| Product Name: | Artemether & Lumefantrine Tablets |
| Brand Name: | Generic |
| Strength: | 20mg+120mg, 40mg+240mg, 80mg+480mg |
| Dosage Form: | Tablets(Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 6s, 24s, 100s,500s |
| 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 |
| Indication: | Artemether & lumefantrine is used to treat malaria caused by Plasmodium falciparum that is not treatable with chloroquine. It is not typically used to prevent malaria. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Artemether & Lumefantrine Tablets 20mg+120mg
- Artemether & Lumefantrine Tablets 40mg+240mg
- Artemether & Lumefantrine Tablets 80mg+480mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Artemether & Lumefantrine Tablets 20mg+120mg
Each uncoated tablet contains:
Artemether…………………………20mg
Lumefantrine………………………120mg
Excipients…………………………….q.s.
Colour: Ferric oxide Red - Artemether & Lumefantrine Tablets 40mg+240mg
Each uncoated tablet contains:
Artemether………………………..40mg
Lumefantrine……………………..240mg
Excipients……………………………q.s.
Colour: Ferric oxide Yellow - Artemether & Lumefantrine Tablets 80mg+480mg
Each uncoated tablet contains:
Artemether………………………….80mg
Lumefantrine……………………….480mg
Excipients…………………………….q.s.
Colour: Ferric oxide Black
THERAPEUTIC INDICATIONS:
Artemether & lumefantrine is used to treat malaria caused by Plasmodium falciparum that is not treatable with chloroquine. It is not typically used to prevent malaria.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].|
Dispense in tight, light-resistant container as defined in USP.
Dosage: As directed by the Physician.