Propofol 10 mg/ml Emulsion for injection/infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Propofol 10 mg/ml is and what it is used for
2. What you need to know before you are given Propofol 10 mg/ml
3. How you are given Propofol 10 mg/ml
4. Possible side effects
5. How to store Propofol 10 mg/ml
6. Contents of the pack and other information.

• If you are allergic to propofol, soybeans, peanuts or any of the other ingredients of this medicine (listed in section 6).
• for the sedation of patients aged 16 years or younger as part of intensive care.

Talk to your doctor, anaesthetist or nurse before using Propofol10 mg/ml:

• 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.
• If you have ever been told that your body has problems using fat.
• If your body has lost lots of water hypvolemia .
• If you have any other health problems, such as problems with your heart, breathing, kidneys or liver.
• If you have been generally unwell for some time.
• If you have mitochondrial disease.

You may feel affected after using Propofol. You should therefore be accompanied by someone when you leave the hospital.

The use of Propofol 10 mg/ml in newborns is not recommended, since this patient group has not been sufficiently evaluated.

Propofol may not be used for sedation in patients 16 years of age or younger during intensive care, since the safety and efficacy of Propofol has not been validated for sedation in this age group.

In the case of elderly patients, smaller doses are required for the induction of anaesthesia with Propofol 10 mg/ml. The patient’s general state of health and age should be taken into account.

The lowered dose should be administered more slowly and titrated according to the reaction.

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

In particular, tell your doctor, anaesthetist or nurse if you are taking any of the following medicines:

• Rifampicin because it can cause low blood pressure in connection with general anesthesia.
• Certain sedative and analgesic medicines such as benzodiazepines and opiates as they may increase the effects of propofol
• Valproate as a reduction in the dose for propofol should be considered if it used concomitantly with propofol

You may not ingest any alcohol after the administration of Propofol 10 mg/ml .

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Pregnancy

Propofol 10 mg/ml should only be used during pregnancy if absolutely necessary.

Breast-feeding

Studies with breast-feeding women have shown that Propofol passes into breast milk in small quantities.

Therefore, mothers should suspend breast-feeding for up to 24 hours after administration of Propofol and discard the corresponding breast milk.

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 having Propofol 10 mg/ml , do not drive a car or use any tools or machines.
• 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 medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

The administered dose varies depending on the age, body weight, the general physical state of health and the premedication. The doctor will use appropriate dose for induction and maintenance of anaesthesia or for achieveing the required depth of sedation, while carefully observing the physical responses and vital signs (pulse, blood pressure, breathing, etc).

The induction and maintenance of anaesthesia and sedation with Propofol is normally gentle with only a few signs of excitation. The most frequently reported side effects are a decrease in blood pressure and impairment of the response from the breathing centre (respiratory depression). The type, severity and frequency of these effects, which were observed in patients that were receiving Propofol, are dependent on the patient’s state of health, the type of procedure and the therapeutic measures taken.

The following side effects were particularly observed:

Very common (may affect more than 1 in 10 people)

• Local pain during the first injection

Common (may affect up to 1 in 10 people)

• Spontaneous movements and muscle spasms during induction of anaesthesia, Headache during the waking phase
• Slowed pulse
• Decrease in blood pressure
• Condition in which you start to breathe very fast (Hyperventilation) and coughing during induction of anaesthesia, temporary ineffective breathing (respiratory arrest) during induction of anaesthesia
• Hiccups during the induction, nausea and vomiting during the waking phase
• Hot flushes during the induction of anaesthesia

Uncommon (may affect up to 1 in 100 people)

• Clotting of the blood in a part of the circulatory system (Thrombosis) and vein inflammation
• Coughing during maintenance of anaesthesia

Rare (may affect up to 1 in 1,000 people)

• Feeling of dizziness, chills and perception of cold during the waking phase
• Episodes similar to epilepsy with seizures and spasm of the muscles causing backward arching of the head, neck, and spine (opisthotonus) during induction, maintenance and the
• Waking phase (very rarely delayed by hours to a few days)
• Coughing during the waking phase

Very rare (may affect up to 1 in 10,000 people)

• Severe allergic reactions (anaphylaxis), which can include angiooedema, respiratory distress due to bronchial cramping, skin redness and a decrease in blood pressure
• Being unconsciousness after operation
• Buildup of fluid in the lungs which can make you very breathless (may also happen when you wake up).
• Inflammation of the pancreas
• Discolouration of urine after longer periods of administration of Propofol 10 mg/ml
• Sexual disinhibition
• Tissue damage
• Fever after surgery

Not known: The frequency cannot be estimated on the basis of the available data

• Excess acid in the blood caused by metabolic functions (metabolic acidosis)
• Elevated potassium values in the blood
• Elevated blood lipid values
• Euphoric mood during the waking phase
• Abuse of the drug and dependency on the drug
• Involuntary movements
• Cardiac arrhythmia,
• Heart failure
• Ineffective breathing (Respiratory depression depending on the dosage)
• Liver enlargement
• Dissolution of striated muscle fibres (rhabdomyolysis)
• Kidney failure
• Local pain, swelling after erroneous extravascular application
• Prolonged, often painful erection (priapism)
• ECG changes
• 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).

After simultaneous administration of lidocaine, the following side effects can occur rarely:

• Dizziness
• Vomiting
• Drowsiness, convulsions
• Bradycardia
• Arrhythmia
• Shock.

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.

The active substance is propofol.

Each ml of emulsion for injection/infusion contains 10 mg of propofol.

Each 20 ml vial contains 200mg of propofol

Each 50 ml vial contains 500mg of propofol

Each 100 ml vial contains1000mg of propofol.

The other ingredients are: Soya-bean oil refined, Medium-chain triglycerides, Glycerol, Egg lecithin, Sodium oleate, Sodium Hydroxide (for pH adjustment) and Water for injections.

White oil-in-water emulsion for injection/infusion.

This medicinal product is supplied as:

Emulsion for injection/infusion in colourless glass vial (type II glass) with grey bromo butyl rubber stopper.

Pack sizes:

Colourless glass vial (type II) of 20 ml with grey bromobutyl rubber closure, packs of 1, 5 and 10 unit

Colourless glass vial (type II) of 50 ml with grey bromobutyl rubber closure, packs of 1 and 10 unit

Colourless glass vial (type II) of 100 ml with grey bromobutyl rubber closure, packs of 1 and 10 unit

Not all pack sizes may be marketed.

United Kingdom

Ireland:

This medicinal product is authorized in the Member States of EEA under the following names:

CMS country Invented Names

Germany (RMS) Propofol Baxter 10 mg/ml MCT Emulsion zur Injektion/Infusion

Austria Propofol Baxter 1% (10 mg/ml) MCT Emulsion zur Injektion/Infusion

Czech Republic Anesia 10 mg/ml injekční/infuzní emulze Denmark Profast 10mg/ml, injektions- og infusionsvæske, emulsion

Estonia Anesia

Greece Propofol/Baxter 10 mg/ml Γαλάκτωμα για ένεση/έγχυση

Finland Profast 10 mg/ml injektio-/infuusioneste, emulsio

France PROPOFOL BAXTER 10 mg/ml, emulsion injectable/pour perfusion

Hungary Anesia 10 mg/ml emulziós injekció vagy infúzió

Ireland Propofol 10mg/ml Emulsion for Injection/ Infusion

Italy Rapiva 10 mg/ml emulsione iniettabile e per infusion

Latvia Anesia 10 mg/ml emulsija injekcijām/ infūzijām

Lithuania Anesia 10 mg/ml injekcinė/infuzinė emulsija

Netherlands Propofol Spiva 10 mg/ml, emulsie voor injectie of infusie

Norway Profast 10 mg/ml injeksjons-/infusjonsvæske, emulsjon

Poland Propofol Baxter, 10mg/ml, emulsja do wstrzzykiwań/ do infuzji

Portugal Propofol Baxter 10 mg/ml emulsão injectável ou para perfusão

Romania Profast 10mg/ml emulsie injectabila/ perfuzabila

Sweden Profast 10 mg/ml injektionsvätska/ infusionsvätska, emulsion

Slovenia Anesia 10 mg/ml emulzija za injiciranje ali infundiranje

UK Propofol 10 mg/ml Emulsion for injection/ infusion