XENETIX Solution for injection (2014)
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Περιεχόμενα
Name of the medicinal product
XENETIX, solution for injection.
Qualitative and quantitative composition
Xenetix 250 (250mg iodine/ml): Per 100ml of solution: Iobitridol: 54.84g (548.4mg/ml) Corresponding mass of iodine: 25g (250mg/ml) Viscosity at 20°C: 6 mPa.s Viscosity at 37°C: 4 mPa.s Osmolality: 585 ...
Pharmaceutical form
Solution for injection.
Therapeutic indications
This medicinal product is for diagnostic use only. Contrast agent for use in: Xenetix 250 Xenetix 300 Xenetix 350 Intravenous digital subtraction angiography Intravenous urography, Intravenous digital ...
Posology and method of administration
The doses must be adapted to the examination and the regions to be opacified, as well as to the body weight and renal function of the subject. There is no data about the use of Xenetix in pediatric patients. ...
Contraindications
Hypersensitivity to iobitridol or any of the excipients. History of a major immediate reaction or delayed skin reaction to a Xenetix injection. Manifest thyrotoxicosis In the absence of specific studies, ...
Special warnings and precautions for use
There is a risk of allergic reactions regardless of the route of administration or the dose. The risk of allergic reactions associated with products administered locally for opacification of body cavities ...
Interaction with other medicinal products and other forms of interaction
Medicinal products Metformin in diabetics (see Section 4.4.1.2.2. Precautions for use renal insufficiency). Radiopharmaceuticals (see Section 4.4.1.1. Warnings) Iodinated contrast agents alter the uptake ...
Pregnancy and lactation
Pregnancy In the interview and with appropriate tests, systemically check for possible pregnancy in women of childbearing age. Exposure of the female genital routes to x-rays must be subjected to careful ...
Effects on ability to drive and use machines
No particular risks are known.
Undesirable effects
During clinical studies on 905 patients, 11% of patients experienced an adverse reaction related to administration of Xenetix (apart from feeling of warmth), the most common being pain, injection site ...
Overdose
If a very high dose of contrast agent is administered, the water and electrolyte loss must be compensated by suitable rehydration. Renal function must be monitored for at least three days. Haemodialysis ...
Pharmacodynamic properties
Pharmacotherapeutic group: Iodinated contrast agent ATC code: V08AB11 Xenetix is a urographic and angiographic water-soluble nonionic contrast agent.
Pharmacokinetic properties
After intravascular injection, iobitridol is distributed in the intravascular system and interstitial compartment. In humans, the elimination half-life is 1.8 h, the volume of distribution is 200 ml/kg ...
Preclinical safety data
Toxicological results for intravenous use show an absence of effects, or effects occurring under conditions much more extreme than those recommended for clinical use (dosage, repeated doses). Following ...
List of excipients
Sodium calcium edetate Trometamol Trometamol hydrochloride Sodium hydroxide or hydrochloric acid Water for injection
Incompatibilities
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Three years.
Special precautions for storage
Keep out of the reach and sight of children. Vials/bottles: Do not store above 30°C and protect from light. Do not use after the expiry date given on the vial.
Marketing authorization holder
GUERBET, BP 57400 F-95943 Roissy CDG Cedex, France Manufacturing site address: GUERBET, 16-24 rue Jean Chaptal, 93600 Aulnay-sous-Bois, France
Date of revision of the text
17 Apr 2014
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