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Zidovudine and Lamivudine Tablets (60 tablets)
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Drug Name:Zidovudine and Lamivudine Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:Each film-coated tablet contains 300mg of zidovudine and 150mg of lamivudine.

PHARMACEUTICAL FORM:White or off-white film-coated tablet.

THERAPEUTIC INDICATIONS:Zidovudine and Lamivudine Tabelts are indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.

Specification: Each tablet contains 300mg of zidovudine and lamivudine 150mg.

POSOLOGY AND METHOD OF ADMINISTRATION:

Zidovudine and Lamivudine Tabelts may be administered with or without food. To ensure administration of the entire dose, the tablets should ideally be swallowed without crushing. For patients who are unable to swallow tablets, tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately.

Adults and Adolescents Weighing ≥30 kg

The recommended oral dose of it in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) twice daily.

Pediatric Patients

The recommended oral dosage of scored tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered twice daily.

CONTRAINDICATIONS

Zidovudine and Lamivudine Tabelts are contraindicated in patients with previously hypersensitivity to any of the components of the products. Zidovudine is contraindicated in patients with abnormally low neutrophil counts (< 0.75 × 109/L), or abnormally low haemoglobin levels (< 7.5g/dL or 4.65mmol/L). Zidovudine and Lamivudine Tablets are therefore contraindicated in these patients.

SPECIAL PRECATIONS FOR STORAGE

Keep the bottle tightly colsed and protect from light. Do not store above 30°C.

NATURE AND CONTENTS OF CONTAINER

Multipacks of 60(6 packs of 10) tablets in aluminium/aluminium foil blister

High density polyethylene (HDPE) bottle containing 30 or 60 tablets.

SHELF LIFE:24 months

Approval Number:  国药准字H20113129

Executive standard:  State Food and Drug Administration standards YBH01082011

MANUFACTURER:Anhui Biochem Bio-Pharmaceutical Co., Ltd