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PROPOFOL 10 MG/ML EMULSION FOR INJECTION OR INFUSION

Active substance(s): PROPOFOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Propofol 10 mg/ml Emulsion for injection/infusion
Propofol
Read all of this leaflet carefully before you are given this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Propofol is and what it is used for
2. Before you are given Propofol
3. How you are given Propofol

4. Possible side effects
5. How to store Propofol
6. Further information.

1. What Propofol is and what it is used for
Propofol belongs to a group of medicines called general anaesthetics. General anaesthetics are used to cause
unconsciousness (deep sleep) while surgical operations or other procedures are being carried out. They can also be
used to sedate you (make you sleepy without sending you to sleep).
Propofol is used to:
 induce and maintain general anaesthesia in adults, adolescents 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 are given Propofol
Do not use Propofol:
 in patients allergic (hypersensitive) to propofol, or any of the other ingredients of this medicinal product
 in patients allergic (hypersensitive) to soya or peanut
 in patients of 16 years of age or younger for sedation in intensive care
Take special care with Propofol
You should not receive Propofol, 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 Propofol is not recommended in newborn infants.
Special care should also be observed when administering Propofol 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 children and adolescents 16 years of age and younger in the intensive care unit has not been demonstrated.
In general, Propofol should be given with caution to elderly or weak patients.
Before receiving Propofol, 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 Propofol:
 heart failure
when there is insufficient blood reaching the tissues
 severe breathing problems (respiratory failure)
(circulatory failure)
 dehydration (hypovolaemia)
seizures (epilepsy)
Propofol 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 Propofol.
Involuntary movements can occur during sedation with Propofol. 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 Propofol 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.
Taking 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 includes medicines, herbal medicines, health foods or supplements that you have
bought yourself.
You must take special care if you are also taking any of the following medicines:
o premedications (your anaesthetist will know this)
o drugs that affect many of the internal body functions
o anaesthetics
such as the heart rate, e.g. atropine
o analgesics (painkillers)
o strong painkillers, e.g. fentanyl
o drugs that relax muscles, e.g. suxamethonium
o alcohol
o benzodiazepines (drugs for anxiety) , e.g. valium
o neostigmine (a treatment for muscle weakness)
o parasympatholytic drugs (drug that inhibit the actions
o ciclosporin (used to prevent rejection of an organ)
of the parasympathetic nervous system which control
smooth muscle contraction, regulate heart muscle, or
stimulate or inhibit glandular secretion.)
Using Propofol with food and drink
Alcohol and propofol make the sedative effects of each other stronger. Therefore you should not drink alcohol just before
or just after you have Propofol until fully recovered.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Propofol should not be given to pregnant women unless clearly necessary. If you are breast-feeding your child you
should stop nursing and discard breast milk for 24 hours after you have received Propofol. Propofol is excreted in small
amounts into the breast milk.
Driving and using machines
After you have been given Propofol, you must not drive, operate machinery, or work in dangerous situations. You should
not go home alone and should not drink alcohol until fully recovered.
Important information about some of the ingredients of Propofol:
Propofol 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 sodium (23 mg) sodium in 20 ml, i. e. essentially ‘sodium free'.
3. How you are given Propofol
Dosage
Propofol will be given to you by your anaesthetist or intensive care doctor.
The amount of Propofol you need depends on your age, size, fitness and the level of sleepiness or sleep that is needed.
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 per kg of body weight to make them sleepy or to put them to
sleep, and then 4 to 12 mg/kg (body weight)/hour after this. For sedation, doses of 0.3 to 4.0 mg propofol per kg body
weight per hour are usually sufficient.
Adults
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
Propofol 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 Propofol 10 mg/ ml) if a rapid
increase of the depth of sedation is required.
Propofol is given as an injection or infusion into a vein, 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
Children usually require slightly higher doses. The dose should be adjusted according to age and/or body weight.
When used for sedation, Propofol must not be administered for more than 7 days.
If you received more Propofol than you should
It is unlikely that this occurs because the doses you receive are very carefully controlled.
If you are accidentally given an overdose, this could lead to depression of heart function, circulation and breathing. In
this case your doctor will employ any necessary treatment immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Propofol can cause side effects, although not everybody gets them.
These effects depend on the propofol dose administered but also on the type of premedication and other concomitant
medication.
Very common (affects more than 1 user in 10)
• local pain during the injection.
Common (affects 1 to 10 users in 100)
• low blood pressure (hypotension)

• spontaneous movements

• rapid heartbeat (tachycardia)

• temporary apnoea (stopping breathing)

• hiccups (singultus)

• hypertriglyceridemia (high blood cholesterol or triglycerides)
Uncommon (affects 1 to 10 users in 1,000)
• severe low blood pressure (hypotension)

shallow breathing (respiratory depression)
slow heartbeat (bradycardia)
hot flushes
coughing after anaesthesia
hyperventilation (increased breathing)

• coughing during anaesthesia

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Rare (affects 1 to 10 users in 10,000)
• anaphylaxis (a severe allergic reaction)
• nausea or vomitting
• headache
• shivering and sensations of cold during the recovery period
• irregular heartbeat (arrhythmia) during recovery
• discoloration of urine
• blood clots (thrombosis) and inflammation of the blood
vessels (phlebitis)
• low blood pressure (hypotension)
Very rare (affects less than 1 user in 10,000)
• delayed epileptiform attacks (epilepsy like symptoms
after recovery)
• inflammation of the pancreas (pancreatitis)
• Post operative unconsciousness
• rhabdomyolysis (breakdown of muscle fibres)
• high blood potassium (hyperkalaemia)

• euphoria (feeling happy) and sexually aroused during
recovery
• vertigo (spinning dizziness)
• epileptiform movements (resembling epilepsy)
• coughing during recovery
• post-operative fever
• red inflammation of the skin (erythema)
• bronchospasm (a condition that causes difficulty in
breathing)
• fluid in the lungs (pulmonary oedema)
• severe tissue responses after accidental injection
into tissues
• metabolic acidosis (acidic blood)
• heart (cardiac) failure

When Propofol 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. How to store Propofol
Keep out of the reach and sight of children.
Do not use Propofol after the expiry date which is stated on the vial and the outer carton after “Exp.”. The expiry date
refers to the last day of that month.
Store below 25° C. Do not freeze.
After opening the product must be used immediately.
Dilutions with 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%) and glucose 40 mg/ml (4%) solution for injection and preservative-free lidocaine 10
mg/ml (1%) solution for injection. The mixture should be prepared aseptically (controlled and validated conditions
preserved) immediately prior to administration and must be administered within 12 hours after preparation.
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.
For single use. Any unused emulsion must be discarded.
Your anaesthetist and hospital pharmacist are responsible for the correct storage, use and disposal of Propofol.
6. Further information
What Propofol contains
The active substance is propofol. Each ml of emulsion for injection/infusion contains 10 mg of propofol.
Each 20 ml vial contains 200 mg of propofol
Each 50 ml vial contains 500 mg of propofol
Each 100 ml vial contains 1000 mg of propofol.
The other ingredients are: Soya-bean oil refined, Medium-chain triglycerides, Glycerol, Egg lecithin, Sodium oleate,
Sodium Hydroxide (for pH adjustment) and Water for injections.
What Propofol looks like and the content of the pack
White oil-in-water emulsion for injection/infusion.
This medicinal product is supplied as:
Emulsion for injection/infusion in colourless glass vial (type II glass) with grey bromo butyl rubber stopper.
Pack sizes :
Colourless glass vial (type II) of 20 ml with grey bromobutyl rubber closure, packs of 1, 5 and 10 unit
Colourless glass vial (type II) of 50 ml with grey bromobutyl rubber closure, packs of 1 and 10 unit
Colourless glass vial (type II) of 100 ml with grey bromobutyl rubber closure, packs of 1 and 10 unit
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road, Sandwich,
Kent CT13 9NJ.

Manufacturer:
Pfizer Service Company BVBA,
Pfizer PGM,
Hoge Wei 10, 1930,
or Zone industrielle, 29, route des Industries,
Zaventem. Belgium
37530 Pocé -Sur-Cisse, France

This Leaflet was last approved in 05/2011
The following information is intended for medical or healthcare professionals only:
Propofol 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 Propofol should not be administered by the same person
conducting the surgical or diagnostic procedure.
When Propofol is infused, it is recommended that equipment such as burettes, drop counter, syringe pumps or
volumetric infusion pumps should always be used to control infusion rates.
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.
For single use only. Any portion of contents remaining after use must be discarded.
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.
Propofol 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 administration set immediately after breaking the vial
seal. Administration must commence without delay.
Asepsis must be maintained for both Propofol and infusion equipment throughout the infusion period. Co-administration
of other medicinal products or fluids added to the Propofol infusion line must occur close to the cannula site using a Ypiece connector or a three-way valve.
Propofol can be used for infusion undiluted or diluted.
Propofol should only be mixed with the following products: 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%) and glucose 40 mg/ml (4%) solution for
injection, and preservative-free lidocaine 10 mg/ml (1%) solution for injection. Final propofol concentration must not be
below 2 mg/ml.
However co-administration of a 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%) and glucose 40 mg/ml (4%) solution for injection with Propofol is
permitted via a Y-piece connector close to the injection site.
Propofol must not be administered via a microbiological filter.
Propofol and any infusion equipment containing Propofol are for single administration in an individual patient. After use
remaining solution of Propofol has to be discarded.
Infusion of undiluted Propofol:
When Propofol is infused undiluted, it is recommended that equipment such as burettes, drop counter, syringe pumps or
volumetric infusion pumps should always be used to control infusion rates.
As usual for fat emulsions, the infusion of Propofol via one infusion system must not exceed 12 hours. After 12 hours, the
infusion system and reservoir of Propofol must be discarded or replaced if necessary.
Infusion of diluted Propofol:
For administering infusion of diluted Propofol, burettes, drop counters or volumetric infusion pumps should always be
used to control infusion rates and to avoid the risk of accidentally uncontrolled infusion of large volumes of diluted
Propofol. This risk has to be taken into account when the decision for the maximum dilution in the burette is made.
The maximum dilution must not exceed 1 part of Propofol with 4 parts of 5% w/v glucose solution, 0.9% w/v sodium
chloride solution, 0.18% sodium chloride & 4% dextrose solution (minimum concentration 2 mg propofol/ml). The
mixture should be prepared aseptically (controlled and validated conditions preserved) immediately prior to
administration and must be administered within 12 hours after preparation.
This medicinal product must not be mixed or co-administered with other medicinal products except those mentioned
above.
To reduce pain at the injection site, lidocaine may be injected immediately before the use of Propofol or Propofol may be
mixed, immediately before use, with preservative free lidocaine injection (20 parts of Propofol with up to 1 part of 1%
lidocaine injection solution) under controlled and validated aseptical conditions. The mixture has to be administered
within 12 hours after preparation.
The neuromuscular blocking agents, atracurium and mivacurium should not be given through the same intravenous line
as Propofol without flushing.
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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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