RESOVIST 0.5 mMol. Solution for Injection
Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Résumé des caractéristiques du produit
(SPC)
18-05-2024
Certains documents pour ce produit ne sont pas disponibles actuellement, vous pouvez envoyer une demande à notre service client et nous vous informerons dès que nous pourrons les obtenir.
Envoyer une demande.
Envoyer une demande.
Ingrédients actifs:
FERUCARBOTRAN
Disponible depuis:
HE Clissmann
DCI (Dénomination commune internationale):
FERUCARBOTRAN
Dosage:
0.5 mMol.
forme pharmaceutique:
Solution for Injection
Type d'ordonnance:
Product subject to prescription which may not be renewed (A)
Statut de autorisation:
Withdrawn
Date de l'autorisation:
2010-01-07
Résumé des caractéristiques du produit
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Resovist 0.5 mmol Fe/ml, solution for injection, prefilled syringe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 540 mg Ferucarbotran, corresponding to 0.5 mmol (28 mg) iron.
0.9 ml of the solution contains 486 mg Ferucarbotran and 1.4 ml contains 756 mg Ferucarbotran.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection, prefilled syringe,
reddish brown liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Resovist is a contrast agent to be used for magnetic resonance imaging (MRI) of the focal liver lesions when
examination without contrast media has given uncertain findings.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_General information_
Nausea and vomiting are known possible adverse events of all contrast media (see section 4.8). The patient should
therefore refrain from eating for two hours prior to the investigation to avoid aspiration.
_Method of administration_
Resovist is a ready-to-use aqueous solution which is to be administered via the 5-
µ
m filter included in the package
through a large-bore needle or indwelling catheter (18-20 gauge is recommended) with connecting tube, if required.
To ensure proper placement of the injection needle, it is recommended to inject sterile 9 mg/ml (0.9%) saline solution
before the administration of Resovist.
After the injection of the contrast medium the connective tubing and the needle should be flushed using sterile 9 mg/ml
(0.9%) saline solution. A three-way stopcock connected to the tube can facilitate this procedure.
The tip cap should be removed from the syringe immediately before use.
For single-use only, any unused product should be discarded in accordance with the loc
Lire le document complet
