FENTANYL KALCEKS SOLUTION FOR INJECTION 0.05 MG/ML [SIN15802P]

Product Info

FENTANYL KALCEKS SOLUTION FOR INJECTION 0.05 MG/ML

[SIN15802P]

4.1 Therapeutic indications

Fentanyl Kalceks is an opioid analgesic.
It is used:

• in low doses to provide analgesia during short surgical procedures;

• in high doses as an analgesic/respiratory depressant in patients requiring assisted ventilation;

• in combination with a neuroleptic in the technique of neuroleptanalgesia

4.2 Posology and method of administration

The dosage of fentanyl should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs, and type of surgery and anaesthesia.

To avoid bradycardia, it is recommended to administer a small intravenous dose of an anticholinergic just before anaesthetic induction.

A neuroleptic may be given to prevent nausea and vomiting.

Adult
Use as an analgesic supplement to general anaesthesia
Low dose: 2 mcg/kg
Fentanyl in small doses is most useful for minor surgery.

Moderate dose: 2–20 mcg/kg
Where surgery becomes more complicated, a larger dose will be required. The duration of activity is dependent on dosage.

High dose: 20–50 mcg/kg
During major surgical procedures, in which surgery is longer, and during which the stress response would be detrimental to the well-being of the patient, doses of 20–50 mcg/kg of fentanyl with nitrous oxide/oxygen have been shown to have an attenuating effect. When doses in this range have been used during surgery, post-operative ventilation and observation are essential in view of the possibility of extended post-operative respiratory depression.

Supplemental doses of 25–250 mcg (0.5–5 ml) should be tailored to the needs of the patient and to the anticipated time until completion of the operation.

Use as an anaesthetic agent
When attenuation of the response to surgical stress is especially important, doses of 50–100 mcg/kg may be administered with oxygen and a muscle relaxant. This technique provides anaesthesia without necessitating the use of additional anaesthetic agents. In certain cases, doses up to 150 mcg/kg may be required to produce this anaesthetic effect. Fentanyl has been used in this fashion for open heart surgery and certain other major surgical procedures in patients for whom protection of the myocardium from excess oxygen demand is particularly indicated.

Pediatrics
For induction and maintenance in children aged 2–12 years, a dose of 2–3 mcg/kg is recommended.

Use in elderly and debilitated patients
The initial dose should be reduced in elderly and debilitated patients. The effect of the initial dose should be taken into account in determining supplemental doses.

Use in patients with renal and/or hepatic impairment
The initial dose should be reduced for patients with renal and/or hepatic impairment.

Method of administration
This medicine should be given only in an environment where the airway can be controlled and by personnel who can control the airway (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
This medicine can be administered intravenously either as a bolus or by infusion, as well as intramuscular injection.

Fentanyl Kalceks may be used intravenously in adults and children.

4.3 Contraindications

Hypersensitivity to the active substance, other morphinomimetics 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.
Respiratory depression, obstructive airway disease.
Head injuries, raised intracranial pressure.
Concurrent administration with monoamine oxidase inhibitors (MAOI), or within 2 weeks of their discontinuation.
Hypovolemia and hypotension
Myasthenia gravis