MONOFER Solution for injection / infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Monofer 100 mg/ml solution for injection/infusion.
Qualitative and quantitative composition
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) ...
Pharmaceutical form
Solution for injection/infusion. Dark brown, non-transparent solution.
Therapeutic indications
Monofer is indicated for the treatment of iron deficiency in the following conditions: When oral iron preparations are ineffective or cannot be used. Where there is a clinical need to deliver iron rapidly. ...
Posology and method of administration
Calculation of the cumulative iron need Iron replacement in patients with iron deficiency The dose of Monofer is expressed in mg of elemental iron. The iron need and the administration schedule for Monofer ...
Contraindications
Hypersensitivity to the active substance, to Monofer or any of its excipients listed in section 6.1. Known serious hypersensitivity to other parenteral iron products. Non-iron deficiency anaemia (e.g. ...
Special warnings and precautions for use
Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been ...
Interaction with other medicinal products and other forms of interaction
As with all parenteral iron preparations the absorption of oral iron is reduced when administered concomitantly. Oral iron therapy should not be started earlier than 5 days after the last injection of ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate and well-controlled trials of Monofer in pregnant women. A careful risk/benefit evaluation is therefore required before use during pregnancy and Monofer should not be used ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
The table presents the adverse drug reactions (ADRs) reported during Monofer treatment in clinical trials and in-market experience. Acute severe hypersensitivity reactions may occur with parenteral iron ...
Overdose
The iron(III) isomaltoside 1000 in Monofer has a low toxicity. The preparation is well tolerated and has a minimal risk of accidental overdosing. Overdose may lead to accumulation of iron in storage sites ...
Pharmacodynamic properties
Pharmacotherapeutic group: Iron parenteral preparation ATC code: B03AC Monofer solution for injection is a colloid with strongly bound iron in spheroidal iron-carbohydrate particles. The Monofer formulation ...
Pharmacokinetic properties
The Monofer formulation contains iron in a strongly bound complex that enables a controlled and slow release of bioavailable iron to iron-binding proteins with little risk of free iron toxicity. After ...
Preclinical safety data
Iron complexes have been reported to be teratogenic and embryocidal in non-anaemic pregnant animals at high single doses above 125 mg iron/kg body weight. The highest recommended dose in clinical use is ...
List of excipients
Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Shelf life of ampoules as packaged for sale: 3 years. Shelf life of vials as packaged for sale: 3 years. Shelf life after first opening of the container (undiluted): From a microbiological point ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions of the reconstituted and diluted solution, see section 6.3.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
Inspect vials/ampoules visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution. Monofer is for single use only and any unused solution should be disposed ...
Marketing authorization holder
Pharmacosmos A/S, Roervangsvej 30, DK-4300, Holbaek, Denmark
Marketing authorization number(s)
PL 18380/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 2009-11-26 Date of latest renewal: 2014-11-26
Date of revision of the text
08.07.2019
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