Gemcitabine 38 mg/ml Concentrate for Solution for Infusion

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

GEMCITABINE HYDROCHLORIDE

थमां उपलब्ध:

Hospira UK Limited

ए.टी.सी कोड:

L01BC05

INN (इंटरनेशनल नाम):

GEMCITABINE HYDROCHLORIDE

डोज़:

38 Base mg/ml

फार्मास्यूटिकल फॉर्म:

Concentrate for solution for infusion

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

gemcitabine

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2011-06-10

सूचना पत्रक

Page 1 of 7 2017-0026539
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 38MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
GEMCITABINE
READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START RECEIVING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, nurse or
pharmacist.

If you get any side effects
, talk to your doctor, or pharmacist or nurse. This includes
any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Gemcitabine Concentrate for Solution for Infusion is and what
it is used for
2.
What you need to know 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.
Contents of the pack and other
information
1. WHAT GEMCITABINE CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT
IT IS USED FOR
Gemcitabine Concentrate for Solution for Infusion (Gemcitabine)
belongs to a group of
medicines called ‘cytotoxics’. These medicines kill dividing
cells, including cancer cells.
Gemcitabine may be given on its own or in combination with other
anti-cancer medicines
(e.g. cisplatin, paclitaxel, carboplatin), depending on the type of
cancer you have.
Gemcitabine is used in the treatment of the following types of cancer:

NON-SMALL CELL LUNG CANCER (NSCLC), when given alone or together with
cisplatin

PANCREATIC CANCER

BREAST CANCER, when given together with paclitaxel

OVARIAN CANCER, when given together with carboplatin

BLADDER CANCER, when given together with cisplatin
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GEMCITABINE CONCENTRATE
FOR SOLUTION
FOR INFUSION
YOU SHOULD NOT BE GIVEN GEMCITABINE IF:

you are allergic to gemcitabine or any of the other ingredients of
this medicine (listed in
section 6).

you are breast-feeding
WARNINGS AND PRECAUTIONS

उत्पाद विशेषताएं

Health Products Regulatory Authority
22 October 2018
CRN008HFZ
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of Gemcitabine Concentrate for Solution for Infusion contains
gemcitabine
hydrochloride, equivalent to 38 mg gemcitabine.
The quantitative composition of each presentation is provided in the
table below:
Presentation
Strength
Quantity of gemcitabine
(as hydrochloride)
Volume of Solution
200mg/ 5.3 ml
38 mg/ml
200 mg
5.3 ml
1g/26.3 ml
38 mg/ml
1 g
26.3 ml
2g/52.6 ml
38 mg/ml
2 g
52.6 ml
Excipients with known effect: Each ml of concentrate contains up to
0.46mg sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate)
A clear, colourless or light straw-coloured solution, practically free
from visible
particles.
pH: 2.0-3.0
Osmolarity: 266 mOsmol/L
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.
Health Products Regulatory Authority
22 October 2018
CRN008HFZ
Page 2 of 26
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 brea