DOTAGRAF Solution for injection (2022)
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
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Dotagraf 0.5 mmol/ml solution for injection.
2. Qualitative and quantitative composition
1 ml solution for injection contains 279.32 mg gadoteric acid (as meglumine salt), equivalent to 0.5 mmol. 10 ml solution for injection contain 2793.2 mg gadoteric acid (as meglumine salt), equivalent ...
3. Pharmaceutical form
Solution for injection. Clear, colourless to yellow solution. Contrast medium concentration 279,32 mg/ml<br>0,5 mmol/ml Osmolality at 37°C 1,35 Osm/kg H<sub>2</sub>O Viscosity at 37°C 1,8 mPas pH value ...
4.1. Therapeutic indications
This medicinal product is for diagnostic use only. Dotagraf is a contrast agent indicated for enhancement of the contrast in Magnetic Resonance Imaging (MRI) for a better visualization/delineation in: ...
4.2. Posology and method of administration
Posology The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patients body weight, and should not exceed the recommended ...
4.3. Contraindications
Hypersensitivity to gadoteric acid, to meglumine or to any medicinal products containing gadolinium.
4.4. Special warnings and precautions for use
Do not use by intrathecal route. Take care to maintain strictly intravenous injection: extravasation may result in local intolerance reactions, requiring the usual local care. The usual precaution measures ...
4.5. Interaction with other medicinal products and other forms of interaction
No interactions with other medicinal products have been observed. Formal drug interaction studies have not been carried out. Concomitant medications to be taken into account Beta-blockers, vasoactive substances, ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no data from the use of gadoteric acid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Ambulant patients while driving vehicles or operating machinery should take into account that nausea may incidentally ...
4.8. Undesirable effects
Side effects in association with the use of gadoteric acid are usually mild to moderate in intensity and transient in nature. Injection site reactions, nausea and headaches are the most frequently observed ...
4.9. Overdose
Gadoteric acid can be removed by haemodialysis. However there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> paramagnetic contrast media <b>ATC code:</b> V08CA02 (gadoteric acid). Dotagraf is a paramagnetic contrast agent for magnetic resonance imaging. The contrast-enhancing ...
5.2. Pharmacokinetic properties
After intravenous administration gadoteric acid is quickly distributed in the extracellular fluids. The distribution volume was approx. 18 l which is approximately equal to the volume of extra-cellular ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or toxicity to reproduction. Animal studies have shown negligible ...
6.1. List of excipients
Meglumine 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA) Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
3 years. Chemical and physical in-use stability has been demonstrated for 72 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, ...
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
1 and 10 Type II single-use colourless glass vials of 10 ml and 20 ml (filled to 15 or 20 ml), sealed with a stopper of bromobutyl rubber and packed in unit carton box. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
The peel-off tracking label on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic ...
7. Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
8. Marketing authorization number(s)
PL 00010/0590
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 16 September 2016 Date of renewal of the authorisation: 02 December 2019
10. Date of revision of the text
2 December 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
