SALOFALK

देश: इंडोनेशिया

भाषा: इंडोनेशियाई

स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

सक्रिय संघटक:

MESALAZINE

थमां उपलब्ध:

DARYA-VARIA LABORATORIA TBK - Indonesia

INN (इंटरनेशनल नाम):

MESALAZINE

डोज़:

500 MG

फार्मास्यूटिकल फॉर्म:

TABLET SALUT ENTERIK

पैकेज में यूनिट:

DUS, 10 BLISTER @ 10 TABLET SALUT ENTERIK

द्वारा बनाया गया:

DR. FALK PHARMA GMBH - Germany

प्राधिकरण की तारीख:

2016-10-12

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SALOFALK
®
Mesalazine (5-aminosalicylic acid)
Enteric-coated tablet 500 mg
2
COMPOSITION
Each tablet contains 500 mg mesalazine.
Excipients with known effect: sodium carbonate and croscarmellose
sodium
For the full list of excipients, see section “Pharmaceutical
particulars” further down.
3
DOSAGE FORM
Enteric-coated tablet
Appearance: oval, light yellow to ochre, enteric-coated tablets, matt
with smooth surface; not
scored.
4
CLINICAL PARTICULARS
4.1
INDICATIONS
Ulcerative colitis, for treatment of mild to moderate acute phases and
prevention of recurrences.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and elderly
Depending upon the clinical requirements in individual cases, the
following daily doses are
recommended:
For the treatment of acute episodes: 1,5 g to 3,0 g mesalazine in
three divided doses (1 or 2
tablets of Salofalk 500 mg three times daily).
For the maintenance of remission: 1,5 g mesalazine in three divided
doses (1 tablet of 500 mg
three times daily).
Method of Administration: Oral
General instructions for use
Salofalk tablets should be taken in the morning, at midday and in the
evening, 1 hour before
meals. They should be swallowed whole, not chewed and taken with
plenty of fluid.
DISETUJUI OLEH BPOM: 01/06/2023
ID REG:EREG10008712100117
Treatment with Salofalk tablets should be administered regularly and
consistently, both in the
acute inflammatory stage and during maintenance therapy in order to
achieve the desired
therapeutic effect.
The duration of use is determined by the physician.
4.3
CONTRAINDICATIONS
Salofalk tablets are contraindicated in cases of
-
Hypersensitivity to the active substance, salicylates or to any of the
excipients listed in
section “Pharmaceutical particulars”.
-
Severe impairment of hepatic or renal function.
-
Gastric and duodenal ulcers
-
Haemorrhagic diathesis (presdisposition to bleeding)
Salofalk
®
500 tablets should not be used to treat infants and small children
because of insuffici