ARTESUNATE AMIVAS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 110MG/VIAL

4.1 Therapeutic indications
Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children (see sections 4.2 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Consideration should be given to official guidance on the appropriate use of antimalarial agents.

4.3 Contraindications
Hypersensitivity to the active substance, to any other artemisinin antimalarial agent or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Posology and method of administration
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.

Posology
Initial treatment of severe malaria with artesunate should always be followed by a complete treatment course with appropriate oral antimalarial therapy.

Adults and children (birth to less than 18 years)
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

Elderly
No dose adjustment is required (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dose adjustment is required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustment is required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
No dose adjustment is recommended based on age or weight (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.