VENOFER Solution for injection (2020)
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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