Diprivan 10mg/ml Injection /

a) Induction and maintenance of general anaesthesia as part of a balanced anaesthetic technique.

b) Sedation of ventilated adult patients receiving intensive care, for a period of up to 72 hours.

c) Conscious sedation for surgical and diagnostic procedures in adults provided that there are adequate facilities for monitoring of haemodynamic and oxygenation parameters and if administered by a qualified anaesthetist.

• Known hypersensitivity to DIPRIVAN 1 %.
• DIPRIVAN 1 % is not recommended in children under the age of 3 years.
• Sedation of children of all ages with croup or epiglottitis receiving intensive care (see WARNINGS AND SPECIAL PRECAUTIONS).
• Appropriate care should be applied in patients with disorders of fat metabolism, patients predisposed to fat embolism and in other conditions where lipid emulsions must be used cautiously.
• Fat metabolism may be disturbed in conditions such as renal insufficiency, uncompensated diabetes mellitus, certain forms of liver insufficiency, metabolic disorders, severe trauma including long-bone and multiple fractures, and sepsis.

Respiration will be depressed and must be monitored to ensure adequate gas exchange. Special care should be exercised when used with other respiratory depressants. Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial ventilation and oxygen enrichment and other resuscitative facilities should be readily available at all times. DIPRIVAN 1 % should not be administered by the person conducting the diagnostic or surgical procedure. A generalised systemic reaction which may be anaphylactic in nature (including angioedema, bronchospasm, erythema and hypotension) may occur following DIPRIVAN 1 % administration - estimated as 1 in 15 000. When DIPRIVAN 1 % is administered to an epileptic patient, there may be a risk of convulsion. In the elderly, debilitated or ASA Grades 3 or 4 patients, rapid single or repeated bolus administration should not be used in order to minimise undesirable cardiorespiratory side effects. DIPRIVAN 1 % should be given by those trained in anaesthesia (or where appropriate, doctors trained in the care of patients in intensive care).

When DIPRIVAN 1 % is administered for conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation. An adequate period is needed prior to discharge of the patient to ensure full recovery after general anaesthesia. Very rarely the use of DIPRIVAN 1 % may be associated with the development of a period of post-operative unconsciousness, which may be accompanied by an increase in muscle tone. This may or may not be preceded by a period of wakefulness. Although recovery is spontaneous, appropriate care of an unconscious patient should be administered. Caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients. The pharmacokinetics of propofol may be prolonged in people with chronic hepatic cirrhosis or chronic renal impairment. Recovery times may double as a result. The effects of acute hepatic or renal failure on the pharmacokinetics of propofol have not been studied. EDTA is a chelator of metal ions, including zinc. The need for supplemental zinc should be considered during prolonged administration of DIPRIVAN 1 %, particularly in patients who are predisposed to zinc deficiency, such as those with burns, diarrhoea and/or major sepsis. DIPRIVAN 1 % lacks vagolytic activity and has been associated with reports of bradycardia, occasionally profound and also asystole. The intravenous administration of an anticholinergic medicine before induction, or during maintenance of anaesthesia should be considered, especially in situations where vagal tone is likely to predominate or when DIPRIVAN 1 % is used in conjunction with other medicines likely to cause a bradycardia.

Patients should be advised that performance at skilled tasks, such as driving and operating machinery, may be impaired for some time after general anaesthesia.

The neuromuscular blocking medicines, atracurium and mivacurium should not be given through the same intravenous line as DIPRIVAN 1 % without prior flushing. DIPRIVAN 1 % has been used in association with spinal and epidural anaesthesia and with commonly used premedication, neuromuscular blocking medicines, inhalation and analgesic medicines; no pharmacological incompatibility has been encountered. Dosage adjustment may be necessary when used together with the above medicines, particularly the narcotics (e.g. morphine, meperidine and fentanyl), combinations of opioids and sedatives (e.g. benzodiazepines, barbiturates, droperidol etc.), supplementary analgesic medicines (e.g. nitrous oxide or opioids) and the potent inhalation medicines (e.g. isoflurane, enflurane and halothane). Where general anaesthesia with DIPRIVAN 1 % is used simultaneously with a regional anaesthetic technique, lower doses of DIPRIVAN 1 % may be required.

Pregnancy: DIPRIVAN 1 % should not be used in pregnancy. DIPRIVAN 1 % crosses the placenta and may be associated with neonatal depression. It should not be used for obstetric anaesthesia. DIPRIVAN 1 % has been used, however, during termination of pregnancy in the first trimester.

Lactation: In mothers who are breastfeeding, safety to the neonate has not been established.

General: Side effects include excitation, involuntary movement, hiccup, flushing and hypertension. During induction and maintenance of anaesthesia, hypotension and apnoea may occur. Hypotension may require use of intravenous fluids and reduction of the rate of administration of DIPRIVAN 1 % during the period of anaesthetic maintenance. Less frequently, tachycardia, premature ventricular contractions, premature atrial contractions, syncope, abnormal ECG, and ST segment depression may occur.

Epileptiform movements, including convulsions and opisthotonos have been reported in 0,5 % at induction of anaesthesia, during maintenance of anaesthesia and during recovery. During the recovery phase nausea, vomiting and headache may occur. There have been reports of rhabdomyolysis when DIPRIVAN 1 % has been administered at doses greater than 4 mg/kg/hr for ICU sedation. Sexual disinhibition has been reported during recovery. Pulmonary oedema. Discolouration of urine has been reported following prolonged administration of DIPRIVAN 1 %. There have been reports of post-operative fever. Pancreatitis has been observed following the use of DIPRIVAN 1 %; a causal relationship has not been clearly established.

Symptoms: Accidental overdosage is likely to cause cardio respiratory depression.

Treatment: Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression would require lowering of the patientu2019s head, and, if severe, use of plasma expanders and pressor medicines.