Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden Phone: +800 2577 2577
Buvidal 8 mg prolonged-release solution for injection.
Buvidal 16 mg prolonged-release solution for injection.
Buvidal 24 mg prolonged-release solution for injection.
Buvidal 32 mg prolonged-release solution for injection.
| Pharmaceutical Form |
|---|
|
Prolonged-release solution for injection. Yellowish to yellow clear liquid. |
8 mg prolonged-release solution for injection: Each pre-filled syringe contains 8 mg buprenorphine
16 mg prolonged-release solution for injection: Each pre-filled syringe contains 16 mg buprenorphine
24 mg prolonged-release solution for injection: Each pre-filled syringe contains 24 mg buprenorphine
32 mg prolonged-release solution for injection: Each pre-filled syringe contains 32 mg buprenorphine
Excipient(s) with known effect: The 8 mg, 16 mg, 24 mg and 32 mg strengths contain small amounts of ethanol (alcohol), less than 100 mg per dose.
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 |
|---|
|
Buvidal 8 mg, 16 mg, 24 mg, 32 mg: Soybean phosphatidylcholine |
A 1 mL pre-filled syringe (glass, Type I) with plunger stopper (fluoropolymer-coated bromobutyl rubber) with needle (½-inch, 23 gauge, 12 mm) and needle shield (styrene butadiene rubber). The prefilled syringe is assembled in a safety device for post-injection needlestick prevention. The needle shield of the safety syringe may contain rubber latex that may cause allergic reactions in latexsensitive individuals.
Pack sizes: Pack contains 1 pre-filled syringe with stopper, needle, needle shield, safety device and 1 plunger rod.
Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden
Phone: +800 2577 2577
Buvidal prolonged-release solution for injection (weekly)
EU/1/18/1336/001 [8 mg buprenorphine/0.16 mL]
EU/1/18/1336/002 [16 mg buprenorphine/0.32 mL]
EU/1/18/1336/003 [24 mg buprenorphine 0.48 mL]
EU/1/18/1336/004 [32 mg buprenorphine/0.64 mL]
Date of first authorisation: 20 November 2018
| Drug | Countries | |
|---|---|---|
| BUVIDAL | Austria, Australia, Estonia, Spain, Finland, Croatia, Ireland, Lithuania, New Zealand, Poland, United Kingdom |
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