Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
Desloratadine, micronized
ORGANON SINGAPORE PTE. LTD.
R06AX27
0.5 mg/ml
SOLUTION
Desloratadine, micronized 0.5 mg/mL
ORAL
Prescription Only
Organon Heist bv
ACTIVE
2004-04-05
1 AERIUS ® SYRUP Brand of desloratadine DESCRIPTION: Each 1 ml of AERIUS ® Syrup contains 0.5 mg of desloratadine. AERIUS ® Syrup is a clear, orange solution. Inactive Ingredients: propylene glycol, sorbitol liquid, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, disodium edetate, sucrose, natural and artificial flavor, FD&C Yellow Dye No. 6 and purified water. Preservative: sodium benzoate 1.00 mg/ml. 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. No Przeczytaj cały dokument
S-CCDS-MK4117-MTL-112017 AERIUS® Syrup and Oral Solution Brand of desloratadine DESCRIPTION for AERIUS® Syrup: Each 1 ml of AERIUS® Syrup contains 0.5 mg of desloratadine. AERIUS® Syrup is a clear, orange solution. Inactive Ingredients: propylene glycol, sorbitol liquid, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, disodium edetate, sucrose, natural and artificial flavor, FD&C Yellow Dye No. 6 and purified water. Preservative: sodium benzoate 1.00 mg/ml. DESCRIPTION for Oral Solution: Each 1 ml of AERIUS® Oral Solution contains 0.5 mg of desloratadine. AERIUS® Oral Solution is a clear solution. Inactive Ingredients: propylene glycol, sorbitol liquid, citric acid anhydrous, sodium citrate dihydrate, disodium edetate, hypromellose, sucralose, natural and artificial flavor, and purified water. 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 met Przeczytaj cały dokument