Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
(Desloratadine coated granules): desloratadine, micronized
MSD PHARMA (SINGAPORE) PTE. LTD.
R06AX27
2.5mg
TABLET, ORALLY DISINTEGRATING
(Desloratadine coated granules): desloratadine, micronized 2.5mg
ORAL
Prescription Only
CIMA Labs Inc
ACTIVE
2012-02-08
034117-DL-TBf-PIPB.4.doc AERIUS ® REDITABS ® TABLETS Brand of desloratadine DESCRIPTION: Each AERIUS Reditabs tablet contains 5.0 or 2.5 milligrams of desloratadine. Inactive Ingredients: Ferric Oxide, Red (E172), aspartame, colloidal silicon dioxide, crospovidone, microcrystalline cellulose, sodium hydrogen carbonate, citric acid anhydrous, granular mannitol 2080, magnesium stearate, mannitol, tutti-frutti flavour. ACTIONS: Desloratadine is a non-sedating long-acting histamine antagonist with potent, selective peripheral H 1 -receptor antagonist activity. Desloratadine has demonstrated antiallergic, antihistaminic, and anti-inflammatory activity. In addition to antihistaminic activity, desloratadine has demonstrated antiallergic and anti- inflammatory activity from numerous in vitro (mainly conducted on cells of human origin) and _in vivo_ studies. These studies have shown that desloratadine inhibits the broad cascade of events that initiate and propagate allergic inflammation, including, the release of proinflammatory cytokines including IL-4, IL-6, IL-8, IL-13, the release of important proinflammatory chemokines such as RANTES (Regulated upon Activation, Normal T-cell Expressed and Secreted), superoxide anion production by activated polymorphonuclear neutrophils, eosinophil adhesion and chemotaxis, the expression of the adhesion molecules such as P-selectin, IgE-dependent release of histamine, prostaglandin (PGD2), and leukotriene (LTC4), the acute allergic bronchoconstrictor response and allergic cough in animal models. PRECLINICAL TOXICOLOGY: Desloratadine is the primary active metabolite of loratadine. Non- clinical studies conducted with desl Przeczytaj cały dokument
S-CCDS-MK4117-MTL-112017 AERIUS ® Reditabs ® tablets Brand of desloratadine DESCRIPTION: Each AERIUS Reditabs tablet contains 5.0 or 2.5 milligrams of desloratadine. Inactive Ingredients: Ferric Oxide, Red (E172), aspartame, colloidal silicon dioxide, crospovidone, microcrystalline cellulose, sodium hydrogen carbonate, citric acid anhydrous, granular mannitol 2080, magnesium stearate, mannitol, tutti-frutti flavour. ACTIONS: Desloratadine is a non-sedating long-acting histamine antagonist with potent, selective peripheral H 1 -receptor antagonist activity. Desloratadine has demonstrated antiallergic, antihistaminic, and anti-inflammatory activity. In addition to antihistaminic activity, desloratadine has demonstrated antiallergic and anti-inflammatory activity from numerous in vitro (mainly conducted on cells of human origin) and in vivo studies. These studies have shown that desloratadine inhibits the broad cascade of events that initiate and propagate allergic inflammation, including, • the release of proinflammatory cytokines including IL-4, IL-6, IL-8, IL-13, • the release of important proinflammatory chemokines such as RANTES (Regulated upon Activation, Normal T-cell Expressed and Secreted), • superoxide anion production by activated polymorphonuclear neutrophils, • eosinophil adhesion and chemotaxis, • the expression of the adhesion molecules such as P-selectin, • IgE-dependent release of histamine, prostaglandin (PGD2), and leukotriene (LTC4), • the acute allergic bronchoconstrictor response and allergic cough in animal models. PRECLINICAL TOXICOLOGY: Desloratadine is the primary active metabolite of loratadine. Non-clinical studies conducted with desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine. Non-clinical data with desloratadine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose t Przeczytaj cały dokument