MULTIHANCE INJECTION 20 ML

Ország: Szingapúr

Nyelv: angol

Forrás: HSA (Health Sciences Authority)

Aktív összetevők:

GADOBENATE DIMEGLUMINE

Beszerezhető a:

DCH AURIGA SINGAPORE

ATC-kód:

V08CA08

Adagolás:

529 mg/ml

Gyógyszerészeti forma:

INJECTION

Összetétel:

GADOBENATE DIMEGLUMINE 529 mg/ml

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

Prescription Only

Gyártó:

Patheon Italia S.P.A.

Engedélyezési státusz:

ACTIVE

Engedély dátuma:

2004-01-30

Betegtájékoztató

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

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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