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FRESENIUS PROPOVEN 1% EMULSION FOR INJECTION OR INFUSION

Active substance(s): PROPOFOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fresenius Propoven 1%

Emulsion for Injection or Infusion
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 1% is and what it is
used for
Before you use Fresenius Propoven 1%
How to use Fresenius Propoven 1%
Possible side effects
How to store Fresenius Propoven 1%
Further information

1. WHAT FRESENIUS PROPOVEN 1% IS AND
WHAT IT IS USED FOR
Fresenius 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).
Propofol is used to:


induce and maintain general anaesthesia


in adults and children > 1 month.

sedate patients > 16 years of age receiving


artificial respiration in intensive care.


sedate adults and children > 1


month during diagnostic and surgical


procedures, alone or in combination with


local or regional anaesthesia

2. BEFORE YOU USE FRESENIUS PROPOVEN 1%
DO NOT use Fresenius Propoven 1%
-




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) to soya or
peanut (see “Important information about
some of the ingredients of Fresenius Propoven 1%
at the end of section 2).

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 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.
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.
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 1%)
- other anaesthetics, including general, regional,

local and inhalational anaesthetics (lower

doses of Fresenius 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)
Using Fresenius Propoven 1% with food and
drink
After you have been given Fresenius Propoven 1%,
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 1% 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 1%.
Driving and using machines
After you have been given Fresenius Propoven
1%, you must not drive, operate machinery, or work
in dangerous situations. You should not go home
alone.

- in patients of 16 years of age or younger for
sedation in intensive care.
Take special care with Fresenius Propoven 1%
You should not receive Fresenius 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)
The use of Fresenius Propoven 1% is not
recommended in newborn infants. Special care
should also be observed when administering
Fresenius 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. The safety of propofol for sedation
in chidren and adolescents 16 years of age and
younger in the intensive care unit has not been
demonstrated.
In general, Fresenius Propoven 1% should be
given with caution to elderly or weak patients.
Before receiving Fresenius 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 Fresenius
Propoven 1%:
- heart failure
- when there is insufficient blood reaching the

tissues (circulatory failure)
- severe breathing problems (respiratory failure)
- dehydration (hypovolaemia)
- seizures (epilepsy)
Fresenius 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 Fresenius Propoven 1%.
Involuntary movements can occur during sedation
with Fresenius Propoven 1%. The doctors will

This can rarely cause severe hypersensitivity
(allergic) reactions (see “Do not use Fresenius
Propoven 1%”). Tell your doctor if you know that
you have allergic reactions to soya-bean oil.
This medicinal product contains less than 1 mmol
(23 mg) sodium per 100 ml, i.e. essentially ´sodiumfree`.

3. HOW TO USE FRESENIUS PROPOVEN 1%
Fresenius Propoven 1% 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 to 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 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 to1 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 1% infusion to the desired level
of sedation. Most patients will require 1.5 to 4.5 mg
propofol per kg body weight per hour. The infusion
may be supplemented by bolus administration of
10 to 20 mg propofol (1 to 2 ml Fresenius Propoven
1% if a rapid increase of the depth of sedation is
required.
Fresenius Propoven 1% 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.
When used for sedation, Fresenius Propoven 1%
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.

Important information about some of the
ingredients of Fresenius Propoven 1%
Fresenius Propoven 1% contains soya-bean oil.

The following information is intended for
medical or healthcare professionals only:
Fresenius Propoven 1% should not be mixed prior
to administration with injection or infusion solutions
other than 5% w/v glucose solution or 0.9% w/v
sodium chloride intravenous infusion solution or 1%
preservative-free lidocaine injection solution. Final
propofol concentration must not be below 2 mg/ml.
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 ampoule neck or rubber
membrane should be cleaned using an
alcohol spray or a swab dipped in alcohol. After use,
tapped containers must be discarded.
Fresenius Propoven 1% must only be given in
hospitals or adequately equipped therapy units by
physicians trained in anaesthesia or in intensive
care. For sedation during surgical and diagnostic
procedures Fresenius Propoven 1% 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.
Propofol may be administered undiluted or diluted
in 5% w/v glucose or 0.9% w/v sodium chloride
intravenous infusion solutions.
5% w/v glucose intravenous infusion solution, 0.9%
w/v sodium chloride intravenous solution or 0.18%
w/v sodium sodium chloride and 4% w/v glucose
intravenous infusion solution may be given through
the same infusion set. Fresenius Propoven 1%
must not be mixed with any other solutions for
infusion or injection.

The emulsion must be drawn aseptically into a
sterile syringe or giving set immediately after
opening the ampoule or breaking the vial seal.
Administration must commence without delay.
Asepsis
must
be
maintained
for
both
Fresenius Propoven 1% and the infusion equipment
throughout the infusion period. Fresenius
Propoven 1% must not be administered through a
microbiological filter.
Infusion of undiluted Fresenius Propoven 1%:
The use of a burette, drop counter, syringe pump or
volumetric infusion pump to control the infusion rate
is recommended when Fresenius Propoven 1% is
infused undiluted.
As usual for fat emulsions, the infusion of
Fresenius Propoven 1% via one infusion system
must not exceed 12 hours. The infusion set for
Fresenius Propoven 1% must be changed at least
every 12 hours.
Infusion of diluted Fresenius 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 Fresenius Propoven 1%
to 4 parts of 5% w/v glucose or 0.9% w/v
sodium chloride intravenous infusion solution
(minimum oncentration 2 mg propofol per ml). The
mixture should be prepared aseptically and
administered within 6 hours.
If the same injection system used for the
Fresenius Propoven 1% is to be used for the
injection of muscle relaxants (e.g. atracurium and
mivacurium), the injection system must first be
flushed.
Lidocaine may be added to the diluted
solution (20 parts of Fresenius Propoven 1% to
1 part of 1% preservative-free lidocaine solution for
injection) to reduce pain at the site of injection of
Fresenius Propoven 1%. Lidocaine must not be used
in patients with hereditary acute porphyria.
Muscle
relaxants
like
atracurium
and
mivacurium should only be adminstered
after flush of the same infusion site used for
Fresenius Propoven 1%.

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

M088702/02 GB

4. POSSIBLE SIDE EFFECTS
Like all medicines, Fresenius Propoven 1% can
cause side effects, although not everybody gets
them.
Evaluation of the side effects is based on the
following frequencies:
Very common affects more than 1 user in 10
Common

affects 1 to 10 users in 100

Uncommon

affects 1 to 10 users in 1,000

Rare

affects 1 to 10 users in 10,000

Very rare

affects less than 1 user in 10,000

Not known



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:
- 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)

-
-
-
-

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
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 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
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 1%
Keep out of the reach and sight of children.

Rare:
- a severe allergic reaction , 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)

Do not use Fresenius Propoven 1% after the expiry
date which is stated on the ampoule/vial and the
outer packaging after EXP. The expiry date refers
to the last day of that month.

w/v glucose solution or 0.9% w/v sodium chloride
intravenous infusion solution or an admixture 1%
preservative-free lidocaine injection solution (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.

Marketing
Authorisation
Manufacturer

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.

Store at or below 25 °C.
Do not freeze.
After opening the product must be used immediately.
Administration systems with undiluted Fresenius
Propoven 1% should be replaced 12 hours after
opening of the ampoule or vial. Dilutions with 5%

Holder

and

Marketing Authorisation Holder:
Fresenius Kabi Ltd
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
This leaflet was last approved in 10/2010

6. FURTHER INFORMATION
What Fresenius Propoven 1% contains
- The active substance is propofol.
1 ml emulsion contains 10 mg propofol.
Each 20 ml ampoule contains 200 mg propofol.
Each 20 ml vial contains 200 mg propofol.
Each 50 ml vial contains 500 mg propofol.
Each 100 ml vial contains 1000 mg propofol.
-




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

What Fresenius Propoven 1% looks like and
contents of the pack
Fresenius Propoven 1% is a white oil-in-water
emulsion for injection or infusion.
Fresenius Propoven 1% is available in colourless
glass ampoules or glass vials. The glass vials are
sealed with rubber stoppers.
Pack sizes:
Packs containing 5 glass ampoules with 20 ml
emulsion
Packs containing 1 glass vial with 20, 50 or 100 ml
emulsion
Packs containing 5 glass vials with 20 ml emulsion
Packs containing 10 glass vials with 20, 50 or 100
ml emulsion
Packs containing 15 glass vials with 50 or 100 ml
emulsion
Not all pack sizes may be marketed.

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

Belgium

Propolipid 1 %

Cyprus

Propofol 1% MCT/LCT Fresenius

Czech Republic Propofol 1% MCT/LCT Fresenius
Denmark

Propolipid

Estonia

Propoven 1%

Germany







Propofol 1% (10 mg/1 ml) MCT
Fresenius, Emulsion zur Injektion
oder Infusion

Greece

Propofol MCT/LCT 1%

Finland

Propolipid 10 mg/ml

Hungary

Propofol 1% MCT/LCT Fresenius

Iceland

Propolipid 10 mg/ml

Ireland

Fresenius Propoven 1%

Italy

Propofol Kabi 10mg/ml



Latvia

Propoven 1%

Lithuania

Propoven 1%

Luxembourg

Propofol 1% MCT Fresenius

Netherlands




Propofol 10mg/ml MCT/LCT
Fresenius

Norway

Propolipid 10 mg/ml

Poland

Propofol 1% MCT/LCT Fresenius

Portugal

Propofol 1% MCT/LCT Fresenius

Slovakia

Propofol 1% MCT/LCT Fresenius

Slovenia




Propoven 10 mg/ml emulzija za
injiciranje ali infundiranje

Spain







Propofol Lipomed 10 mg/ml
Fresenius emulsión para
inyección o perfusión

Sweden

Propolipid 10 mg/ml

United Kingdom Fresenius Propoven 1%

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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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