AZROMAX 250 Milligram Coated Tablets
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
07-06-2024
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:
AZITHROMYCIN
थमां उपलब्ध:
McDermott Laboratories Ltd t/a Gerard Laboratories
INN (इंटरनेशनल नाम):
AZITHROMYCIN
डोज़:
250 Milligram
फार्मास्यूटिकल फॉर्म:
Coated Tablets
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
2008-02-06
उत्पाद विशेषताएं
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azromax 250mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg azithromycin (as 263.68
mg azithromycin monohydrate).
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Azromax 250mg Film-Coated Tablets are white, capsule shaped
tablets with ‘AZ’ ‘250’ on one side, and ‘G’ on
the
reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated in the following infections caused by
microorganisms that are sensitive to azithromycin:
-
Lower respiratory tract infections, such as bronchitis and
mild to moderately
severe community acquired pneumonia
-
Upper respiratory tract infections, such as sinusitis and
pharyngitis/tonsillitis (see section 4.4)
-
Acute otitis media
-
Skin and soft tissue infections
-
Uncomplicated _Chlamydia trachomatis_ urethritis and cervicitis.
When giving antibiotic treatment consideration must be taken
of bacterial resistance and of the official/local regulations
relating to the appropriate use of antimicrobial therapy.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Azithromycin tablets should be given as a single daily dose.
The tablets can be taken with or without food. The
duration of treatment in each
of the infectious diseases is given below.
_Children and adolescents over 45 kg body weight, adults and
the elderly: _
The total dosage of azithromycin is 1500 mg which is spread
over three days (500 mg once daily). Alternatively, the
dosage can be spread over five days (500 mg
as a single dose on the first day and thereafter 250 mg
once daily).
In uncomplicated _Chlamydia trachomatis_ urethritis and
cervicitis the dosage is 1000 mg as a single oral dose.
_Children and adolescents under 45 kg body weight:_
Tablets are not indicat
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