Vinorelbine Sandoz 10 mg/ml, concentraat voor oplossing voor infusie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

VINORELBINEDITARTRAAT 13,85 mg/ml SAMENSTELLING overeenkomend met ; VINORELBINE 10 mg/ml

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

L01CA04

INN (Algemene Internationale Benaming):

VINORELBINEDITARTRAAT 13,85 mg/ml SAMENSTELLING overeenkomend met ; VINORELBINE 10 mg/ml

farmaceutische vorm:

Concentraat voor oplossing voor infusie

Samenstelling:

STIKSTOF (HEAD SPACE) (E 941) ; WATER, GEZUIVERD,

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Vinorelbine

Product samenvatting:

Hulpstoffen: STIKSTOF (HEAD SPACE) (E 941); WATER, GEZUIVERD;

Autorisatie datum:

2008-12-01

Bijsluiter

Sandoz B.V.
Page 1
FOUT! ONBEKENDE NAAM VOOR
DOCUMENTEIGENSCHAP. Sandoz
®
10 mg/ml,
concentraat voor infusievloeistof, RVG 35140
1313-V12
1.3.1.3 Bijsluiter
Augustus 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
VINORELBINE SANDOZ
® 10 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
vinorelbine
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 or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What [nationally completed name] is and what it is used for
2. What you need to know before you use [nationally completed name]
3. How to use [nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] is an anti-cancer medicine. It belongs to
a group of drugs called vinca
alkaloids.
[Nationally completed name] is used for certain types of advanced lung
and breast cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE [NATIONALLY COMPLETED NAME]
DO NOT USE [NATIONALLY COMPLETED NAME]:
•
if you are allergic (hypersensitive) to vinorelbine, other vinca
alkaloids, or any of the other
ingredients of this medicine (listed in section 6)
•
if you have or have recently had a serious infection, or if you have a
significant reduction of your
white blood cells (neutropenia)
•
if you have a significant reduction of your blood platelets
•
if you are breast feeding
•
if you have recently had or you are going to have a vaccine against
yellow fever.
If any of the above applies to you,
DO NOT USE THIS MEDICINE AND TALK TO YOUR DOCTOR.
Sandoz B.V.
Page 2
FOUT! ONBEKENDE NAAM VOOR
DOCUMENTEIGENSCHAP. Sandoz
®
10 mg/ml,
concentraat voor infusievloeistof, RVG 35140

Productkenmerken

Sandoz B.V.
Page 1
FOUT! ONBEKENDE NAAM VOOR
DOCUMENTEIGENSCHAP.
Sandoz 10 mg/ml,
concentraat voor oplossing voor infusie
RVG 35140
1311-V11
1.3.1.1 Summary of Product Characteristics
Augustus 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vinorelbine Sandoz 10 mg/ml, concentraat voor oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 1 ml concentrate for solution for infusion contains
vinorelbine tartrate equivalent to 10
mg vinorelbine.
Each vial of 5 ml concentrate for solution for infusion contains
vinorelbine tartrate equivalent to 50
mg vinorelbine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless or pale yellow solution (pH 3- 4).
The osmolarity is 32-38 mOsm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vinorelbine is indicated in the treatment of:
•
Non-small cell lung cancer (stage 3 or 4).
•
As single agent in patients with metastatic breast cancer (stage 4),
where treatment with
anthracycline- and taxane containing chemotherapy has failed or is not
appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
−
Strictly intravenous administration after appropriate dilution.
−
Intra-thecal administration of [Nationally completed name] may be
fatal.
−
[Nationally completed name] should be given in cooperation with a
physician with extensive
experience in therapy with cytostatics.
−
For instructions regarding use and handling, see section 6.6.
Administration
−
[Nationally completed name] may be administered by slow bolus (6-10
minutes) after dilution in
20-50 ml of normal saline or glucose 50 mg/ml (5%) solution.
Sandoz B.V.
Page 2
FOUT! ONBEKENDE NAAM VOOR
DOCUMENTEIGENSCHAP.
Sandoz 10 mg/ml,
concentraat voor oplossing voor infusie
RVG 35140
1311-V11
1.3.1.1 Summary of Product Characteristics
Augustus 2023
−
Administration should always be followed with at least 250 ml of a
normal saline infusion to
flush the vein.
−
_Non-small cell lung cancer: _