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PROPOVEN 1% EMULSION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE

Active substance(s): PROPOFOL

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Product Name:
Propoven 1% MCT
Type of Packaging:
PIL
Material number:
M0xxxxx/xx UK
Pharma-Code (Laetus)
x
Dimension:
180 x 588 mm

Territory:

Colour:

UK

BLACK
DIE CUT

Dosage:
2-D-Matrix Code
M0xxxxx/xx UK
EAN
Code:
Font:

Arial

12. Correction
13. Correction
14. Correction
15. Correction
16. Correction
17. Correction

Propoven 1%

emulsion for injection/ infusion in pre-filled syringe
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,
pharmacist or nurse.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
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
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 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, pharmacist or nurse 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 your body has lost lots of water (you are
hypovolaemic).
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.
If you are able to go home shortly after receiving propofol
you should not go home unaccompanied.
Children and adolescents
The use of Propoven 1% is not recommended for use in
new-born infants or children younger than 1 month.
Due to the limited data available, the use of target
controlled infusion (TCI) in the paediatric population
below 2 years of age cannot be recommended.
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/receiving
any of the following medicines:
Premedications (your anaesthetist will know which
medicines can be influenced by Propoven 1%)
-

-

14.49 Uhr
07.40 Uhr
10.36 Uhr
13.12 Uhr
08.15 Uhr
12.55 Uhr

Variable Data:

Operator: Christian Nagy +43(0) 34 52 72266-22 P. Marko +43(0) 34 52 72266-20

Smallest Size: 8 Pt.

Package leaflet: Information for the user

1.

04.06. 2014
26.03. 2015
11.06. 2015
22.06. 2015
11.07. 2016
19.07. 2016

Other anaesthetics, including general, regional, local
and inhalational anaesthetics (Lower doses of
Propoven 1% may be required. Your anaesthetist will
know this.)
Painkillers (analgesics)
Strong painkillers (fentanyl or opioids)
Parasympatholytic agents (medicines used to treat
e.g. painful cramps of organs, asthma or Parkinson’s
disease)
Benzodiazepines (medicines used to treat anxiety)
Suxamethonium (muscle relaxant)
Drugs that affect many of the internal body functions

-

such as the heart rate, e.g. atropine
Alcohol containing medicines or beverages
Neostigmine (medicine used to treat a disease called
myasthenia gravis)
Cyclosporine (medicine 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 breastfeeding
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. You should stop breast-feeding
and discard any breast milk for 24 hours after receiving
Propoven 1%.
Driving and using machines
After having propofol you may still feel sleepy for some
time. Do not drive or use any tools or machines until you
are sure the effects have worn off.
If you are able to go home shortly after receiving Propofol,
do not drive a car or go home unaccompanied.
Ask your doctor when you can start doing these activities
again and when you can go back to work.
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, or under the direct supervision
of your anaesthetist or 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).
You may need several different medicines to keep you
asleep or sleepy, free from pain, breathing in a healthy
way and to keep your blood pressure steady. The doctor
will decide which medicines you need and when you need
them.
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 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.
To provide sedation for ventilated patients older than 16
years of age under intensive care conditions the dose will
be adjusted according to the depth of sedation required.
Usually satisfactory sedation is achieved by continuous
infusion with administration rates in the range of 0.3 to
4.0 mg propofol per kg body weight per hour. Rates of
infusion greater than 4.0 mg propofol per kg bodyweight
per hour are not recommended.
Elderly and weak patients
Elderly and weak patients may require lower doses.
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.
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
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.

&
The following information is intended for healthcare
professionals only:
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 (1 %) solution for injection. Final propofol concentration must not be below 2 mg/ml.
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.
Propofol should be given by those trained in anaesthesia
(or, where appropriate, doctors trained in the care of patients in Intensive Care).
Patients should be constantly monitored and facilities for
maintenance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should

be readily available at all times. Propofol should not be
administered by the person conducting the diagnostic or
surgical procedure.
Abuse of, and dependence on propofol, predominantly
by health care professionals, have been reported. As with
other general anaesthetics, the administration of propofol
without airway care may result in fatal respiratory complications.
When propofol is administered for conscious sedation,
for surgical and diagnostic procedures, patients should
be continually monitored for early signs of hypotension,
airway obstruction and oxygen desaturation.
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.
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 may be given
through the same infusion set.

M0xxxxx/xx UK
V006/GZ

Duration of treatment
When used for sedation, Propoven 1% must not be
administered for more than 7 days.
If you received more propofol than you should
Your doctor will ensure that you receive the right amount of
propofol for you and for the procedure you are undergoing.
However, different people need different doses and if you
do receive too much for you, your anaesthetist may need
to take measures to make sure your heart and breathing
are adequately supported. This is why anaesthetic drugs
are only administered by doctors trained in anaesthesia or
in the care of patients in intensive care.
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.
Side effects that can happen during anaesthesia
The following side effects can happen during anaesthesia
(while the injection is being given to you or when you are
sleepy or asleep). Your doctor will be looking out for these.
If they happen, your doctor will give you appropriate
treatment.
Very common (may affect more than 1 in 10 people)

A feeling of pain at the site of the injection (while the
injection is being given, before you fall asleep).
Common (may affect up to 1 in 10 people)

Slow or fast heartbeat

Low blood pressure

Changes in your breathing pattern (low respiratory
rate, breathing arrest)

Hiccups

Cough (may also happen when you wake up)
Uncommon (may affect up to 1 in 100 people)

Swelling and redness or blood clots at the vein along
the injection site.


Twitching and shaking of your body, or fits (may also
happen when you wake up).

Very rare (may affect up to 1 in 10, 000 people)

Serious allergic reaction which causes difficulty in
breathing, swollen and reddened skin, hot flushes

Build up of fluid in the lungs which can make you very
breathless (may also happen when you wake up)

Unusual colour of urine (may also happen when you
wake up).

medicines you no longer use. These measures will help
protect the environment.
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 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/
infusion in a pre-filled syringe.
Propoven 1% is available in plastic and glass pre-filled
syringes.
Pack sizes:
Packs containing
emulsion
Packs containing
emulsion
Packs containing
emulsion
Packs containing
emulsion
Packs containing
emulsion

6 plastic pre-filled syringes with 10 ml
5 glass pre-filled syringes with 20 ml
6 plastic pre-filled syringes with 20 ml
1 plastic pre-filled syringe with 50 ml

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:
Name of the member
state

Name of the medicinal
product

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

Very rare (may affect up to 1 in 10,000 people)

Being unconscious after the operation (when this has
happened, the patients have recovered without
problems)

Inflamed pancreas (pancreatitis) which causes
severe stomach pain (a causal relationship could not
be shown)

Fever following surgery

Denmark

Propolipid

Estonia

Propoven 1%

Germany

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

Not known (frequency cannot be estimated from the
available data)

Feeling euphoric

Feeling sexually aroused

Irregular heart beat

Changes in ECG (Brugada type ECG)

Increase in liver size

Kidney failure

Breakdown of muscle cells (rhabdomyolysis),
increase in acidity of your blood, high potassium and
fat levels in your blood, heart failure

Drug abuse, mostly by healthcare professionals

Greece

Propofol
MCT/LCT/
Fresenius 1% (10 mg/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 prefilled syringe

Italy

Propofol Kabi

Latvia

Propoven 1 % emulsija
injekcijām vai infūzijām
pilnšļircē

Lithuania

Propoven 1% injekcinė/
infuzinė emulsija
užpildytame švirkšte

Netherlands

Propofol 10mg/ml
MCT/LCT Fresenius

Norway

Propolipid

Poland

Propofol 1% MCT/LCT
Fresenius

Portugal

Propofol 1% MCT/LCT
Fresenius

Slovakia

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

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

Sweden

Propolipid

United Kingdom

Propoven 1% emulsion for
injection/infusion in prefilled syringe

Not known (frequency cannot be estimated from the
available data)

Involuntary movements

Severe skin and tissue reaction following accidental
application beside the vein.
Side effects that can happen after anaesthesia
The following side effects can happen after anaesthesia
(when you are waking up or after you have woken up).
Common (may affect up to 1 in 10 people)

Headache

Feeling sick (nausea), being sick (vomiting).

Cough.
Rare (may affect up to 1 in 1,000 people)

Dizziness, chills and sensations of cold

Excitations

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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the national reporting system
For the UK:
You can report side effects directly via the Yellow card
Scheme
www.mhra.gov.uk/yellowcard
For Ireland:
You can also report side effects directly via
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.
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.
Do not store above 25 °C.
Do not freeze.
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 (1%) 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.

&

5 glass pre-filled syringes with 10 ml

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away

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 into a giving set
immediately after opening the syringe. Administration
must commence without delay.
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 undiluted 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.

This leaflet was last revised in June 2016

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% with
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 (controlled and validated
conditions preserved) immediately prior to administration
and must be administered within 6 hours after preparation.
To reduce pain on the injection site, Propoven 1% should
be administered in a larger vein and/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 1% preservative free lidocaine solution for injection) to
reduce pain at the site of injection of Propoven 1%.
Intravenous lidocaine must not be used in patients with
hereditary acute porphyria.
Muscle relaxants like atracurium and mivacurium should
only be administered after flush of the same infusion site
used for Propoven 1%.

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