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Gemcitabin 1000 mg
NAME OF THE MEDICINE
Gemcitabin Onkovis
Gemcitabin Hydrochlorid 1000mg powder for solution for infusion
COMPOSITION
Each vial contains 1000 mg gemcitabine (as gemcitabine hydrochloride).
Each ml contains 38 mg gemcitabine when reconstituted.
Excipients:
Each 1000 mg vial contains up to 20,3 mg sodium.
INDICATIONS
Gemcitabine is indicated for the treatment of locally advanced or metastatic urinary bladder cancer in combination with cisplatin.
Gemcitabine is indicated for patients with locally advanced or metastatic adenocarcinoma of the pancreas.
Gemcitabin is indicated as first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with cisplatin. Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2.
Locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first line therapy.
Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with inoperable, locally recurring or metastatic breast cancer, who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline, unless clinically contraindicated.
PRESENTATION
Type I glass vials with bromobutyl rubber stopper and flip-off aluminium cap.
Each carton contains 1 or 5 vials.
Not all pack sizes may be marketed.
THE MANUFACTURER
Actavis Italy S.p.A.
Nerviano Plant, Viale Pasteur 10
20014 Nerviano (Milan) – Italy
Marketing Authorisation Holder
Onkovis GmbH
Grube 45, 82377 Penzberg, Germany
Read the package insert carefully before use.
For any more information, please consult your doctor