Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Amivas Ireland Ltd, 7 Durands Court, Parnell Street, Waterford, Ireland
Artesunate Amivas 110 mg powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
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Powder and solvent for solution for injection. Powder: white or almost white, fine crystalline powder. Solvent: clear and colourless solution. |
Each vial of powder contains 110 mg of artesunate.
Each vial of solvent for reconstitution contains 12 mL of 0.3 M sodium phosphate buffer.
After reconstitution, the solution for injection contains 10 mg of artesunate per mL.
Excipient(s) with known effect:
After reconstitution, the solution for injection contains 13.4 mg sodium per mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Artesunate |
Artesunate is a semi-synthetic artemisinin derivative, indicated for the initial treatment of severe malaria in adults and children. The antimalarial mechanism of action of artesunate is generally thought to depend upon activation involving iron-mediated cleavage of the endoperoxide bridge of DHA to generate an unstable organic free radical followed by alkylation, where the free radical binds to malarial proteins leading to destruction of parasite membranes. |
| List of Excipients |
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Solvent: Monosodium phosphate monohydrate |
The powder is supplied in a Type I glass vial capped with a latex-free bromobutyl rubber stopper and aluminium seal, containing 110 mg of artesunate.
The solvent is supplied in a Type I glass vial capped with a latex-free bromobutyl rubber stopper and aluminium seal, containing 12 mL of sterile 0.3 M sodium phosphate buffer for reconstitution.
Each pack contains 2 or 4 vials of artesunate powder and 2 or 4 vials of sodium phosphate buffer solvent.
Not all pack sizes may be marketed.
Amivas Ireland Ltd, 7 Durands Court, Parnell Street, Waterford, Ireland
EU/1/21/1582/001
EU/1/21/1582/002
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