FENTANYL Solution for injection Ref.[7246] Active ingredients: Fentanyl

Posology

Adult

The usual dosage regimen is as follows:

Doses greater than 200 micrograms are solely for use in anaesthesia.

As a premedicant, 1-2ml may be administered intramuscularly before induction of anaesthesia.

Following intravenous administration in the non-premedicated adult patient, 2ml fentanyl may be anticipated to provide adequate analgesia for 10–20 minutes in surgical procedures involving low pain intensity. A bolus of 10ml of fentanyl can be expected to provide analgesia for about one hour. The analgesia produced is generally adequate for surgery involving moderate pain intensity. Administration of 50 microgram/kg will provide intense analgesia for some four to six hours for surgery associated with intense stimulation.

Fentanyl 50 micrograms/ml Solution for Injection/Infusion may also be administered as an intravenous infusion.

Ventilated patients may be given a loading dose as a fast infusion of approximately 1 microgram/kg/minute for the first 10 minutes, followed by an infusion of approximately 0.1 microgram/kg/minute. Alternatively, the loading dose may be administered as a bolus. The rate of infusion should be titrated to the individual patient response and lower infusion rates may be adequate. The infusion should be discontinued approximately 40 minutes before the end of surgery, unless post-operative ventilation is intended.

Lower infusion rates, e.g. 0.05-0.08 microgram/kg/minute, are required if spontaneous ventilation is to be maintained. Higher infusion rates of up to 3 micrograms/kg/minute have been employed in cardiac surgery.

It is important when estimating the required dose to assess the likely degree of surgical stimulation, the effect of premedicant drugs, and the duration of the procedure.

Paediatric population

Children aged 12 to 17 years old

Follow adult dosage

Children aged 2 to 11 years old

The usual dosage regimen in children is as follows:

Use in children

Analgesia during operation, enhancement of anaesthesia with spontaneous respiration.

Techniques that involve analgesia in a spontaneous breathing child should only be used as part of an anaesthetic technique, or given as part of a sedation/analgesia technique with experienced personnel in an environment that can manage sudden chest wall rigidity requiring intubation, or apnoea requiring airway support.

Method of administration

Fentanyl should be given only when in an environment where the airway can be controlled and by personnel who can control the airway (see section 4.4).

Intravenous and Intramuscular routes. Fentanyl 50 micrograms/ml Solution for Injection/Infusion can be administered to both adults and children via the intravenous route as a bolus or as an infusion.

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

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

Symptoms

An overdosage of fentanyl manifests itself as an extension of its pharmacologic actions. Depending on the individual sensitivity, the clinical picture is determined primarily by the degree of respiratory depression, which varies from bradypnoea to apnoea.

Management

In the presence of hypoventilation or apnoea, oxygen should be administered and respiration should be assisted or controlled as indicated. A specific narcotic antagonist, such as naloxone, should be used as indicated to control respiratory depression. This does not preclude the use of more immediate countermeasures. The respiratory depression may last longer than the effect of the antagonist; additional doses of the latter may therefore be required.

If depressed respiration is associated with muscular rigidity, an intravenous neuromuscular blocking agent might be required to facilitate assisted or controlled respiration.

The patient should be carefully observed; body warmth and adequate fluid intake should be maintained. If hypotension is severe or if it persists, the possibility of hypovolaemia should be considered and, if present, it should be controlled with appropriate parenteral fluid administration.

Shelf life: 3 years.

Do not store above 25°C.

Keep container in the outer carton.

2ml/10ml clear One point cut (OPC) glass ampoules, glass type I Ph. Eur. borosilicate glass, packed in cardboard cartons to contain 10 × 2ml/10ml ampoules.

Not all pack sizes may be marketed.

The injection is for single patient use and should be used immediately after opening. The injection should not be used if particles are present. Any unused portion should be discarded.

Fentanyl for infusion may be prepared by dilution with infusion fluids containing 5% glucose or 0.9% sodium chloride.

Fentanyl 5 microgram/ml in 5% glucose or 0.9% sodium chloride exhibited no loss due to sorption to PVC infusion solution containers.

Chemical and physical in-use stability of the diluted product has been demonstrated for 48 hours at 25°C and at 2-8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements