Gemcitabine ratiopharm 40 mg/ml, concentraat voor oplossing voor infusie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

GEMCITABINEHYDROCHLORIDE 45,6 mg/ml SAMENSTELLING overeenkomend met ; GEMCITABINE 40 mg/ml

Beschikbaar vanaf:

Actavis Group PTC ehf Reykjavikurvegur 76-78 220 HAFNARFJÖRDUR (IJSLAND)

ATC-code:

L01BC05

INN (Algemene Internationale Benaming):

GEMCITABINEHYDROCHLORIDE 45,6 mg/ml SAMENSTELLING overeenkomend met ; GEMCITABINE 40 mg/ml

farmaceutische vorm:

Concentraat voor oplossing voor infusie

Samenstelling:

STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Gemcitabine

Product samenvatting:

Hulpstoffen: STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Autorisatie datum:

2016-09-13

Bijsluiter

Gemcitabine, NL/H/3383/001, 26.10.23
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PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE RATIOPHARM 40 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR
INFUSIE
gemcitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What /…/ is and what it is used for
2.
What you need to know before you use /…/
3.
How to use /…/
4.
Possible side effects
5.
How to store /…/
6.
Contents of the pack and other information
1.
WHAT /…/ IS AND WHAT IT IS USED FOR
/…/ belongs to a group of medicines called “cytotoxics”. These
medicines kill dividing cells, including
cancer cells.
/…/ may be given alone or in combination with other anti-cancer
medicines, depending on the type of
cancer.
/…/ 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 /…/
DO NOT USE /…/:
-
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
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
/.../. 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

Productkenmerken

Gemcitabine, NL/H/3383/001, 26.10.23
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine ratiopharm 40 mg/ml, concentraat voor oplossing voor
infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 40 mg
gemcitabine (as gemcitabine
hydrochloride).
Each 5 ml vial contains 200 mg gemcitabine (as gemcitabine
hydrochloride)
Each 25 ml vial contains 1 g gemcitabine (as gemcitabine
hydrochloride)
Each 50 ml vial contains 2 g gemcitabine (as gemcitabine
hydrochloride)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The pH of the concentrate is 2.4 ± 0.4 and the osmolarity is 270-280
mOsmol/kg.
Clear, colourless or pale 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, 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 on