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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Product name and form

Fentanyl 50 micrograms/ml Solution for Injection/Infusion.

Pharmaceutical Form

Solution for injection.

A clear, colourless, sterile solution.

Qualitative and quantitative composition

Contains Fentanyl citrate the equivalent of 50 micrograms of Fentanyl in 1ml.

Each 2ml ampoule contains 100 micrograms of Fentanyl as Fentanyl citrate.

Each 10ml ampoule contains 500 micrograms of Fentanyl as Fentanyl citrate.

For the full list of excipients, see section 6.1

Active Ingredient Description
Fentanyl

Fentanyl is a potent ยต-opioid analgesic with rapid onset of analgesia and short duration of action. Its primary therapeutic actions are analgesia and sedation and is approximately 100-fold more potent than morphine as an analgesic. Secondary effects of fentanyl on central nervous system (CNS), respiratory and gastro-intestinal function are typical of opioid analgesics and are considered to be class effects.

List of Excipients

Sodium chloride
Sodium hydroxide
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization dates and numbers

PL 12762/0575

18/10/1999

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