SUBLIMAZE

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

The safety of fentanyl IV was evaluated in 376 subjects who participated in 20 clinical trials evaluating fentanyl IV as an anaesthetic. These subjects took at least 1 dose of fentanyl IV and provided safety data. 3). Including the above-mentioned adverse reactions, Table 1 displays adverse reactions that have been reported with the use of fentanyl IV from either clinical trials or postmarketing experience.

The displayed frequency categories use the following convention:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

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. 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:

Initial Supplemental Spontaneous Respiration 50-200 mcg 50 mcg Assisted Ventilation 300-3500 mcg 100-200 mcg 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.

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.

g. 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.

1 or other opioids. Respiratory depression, obstructive airways disease. Concurrent administration with monoamine oxidase inhibitors, or within 2 weeks of their discontinuation.