Rapifen 500 micrograms/ml solution for injection or infusion Ref.[2472] Active ingredients: Alfentanil

For intravenous administration.

Rapifen by the intravenous route can be administered to both adults and children. The dosage of Rapifen should be individualised according to age, bodyweight, physical status, underlying pathological condition, use of other drugs and type of surgery and anaesthesia. The usual recommended dosage regimen is as follows:

If desired, Rapifen can be mixed with sodium chloride injection BP, dextrose injection BP or compound sodium lactate injection BP (Hartmann’s solution). Such dilutions are compatible with plastic bags and giving sets. These dilutions should be used within 24 hours of preparation.

Children may require higher or more frequent dosing owing to a shorter half-life of Rapifen in this age group. The elderly and debilitated may require lower or less frequent dosing owing to a longer half-life of Rapifen in this age group (dilution may be helpful).

In spontaneously breathing patients, the initial bolus dose should be given slowly over about 30 seconds (dilution may be helpful).

After intravenous administration in unpremedicated adult patients, 1 ml Rapifen may be expected to have a peak effect in 90 seconds and to provide analgesia for 5-10 minutes. Periods of more painful stimuli may be overcome by the use of small increments of Rapifen. For procedures of longer duration, additional increments will be required.

In ventilated patients, the last dose of alfentanil should not be given later than about 10 minutes before the end of surgery to avoid the continuation of respiratory depression after surgery is complete.

In ventilated patients undergoing longer procedures, Rapifen may be infused at a rate of 0.5-1 microgram/kg/minute. Adequate plasma concentrations of alfentanil will only be achieved rapidly if this infusion is preceded by a loading dose of 50-100 microgram/kg given as a bolus or fast infusion over 10 minutes.

Lower doses may be adequate, for example, in geriatric patients or where anaesthesia is being supplemented by other agents.

The infusion should be discontinued up to 30 minutes before the anticipated end of surgery.

Increasing the infusion rate may prolong recovery. Supplementation of the anaesthetic, if required, for periods of painful stimuli, is best managed by extra bolus doses of Rapifen (1-2 ml) or low concentrations of a volatile agent for brief periods.

Patients with severe burns presenting for dressing, etc, have received a loading dose of 18-28 µg/kg/min for up to 30 minutes without requiring mechanical ventilation. In heart surgery, when used as a sole anaesthetic, doses in the range of 12-50 mg/hour have been used.

The manifestations of alfentanil overdose are generally an extension of its pharmacological action, which include the following:

If hypotension is severe or persists, the possibility of hypovolaemia should be considered and controlled with appropriate parenteral fluid administration.

The suggested treatments given above do not preclude the use of other clinically indicated counter measures.

Body temperature and adequate fluid intake should be maintained and the patient observed for 24 hours. A specific opioid antagonist (e.g. naloxone) should be available to treat respiratory depression.

5 years.

Store in a controlled drug store. This medicinal product does not require any special storage conditions.

Colourless glass one-point-cut ampoules (PhEur, Type I).

Pack size: packs of 10 × 2 ml ampoules; packs of 5 and 10 × 10 ml ampoules.

For single use only. Discard any unused contents.