Gemcitabine 200 mg Pharmachemie B.V., poeder voor oplossing voor infusie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

GEMCITABINEHYDROCHLORIDE 228 mg/flacon SAMENSTELLING overeenkomend met ; GEMCITABINE 200 mg/flacon

Beschikbaar vanaf:

Pharmachemie B.V. Swensweg 5 2031 GA HAARLEM

ATC-code:

L01BC05

INN (Algemene Internationale Benaming):

GEMCITABINEHYDROCHLORIDE 228 mg/flacon SAMENSTELLING overeenkomend met ; GEMCITABINE 200 mg/flacon

farmaceutische vorm:

Poeder voor oplossing voor infusie

Samenstelling:

MANNITOL (D-) (E 421) ; NATRIUMACETAAT 3-WATER (E 262) ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941),

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Gemcitabine

Product samenvatting:

Hulpstoffen: MANNITOL (D-) (E 421); NATRIUMACETAAT 3-WATER (E 262); NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941);

Autorisatie datum:

2009-02-24

Bijsluiter

Gemcitabine, NL/H/1240/001-002, 26.10.23
1
rvg 101090-1 EU PIL IA/030 met NL info-clean
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 200 MG PHARMACHEMIE B.V., POEDER VOOR OPLOSSING VOOR
INFUSIE
GEMCITABINE 1000 MG PHARMACHEMIE B.V., POEDER 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 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
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 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
evaluate if you have sufficient
kidney and liver function. Before each infusion you will have samples
of your blood taken to evaluate
if you have enough blood cells to receive Gemcitabine. Your do

Productkenmerken

Gemcitabine, NL/H/1240/001-002, 26.10.23
1
rvg 101090-1 EU SPC IA/030 met NL info-clean
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine 200 mg Pharmachemie B.V., poeder voor oplossing voor
infusie
Gemcitabine 1000 mg Pharmachemie B.V., poeder voor oplossing voor
infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_GEMCITABINE 200 MG: _
Each vial contains 200 mg of gemcitabine (as hydrochloride).
_GEMCITABINE 1 G: _
Each vial contains 1 g of gemcitabine (as hydrochloride).
One ml of the reconstituted solution for infusion (see section 6.6)
contains 38 mg gemcitabine (as
hydrochloride).
Excipient with known effect:
Each 200 mg vial contains approximately 3.56 mg (0.15 mmol) sodium.
Each 1 g vial contains approximately 17.81 mg (0.77 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White or almost white compact aggregate. After reconstitution in
sodium chloride 9 mg/ml (0.9%) the
solution is clear to pale opalescent and colourless to pale yellow.
The pH of the reconstituted solution in sodium chloride 9 mg/ml (0.9%)
solution is 3.0 ± 0.3.
The osmolarity of the reconstituted solution (38 mg/ml of gemcitabine
(as hydrochloride) in sodium chloride
0.9% solution) is 775 mOsm/l.
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 followin