Budesonid Teva 3 mg Enterokapsel, hård

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

budesonid

Tillgänglig från:

Teva B.V.

ATC-kod:

A07EA06

INN (International namn):

budesonide

Dos:

3 mg

Läkemedelsform:

Enterokapsel, hård

Sammansättning:

budesonid 3 mg Aktiv substans; natriumlaurilsulfat Hjälpämne; sockersfärer Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

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

Bemyndigande status:

Godkänd

Tillstånd datum:

2022-03-07

Produktens egenskaper

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