Zithrocyn tablets film-coated

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktív összetevők:

azithromycin (azithromycin dihydrate)

Beszerezhető a:

A LAB PHARMACEUTICALS LLC

ATC-kód:

J01FA10

INN (nemzetközi neve):

azithromycin (azithromycin dihydrate)

Adagolás:

500mg

Gyógyszerészeti forma:

tablets film-coated

db csomag:

(3/1x3/) in blister

Recept típusa:

Prescription

Engedélyezési státusz:

Registered

Engedély dátuma:

2022-04-12

Termékjellemzők

A - L A B P H A R M A C E U P T I C A L S , L L C
Address: Kochinyan 13/16 street Yerevan - Armenia
Tell: ( [phone] Web: www.alab.am E-Mail: [e-mail]
C O N F I D E N T I A L
Page 13 of
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SUMMARY PRODUCT CHARACTERISTICS
1.
NAME OF THE PROPRIETARY PRODUCT: ZITHROCYN
NAME OF THE NONPROPRIETARY INTERNATIONAL PRODUCT: Azithromycin Tablets
500 mg
ROUTE OF ADMINISTRATION: Oral
PROMOTIONAL CATEGORY: Prescription Only
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
COMPOSITION:
Each film-coated tablet contains:
Azithromycin Dihydrate
Eq. to Azithromycin (Anhydrous)...… 500.00 mg
Excipients …………………………… q. s.
Colour: Titanium Dioxide
3. PHARMACEUTICAL FORM: Oral film-coated tablet
4. CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
Azithromycin tablets can be applied for the treatment of the following
infections, when caused
by microorganisms sensitive to azithromycin:
− acute bacterial sinusitis (adequately diagnosed)
− acute bacterial otitis media (adequately diagnosed)
− pharyngitis, tonsillitis
− acute exacerbation of chronic bronchitis (adequately diagnosed)
− mild to moderately severe community acquired pneumonia
− skin and soft tissue infections
−
sexually
transmitted
diseases
caused
by
organisms
called
Chlamydia
trachomatis
and
Neisseria gonorrhoea.
Considerations should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
Posology
Adults
In uncomplicated Chlamydia trachomatis urethritis and cervicitis the
dosage is 1000 mg as a
single oral dose.
For all other indications the dose is 1500 mg, to be administered as
500 mg per day for three
consecutive days. As an alternative the same total dose (1500 mg) can
also be administered
over a period of five days with 500 mg on the first day and 250 mg on
the second to the fifth
day.
Older people
The same dosage as in adult patients is used for older people. Since
older people can be
patients with ongoing proarrhythmic conditions a particular caution is
recomm