MULTIHANCE Solution for Injection 529
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-05-2024
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Active ingredient:
GADOBENATE DIMEGLUMINE
Available from:
Bracco SPA
Dosage:
529
Pharmaceutical form:
Solution for Injection
Authorization date:
2008-07-04
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MultiHance 529 mg/ml solution for injection in pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains: gadobenic acid 334 mg (0.5 mmol) as dimeglumine salt. [Gadobenate
dimeglumine 529 mg = gadobenic acid 334 mg + meglumine 195 mg].
10 ml of solution for injection contain: gadobenic acid 3340 mg (0.5 mmol) as dimeglumine salt. [gadobenate
dimeglumine 5290 mg = gadobenic acid 3340 mg + meglumine 1950 mg].
15 ml of solution for injection contain: gadobenic acid 5010 mg (0.5 mmol) as dimeglumine salt. [gadobenate
dimeglumine 7935= gadobenic acid 5010 mg + meglumine 2925].
20 ml of solution for injection contain: gadobenic acid 6680 mg (0.5 mmol) as dimeglumine salt. [gadobenate
dimeglumine 10580 mg = gadobenic acid 6680 mg + meglumine 3900].
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in a pre-filled syringe.
Clear, colourless to slightly yellow, aqueous solution.
Osmolality at 37°C: 1.97 osmol/kg
Viscosity at 37°C: 5.3 mPa.s
pH: 6.9-7.3
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
MultiHance is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) indicated for :
MRI of the liver for the detection of focal liver lesions in patients with known or suspected primary liver cancer
(eg. hepatocellular carcinoma) or metastatic disease.
MRI of the brain and spine where it improves the detection of lesions and provides diagnostic information
additional to that obtained with unenhanced MRI.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
MRI of the liver: the recommended dose of MultiHance in adult patients is 0.05 mmol/kg body weight. T
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