| Product Name: | Artemether Injection |
| Brand Name: | Generic |
| Strength: | 40mg/mL, 80mg/mL |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1mL, 2 mL Ampoule |
| Route of Administration: | For I.M. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antimalarial/Antiparasitic |
| Indication: | Treatment of severe malaria caused by Plasmodium falciparum. |
| Storage: | Store Protected from moisture at a temperature Below 30°C. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Artemether Injection 40mg/mL
- Artemether Injection 80mg/mL
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Artemether Injection 40mg/mL
Each ml contains:
Artemether…………………40mg
Benzyl Alcohol BP………..1% v/v
Arachis Oil BP……………….…q.s - Artemether Injection 80mg/mL
Each ml contains:
Artemether…………………80mg
Benzyl Alcohol BP………..1% v/v
Arachis Oil BP……………….…q.s
THERAPEUTIC INDICATION:
Treatment of severe malaria caused by Plasmodium falciparum.
CAUTION & WARNING:
CAUTION: Do not use it if the solution is not clear or has suspended matter.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store Protected from Light at a temperature between 30°C.
KEEP OUT OF REACH OF CHILDREN.
Dosage: As directed by the Physician.