Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
IOTALAMATE MEGLUMINE
Covidien (UK) Commerical Limited
14/50
Solution for Injection
2012-01-06
License Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Conray 280 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The solution for injection contains meglumine iotalamate 60% w/v (formed in situ by reaction of iotalamic acid and meglumine) equivalent to organically bound iodine: 280 mg per ml. Concentration of iotalamic acid: 0.74 millimole/ml. Each 50ml bottle contains the equivalent of 14g organically bound iodine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Colourless to pale yellow aqueous solution. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications This medicinal product is for diagnostic use only. X-ray contrast medium used for the opacification of vascular and renal systems and female genital tract. 4.2 Posology and method of administration Route of administration: By intravenous, intra-uterine or intra-arterial injection or injection directly into the chamber of the heart, depending on the procedure. Recommended Dosage: Intravenous Urography Adults: 40 to 80 ml. In the absence of preliminary dehydration 40 to 100ml may be used. Infants and children: Under 12kg: 2ml/kg body weight. Over 12kg: 1.5ml/kg. Minimum of 24 ml. Over 10 years of age: Read the complete document