COMPOSITION:
Each ml (of emulsion) contains:
Propofol 10 mg
Water for Injections q. s.

DESCRIPTION:
NIRFOL MCT-LCT is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. Propofol is chemically described as 2,6 diisopropylphenol. Its empirical formula is C12H18O, with a molecular weight of 178.27.

AVAILABILITY:

Domestic Yes Export Yes Domestic Product insert

INDICATIONS AND CLINICAL USES:

NIRFOL MCT-LCT is a short-acting intravenous general anaesthetic for:

• Induction and maintenance of general anaesthesia in adults and children >1 month.

• Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children >1 month.

• Sedation of ventilated patients >16 years of age in the intensive care unit).

SPECIAL PRECAUTIONS AND WARNING:

As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or hypovolaemic or debilitated patients. Propofol clearance is blood flow dependent; therefore, concomitant medication which reduces cardiac output will also reduce propofol clearance.

Cardiac, circulatory or pulmonary insufficiency and hypovolaemia should be compensated before administration of Propofol.

Before anaesthesia of an epileptic patient, it should be checked that the patient has received the antiepileptic treatment. Although several studies have demonstrated efficacy in treating status epilepticus, administration of propofol in epileptic patients may also increase the risk of seizure.

Propofol should not be administered in patients with advanced cardiac failure or other severe myocardial disease except with extreme caution and intensive monitoring.

The risk of relative vagotonia may be increased because propofol lacks vagolytic activity. It has been associated with reports of bradycardia (occasionally profound) and also asystole. The intravenous administration of an anticholinergic agent before induction, or during maintenance of anaesthesia with Propofol should be considered, especially in situations where vagal tone is likely to predominate or when Propofol is used in conjunction with other agents likely to cause a

bradycardia.

Use of NIRFOL MCT-LCT is not recommended with electroconvulsive therapy.

As with other sedative agents, when propofol is used for sedation during operative procedures, involuntary patient movements may occur. During procedures requiring immobility these movements may be hazardous to the operative site.

Special care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used with caution. If patients receive parenteral nutrition it is necessary to take account of the amount of lipid infusion as part of the Propofol 1% formulation: 1.0 ml NIRFOL MCT-LCT contains 0.1 gram of fat.

Lipids should be monitored in the Intensive Care Unit treatment every 2 days.

Due to a higher dosage in patients with severe overweight the risk of haemodynamic effects on the cardiovascular system should be taken into consideration.

Special care should be recognised in patients with a high intracranial pressure and a low mean arterial pressure as there is a risk of a significant decrease of the intracerebral perfusion pressure.

To reduce pain on the injection site during induction of anaesthesia with NIRFOL MCT-LCT, lidocaine can be injected prior to the propofol emulsion. Lidocaine must not be used in patients with hereditary acute porphyria.

Pregnancy and lactation: Pregnancy Category B

The safety of propofol during pregnancy has not been established, so it should propofol not be given to pregnant women unless absolutely necessary. Propofol crosses placenta and could cause neonatal depression. High doses (more than 2.5 mg propofol / kg body weight for induction of anesthesia, or 6 mg propofol/kg bw/hr as maintenance dose for anesthesia) should not be serving.

Studies in lactating women with propofol showed that a small amount is excreted in breast milk, therefore mothers should discontinue breast-feeding and not to use breast milk for 24 hours after administration of propofol.

DOSAGE AND DIRECTIONS FOR USE:

NIRFOL MCT-LCT must only be given in hospitals or adequately equipped day therapy units by

physicians trained in anaesthesia or in the care of patients in intensive care.

Circulatory and respiratory functions should be constantly monitored and facilities for maintenance of patient airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times.

For sedation during surgical and diagnostic procedures Propofol should not be administered by the same person conducting the surgical or diagnostic procedure.

The dose of NIRFOL MCT-LCT 1% emulsion should be individualized based on the response of the patient and premedications used.

Supplementary analgesic agents are generally required in addition to NIRFOL MCT-LCT.

PRESENTATION:

Nirfol Intravenous Infusion with MCT-LCT (1%w/v) is available in 10 ml, 20 ml & 50 ml Transparent Glass vial. Nirfol Intravenous Infusion with MCT-LCT (1%w/v) is also available in 10 ml & 20 ml Transparent Glass Ampoule .