Name of the product: NAGUN 10

Active ingredient: Doxorubicin hydrochloride 10 mg

Dosage form: lyophilised injection

Name of the product: NAGUN 50

Active ingredient: Doxorubicin hydrochloride 50 mg

Dosage form: lyophilised injection

Name of the product: NAGUN 10 (*)

Active ingredient: Doxorubicin hydrochloride 10 mg

Dosage form: injection solution

Name of the product: NAGUN 20 (*)

Active ingredient: Doxorubicin hydrochloride 20 mg

Dosage form: injection solution

Name of the product: NAGUN 50 (*)

Active ingredient: Doxorubicin hydrochloride 50 mg

Dosage form: injection solution

Name of the product: NAGUN 100 (*)

Active ingredient: Doxorubicin hydrochloride 100 mg

Dosage form: injection solution

Name of the product: NAGUN 200 (*)

Active ingredient: Doxorubicin hydrochloride 200 mg

Dosage form: injection solution

Dispensing requirements: Rx only

Argentine Industry

Composition:

NAGUN 10 lyophilised injection:

Each glass bottle with lyophilised injection contains doxorubicin hydrochloride 10 mg and mannitol.

Each glass bottle with dissolving solution contains water for injection.

NAGUN 50 lyophilised injection:

Each glass bottle with lyophilised injection contains doxorubicin hydrochloride 50 mg and mannitol.

Each glass bottle with dissolving solution contains water for injection.

NAGUN injection solution:

Each millilitre of solution contains doxorubicin hydrochloride 2 mg, sodium chloride and water for injection.

Indications:

NAGUN is indicated to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukaemia, acute myeloblastic leukaemia, Wilm's tumour, neuroblastoma, soft tissue and bone sarcomas, breast and ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, Hodgkin and non-Hodgking type lymphomas, bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types, and gastric carcinoma.

Therapeutic action:

Antineoplastic.

Storage:

NAGUN lyophilised injection: Keep at temperature below 30º C, in the marketed packing.

NAGUN injection solution: Keep at temperature between 2º and 8º C, in the marketed packing.

Marketed presentations:

NAGUN 10 lyophilised injection:

Packs containing 1 glass bottle with lyophilised injection + 1 glass bottle with dissolving solution.

NAGUN 50 lyophilised injection:

Packs containing 1 glass bottle with lyophilised injection + 1 glass bottle with dissolving solution.

NAGUN 10 injection solution (doxorubicin hydrochloride 10 mg/5 ml):

Packs containing 1 and 10 glass bottles.

NAGUN 20 injection solution (doxorubicin hydrochloride 20 mg/10 ml):

Packs containing 1 and 5 glass bottles.

NAGUN 50 injection solution (doxorubicin hydrochloride 50 mg/25 ml):

Packs containing 1 glass bottle.

NAGUN 100 injection solution (doxorubicin hydrochloride 100 mg/50 ml):

Packs containing 1 glass bottle.

NAGUN 200 injection solution (doxorubicin hydrochloride 200 mg/100 ml):

Packs containing 1 glass bottle.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 50765

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist