ALFENTANIL-HAMELN

What it is

Alfentanil-Hameln contains alfentanil hydrochloride equivalent to 0.5 mg alfentanil per mL, with 9.0 mg sodium chloride in water for injection. It is supplied as a sterile, clear and colourless solution for injection. Alfentanil is a potent, short-acting opioid analgesic chemically related to fentanyl.

Approved indications

Alfentanil-Hameln is indicated for intravenous use by specialist anaesthetists and their trainees as an analgesic supplement given by incremental intravenous boluses or continuous infusion, and as an anaesthetic induction agent in patients undergoing in-patient surgery when endotracheal intubation and controlled ventilation are to be used. — Analgesic supplement for short procedures and outpatients, provided that patients are maintained under appropriate post-operative surveillance — Analgesic supplement for procedures of medium to long duration — Anaesthetic induction agent in patients with adequate muscle relaxation undergoing in-patient surgery

Dosing overview

Alfentanil-Hameln should be administered intravenously. Dosage should be individualised taking into consideration factors such as age, body weight, physical status, underlying pathological condition, use of other medicines, type of anaesthesia to be used and type and duration of the surgical procedure. The lowest effective dose should be used. For analgesic supplementation with controlled ventilation techniques, dosing varies by procedure duration:

The initial dose of alfentanil should be appropriately reduced in the elderly (>65 years of age) and in cirrhotic patients. Alfentanil-Hameln should not be given in the last 10 minutes prior to completion of surgery.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of alfentanil. Healthcare practitioners should be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase. Marked respiratory depression has been reported as occurring after periods of up to several hours after the patient has been perceived to be alert, conversing coherently, and with normal respiration. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Dosages and durations should be limited to the minimum required and patients monitored for signs and symptoms of respiratory depression and sedation. Because of the risks associated with the use of opioids, alfentanil should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain. Alfentanil poses risks of hazardous and harmful use which can lead to overdose and death. Patients' risk of hazardous and harmful use should be assessed before prescribing and monitored regularly during treatment. Alfentanil may cause skeletal muscular rigidity, particularly of the truncal muscles, at doses below 20 micrograms/kg. The incidence and severity of muscular rigidity is usually dose related, and at anaesthetic induction dosages (above 120 micrograms/kg) will consistently produce muscular rigidity with an immediate onset.

Contraindications

Alfentanil-Hameln is contraindicated in those with a known intolerance to the medicine, components of the formulation or to other opioid analgesics. It is contraindicated in post-operative analgesia. It is contraindicated for use in patients with severe respiratory disease, acute respiratory disease and respiratory depression. It is contraindicated for use in chronic (long-term) non-cancer pain.

Regulatory history

Alfentanil-Hameln was first approved on 17 March 2023. Two strengths are registered on the ARTG: 1 mg/2 mL solution for injection ampoule (ARTG 386331) and 5 mg/10 mL solution for injection ampoule (ARTG 386330), both first listed 2023-03-17 under licence category RE.