Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMOXYCILLIN TRIHYDRATE
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
AMOXYCILLIN TRIHYDRATE
12Tablet Tablets; 14Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets; 1000Tablet Tablets
SANDOZ GMBH
OSPAMOX FILM-COATED TABLET Amoxicillin Trihydrate (500 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET: 1. What is Ospamox used for 2. How Ospamox works 3. Before you use Ospamox 4. How to use Ospamox 5. While you are using Ospamox 6. Side effects 7. Storage and disposal of Ospamox 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT IS OSPAMOX USED FOR Ospamox is used to treat infections caused by bacteria in different parts of the body such as: • Infections of the ear, throat, nose and sinuses • Chest infections such as bronchitis and pneumonia • Infections affecting urinary and genital tract • Prevention of heart infections during mouth or throat surgery • Gastrointestinal infections _ _ • Skin and soft tissues infections _ _ Your doctor may have prescribed Ospamox for another reason. _ _ HOW OSPAMOX WORKS Ospamox is an antibiotic. It belongs to a group of antibiotics called penicillins which is amoxicillin. It is used to treat infections caused by bacteria which are sensitive to amoxicillin. BEFORE YOU USE OSPAMOX - _When you must not use it _ • If you are allergic (hypersensitive) to amoxicillin, penicillins, cephalosporins or to any of the other ingredients of this medicine _Pregnancy _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. As a precautionary measure, amoxicillin should only be used during pregnancy if in the judgement of the physician the potential benefits outweigh the possible hazards. _ _ _Breast-feeding _ This medicine passes into breast milk in small quantities, therefore in some cases it may be necessary to stop breastfeeding. - _Before you start use it _ Talk to your doctor or pharmacist before taking Ospamox if you have: • any allergic conditions • fits/ convulsions • kidney disease • severe and persistent diarrhea - _Taking other medicines _ Tell your doctor or pharmacist, i Прочитать полный документ
OSPAMOX ® 500 MG FILM-COATED TABLETS ____________________________________________________________________________________ 1. NAME OF THE MEDICINAL PRODUCT Ospamox 500 mg Film-Coated Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains Amoxicillin 500 mg. White to off-white, oblong, biconvex, scored on both sides. Approx. 7mm x 18mm. 3. PHARMACEUTICAL FORM Film-coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ospamox is useful in the treatment of infections caused by amoxicillin-susceptible organisms: _Respiratory tract infections_ • Upper airways and ENT infections • Lower airways infections, e.g. acute and chronic bronchitis, pneumonia, Iung abscesses, pertussis (incubation period and early stages) _Urogenital Infections_ • Acute and chronic pyelonephritis, pyelitis, prostatitis, epididymitis • Cystitis, urethritis, asymptomatic bacteriuria during pregnancy • Gonorrhea _Gynecologic infections _(septic abortion, adnexitis, endometritis, etc.) _ _ _Gastro-intestinal infections_ • Typhoid fever, paratyphoid, particularly if complicated by septicemia (in combination with an • aminoglycoside antibiotic); control of Salmonella carriers • Shigellosis • Infections of the biliary system (cholangitis, cholecystitis) _Skin and soft tissue infections_ _ _ _Leptospirosis_ _ _ _Acute and latent listeriosis_ _ _ Unless parenteral treatment (e.g. with ampicillin) is required, Ospamox is also active in the conditions below: • Short-term (24 to 48 hours) prophylactic treatment of patients undergoing surgery (e.g. in the oral cavity) • Endocarditis, e.g. enterococcal endocarditis (alone or in combination with an aminoglycoside antibiotic) • Bacterial meningitis (pending the outcome of susceptibility tests; particularly in children) • Septicemias caused by amoxicillin-susceptible pathogens. Infections caused by pathogens with established with penicillin G susceptibility should preferentially be treated with penicillin G. Consideration should be given to off Прочитать полный документ