国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Amoxicillin Trihydrate; DILUTED POTASSIUM CLAVULANATE
EUCOGEN SDN BHD
Amoxicillin Trihydrate; DILUTED POTASSIUM CLAVULANATE
20 Tablets
Remedica Ltd.
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ REMEDICA CO-AMOXICLAV FILM-COATED TABLETS Amoxicillin trihydrate/Clavulanic acid (250mg/125mg, 500mg/125mg) WHAT IS IN THIS LEAFLET 1. What Remedica Co-Amoxiclav is used for 2. How Remedica Co-Amoxiclav works 3. Before you use Remedica Co-Amoxiclav 4. How to use Remedica Co-Amoxiclav 5. While you are using it 6. Side effects 7. Storage and Disposal of Remedica Co-Amoxiclav 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT REMEDICA CO-AMOXICLAV IS USED FOR Remedica Co-Amoxiclav is used in adults and children to treat the following infections: • Respiratory tract infections. • Genito-urinary tract infections • Skin and soft tissue infections • Bone and joint infections • Dental infections • Other infections (eg: sepsis) HOW REMEDICA CO-AMOXICLAV WORKS Remedica Co-Amoxiclav is an antibiotic. It contains two different medicines called amoxicillin (belongs to a group of medicine called 'penicillin') and clavulanic acid. Remedica Co-Amoxiclav works by killing bacteria that cause infections. BEFORE YOU USE REMEDICA CO- AMOXICLAV - _When you must not use it _ _ _ • If you are allergic to amoxicillin, clavulanic acid, penicillin or any other ingredients of this medicine (see _Ingredients_ ). • If you have ever had a severe allergic (hypersensitive) reaction to any other antibiotic. This can include skin rash or swelling of the face or neck. • If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. Do not take Remedica Co-Amoxiclav if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Remedica Co-Amoxiclav. - _Before you start to use it _ _ _ Tell your doctor or pharmacist before taking Remedica Co-Amoxiclav if you: • have glandular fever (a type of viral infection) • are having liver or kidney problem • are not passing water regularly If you are not sure if any of the above apply to you, talk 阅读完整的文件
my-pi-remedica-co-amoxiclav-375mg-fc-tabs-a3 page 1 of 12 PACKAGE INSERT 1. NAME OF THE PRODUCT Remedica Co-Amoxiclav 375 mg film-coated tablets 2. NAME AND STRENGTH OF ACTIVE INGREDIENT Each film-coated tablet contains amoxicillin trihydrate equivalent to 250 mg amoxicillin and diluted potassium clavulanate equivalent to 125 mg clavulanic acid. 3. DOSAGE FORM Film-coated tablet White, oval, film-coated tablets. 4. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMICS Pharmacotherapeutic group: Antibacterials for systemic use; Beta-lactam antibacterials, penicillins, ATC code: J01CR02 Mechanism of action: Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death. Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes. Clavulanic acid is a beta- structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. Clavulanic acid alone does not exert a clinically useful antibacterial effect. Pharmacodynamics effects The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin. Mechanisms of resistance The two main mechanisms of resistance to amoxicillin/clavulanic acid are: • Inactivation by those bacterial beta-lactamases that are not themselves inhibited by clavulanic acid, including class B, C and D. my-pi-remedica-co-amoxiclav-375mg-fc-tabs-a3 page 2 of 12 • Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target. Impermeability of bacteria or efflux pump mechanisms 阅读完整的文件