国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Amoxicillin Trihydrate; POTASSIUM CLAVULANATE
RANBAXY (MALAYSIA) SDN. BHD.
Amoxicillin Trihydrate; POTASSIUM CLAVULANATE
100Tablet Tablets
Sun Pharmaceutical Industries Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ENHANCIN TABLET Amoxicillin/ clavulanic acid (500mg/125mg) Page 1 WHAT IS IN THIS LEAFLET 1. What Enhancin Tablet is used for 2. How Enhancin Tablet works 3. Before you start to use Enhancin Tablet 4. How to use Enhancin Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Enhancin Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT ENHANCIN TABLET IS USED FOR Enhancin Tablet are to treat the following infections: respiratory tract infections urinary tract infection skin and soft tissue infections (e.g. boils, wound) dental infections bone and joint infections. other infections HOW ENHANCIN TABLET WORKS Enhancin Tablet is an antibiotic that contains amoxicillin and clavulanate, which works by killing bacteria that cause infections. BEFORE YOU START TO USE ENHANCIN TABLET - _When you must not use it _ Do not take Enhancin Tablet if you: are allergic to amoxicillin, clavulanate, other penicillin-based antibiotics, or similar antibiotics called cephalosporins or any other ingredients of this medicine (listed in Product Description). have ever had liver problems or jaundice (yellowing of the skin and/or whites of the eyes) when taking an antibiotic. If you are not sure whether you should start taking Enhancin Tablet, talk to your doctor or pharmacist. - _Before you start to use it _ Tell your doctor if you: have viral infections (eg: common cold) are being treated for liver or kidney problems are not urinating regularly If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Enhancin Tablet . _Pregnancy and Lactation _ Amoxicillin/ clavulanate potassium is secreted into the breast milk. Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breast-feeding before using any medicine. Avoid the use of the medicine in the first three months of pregnancy unles 完全なドキュメントを読む
1 _For the use only of a Registered Medical Practitioner _ PRESCRIBING INFORMATION ENHANCIN TABLETS (Amoxicillin and Clavulanate Potassium Tablets) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. COMPOSITION Each tablet contains: Amoxicillin trihydrate Ph. Eur. equivalent to Amoxicillin…500 mg Potassium Clavulanate equivalent to Clavulanic acid….125 mg _EXCIPIENTS_: Microcrystalline Cellulose, Sodium Starch Glycolate, Colloidal Silicon dioxide, Povidone (K30), Eudragit E 100, Isopropyl Alcohol, Magnesium stearate, Opadry 03B58965 white, Polyethylene glycol-400, Methylene chloride PRODUCT DESCRIPTION White to off-white film coated oval shaped tablets debossed with “RX713” on one side and plain on the other DESCRIPTION ENHANCIN TABLETS contain amoxicillin and clavulanate potassium. Amoxicillin/clavulanate potassium is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.46. Chemically, amoxicillin is (2_S, _ 5_R, _ 6_R_)-6-[(_R_)-(-)-2-Amino-2-(_p_-hydroxyphenyl) acetamido]-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as: AMOXICILLIN 2 Clavulanic acid is produced by the fermentation of _ Streptomyces clavuligerus_. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β- lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically imp 完全なドキュメントを読む