BUDENOFALK Gastro-resistant capsule (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Budenofalk 3 mg gastro-resistant capsules.
Qualitative and quantitative composition
Each capsule contains 3 mg budesonide. Excipients with known effect: each capsule contains 240 mg sucrose and 12 mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Gastro-resistant capsules, hard (gastro-resistant capsules). Capsule, hard, pink containing white gastro-resistant granules.
Therapeutic indications
Crohns disease.Induction of remission in patients with mild to moderate active Crohns disease affecting the ileum and/or the ascending colon. Collagenous colitis.Induction of remission in patients with ...
Posology and method of administration
Posology Crohns disease Adults aged >18 years The recommended daily dose is three capsules once daily in the morning or one capsule (containing 3 mg budesonide) three times daily (morning, midday and evening; ...
Contraindications
Budenofalk 3mg 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 3mg results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy. Transfer from other glucocorticosteroid therapy may result in symptoms relating ...
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 3mg. There are few data of pregnancy outcomes after oral administration of budesonide ...
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: Glucocorticosteroid ATC code: A07EA06 The exact mechanism of budesonide in the treatment of Crohns disease is not fully understood. Data from clinical pharmacology studies and ...
Pharmacokinetic properties
Absorption Budenofalk 3mg capsules, which contain gastric juice resistant granules, have – due to the specific coating of the granules a lag phase of 2-3 hours. In healthy volunteers, as well as in patients ...
Preclinical safety data
Preclinical data in acute, subchronic and chronic toxicological studies with budesonide showed atrophies of the thymus gland and adrenal cortex and a reduction especially of lymphocytes. These effects ...
List of excipients
<u>Capsule contents:</u> Ammonio methacrylate copolymer (type A) (Eudragit RL) Ammonio methacrylate copolymer (type B) (Eudragit RS) Lactose monohydrate Maize starch Methacrylic acid-methyl methacrylate ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Al/PVC/PVDC blister strips. Pack sizes: 10, 50, 90, 100 or 120 capsules. Not all pack sizes may be marketed.
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)
PL 08637/0002
Date of first authorization / renewal of the authorization
04/01/2009
Date of revision of the text
08/11/2018
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