TEMGESIC Solution for injection Ref.[27662] Active ingredients: Buprenorphine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Indivior UK Limited, The Chapleo Building, Henry Boot Way, Priory Park, Hull, HU4 7DY, United Kingdom

Product name and form

Temgesic Injection 1ml.

Pharmaceutical Form

Solution for injection.

Qualitative and quantitative composition

Each ml contains buprenorphine hydrochloride 324 µg, equivalent to 300 µg buprenorphine base.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Buprenorphine

Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the μ (mu) and κ (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the μ receptors which, over a prolonged period, minimises the need of illicit opioids for patients with opioid dependence.

List of Excipients

Glucose monohydrate
Hydrochloric acid
Water for injections

Pack sizes and marketing

Sealed Type 1 glass ampoules.

Pack size: five ampoules containing 1 ml.

Marketing authorization holder

Indivior UK Limited, The Chapleo Building, Henry Boot Way, Priory Park, Hull, HU4 7DY, United Kingdom

Marketing authorization dates and numbers

PL 36699/0006

03/10/1977 / 17/05/2002

Drugs

Drug Countries
TEMGESIC Austria, Germany, Finland, France, Hong Kong, Ireland, Mexico, Netherlands, New Zealand, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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