GYSATY®
Bortezomib 3.5 mg

Lyophilized powder for injection

Argentine Industry - Dispense under prescription

 

Qualitative and quantitative composition

Each glass bottle contains of lyophilized contains

Bortezomib 3.5 mg
Excipients:
Manitol 35.0 mg

Each dissolving solution glass bottle contains:

Normal saline solution USP / EP (Sodium chloride 0.9%) 3.5 mL

Indications and usage

GYSATY® is indicated for the treatment of multiple myeloma patients.

GYSATY® is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

Clinical Pharmacology

Pharmacotherapeutic group: antineoplastic agent, other antineoplastic agents. 

Dosage and administration

GYSATY® may be administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL

Marketed Presentation

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

Storage

Unopened vials can be stored below 30 °C. Keep the product inside the marketed packing and protected from light.

Information for the patient

"If any inconvenience is presented with the product, the patient can fill the sheet provided on the website of ANMAT: http://www.anmat.gov.ar/farmacovigilancia/Notificar.asp or call ANMAT, which responds to 0800-333 -1234 ".

Medicinal speciality authorised by the Ministry of Health.
Certificado Nº  57464

Laboratorio DOSA S.A. 
Girardot 1369 (C1427AKC) City of Buenos Aires, Argentina.
Pharmaceutical Director: María C. Terzo, Pharmacist.