Gemcitabine 2g powder for solution for infusion vials

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Gemcitabine hydrochloride

Dostupné s:

Pfizer Ltd

ATC kód:

L01BC05

INN (Mezinárodní Name):

Gemcitabine hydrochloride

Dávkování:

2gram

Léková forma:

Powder for solution for infusion

Podání:

Intravenous

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 08010300; GTIN: 5015997274919

Informace pro uživatele

Page 1 of 7
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 USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, 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.
WHAT IS IN THIS LEAFLET:
1.
What Gemcitabine Powder for Solution for Infusion is and what it is
used for
2.
What you need to know before you use Gemcitabine Powder for Solution
for Infusion
3.
How to use Gemcitabine Powder for Solution for Infusion
4.
Possible side effects
5.
How to store Gemcitabine Powder for Solution for Infusion
6.
Contents of the pack and other 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 may be given alone or in combination with other
anti-cancer medicines,
depending on the type of cancer you have.
Gemcitabine Powder for Solution for Infusion is used in the treatment
of a number of types of
cancer including:

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 GEMCITABINE POWDER FOR SOLUTION
FOR
INFUSION
YOU SHOULD NOT BE GIVEN GEMCITABINE POWDER FOR SOLUTION FOR INFUSION

If you are allergic to gemcitabine or any of the other ingredients of
this medicine (listed
in section 6).

If you are breast-feeding.
Tell the doctor if you think any of the above applies to you.
WARNINGS AND PRECAUTIONS
Before the firs

Charakteristika produktu

OBJECT 1
GEMCITABINE 200 MG POWDER FOR SOLUTION FOR
INFUSION GEMCITABINE 1 G POWDER FOR SOLUTION FOR
INFUSION GEMCITABINE 2 G POWDER FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 12-Jun-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Gemcitabine 200mg Powder for Solution for Infusion
Gemcitabine 1g Powder for Solution for Infusion
Gemcitabine 2g Powder for Solution for Infusion
2. Qualitative and quantitative composition
One vial contains gemcitabine hydrochloride, equivalent to 200 mg
gemcitabine.
One vial contains gemcitabine hydrochloride, equivalent to 1 g
gemcitabine.
One vial contains gemcitabine hydrochloride, equivalent to 2 g
gemcitabine.
After reconstitution, the solution contains 38 mg/ml gemcitabine (as
hydrochloride).
Excipients
Each 200 mg vial contains approximately 3.5 mg (0.15 mmol) sodium.
Each 1 g vial contains approximately 17.5 mg (0.75 mmol) sodium.
Each 2 g vial contains approximately 35 mg (1.5 mmol) sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for infusion (powder for infusion)
White to off-white plug or powder.
4. Clinical particulars
4.1 Therapeutic indications
BLADDER CANCER:
Locally advanced or metastatic bladder cancer, in combination with
cisplatin.
PANCREATIC CANCER:
Locally advanced or metastatic adenocarcinoma of the pancreas.
NON-SMALL CELL LUNG CANCER:
First-line treatment of patients with locally advanced or metastatic
non-small cell lung cancer, in
combination with cisplatin. Gemcitabine monotherapy can be considered
in elderly patients or those with
performance status 2.
OVARIAN CANCER:
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.
BREAST CANCER:
Unresectable, locally recurrent or metastatic breast cancer, in
combination with paclitaxel, in patients
experiencing a relapse after adjuvant/neoadjuvant chemotherapy. T