Gemcitabine 200mg/2ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gemcitabine hydrochloride

Available from:

Accord-UK Ltd

ATC code:

L01BC05

INN (International Name):

Gemcitabine hydrochloride

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010300; GTIN: 5055565704646

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
GEMCITABINE
Read all of this leaflet carefully before you start using 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.
IN THIS LEAFLET:
1. What Gemcitabine Concentrate for solution for infusion is and what
it is used for
2. Before you are given Gemcitabine Concentrate for solution for
infusion
3. How Gemcitabine Concentrate for solution for infusion is given
4. Possible side effects
5. How to store Gemcitabine Concentrate for solution for infusion
6. Further information
1. WHAT GEMCITABINE CONCENTRATE FOR SOLUTION FOR INFUSION
IS AND WHAT IT IS USED FOR
The name of your medicine is ‘
GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
’ but in the rest of the leaflet
it will be called ‘Gemcitabine concentrate for solution for
infusion’.
Gemcitabine Concentrate for solution for infusion belongs to a group
of medicines called “cytotoxics”. These medicines kill
dividing cells, including cancer cells.
Gemcitabine Concentrate for solution for infusion may be given alone
or in combination with other anti-cancer medicines,
depending on the type of cancer.
Gemcitabine Concentrate 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 CONCENTRATE FOR SOLUTION FOR
INFUSION
YOU SHOULD NOT BE GIVEN GEMCITABINE CONCENTRATE FOR

Summary of Product characteristics

OBJECT 1
GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
Summary of Product Characteristics Updated 01-Nov-2012 | Accord
Healthcare Limited
1. Name of the medicinal product
Gemcitabine 100 mg/ml Concentrate for Solution for Infusion
2. Qualitative and quantitative composition
Each ml contains Gemcitabine hydrochloride equivalent to 100 mg
gemcitabine.
Each vial of 2 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to
200 mg gemcitabine.
Each vial of 10 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to
1000 mg gemcitabine
Each vial of 15 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to
1500 mg gemcitabine
Each vial of 20 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to
2000 mg gemcitabine
EXCIPIENTS:
8.87 mg/ml (0.39 mmol/ml) sodium.
440 mg/ml ethanol anhydrous
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion
Clear, colourless to slightly yellow solution
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