DIAFER Solution for injection Ref.[27657] Active ingredients:

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark

Product name and form

Diafer 50 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Dark brown, non transparent solution with pH 5.0-7.0 and an approximate osmolarity of 400 mOsm/l.

Qualitative and quantitative composition

One millilitre of solution contains 50 mg iron as ferric derisomaltose.

A 2 ml ampoule contains 100 mg iron as ferric derisomaltose.

One ml of solution contains up to 4.6 mg (0.2 mmol) sodium, see section 4.4.

For the full list of excipients, see section 6.1.

List of Excipients

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

Pack sizes and marketing

Type 1 glass ampoule.

Pack sizes: 1 × 2 ml, 5 × 2 ml, 10 × 2 ml, 25 × 2 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark

Marketing authorization dates and numbers

PL 18380/0004

Date of first authorisation: 26/03/2013

Drugs

Drug Countries
DIAFER Austria, Estonia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom

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