Gemtero Description

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Description

GEMTERO (Gemcitabine for Injection 200 mg): Each vial contains Gemcitabine Hydrochloride 227.6 mg Ph.Eur. equivalent to Gemcitabine 200 mg.
GEMTERO (Gemcitabine for Injection 1 g): Each vial contains Gemcitabine Hydrochloride 1138 mg Ph.Eur. equivalent to Gemcitabine 1 g.
Gemcitabine for injection is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HCl is 2'-deoxy-2',2'-difluorocytidine monohydrochloride (β-isomer).
The empirical formula for gemcitabine HCl is C₉H₁₁F₂N₃O₄·HCl. Gemcitabine HCl is a white to off-white solid. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents.
The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine for injection contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) and the excipients are Mannitol, Sodium Acetate Trihydrate, Sodium Hydroxide, Hydrochloric Acid & water for injection.

gemcitabine

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma