OMNIPAQUE Solution (2019)
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Περιεχόμενα
Name of the medicinal product
OMNIPAQUE.
Qualitative and quantitative composition
Iohexol 180, 240, 300 and 350 mg iodine per ml.
Pharmaceutical form
180 mg, bottles containing 388 mg iohexol per ml, equivalent to 180 mg iodine per ml. 240 mg, bottles containing 518 mg iohexol per ml, equivalent to 240 mg Iodine per ml. 300 mg, bottles containing 647 ...
Therapeutic indications
This medicinal product is for diagnostic use only. Intravascular OMNIPAQUE is indicated in adults for angiography, excretory urographyand CT-enhancement. In children, OMNIPAQUE is indicated for angiography ...
Posology and method of administration
Administration of contrast media should be performed by qualified personnel familiar with the procedure, and an appropriate technique should be utilised. The dosage varies depending on the type of examination, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. History of serious reaction to OMNIPAQUE. Iodine-containing radiographic contrast media, whether ionic or non-ionic, should not be ...
Special warnings and precautions for use
Hydration: Adequate hydration should be assured before and after contrast media administration. This applies especially to patients with multiple myeloma, diabetes mellitus, renal dysfunction, as well ...
Interaction with other medicinal products and other forms of interaction
Use of contrast media may result in a transient impairment of renal function and this may precipitate lactic acidosis in diabetics who are taking metformin (see section 4.4). Patients treated with interleukin-2 ...
Pregnancy and lactation
Pregnancy The safety of OMNIPAQUE for use in human pregnancy has not been established. Teratogenicity studies have been performed in rats and rabbits at doses up to 4 g I/kg and 2.5 g I/kg, respectively. ...
Effects on ability to drive and use machines
It is not advisable to drive a car or use machines during the first 24 hours following intrathecal examination.
Undesirable effects
General (applies to all uses of iodinated contrast media) Below are listed possible general side effects in relation with radiographic procedures, which include the use of non-ionic monomeric contrast ...
Overdose
Preclinical data indicate a high safety margin for OMNIPAQUE and no fixed upper dose level has been established for routine intravascular use. Symptomatic overdosing is unlikely in patients with normal ...
Pharmacodynamic properties
Pharmacotherapeutic group: X-ray contrast media, iodinated ATC code: V08AB09 Intravascular Use For most of the haemodynamic, clinical-chemical and coagulation parameters examined following intravenous ...
Pharmacokinetic properties
Intravascular Use 87-99 per cent of the intravenously injected iohexol is excreted unchanged through the kidneys within 24 hours in patients with normal renal function. The maximum urinary concentration ...
Preclinical safety data
Iohexol has a very low acute intravenous toxicity in mice and rats. Animal studies have shown that iohexol has a very low protein binding and is well tolerated by the kidneys. The cardiovascular and neurotoxicity ...
List of excipients
Each millilitre of iohexol solution also contains 1.2 mg of tromethamine USP and 0.l mg of edetate calcium disodium USP with the pH adjusted between 6.8 and 7.6 with hydrochloric acid or sodium hydroxide. ...
Incompatibilities
Although no incompatibility has been found, OMNIPAQUE should not be directly mixed with other drugs. A separate syringe should be used.
Shelf life
Shelf life Glass or polypropylene bottles (10–150 ml): 36 months. Polypropylene bottles (200–500 ml): 24 months.
Special precautions for storage
OMNIPAQUE should be stored at 2-30oC protected from light and secondary X-rays. The product in glass vials and bottles may be stored at 37°C for up to 3 months prior to use. The product in 50 ml polypropylene ...
Nature and contents of container
180 mg I/ml: 10 ml: Packs of 10 glass or polypropylene bottles. 240 mg I/ml: 20 ml: Packs of 6 or 25 glass bottles and 10 polypropylene bottles. 50 ml: Packs of 10 glass or polypropylene bottles. 500 ml: ...
Special precautions for disposal and other handling
Instructions for Use/Handling Like all parenteral products, OMNIPAQUE should be inspected visually for particulate matter, discoloration and the integrity of the container prior to use. The product should ...
Marketing authorization holder
GE Healthcare, 300 Great South Road, PO Box 17122, Greenlane, Auckland 1130 Ph (09) 523-5896 Fax (09) 522-7342
Date of first authorization / renewal of the authorization
Date of first approval: 8 August 1985
Date of revision of the text
23 April 2019
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