Fresenius Propoven 1 % Injection

Fresenius Propoven 1 % is a short - acting intravenous general anaesthetic. 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).

Fresenius Propoven 1 % is used to:

• Help put you to sleep before an operation or other procedure
• Sedate you when receiving artificial respiration in an Intensive Care Unit (ICU) for a period of up to 72 hours.
• Sedate you during surgical and diagnostic procedures

You should not be administered Fresenius Propoven 1 % - if you have a known hypersensitivity (allergy) to propofol or to any of the excipients of Fresenius Propoven 1 % (listed in section 6)

• if you have an allergy to soya or peanut
• for sedation of children of all ages with croup or epiglottitis receiving intensive care
• Fresenius Propoven 1 % is not recommended in children under the age of 3 years.
• Fresenius Propoven 1 % must not be used for sedation of patients less than 16 years of age in the intensive care unit.

You will not be expected to give yourself Fresenius Propoven 1 %. It will be given to you by a person who is qualified to do so. The dose will be adjusted depending on your condition and the indication. Fresenius Propoven 1 % is for intravenous use, usually on the back of your hand or in the forearm. Your anaesthetist may use a needle or cannula (a fine plastic tube). Fresenius Propoven 1 % will be injected into a vein either manually or by electric pumps. An electric pump may be used to give the injection for long operations and for use in intensive care. When used for sedation, Fresenius Propoven 1 % should not be administered for more than 72 hours. For induction of anaesthesia, Fresenius Propoven 1 % is not recommended for neonates below the age of 1 month. For maintenance of anaesthesia Fresenius Propoven 1 % is not recommended for children (neonates). Administration of Fresenius Propoven 1 % via a TCI (target controlled infusion) system is restricted to induction and maintenance of general anaesthesia in adults. It is not recommended for use in children or in the intensive care unit (ICU) sedation or sedation for surgical and diagnostic procedures.

Fresenius Propoven 1 % can have side effects. Not all side effects reported for Fresenius Propoven 1 % are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving Fresenius Propoven 1 %, please consult your healthcare provider for advice. Tell your doctor immediately if you have the following side effects, which may occur less frequently:

• Serious allergic reaction which causes swelling of the lips, face and throat, difficulty in breathing, swollen and reddened skin, hot flushes
• Build up of fluid in the lungs which can make you feeling breathless (may also happen when you wake up)
• Inflamed pancreas (pancreatitis) which causes severe stomach pain
• Kidney failure
• Convulsions or fits.

If you have these serious side effects, you may need urgent medical attention and further hospitalisation. Tell your doctor or healthcare provider if you notice any of the following side effects:

• Frequent Headache
• Involuntary movements
• Slow or fast heartbeat
• Respiratory depression
• Low blood pressure
• Changes in your breathing pattern, cough, hiccups
• Feeling sick (nausea), being sick (vomiting)
• A feeling of pain at the site of the injection

Less frequent:

• Twitching and shaking of your body, or fits (may also happen when you wake up)
• Dizziness, shivering, chills and sensations of cold
• Being unconscious after the operation
• Swelling and redness or blood clots at the vein along the injection site
• Unusual colour of urine (may also happen when you wake up)
• Fever following surgery
• Premature contractions in your heart's upper (atria) or lower (ventricles) chambers, syncope (loss of consciousness), changes in ECG
• Delayed epilepsy - like attacks. The delay period ranges from a few hours to several days
• Sexual disinhibition.

Frequency not known:

• Infection after the operation, or other infections
• Feeling euphoric
• Feeling sexually aroused
• Medicine abuse
• Irregular heart beat, heart failure
• Hypertension (high blood pressure)
• Increase in liver size
• Breakdown of muscle cells (rhabdomyolysis)
• Increase in acidity of your blood, high potassium and fat levels in your blood
• Severe skin and tissue reaction following accidental application beside the vein.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist, or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Fresenius Propoven 1 %.

Store all medicines out of reach of children. Store at or below 25 °C. Do not refrigerate or freeze. Protect from light. Do not remove from outer container until required for use. Single dose vial. Unused portions should be disposed of by a healthcare provider.

Do not use after the expiry date stated on the carton and vial.