Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Gadovist 1.0 mmol/ml solution for injection in prefilled syringe/cartridge.
| Pharmaceutical Form |
|---|
|
Solution for injection in prefilled syringe/cartridge. Clear, colourless to pale yellow liquid. Physico-chemical properties: Osmolality at 37°C: 1603 mOsm/kg H2O |
1 ml of solution for injection contains 604.72 mg gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium).
1 prefilled syringe with 5.0 ml contains 3023.6 mg gadobutrol,
1 prefilled syringe with 7.5 ml contains 4535.4 mg gadobutrol,
1 prefilled syringe with 10 ml contains 6047.2 mg gadobutrol,
1 prefilled syringe with 15 ml contains 9070.8 mg gadobutrol,
1 prefilled syringe with 20 ml contains 12094.4 mg gadobutrol.
1 cartridge with 15 ml contains 9070.8 mg gadobutrol,
1 cartridge with 20 ml contains 12094.4 mg gadobutrol,
1 cartridge with 30 ml contains 18141.6 mg gadobutrol.
Excipient with known effect: 1 ml contains 0.00056 mmol (equivalent to 0.013 mg) of sodium (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Gadobutrol |
Gadobutrol is a gadolinium-based, hydrophilic, macrocyclic, electrically neutral contrast agent used in contrast-enhanced MRI (CE-MRI). |
| List of Excipients |
|---|
|
Calcobutrol sodium |
Glass syringes:
One 10-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 5 ml, 7.5 ml and 10 ml solution for injection.
One 17-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 15 ml solution for injection.
One 20-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 20 ml solution for injection.
Plastic syringes:
One 10-ml prefilled syringe (cyclo-olefin polymer) with a plunger stopper (siliconized bromobutyl) and a tip seal (thermoplastic elastomer) contains 5 ml, 7.5 ml, 10 ml solution for injection.
One 20-ml prefilled syringe (cyclo-olefin polymer) with a plunger stopper (siliconized bromobutyl) and a tip seal (thermoplastic elastomer) contains 15 ml, 20 ml solution for injection.
Cartridge:
One 65-ml cartridge (cyclo-olefine-polymer) with a plunger stopper (polyisoprene, type I, siliconised with silicone oil), a tip cap (chlorobutyl rubber), a hard core (polycarbonate), a safety cap (polypropylene) and a swivelnut (polycarbonate) contains 15, 20 or 30 ml solution for injection.
Pack sizes of:
1 and 5 prefilled syringes
1 and 5 cartridges
Hospital pack:
5 prefilled syringes with 5, 7.5, 10, 15, 20 ml solution for injection
5 prefilled cartridges with 15, 20, 30 ml solution for injection
Not all pack sizes may be marketed.
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
PL 00010/0536
Date of first authorisation: 01 May 2008
Date of last renewal: 14 October 2010
| Drug | Countries | |
|---|---|---|
| GADOVIST | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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