Actilor Syrup 2.5 mg 5 ml

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

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

সক্রিয় উপাদান:

DESLORATADINE

থেকে পাওয়া:

MEDISPEC (M) SDN.BHD

INN (International Name):

DESLORATADINE

প্যাকেজ ইউনিট:

120 ml

Manufactured by:

Neopharma

তথ্য লিফলেট

ACTILOR SYRUP
desloratadine (2.5mg/5ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Actilor syrup_
is used for
2.
How
_Actilor syrup_
works
3.
Before you use
_Actilor syrup_
4.
How to use
_Actilor syrup_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Actilor _
_syrup_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _ACTILOR SYRUP_ IS USED FOR
Actilor Syrup is indicated for the rapid
relief
of
symptoms
associated
with
allergic
rhinitis,
such
as
sneezing,
nasal
discharge
and
itching,
congestion/stuffiness,
as
well
as
ocular
itching,
tearing
and
redness.
Actilor Syrup is also indicated for the
relief
of
symptoms
associated
with
urticaria such as the relief of itching
and the size and number of hives.
HOW _ACTILOR SYRUP_ WORKS
Actilor syrup is an anti-allergy
medicine that does not make you
drowsy. It helps control your allergic
reaction and its symptoms.
BEFORE YOU USE _ACTILOR SYRUP_
-
_When you must not use it _
Do not use Actilor syrup if:
•
If you are hypersensitivity to the
active
substance,
to
any
of
the
excipients, or to loratadine.
_Pregnancy and lactation _
Do not take
_Actilor syrup_
if you are
pregnant,
trying
to
get
pregnant
or
think you may be pregnant.
Do not take
_Actilor syrup_
if you are
breast-feeding.
Ask
your
doctor
or
pharmacist
for
advice
before
taking
any medicine.
_ _
-
_Before you start to use it _
_Paediatric population: _
Tell
doctors
if
you
have
renal
insufficiency.
_Convulsions:_
Tell the doctors if you have medical or
familial
history
of
seizures
(mainly
young children)
_Desloratadine syrup contains sorbitol: _
Tell doctors if you have rare
hereditary problems of fructose
intolerance (HFI).
_Desloratadine syrup contains sodium: _
Tell doctors if you are on sodium diet.
-
_Taking other medicines _
Tell your doctor if you are taking any
other
medicines,
including
any
that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
Avoid
alcohol
when
you
t

পণ্য বৈশিষ্ট্য

ACTILOR SYRUP 2.5 MG/ 5 ML
(Desloratadine Syrup 2.5 mg/ 5 ml)
Each ml of syrup contains 0.5 mg desloratadine.
PRODUCT DESCRIPTION
Clear, colorless, raspberry flavored solution, free from visible
extraneous matter.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: antihistamines – H
1
antagonist, ATC code: R06A X27
Mechanism of action
Desloratadine is a non-sedating, long-acting histamine antagonist with
selective peripheral H
1
-receptor antagonist
activity. After oral administration, desloratadine selectively blocks
peripheral histamine H
1
-receptors because the
substance is excluded from entry to the central nervous system.
Desloratadine has demonstrated antiallergic properties. These include
inhibiting the release of proinflammatory
cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast
cells/basophils, as well as inhibition of the expression of
the adhesion molecule P-selectin on endothelial cells. The clinical
relevance of these observations remains to be
confirmed.
PHARMACOKINETIC PROPERTIES
Absorption
Desloratadine plasma concentrations can be detected within 30 minutes
of desloratadine administration in adults and
adolescents. Desloratadine is well absorbed with maximum concentration
achieved after approximately 3 hours; the
terminal phase half-life is approximately 27 hours. The degree of
accumulation of desloratadine was consistent with its
half-life (approximately 27 hours) and a once daily dosing frequency.
The bioavailability of desloratadine was dose
proportional over the range of 5 mg to 20 mg.
The exposure (AUC) to desloratadine was about 6-fold higher and the C
max
was about 3 to 4 fold higher at 3-6 hours
with a terminal half-life of approximately 120 hours. Exposure was the
same in adult and paediatric poor metabolisers
when treated with age-appropriate doses. The overall safety profile of
these subjects was not different from that of the
general population. The effects of desloratadine in poor metabolizers
< 2 years of age have not been studied.
At the recommended doses, paediatr