Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Vinorelbine 10 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. A clear, colourless to pale yellow solution, free from visible particles. pH in the range of approximately 3.0 to 4.0 and osmolality in the range of approximately 30 to 40 mOsm/Kg. |
1 ml of solution contains 10 mg vinorelbine (as vinorelbine tartrate).
Each 1 ml vial contains a total of 10 mg vinorelbine (as tartrate).
Each 5 ml vial contains a total of 50 mg vinorelbine (as tartrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vinorelbine |
Vinorelbine is an antineoplastic drug of the vinca alkaloid family but unlike all the other vinca alkaloids. Vinorelbine inhibits tubulin polymerization and blocks mitosis at G2-M, causing cell death in interphase or at the following mitosis. |
| List of Excipients |
|---|
|
Water for injection. |
Vinorelbine solution is packaged in Type I clear glass vial with bromobutyl rubber stopper and aluminium flip off blue seal.
Vinorelbine solution is available in:
Vial – 1 unit(s) - 1 ml
Vial – 1 unit(s) - 5 ml
Not all pack sizes may be marketed.
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
PL 20075/0450
03/11/2016
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