Dezal Oral Solution 0.5mgml

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

DESLORATADINE

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DESLORATADINE

Unit dalam pakej:

60ml ml; 100ml ml

Dikeluarkan oleh:

Balkanpharma-Troyan

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DEZAL ORAL SOLUTION 0.5MG/ML
Desloratadine (0.5 mg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What Dezal is used for
2.
How Dezal works
3.
Before you use Dezal
4.
How to take it
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Dezal
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT DEZAL IS USED FOR
Dezal
relieves
symptoms
associated with allergic rhinitis
(inflammation
of
the
nasal
passages caused by an allergy,
for
example,
hay
fever
or
allergy
to
dust
mites).
These
symptoms
include
sneezing,
runny
or
itchy
nose,
itchy
palate, and itchy, red or watery
eyes.
Dezal is also used to relieve the
symptoms
associated
with
urticaria
(a
skin
condition
caused
by
an
allergy).
These
symptoms
include
itching
and
hives.
Relief of these symptoms lasts a
full
day
and
helps
you
to
resume
your
normal
daily
activities and sleep.
HOW DEZAL WORKS
Dezal is an antiallergy medicine
that does not make you drowsy.
It
helps
control
your
allergic
reaction and its symptoms.
BEFORE YOU USE DEZAL
_-When you must not take it_
Do
not
use
Dezal
if
you
are
allergic
(hypersensitive)
to
desloratadine,
to
any
of
the
other ingredients of Dezal or to
loratadine.
Dezal oral solution is indicated
for children 1 through 11 years
of age, adolescents (12 years of
age
and
older),
and
adults,
including the elderly.
_-Before you start to take it _
Take special care with Dezal if
you have poor kidney function.
If this applies to you, or if you
are not sure, please check with
your doctor before taking Dezal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist
for
advice
before
taking
any
medicine during pregnancy and
breast-feeding.
If you are pregnant or nursing a
baby,
taking
Dezal
is
not
recommended.
Important
information
about
some of the ingredients of Dezal
Oral Solution
Dezal
oral
solution
contains
sorbitol. If you have been told
by your doctor that you have an
intolerance
to
some
sugars,
contact
your
doctor
before
taking this medicinal prod

Ciri produk

PRODUCT NAME
Dezal Oral Solution 0.5mg/ml
COMPOSITION
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each ml contains 0.5mg desloratadine
PRODUCT DESCRIPTION
Oral solution: Clear, colourless solution, free from foreign matter.
PHARMACOLOGY
Actions: Desloratadine is a non-sedating long-acting histamine
antagonist with potent, selective peripheral
H
1
-receptor antagonist activity. It has demonstrated anti-allergic,
antihistaminic and anti-inflammatory activity.
Pharmacodynamics: After oral administration, desloratadine selectively
blocks peripheral histamine
H
1
- receptors because the drug is effectively excluded from entry to the
central nervous system (CNS).
In addition to antihistaminic activity, desloratadine has demonstrated
anti-allergic 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 pro-inflammatory cytokines
including IL-4, IL-6, IL-8 and IL-13; the
release of important pro-inflammatory chemokines eg, Regulated upon
Activation, Normal T-cell Expressed
and Secreted (RANTES); superoxide anion production by activated
polymorphonuclear neutrophils; eosinophil
adhesion and chemotaxis; the expression of the adhesion molecules eg,
P-selectin; IgE-dependent release of
histamine, prostaglandin (PGD2), and leukotriene (LTC4); the acute
allergic bronchoconstrictor response and
allergic cough in animal models.
Desloratadine does not readily penetrate the CNS. At the recommended
dose of 5mg daily, there was no excess
incidence of somnolence as compared to placebo. Desloratadine tablet
even at a dose of 7.5 mg daily, did not
affect psychomotor performance. A single dose of desloratadine 5 mg
did not affect standard measures of flight
performance including exacerbation of subjective sleepiness or tasks
related to flying.
No clinically relevant changes in desloratadine plasma concentrations
were o