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
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
®
 

VISIPAQUE Solution for injection (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

VISIPAQUE.

Qualitative and quantitative composition

Iodixanol Injection 270 mg I/ml, 320 mg I/ml.

Pharmaceutical form

VISIPAQUE injectable solution is provided as a ready-to-use sterile, pyrogen-free, colourless to pale yellow solution, in concentrations of 270 and 320 mg of organically bound iodine per ml (550 and 652 ...

Therapeutic indications

This medicinal product is for diagnostic use only. VISIPAQUE is indicated, in adult patients, for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced ...

Posology and method of administration

Diagnostic procedures that involve the use of radiopaque imaging agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular ...

Contraindications

Hypersensitivity to the active substance or iodine or hypersensitivity to any of the excipients. Manifest thyrotoxicosis. History of serious hypersensitivity reaction to VISIPAQUE.

Special warnings and precautions for use

Precautions for use of non-ionic contrast media in general: The risk of serious reactions in connection with use of VISIPAQUE is regarded as minor. However, iodinated contrast media may provoke anaphylactoid ...

Interaction with other medicinal products and other forms of interaction

Use of iodinated contrast media may result in a transient impairment of renal function and this may precipitate lactic acidosis in diabetics who are taking biguanides/metformin (see section 4.4). Patients ...

Fertility, pregnancy and lactation

Use in Pregnancy Category B1. Since, wherever possible, radiation exposure should be avoided during pregnancy, the benefits of any X-ray examination, with or without contrast media, should be carefully ...

Effects on ability to drive and use machines

None known.

Undesirable effects

None known.Below are listed possible side effects in relation with radiographic procedures which include the use of VISIPAQUE. Serious reactions as well as fatalities are only seen on very rare occasions. ...

Overdose

Overdosage is unlikely in patients with a normal renal function. The duration of the procedure is important for the renal tolerability of high doses of contrast media (t½ ~ 2 hours). In the event of accidental ...

Pharmacodynamic properties

Pharmacotherapeutic group: X-ray contrast media, iodinated ATC code: V08AB09 VISIPAQUE is a dimeric, non-ionic, water-soluble, radiographic contrast medium with a molecular weight of 1550.20 (iodine content ...

Pharmacokinetic properties

Iodixanol is rapidly distributed in the body with a mean distribution half-life of approximately 21 minutes. The apparent volume of distribution is of the same magnitude as the extracellular fluid (0.26 ...

Preclinical safety data

Carcinogenicity No long-term animal studies have been performed to evaluate the carcinogenic potential of VISIPAQUE. Genotoxicity VISIPAQUE did not induce gene mutation in bacteria or Chinese hamster ovary ...

List of excipients

Trometamol Sodium chloride Calcium chloride Sodium calciumedetate Hydrochloric acid (pH adjustment) Water for injections The pH of the product is 6.8-7.6.

Incompatibilities

No incompatibility has been found. However, VISIPAQUE should not be directly mixed with other drugs. A separate syringe should be used.

Shelf life

Shelf life: 36 months.

Special precautions for storage

Protect vials, bottles and flexible containers of VISIPAQUE from strong daylight and direct exposure to sunlight. Store at controlled room temperature, 15°C to 30ºC. Do not remove foil overwrap, which ...

Nature and contents of container

VISIPAQUE (iodixanol) injection 270 mg l/ml: 20 ml glass vial, boxes of 10 50 ml glass or polypropylene bottles, boxes of 10 75 ml polypropylene bottles, boxes of 10 100 ml glass or polypropylene bottles, ...

Special precautions for disposal and other handling

Instructions for Use / Handling Like all parenteral products, VISIPAQUE should be inspected visually for particulate matter, discolouration and the integrity of the container prior to use. The product ...

Marketing authorization holder

GE Healthcare, 8 Tangihua Street, PO Box 106911, Auckland 1010, Ph 0800 659465, Fax (09) 353-6701

Date of first authorization / renewal of the authorization

9 March 1995

Date of revision of the text

22 December 2017

Πηγαίο έγγραφο

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