Aerius Reditabs Tablet 5mg

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

(Desloratadine coated granules):desloratadine, micronized

Dostupné z:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC kód:

R06AX27

Dávkovanie:

5mg

Forma lieku:

TABLET, ORALLY DISINTEGRATING

Zloženie:

(Desloratadine coated granules):desloratadine, micronized 5mg

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

CIMA Labs Inc

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2012-02-08

Príbalový leták

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

Súhrn charakteristických

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