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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

VENOFER Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Venofer 20 mg iron/ml, solution for injection or concentrate for solution for infusion.

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). ...

Pharmaceutical form

Solution for injection or concentrate for solution for infusion. Venofer is a dark brown, non transparent, aqueous solution.

Therapeutic indications

Venofer is indicated for the treatment of iron deficiency in the following indications: Where there is a clinical need for a rapid iron supply, In patients who cannot tolerate oral iron therapy or who ...

Posology and method of administration

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Venofer. Venofer should only be administered when staff trained to evaluate and ...

Contraindications

The use of Venofer is contraindicated in the following conditions: Hypersensitivity to the active substance, to Venofer or any of its excipients listed in section 6.1 Known serious hypersensitivity to ...

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, Venofer should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced. Therefore, oral iron therapy should ...

Fertility, pregnancy and lactation

Pregnancy There is no data from the use of iron sucrose in pregnant women in the first trimester. Data (303 pregnancy outcomes) from the use of Venofer in pregnant women in the second and third trimester ...

Effects on ability to drive and use machines

In the case of symptoms of dizziness, confusion or light headedness following the administration of Venofer, patients should not drive or use machinery until the symptoms have ceased.

Undesirable effects

The most commonly reported adverse drug reaction in clinical trials with Venofer was dysgeusia, which occurred with a rate of 4.5 events per 100 subjects. The most important serious adverse drug reactions ...

Overdose

Overdose can cause iron overload which may manifest itself as haemosiderosis. Overdose should be treated, as deemed necessary by the treating physician, with an iron chelating agent or according to standard ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-anaemic preparation, iron, parenteral preparation ATC code: B03AC Mechanism of action Iron sucrose, the active ingredient of Venofer, is composed of a polynuclear iron(III)-hydroxide ...

Pharmacokinetic properties

Distribution The ferrokinetics of iron sucrose labelled with <sup>52</sup>Fe and <sup>59</sup>Fe were assessed in 6 patients with anaemia and chronic renal failure. In the first 6–8 hours, <sup>52</sup> ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity and toxicity to reproduction and development.

List of excipients

Water for injections Sodium hydroxide (for pH adjustment)

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. There is the potential for precipitation and/or interaction if mixed with other solutions or ...

Shelf life

Shelf life Shelf life of the product as packaged for sale: 3 years. Shelf life after first opening of the container: From a microbiological point of view, the product should be used immediately. Shelf ...

Special precautions for storage

Do not store above 25°C. Do not freeze. Store in the original package. For storage conditions after dilution or first opening of the medicinal product, see section 6.3.

Nature and contents of container

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 ...

Special precautions for disposal and other handling

Ampoules or vials should be visually inspected for sediment and damage before use. Use only those containing a sediment free and homogenous solution. Venofer must not be mixed with other medicinal products ...

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 number(s)

UK: PL 15240/0001

Date of first authorization / renewal of the authorization

UK: 08.06.1998 / 20.05.2008

Date of revision of the text

14/01/2020

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