ULTRAVIST Solution for injection (2015)
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
Name of the medicinal product
Ultravist 300mg/ml Solution for Injection (20ml).
Qualitative and quantitative composition
Ultravist 300: 1 ml contains 623mg iopromide, equivalent to 300 mg iodine. One 20 ml vial of Ultravist 300 contains 12.46 g iopromide. This medicinal product contains 12.3 micrograms sodium per ml. For ...
Pharmaceutical form
Solution for injection. Clear, colourless to pale yellow aqueous solution. The physico-chemical properties of Ultravist at the concentrations listed below are: Iodine concentration (mg/ml) 240 300 ...
Therapeutic indications
This medicinal product is for diagnostic use only. Ultravist 300: For intravascular use and use in body cavities. Contrast enhancement in computerised tomography (CT), digital subtraction angiography (DSA), ...
Posology and method of administration
General information Warning prior to use Contrast media which are warmed to body temperature before administration are better tolerated and can be injected more easily because of reduced viscosity. For ...
Contraindications
Manifest hyperthyroidism. Use in patients with a history of serious hypersensitivity to iopromide.
Special warnings and precautions for use
For all indications Hypersensitivity reactions Ultravist can be associated with anaphylactoid/hypersensitivity (see section 4.3) or other idiosyncratic reactions characterized by cardiovascular, respiratory ...
Interaction with other medicinal products and other forms of interaction
Biguanides (metformin): In patients with acute kidney failure or severe chronic kidney disease biguanide elimination can be reduced leading to accumulation and the development of lactic acidosis. As the ...
Pregnancy and lactation
Pregnancy Adequate and well-controlled studies in pregnant women have not been conducted. It has not been sufficiently demonstrated that non ionic contrast media are safe for use in pregnant patients. ...
Effects on ability to drive and use machines
No data available.
Undesirable effects
Summary of the safety profile The overall safety profile of Ultravist is based on data obtained in pre-marketing studies in more than 3,900 patients and post-marketing studies in more than 74,000 patients, ...
Overdose
Results from acute toxicity studies in animals do not indicate a risk of acute intoxication following use of Ultravist. Intravascular overdose Symptoms may include fluid and electrolyte imbalance, renal ...
Pharmacodynamic properties
Pharmacotherapeutic group: Watersoluble, nephrotropic, low osmolar X-ray contrast media ATC code: V08AB05 The contrast-giving substance in the Ultravist formulations is iopromide, a non-ionic water-soluble ...
Pharmacokinetic properties
General Information Iopromide behaves in the organism like other highly hydrophilic biologically inert, renally excreted compounds (e.g. mannitol or inulin). Absorption and distribution Following intravenous ...
Preclinical safety data
Preclinical data reveal no evidence of risk for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and reproduction toxicity. Systemic toxicity Experimental ...
List of excipients
Sodium calcium edetate Hydrochloric acid (for pH adjustment) Trometamol Water for injection
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Microbiological ...
Special precautions for storage
Do not store above 30°C. Keep the vials in the outer carton and protect from X-rays.
Nature and contents of container
Vials: Glass type I Stopper: Stopper type I, chlorobutyl-elastomer Presentation: Ultravist 300: Vials of 20 ml. Cartons contain 10 vials of 20 ml.
Special precautions for disposal and other handling
Ultravist should be warmed to body temperature prior to use (See also Section 4.2). Visual Inspection Ultravist is supplied ready to use as a clear, colourless to pale yellow solution. Contrast media should ...
Marketing authorization holder
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18
Marketing authorization number(s)
PA 1410/011/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 24 September 1986 Date of last renewal: 24 September 2006
Date of revision of the text
January 2015
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
