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PROPOFOL CORDEN 20 MG/ML (2%) EMULSION FOR INJECTION/INFUSION

Active substance(s): PROPOFOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
10 mg/ml emulsion for injection/infusion
20 mg/ml emulsion for injection/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 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 10 mg/ml 20 mg/ml is and what it is used for
2. Before you use 10 mg/ml 20 mg/ml
3. How to use 10 mg/ml 20 mg/ml
4. Possible side effects
5. How to store 10 mg/ml 20 mg/ml
6. Further information

1.

WHAT 10 MG/ML 20 MG/ML IS AND WHAT IT IS USED FOR

10 mg/ml 20 mg/ml 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).
10 mg/ml 20 mg/ml will be given to you as an injection by a doctor.
10 mg/ml emulsion for injection/infusion
10 mg/ml is used to:
Induce and maintain general anaesthesia in adults and paediatric patients over 1 month of age
Sedate patients over16 years of age receiving artificial respiration in intensive care
sedate adults and paediatric patients over 1 month of age during diagnostic and surgical
procedures, alone or in combination with local or regional anaesthesia
20 mg/ml emulsion for injection/infusion
20 mg/ml is used to:
Induce and maintain general anaesthesia in adults and paediatric patients over3 years of age
Sedate patients over16 years of age receiving artificial respiration in intensive care
sedate adults and paediatric patients over3 years of age during diagnostic and surgical procedures,
alone or in combination with local or regional anaesthesia

2.

BEFORE YOU RECEIVE 10 MG/ML 20 MG/ML

Do not use 10 mg/ml 20 mg/ml
in patients allergic (hypersensitive) to propofol or any of the other ingredients of name> 10 mg/ml 20 mg/ml.

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in patients allergic to peanut or soya. This is because 10 mg/ml 20 mg/ml
contains soya-bean oil.
in patients 16 years of age or younger for sedation in intensive care.

Take special care with 10 mg/ml 20 mg/ml
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 had a head injury together with a high pressure in your head.
if you have a condition called hereditary predisposition to acute porphyria.
if you are eldery or debilitated, or severely overweight.
10 mg/ml emulsion for injection/infusion
The use of 10 mg/ml is not recommended in newborn infants.
20 mg/ml mulsion for injection/infusion
20 mg/ml is not recommended in children under 3 years of age.
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 recieving
10 mg/ml 20 mg/ml.
Using other medicines
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 opiods)
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)
Using 10 mg/ml 20 mg/ml with food and drink
When receiving propofol you should avoid drinking alcohol for at least 8 hours before and after
administration of 10 mg/ml 20 mg/ml.
Pregnancy and breast-feeding
If you are pregnant you should receive 10 mg/ml 20 mg/ml only if absolutely
necessary. If you are trying to get pregnant or if you are breast-feeding, talk to your doctor or nurse
before receiving this medicine.

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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 10 mg/ml 20 mg/ml 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.
Important information about some of the ingredients of 10 mg/ml 20 mg/ml
This medicinal product contains soya-bean oil. If you are allergic to peanut or soya, do not use this
medicine (see above “Do not use 10 mg/ml 20 mg/ml”).
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially ‘sodiumfree’.

3.

HOW TO USE 10 MG/ML 20 MG/ML

You will be given 10 mg/ml 20 mg/ml 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 of 10 mg/ml 20 mg/ml will vary depending on other medicines including
premedication, your age, body weight and physical condition. The doctor will give you the correct
dose to start and to sustain anaesthesia or to achieve the required level of sedation (sleepiness), 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
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For induction of anaesthesia most adult patients aged less than 55 years are likely to require 1.5
to 2.5 mg propofol/kg body weight.
For maintenance of anaesthesia generally doses of 4 to 12 mg propofol/kg body weight/hr or
repeat bolus injections (using 10 mg/ml) dose increments of 25 mg to 50 mg
are given.

Dose requirements may be lower for elderly patients.
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
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of 0.3 to 4.0 mg propofol/kg body weight/hr are typically given. Rates of infusion greater than
4.0 mg propofol/kg body weight/hr are not recommended.
For sedation for diagnostic and surgical procedures in adults and adolescents older than 16 years
of age generally doses of 0.5 to 1 mg propofol/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 propofol/kg body
weight/hr. Additionally, single administration of 10 to 20 mg propofol can be given if a rapid
increase of the level of sedation (sleepiness) is required.

General anaesthesia
10 mg/ml emulsion for injection/infusion
Paediatric patients older than 1 month of age
For induction of anaesthesia most paediatric patients over 8 years are likely to require
approximately 2.5 mg propofol/kg body weight.
In patients younger than 8 years the dose might be higher (2.5-4 mg propofol/kg body weight).
For maintenance of anaesthesia using continuous infusion doses of 9 to 15 mg propofol/kg body
weight/hr usually achieve satisfactory anaesthesia.
In younger children, especially between the age of 1 month and 3 years, may have higher
dosage requirements.
20 mg/ml emulsion for injection/infusion
Paediatric patients younger than 3 years of age
20 mg/ml is not recommended for induction and maintenance of anaesthesia in
paediatric patients between 1 month and 3 years old, because the 20 mg/ml strength is difficult
to titrate in paediatric patients because of the very small volumes that are necessary.
Paediatric patients older than 3 years of age
For induction of anaesthesia most paediatric patients over 8 years are likely to require
approximately 2.5 mg propofol/kg body weight.
In patients younger than 8 years the dose might be higher (2.5-4 mg propofol/kg body weight).
For maintenance of anaesthesia using continuous infusion doses of 9 to 15 mg propofol/kg body
weight/hr usually achieve satisfactory anaesthesia. In younger patients, dose requirements may
be higher.
Sedation
10 mg/ml emulsion for injection/infusion
Paediatric patients older than 1 month of age
For sedation of paediatric patients during diagnostic and surgical interventions the dose
should be adjusted according to the level of sedation required. Most paediatric patients require
doses of 1 – 2 mg propofol/kg body weight for onset of sedation. Maintenance of sedation will
require 1.5-9 mg propofol/kg body weight/hr. Additionally, single administration of up to 1 mg
propofol/kg body weight can be given if a rapid increase of level of sedation is required.
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10 mg/ml must not be used in paediatric patients of 16 years of age or younger
in the indication for sedation in intensive care.

20 mg/ml emulsion for injection/infusion
Paediatric patients older than 3years of age
For sedation of paediatric patients during diagnostic and surgical interventions the dose
should be adjusted according to the level of sedation required. Most paediatric patients require

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doses of 1 – 2 mg propofol/kg body weight for onset of sedation. Maintenance of sedation will
require 1.5-9 mg propofol/kg body weight/hr.
20 mg/ml must not be used in paediatric patients of 16 years of age or
younger in the indication for sedation in intensive care.

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Duration of treatment
When used for sedation, 10 mg/ml 20 mg/ml must not be administered for more than
7 days.
If you received more 10 mg/ml 20 mg/ml 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 product, ask your anaesthesist or intensive care
doctor.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, 10 mg/ml 20 mg/ml can cause side effects, although not
everybody gets them.
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 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data

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
A feeling of pain at the site of the injection (while the injection is being given, before you fall
asleep)
Common
Slow heart beat
Mild to moderate low blood pressure
Changes in your breathing pattern
Hiccups
Hot flushes
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Uncommon
Marked low blood pressure
Cough (may also happen when you wake up)
-

Rare
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Twitching and shaking of your body, or fits (may also happen when you wake up)

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Very rare
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
Spontaneous movements and fits

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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
Excitations, headache
Feeling sick (nausea), being sick (vomiting)
-

Uncommon
Swelling and redness or blood clots at the vein along the injection site
Rare
-

Feeling sexually aroused
Dizziness, chills and sensations of cold
Cough

Very rare
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)
Fever following surgery
Changes in ECG (Brugada type ECG)
-

Not known
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 with fatal outcome (seen when propofol is used in
intensive care at higher doses than recommended)
Severe skin and tissue reaction following accidental application beside the vein
-

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via 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 10 MG/ML 20 MG/ML

Keep out of the reach and sight of children.
Do not use 10 mg/ml 20 mg/ml after the expiry date which is stated on the label
after EXP. The expiry date refers to the last day of that month.

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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
10 mg/ml emulsion for injection/infusion
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 name> 10 mg/ml must not exceed 12 hours. At the end of the procedure or at 12 hours, whichever is
the sooner, both the container of 10 mg/ml and the infusion line must be discarded
and replaced as appropriate.
20 mg/ml emulsion for injection/infusion
To be used immediately.
Must not be diluted.
10 mg/ml emulsion for injection/infusion AND 20 mg/ml emulsion
for injection/infusion
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.
Do not use 10 mg/ml 20 mg/ml if you notice particulate matter.
Medicines should not be disposed of via wastewater or household waste. Your doctor or hospital
pharmacist are responsible for the correct storage, use and disposal.

6.

FURTHER INFORMATION

What 10 mg/ml 20 mg/ml contains
-

The active substance(s) is propofol. 1 milliliter emulsion for injection/infusion contains 10 mg
20 mg propofol.
The other ingredients are soya-bean oil, refined; egg phospholipids, purified; glycerol; sodium
hydroxide (for pH-adjustment); water for injections.

What 10 mg/ml 20 mg/ml looks like and contents of the pack
10 mg/ml 20 mg/ml 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
1 x 100 ml vial
1 x 50 ml vial

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Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
{Name and address}
{tel}
{fax}
{e-mail}
This medicinal product is authorised in the Member States of the EEA under the following
names:
{Name of the Member State}
{Name of the Member State}

{Name of the medicinal product}
{Name of the medicinal product}

This leaflet was last approved in 06/2015.

-------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Method of administration
For intravenous use.
Administering 10 mg/ml 20 mg/ml 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.
10 mg/ml emulsion for injection/infusion:
Containers should be shaken before use. If two layers can be seen after shaking, the emulsion should
not be used.
10 mg/ml 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.
10 mg/ml 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 10 mg/ml
as well as the infusion system must be maintained.

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Medicinal products or liquids that are added to a running 10 mg/ml infusion should
be added close to the cannula.
10 mg/ml must not be administered via infusion systems that are provided with a
microbiological filter.
The contents of one vial of 10 mg/ml and any infusion equipment are intended for
single use in one patient.
Any remainder must be discarded immediately after use.
Infusion of undiluted 10 mg/ml
When 10 mg/ml is administered 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.
As applies to parenteral administration of all kinds of fat emulsions, the duration of use for one
infusion system for a continuous infusion of 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 10 mg/ml 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 10 mg/ml remaining at the end of the infusion period or after changing the
system needs to be discarded and destroyed.
Infusion of diluted 10 mg/ml
When 10 mg/ml 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 10 mg/ml.
The maximum dilution must not exceed 1 part of 10 mg/ml 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.
10 mg/ml 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 name> 10 mg/ml or 10 mg/ml 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 10 mg/ml.
20 mg/ml emulsion for injection/infusion
Containers should be shaken before use. If two layers can be seen after shaking, the emulsion should
not be used.
20 mg/ml is administered intravenously as an injection or as a continuous, undiluted.
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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.
20 mg/ml 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 spiking the vial.
Administration must commence without delay. During infusion sterility of 20 mg/ml
as well as the infusion system must be maintained.
Medicinal products or liquids that are added to a running 20 mg/ml infusion should
be added close to the cannula.
20 mg/ml must not be administered via infusion systems that are provided with a
microbiological filter.
The contents of one vial of 20 mg/ml and any infusion equipment are intended for
single use in one patient.
Any remainder must be discarded immediately after use.
20 mg/ml must not be diluted.
Infusion of 20 mg/ml
When 20 mg/ml is administered 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.
As applies to parenteral administration of all kinds of fat emulsions, the duration of use for one
infusion system for a continuous infusion of 20 mg/ml 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 20 mg/ml 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 < 20 mg/ml remaining at the end of the infusion period or after changing the
system needs to be discarded and destroyed.
To reduce pain on the injection site lidocaine may be injected immediately before the use of name> 20 mg/ml.
The infusion system should be rinsed before administration of muscle relaxants like atracurium and
mivacurium when using the same infusion system for 20 mg/ml.
Disposal
Any remaining contents after use should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.

June 2015

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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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