Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108, Freiburg, Germany
For the treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon.
One actuation of 2 mg budesonide daily.
Budenofalk 2mg rectal foam should not be used in children due to insufficient experience in this age group.
Budenofalk 2mg rectal foam can be applied in the morning or evening.
The canister is first fitted with an applicator and then shaken for about 15 seconds before the applicator is inserted into the rectum as far as comfortable. Note that the dose is only sufficiently accurate when the pump dome is held downwards as vertically as possible. To administer a dose of Budenofalk 2mg rectal foam, the pump dome is fully pushed down and very slowly released. Following the activation the applicator should be held in position for 10-15 seconds before being withdrawn from the rectum.
The best results are obtained when the intestine is evacuated prior to administration of Budenofalk 2mg rectal foam.
The attending physician determines the duration of use. An acute episode generally subsides after 6 to 8 weeks. Budenofalk 2mg rectal foam should not be used after this period of time.
To date, no cases of overdose with budesonide are known.
Shelf life: 3 years.
After first opening: 4 weeks.
Do not store above 25°C.
Do not refrigerate or freeze.
This is a pressurised container, containing inflammable propellant.
Do not expose to temperature higher than 50°C, protected from direct sunlight. Do not pierce or burn even when empty.
Aluminium pressurised container with metering valve together with 14 PVC applicators coated with white soft paraffin and liquid paraffin for administration of the foam and 14 plastic bags for hygienic disposal of the applicators.
Pack sizes:
Original pack with 1 pressurised container, contains at least 14 doses of 1.2 g rectal foam each.
Original pack with 2 pressurised containers, contains at least 2 × 14 doses of 1.2 g rectal foam each.
Hospital pack with 1 pressurised container, contains at least 14 doses of 1.2 g rectal foam each.
Not all pack sizes may be marketed.
No special requirements.
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