देश: तंज़ानिया
भाषा: अंग्रेज़ी
स्रोत: Tanzania Medicinces & Medical Devices Authority
Iodixanol
Unique Pharmaceutical Laboratories (A division of J.B. Chemicals & Pharmaceuticals Ltd), INDIA
X-raycontrastmedium, iodinated
Iodixanol
320 mg
Injection
Unique Pharmaceutical Laboratories (A Div. Of. J. B. Chemicals & Pharmaceutical Ltd), INDIA
Physical description: Clear, colourless slightly viscous liquid, free from foreign matter; Local technical representative: JILICHEM (T) Limited (5053)
Registered/Compliant
2021-06-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CARDIOLEK-320 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains; Iodixanol USP--------------652 mg equivalent to 320 mg of Iodine 3 PHARMACEUTICAL FORM Physical description/appearance of the product: Clear, colorless slightly viscous liquid. Free from foreign matter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. X-ray contrast medium for use in adults for cardioangiography, cerebral angiography (conventional and i.a.DSA), peripheral arteriography (conventional and i.a.DSA), abdominal angiography (i.a.DSA), urography, venography, CT-enhancement. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be administered Intravenous & Intra-arterial 4.3 CONTRAINDICATIONS Hypersensitivity to Iodixanol or any components of its formulation. Manifested thyrotoxicosis. Decompensated cardiac insufficiency. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE WARNINGS: The risk of serious reactions in connection with use of CARDIOLEK is regarded as very minor. However, iodinated contrast media may provoke serious or fatal reactions, anaphylactoid reactions or other manifestations of hypersensitivity. A course of action should therefore be planned in advance with necessary drugs and equipment available for immediate treatment, should a serious reaction occur. A property of non-ionic contrast media is the low interference with normal physiological functions. As a consequence of this, non-ionic contrast media have less anticoagulant activity in vitro than ionic media. When performing vascular catheterization procedures one should be aware of this and pay meticulous attention to the angiographic technique and flush the catheter frequently with physiological saline (if necessary with the addition of heparin) so as to minimize the risk of procedure-related thrombosis and embolism. Iodinated contrast media may give rise to transient renal dysfunction or failure. Patients with preexisting renal dysfunction, diabet पूरा दस्तावेज़ पढ़ें