| Product Name: | Raltegravir Tablets |
| Brand Name: | Generic |
| Strength: | 25mg, 100mg, 400mg, 600mg |
| Dosage Form: | Tablets (film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 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: | Antiretrovirals, HIV, AIDS. |
| Indication: | Raltegravir is in a class of medications called HIV integrase inhibitors. It works by decreasing the amount of HIV in the blood. |
| Storage: | Store at 20° to 25°C (68° to 77°F). See USP-controlled room temperature. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Raltegravir Tablets 25mg
- Raltegravir Tablets 100mg
- Raltegravir Tablets 400mg
- Raltegravir Tablets 600mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Raltegravir Tablets 25mg
Each Film-coated tablet contains:
Raltegravir
Equivalent to Raltegravir ……25mg
Excipients……………………………Q.s.
Color: Titanium dioxide and Black iron oxide - Raltegravir Tablets 100mg
Each Film-coated tablet contains:
Raltegravir
Equivalent to Raltegravir ……100mg
Excipients……………………………Q.s.
Color: Titanium dioxide and Black iron oxide - Raltegravir Tablets 400mg
Each Film-coated tablet contains:
Raltegravir
Equivalent to Raltegravir ……400mg
Excipients……………………………Q.s.
Color: Titanium dioxide and Black iron oxide - Raltegravir Tablets 600mg
Each Film-coated tablet contains:
Raltegravir
Equivalent to Raltegravir ……600mg
Excipients……………………………Q.s.
Color: Titanium dioxide and Black iron oxide
THERAPEUTIC INDICATIONS:
Raltegravir is in a class of medications called HIV integrase inhibitors. It works by decreasing the amount of HIV in the blood.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Do not use it if the seal over the bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep stored in a tightly closed container.
Dispense in original container.
Keep the 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.
Store in a dry place protected from light and moisture.
DOSAGE:
As directed by the Physician.