ALFENTANIL KALCEKS SOLUTION FOR INJECTION/ INFUSION 0.5MG/ML [SIN17055P]

Product Info

ALFENTANIL KALCEKS SOLUTION FOR INJECTION/ INFUSION 0.5MG/ML

[SIN17055P]

4.1 Therapeutic indications

Alfentanil is indicated for use as:

• an anesthetic induction agent.

• an opioid analgesic in general as well as an adjuvant to regional anesthesia and for both short (bolus injections) and long (bolus, supplemented by increments or by infusion) surgical procedures.

Because of its rapid and short-lasting action, alfentanil is particularly suited as an opioid analgesic for short procedures and outpatient surgery, but also as an analgesic supplement for procedures of medium and long duration, since periods of very painful stimuli can usually be overcome by small increments of alfentanil or by adapting its infusion rate.

4.2 Posology and method of administration

The dosage of alfentanil should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anesthesia.
The initial dose should be reduced in the elderly (>65 years of age) and in debilitated patients. In children it should be increased. The effect of the initial dose should be taken into account in determining supplemental doses.
To avoid bradycardia, a small intravenous (i.v.) dose of an anti-cholinergic agent just before anesthetic induction may be administered.

Dosage

Adults

For use as an anesthetic induction agent
An i.v. bolus dose of ≥120 mcg/kg (17 ml/70 kg) alfentanil will induce unconsciousness and analgesia while maintaining good cardiovascular stability in patients with adequate muscle relaxation.

For short procedures and use in outpatients
Small doses of alfentanil are most useful for minor, short surgical procedures and for outpatients, provided cardiopulmonary monitoring equipment is available.

An i.v. bolus dose of 7 to 15 mcg/kg (1 to 2 ml/70 kg) is usually adequate for procedures lasting less than 10 minutes. Should the duration of the procedure exceed 10 minutes, further increments of 7 to 15 mcg/kg (1 to 2 ml/70 kg) should be given every 10 to 15 minutes or as required.

Although ventilatory support must be available, spontaneous breathing is maintained in most instances with a dose of 7 mcg/kg (1 ml/70 kg) or less, slowly injected; suggested increments with this technique are 3.5 mcg/kg (0.5 ml/70 kg). When postoperative nausea occurs, it is of relatively short duration and usually controlled by conventional measures.

For procedures of medium duration
The dose of initial i.v. bolus should be adapted to the expected duration of the surgical procedure as follows:

When surgery is more prolonged or more aggressive, analgesia can be maintained by:

• either increments of 15 mcg/kg (2 ml/70 kg) alfentanil when required (to avoid postoperative respiratory depression, no alfentanil should be administered during the last 10 minutes of surgery);

• or a alfentanil infusion at a rate of 1 mcg/kg/min (0.14 ml/70 kg/min) until 5 to 10 minutes before the completion of surgery.

Periods of painful stimuli can easily be managed by small dose increments or by temporarily increasing the infusion rate.

When alfentanil is used without N₂O/O₂ or another inhalation anesthetic, a higher maintenance dose of alfentanil is required.

For long procedures
Alfentanil may be used as the analgesic component of anesthesia for long lasting surgical procedures especially when rapid extubation is indicated. Optimum analgesia and stable autonomic condition are maintained through an individually adapted initial intravenous dose and by adjusting the infusion rate to the severity of the surgical stimuli and the reactions of the patient.

Administration
Alfentanil is administered by bolus injection, or bolus supplemented by increments, or by infusion.

4.3 Contraindications

Hypersensitivity to the active substance, other opioids or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.