RAFASSAL 1.5 GRAM GRANULES

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

MESALAZINE (5 - AMINOSALICYLIC ACID)

Verfügbar ab:

RAFA LABORATORIES LTD

ATC-Code:

A07EC02

Darreichungsform:

GRANULES PROLONGED RELEASE GASTRO RESISTANT

Zusammensetzung:

MESALAZINE (5 - AMINOSALICYLIC ACID) 1.5 G

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

DR. FALK PHARMA, GERMANY

Therapiebereich:

MESALAZINE

Anwendungsgebiete:

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

Berechtigungsdatum:

2019-03-31

Gebrauchsinformation

[לוגו מדינת ישראל] [http://www.gov.il/]
[http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד
הבריאות] [*5400]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
הציבור הרחב עסקים ומוסדות עובדים
בבריאות חפש מידע
תפריט *
[סגירה]
סגור *
דף הבית [http://www.health.gov.il/] *
אודות *
אודות המשרד
[http://www.health.gov.il/About/Pages/about_us.aspx] *
תוכנית עבודה
[http://www.health.gov.il/About/Pages/Agenda.aspx] *
תקציב המשרד
[http://www.health.gov.il/About/Pages/budget.aspx] *
תרשים מבנה ארגוני
[http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] *
בעלי תפקידים
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] *
אמנת שירות
[http://www.health.gov.il/About/sla/Pages/default.aspx] *
אותות ופרסים
[http://www.health.gov.il/About/Awards/Pages/mifal.aspx] *
פרוייקטים תשתיתיים
[http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] *
דרושים
[http://www.health.gov.il/About/Careers/Pages/default.aspx] *
מנכ"לי משרד הבריאות לדורותיהם
[http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] *
יחידות המשרד *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] *
וועדות ומועצות
[http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] *
נושאים *
בריאות הנפש
[http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] *
בריאות הסביבה
[http://www.health.gov.il/Subjects/Environmental_Health/

Fachinformation

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