国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
IOTALAMATE MEGLUMINE
Mallinckrodt UK Commercial Ltd
IOTALAMATE MEGLUMINE
14/50 Micromol
Solution for Injection
Authorised
0000-00-00
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: Lower range of adult dosage. Angiocardiography May be used as a test dose in positioning catheter tip. Volumes of up to 20 ml have been used for this purpose prior to the diagnostic dose of a more concentrated medium. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/05/2013_ _CRN 2131893_ _page number: 1_ Splenography Adults: 20 - 40 ml. Femoral Venography _Inferior Vena Cavography_: Adults: 20 to 60 ml. _Hysterosalpingography_: Adults: About 10ml is usually required, 完全なドキュメントを読む