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PROPOFOL 20MG/ML EMULSION FOR INJECTION AND INFUSION

Active substance(s): PROPOFOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Propofol 20 mg/ml, emulsion for injection and infusion
Read all of this leaflet carefully before you start using this medicine.
x Keep this leaflet. You may need to read it again.
x If you have any further questions, ask your doctor.
x If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Propofol 20 mg/ml is and what it is used for
Before you use Propofol 20 mg/ml
How to use Propofol 20 mg/ml
Possible side effects
How to store Propofol 20 mg/ml
Further information

1. What Propofol 20 mg/ml is and what
it is used for

Propofol 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 20 mg/ml is used to:
x induce and maintain general anaesthesia in adults and children > 1
month
x sedate patients > 16 years of age receiving artificial respiration in
intensive care

2. Before you are given Propofol 20
mg/ml

3. How you will be given Propofol
20 mg/ml

Propofol will be given to you by your anaesthetist or 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).
Propofol will be given to you either as an injection or as an infusion
into a vein, usually in the back of the hand or in the forearm. Your
anaesthetist may use a needle, or a fine plastic tube called a cannula.
For long operations and for use in intensive care situations, an electric
pump may be used to control the rate at which the injection is given.
To reduce pain caused by the initial injection, your doctor may choose
to give a local anaesthetic (lidocaine) before injection with propofol.
The use of propofol should not exceed 7 days.
If you are given more Propofol 20 mg/ml than you should
If by accident you have received more propofol than you should, your
breathing and blood circulation can be impaired. In this case artificial
breathing should be applied and your blood pressure will be corrected
by additional treatment.
If you have any further questions on the use of this product, ask
your doctor.

4. Possible side effects
Do not use Propofol 20 mg/ml
x if you are allergic (hypersensitive) to propofol or any of the other
ingredients of Propofol 20 mg/ml
x if you are allergic to peanut or soya. Propofol contains soya bean
oil
x in patients of 16 years of age or younger for sedation in intensive
care

Like all medicines, Propofol 20 mg/ml can cause side effects,
although not everybody gets them.
Very Common side effects (more than 1 in 10 people given Propofol
20 mg/ml will experience these side effects):
Local pain during injection or start of infusion with propofol*

Take special care with Propofol 20 mg/ml
Check if one of the warnings listed below applies to you or applied to
you in the past. Tell your doctor or pharmacist:
x if you are over 55 years of age or weakened, if you have an
impaired heart, lung, liver or kidney function or if you have a
reduced blood volume (hypovolaemia). The dosage of propofol
that you receive might have to be adjusted.
x if you have ever had a fit. There is an increased risk ofa fit.
x if you have an increased pressure within the skull (high
intracranial pressure), and a low bloodressure (low arterial
pressure), the blood supply to your brain might be impaired.
x if you undergo shock therapy (electronvulsive therapy)
x if you have very high fat levels in your blood or if you have
problems in relation to your body being able to handle or use fat
(fat metabolism)
Using other medicines
x certain medicines to be used before you undergo surgery
(premedication), certain medicines to put you to sleep for surgery
which are administered by breathing through an anesthesia mask
(inhalation anaesthetics), medicines to render part of the body
insensitive to pain without affecting consciousness (local
anaesthetics). medicines to relieve pain (analgesic agents) or
medicines that reduce the tension in the muscles (muscle
relaxants). These medicines may increase the anaesthetic effect of
propofol and increase the risk of side effects related to the heart
and blood pressure.
x a certain medicine to relieve pain and that has a sedative effect
(fentanyl). This can increase the risk of breathing difficulties.
x a certain muscle relaxant often used during surgery under general
anaesthesia (suxamethonium) and an agent to reverse this effect
(neostigmine). Slowed heart beat and cardiac arrest may occur.
x a certain medicine to suppress the immune response (ciclosporin),
the combination with propofol can do damage to certain brain
tissue (leucoencephalopathy).
Please tell your doctor if you are taking or have recently taken any of
the medicines listed above or any other medicines, including
medicines obtained without a prescription.
Using Propofol 20 mg/ml with food and drink
Your doctor will inform you about the use of propofol with food and
drink.
Pregnancy
Please tell your doctor if you are pregnant. Propofol should not be
used during pregnancy since propofol crosses the placenta and may
harm your child. Your doctor may decide to give you propofol if the
benefit to you outweighs the risk to your child.
Breast-feeding
Please tell your doctor if you are breast-feeding. You should stop
breast-feeding after receiving propofol, as propofol is released (in
small amounts) into breast milk. You should discard breast milk for
24 hours after receiving propofol.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Do not drive shortly after receiving propofol. Your ability to drive a car
or to operate machinery may be affected for some time. Ask your
doctor when you can return to work, particularly if you use machinery
or heavy equipment.
Important information about some of the ingredients of Propofol 20
mg/ml
Propofol contains soya oil. If you are allergic to peanut or soya, do
not use this medicinal product.

Bijsluiter PRL 20 mg mei 2011.pdf 1

Common side effects (more than 1 in 100, but less than 1 in 10
people given Propofol 20 mg/ml will experience these side effects):
Changes in breathing pattern (apnoea) during induction of
anaesthesia* • Low blood pressure (hypotension) • Reddening of the
face and/or neck in children • Slowed heart beat (bradycardia)
During recovery you may experience: Nausea and vomiting •
Headache • Withdrawal symptoms (in children)
Uncommon side effects (more than 1 in 1000, but less than 1 in 100
people given Propofol 20 mg/ml will experience these side effects):
Formation of blood cloths in the vein after injection (thrombosis)* •
Redness or soreness where the injection was given (phlebitis)*
Rare side effects (more than 1 in 10.000, but less than 1 in 1000
people given Propofol 20 mg/ml will experience these side effects):
During induction, maintenance and recovery you may experience:
Twitching and shaking of your body* • A fit* • Contraction of the
muscles in your head, neck and back causing arching of the body
Very rare side effects (less than 1 in 10.000 people given Propofol 20
mg/ml will experience these side effects):
Breakdown of muscle cells causing muscle cramps, fever and a
red/brown discolouration of the urine (rhabdomyolysis)* • Fierce pain
in the upper abdomen (due to inflammation of a large gland situated
close to the stomach) which radiates to the back (pancreatitis)* •
Severe hypersensitivity reaction (anaphylaxis) which symptoms can
include sudden large decrease in blood pressure, pallor, agitation,
weak but rapid pulse rate, clammy skin, swelling/oedema, lapse of
consciousness, difficulty breathing, and heart failure* • Accumulation
of fluid in the lungs (pulmonary oedema)* • Fainting after undergoing
surgery* • Post-operative fever • Discolouration of urine following
prolonged use of propofol • Sexual disinhibition •
*These side effects are considered serious. If you experience any of
these, inform your doctor immediately.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor

5. How to store Propofol 20 mg/ml

Keep out of the reach and sight of children.
Do not use propofol after the expiry date which is stated on the
packaging after ‘EXP’. The first two digits indicate the month and the
last four digits indicate the year. The expiry date refers to the last day
of that month.
Prior to dilution:
x Do not store above 25˚C
x Store in the original package in order to protect from light.
x Do not freeze
Diluted product:
x Dilutions should be prepared aseptically immediately before
administration and must be used within 6 hours of preparation
x Any portion of the contents remaining after first use should be
discarded
Shake well before use.
Do not use the product if you notice two layers after shaking the
product.

23/05/2011 14:39:44

6. Further information

What Propofol 20 mg/ml contains
x
The active substance is propofol.
One ml contains 20 mg propofol.
One 20 ml ampoule contains 400 mg propofol.
One 50 ml vial contains 1000 mg propofol.
One 100 ml vial contains 2000 mg propofol.
x
The other ingredients are glycerol, purified egg-lecithin, refined
soya-bean oil, oleic acid, sodium hydroxide and water for
injections.
What Propofol 20 mg/ml looks like and contents of the pack
Propofol 20 mg/ml is a white oil-in-water emulsion packaged in a
clear colourless glass ampoule or vial.
Propofol 20 mg/ml is available in cartons containing 1, 5 or 10 of
either 20 ml ampoules or 50 or 100 ml vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
[To be completed nationally]
Manufacturer:
[To be completed nationally]
This medicinal product is authorised in the Member States of the EEA
under the following names:
United Kingdom
Propofol 20mg/ml, emulsion for injection and
infusion
Ireland
Propofol 20 mg/ml, Emulsion for Injection
and Infusion
Italy
Propofol IBI 20 mg/ml emulsione per
preparazione iniettabile e per infusione
Portugal
Propofol, 20 mg/ml, Emulsão injectável
Spain
Propofol Hospira 20 mg/ml emulsión para
inyección y perfusión EFG
This leaflet was last approved in {MM/YYYY}
[To be completed nationally]

Bijsluiter PRL 20 mg mei 2011.pdf 2

23/05/2011 14:39:53

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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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