Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AZITHROMYCIN DIHYDRATE
ZIWELL MEDICAL SDN BHD
AZITHROMYCIN DIHYDRATE
15ml mL; 30ml mL
Neuraxpharm Pharmaceuticals S.L.
Consumer Medica on Informa on Leaflet (RiMUP) Azithromycin Powder for Oral Suspension 200mg/5ml Lesvi Lab Azithromycin 200mg/5ml What is in this leaflet 1. What Azithromycin Powder for Oral Suspension 200mg/5ml Lesvi Lab is used for 2. How it works 3. Before you use 4. How to use 5. While you are using 6. Side effects 7. Storage and disposal 8. Product descrip on 9. Manufacturer and Product Registra on Holder 10. Date of Revision Health problems, including: i. Liver problems ii. Kidney problems iii. Heart problems iv. Diabetes v. Hereditary fructose intolerance vi. Glucose-galactose malabsorp on or saccharise-isomaltase deficiency Taking other medicines appropriate for you. This medicine can be taken with or without food. For children, the dosage is based on their weight and must be determined by a doctor. Please give the medicine to your child based on the doctor’s instruc ons. How long to use it Your doctor will tell you how long you should take the medicine. If you forget to use it Do not take a double dose to make up for a missed dose. What Azithromycin Powder for Oral Suspension 200mg/5ml Lesvi Lab is used for This medicine is usually prescribed to treat: Chest, throat, ear or nasal infec ons (e.g. bronchi s, pneumonia, tonsilli s, pharyngi s, acute o s media and sinusi s) Skin and so ssue infec ons Sexually-transmi ed diseases due to Chlamydia, Haemophilus or Gonorrhoea How it works Azithromycin belongs to the macrolide an bio cs group. It stops the growth of certain bacteria. Before you use When you must not use Do not take this medicine if you are allergic to azithromycin, erythromycin, macrolide or ketolide an bio cs, or any of the ingredients in this medicine. Pregnancy and lacta on Tell your doctor or pharmacist if you are pregnant, planning to get pregnant or breast-feeding before taking any medicine. You should not use this medicine during pregnancy or breast- feeding, unless your doctor has prescribed it. Before you start to use it Tell your doctor if you have any of the follow Belgenin tamamını okuyun
PACK INSERT PRODUCT NAME Azithromycin Film-coated _ _ Tablet 500mg Lesvi Lab Azithromycin _ _ Powder for Oral Suspension 200mg/5ml Lesvi Lab NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Azithromycin Film-coated tablets 500mg Lesvi Lab: Azithromycin dihydrate 524.03mg equivalent to azithromycin 500mg Azithromycin _ _ Powder for Oral Suspension 200mg/5ml Lesvi Lab: Azithromycin dihydrate 209.62mg equivalent to azithromycin 200mg/5ml PRODUCT DESCRIPTION Film-coated tablets Oblong, biconvex tablets, scored on one side and with the inscription “500” on the other. Powder for oral suspension. Nearly white powder presented in a bottle. A whitish suspension is obtained after its reconstitution with water. PHARMACODYNAMICS Azithromycin is the first of a subclass of macrolides antibiotics, known as azalides, and is chemically different from erythromycin. Chemically it is derived by insertion of a nitrogen atom into the lactone ring of erythromycin A. The mode of action of azithromycin is inhibition of protein synthesis in bacteria by binding to the 50s ribosomal subunit and preventing translocation of peptides. Azithromycin demonstrates activity in vitro against a wide range of bacteria including: Gram-positive Aerobic Bacteria _Staphylococcus aureus, Streptococcus pyogenes _ (group A beta-hemolytic streptococci), _Streptococcus pneumoniae, alpha-hemolytic streptococci _ (viridans group) and other streptococci, and _Corynebacterium diphtheriae_ . Azithromycin demonstrates cross-resistance with erythromycin-resistant Gram-positive strains, including _Streptococcus faecalis _ (enterococcus) and most strains of methicillin-resistant staphylococci. Gram-negative Aerobic Bacteria _Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Acinetobacter _ species, _Yersinia _ species, _Legionella pneumophila_ , _Bordetella pertussis, Bordetella _ _parapertussis, Shigella species, Pasteurella species, Vibrio cholerae _ and _parahaemolyticus, _ _Plesiomonas shigelloides_ . Activities against _Escherichia coli, Salmo Belgenin tamamını okuyun