IOMERON Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Iomeron 250, solution for injection.
Qualitative and quantitative composition
Contains 51.03% w/v of iomeprol equivalent to 25% iodine or 250mg iodine/ml. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection.
Therapeutic indications
X-ray contrast medium used for: venography cerebral arteriography digital subtraction angiography computed tomography enhancement urography cavernosography myelography
Posology and method of administration
venography adults 10-100ml* max 250ml 10-50ml upper extremity 50-100 lower extremity cerebral arteriography adults 5-12ml* children 3-7ml or** digital subtraction angiography Intra arterial ...
Contraindications
Hypersensitivity to the active substance or any of the excipients. Intrathecal concomitant administration of corticosteroids with contrast media is contraindicated.
Special warnings and precautions for use
In consideration of possible complications, the patient should be kept under observation for at least 30 minutes after the examination. Extreme caution during injection of contrast media is necessary to ...
Interaction with other medicinal products and other forms of interaction
Use of the product may interfere with tests for thyroid function. Vasopressor agents should not be administered prior to iomeprol. Treatment with drugs that lower the seizure threshold such as certain ...
Fertility, pregnancy and lactation
Women of childbearing potential Appropriate investigations and measures should be taken when exposing women of child-bearing potential to any X-ray examination, whether with or without contrast medium. ...
Effects on ability to drive and use machines
There is no known effect on the ability to drive and operate machines. After intrathecal administration, it is recommended that the patient should wait 24 hours before driving or operating machinery. ...
Undesirable effects
General The use of iodinated contrast media may cause untoward side effects. They are usually mild to moderate and transient in nature. However, severe and life-threatening reactions sometimes leading ...
Overdose
The effects of overdose on the pulmonary and cardiovascular systems may become life-threatening. Treatment consists of support of the vital functions and prompt use of symptomatic therapy. Iomeprol does ...
Pharmacodynamic properties
ATC code: V08AB10 Iomeprol is a low osmolality, non-ionic organic molecule with radio-opacity conferred by an iodine content of 49% of the molecular weight. It is formulated for use as an intravascular/intracavitary/intrathecal ...
Pharmacokinetic properties
The pharmacokinetics of intravascularly administered iomeprol are similar to those of other iodinated contrast media and conform to a two-compartment model with a rapid distribution and a slower elimination ...
Preclinical safety data
Pre-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction. Results from studies in rats, ...
List of excipients
Trometamol Hydrochloric acid Water for injection
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Five years.
Special precautions for storage
Store below 30°C. Protect from light.
Nature and contents of container
Colourless Type I or Type II glass bottles with rubber/aluminium cap. Quantities of 20, 30, 50, 75, 100, 150, 200 or 250 ml of solution.
Special precautions for disposal and other handling
Bottles containing contrast media solution are not intended for the withdrawal of multiple doses. The rubber stopper should never be pierced more than once. The use of proper withdrawal cannulas for piercing ...
Marketing authorization holder
Bracco U.K. Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ, United Kingdom
Marketing authorization number(s)
18920/0003
Date of first authorization / renewal of the authorization
11 December 1992 / 29 December 1998
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