Fentanyl Citrate

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fentanyl citrate 78.5 µg/mL equivalent to Fentanyl 50 µg/mL

Available from:

Juno Pharmaceuticals NZ Limited

INN (International Name):

Fentanyl citrate 78.5 µg/mL (equiv. Fentanyl 50 µg/mL)

Dosage:

50 mcg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Fentanyl citrate 78.5 µg/mL equivalent to Fentanyl 50 µg/mL Excipient: Nitrogen Sodium chloride Sodium hydroxide Water for injection

Units in package:

Ampoule, glass, 2 mL Type I clear colourless ampoules. 10 x 2mL, 20 mL

Class:

Class B3 Controlled Drug

Prescription type:

Class B1 Controlled Drug

Manufactured by:

Macfarlan Smith Ltd

Therapeutic indications:

Fentanyl is indicated for: · analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises; · use as a narcotic analgesic supplement in general and regional anaesthesia; · administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 2 mL Type I clear colourless ampoules. 10 x 2mL - 20 mL - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, 10 mL Type I clear colourless ampoules. 10 x 10mL - 100 mL - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2006-06-29

Summary of Product characteristics

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