Gemcitabine CF 38 mg/ml, concentraat voor oplossing voor infusie

देश: नीदरलैंड

भाषा: डच

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

सक्रिय संघटक:

GEMCITABINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; GEMCITABINE

थमां उपलब्ध:

Centrafarm B.V.

ए.टी.सी कोड:

L01BC05

INN (इंटरनेशनल नाम):

GEMCITABINEHYDROCHLORIDE COMPOSITION corresponding to ; GEMCITABINE

फार्मास्यूटिकल फॉर्म:

Concentraat voor oplossing voor infusie

रचना:

ETHANOL 96 % 421,1 mg/ml ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

प्रशासन का मार्ग:

Intraveneus gebruik

चिकित्सीय क्षेत्र:

Gemcitabine

उत्पाद समीक्षा:

Hulpstoffen: ETHANOL 96 % 421,1 mg/ml; NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

प्राधिकरण की तारीख:

2009-07-06

सूचना पत्रक

PL Gemcitabine DE5530
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE CF 38 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
Gemcitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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 CF is and what it is used for
2.
What you need to know before you are given Gemcitabine CF
3.
How Gemcitabine CF is given
4.
Possible side effects
5.
How to store Gemcitabine CF
6.
Contents of the pack and other information
1. WHAT GEMCITABINE CF IS AND WHAT IT IS USED FOR
Gemcitabine CF belongs to a group of medicines called
“cytotoxics”. These medicines kill
dividing cells, including cancer cells.
Gemcitabine CF may be given alone or in combination with other
anti-cancer medicines,
depending on the type of cancer.
Gemcitabine CF 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 CF
YOU SHOULD NOT BE GIVEN GEMCITABINE CF

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
CF.
Your
doctor may
decide
to change the
dose or delay
treating
y

उत्पाद विशेषताएं

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Gemcitabine CF 38 mg/ml, concentraat voor oplossing voor infusie
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains gemcitabine hydrochloride equivalent to 38 mg
gemcitabine.
Each vial of 5.26 ml concentrate for solution for infusion contains
gemcitabine hydrochloride
equivalent to 200 mg gemcitabine.
Each vial of 26.3 ml concentrate for solution for infusion contains
gemcitabine hydrochloride
equivalent to 1,000 mg gemcitabine.
Each vial of 39.5 ml concentrate for solution for infusion contains
gemcitabine hydrochloride
equivalent to 1,500 mg gemcitabine.
Each vial of 52.6 ml concentrate for solution for infusion contains
gemcitabine hydrochloride
equivalent to 2,000 mg gemcitabine.
Excipients with known effect:
Each vial contains 3.32 mg/ml (0.144 mmol/ml) sodium and 421 mg/ml
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
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
2
unresectable, locally recurrent or metastatic breast cancer who hav