Mycophenolate mofetil - Mycoldosa EN.pdf

Name of the product: MYCOLDOSA 250 (*)

Active ingredient: Mycophenolate mofetil

Dosage form: hard capsules

Name of the product: MYCOLDOSA 500

Active ingredient: Mycophenolate mofetil

Dosage form: film-coated tablets

Dispensing requirements: Rx only

Argentine Industry

Composition:

Each MYCOLDOSA 250 capsule contains mycophenolate mofetil 250 mg, povidone K90, sodium croscarmelose, pregelatinised starch, and magnesium estearate.

Each MYCOLDOSA 500 film-coated tablet contains mycophenolate mofetil 500 mg, povidone K90, sodium croscarmelose, microcrystalline cellulose PH 120, magnesium estearate, and OPADRY II 85G28725.

Indications:

MYCLODOSA is indicated for the prevention of organ rejection following transplants, and for the treatment of resistant organ rejection in patients with kidney transplant. MYCOLDOSA must be concomitantly administered with cyclosporine and corticoids.

Therapeutic action:

Immunosuppressant.

Storage:

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

Marketed presentations:

MYCOLDOSA 250:

Packs containing 10, 20, 30, 40, 50, 60 and 100 capsules.

Packs containing 250, 500 and 1000 capsules, for use in hospitals.

MYCOLDOSA 500:

Packs containing 10, 20, 30, 40, 50, 60 and 100 film-coated tablets.

Packs containing 250, 500 and 1000 film-coated tablets, for use in hospitals.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 52115

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist