VISIPAQUE Solution for injection (2017)
Βιβλιογραφική αναφορά
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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 (t<sub>1/2</sub> ~ 2 hours). In the ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> X-ray contrast media, iodinated <b>ATC code:</b> V08AB09 VISIPAQUE is a dimeric, non-ionic, water-soluble, radiographic contrast medium with a molecular weight of 1550.20 ...
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
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
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