| 1 – Name:
Clarification to add ‘per dose’ in the name: ‘Budenofalk 2mg/dose rectal foam’
2 – Qualitative and quantitative:
Clarification of dose (as section 1) and to list excipients to comply with guidance.
3 – Pharmaceutical form:
To add ‘pressurised container’ and clarify colour of foam.
4.2 – Posology and administration:
To add ‘and adolescents’ to the header concerning use in children.
4.4 – Special warnings:
To add:
‘If a patient is transferred from systemic corticoids to Budenofalk, the theoretical risk of recurrence of symptoms due to differences in the pharmacokinetics has to be taken into account’
and to delete:
‘transfer from other steroid therapy may result in symptoms relating to the change in systemic steroid levels.’
4.6 - Pregnancy and lactation:
To add:
‘It is not known if budesonide passes into breastmilk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Budenofalk 2mg rectal foam should be made taking into account the benefit of breast-feeding to the child and the benefit of the therapy to the woman’
and to delete:
‘Since it is not known if budesonide passes into breast milk, the infant should not be breast fed during treatment with Budenofalk 2mg rectal foam.’
4.8 – Undesirable effects:
1) To update the ‘vary rare’ frequency to be according to the guidance:
Very rare: (<1/10,000), including isolated reports not known (cannot be estimated from the available data).
2) To remove sorbic acid from the ‘Skin and subcutaneous tissue disorders’ section as this excipient has been removed from the product.
5.1 – Pharmacodynamics
1) To correct the Pharmacotherapeutic group: intestinal antiinflamatory agent Corticosteroids acting locally
2) To remove the phrase ‘which is clinically equieffective to systemically acting glucocorticoids’ from the text after: ‘at a dosage of 2mg budesonide, applied rectally’.
5.2 – Pharmacokinetics
To make the shown change in the Absorption section:
After rectal administration the areas under the concentration time curves are slightly about 1.5-fold higher than in historical controls considering the identical oral budesonide dose.
6.1 – Excipients
To remove sorbic acid.
6.3 – Shelf life
To change ‘After first actuation’ to ‘After first opening’.
6.4 – Special storage precautions
Change from:
This is a pressurised container, containing 6.5% by mass of inflammable propellant. It should be kept away from any flames or sparks including cigarettes, protected from direct sunlight and must not be pierced or burned even when empty.
to
This is a pressurised container, containing inflammable propellant.
Do not expose to temperature higher than 50°C, protect from direct sunlight. Do not pierce or burn even when empty
6.5 – Container
Replaced:
‘spray can’ with ‘pressurised container’
‘actuation’ with ‘dose’
Added: ‘Not all pack sizes may be marketed’.
10 – Revision date
Added ‘July 2009’.
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