Gemcitabin Ebewe concentrate for solution for i/v infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

gemcitabine (gemcitabine hydrochloride)

Available from:

EBEWE Pharma Ges. m.b.H. Nfg. KG

ATC code:

L01BC05

INN (International Name):

gemcitabine (gemcitabine hydrochloride)

Dosage:

10mg/ml

Pharmaceutical form:

concentrate for solution for i/v infusion

Units in package:

glass vial 20ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-02-02

Patient Information leaflet

11784209-04
WHAT IS IN THIS LEAFLET
1. What Gemcitabin Ebewe is and
what it is used for
2. What you need to know before you
use Gemcitabin Ebewe
3. How to use Gemcitabin Ebewe
4. Possible side effects
5. How to store Gemcitabin Ebewe
6. Contents of the pack and other
information
1. WHAT GEMCITABIN EBEWE IS
AND WHAT IT IS USED FOR
Gemcitabin Ebewe belongs to a group
of medicines called “cytotoxics”.
These medicines kill dividing cells,
including cancer cells.
Gemcitabin Ebewe may be given alone
or
in
combination
with
other
anti-cancer medicines, depending on
the type of cancer.
Gemcitabin Ebewe 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.
WHAT YOU NEED TO KNOW BEFORE
YOU USE GEMCITABIN EBEWE
DO NOT USE Gemcitabin Ebewe:
- if you are allergic (hypersensitive) to
gemcitabine or any of the other
ingredients of this medicine (listed in
section 6)
- if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Before the first infusion you will have
samples of your blood taken to check
if your liver and kidneys are working
well enough for you to receive this
medicine. Before each infusion you will
have samples of your blood taken to
check if you have enough blood cells
to receive Gemcitabin Ebewe. Your
doctor may decide to change the dose
or delay treating you depending on
your general condition and if your
blood cell counts are too low.
Periodically you will have samples of
your blood taken to check how well
your kidneys and liver are working.
Talk to your doctor, nurse or hospital
pharmacist before using Gemcitabin
Ebewe
If you have, or have previously had
liver disease, heart disease, vascular
disease or problems with your kidneys
talk to your doctor or hospital
pharmacist as you may not be able to
receive Gemcitabin Ebewe.
If you have recently had, or are going
to have radi

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabin Ebewe 10 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 11.4 mg gemcitabine hydrochloride which corresponds to
10 mg of the active ingredient
gemcitabine.
Each vial contains 10 mg/ml gemcitabine (as hydrochloride).
Each 20 ml vial contains 200 mg gemcitabine (as hydrochloride).
Each 50 ml vial contains 500 mg gemcitabine (as hydrochloride).
Each 100 ml vial contains 1000 mg gemcitabine (as hydrochloride).
Excipients with known effect
20 ml vial:
sodium (as sodium acetate trihydrate and sodium hydroxide) 21.49 mg
(0.93 mmol).
50 ml vial: sodium (as sodium acetate trihydrate and sodium hydroxide)
53.74 mg
(2.34 mmol).
100 ml vial: sodium (as sodium acetate trihydrate and sodium
hydroxide) 107.47 mg
(4.67 mmol).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Product description: clear, colourless or almost colourless solution.
Free from visible particles.
pH: 5.0 – 6.0
Osmolality: 121.7 mOsmol/kg
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 meta