Propofol 20 mg / ml (2%) emulsion for injection/infusion – patient leaflet, side effects, dosage

1. What Propofol Sandoz is and what it is used for

Propofol Sandoz 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 Sandoz will be given to you as an injection by a doctor.

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

is used to: - Induce and maintain general anaesthesia in adults and children > 3 years of age - Sedate patients > 16 years of age receiving artificial respiration in intensive care - sedate adults and children > 3 years during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia

2. What you need to know before you take Propofol Sandoz

Do not use Propofol Sandoz

• if you are allergic to propofol or any of the other ingredients of this medicine (listed in section 6).
• in patients allergic to peanut or soya. This is because Propofol Sandoz 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 Sandoz is not recommended in newborn infants.

mended in children < 3 years of age.

Propofol Sandoz must not be used in patients of 16 years of age or younger for sedation for intensive care.

Talk to your doctor, anaesthesist or nurse before taking Propofol Sandoz

• if you have any other health problems, such as problems with your heart, breathing, kidneys or liver.
• if you have lost an extreme amount of blood or have an impaired general condition. - if your body has lost lots of water (you are dehydrated).
• 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.

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-

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• if you have a condition called hereditary predisposition to acute porphyria. - if you have mitochondrial disease (an energy metabolism disorder).

If you suffer from any of the following conditions, there is a chance that you may experience side effects that occur very rarely. These disorders are:

• decreased tissue blood flow
• severe nerve damage
• blood poisoning (sepsis)

You may feel fatigued after using Propofol Sandoz. If you are able to go home shortly after receiving propofol you should not go home unaccompanied.

In rare cases, when you receive propofol for a long period of time, you may develop a disease called propofol infusion syndrome (PIS). However, your doctor will monitor you closely and take steps to prevent this from happening.

If you are not sure if any of the above apply to you, talk to your doctor or nurse before receiving Propofol Sandoz.

Other medicines and Propofol Sandoz

Tell your doctor if you are taking, have recently taken or might take any other medicines.

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)
• Rifampicin (an antibiotic)
• Valproic acid (medicine used to treat epilepsy)

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 Sandoz should not be used unless absolutely necessary if you are pregnant. You should not breast-feed while receiving Propofol Sandoz and breast milk must be discarded for 24 hours after receiving Propofol Sandoz.

Driving and using machines

After having Propofol Sandoz 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 Sandoz, 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 Sandoz contains soya-bean oil

If you are allergic to peanut or soya, do not use this medicine (see above “Do not use Propofol Sandoz”).

Propofol Sandoz contains purified egg phospholipids. This can cause problems if you are hypersensitive to these.

Propofol Sandoz contains sodium.

This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, that is to say essentially ‘sodium- free’.

3. How to use Propofol Sandoz

You will be given Propofol Sandoz 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 6 to 12 mg/kg/h or repeat bolus injections

  (using

) 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 continuous infusion doses of 0.3 to 4.0 mg/kg/h are typically given.

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

]. 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 dose requirements.

Paediatric patients younger than 3 years of age -

n] 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.

Children over 3 years of age

• For induction of anaesthesia most paediatric patients over 8 years are likely to require approximately 2.5 mg/kg body weight

]. 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, dose requirements may be higher.

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 [

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.

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must not be used in paediatric patients of 16 years of age or younger in the indication for sedation in intensive care.

Children over 3 years 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 [P

for onset of sedation. Maintenance of sedation will require 1.5-9 mg/kg/h

].

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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 Sandoz must not be administered for more than 7 days.

If you received more Propofol Sandoz than you should

Your doctor will ensure that you receive the right amount of Propofol Sandoz 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the induction of the general anaesthesia, low blood pressure and transient breathing disturbances may occur.

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
• Temporary changes in your breathing pattern (apnoea) (while the injection is being given, before

you fall asleep)

• Hyperventilation and coughing (while the injection is being given, before you fall asleep) - Hiccups
• Hot flushes

Uncommon (may affect up to 1 in 100 people)

• Cough (during maintenance)

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
• Respiratory depression (dose depended)

• Prolonged, often painful erection (priapism).

  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 (when you are waking up)

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)
• Severe tissue damage and tissue necrosis after accidental extravascular administration

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
• Local pain, swelling after accidental extravascular administration

• Anaphylactic shock
• Drug abuse and drug dependance, mostly by healthcare professionals - Hepatitis (inflammation of the liver), acute liver failure (symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right-hand side), sometimes with loss of appetite)

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Propofol Sandoz

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 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

emulsion for injection/infusion and the infusion line must be discarded and replaced as appropriate.

n 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 this medicine if you notice particulate matter.

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

6. Contents of the pack and other information

What Propofol Sandoz contains

• The active substance is propofol. Each ml emulsion for injection/infusion contains 10 mg of propofol.

20

.

• The other ingredients are refined soya-bean oil, egg phospholipids, glycerol, sodium hydroxide

  (for pH-adjustment), water for injection.

What Propofol Sandoz looks like and contents of the pack

Propofol Sandoz emulsion for injection/infusion is a white or almost white, aqueous isotonic oil- in-water emulsion, practically free of extraneous particulate contamination and large oil droplets. Slight creaming may be visible on prolonged standing. 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

s:

l

l

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

This medicine is authorised in the Member States of the European Economic Area and in

under the following names:

This leaflet was last revised in {MM/YYYY}.

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

Method of administration

For intravenous use.

Administering Propofol Sandoz 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.

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.

n 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 P

n as well as the infusion system must be maintained. Medicinal products or liquids that are added to a running

should be added close to the cannula.

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

The contents of one vial of

and any infusion equipment are intended for single use in one patient.

Any remainder must be discarded immediately after use.

Infusion of undiluted P

When

n 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 Propofol Sandoz 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 P

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

n at the end of the infusion

period or after changing the system needs to be discarded and destroyed.

Infusion of diluted Propofol Sandoz 10 mg/ml emulsion for injection/infusion When Propofol Sandoz 10 mg/ml emulsion for injection/infusion 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 S

injection/infusion.

The maximum dilution must not exceed 1 part of Propofol Sandoz 10 mg/ml emulsion for injection/infusion 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 Sandoz 10 mg/ml emulsion for injection/infusion 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 Sandoz 10 mg/ml emulsion for injection/infusion or Propofol Sandoz 10 mg/ml emulsion for injection/infusion 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 S

injection/infusion.

Propofol Sandoz 20 mg/ml emulsion for injection/infusion:

hould

n

ted.

.

s

ly

g the vial.

fusion

stem must be maintained.

with a microbiological filter.

tended for single use in one patient.

Any remainder must be discarded immediately after use.

Propofol Sandoz 20 mg/ml emulsion for injection/infusion must not be diluted.

sion for injection/infusion

ntrol infusion rates.

12 hours.

l

lace of injection, is possible.

be discarded and destroyed.

usion.

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for injection/infusion.

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.