RAFASSAL 1.5 GRAM GRANULES

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

MESALAZINE (5 - AMINOSALICYLIC ACID)

Dostupné z:

RAFA LABORATORIES LTD

ATC kód:

A07EC02

Forma lieku:

GRANULES PROLONGED RELEASE GASTRO RESISTANT

Zloženie:

MESALAZINE (5 - AMINOSALICYLIC ACID) 1.5 G

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

DR. FALK PHARMA, GERMANY

Terapeutické oblasti:

MESALAZINE

Terapeutické indikácie:

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

Dátum Autorizácia:

2020-01-22

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Súhrn charakteristických

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