Skip to Content

UK Edition. Click here for US version.

FRESENIUS PROPOVEN 2%

Active substance(s): PROPOFOL

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Fresenius Propoven 2%
Emulsion for Injection or Infusion
Active substance: Propofol

Read all of this leaflet carefully before you start
using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.

2.
3.
4.
5.
6.

What Fresenius Propoven 2 % is and what it is
used for
Before you use Fresenius Propoven 2 %
How to use Fresenius Propoven 2 %
Possible side effects
How to store Fresenius Propoven 2 %
Further information

1. WHAT FRESENIUS PROPOVEN 2 % IS AND
WHAT IT IS USED FOR
Fresenius 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).
Propofol is used to:
- induce and maintain general anaesthesia in adults
and children > 3 years.
- sedate patients > 16 years of age receiving
artificial respiration in intensive care.
- sedate adults and children > 3 years during
diagnostic or surgical procedures, alone or in
combination with local or regional anaesthesia.
2. BEFORE YOU USE FRESENIUS PROPOVEN 2 %
DO NOT use Fresenius Propoven 2 %
-




if you are hypersensitive (allergic) to propofol or
to any of the other ingredients of this medicine
(see section 6 “Further information” at the end of this
leaflet).

-




if you are hypersensitive (allergic) soya or peanut
(see “Important information about some of the
ingredients of Fresenius Propoven 2 %” at the end
of section 2).

- in patients of 16 years of age or younger for
sedation in intensive care.
Take special care with Fresenius Propoven 2 %
You should not receive Fresenius Propoven 2 %, or
only under extreme caution and intensive monitoring,
if you:
- have advanced heart failure

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 Fresenius
Propoven 2 %)
- other anaesthetics, including general, regional,
local and inhalational anaesthetics (lower doses
of Fresenius 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)
Using Fresenius Propoven 2 % with food and drink
After you have been given Fresenius Propoven 2 %,
you should not drink alcohol until fully recovered.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
Fresenius Propoven 2 % should not be given to
pregnant women unless necessary. Mothers should
stop breast-feeding and discard any breast milk for 24
hours after receiving Fresenius Propoven 2 %.
Driving and using machines
After you have been given Fresenius Propoven 2 %,
you must not drive, operate machinery, or work in
dangerous situations. You should not go home alone.
Important information about some of the
ingredients of Fresenius Propoven 2 %
Fresenius Propoven 2 % contains soya-bean oil.
This can rarely cause severe hypersensitivity (allergic)
reactions (see “Do not use Fresenius Propoven 2 %”).
Tell your doctor if you know that you have allergic
reactions to soya-bean oil.

- have any other serious disease of the heart
- are receiving electroconvulsive therapy (ECT,
a treatment for psychiatric problems)
Fresenius Propoven 2% is not recommended in
children < 3 years of age. However, evidence now
available does not suggest that this is any less safe
than in older children. The safety of propofol for
sedation in children and adolescents 16 years of age
and younger in the intensive care unit has not been
demonstrated.
In general, Fresenius Propoven 2 % should be given
with caution to elderly or weak patients.
Before receiving Fresenius 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 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 Fresenius
Propoven 2 %:
- heart failure
- when there is insufficient blood reaching the
tissues (circulatory failure)
- severe breathing problems (respiratory failure)
- dehydration (hypovolaemia)
- seizures (epilepsy)
Fresenius 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 Fresenius Propoven 2%.
Involuntary movements can occur during sedation
with Fresenius 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 Fresenius 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.
Using other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

This medicinal product contains less than 1 mmol
(23 mg) sodium per 100 ml, i.e. essentially
´sodium-free`.
3. HOW TO USE FRESENIUS PROPOVEN 2 %
Fresenius Propoven 2 % will only be given to you in
hospitals or suitable therapy units by your anaesthetist
or by an intensive care doctor.
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. 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 wight 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 Fresenius Propoven
2% infusion to the desired level of sedation. Most
patients 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 (0.5 - 1
ml Fresenius Propoven 2%) if a rapid increase of the
depth of sedation is required.
Fresenius Propoven 2 % is for intravenous use,
usually on the back of the hand or in the forearm.
Your anaesthetist may use a needle or cannula (a fine
plastic tube). An electric pump may be used to give the
injection for long operations and for use in intensive
care.
Elderly and weak patients may require lower doses.
Children usually require slightly higher doses. The
dose should be adjusted according to age and/or body
weight.

&
The following information is intended for medical
or healthcare professionals only:
For single use. Any unused emulsion must be
discarded.
Containers 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
containers.
Prior to use, the rubber membrane should be cleaned
using an alcohol spray or a swab dipped in alcohol.
After use, tapped containers must be discarded.
Fresenius 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. For sedation during surgical
and diagnostic procedures Fresenius Propoven 2%
should not be administered by the same person
conducting the surgical or diagnostic procedure.

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.
Fresenius Propoven 2 % is not advised for general
anaesthesia in children younger than 3 years of age
since the 2% strength is difficult to be titrated in small
children due to the extremely small volumes needed.
The use of Fresenius 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.
Fresenius Propoven 2 % is administered undiluted
intravenously by continuous infusion.
Fresenius Propoven 2 % must not be mixed with
any other solutions for infusion or injection. 5% w/v
glucose intravenous infusion solution, 0.9% w/v
sodium chloride intravenous infusion solution or
0.18% w/v w/v sodium chloride and 4% w/v glucose
intravenous infusion solutio may be given through the
same infusion set.

M092553/04 GB

When used for sedation, Fresenius Propoven 2 %
must not be administered for more than 7 days.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fresenius Propoven 2 % can cause
side effects, although not everybody gets them.
Evaluation of the side effects is based on the following
frequencies:
Very common
Common
Uncommon
Rare
Very rare
Not known



affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 in 10 users in 1,000
affects 1 in 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated
from the available data.

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:
- local pain during the injection.
Common:
- increase of levels of fat in the blood (hypertriglyceridemia)
These side effects may occur during the induction of
anaesthesia:
- 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)
Uncommon:
- severe low blood pressure (hypotension)
- coughing during anaesthesia
- slowing of the pulse rate (progressive bradycardia)

These rare side effects may occur during the recovery
period (waking up):
- euphoria (feeling happy) and sexual arousal
- shivering and feeling cold
- coughing
- irregular heartbeat (arrhythmia)
- feeling sick (nausea) or vomiting
Very rare:
- 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.
When Fresenius 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 heartbeat (bradycardia)
- irregular heartbeat (cardiac arrhythmias)
- shock
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE FRESENIUS PROPOVEN 2 %
Keep out of the reach and sight of children.
Do not use Fresenius Propoven 2 % after the expiry
date which is stated on the vial and the outer packaging
after EXP. The expiry date refers to the last day of that
month.
Store at or below 25 °C.

Rare:
- 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

Do not freeze.

6. FURTHER INFORMATION

This medicinal product is authorised in the Member
States of the EEA under the following names:

What Fresenius Propoven 2 % contains
- The active substance is propofol.

Country Trade Name

1 ml emulsion contains 20 mg propofol.
Each 50 ml vial contains 1000mg propofol.
-




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

After opening the product must be used immediately.
Administration systems with Fresenius Propoven 2 %
should be replaced 12 hours after opening of the vial.
Containers should be shaken before use.
If two layers can be seen after shaking the emulsion
should not be used. Use only homogenous
preparations and undamaged containers.
Medicines should not be disposed via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help protect the environment.

Austria





Propofol “Fresenius” 2 % mit MCT
- Emulsion zur Injektion oder
Infusion

Belgium

Propolipid 2%

Cyprus


Czech Republic

Propofol 2% MCT/LCT Fresenius
Propofol 2% MCT/LCT Fresenius

Denmark

Propolipid

Estonia

Propoven 2%

Germany





Propofol 2% (20 mg/1 ml) MCT
Fresenius, Emulsion zur Injektion
oder Infusion

Fresenius Propoven 2 % is available in colourless
glass vials. The glass vials are sealed with rubber
stoppers.

Greece

Propofol MCT/LCT 2%
Propolipid 20 mg/ml

Packsizes:
Packs containing 1 glass vial with 50 ml emulsion
Packs containing 10 glass vial with 50 ml emulsion
Packs containing 15 glass vial with 50 ml emulsion

Finland

Hungary

Propofol 2% MCT/LCT Fresenius

Iceland

Propolipid 20 mg/ml

Ireland

Fresenius Propoven 2%

Italy



Propofol Kabi 20 mg/ml

Not all pack sizes may be marketed.

Latvia



Propoven 2%

Marketing Authorisation Holder and Manufacturer

Lithuania

Propoven 2%

What Fresenius Propoven 2 % looks like and
contents of the pack
Fresenius Propoven 2 % is a white oil-in-water
emulsion for injection or infusion.

Marketing Authorisation Holder:
Fresenius Kabi, Cestrian Court, Eastgate Way
Manor Park Runcorn Cheshire
WA7 1NT UK
Manufacturer:
Fresenius Kabi Austria GmbH
A-8055 Graz, Hafnerstrasse 36
Austria
Fresenius Kabi AB
S-75174 Uppsala, Rapsgatan 7
Sweden

Luxembourg

Propofol 2% MCT Fresenius

Norway

Propolipid 20 mg/ml

Poland

Propofol 2% MCT/LCT Fresenius

Portugal

Propofol 2% MCT/LCT Fresenius

Slovakia

Propofol 2% MCT/LCT Fresenius

Slowenia



Propoven 20 mg/ml emulzija za
injiciranje ali infundiranje

Spain



Propofol Lipomed 20 mg/ml
Fresenius emulsión para inyección
o perfusión





Sweden

Propolipid 20 mg/ml

United Kingdom Fresenius Propoven 2%

This leaflet was last approved in
10/2010.

&
Co-administration of other medicinal products or fluids
added to the Fresenius Propoven 2 % infusion line
must occur close to the cannula site using a Y-piece
connector or a three-way valve.
Fresenius Propoven 2 % is a lipid containing emulsion
without antimicrobial preservatives and may support
rapid growth of microorganisms.
The emulsion must be drawn aseptically into a sterile
syringe or giving set immediately after breaking the
vial seal. Administration must commence without
delay.
Asepsis must be maintained for both Fresenius
Propoven 2 % and the infusion equipment throughout
the infusion period. Fresenius Propoven 2 %must not
be administered through a microbiological filter.
The use of a drop counter, syringe pump or
volumetric infusion pump to control the infusion rate
is recommended when Fresenius Propoven 2 % is
infused.

As usual for fat emulsions, the infusion of Fresenius
Propoven 2 % via one infusion system must not
exceed 12 hours. The infusion set for Fresenius
Propoven 2 % must be changed at least every 12
hours.
To reduce pain on the injection site, Fresenius
Propoven 2 % should be administered in a larger vein
or lidocaine injection solution may be administered
before induction of anaesthesia with Fresenius
Propoven 2 %. 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 Fresenius Propoven 2 %.

Expand view ⇕

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.

Hide