Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AZITHROMYCIN DIHYDRATE
MEDISPEC (M) SDN.BHD
AZITHROMYCIN DIHYDRATE
1 x 30 ml
World Medicine Ilac San. ve Tic. A.S
ZIROMIN 200MG/5ML POWDER FOR ORAL SUSPENSION Azithromycin 200 mg/5 ml as Azithromycin Dihydrate 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Ziromin _ is used for 2. How _Ziromin_ works 3. Before you use _Ziromin_ 4. How to use _Ziromin_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Ziromin_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT _ZIROMIN _IS USED FOR This medicine contains _azithromycin_ , which is one of a group of antibiotics called macrolides. It is used to treat infections caused by certain bacteria and other micro-organisms which include: • Chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis) and sinusitis) • Ear infections • Skin and soft tissue infections (such as an abscess or boil) • Sexually-transmitted diseases caused by organisms called _Chlamydia _ _trachomatis_ or _Neisseria gonorrhea_ . It is also indicated in the treatment of chancroid due to _Haemophilus Ducreyi_ . HOW _ZIROMIN_ WORKS Ziromin is an antibiotic, which belongs to a group of medicines called azalides. The azalides are a sub-class of a group of antibiotics called macrolides. It works by killing or stopping the growth of bacteria causing your infection. BEFORE YOU USE _ZIROMIN_ - _When you must not use it _ • If you/your child are allergic to _azithromycin_ , _erythromycin_ , or any macrolide or ketolide antibiotic, or to any of the ingredients of this medicine. • If you have rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency problems _Pregnancy and lactation _ _ _ Do not take _Ziromin_ if you are pregnant or breast-feeding, are planning to pregnant or think you may be pregnant. Get advice from your doctor or pharmacist before taking any medicine. - _Before you start to use it _ Talk to your doctor or pharmacist before taking _Ziromin_ if you/your child have or have had any of the Läs hela dokumentet
NAME OF THE MEDICINAL PRODUCT Ziromin 200 mg/5 mL Powder for Oral Suspension QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: In Each 5 ml: Azithromycin dihydrate 209.6 mg (equivalent to 200.00 mg azithromycin) PRODUCT DESCRIPTION Powder: White colored, cherry scented, homogeneous powder free from particles. Suspension: White or off-white homogeneous suspension. _ _ PHARMACODYNAMICS Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is constructed by adding a nitrogen atom to the lactone ring of erythromycin A. The mechanism of action of azithromycin is based upon the suppression of bacterial protein synthesis by means of binding to the ribosomal 50S sub-unit and inhibition of peptide translocation. 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. Azithromycin demonstrates cross resistance with erythromycin resistant gram positive isolates. A decrease in macrolide susceptibility over time has been noted particularly in Streptococcus pneumoniae and Staphylococcus aureus. Similarly, decreased susceptibility has been observed among Streptococcus viridans and Streptococcus agalactiae (Group B) streptococcus against other macrolides and lincosamides. Antibacterial spectrum of Azithromycin: Commonly susceptible species: Aerobic Gram-positive microorganisms: Staphylococcus aureus, Methycillin-susceptible, Streptococcus pneumonia, Penicillin-susceptible, Streptococcus pyogenes (Group A). Aerobic Gram-negative microorganisms: Haemophilus influenza, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Neisseria gonorrhoeae, Pasteurella multocida Anaerobic microorganisms: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyromonas spp. Other microorganisms: Chlamydia trachomatis. Species for which acquired resistance: Aerobic Gram-positive microorganisms: Streptococcus pneumonia, Penici Läs hela dokumentet