FERINJECT Solution for injection/infusion Ref.[9417] Active ingredients: Ferric carboxymaltose Iron polymaltose

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  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

Ferinject 50 mg iron/mL solution for injection/infusion.

Pharmaceutical Form

Solution for injection/infusion.

Dark brown, non-transparent, aqueous solution.

Qualitative and quantitative composition

One mL of solution contains 50 mg of iron as ferric carboxymaltose.

Each 2 mL vial contains 100 mg of iron as ferric carboxymaltose.

Each 10 mL vial contains 500 mg of iron as ferric carboxymaltose.

Each 20 mL vial contains 1,000 mg of iron as ferric carboxymaltose.

Excipient(s) with known effect: One mL of solution contains up to 5.5 mg (0.24 mmol) sodium, see section 4.4.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ferric carboxymaltose

The iron complex ferric carboxymaltose is designed to provide, in a controlled way, utilisable iron for the iron transport and storage proteins in the body (transferrin and ferritin, respectively). Ferric carboxymaltose treatment results in an increase in reticulocyte count, serum ferritin levels and TSAT levels to within normal ranges.
Iron polymaltose
List of Excipients

Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and marketing

Ferinject is supplied in a vial (type I glass) with a stopper (bromobutyl rubber) and an aluminium cap as:

  • 2 mL solution containing 100 mg iron. Available in pack sizes of 1, 2 and 5 vials.
  • 10 mL solution containing 500 mg iron. Available in pack sizes of 1, 2 and 5 vials.
  • 20 mL solution containing 1,000 mg iron. Available in a pack size of 1 vial.

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

PL 15240/0002

Date of first authorisation: 19.07.2007
Date of latest renewal: 18.06.2012

Drugs

Drug Countries
FERINJECT Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, South Africa
 
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