PROPOFOL 20 MG / ML (2%) EMULSION FOR INJECTION/INFUSION - patient leaflet, side effects, dosage

Propofol 20 mg/ml (2%) Emulsion for Injection/Infusion

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.
• 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.

• 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 > 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 receive propofol

Do not use Propofol

• 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 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.

Propofol is not recommended in children < 3 years of age.

Propofol 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

• 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 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.
• 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 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:
• reduced tissue perfusion
• severe nerve damage
• blood poisoning (sepsis)

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

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 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”).

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

Propofol contains sodium.

This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially ‘sodium- free’.

• 3. HOWTOUSE 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 controls 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 2.5mg/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.

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

Paediatric patients younger than 3 years of age

• Propofol 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 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, dose requirements may be higher.

Sedation

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 Propofol for onset of sedation. Maintenance of sedation will require 1.5–9 mg/kg/h Propofol.
• 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.

4. possible side effects

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

• - Temporrary 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

• – Drug abuse and drug dependance, 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 () or search for MHRA Yellow Card in Google play or Apple App store.

By reporting side effects you can help provide more information on the safety of this medicine.

• 5. HOWTOSTORE 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 in the outer carton in order to protect from light.

Shelf life after first opening/dilution

To be used immediately.

Must not be diluted.

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 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.

6. contents of the pack and other information

What Propofol contains

• The active substance is propofol. Each ml emulsion for injection/infusion contains 20 mg of 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 20 mg/ml (2%) Emulsion for Injection/Infusion is a white or almost white, homogeneous aqueous isotonic oilin-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: 1 × 50 ml vial 5 × 50 ml vials

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 07/2020.

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 is administered intravenously as an injection or as a continuous, undiluted.

Prior to use, the 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 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.

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. Propofol must not be diluted.

Infusion of Propofol

When Propofol 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 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