Gemcitabine 200mg powder for solution for infusion vials

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Gemcitabine hydrochloride

Dostupné z:

Sun Pharmaceutical Industries Europe B.V.

ATC kód:

L01BC05

INN (Medzinárodný Name):

Gemcitabine hydrochloride

Dávkovanie:

200mg

Forma lieku:

Powder for solution for infusion

Spôsob podávania:

Intravenous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 08010300; GTIN: 8718104050075

Súhrn charakteristických

OBJECT 1
GEMCITABINE 200MG POWDER FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 10-May-2018 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Gemcitabine 200 mg, powder for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 200 mg gemcitabine (as hydrochloride)
Excipient with known effect:
Each vial contains 3.5 mg sodium.
One ml of the reconstituted solution for infusion contains 38 mg
gemcitabine (as hydrochloride).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for infusion.
White to off-white lyophilized cake.
4. Clinical particulars
4.1 Therapeutic indications
Gemcitabine is indicated for the treatment of locally advanced or
metastatic bladder cancer in
combination with cisplatin.
Gemcitabine is indicated for treatment of patients with locally
advanced or metastatic adenocarcinoma of
the pancreas.
Gemcitabine, in combination with cisplatin is indicated as first line
treatment of patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine
monotherapy can be
considered in elderly patients or those with performance status 2.
Gemcitabine is indicated for the treatment of patients with 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 unresectable,
locally recurrent or metastatic breast cancer who have relapsed
following adjuvant/neoadjuvant
chemotherapy. Prior chemotherapy should have included an anthracycline
unless clinically
contraindicated.
4.2 Posology and method of administration
Gemcitabine should only be prescribed by a physician qualified in the
use of anti-cancer chemotherapy.
Posology
_Bladder cancer_
_Combination use_
The recommended dose for gemcitabine is 1000 mg/m