Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AZITHROMYCIN DIHYDRATE
Generic Health Sdn. Bhd.
AZITHROMYCIN DIHYDRATE
6tablet Tablets
Jubilant Generics Limited
_Consumer Medication Information Leaflet (RiMUP) _ AZISWIFT TABLETS Azithromycin 250mg Azithromycin 500mg 1 WHAT IS IN THIS LEAFLET 1. What Aziswift Tablet is used for 2. How Aziswift Tablet works 3. Before you take Aziswift Tablets 4. How to take Aziswift Tablets 5. While you are using Aziswift Tablets 6. Side Effects 7. Storage and Disposal of Aziswift Tablets 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 1. WHAT AZISWIFT TABLET IS USED FOR Azithromycin tablets can be applied in situations where micro-organisms sensitive to azithromycin have caused: - chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis) and sinusitis) - ear infections - skin and soft tissue infections - infection of the tube that carries urine from the bladder (urethra) or the neck of the womb (cervix) caused by Chlamydia trachomatis (bacteria). 2. HOW AZISWIFT TABLET WORKS Azithromycin is an antibiotic. It belongs to a group of antibiotics called `macrolides` 3. BEFORE YOU USE AZISWIFT TABLETS _WHEN YOU MUST NOT USE IT_ - if you are allergic (hypersensitive) to azithromycin dihydrate, erythromycin or any of the other ingredients in this medicine (listed in section 8) -if you are allergic (hypersensitive) to any macrolide or ketolide antibiotic. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Aziswift Tablets. _BEFORE YOU START TO USE IT_ Follow all instructions given to you by your doctor carefully, even if they differ from the information contained in this leaflet. _TAKING OTHER MEDICINES_ Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Antacids used for heartburn and indigestion. Aziswift Tablets should be taken at least 1 hour before or 2 hours after the antacid Fluconazole used to treat fungal infections Zidovudine or nelfinavir used to treat HIV infections. Rifabutin used to treat tuberculosis (TB) Terf Прочетете целия документ
For the use of a registered medical practitioner or a hospital or a laboratory only AZISWIFT 250 MG & 500 MG TABLETS PRODUCT NAME: Aziswift 250 mg Tablets Aziswift 500 mg Tablets NAME AND STRENGTH OF ACTIVE INGREDIENT: EACH FILM-COATED TABLET CONTAINS: FOR 250 MG: Azithromycin Dihydrate Ph.Eur. 262.02 mg equivalent to Azithromycin 250 mg FOR 500 MG: Azithromycin Dihydrate Ph.Eur. 524.04 mg equivalent to Azithromycin 500 mg PRODUCT DESCRIPTION: FOR 250 MG: White to off-white, capsule shaped, film-coated tablets debossed with ‘AZ’ and ‘250’ on one side and plain on other side of the tablet. FOR 500 MG: White to off-white, capsule shaped, film-coated tablets, debossed with ‘AZ’ and ‘500’ on either side of scoreline on one side and plain on other side of the tablets. PHARMACODYNAMICS / PHARMACOKINETICS: PHARMACOLOGICAL/CLINICAL PARTICULARS PHARMACOTHERAPEUTIC GROUP: antibacterials for systemic use ATC CODE: J01FA10 PHARMACODYNAMIC EFFECTS: _Mode of action: _ Azithromycin is an azalide, a sub-class of the macrolid antibiotics. By binding to the 50S-ribosomal sub-unit, azithromycin avoids the translocation of peptide chains from one side of the ribosome to the other. As a consequence of this, RNA- dependent protein synthesis in sensitive organisms is prevented. _PK/PD relationship _ For azithromycin the AUC/MIC is the major PK/PD parameter correlating best with the efficacy of azithromycin. _Mechanism of resistance: _ Resistance to azithromycin may be inherent or acquired. There are three main mechanisms of resistance in bacteria: target site alteration, alteration in antibiotic transport and modification of the antibiotic. Complete cross resistance exists among _Streptococcus pneumoniae_, betahaemolytic streptococcus of group A, _Enterococcus _ _faecalis_ and _ Staphylococcus aureus_, including methicillin resistant _ S. aureus_ (MRSA) to erythromycin, azithromycin, other macrolides and lincosamides._ _ _ _ _Susceptibility: _ The prevalence of acquired resistance may vary geographically and with time f Прочетете целия документ