국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CEFUROXIME AXETIL
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
CEFUROXIME AXETIL
1 mcg/mL; 50 1 mcg/mL; 100 1 mcg/mL
GLAXO WELLCOME OPERATIONS UK LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 ZINNAT SUSPENSION Cefuroxime axetil (125 mg/5 ml, 250 mg/5 ml) WHAT IS IN THIS LEAFLET 1. What Zinnat is used for 2. How Zinnat works 3. Before you use Zinnat 4. How to use Zinnat 5. While you are using it 6. Side Effects 7. Storage and Disposal of Zinnat 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial number WHAT ZINNAT IS USED FOR Zinnat is used in adults and children to treat severe infections of the: • Ear, nose and throat • Lungs or chest • Urinary tract • Skin and soft tissues Zinnat is also used to treat: • Sexually transmitted infections (gonorrhoea, urethritis and cervicitis) Your doctor should test the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Zinnat during your treatment. HOW ZINNAT WORKS Zinnat belongs to a group of antibiotics called _cephalosporins_ . It works by killing bacteria that cause infections. BEFORE YOU USE ZINNAT - _When you must not use it _ _ _ Do not take Zinnat: - if you are allergic ( _hypersensitive_ ) to antibiotics or any of the other ingredients of Zinnat. If you think this applies to you, do not take Zinnat until you have checked with your doctor. - _Before you start to use it _ _ _ Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta- lactams. There is only limited information about the safety of Zinnat in pregnant women. If you are pregnant your doctor will discuss with you if the benefits of taking Zinnat outweigh the possible risks to your baby. The ingredients in Zinnat can pass into breast milk. If you are breast-feeding, you must check with your doctor before you take Zinnat. Zinnat suspension contains sugar. If you are diabetic, you need to take this into account for your diet. Zinnat suspension also contains aspartame, which is a source of phenylalanine. If you have an intolerance to aspartame or have a condition called phenylketonuria (PKU): • Check 전체 문서 읽기
ZINNAT CEFUROXIME AXETIL QUALITATIVE AND QUANTITATIVE COMPOSITION ZINNAT Suspension contains granules of cefuroxime axetil for oral suspension. Reconstitution of multidose bottles as directed yields a suspension containing 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) in each 5 ml. ZINNAT Sachets contain 125 mg granules of cefuroxime (as cefuroxime axetil) for single dose administration when reconstituted. CLINICAL INFORMATION INDICATIONS _ZINNAT _ is an oral prodrug of the bactericidal cephalosporin antibiotic cefuroxime, which is resistant to most β (beta)-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms. It is indicated for the treatment of infections caused by susceptible bacteria. Susceptibility to _ZINNAT_ will vary with geography and time, and it should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data (See _Pharmacological properties, _ _Pharmacodynamics_ ). INDICATIONS INCLUDE: – upper respiratory tract infections for example, ear, nose and throat infections, such as otitis media, sinusitis, tonsillitis and pharyngitis – lower respiratory tract infections for example, pneumonia, acute exacerbations of chronic obstructive pulmonary disease – genito-urinary tract infections for example, pyelonephritis, cystitis and urethritis – skin and soft tissue infections for example, furunculosis, pyoderma and impetigo – gonorrhoea, acute uncomplicated gonococcal urethritis and cervicitis DOSAGE AND ADMINISTRATION Pharmaceutical Form: Dry, white to off-white, tutti-frutti flavoured granules for oral suspension. The usual course of therapy is seven days (range 5 to 10 days). The dose of cefuroxime that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to cefuroxime axetil • The severity and the site of the infection • The age, weight and renal function of the patient; as shown below. The duration of therapy should be dete 전체 문서 읽기