DESLORATADINE 0.5 Mg/Ml Oral Solution

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

DESLORATIDINE

থেকে পাওয়া:

Rosemont Pharmaceuticals Ltd

এটিসি কোড:

R06AX27

INN (আন্তর্জাতিক নাম):

DESLORATIDINE

ডোজ:

0.5 Mg/Ml

ফার্মাসিউটিকাল ফর্ম:

Oral Solution

প্রশাসন রুট:

Oral use

প্যাকেজ ইউনিট:

Bottle holding 150 ml of solution

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

Manufactured by:

Rosemont Pharmaceuticals Ltd

থেরাপিউটিক গ্রুপ:

Antihistamines – H1 antagonist

থেরাপিউটিক এলাকা:

Other antihistamines for systemic use

থেরাপিউটিক ইঙ্গিত:

It is indicated in adults, adolescents and children over the age of 1 year for the relief of symptoms associated with: allergic rhinitis, urticaria

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2015-05-15

তথ্য লিফলেট

DESLORATADINE 0.5MG/ML ORAL SOLUTION
20.03.15
SEVEN
212
1 of 2
0.5MG/ML
N/A
Rosemont
YES
-
210 x 300mm (folded 150 x 30mm)
1
Black
Keyline
150ML
P0723
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor, 
pharmacist or nurse.
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This medicine has been prescribed for you only. Do not 
pass it on to others. It may harm them, even if their signs 
of illness are the same as yours. 
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If you get any side effects talk to your doctor, pharmacist 
or nurse. This includes any possible side effects not 
listed in this leaflet. SEE SECTION 4.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_Continued overleaf_
1. WHAT DESLORATADINE ORAL SOLUTION IS AND WHAT IT IS USED FOR
WHAT DESLORATADINE IS
It contains desloratadine which is an antihistamine.
HOW DESLORATADINE WORKS
It is an antiallergy medicine that does not make you drowsy. It helps
control your allergic reaction and 
its symptoms.
WHEN DESLORATADINE SHOULD BE USED
Desloratadine relieves symptoms associated with allergic rhinitis
(inflammation of the nasal passages 
caused by an allergy, for example, hay fever or allergy to dust mites)
in adults, adolescents and children 
1 year of age and older. These symptoms include sneezing, runny or
itchy nose, itchy palate, and itchy, 
red or watery eyes.
Desloratadine 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE ORAL SOLUTION
DO NOT TAKE DESLORATADINE ORAL SOLUTION
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if you are allergic to desloratadine, or to any of the other
ingredients of this medicine (listed in section 
6) or to loratadine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking desloratadine:
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if you have poor kidney function.
USE IN CHILDREN AND ADOLESCENTS
Do not give th

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desloratadine 0.5 mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.5mg desloratadine_._
Excipient(s) with known effect
This medicinal product contains 150 mg/ml sorbitol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desloratadine is indicated in adults, adolescents and children over the age of 1 year for the relief of symptoms
associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents 12 years of age and over._
The recommended dose of desloratadine oral solution is 10ml (5mg) oral solution once a day.
_Paediatric Population_
The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin (see section 4.4)
and there are no data supporting the treatment of infectious rhinitis with desloratadine oral solution.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) desloratadine oral solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) desloratadine oral solution once a day.
The safety and efficacy of desloratadine 0.5mg/ml oral solution in children below the age of 1 year have not been
established. No data are available.
There is limited clinical trial efficacy experience with the use of desloratadine in children 1 through 11 years of age and
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 08/09/2016_
_CRN 2174792_
_page number: 1_
adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Inter