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SPC, UK: BUDENOFALK Rectal foam (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Budenofalk 2mg/dose rectal foam.

Qualitative and quantitative composition

Each dose of 1.2 g foam contains 2 mg of budesonide. Excipients with known effect: cetyl alcohol, propylene glycol. For the full list of excipients, see section 6.1.

Pharmaceutical form

Rectal foam, pressurised container. White to pale white, creamy firm foam.

Therapeutic indications

For the treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon.

Posology and method of administration

Posology Adults aged >18 years One actuation of 2 mg budesonide daily. Paediatric population Budenofalk 2mg rectal foam should not be used in children due to insufficient experience in this age group. ...

Contraindications

Budenofalk 2mg rectal foam must not be used in patients with: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hepatic cirrhosis.

Special warnings and precautions for use

Treatment with Budenofalk 2mg rectal foam results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy with systemically acting corticoids. Transfer from other glucocorticosteroid ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions Cardiac glycosides The action of the glycoside can be potentiated by potassium deficiency. Saluretics Potassium excretion can be enhanced. Pharmacokinetic interactions Cytochrome ...

Fertility, pregnancy and lactation

Pregnancy Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Budenofalk 2mg rectal foam. There are few data of pregnancy outcomes after oral administration ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

The following frequency conventions are used in the evaluation of undesirable effects: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare ...

Overdose

To date, no cases of overdose with budesonide are known.

Pharmacodynamic properties

Pharmacotherapeutic group: Intestinal antiinflammatory agents, corticosteroids acting locally ATC code: A07EA06 The exact mechanism of action of budesonide in the treatment of ulcerative colitis/procto-sigmoiditis ...

Pharmacokinetic properties

Absorption After oral application the systemic availability of budesonide is about 10%. After rectal administration the areas under the concentration time curves are about 1.5-fold higher than in historical ...

Preclinical safety data

Preclinical investigations on dogs have shown that Budenofalk 2mg rectal foam is well tolerated locally. Preclinical data in acute, subchronic and chronic toxicological studies with budesonide showed atrophies ...

List of excipients

Cetyl alcohol Citric acid monohydrate Disodium edetate Emulsifying wax Macrogol stearyl ether Propylene glycol Purified water Propellant: n-Butane Isobutane Propane

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years. After first opening: 4 weeks.

Special precautions for storage

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. ...

Nature and contents of container

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 ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108, Freiburg, Germany

Marketing authorization number(s)

PL08637/0011

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 Jun 2006 Date of last renewal: 15 Jun 2011

Date of revision of the text

05/2017

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