Gemcitabine 1g powder for solution for infusion vials

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Gemcitabine hydrochloride

Pieejams no:

Sun Pharma UK Ltd

ATĶ kods:

L01BC05

SNN (starptautisko nepatentēto nosaukumu):

Gemcitabine hydrochloride

Deva:

1gram

Zāļu forma:

Powder for solution for infusion

Ievadīšanas:

Intravenous

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 08010300; GTIN: 8718104050082

Lietošanas instrukcija

V025
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
GEMCITABINE 200 MG, POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE 1000 MG, POWDER FOR SOLUTION FOR INFUSION
gemcitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Gemcitabine is and what it is used for
2.
What you need to know before you are given Gemcitabine
3.
How Gemcitabine is given
4.
Possible side effects
5.
How to store Gemcitabine
6.
Contents of the pack and other information
1.
WHAT GEMCITABINE IS AND WHAT IT IS USED FOR
Gemcitabine belongs to a group of medicines called "cytotoxics". These
medicines kill dividing cells,
including cancer cells.
Gemcitabine may be given alone or in combination with other
anti-cancer medicines, depending on the
type of cancer.
Gemcitabine 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 ARE GIVEN GEMCITABINE
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)
-
if you are breast-feeding
WARNINGS AND PRECAUTIONS
Talk to your doctor before you are given Gemcitabine.
Before the first infusion you will have samples of your blood taken to
evaluate if you have sufficient
kidney and liver function. Before each infusion you will have samples
of your blo

Produkta apraksts

OBJECT 1
GEMCITABINE 1000 MG POWDER FOR SOUTION FOR
INFUSION
Summary of Product Characteristics Updated 10-May-2018 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Gemcitabine 1000 mg, powder for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 1000 mg gemcitabine (as hydrochloride)
Excipient with known effect:
Each vial contains 17.5 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