Product Details
Artesunate injection (combipack)
60MG
Product Description :
ARTESUNATE INJECTION 60 mg – COMBIPACK
Sterile Powder for Solution for Intravenous or Intramuscular Administration
1. COMPOSITION
Each vial contains:
• Artesunate 60 mg.
• Excipients: As applicable.
Each combipack contains the Artesunate 60 mg vial with the supplied diluent/solvent and necessary administration components, as applicable.
2. PHARMACEUTICAL FORM
Sterile, white to off-white powder for solution for intravenous or intramuscular administration.
3. THERAPEUTIC CLASS
Antimalarial Agent – Artemisinin Derivative.
4. INDICATIONS
Artesunate Injection is indicated for the treatment of severe malaria, including severe Plasmodium falciparum malaria. It may be used in patients who require parenteral antimalarial therapy according to applicable treatment guidelines.
5. CONTRAINDICATIONS
• Hypersensitivity to artesunate, artemisinin derivatives, or any component of the formulation.
• Use should be based on an appropriate clinical assessment and applicable malaria treatment guidelines.
6. DRUG INTERACTIONS
• Concomitant medicines should be reviewed for potential interactions.
• Particular attention should be given to medicines affecting hepatic metabolism or having overlapping safety concerns.
• Antimalarial therapy should follow the recommended treatment regimen and applicable guidelines.
The treating physician should review all concomitant medications before administration.
7. ADMINISTRATION
For intravenous or intramuscular administration after reconstitution with the supplied diluent/solvent, as applicable. Reconstitute under aseptic conditions and administer according to the approved product information and institutional malaria treatment protocol.
8. STORAGE
Store according to the storage conditions stated on the approved product label. Protect from excessive heat, moisture and light. After reconstitution, use within the period specified in the approved product informatio