doses of
Propoven 2% may be required. Your anaesthetist will
know this.)
- analgesics (painkillers)
- drugs that relax muscles, e.g. suxamethonium
- benzodiazepines (drugs for anxiety)
- drugs that affect many of the internal body functions
such as the heart rate, e.g. atropine
- strong painkillers, e.g. fentanyl
- alcohol
- neostigmine (a treatment for muscle weakness)
- cyclosporin (used to prevent transplant rejections)
Propoven 2% with food, drink and alcohol
After you have been given Propoven 2%, you should not
eat, drink or consume alcohol until fully recovered.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Propoven 2% should not be given to pregnant women
unless clearly necessary. Mothers should stop breastfeeding and discard any breast milk for 24 hours after
receiving Propoven 2%.
Driving and using machines
After you have been given Propoven 2%, you must not
drive, operate machinery, or work in dangerous situations.
You should not go home alone.
Propoven 2% contains soya-bean oil and sodium
Propoven 2% contains soya-bean oil. If you are allergic to
peanut or soya, do not use this medicinal product.
This medicinal product contains less than 1 mmol (23 mg)
sodium per 100 ml, i.e. essentially ´sodium-free`.
3. How to use Propoven 2%
Propoven 2% will only be given to you in hospitals or
suitable therapy units by your anaesthetist or by an
intensive care doctor.
Dosage
The dose you are given will vary depending on your age,
body weight and physical condition. The doctor will give
the correct dose to start and to sustain anaesthesia or
to achieve the required level of sedation, by carefully
watching your responses and vital signs (pulse, blood
pressure, breathing, etc). It can also be affected by other
medicines you may be taking.
Adults
Most people need 1.5-2.5 mg propofol per kg body weight
to make them go to sleep (induction of anaesthesia), and
then 4 to 12 mg propofol per kg body weight per hour after
this to keep them asleep (maintenance of anaesthesia).
For sedation, doses of 0.3 to 4.0 mg propofol per kg body
weight per hour are usually sufficient.
For sedation during surgical and diagnostic procedures in
adults, most patients will require 0.5 - 1 mg propofol per
kg body weight over 1 to 5 minutes for onset of sedation.
Maintenance of sedation may be accomplished by titrating
Propoven 2% infusion to the desired level of sedation.
Most patients will require 1.5 - 4.5 mg propofol per kg
body weight per hour. The infusion may be supplemented
by bolus administration of 10 – 20 mg propofol (1 – 2
ml Propoven 1% or 0.5 - 1ml Propoven 2%) if a rapid
increase of the depth of sedation is required.
Use in children and adolescents over three years of age
The use of Propoven is not recommended in children
younger than 3 years of age.
The dose should be adjusted according to age and/or
body weight.
Most patients over 8 years of age require approximately
2.5 mg/kg bodyweight Propoven 2% to make them go to
sleep (induction of anaesthesia). In younger children dose
requirements may be higher (2.5 – 4 mg/kg bodyweight).
Rates in the region of 9-15 mg/kg/h usually achieve
satisfactory anesthesia to keep them asleep (maintenance
of anaesthesia). In younger children dose requirements
may be higher.
For sedation during surgical and diagnostic procedures
in children over 3 years of age with Propoven 2% most
paediatric patients require 1 – 2 mg/kg bodyweight
propofol for onset of sedation. Maintenance of sedation
may be accomplished by titrating Propoven 2% infusion to
the desired level of sedation. Most patients require 1.5 - 9
mg/kg/h propofol.
Propoven 2% must not be given to children and
adolescents younger than 16 years of age for sedation
in the intensive care unit, since its safety has not been
demonstrated in this patient group for this indication.
Elderly and weak patients
Elderly and weak patients may require lower doses.
Method of administration
Propoven 2% is for intravenous use, usually administered
on the back of your hand or in the forearm. Your
anaesthetist may use a needle or cannula (a fine plastic
tube). Propoven 2% will be injected into a vein by electric
pumps. Your doctor will make sure that the pump is
compatible with the pre-filled syringes.
Propoven 2% is for single use only. Any unused emulsion
must be discarded. The pre-filled syringes should be
shaken before use. If two layers can be seen after shaking
the emulsion should not be used. Use only homogeneous
preparations and undamaged pre-filled syringes.
Application of pre-filled syringes:
Sterility has to be ensured. The outer surface of the
syringe and the plunger rod are not sterile!








1) Take out the syringe from the blister and shake it.
2) Insert the plunger rod by screwing it clock-wise into
the syringe.
3) Remove the tip cap from the syringe and connect
the infusion line to the syringe. Get rid of the air
bubble (a small bubble can remain) and the ready-
to-use syringe will be installed in the pump.

injection, sodium chloride 9 mg/ml (0.9%) solution for injection or sodium chloride 1.8 mg/ml (0.18%) solution for
injection and glucose 40 mg/ml (4%) solution for injection
with Propoven 2% is permitted via a Y-piece connector
close to the injection site.
Co-administration of other medicinal products or fluids added to the Propoven 2% infusion line must occur close to
the cannula site using a Y-piece connector or a three-way
valve.
Propoven 2% is not recommended for general anaesthesia in children younger than 3 years of age since the 20
mg/ml strength is difficult to be titrated in small children
due to the extremely small volumes needed. The use of
Propoven 1% should be considered in children between
1 month and 3 years of age if a dose less than e.g. 100
mg/h is expected
Propoven 2% is a lipid containing emulsion without antimicrobial preservatives and may support rapid growth of
microorganisms.
The emulsion must be drawn aseptically. Administration
must commence without delay.
Asepsis must be maintained for both Propoven 2% and
the infusion equipment throughout the infusion period.
Propoven 2% must not be administered through a micro-

M0xxxxx/xx UK
V002

Duration of treatment
When used for sedation, Propoven 2% must not be
administered for more than 7 days.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
These side effects may occur during the induction of
anaesthesia (common may affect up to 1 in 10 people):
- spontaneous movements
- muscle jerks (myoclonus)
- muscle twitching (minimal excitation)
- low blood pressure (hypotension)
- slow heartbeat (bradycardia)
- rapid heartbeat (tachycardia)
- hot flushes
- increased breathing (hyperventilation)
- stopping breathing (temporary apnoea)
- coughing after anaesthesia
- hiccups (singultus)
If you think you have any of the below mentioned side
effects or any other side effects, please inform a physician
as soon as possible.
Very common (may affect more than 1 in 10 people):
- local pain during the injection.
Common( may affect up to 1 in 10 people):
- increase of levels of fat in the blood (hypertriglyceridemia)
Uncommon (may affect up to 1 in 100 people):
- severe low blood pressure (hypotension)
- coughing during anaesthesia
- slowing of the pulse rate (progressive bradycardia)
Rare (may affect up to 1 in 1,000 people):
- a severe allergic reaction (anaphylaxis), including:
-
swelling of the skin of the face, mouth and

throat (angioedema)
-
narrowing of the airways in the lungs that

makes it difficult to breathe (bronchospasm)
-
reddening of the skin (erythema)
-
low blood pressure (hypotension)
- headache
- dizziness (vertigo)
- epileptiform movements (involuntary movements similar
to epilepsy), including convulsions and opisthotonus (a
rigid posture with the head arched backwards)
- blood clots (thrombosis)
- inflammation of the blood vessels (phlebitis)
- discoloration of urine
- postoperative fever

Pack sizes:
Packs containing 1 pre-filled syringe with 50 ml emulsion
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi, Cestrian Court, Eastgate Way,
Manor Park, Runcorn, Cheshire,
WA7 1NT
Manufacturer:
Fresenius Kabi Austria GmbH
A-8055 Graz, Hafnerstraße 36
Austria
This medicinal product is authorised in the Member
States of the EEA under the following names:
Country

Trade Name

Austria





Propofol „Fresenius” 2 % mit MCT
Emulsion zur Injektion oder Infusion
in einer Fertigspritze

Belgium

Propolipid 2%

Cyprus





PropofolMCT/LCT/Fresenius20mg/ml
(20 mg/ml) γαλάκτωμα για έγχυση ή
ένεση σε προγεμισμένη σύριγγα

Czech Republic





Propofol MCT Fresenius 20 mg/ml
injekční/infuzní emulze v předplněné
injekční stříkačce

Denmark

Propolipid

Estonia




Propofol Lipomed Fresenius
20 mg/ml emulsión inyectable
y para perfusión en
jeringa precargada






Germany





Propofol Fresenius MCT 20 mg/ml
Emulsion zur Injektion/Infusion
in einer Fertigspritze

Greece





PropofolMCT/LCT/Fresenius20mg/ml
(20 mg/ml) γαλάκτωμα για έγχυση ή
ένεση σε προγεμισμένη σύριγγα

Finland





Propolipid 20 mg/ml injektio-/
infuusioneste, emulsion, esitäytetyssä
ruiskussa

Hungary





Propofol MCT Fresenius
20 mg/ml emulzió injekcióhoz vagy
infúzióhoz előretöltött fecskendőben

Iceland



Propolidid 20 mg/ml, stungu- eða
innrennslislyf, fleyti í áfylltri sprautu

Ireland



Propoven 20 mg/ml emulsion for
injection/infusion in pre-filled syringe

Italy



Propofol Kabi

Latvia





Propoven 2% injekcinė/infuzinė
emulsija užpildytame švirkšte

Lithuania



Propoven 2% injekcinė/infuzinė
emulsija užpildytame švirkšte

Luxembourg





Propofol MCT Fresenius 20 mg/ml
Emulsion zur Injektion/Infusion in
einer Fertigspritze

Norway

Propolipid

Poland

Propofol 2% MCT/LCT Fresenius

Portugal

Propofol 2% MCT/LCT Fresenius

Slovakia





Propofol MCT Fresenius 20 mg/m
injekčná/infúzna emulzia v
predplnenej injekčnej striekačke

Slovenia





Propoven 20 mg/ml emulzija za
injiciranje/infundiranje v napolnjeni
injekcijski brizgi

If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.

Spain



Propofol
Lipomed
Fresenius
20 mg/ml emulsión inyectable y
para perfusión en jeringa precargada

5. How to store Propoven 2%

Sweden

Propolipid

Keep this medicine out of the sight and reach of children.

United Kingdom



Propoven 2% emulsion for
injection/infusion in pre-filled syringe

These rare side effects may occur during the recovery
period (waking up):
- euphoria (feeling happy) and sexual arousal
- shivering and feeling cold
- irregular heartbeat (arrhythmia)
- coughing
- feeling sick (nausea) or vomiting
When Propoven 2% is administered in combination with
lidocaine (a local anaesthetic used to reduce the pain at
the site of injection), certain side effects may occur rarely:
- dizziness
- vomiting
- sleepiness
- fits
- a slowing of the heart rate (bradycardia)
- irregular heartbeat (cardiac arrhythmias)
- shock
Very rare (may affect up to 1 in 10,000 people):
- allergic reactions caused by soya-bean oil
- delayed epileptiform attacks (involuntary movements
similar to epilepsy after waking up)
- convulsions in epileptic patients
- unconsciousness after anaesthesia
- fluid on the lungs (pulmonary oedema)
- inflammation of the pancreas (pancreatitis)
- severe tissue responses after accidental injection into
tissues
- rhabdomyolysis (a disorder of muscle)
- a change in the acidity of the blood (metabolic acidosis)
- a high level of potassium in the blood (hyperkalaemia)
- heart failure.

Do not use this medicine after the expiry date which is
stated on the syringe and the outer packaging after EXP.
The expiry date refers to the last day of that month.
Store at or below 25 °C.
Do not freeze.
After first opening the product must be used immediately.
Administration systems with Propoven 2% should be
replaced 12 hours after opening of the syringe.
6. Contents of the pack and other information
What Propoven 2% contains
- The active substance is propofol.
Each ml emulsion contains 20 mg propofol.
Each 50 ml syringe contains 1000 mg propofol.
-




The other ingredients are soya-bean oil, refined,
medium-chain
triglycerides,
purified
egg
phosphatides,
glycerol,
oleic
acid,
sodium
hydroxide, water for injections

What Propoven 2% looks like and contents of the
pack
Propoven 2% is a white oil-in-water emulsion for injection
or infusion in a pre-filled syringe.
Propoven 2% is available in plastic pre-filled syringes.

biological filter.
Infusion of Propoven 2% 20 mg/ml:
The use of a burette, drop counter, syringe pump or volumetric infusion pump to control the infusion rate is recommended when Propoven 2% is infused.
As usual for fat emulsions, the infusion of Propoven 2%
via one infusion system must not exceed 12 hours. The
infusion set for Propoven 2% must be changed at least
every 12 hours.
If the same injection system used for Propoven 2% is to
be used for the injection of muscle relaxants (e.g. atracurium and mivacurium), the injection system must first be
flushed.
To reduce pain on the injection site, Propoven 2% should
be administered in a larger vein or lidocaine injection solution may be administered before induction of anaesthesia
with Propoven 2%.
Intravenous lidocaine is to be avoided in patients with
acute porphyrias.





This leaflet was last revised Feb 2014

Package Insert M0xxxxx/xx UK
Propoven 1% MCT
Size

180 x 588 mm

BPZ gefalzt
45 x 98mm
2D-Matrix-Code M0xxxxx/xx UK
Smallest Fontsize

EAN-Code:
12. Korrektur

9 pt.
-

Schwarz
Stanzform

04.06.2014 | 14:49 uhr

PACKAGE LEAFLET: INFORMATION FOR THE USER

Propoven 1%

emulsion for injection/ infusion in pre-filled syringe
Active substance: Propofol

Read all of this leaflet carefully before you are
given this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4
The name of this medicine is Propoven 1% emulsion for
injection/for infusion in pre-filled syringe. In the rest of this
leaflet it will be referred to as Propoven 1%.
What is in this leaflet:
1. What Propoven 1% is and what it is used for
2. What you need to know before you are given
Propoven 1%
3. How to use Propoven 1%
4. Possible side effects
5. How to store Propoven 1%
6. Contents of the pack and other information
1. What Propoven 1% is and what it is used for
Propoven 1% belongs to a group of medicines called
general anaesthetics. General anaesthetics are used
to cause unconsciousness (sleep) so that surgical
operations or other procedures can be performed. They
can also be used to sedate you (so that you are sleepy but
not completely asleep).
Propoven 1% is used to:
• induce and maintain general anaesthesia in adults,
adolescents and children older than 1 month.
• sedate patients older than 16 years of age receiving
artificial respiration in intensive care.
• sedate adults, adolescents and children older than 1
month during diagnostic and surgical procedures,
alone or in combination with local or regional
anaesthesia.
2. What you need to know before you are given
Propoven 1%
Do not use Propoven 1%
- if you are allergic to propofol, soya, peanut or to any of
the other ingredients of this medicine (listed in section 6).
- in patients of 16 years of age or younger for sedation in
intensive care.
Warnings and precautions
Talk to your doctor or pharmacist before you are given
Propoven 1% and if any of the subsequent mentioned
applies to you or applied to you in the past.
You should not receive Propoven 1%, or only under
extreme caution and intensive monitoring, if you:
- have advanced heart failure
- have any other serious disease of the heart
- are receiving electroconvulsive therapy (ECT, a
treatment for psychiatric problems)
In general, Propoven 1% should be given with caution to
elderly or weak patients.
Before receiving Propoven 1%, tell your anaesthetist or
intensive care doctor if you have:
- heart disease
- lung disease
- kidney disease
- liver disease
- seizures (epilepsy)
- a raised pressure inside the skull (raised intracranial
 pressure). In combination with low blood pressure the
amount of blood reaching the brain may be decreased.
- altered levels of fat in the blood. If you are receiving
total parenteral nutrition (feeding through a vein), the
levels of fat in your blood must be monitored.
If you have any of the following conditions, they must be
treated before you receive Propoven 1%:
- heart failure
- when there is insufficient blood reaching the tissues
(circulatory failure)
- severe breathing problems (respiratory failure)
- dehydration (hypovolaemia)
- seizures (epilepsy)
Propoven 1% may increase the risk of
- epileptic seizures
- a nervous reflex that slows the heart rate (vagotonia,
bradycardia)
- changes in the blood flow to the organs of the body
(haemodynamic effects on the cardiovascular system)
if you are overweight and receive high doses of
Propoven 1%.
Involuntary movements can occur during sedation with
Propoven 1%. The doctors will take into account how this
might affect surgical procedures being performed under
sedation and will take the necessary precautions.
Very occasionally, after anaesthesia, there may be a
period of unconsciousness associated with stiffness of the
muscles. This requires observation by the medical staff
but no other treatment. It will resolve spontaneously.
The injection of Propoven 1% can be painful. A local
anaesthetic can be used to reduce this pain but can have
its own side effects.
You will not be allowed to leave the hospital until you are
fully awake.
Children and adolescents (Propoven 1%)
The use of Propoven 1% is not recommended in newborn infants or children younger than 1 month.
Special care should also be observed when administering
Propoven 1% to children less than 3 years of age.
However, evidence now available does not suggest that
this is any less safe than in older children.
Propoven 1% must not be given to children and
adolescents younger than 16 years of age for sedation
in the intensive care unit, since its safety has not been

demonstrated in this patient group for this indication.
Other medicines and Propoven 1%
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
You must take special care if you are also taking any of
the following medicines:
- premedications (your anaesthetist will know which
medicines may interact with Propoven 1%)
- other anaesthetics, including general, regional, local
and inhalational anaesthetics (Lower doses of
Propoven 1% may be required. Your anaesthetist will
know this.)
- analgesics (painkillers)
- drugs that relax muscles, e.g. suxamethonium
- benzodiazepines (drugs for anxiety)
- drugs that affect many of the internal body functions
such as the heart rate, e.g. atropine
- strong painkillers, e.g. fentanyl
- alcohol
- neostigmine (a treatment for muscle weakness)
- cyclosporin (used to prevent transplant rejections)
Propoven 1% with food, drink and alcohol
After you have been given Propoven 1%, you should not
eat, drink or consume alcohol until fully recovered.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Propoven 1% should not be given to pregnant women
unless clearly necessary. Mothers should stop breastfeeding and discard any breast milk for 24 hours after
receiving Propoven 1%.
Driving and using machines
After you have been given Propoven 1%, you must not
drive, operate machinery, or work in dangerous situations.
You should not go home alone.
Propoven 1% contains soya-bean oil and sodium
Propoven 1% contains soya-bean oil. If you are allergic to
peanut or soya, do not use this medicinal product.
This medicinal product contains less than 1 mmol (23 mg)
sodium per 100 ml, i.e. essentially ´sodium-free`.
3. How to use Propoven 1%
Propoven 1% will only be given to you in hospitals or
suitable therapy units by your anaesthetist or by an
intensive care doctor.
Dosage
The dose you are given will vary depending on your age,
body weight and physical condition. The doctor will give
the correct dose to start and to sustain anaesthesia or
to achieve the required level of sedation, by carefully
watching your responses and vital signs (pulse, blood
pressure, breathing, etc). It can also be affected by other
medicines you may be taking.
Adults
Most people need 1.5 to 2.5mg propofol per kg body weight
to make them go to sleep (induction of anaesthesia), and
then 4 to 12 mg propofol per kg body weight per hour after
this to keep them asleep (maintenance of anaesthesia).
For sedation, doses of 0.3 to 4.0 mg propofol per kg body
weight per hour are usually sufficient.
For sedation during surgical and diagnostic procedures in
adults, most patients will require 0.5 - 1 mg propofol per
kg body weight over 1 to 5 minutes for onset of sedation.
Maintenance of sedation may be accomplished by titrating
Propoven 1% infusion to the desired level of sedation.
Most patients will require 1.5 - 4.5 mg propofol per kg
body weight per hour. The infusion may be supplemented
by bolus administration of 10 – 20 mg propofol (1 – 2 ml
Propoven 1%) if a rapid increase of the depth of sedation
is required.
Use in children and adolescents over one month of age
The use of Propoven 1% is not recommended in children
younger than 1 month.
Special care should also be observed when administering
Propoven 1% to children less than 3 years of age.
However, evidence now available does not suggest that
this is any less safe than in children older than 3 years.
The dose should be adjusted according to age and/or
body weight. Most patients over 8 years of age require
approximately 2.5 mg/kg bodyweight Propoven 1% to
make them go to sleep (induction of anaesthesia). In
younger children, especially between the age of 1 month
and 3 years, dose requirements may be higher (2.5 – 4
mg/kg bodyweight).
Rates in the region of 9-15 mg/kg/h usually achieve
satisfactory anaesthesia to keep them asleep
(maintenance of anaesthesia). In younger children,
especially between the age of 1 month and 3 years, dose
requirements may be higher.
For sedation during surgical and diagnostic procedures
in children over 1 month of age with Propoven 1% most
paediatric patients require 1 – 2 mg/kg bodyweight
propofol for onset of sedation. Maintenance of sedation
may be accomplished by titrating Propoven 1% infusion to
the desired level of sedation. Most patients require 1.5 - 9
mg/kg/h propofol. The infusion may be supplemented by
bolus administration of up to 1 mg/kg bodyweight if a rapid
increase of depth of sedation is required.
Propoven 1% must not be given to children and
adolescents younger than 16 years of age for sedation
in the intensive care unit, since its safety has not been
demonstrated in this patient group for this indication.
Elderly and weak patients
Elderly and weak patients may require lower doses.
Method of administration
Propoven 1% is for intravenous use, usually administered
on the back of your hand or in the forearm. Your
anaesthetist may use a needle or cannula (a fine plastic
tube). Propoven 1% will be injected into a vein either
manually or by electric pumps. Your doctor will make sure
that the pump is compatible with the pre-filled syringes.
10 ml and 20 ml glass syringes and 10 ml plastic syringes
are suitable for manual use only and must not be used
with a pump.
Propoven 1% is for single use only. Any unused emulsion
must be discarded. The pre-filled syringes should be

The following information is intended for medical or
healthcare professionals only:

Propoven 1% should not be administered by the same
person conducting the surgical or diagnostic procedure.

Propoven 1% should not be mixed prior to administration with injection or infusion solutions other than glucose
50 mg/ml (5%) solution for injection or sodium chloride 9
mg/ml (0.9%) solution for injection or preservative free
lidocaine 10 mg/ml (10mg/ml) solution for injection. Final
propofol concentration must not be below.

Propoven 1% may be administered undiluted or diluted
in glucose 50 mg/ml (5%) solution for injection or sodium
chloride 9 mg/ml (0.9%) solution for injection.
Propoven 1% must not be mixed with any other solutions
for infusion or injection except those mentioned above.

For single use only. Any unused emulsion must be discarded.
Pre-filled syringes should be shaken before use.
If two layers can be seen after shaking the emulsion
should not be used.
Use only homogeneous preparations and undamaged
pre-filled syringes.
After use, tapped pre-filled syringes must be discarded.
Propoven
1%
must
only
be
given
in
hospitals or adequately equipped day therapy units by
physicians trained in anaesthesia or in the care of patients in
intensive care. Circulatory and respiratory functions
should be constantly monitored (e.g. ECG, pulse
oxymetry) and facilities for maintenance of patient
airways, artificial ventilation, and other resuscitation
facilities should be immediately available at all times.
For sedation during surgical and diagnostic procedures

Co-administration of Glucose 50 mg/ml (5%) solution for
injection, sodium chloride 9 mg/ml (0.9%) solution for
injection or sodium chloride 1.8 mg/ml (0.18%) solution for
injection and glucose 40 mg/ml (4%) solution for injection
with Propoven 1% is permitted via a Y-piece connector
close to the injection site.
Co-administration of other medicinal products or fluids added to the Propoven 1% infusion line must occur close to
the cannula site using a Y-piece connector or a three-way
valve.
Propoven 1% is a lipid containing emulsion without
antimicrobial preservatives and may support rapid growth
of microorganisms.
The emulsion must be drawn aseptically. Administration
must commence without delay.
Asepsis must be maintained for both Propoven 1% and

M0xxxxx/xx UK
V002

shaken before use. If two layers can be seen after shaking
the emulsion should not be used. Use only homogeneous
preparations and undamaged pre-filled syringes.
Application of pre-filled syringes (for pre-assembled
syringes step 2 can be omitted):
Sterility has to be ensured. The outer surface of the
syringe and the plunger rod are not sterile.









1) Take out the syringe from the packaging and shake it.
2) Insert the plunger rod by screwing it clock-wise into
the syringe.
3) Remove the tip cap from the syringe and connect
the infusion line, needle or cannula to the syringe.
Get rid of the air bubble (a small bubble can
remain) and the ready-to-use syringe will be
installed in the pump or administered manually.

Duration of treatment
When used for sedation, Propoven 1% must not be
administered for more than 7 days.

6. Contents of the pack and other information
What Propoven 1% contains
- The active substance is propofol.
Each ml emulsion contains 10 mg propofol.
Each 10 ml syringe contains 100 mg propofol.
Each 20 ml syringe contains 200 mg propofol.
Each 50 ml syringe contains 500 mg propofol.





-




The other ingredients are soya-bean oil, refined,
medium-chain triglycerides, purified egg
phosphatides, glycerol, oleic acid, sodium
hydroxide, water for injections

What Propoven 1% looks like and contents of the
pack
Propoven 1% is a white oil-in-water emulsion for injection
or infusion in a pre-filled syringe.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Propoven 1% is available in plastic and glass pre-filled
syringes.

4. Possible side effects

Pack sizes:
Packs containing 5 glass pre-filled syringes
with 10 ml emulsion
Packs containing 6 plastic pre-filled syringes
with 10 ml emulsion
Packs containing 5 glass pre-filled syringes
with 20 ml emulsion
Packs containing 1 plastic pre-filled syringe
with 50 ml emulsion

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
These side effects may occur during the induction of
anaesthesia (common may affect up to 1 in 10 people):
- spontaneous movements
- muscle jerks (myoclonus)
- muscle twitching (minimal excitation)
- low blood pressure (hypotension)
- slow heartbeat (bradycardia)
- rapid heartbeat (tachycardia)
- hot flushes
- increased breathing (hyperventilation)
- stopping breathing (temporary apnoea)
- coughing after anaesthesia
- hiccups (singultus)
If you think you have any of the below mentioned side
effects or any other side effects, please inform a physician
as soon as possible.
Very common (may affect more than 1 in 10 people):
- local pain during the injection.
Common( may affect up to 1 in 10 people):
- increase of levels of fat in the blood (hypertriglyceridemia)
Uncommon (may affect up to 1 in 100 people):
- severe low blood pressure (hypotension)
- coughing during anaesthesia
- slowing of the pulse rate (progressive bradycardia)
Rare (may affect up to 1 in 1,000 people):
- a severe allergic reaction (anaphylaxis), including:
-
swelling of the skin of the face, mouth and

throat (angioedema)
-
narrowing of the airways in the lungs that

makes it difficult to breathe (bronchospasm)
-
reddening of the skin (erythema)
-
low blood pressure (hypotension)
- headache
- dizziness (vertigo)
- epileptiform movements (involuntary movements similar
to epilepsy), including convulsions and opisthotonus (a
rigid posture with the head arched backwards)
- blood clots (thrombosis)
- inflammation of the blood vessels (phlebitis)
- discoloration of urine
- postoperative fever
These rare side effects may occur during the recovery
period (waking up):
- euphoria (feeling happy) and sexual arousal
- shivering and feeling cold
- irregular heartbeat (arrhythmia)
- coughing
- feeling sick (nausea) or vomiting
When Propoven 1% is administered in combination with
lidocaine (a local anaesthetic used to reduce the pain at
the site of injection), certain side effects may occur rarely:
- dizziness
- vomiting
- sleepiness
- fits
- a slowing of the heart rate (bradycardia)
- irregular heartbeat (cardiac arrhythmias)
- shock

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi, Cestrian Court, Eastgate Way,
Manor Park, Runcorn, Cheshire,
WA7 1NT
Manufacturer:
Fresenius Kabi Austria GmbH
A-8055 Graz, Hafnerstraße 36
Austria
This medicinal product is authorised in the Member
States of the EEA under the following names:
Country

Trade Name

Austria





Propofol „Fresenius” 1 % mit MCT
Emulsion zur Injektion oder Infusion
in einer Fertigspritze

Belgium

Propolipid 1 %

Cyprus





Propofol MCT/LCT/ Fresenius 1%
(10 mg/ml) γαλάκτωμα για έγχυση ή
ένεση σε προγεμισμένη σύριγγα

Czech Republic





Propofol MCT Fresenius 10 mg/ml
injekční/infuzní emulze v předplněné
injekční stříkačce

Denmark

Propolipid

Estonia

Propoven 1%

Germany





Propofol Fresenius MCT 10 mg/ml
Emulsion zur Injektion/Infusion
in einer Fertigspritze

Greece





Propofol MCT/LCT/ Fresenius 1%
(10mg/ml) γαλάκτωμα για έγχυση ή
ένεση σε προγεμισμένη σύριγγα

Finland





Propolipid 10 mg/ml injektio-/
infuusioneste, emulsio,
esitäytetyssä ruiskussa

Hungary





Propofol MCT Fresenius 10 mg/ml
emulzió injekcióhoz vagy infúzióhoz
előretöltött fecskendőben

Iceland



Propolidid 10 mg/ml, stungu- eða
innrennslislyf, fleyti í áfylltri sprautu

Ireland



Propoven
1%
emulsion
for
injection/infusion in pre-filled syringe

Italy



Propofol Kabi

Latvia





Propoven 1 % emulsija injekcijām
vai infūzijām pilnšļircē

Lithuania



Propoven 1% injekcinė/infuzinė
emulsija užpildytame švirkšte

Luxembourg





Propofol MCT Fresenius 10 mg/ml
Emulsion zur Injektion/Infusion in
einer Fertigspritze

Netherlands



Propofol
Fresenius

Norway

Propolipid

Poland

Propofol 1% MCT/LCT Fresenius

Very rare (may affect up to 1 in 10,000 people):
- allergic reactions caused by soya-bean oil
- delayed epileptiform attacks (involuntary movements
similar to epilepsy after waking up)
- convulsions in epileptic patients
- unconsciousness after anaesthesia
- fluid on the lungs (pulmonary oedema)
- inflammation of the pancreas (pancreatitis)
- severe tissue responses after accidental injection into
tissues
- rhabdomyolysis (a disorder of muscle)
- a change in the acidity of the blood (metabolic acidosis)
- a high level of potassium in the blood (hyperkalaemia)
- heart failure.

Portugal

Propofol 1% MCT/LCT Fresenius

Slovakia





Propofol MCT Fresenius 10 mg/ml
injekčná/infúzna
emulzia
v
naplnenej injekčnej striekačke

If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.

Slovenia





Propoven 10 mg/ml emulzija za
injiciranje/infundiranje v napolnjeni
injekcijski brizgi

Spain



Propofol
Lipomed
Fresenius
10 mg/ml emulsión inyectable y
para perfusión en jeringa precargada

5. How to store Propoven 1%
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the syringe and the outer packaging after EXP.
The expiry date refers to the last day of that month.
Store at or below 25 °C.
Do not freeze.





10mg/ml

MCT/LCT

Sweden

Propolipid

United Kingdom



Propoven
1%
emulsion
for
injection/infusion in pre-filled syringe

This leaflet was last revised Jun 2014

After first opening the product must be used immediately.
Administration systems with undiluted Propoven 1%
should be replaced 12 hours after opening of the syringe.
Dilutions with glucose 50 mg/ml (5%) solution for injection
or sodium chloride 9 mg/ml (0.9%) solution for injection
or an admixture with preservative-free lidocaine 10 mg/
ml (10mg/ml) solution for injection (at least 2 mg propofol
per ml) should be prepared aseptically (controlled and
validated conditions preserved) immediately before
administration and has to be administered within 6 hours
after preparation.

the infusion equipment throughout the infusion period.
Propoven 1% must not be administered through a microbiological filter.
Infusion of Propoven 1%:
The use of a burette, drop counter, syringe pump or volumetric infusion pump to control the infusion rate is recommended when Propoven 1% is infused undiluted.
As usual for fat emulsions, the infusion of Propoven 1%
via one infusion system must not exceed 12 hours. The
infusion set for Propoven 1% must be changed at least
every 12 hours.
Infusion of diluted Propoven 1%:
Burettes, drop counters or volumetric infusion pumps
should always be used to control infusion rates. The maximum dilution must not exceed 1 part of Propoven 1% to
4 parts of glucose 50 mg/ml (5%) solution for injection or
sodium chloride 9 mg/ml (0.9%) solution for injection (minimum concentration 2 mg propofol per ml). The mixture
should be prepared aseptically and administered within
6 hours.
If the same injection system used for Propoven 1% is to
be used for the injection of muscle relaxants (e.g. atracurium and mivacurium), the injection system must first be
flushed.

To reduce pain on the injection site, Propoven 1% should
be administered in a larger vein or lidocaine injection solution may be administered before induction of anaesthesia
with Propoven 1%. Alternatively, Lidocaine may be added to the solution (20 parts of Propoven 1% to 1 part of
10mg/ml preservative free lidocaine solution for injection)
to reduce pain at the site of injection of Propoven 1%.
Intravenous lidocaine is to be avoided in patients with
acute porphyrias.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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