Gemcitabine Fresenius Kabi 40 mg/ml, concentraat voor oplossing voor infusie

Ülke: Hollanda

Dil: Hollandaca

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

Aktif bileşen:

GEMCITABINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; GEMCITABINE

Mevcut itibaren:

Fresenius Kabi Nederland B.V. Amersfoortseweg 10 E 3712 BC HUIS TER HEIDE

ATC kodu:

L01BC05

INN (International Adı):

GEMCITABINEHYDROCHLORIDE COMPOSITION corresponding to ; GEMCITABINE

Farmasötik formu:

Concentraat voor oplossing voor infusie

Kompozisyon:

ETHANOL 96 % 421 mg/ml ; NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Uygulama yolu:

Intraveneus gebruik

Terapötik alanı:

Gemcitabine

Ürün özeti:

Hulpstoffen: ETHANOL 96 % 421 mg/ml; NATRIUMHYDROXIDE (E 524); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Yetkilendirme tarihi:

2013-05-22

Bilgilendirme broşürü

110700PILD
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE FRESENIUS KABI 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, nurse or
pharmacist.
-
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 Gemcitabine is and what it is used for
2. What you need to know before you use Gemcitabine
3. How to use Gemcitabine
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
[National approved name] belongs to a group of medicines called
“cytotoxics”. These medicines kill
dividing cells, including cancer cells.
This medicine may be given alone or in combination with other
anti-cancer medicines, depending on
the type of cancer.
This medicine 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 GEMCITABINE
DO NOT USE 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:
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
Gemcitabine. Your doctor may
decide to change the dose or delay treating you depending on your
general condition and if your blood
cell

Ürün özellikleri

110700SPCD SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine Fresenius Kabi 40mg/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 hydrochloride).
Each 25 ml vial contains 1000 mg gemcitabine (as hydrochloride).
Each 50 ml vial contains 2000 mg gemcitabine (as hydrochloride).
Excipient(s) with known effect:
3.40 mg/ml to 3.70 mg/ ml (0.15 mmol/ml to 0.16 mmol/ml) sodium.
421.0 mg/ml (42.1% w/v) ethanol (96%)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to slightly yellow solution,
free from visible particles
.
pH: 7.0 to 9.0
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.
110700SPCD
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gemci