Composition

Each mL contains 11.4 mg Gemcitabine hydrochloride which corresponds to 10 mg of the active ingredient Gemcitabine. Each vial contains 10 mg/mL Gemcitabine (as hydrochloride) Each 20 mL vial contains 200 mg Gemcitabine (as hydrochloride). Each 50 mL vial contains 500 mg Gemcitabine (as hydrochloride). Each 100 mL vial contains 1000 mg Gemcitabine (as hydrochloride) Excipients with known effect: 20 mL vial: Sodium (as sodium acetate trihydrate and sodium hydroxide) 21.49 mg (0.93 mmol). 50 mL vial: Sodium (as sodium acetate trihydrate and sodium hydroxide) 53.74 mg (2.34 mmol). 100 mL vial: Sodium (as sodium acetate trihydrate and sodium hydroxide) 107.47 mg (4.67 mmol)  

ATC Code

L01BC05  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

200 mg/20 mL x 1's; 1000 mg/100 mL x 1's (in colourless vials)  

Product Description

Concentrate for solution for infusion. Clear, colourless or almost colourless solution. Free from visible particles. pH: 5.0 – 6.0 Osmolality: 121.7 mOsmol/kg

Manufacturer Name

Fareva Unterach GmbH

Manufacturer Country

AUSTRIA  

Approval Date

2023-05-25  

Expiry Date

2028-05-24