TEMGESIC Solution for injection Ref.[27662] Active ingredients: Buprenorphine

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with buprenorphine in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

Posology

Adults and children over 12 years

1-2 ml (300-600 micrograms of buprenorphine) every 6-8 hours as required

Elderly

There is no evidence that dosage need be modified for the elderly.

Children aged under 12 years

3-6 micrograms/kg body weight every 6-8 hours. In refractory cases up to 9 micrograms/kg may be administered. There is no clinical experience in infants below the age of 6 months.

Temgesic Injection may be employed in balanced anaesthetic techniques as a pre-medication at a dose of 300 micrograms 1.m., or as an analgesic supplement at doses of 300 to 450 micrograms i.v.

Special populations

Patients with hepatic insufficiency

Buprenorphine is metabolised in the liver. The degree and duration of its action may be different in patients with hepatic impairment. Therefore, the Temgesic dose should be reduced for these patients accordingly (see section 4.4 and 5.2).

Method of administration

Administration by i.m. or slow i.v. injection.

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

The expected symptoms of overdose would be drowsiness, nausea and vomiting; marked miosis may occur.

Supportive measures should be instituted and if appropriate naloxone or respiratory stimulants can be used.

3 years.

Store below 30°C.

Store in the original package in order to protect from light.

Sealed Type 1 glass ampoules.

Pack size: five ampoules containing 1 ml.

Administration by i.m. or slow i.v. injection.