CONRAY 280 14/50 Micromol Solution for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-05-2024
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Active ingredient:
IOTALAMATE MEGLUMINE
Available from:
Mallinckrodt UK Commercial Ltd
INN (International Name):
IOTALAMATE MEGLUMINE
Dosage:
14/50 Micromol
Pharmaceutical form:
Solution for Injection
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
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,
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