Gemcitabine 2g powder for solution for infusion vials

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Gemcitabine hydrochloride

Tilgjengelig fra:

Accord-UK Ltd

ATC-kode:

L01BC05

INN (International Name):

Gemcitabine hydrochloride

Dosering :

2gram

Legemiddelform:

Powder for solution for infusion

Administreringsrute:

Intravenous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 08010300; GTIN: 5060149316023

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 200 MG POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE 1 G POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE 2 G POWDER FOR SOLUTION FOR INFUSION
Gemcitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor, nurse or
pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are
the same as yours.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor,
nurse or pharmacist. See section 4.
IN THIS LEAFLET
:
1. What Gemcitabine powder for solution for infusion is and what it is
used for
2. Before you are given Gemcitabine powder for solution for infusion
3. How Gemcitabine powder for solution for infusion is given
4. Possible side effects
5. How to store Gemcitabine powder for solution for infusion
6. Further information
1. WHAT GEMCITABINE POWDER FOR SOLUTION FOR INFUSION IS AND WHAT IT IS
USED FOR
Gemcitabine powder for solution for infusion belongs to a group of
medicines called “cytotoxics”. These medicines
kill dividing cells, including cancer cells.
Gemcitabine powder for solution for infusion may be given alone or in
combination with other anti-cancer medicines,
depending on the type of cancer.
Gemcitabine powder for solution for infusion is used in the treatment
of the following types of cancer:

non-small cell lung cancer (NSCLC), alone or together with cisplatin

pancreatic cancer.

breast cancer, together with paclitaxel.

ovarian cancer, together with carboplatin.

bladder cancer, together with cisplatin.
2. BEFORE YOU ARE GIVEN GEMCITABINE POWDER FOR SOLUTION FOR INFUSION
YOU SHOULD NOT BE GIVEN GEMCITABINE POWDER FOR SOLUTION FOR INFUSION:
- if you are allergic (hypersensitive) to gemcitabine or any of the
other ingredients of Gemcitabine powder for solution
for inf

Preparatomtale

OBJECT 1
GEMCITABINE 2 G POWDER FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 16-Mar-2017 | Accord
Healthcare Limited
1. Name of the medicinal product
Gemcitabine 2 g Powder for Solution for Infusion
2. Qualitative and quantitative composition
One vial contains gemcitabine hydrochloride equivalent to 2 g
gemcitabine.
After reconstitution, the solution contains 38 mg/ml of gemcitabine.
Excipients
Each 2 g vial contains 35 mg (1.52 mmol) sodium.
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Powder for solution for infusion.
White to off-white plug or powder.
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.
Recommended posology
_Bladder cancer _
_Combination use_
The recommended dose for gemcitabine is 1000 mg/m
2
, given by 30-minute infusion. T