FERINJECT Solution for injection/infusion (2021)
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Περιεχόμενα
Name of the medicinal product
Ferinject 50 mg iron/mL solution for injection/infusion.
Qualitative and quantitative composition
One mL of solution contains 50 mg of iron as ferric carboxymaltose. Each 2 mL vial contains 100 mg of iron as ferric carboxymaltose. Each 10 mL vial contains 500 mg of iron as ferric carboxymaltose. Each ...
Pharmaceutical form
Solution for injection/infusion. Dark brown, non-transparent, aqueous solution.
Therapeutic indications
Ferinject is indicated for the treatment of iron deficiency when (see section 5.1): oral iron preparations are ineffective. oral iron preparations cannot be used. there is a clinical need to deliver iron ...
Posology and method of administration
Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Ferinject. Ferinject should only be administered when staff trained to evaluate ...
Contraindications
The use of Ferinject is contraindicated in cases of: hypersensitivity to the active substance, to Ferinject or any of its excipients listed in section 6.1. known serious hypersensitivity to other parenteral ...
Special warnings and precautions for use
Hypersensitivity reactions Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity ...
Interaction with other medicinal products and other forms of interaction
The absorption of oral iron is reduced when administered concomitantly with parenteral iron preparations. Therefore, if required, oral iron therapy should not be started for at least 5 days after the last ...
Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of Ferinject in pregnant women (see section 5.1). A careful benefit/risk evaluation is required before use during pregnancy and Ferinject should not be used ...
Effects on ability to drive and use machines
Ferinject is unlikely to impair the ability to drive and use machines.
Undesirable effects
Table 4 presents the adverse drug reactions (ADRs) reported during clinical studies in which >8,000 subjects received Ferinject, as well as those reported from the post-marketing experience (see table ...
Overdose
Administration of Ferinject in quantities exceeding the amount needed to correct iron deficit at the time of administration may lead to accumulation of iron in storage sites eventually leading to haemosiderosis. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Iron trivalent, parenteral preparation ATC code: B03AC Ferinject solution for injection/infusion is a colloidal solution of the iron complex ferric carboxymaltose. The complex ...
Pharmacokinetic properties
Distribution Positron emission tomography demonstrated that <sup>59</sup>Fe and <sup>52</sup>Fe from Ferinject was rapidly eliminated from the blood, transferred to the bone marrow, and deposited in the ...
Preclinical safety data
Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity and genotoxicity. Preclinical studies indicate that iron released from ...
List of excipients
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. The compatibility with containers other than polyethylene and glass is not known.
Shelf life
<u>Shelf life of the product as packaged for sale:</u> 3 years. <u>Shelf life after first opening of the container:</u> From a microbiological point of view, preparations for parenteral administration ...
Special precautions for storage
Store in the original package in order to protect from light. Do not store above 30°C. Do not freeze. For storage conditions after dilution or first opening of the medicinal product, see section 6.3. ...
Nature and contents of container
Ferinject is supplied in a vial (type I glass) with a stopper (bromobutyl rubber) and an aluminium cap as: 2 mL solution containing 100 mg iron. Available in pack sizes of 1, 2 and 5 vials. 10 mL solution ...
Special precautions for disposal and other handling
Inspect vials visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution. Each vial of Ferinject is intended for single use only. Any unused product or waste ...
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)
PL 15240/0002
Date of first authorization / renewal of the authorization
Date of first authorisation: 19.07.2007 Date of latest renewal: 18.06.2012
Date of revision of the text
26 November 2021
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