SUBLIMAZE Solution for injection Ref.[49878] Active ingredients: Fentanyl

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with fentanyl citrate in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

Route of administration

Intravenous administration either as a bolus or by infusion.

Intramuscular administration.

Fentanyl 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 Special warnings and precautions).

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

It is recommended to wear gloves while opening the ampoule (see section 6.6 Special precautions for disposal and other handling).

Posology

Sublimaze, by the intravenous route, can be administered to both adults and children. The dose of Sublimaze should be individualised according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anaesthesia. Adults

The usual dosage regimen in adults is as follows:

Doses in excess of 200 mcg are for use in anaesthesia only. As a premedicant, 1-2 ml Sublimaze may be given intramuscularly 45 minutes before induction of anaesthesia.

After intravenous administration in unpremedicated adult patients, 2 ml Sublimaze may be expected to provide sufficient analgesia for 10-20 minutes in surgical procedures involving low pain intensity. 10 ml Sublimaze injected as a bolus gives analgesia lasting about one hour. The analgesia produced is sufficient for surgery involving moderately painful procedures. Giving a dose of 50 mcg/kg Sublimaze will provide intense analgesia for some four to six hours, for intensely stimulating surgery.

Sublimaze may also be given as an infusion. In ventilated patients, a loading dose of Sublimaze may be given as a fast infusion of approximately 1 mcg/kg/min for the first 10 minutes followed by an infusion of approximately 0.1 mcg/kg/min. Alternatively the loading dose of Sublimaze may be given as a bolus. Infusion rates should be titrated to individual patient response; lower infusion rates may be adequate. Unless it is planned to ventilate post-operatively, the infusion should be terminated at about 40 minutes before the end of surgery.

Lower infusion rates, e.g. 0.05-0.08 mcg/kg/minute are necessary if spontaneous ventilation is to be maintained. Higher infusion rates (up to 3 mcg/kg/minute) have been used in cardiac surgery.

Sublimaze is chemically incompatible with the induction agents thiopentone and methohexitone because of wide differences in pH.

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 (see section 4.4).

Use in elderly and debilitated patients

As with other opioids, the initial dose should be reduced in the elderly (>65 years of age) and in debilitated patients. The effect of the initial dose should be taken into account in determining supplemental doses.

Obese patients

In obese patients there is a risk of overdosing if the dose is calculated based on body weight. Obese patients should have dosage calculated according to their estimated lean body mass.

Renal Impairment

In patients with renal impairment reduced dosing of Sublimaze should be considered and these patients should be observed carefully for signs of fentanyl toxicity (see section 5.2 Pharmacokinetic properties).

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

Symptoms and signs

The manifestations of fentanyl overdosage are generally an extension of its pharmacological action. Depending on the individual sensitivity, the clinical picture is determined primarily by the degree of respiratory depression, which varies from bradypnoea to apnoea.

Treatment

Hypoventilation or apnoea: O₂ administration, assisted or controlled respiration.

Respiratory depression: Specific opioid antagonist. This does not preclude the use of immediate countermeasures.

The respiratory depression may last longer than the effect of the antagonist; additional doses of the latter may therefore be required.

Muscular rigidity: Intravenous neuromuscular blocking agent 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.

36 months.

Protect from light.

Do not store above 30°C.

Keep container in the outer carton.

Colourless glass ampoules (PhEur, USP Type I).

Pack size: packs of 10 and 50* of 2 ml and 5 ml* ampoules; packs of 5 and 10* of 10 ml ampoules.

^* not marketed

Wear gloves while opening ampoule.

Accidental dermal exposure should be treated by rinsing the affected area with water. Avoid usage of soap, alcohol, and other cleaning materials that may cause chemical or physical abrasions to the skin.

Store as a CD.