GADOVIST Solution for injection in prefilled syringe/cartridge (2017)
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Περιεχόμενα
Name of the medicinal product
Gadovist 1.0 mmol/ml solution for injection in prefilled syringe/cartridge.
Qualitative and quantitative composition
1 ml of solution for injection contains 604.72 mg gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium). 1 prefilled syringe with 5.0 ml contains 3023.6 mg gadobutrol, 1 prefilled ...
Pharmaceutical form
Solution for injection in prefilled syringe/cartridge. Clear, colourless to pale yellow liquid. Physico-chemical properties: Osmolality at 37°C: 1603 mOsm/kg H2O Viscosity at 37°C: 4.96 mPa·s
Therapeutic indications
This medicinal product is for diagnostic use only. Gadovist is indicated in adults and children of all ages (including term neonates) for: Contrast enhancement in cranial and spinal magnetic resonance ...
Posology and method of administration
Gadovist should only be administered by healthcare professionals experienced in the field of clinical MRI practice. Method of administration This medicinal product is for intravenous administration only. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
While injecting Gadovist into veins with a small lumen there is the possibility of adverse effects such as reddening and swelling. The usual safety requirements for magnetic resonance imaging, especially ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Pregnancy and lactation
Pregnancy There are no data from the use of gadobutrol in pregnant women. Animal studies have shown reproductive toxicity at repeated high doses (see section 5.3). Gadovist should not be used during pregnancy ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
The overall safety profile of Gadovist is based on data from more than 6,300 patients in clinical trials and from post-marketing surveillance. The most frequently observed adverse drug reactions (≥0.5%) ...
Overdose
The maximum daily single dose tested in humans is 1.5 mmol gadobutrol/kg body weight. No signs of intoxication from an overdose have so far been reported during clinical use. In case of inadvertent overdosage, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Paramagnetic contrast media, ATC code: V08CA09 Mechanism of action The contrast-enhancing effect is mediated by gadobutrol, the nonionic complex consisting of gadolinium (III) ...
Pharmacokinetic properties
Distribution After intravenous administration, gadobutrol is rapidly distributed in the extracellular space. Plasma protein binding is negligible. The pharmacokinetics of gadobutrol in humans are dose ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Repeated intravenous treatment in reproductive toxicology ...
List of excipients
Calcobutrol sodium Trometamol Hydrochloric acid 1N (pH-adjustment) 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 (prefilled syringe), 3 years (cartridge) Shelf life after first opening of the container: Any solution for injection not used in one examination must be discarded. Chemical, physical ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions after first opening of the medicinal product, see section 6.3.
Nature and contents of container
Glass syringes: One 10-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 5 ml, 7.5 ml and 10 ml solution for injection. ...
Special precautions for disposal and other handling
Any contrast medium solution not used in one examination must be discarded. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The peel-off tracking ...
Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Marketing authorization number(s)
PL 00010/0536
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 May 2008 Date of last renewal: 14 October 2010
Date of revision of the text
06 October 2017
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