Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042, Paris La Défense Cedex, France Tel. +33 (0)1 41 06 58 90 Fax +33 (0)1 41 06 58 99
Venofer 20 mg iron/ml, solution for injection or concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection or concentrate for solution for infusion. Venofer is a dark brown, non transparent, aqueous solution. |
One millilitre of solution contains 20 mg of iron as iron sucrose (iron(III)-hydroxide sucrose complex).
Each 5 ml ampoule of Venofer contains 100 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex).
Each 2.5 ml vial of Venofer contains 50 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex).
Each 5 ml vial of Venofer contains 100 mg iron as iron sucrose (iron(III)-hydroxide sucrose complex).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Iron sucrose |
Iron sucrose is composed of a polynuclear iron(III)-hydroxide core surrounded by a large number of non-covalently bound sucrose molecules. The polynuclear iron core has a structure similar to that of the core of the physiological iron storage protein ferritin. The complex is designed to provide, in a controlled manner, utilisable iron for the iron transport and storage proteins in the body (i.e., transferrin and ferritin, respectively). |
| List of Excipients |
|---|
|
Water for injections |
5 ml solution in one ampoule (type I glass) in pack sizes of 5.
2.5 ml solution in one vial (type I glass) in pack sizes of 5.
5 ml solution in one vial (type I glass) in pack sizes of 5.
Not all pack-sizes may be marketed.
Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042, Paris La Défense Cedex, France
Tel. +33 (0)1 41 06 58 90
Fax +33 (0)1 41 06 58 99
UK: PL 15240/0001
UK: 08.06.1998 / 20.05.2008
| Drug | Countries | |
|---|---|---|
| VENOFER | Austria, Australia, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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