Abacavir 300 mg - Plusabcir DOSA EN.pdf

Name of the product: PLUSABCIR

Active ingredient: Abacavir 300 mg (as abacavir sulphate)

Dosage form: film-coated tablets

Dispensing requirements: Rx only

Argentine Industry

Composition:

Each film-coated tablet contains abacavir 300 mg (as abacavir sulphate), avicel PH 200, lactose DT, sodium starch glycolate, cellactose 80, colloidal silicium dioxide, magnesium estearate and OPADRY II HP 85G28725.

Indications:

PLUSABCIR in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection.

Contraindications:

PLUSABCIR is contraindicated in patients with previously demonstrated hypersensitivity to abacavir or to any other component of the product. After a hypersensitivity reaction to abacavir, NEVER restart PLUSABCIR or any other product containing abacavir.

PLUSABCIR is contraindicated in patients with severe or moderate hepatic impairment.

Therapeutic action:

Antiretroviral.

Storage:

Keep at temperature between 15º and 30º C in the marketed packing.

Marketed presentations:

Packs containing 60 film-coated tablets.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 53173

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist