দেশ: সুইডেন
ভাষা: সুইডিশ
সূত্র: Läkemedelsverket (Medical Products Agency)
budesonid
Teva B.V.
A07EA06
budesonide
3 mg
Enterokapsel, hård
budesonid 3 mg Aktiv substans; natriumlaurilsulfat Hjälpämne; sockersfärer Hjälpämne
Receptbelagt
Förpacknings: Blister, 20 x 1 kapslar (endos); Blister, 120 x 1 kapslar (endos); Blister, 100 x 1 kapslar (endos); Blister, 90 x 1 kapslar (endos); Blister, 60 x 1 kapslar (endos); Blister, 50 x 1 kapslar (endos); Burk, 100 kapslar
Godkänd
2022-03-07
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Budesonid Teva 3 mg gastro-resistant capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 3 mg budesonide. Excipient(s) with known effect Each capsule contains up to 305 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant capsule, hard Hard gelatin capsules filled with white pellets. Body: dark pink, opaque. Cap: dark pink, opaque. Dimensions: Approx. 20 mm length and 7 mm diameter 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Crohn's disease Induction of remission in patients with mild to moderate active Crohn's disease affecting the ileum and/or the ascending colon. - Microscopic colitis - Autoimmune hepatitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Crohn's disease _ _Induction of remission_ 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; corresponding to a total daily dose of 9 mg budesonide) if this is more convenient to the patient. _Duration of treatment_ The duration of treatment in active Crohn’s Disease should be limited to 8 weeks. _Microscopic colitis _ _Induction of remission_ 2 The recommended dose is three capsules once daily in the morning (corresponding to a daily dose of 9 mg budesonide). _Maintenance of remission_ Maintenance therapy should only be initiated in patients with frequently recurring symptoms of microscopic colitis after successful induction treatment. A dosage regimen of two capsules once daily in the morning (6 mg budesonide) or of two capsules once daily in the morning alternating with one capsule daily in the morning (corresponding to an average daily dose of 4.5 mg budesonide) can be applied, according to the individual requirements of the patient. The lowest effective dose should be used. _Duration of treatment _ The duration of treatment in active microscopic colitis should be limited to 8 wee সম্পূর্ণ নথি পড়ুন