Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
GADOBENATE DIMEGLUMINE; GADOBENATE DIMEGLUMINE
DCH AURIGA SINGAPORE
V08CA08
529 mg/ml
INJECTION
GADOBENATE DIMEGLUMINE 529 mg/ml; GADOBENATE DIMEGLUMINE 529 mg/ml
INTRAVENOUS
Prescription Only
Patheon Italia S.P.A.
ACTIVE
2004-01-30
Singapore- MultiHance package insert 1 NAME OF THE MEDICINAL PRODUCT MultiHance, 0.5 M solution for injection_ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains: gadobenic acid 334 mg (0.5M) as the dimeglumine salt. [Gadobenate dimeglumine 529 mg = gadobenic acid 334 mg + meglumine 195 mg]. 5 ml of solution for injection contain: gadobenic acid 1670 mg (2.5 mmol) as dimeglumine salt. [gadobenate dimeglumine 2645 mg = gadobenic acid 1670 mg + meglumine 975 mg] 10 ml of solution for injection contain: gadobenic acid 3340 mg (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 (7.5 mmol) as dimeglumine salt. [gadobenate dimeglumine 7935= gadobenic acid 5010 mg + meglumine 2925 mg] 20 ml of solution for injection contain: gadobenic acid 6680 mg (10 mmol) as dimeglumine salt. [gadobenate dimeglumine 10580 mg = gadobenic acid 6680 mg + meglumine 3900 mg] For excipients, see 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear aqueous solution filled into colourless glass vials. Osmolality at 37°C: 1.97 osmol/kg Viscosity at 37°C: 5.3 mPa.s 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 Read the complete document
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 42 43 44 45 46 47 48 49 50 51 52 53 54 55 SYSTEM ORGAN CLINICAL TRIALS POST-MARKETING CLASSES SURVEILLANCE COMMON UNCOMMON RARE FREQUENCY (≥1/100, (≥1/1,000, (≥1/10,000, UNKNOWN** <1/10) <1/100) <1/1,000) Investigations Electrocardiogram Blood albumin abnormalities*, decreased, Alkaline Blood bilirubin phosphatase increased, increased, Blood Increases in serum iron increased, transaminases, Increase in lactic gamma-glutamyl- dehydrogenase transferase and creatinine * Electrocardiogram abnormalities include electrocardiogram QT prolonged, electrocardiogram QT shortened, electrocardiogram T wave inversion, electrocardiogram PR prolongation, electrocardiogram QRS complex prolonged. ** Since the reactions were not observed during clinical trials with 5,712 subjects, best estimate is that their relative occurrence is rare (≥ 1/10,000 to <1/1000). The most appropriate MedDRA (version 16.1) term is used to describe a certain reaction and its symptoms and related conditions. *** Allergic acute coronary syndrome Laboratory findings were mostly seen in patients with evidence of pre-existing impairment of hepatic function or pre-existing metabolic disease. The majority of these events were non-serious, transient and spontaneously resolved without residual effects. There was no evidence of any correlation with age, gender or dose administered. As with other gadolinium-chelates, there were reports of anaphylactic/ anaphylactoid/ hypersensitivity reactions. These reactions manifested with various degrees of severity up to anaphylactic shock and death, and involved one or more body system, mostly respiratory, cardiovascular, and/or mucocutaneous systems. In patients with history of convulsion, brain tumours or metastasis, or other cerebral disorders, convulsions have been reported after MultiHance administration. (see sectio Read the complete document