Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Amivas Ireland Ltd, 7 Durands Court, Parnell Street, Waterford, Ireland
Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children (see sections 4.2 and 5.1).
Consideration should be given to official guidance on the appropriate use of antimalarial agents.
It is recommended that Artesunate Amivas should be used to treat patients with severe malaria only after consultation with a physician with appropriate experience in the management of malaria.
Initial treatment of severe malaria with artesunate should always be followed by a complete treatment course with appropriate oral antimalarial therapy.
The recommended dose is 2.4 mg/kg (0.24 mL of reconstituted solution for injection per kg body weight) by intravenous (IV) injection at 0, 12 and 24 hours (see sections 4.4 and 5.2).
After at least 24 hours (3 doses) treatment with Artesunate Amivas, patients unable to tolerate oral treatment may continue to receive intravenous treatment with 2.4 mg/kg once every 24 hours (from 48 hours after start of treatment).
Treatment with Artesunate Amivas should be stopped when patients can tolerate oral treatment. After stopping Artesunate Amivas, all patients should receive a complete treatment course of an appropriate oral combination antimalarial regimen.
No dose adjustment is required (see sections 4.4 and 5.2).
No dose adjustment is required (see section 5.2).
No dose adjustment is required (see section 5.2).
No dose adjustment is recommended based on age or weight (see sections 4.4 and 5.2).
Artesunate Amivas is for IV administration only. The reconstituted solution should be administered as a slow bolus injection over 1-2 minutes.
Artesunate Amivas must be reconstituted with the supplied solvent prior to administration. Because of the instability of artesunate in aqueous solutions the reconstituted solution must be used within 1.5 hours of preparation. Therefore, the required dose of artesunate should be calculated (dose in mg = patient’s weight in kg x 2.4) and the number of vials of artesunate needed should be determined prior to reconstituting the artesunate powder.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
In cases of suspected overdosage symptomatic and supportive therapy should be given as appropriate.
2 years.
Chemical and physical in-use stability has been demonstrated for 1.5 hours at 25°C.
From a microbiological point of view, unless the method of opening/reconstituting/dilution precludes the risks of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
This medicinal product does not require any special storage conditions.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
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.
Withdraw 11 mL of the supplied 0.3 M sodium phosphate buffer with a needle and syringe and inject into the vial containing Artesunate Amivas powder for injection (the final concentration of artesunate is 10 mg/mL when reconstituted). Swirl gently (do not shake) for up to 5 to 6 minutes until the powder is fully dissolved and no visible particles remain.
Visually inspect the solution within the vial to ensure that no visible particles remain and there is no discolouration of the solution. Do not administer if the solution is discoloured or contains particulate matter.
Inject the reconstituted solution IV as a slow bolus over 1-2 minutes. Do not administer via continuous IV infusion.
Discard the vial and any unused portion of the medicinal product after use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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