AERIUS ORAL SOLUTION 0.5 mgml

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

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资料单张 资料单张 (PIL)
30-11-2012
产品特点 产品特点 (SPC)
16-08-2022

有效成分:

Desloratadine, micronized

可用日期:

ORGANON SINGAPORE PTE. LTD.

ATC代码:

R06AX27

剂量:

0.5 mg/ml

药物剂型:

SOLUTION

组成:

Desloratadine, micronized 0.5 mg/mL

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Organon Heist bv

授权状态:

ACTIVE

授权日期:

2004-04-05

资料单张

                                 
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
                                
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产品特点

                                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
                                
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