RAFASSAL 3 GRAM GRANULES

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

MESALAZINE (5 - AMINOSALICYLIC ACID)

Tilgjengelig fra:

RAFA LABORATORIES LTD

ATC-kode:

A07EC02

Legemiddelform:

GRANULES PROLONGED RELEASE GASTRO RESISTANT

Sammensetning:

MESALAZINE (5 - AMINOSALICYLIC ACID) 3 G

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

DR. FALK PHARMA, GERMANY

Terapeutisk område:

MESALAZINE

Indikasjoner:

For the treatment of acute episodes and the maintenance of remission of ulcerative colitis.

Autorisasjon dato:

2019-03-31

Informasjon til brukeren

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Preparatomtale

1
Rafassal Granules -DL-Jun 2023-05
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
_RAFASSAL 1 GRAM GRANULES _gastro-resistant prolonged-release granules
_RAFASSAL 1.5 GRAM_ _GRANULES _gastro-resistant prolonged-release
granules
_RAFASSAL 3 GRAM_ _GRANULES _gastro-resistant prolonged-release
granules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of _RAFASSAL 1 GRAM GRANULES _contains 1 gram mesalazine.
Each sachet of _RAFASSAL 1.5 GRAM GRANULES_ contains 1.5 gram
mesalazine.
Each sachet of _RAFASSAL 3 GRAM GRANULES_ contains 3 gram mesalazine.
Excipients
_ _
with known effect:
Each sachet of _RAFASSAL 1 GRAM GRANULES_ contains 2.0 mg aspartame
and
0.08mg sucrose.
Each sachet of _RAFASSAL 1.5 GRAM GRANULES_ contains 3.0 mg aspartame
and
0.12mg sucrose.
Each sachet of _RAFASSAL 3 GRAM GRANULES_ contains 6.0 mg aspartame
and
0.24mg sucrose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant prolonged-release granules.
Description: greyish white granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of acute episodes and the maintenance of remission
of
ulcerative colitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Adults and elderly: _
For the treatment of acute episodes of ulcerative colitis:
Once daily 1 sachet of _RAFASSAL 3 GRAM GRANULES_, 1 or 2 sachets of
_RAFASSAL 1.5 _
_GRAM GRANULES_, or 3 sachets of _RAFASSAL 1 GRAM_ _GRANULES
_(equivalent to 1.5-
3 gram mesalazine daily) preferably to be taken in the morning
according to the
individual clinical requirement.
It is also possible to take the prescribed daily dose in three divided
doses
(1 sachet of _RAFASSAL 1 GRAM GRANULES three_ times daily) if this is
more
convenient to the patient.
For the maintenance of remission of ulcerative colitis:
2
Total dose of 1.5 gram mesalazine per day as a single daily dose. For
patients
known to be at increased risk for relapse for medical reasons, the
dosing schedule
can be adapted to 3 gram mesalazine given as a single da