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PROPOFOL 10 MG/ML (1%) EMULSION FOR INJECTION/INFUSION

Active substance(s): PROPOFOL

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Propofol 10 mg/ml (1%) Emulsion
for Injection/Infusion

000000
ref.: D300.026/I F.19

SZ00000LT000

Propofol

Read all of this leaflet carefully before you start using 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.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness
are the same as yours.
• 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 Propofol is and what it is used for
2. What you need to know before you receive Propofol
3. How to use Propofol
4. Possible side effects
5. How to store Propofol
6. Contents of the pack and other 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 (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 will be given to you as an injection by a doctor.

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

Draft: 44044099, 44044101
Laetus code: 000
Mat.no.: 000000

2. WHAT YOU NEED TO KNOW BEFORE
YOU RECEIVE PROPOFOL

Do not use Propofol
• in patients allergic (hypersensitive) to propofol or any of the
other ingredients of Propofol
• in patients allergic to peanut or soya. This is because Propofol
contains soya-bean oil.
• in patients of 16 years of age or younger for sedation in
intensive care.
Warnings and precautions
The use of Propofol is not recommended in newborn infants.

• if you have any other health problems, such as problems with
your heart, breathing, kidneys or liver.
• if your body has lost lots of water (you are hypovolaemic).
• if you have ever had a fit or convulsion
• if you have ever been told that you have very high levels of fat
in your blood. In these cases your doctor might have to
determine your blood fat levels.
• if you have ever been told that your body has problems using
fat. In these cases your doctor might have to determine your
blood fat levels.
• if you have a condition called hereditary predisposition to
acute porphyria.
If you are able to go home shortly after receiving propofol you
should not go home unaccompanied.

If you are not sure if any of the above apply to you, talk to your
doctor or nurse before receiving Propofol.
Other medicines and Propofol
Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription. This includes medicines, herbal remedies, health
foods or supplements that you have bought yourself.
Take special care when taking/receiving the following
medicines:
• Certain premedications (your anaesthesist knows which
medicines can be influenced)
• Other anaesthetics (including general, local or volatile
anaesthetics)
• Painkillers (analgetics)
• 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)

• Neostigmin (medicine used to treat a disease called
myasthenia gravis)
• Ciclosporin (medicine used to prevent transplant rejection).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
nurse for advice before taking this medicine.
Propofol should not be used unless absolutely necessary if you
are pregnant.
You should not breast-feed while receiving Propofol and breast
milk must be discarded for 24 hours after receiving Propofol.

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.
Ask your doctor when you can start doing these activities again
and when you can go back to work.
Propofol contains soya-bean oil
If you are allergic to peanut or soya, do not use this medicine
(see above “Do not use Propofol”).
This medicinal product contains less than 1 mmol sodium
(23 mg) per 100 ml, i.e. essentially ‘sodium- free’.

3. HOW TO USE PROPOFOL
You will be given Propofol by, or under the direct supervision of
your anaesthesist or intensive care doctor. It will be given to you
as an injection or infusion (drip) into a vein. This is usually in the
back of your hand or in your forearm.
• Your doctor will give you the injection using a needle or
through a fine plastic tube called a ‘cannula’
• For maintenance of anaesthesia or sedation your medicine
may be given as an intravenous infusion (drip) using an
electric pump which automatically control the rate at which
the infusion is given. This may be done if you are having a
long operation or if you are in an Intensive Care Unit.

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.

General anaesthesia

Adults
• For induction of anaesthesia most adult patients aged less
than 55 years are likely to require 1.5 to 2.5 mg/kg body
weight.
• For maintenance of anaesthesia generally doses of 4 to
12 mg/kg/h or repeat bolus injections (using Propofol) dose
increments of 25 mg to 50 mg are given.
Dose requirements may be lower for older people.
Sedation

Adults and adolescents older than 16 years of age
• For sedation of adults and adolescents older than 16 years of
age during intensive care the dose should be adjusted
according to the level of sedation required. Using continous
infusion doses of 0.3 to 4.0 mg/kg/h are typically given. Rates
of infusion greater than 4.0 mg propofol/kg body weight/hr are
not recommended.
Adults
• For sedation for diagnostic and surgical procedures in adults
generally doses of 0.5 to 1 mg/kg body weight over 1 to 5
minutes are required for onset of sedation. Maintenance of
sedation will require 1.5 to 4.5 mg/kg/h. Additionally, single
administration of 10 to 20 mg can be given if a rapid increase
of the level of sedation (sleepiness) is required.
General anaesthesia

Children over 1 month of age
• For induction of anaesthesia most paediatric patients over 8
years are likely to require approximately 2.5 mg/kg body
weight Propofol.
In children younger than 8 years the dose might be higher
(2.5-4 mg/kg body weight).
• For maintenance of anaesthesia using continuous infusion
doses of 9 to 15 mg/kg/h usually achieve satisfactory
anaesthesia.
In younger children, especially between the age of 1 month
and 3 years, may have higher dosage requirements.
Sedation

Children over 1 month of age
• For sedation of paediatric patients during diagnostic and
surgical procedures the dose should be adjusted according
to the depth of sedation required. Most paediatric patients
require doses of 1 – 2 mg/kg body weight Propofol for onset of
sedation. Maintenance of sedation will require 1.5-9 mg/kg/h
Propofol. Additionally, single administration of up to 1 mg/kg
body weight can be given if a rapid increase of level of
sedation is required.
• Propofol must not be used in paediatric patients of 16 years of
age or younger in the indication for sedation in intensive
care.

Duration of treatment
When used for sedation, Propofol 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 anaesthesist 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 anaesthesist or intensive care doctor.

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 heart beat
• Low blood pressure
• Changes in your breathing pattern
• Hiccups
• Hot flushes.

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

Rare (may affect up to 1 in 1,000 people)
• 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
or dizziness
• 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).

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

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)
• Excitations, headache
• Feeling sick (nausea), being sick (vomiting).

Uncommon (may affect up to 1 in 100 people)
• Swelling and redness or blood clots at the vein along the
injection site.
Rare (may affect up to 1 in 1,000 people)
• Dizziness, chills and sensations of cold
• Cough.

Not known (frequency cannot be estimated from the available
data)
• Feeling euphoric
• Irregular heart beat
• 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
• Severe skin and tissue reaction following accidental
application beside the vein.
• Drug abuse, mostly by healthcare professionals

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 Yellow
Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE PROPOFOL

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 label after EXP. The expiry date refers to the last day of that
month.
Store below 30°C.
Do not freeze.
Keep the vial/ampoule in the outer carton in order to protect
from light.

Shelf life before opening
Ampoules/vials: 2 years.

Shelf life after first opening/dilution
The mixture should be prepared aseptically immediately prior to
administration and must be administered within 6 hours after
preparation.
In accordance with established guidelines for other lipid
emulsions, a single infusion of Propofol must not exceed 12
hours. At the end of the procedure or at 12 hours, whichever is
the sooner, both the container of Propofol and the infusion line
must be discarded and replaced as appropriate.
Chemical and physical in-use stability of the reconstituted
product has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage times
and conditions prior to use are the responsibility of the user.

Draft: 44044099, 44044101
Laetus code: 000
Mat.no.: 000000

Do not use this medicine if you notice particulate matter.

Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.

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ref.: D300.026/I F.19

4. POSSIBLE SIDE EFFECTS

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)
• Feeling sexually aroused
• Fever following surgery
• Changes in ECG (Brugada type ECG).

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

What Propofol contains
• The active substance(s) is propofol. Each 1 milliliter emulsion
for injection/infusion contains 10 mg propofol.
• The other ingredients are refined soya-bean oil, egg
phospholipids, glycerol, sodium hydroxide (for pH-adjustment),
water for injections.
What Propofol looks like and contents of the pack
Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion is a
white aqueous isotonic oil-in-water emulsion. It is available in
20 ml Type I glass ampoules, or 20, 50 and 100 ml Type I glass
vials with bromobutyl rubber stoppers.
Pack sizes:
5 x 20 ml ampoules
5 x 20 ml vials
1 x 50 ml vial
5 x 50 ml vials
1 x 100 ml vial

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Corden Pharma S.p.A.,
Viale dell’Industria 3 E, Reparto via Galilei 17,
Caponago, 20040.
Or

Salutas Pharma GmbH
Otto-Guericke Allee 1
39179 Barleben
Germany
Or

Lek Pharmaceuticals d.d.
Verovskova 57, 1526 Ljubljana
Slovenia

This leaflet was last revised in 11/2014.

------------------------------------------------------------------------------------The following information is intended for medical or healthcare
professionals only:

Method of administration
For intravenous use.

Administering Propofol through a TCI-system for sedation in
intensive care is not recommended.
For single use only.

Parenteral products should be inspected visually for particulate
matter prior to administration. If particulate matter is evident
emulsion should not be used.
Containers should be shaken before use. If two layers can be
seen after shaking, the emulsion should not be used.

Propofol can be used for infusion undiluted or diluted with
glucose 50 mg/ml (5%) intravenous infusion solution or sodium
chloride 9 mg/ml (0.9%) intravenous infusion solution or a
combination solution of glucose 40 mg/ml (4%) and sodium
chloride 1.8 mg/ml (0.18%).
Prior to use, the ampoule neck and rubber stopper should be
disinfected using a medicinal alcohol (spray or dipped swab).
After use, any remaining contents must be discarded.
Propofol does not contain antimicrobial preservatives and is
capable of supporting the growth of microorganisms. The
emulsion must be drawn aseptically into a sterile syringe or
infusion system immediately after opening the ampoule or
spiking the vial.

Administration must commence without delay. During infusion
sterility of Propofol as well as the infusion system must be
maintained.
Medicinal products or liquids that are added to a running
Propofol infusion should be added close to the cannula.

syringe pumps or volumetric infusion pumps should always be
used to control infusion rates.
As applies to parenteral administration of all kinds of fat
emulsions, the duration of use for one infusion system for a
continuous infusion of Propofol must not exceed 12 hours. The
infusion system and the container must be discarded and
replaced after a maximum of 12 hours.

The simultaneous administration of Propofol together with an
infusion solution of glucose 50 mg/ml (5%), sodium chloride
9 mg/ml (0.9%) intravenous infusion solution or a combination
solution of glucose 40 mg/ml (4%) and sodium chloride
1.8 mg/ml (0.18%) close to the Y-connector near the place of
injection, is possible.
Any Propofol remaining at the end of the infusion period or after
changing the system needs to be discarded and destroyed.
Infusion of diluted Propofol
When Propofol is administered diluted as a continuous infusion
it is recommended that equipment such as burettes, drop
counter, syringe pumps or volumetric infusion pumps should
always be used to control infusion rates and to prevent the
accidental administration of large volumes of diluted Propofol.

The maximum dilution must not exceed 1 part of Propofol and 4
parts of glucose 50 mg/ml (5%) (at least 2 mg propofol/ml)
intravenous infusion solution or sodium chloride 9 mg/ml (0.9%)
intravenous infusion solution or a combination solution of
glucose 40 mg/ml (4%) and sodium chloride 1.8 mg/ml (0.18%).
The mixture should be prepared aseptically immediately prior to
administration and must be administered within 6 hours after
preparation.
Propofol must not be mixed with other solutions for injection or
infusion except those mentioned above.
To reduce pain on the injection site lidocaine may be injected
immediately before the use of Propofol may be mixed,
immediately prior to administration, with preservative-free
lidocaine injection.

The infusion system should be rinsed before administration of
muscle relaxants like atracurium and mivacurium when using
the same infusion system for Propofol.
Disposal
Any remaining contents after use should be discarded.

Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.

Propofol must not be administered via infusion systems that are
provided with a microbiological filter.

The contents of one vial of Propofol and any infusion equipment
are intended for single use in one patient.
Any remainder must be discarded immediately after use.

Infusion of undiluted Propofol
When Propofol is administered as a continuous infusion, it is
recommended that equipment such as burettes, drop counter,

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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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