Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pharmacosmos A/S, Roervangsvej 30, DK-4300, Holbaek, Denmark
Monofer 100 mg/ml solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Dark brown, non-transparent solution. |
One millilitre of solution contains 100 mg iron as iron(III) isomaltoside 1000.
1 ml vial/ampoule contains 100 mg iron as iron(III) isomaltoside 1000.
2 ml vial/ampoule contains 200 mg iron as iron(III) isomaltoside 1000.
5 ml vial/ampoule contains 500 mg iron as iron(III) isomaltoside 1000.
10 ml vial/ampoule contains 1,000 mg iron as iron(III) isomaltoside 1000.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Iron (III) isomaltoside |
Iron(III) complex enables a controlled and slow release of bioavailable iron to iron-binding proteins with little risk of free iron. Evidence of a therapeutic response can be seen within a few days of administration of iron(III) as an increase in the reticulocyte count. |
| List of Excipients |
|---|
|
Water for injections |
Type 1 glass ampoule.
Pack sizes: 5 × 1 ml, 10 × 1 ml, 5 × 2 ml, 10 × 2 ml, 2 × 5 ml, 5 × 5 ml, 2 × 10 ml, 5 × 10 ml
Type 1 glass vial with chlorobutyle rubber stopper and aluminium cap.
Pack sizes: 1 × 1 ml, 5 × 1 ml, 10 × 1 ml, 5 × 2 ml, 10 × 2 ml, 1 × 5 ml, 2 × 5 ml, 5 × 5 ml, 1 × 10 ml, 2 × 10 ml, 5 × 10 ml
Not all pack sizes may be marketed.
Pharmacosmos A/S, Roervangsvej 30, DK-4300, Holbaek, Denmark
PL 18380/001
Date of first authorisation: 2009-11-26
Date of latest renewal: 2014-11-26
| Drug | Countries | |
|---|---|---|
| MONOFER | Austria, Australia, Brazil, Estonia, Finland, Hong Kong, Croatia, Lithuania, Netherlands, New Zealand, Romania, Singapore, United Kingdom, South Africa |
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