OPTIMINE 500mcg/5ml MG/5ml Unknown
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
26-05-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
AZATADINE MALEATE
थमां उपलब्ध:
Schering-Plough Limited
INN (इंटरनेशनल नाम):
AZATADINE MALEATE
डोज़:
500mcg/5ml MG/5ml
फार्मास्यूटिकल फॉर्म:
Unknown
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
2006-02-23
उत्पाद विशेषताएं
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Optimine Syrup oral solution 500 mcg/5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of solution contains azatadine maleate 500 micrograms.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A clear, colourless, blackcurrant flavoured solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of allergic conditions such
as hayfever, vasomotor rhinitis, urticaria, pruritus of allergic
origin and allergic reactions associated with insect bites and
stings.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
_Adults, the elderly and children over the age of 12
years : _- 1mg of azatadine maleate (10ml of syrup) in
the morning
and evening is recommended. In refractory or more severe cases,
2mg (20ml) may be used.
_Children (6-12 years):_
0.5 - 1.0mg azatadine maleate (5 - 10ml syrup), twice daily.
Optimine Syrup may be diluted with syrup BP.
Method of administration : Oral.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active ingredient or any
of the other constituents.
Monoamine oxidase inhibitors, which are known to intensify
or prolong the anticholinergic and sedative action of
drugs, should not be used concomitantly with azatadine maleate.
Due to
the anticholinergic effect of azatadine maleate, the drug
should be used with caution in patients with prostatic
hypertrophy, urinary retention, glaucoma, stenosing
peptic ulcer or pyloroduodenal obstructions.
Patients with rare hereditary
problems of fructose intolerance should not take this medicine.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None known.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/12/2005_
_CRN 2017838_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER F
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