Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

GADOVIST Solution for injection in prefilled syringe/cartridge (2017)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: