MULTIHANCE Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
MultiHance, 0.5 M solution for injection.
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 ...
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.
Therapeutic indications
This medicinal product is for diagnostic use only. MultiHance is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) of the liver in adults and children (above the age ...
Posology and method of administration
Posology The recommended dose of gadobenic acid in adult patients and children is 0.05 mmol/kg body weight (0.1 mL/kg of the 0.5 M solution). The lowest dose that provides sufficient enhancement for diagnostic ...
Contraindications
MultiHance is contra-indicated in: patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1 patients with a history of allergic or adverse reactions to other ...
Special warnings and precautions for use
The use of diagnostic contrast media, such as MultiHance, should be restricted to hospitals or clinics staffed for intensive care emergencies and where cardiopulmonary resuscitation equipment is readily ...
Interaction with other medicinal products and other forms of interaction
Interaction studies with other medicinal products were not carried out during the clinical development of MultiHance. However no drug interactions were reported during the clinical development programme. ...
Pregnancy and lactation
Pregnancy There are no data from the use of gadobenate dimeglumine in pregnant women. Animal studies have shown reproductive toxicity at repeated high doses (see section 5.3). MultiHance should not be ...
Effects on ability to drive and use machines
MultiHance has no or negligible influence on the ability to drive and use machines.
Undesirable effects
The following adverse events were seen during the clinical development of MultiHance. Clinical trials: Common (≥1/100, <1/10) Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000) Post-marketing surveillance: ...
Overdose
There have been no cases of overdose reported. Therefore, the signs and symptoms of overdosage have not been characterised. Doses up to 0.4 mmol/kg were administered to healthy volunteers, without any ...
Pharmacodynamic properties
Pharmacotherapeutic group: paramagnetic contrast media ATC code: V08CA08 Mechanism of action and pharmacodynamic effects The gadolinium chelate, gadobenate dimeglumine, shortens longitudinal (T1), and ...
Pharmacokinetic properties
Modelling of the human pharmacokinetics was well described using a biexponential decay model. The apparent distribution and elimination half-times range from 0.085 to 0.117 h and from 1.17 to 1.68 respectively. ...
Preclinical safety data
Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential. Indeed, preclinical effects were ...
List of excipients
Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. From a microbiological point of view, the product should be used immediately after drawing into the syringe.
Special precautions for storage
Do not freeze.
Nature and contents of container
5 mL, 10 mL, 15 mL and 20 mL of a clear aqueous solution filled into single dose colourless type I glass vials with elastomeric closures, aluminium sealing crimps and polypropylene caps. Kit with administration ...
Special precautions for disposal and other handling
MultiHance should be drawn up into the syringe immediately before use and should not be diluted. Before use, examine the product to assure that the container and closure have not been damaged, the solution ...
Marketing authorization holder
Bracco UK Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ, United Kingdom
Marketing authorization number(s)
PL 18920/0039
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 July 1997 Date of last renewal: 21 July 2012
Date of revision of the text
July 2019
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