Name of the product: PLUSTAXANO ANHIDRO 20

Active ingredient: Anhydrous docetaxel 20 mg

Dosage form: concentrated solution for perfusion

Name of the product: PLUSTAXANO ANHIDRO 80

Active ingredient: Anhydrous docetaxel 80 mg

Dosage form: concentrated solution for perfusion

Dispensing requirements: Rx only

Argentine Industry

Composition:

Each millilitre of solution contains anhydrous docetaxel 40 mg and plysorbate 80.

Each glass bottle with diluting solution contains alcohol 96 % and water for injection.

Indications:

PLUSTAXANO ANHIDRO is indicated for the treatment of locally advanced or metastasic breast carcinoma after the previous therapies have failed, and the locally advanced or metastatic non-small cell lung carcinoma after the failure of prior platinum-based therapy.

Therapeutic action:

Antineoplastic.

Storage:

Keep at temperature between 2º and 8º C in the marketed packing. Protect from the bright light.

Marketed presentations:

PLUSTAXANO ANHIDRO 20 (anhydrous docetaxel 20 mg/0.5 ml):

Packs containing 1 glass bottle with concentrated solution + 1 glass bottle with diluting solution.

Packs containing 50 glass bottles with concentrated solution + 50 glass bottles with diluting solution and 100 glass bottles with concentrated solution + 100 glass bottles with diluting solution, for use in hospitals.

PLUSTAXANO ANHIDRO 80 (anhydrous docetaxel 80 mg/2 ml):

Packs containing 1 glass bottle with concentrated solution + 1 glass bottle with diluting solution.

Packs containing 50 glass bottles with concentrated solution + 50 glass bottles with diluting solution and 100 glass bottles with concentrated solution + 100 glass bottles with diluting solution, for use in hospitals.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 48019

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist