SALOFALK

Nazione: Indonesia

Lingua: indonesiano

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

Principio attivo:

MESALAZINE

Commercializzato da:

DARYA-VARIA LABORATORIA TBK - Indonesia

INN (Nome Internazionale):

MESALAZINE

Dosaggio:

1500 MG

Forma farmaceutica:

GRANUL SALUT ENTERIK

Confezione:

DUS,35 SACHET @2,79 G

Prodotto da:

LOSAN PHARMA GMBH - Federal Republic of Germany

Data dell'autorizzazione:

2021-12-06

Scheda tecnica

SALOFALK
®
MESALAZINE
ENTERIC-COATED GRANULES1.5 G
COMPOSITION
-
Each sachet of 2.79 g Salofalk
®
1.5g granules contains:
Mesalazine ………………………………...............… 1.5
g
PHARMACEUTICAL FORM
Enteric-coated granules
Description: stick-formed or round, greyish white granules
PHARMACOLOGY
PHARMACODYNAMIC
Pharmacotherapeutic group: Aminosalicylic acid and similar agents
ATC code: A07EC02
The mechanism of the anti-inflammatory action is unknown. The results
of in vitro studies indicate that inhibition of
lipoxygenase may play a role.
Effects on prostaglandin concentrations in the intestinal mucosa have
also been demonstrated. Mesalazine (5-
aminosalicylic acid / 5-ASA) may also function as a radical scavenger
of reactive oxygen compounds.
Mesalazine, orally administered, acts predominantly locally at the gut
mucosa and in the submucosal tissue from
the luminal side of the intestine. It is important, therefore, that
mesalazine is available at the regions of
inflammation. Systemic bioavailability/plasma concentrations of
mesalazine are therefore of no relevance for
therapeutic efficacy, but rather a factor for safety. In order to
realise this, Salofalk
®
granules are gastric juice
resistant and release mesalazine in a pH-dependent manner, due to a
Eudragit L coating, and prolonged manner,
due to the matrix granule structure.
PHARMACOKINETIC
General considerations of mesalazine:
_Absorption: _
Mesalazine absorption is highest in proximal and lowest in distal gut
areas.
_Biotransformation _
Mesalazine is metabolised both pre-systemically by the intestinal
mucosa and the liver to the pharmacologically
inactive N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). The acetylation
seems to be independent of the acetylator
phenotype of the patient. Some acetylation also occurs through the
action of colonic bacteria. Protein binding of
mesalazine and N-Ac-5-ASA is 43% and 78%, respectively.
_Elimination: _
Mesalazine and its metabolite N-Ac-5-ASA are eliminated via the faeces
(major part), renally (varies betw