VENOFER Solution for injection Ref.[9414] Active ingredients: Iron sucrose

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

Product name and form

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.

Qualitative and quantitative composition

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
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

UK: PL 15240/0001

UK: 08.06.1998 / 20.05.2008

Drugs

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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