We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Bayer Limited

The Atrium, Blackthorn Road, Dublin 18,
Telephone: +353 1 2999 313
Fax: +353 1 2061 456
Summary of Product Characteristics last updated on medicines.ie: 10/01/2018
SPC Gadovist

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10/01/2018 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   30-Nov-2017
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

In section 4.1 - Addition of "Gadovist should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI)."

In Section 4.2 - Addition of "The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patient's body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section."

Date of revision has been updated to November 2017.
Updated on 13/05/2016 and displayed until 10/01/2018
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11-May-2016
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

In section 5.1 Pharmacodynamic properties:
Pharmacodynamic effects:

-Gadobutrol does not cross an intact blood-brain barrier and therefore does not accumulate in healthy brain
tissue or in lesions featuring an intact blood-brain barrier.
With high local tissue concentrations of gadobutrol
the T2 effect results in a lessening of signal intensity. -was removed.

In section 10. DATE OF REVISION OF THE TEXT:
October 2015 May 2016 -was removed and added respectively.
Updated on 02/11/2015 and displayed until 13/05/2016
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   27-Oct-2015
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 6.5 has been changed and now includes the following:

 

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.

 

Updated on 11/08/2015 and displayed until 02/11/2015
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   05-Aug-2015
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 4.1 has been changed from:

'This medicinal product is for diagnostic use only. Gadovist is indicated in adults, adolescents and children aged 2 years and older for:.......'

to:

'This medicinal product is for diagnostic use only. Gadovist is indicated in adults and children of all ages (including term neonates) for:.....'

Section 4.2 has been changed from:

'....

Paediatric population

For children aged 2 years and older and for adolescents the recommended dose is 0.1 mmol Gadovist per kg body weight (equivalent to 0.1 ml Gadovist per kg body weight) for all indications (see section 4.1).

Gadovist is not recommended for use in children below age 2 years due to a lack of data on efficacy and safety.....'

to:

'.....

Paediatric population

For children of all ages (including term neonates) the recommended dose is 0.1 mmol gadobutrol per kg body weight (equivalent to 0.1 ml Gadovist per kg body weight) for all indications (see section 4.1).

Neonates up to 4 weeks of age and infants up to 1 year of age

Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Gadovist should only be used in these patients after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Gadovist injections should not be repeated unless the interval between injections is at least 7 days.....'

Section 4.4 has been changed to include:

'....

Neonates and infants

Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Gadovist should only be used in these patients after careful consideration....'

Section 4.8 has been changed from:

'

The overall safety profile of Gadovist is based on data from more than 5,700 patients in clinical trials and from post-marketing surveillance...................................................

Paediatric population

Based on a single dose phase I/III study in 140 paediatric patients (see section 5.1) the frequency, type and severity of adverse reactions in children aged 2 years and older are expected to be comparable to the adverse event profile known in adults.........'

to:

'The overall safety profile of Gadovist is based on data from more than 6,300 patients in clinical trials and from post-marketing surveillance......................

Paediatric population

Based on two single dose phase I/III studies in 138 paediatricsubjects aged 2-17 years and 44 subjects aged 0-<2 years (see section 5.1) the frequency, type and severity of adverse reactions in children of all ages (including term neonates) are consistent with the adverse drug reaction profile known in adults. This has been confirmed in a phase IV study including more than 1,100 paediatric patients and postmarketing surveillance.....'

Section 5.1 has been changed from:

'.............

Paediatric population

A single dose phase I/III study in 140 paediatric patients (aged 2 to 17 years) scheduled for CE-MRI of CNS, liver and kidneys or CE-MRA has been performed.

It was shown that the overall pharmacokinetic (PK) profile of gadobutrol in children over 2 is similar to that in adults. PK parameters such as total clearance (CLtot), area under the curve (AUC) and volume of distribution (V) increased with increasing body weight. Neither age nor gender was found to have an additional independent effect on PK. The amount of gadobutrol excreted into urine within 6 hours p.i. was 98.7 % (median) of the administered dose, confirming fast renal excretion of gadobutrol also in the paediatric population.....'

to:

'...........

Paediatric population

Two single dose phase I/III studies in 138 subjects scheduled for CE-MRI of CNS, liver and kidneys or CE-MRA and in 44 subjects aged 0-<2 years (including term neonates) scheduled to undergo routine CE-MRI of any body region have been performed. Diagnostic efficacy and an increase in diagnostic confidence was demonstrated for all parameters evaluated in the studies and there was no difference among the paediatric age groups and when compared to adults. Gadovist was well tolerated in these studies with the same safety profile of gadobutrol as in adults.....'

Section 5.2 has been changed from:

'....

Characteristics in special patient populations

 Paediatric population

A single dose phase I/III study in 140 paediatric patients (aged 2 to 17 years) scheduled for CE-MRI of CNS, liver and kidneys or CE-MRA has been performed.

It was shown that the overall pharmacokinetic (PK) profile of gadobutrol in children over 2 is similar to that in adults. PK parameters such as total clearance (CLtot), area under the curve (AUC) and volume of distribution (V) increased with increasing body weight. Neither age nor gender was found to have an additional independent effect on PK. The amount of gadobutrol excreted into urine within 6 hours p.i. was 98.7 % (median) of the administered dose, confirming fast renal excretion of gadobutrol also in the paediatric population....'

to:

'...