GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Lamivudine USP………………………150mg
Nevirapine anhydrous USP…….200mg
Zidovudine USP………………………300mg
Color: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Dispense in a tight, light-resistance, container.
Dispense in original container.
DO NOT BREAK OR CRUSH TABLET.
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:
Store in dry place protected from light and moisture.
DOSAGE: As directed by the Physician.
Attach dispensing label as per end country.
Lamivudine, Nevirapine and Zidovudine Tablets 150mg+200mg+300mg Technical Specification:
| Product Name: | Lamivudine, Nevirapine and Zidovudine Tablets |
| Brand Name: | Generic |
| Strength: | 150mg+200mg+300mg |
| 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: | The combination of lamivudine and zidovudine is used along with other medications to treat human immunodeficiency virus (HIV) infection. Lamivudine and zidovudine are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). They work 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:
A) Lamivudine, Nevirapine and Zidovudine Tablets 150mg+200mg+300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Lamivudine, Nevirapine and Zidovudine Tablets 150mg+200mg+300mg
Each film-coated tablet contains:
Lamivudine USP………………………150mg
Nevirapine anhydrous USP…….200mg
Zidovudine USP………………………300mg
Color: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
The combination of lamivudine and zidovudine is used along with other medications to treat human immunodeficiency virus (HIV) infection. Lamivudine and zidovudine are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). They work by decreasing the amount of HIV in the blood.
CAUTION & WARNING:
CAUTION: Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Dispense in original container.
DO NOT BREAK OR CRUSH TABLET.
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.
Store in dry place protected from light and moisture.
DOSAGE: As directed by the Physician.
Attach dispensing label as per end country.
