Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
azithromycin (azithromycin monohydrate)
Artesan Pharma GmbH & Co. KG
J01FA10
azithromycin (azithromycin monohydrate)
500mg
tablets film-coated
(3/1x3/) in blister
Prescription
Registered
2019-11-14
Version 50001786/003 1 AZITHRO-DENK 500 MG Film-coated tablet – oral use Macrolide antibiotic Active substance: Azithromycin PACKAGE LEAFLET: INFORMATION FOR THE PATIENT READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. 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. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Azithro-Denk is and what it is used for 2. What you need to know before you take Azithro-Denk 3. How to take Azithro-Denk 4. Possible side effects 5. How to store Azithro-Denk 6. Contents of the pack and other information 1. WHAT AZITHRO-DENK IS AND WHAT IT IS USED FOR Azithromycin is one of a group of antibiotics called macrolides, which prevents sensitive bacteria from growing. It is used to treat infections caused by certain bacteria and other micro-organisms, which include: Upper respiratory tract infections, including sinusitis, sore throat (pharyngitis) and tonsillitis Lower respiratory tract infections, including bronchitis and pneumonia Ear infections (acute otitis media) Skin and soft tissue infections Uncomplicated genital infections caused by organisms called _Chlamydia trachomatis _ or _Neisseria _ _gonorrhoeae _ (non-multidrug-resistant strains). When using antibiotics, the resistance status and official/local guidelines on the appropriate use of antibacterial agents must be considered. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZITHRO-DENK DO NOT TAKE AZITHRO-DENK, IF you are allergic to azithromycin, erythromycin or any antibiotic which belongs to a group called macrolide or ketolide antibiotics you are allergic to any of the othe Les hele dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCTS Azithro-Denk 250 mg Azithro-Denk 500 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: azithromycin _ _ _Azithro-Denk 250 mg _ Each film-coated tablet contains 250 mg azithromycin (as azithromycin monohydrate). Excipient with known effect: Each film-coated tablet contains less than 1 mmol sodium (23 mg). _Azithro-Denk 500 mg _ Each film-coated tablet contains 500 mg azithromycin (as azithromycin monohydrate). Excipient with known effect: Each film-coated tablet contains less than 1 mmol sodium (23 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet _Azithro-Denk 250 mg _ White or off-white, oblong and biconvex film-coated tablet. _Azithro-Denk 500 mg _ White or off-white, oblong and biconvex film-coated tablet with a breaking score on both sides. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the following infections, when caused by azithromycin-susceptible bacteria (see sections 4.4 and 5.1): - Upper respiratory tract infections (including and sinusitis, pharyngitis and tonsillitis) - Lower respiratory tract infections (including bronchitis and pneumonia) - Acute otitis media - Skin and soft tissue infections - Uncomplicated genital infections due to _Chlamydia trachomatis_ or _Neisseria gonorrrhoeae_ (non- multiresistant strains). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Azithromycin differs from other antibiotics by its high tissue affinity. Tissue concentrations exceed serum levels by up to 50-fold, and the half-life in tissues ranges from 2 to 4 days. For these reasons, 2 there is a difference between the dosing regimen of azithromycin and that of other antimicrobial substances. Posology ADOLESCENTS OVER 45 KG BODY WEIGHT AND ADULTS, INCLUDING ELDERLY PATIENTS For upper and lower respiratory tract infections, acute o Les hele dokumentet