agenic effects (induction of aneuploidy of polyploidy) in man.
In animal reproductive studies, vinorelbine was embryo-feto-lethal and teratogenic.
No haemodynamic effects were found in dogs receiving vinorelbine at maximal tolerated dose; only some minor, non significant disturbances of repolarisation were observed as with other vinca alkaloids tested.
No effect on the cardiovascular system was observed in primates receiving repeated doses of vinorelbine over 39 weeks.
6. Pharmaceutical particulars
6.1 List of excipients
Fill solution:
Ethanol, anhydrous
Water, purified
Glycerol
Macrogol 400
Shell capsule:
Gelatin
Glycerol 85%
Sorbitol/Sorbitan Anidrisorb 85/70)
Red iron oxide E172
Titanium dioxide E171
Triglycerides, medium chain
Phosal 53 MCT (Phosphatidylcholine; Glycerides; Ethanol, anhydrous)
Edible printing ink:
Cochineal extract E120
Hypromellose
Propylene glycol
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store at 2° C - 8° C (in a refrigerator). Store in the original container.
6.5 Nature and contents of container
Peel-push PVC/PVDC/ aluminium blister.
Pack size: 1 capsule
6.6 Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Instructions for use/handling
To open the packaging:
1. Cut the blister along the black dotted line
2. Peel the soft plastic foil off
3. Push the capsule through the aluminium foil.
7. Marketing authorisation holder
Pierre Fabre Limited
250 Longwater Avenue
Green Park
Reading RG2 6GP
United Kingdom
8. Marketing authorisation number(s)
PL 00603/0030
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 31st March 2005
Renewal of authorisation: 30th March 2010
10. Date of revision of the text
December 2016
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