MAGNEVIST Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Magnevist 2 mmol/l solution for injection.
Qualitative and quantitative composition
1 ml aqueous solution contains 1.876 mg gadopentetic acid, dimeglumine salt as active ingredient (equivalent to 0.002 mmol gadopentetic acid, dimeglumine, containing 0.32 mg gadolinium). Excipient with ...
Pharmaceutical form
Solution for injection. Clear, colourless to pale yellow or brownish-yellow solution.
Therapeutic indications
For contrast enhancement in direct magnetic resonance arthrography. This medicinal product is for diagnostic use by intraarticular administration only. Magnevist 2 mmol/l should be used only when diagnostic ...
Posology and method of administration
The usual precautions for MRI (e.g. exclusion of cardiac pacemakers and other ferro-magnetic objects including vascular clips etc) must be observed. Posology The recommendations for the use of Magnevist ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Strict aseptic technique is required to prevent infection. Fluoroscopic control should be used to ensure proper needle placement and prevent extracapsular injection. Undue pressure should not be exerted ...
Interaction with other medicinal products and other forms of interaction
As for all other gadolinium containing contrast media, no interactions with other medicaments have been observed. Formal drug interaction studies have not been carried out. See also section 6.2. Magnevist ...
Pregnancy and lactation
Pregnancy For gadopentetic acid, dimeglumine no clinical study data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal ...
Effects on ability to drive and use machines
No effects of Magnevist 2 mmol/l on driving ability and use of machinery can be expected. However, joint effusion may affect the ability to drive due to a limited joint mobility.
Undesirable effects
Frequency of adverse reactions from clinical trial data Based on experience in more than 4,900 patients, the undesirable effects listed below have been observed and classified by investigators as drug-related. ...
Overdose
No signs of intoxication secondary to an overdose have so far been observed or reported on clinical use.
Pharmacodynamic properties
Pharmacotherapeutic group: paramagnetic contrast media ATC code: V08CA01 Magnevist 2 mmol/l is a paramagnetic contrast agent for magnetic resonance imaging. The contrast-enhancing effect is mediated by ...
Pharmacokinetic properties
The pharmacokinetic properties of gadopentetic acid, dimeglumine have been extensively studied after intravenous and oral administration in doses exceeding the amount injected intraarticularly. After intraarticular ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of systemic toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and contact sensitising potential. ...
List of excipients
Pentetic acid Meglumine Sodium chloride Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years.
Special precautions for storage
None.
Nature and contents of container
Colourless Type I, glass pre-filled syringe with chlorinated butyl rubber stopper and combined luer lock adapter, tip cap (chlorobutyl rubber), safety cap. Pack size: syringe containing 20 ml of Magnevist ...
Special precautions for disposal and other handling
The prefilled syringe must be taken from the pack and prepared for the injection immediately before the examination and injected under sterile conditions. The tip cap should be removed from the prefilled ...
Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Marketing authorization number(s)
PL 00010/0544
Date of first authorization / renewal of the authorization
Date of First Authorisation: 01 May 2008 Date of Renewal of the Authorisation: 23 February 2009
Date of revision of the text
15 January 2019
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