Propofol Mct/Lct 1 % Injection

PROPOFOL MCT/LCT 1 % FRESENIUS 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).

PROPOFOL MCT/LCT 1 % FRESENIUS is used to:

• induce and maintain general anaesthesia
• 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.

PROPOFOL MCT/LCT 1 % FRESENIUS should not be administered:

• if you are hypersensitive (allergic) to propofol or to any of the other ingredients of PROPOFOL MCT/LCT 1 % FRESENIUS (listed in section 6)
• if you have an allergy to soya or peanuts
• in children under the age of 3 years
• for sedation of children of all ages with croup or epiglottitis (inflammation of the glottis) receiving intensive care
• for sedation of patients less than 16 years of age in the intensive care unit.

Warnings and precautions

Special care should be taken with PROPOFOL MCT/LCT 1 % FRESENIUS. Tell your doctor or healthcare provider before being given the injection:

• if you have advanced heart failure, or heart disease
• if you have lung disease, severe breathing problems (respiratory failure)
• if you have kidney disease
• if you have liver disease
• if your body has lost lots of water (you are hypovolaemic)
• if you have seizures (epilepsy)
• if you have altered levels of fat in the blood. If you are receiving total parenteral nutrition (feeding through a vein), the levels of fat in your blood must be monitored
• if you are receiving electroconvulsive therapy (ECT, a treatment for psychiatric problems)
• if you have a raised pressure inside the skull (raised intracranial pressure). In combination with low blood pressure the amount of blood reaching the brain may be decreased.
• if you have been told you have mitochondrial disease (a genetic disorder).

PROPOFOL MCT/LCT 1 % FRESENIUS may increase the risk of:

• epileptic seizures (“fits”)
• a nervous reflex that slows the heart rate (vagotonia, bradycardia).

Very occasionally, after anaesthesia, there may be a period of unconsciousness associated with stiffness of the muscles. This requires observation by the medical staff, but no other treatment. It will resolve spontaneously.

You will not be expected to give yourself PROPOFOL MCT/LCT 1 % FRESENIUS. It will be given to you by a person who is qualified to do so. 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 (such as 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.

Children and adolescents over 3 years of age: The use of PROPOFOL MCT/LCT 1 % FRESENIUS is not recommended in children younger than 3 years of age. The dose should be adjusted according to age and/or body weight. PROPOFOL MCT/LCT 1 % FRESENIUS must not be given to children and adolescents younger than 16 years of age for sedation in the intensive care unit, since its safety has not been demonstrated in this patient group for this indication.

Method of administration:

PROPOFOL MCT/LCT 1 % FRESENIUS 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). PROPOFOL MCT/LCT 1 % FRESENIUS 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, PROPOFOL MCT/LCT 1 % FRESENIUS should not be administered for more than 72 hours.

PROPOFOL MCT/LCT 1 % FRESENIUS can have side effects. Not all side effects reported for PROPOFOL MCT/LCT 1 % FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PROPOFOL MCT/LCT 1 % FRESENIUS, please consult your healthcare provider for advice.

If any of the following happens, tell your doctor immediately in order to stop administrating PROPOFOL MCT/LCT 1 % FRESENIUS:

• 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 (decreased urine output, swelling, shortness of breath).

These are all very serious side effects. If you have them, you may have had a serious reaction to PROPOFOL MCT/LCT 1 % FRESENIUS. 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 side effects:

• Headache
• Slow or fast heartbeat
• Low blood pressure
• Changes in your breathing pattern, hiccups
• Cough
• Feeling sick (nausea), being sick (vomiting)
• A feeling of pain at the site of the injection (while the injection is being given, before you fall asleep).

Less frequent side effects:

• 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 (when this has happened, the patients have recovered without problems)
• 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.

Frequency not known:

• Feeling euphoric (intense excitement)
• Feeling sexually aroused (inappropriate sexual behaviour)
• Medicine abuse, dependence, mostly by healthcare professionals
• Involuntary movements
• Irregular heart beat, changes in ECG
• Respiratory depression (you may experience shallow breathing and shortness of breath)
• Increase in liver size (your doctor will conduct tests to determine this)
• Breakdown of muscle cells (rhabdomyolysis) – you may notice muscle weakness, pain and dark red or brown urine
• Increase in acidity of your blood, high potassium and fat levels in your blood, heart failure (your doctor will conduct blood tests to determine this)
• Prolonged erection
• Pain, swelling, 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 side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of PROPOFOL MCT/LCT 1 % FRESENIUS. Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.

Store all medicines out of reach of children. Store at or below 30 °C. Do not freeze. 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 ampoule/ vial.