GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Abacavir and Lamivudine tablet USP 600mg/300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Abacavir and Lamivudine tablet USP 600mg/300mg
Each Film-coated tablet contains:
Abacavir Sulfate USP
Equivalent to abacavir…………………………………600mg
Lamivudine USP…………………………………………..300mg
Excipients……………….q.s.
Colour: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Abacavir/Lamivudine is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: It is dangerous to take this preparation exept in accordance with the medical advice
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) excusions permitted to 15°C to 30°C [see USP Controlled Room Temperature].
Dispense in tight, light resistant Container.
Dosage: As directed by the Physician.
The usual dose is 1 tablet twice a day or 2 tablets once a day.
Do not skip doses.
Attach dispensing label as per end country.

Abacavir and Lamivudine tablet USP 600mg/300mg Technical Specification:

Product Name:Abacavir and Lamivudine tablet USP
Brand Name:Generic
Strength:600mg/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:Anti-HIV, Antiretrovirals, AIDS
Indication: Abacavir/Lamivudine is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg.
Storage:Store at 20° to 25°C (68° to 77°F) excusions permitted to 15°C to 30°C [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Abacavir and Lamivudine tablet USP 600mg/300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Abacavir and Lamivudine tablet USP 600mg/300mg
    Each Film-coated tablet contains:
    Abacavir Sulfate USP
    Equivalent to abacavir…………………………………600mg
    Lamivudine USP…………………………………………..300mg
    Excipients……………….q.s.
    Colour: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Abacavir/Lamivudine is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: It is dangerous to take this preparation exept in accordance with the medical advice
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) excusions permitted to 15°C to 30°C [see USP Controlled Room Temperature].
Dispense in tight, light resistant Container.
Dosage: As directed by the Physician.
The usual dose is 1 tablet twice a day or 2 tablets once a day.
Do not skip doses.
Attach dispensing label as per end country.