ประเทศ: ออสเตรเลีย
ภาษา: อังกฤษ
แหล่งที่มา: Department of Health (Therapeutic Goods Administration)
amoxicillin sodium, Quantity: 530.1 mg (Equivalent: amoxicillin, Qty 500 mg); potassium clavulanate, Quantity: 119.2 mg (Equivalent: clavulanic acid, Qty 100 mg)
Sandoz Pty Ltd
Injection, powder for
Excipient Ingredients:
Intravenous Infusion, Intravenous
50, 1, 5, 10, 20
(S4) Prescription Only Medicine
CURAM is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed Gram negative and Gram positive infections, and situations where microbial confirmation has not yet been obtained.,Infections caused by amoxicillin susceptible organisms are amenable to CURAM treatment due to its amoxicillin content.,Infections caused by beta-lactamase producing amoxicillin resistant organisms are also amenable to CURAM due to its clavulanic acid content.,Susceptibility to CURAM will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. Amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.,CURAM is indicated for the short term treatment of serious bacterial infections such as:,? Upper Respiratory Tract Infections (including ENT): e.g. mastoiditis, tonsillitis, otitis media, epiglotitis and sinusitis when accompanied by severe signs and symptoms,? Lower Respiratory Tract Infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia,? Genito-urinary Tract Infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections,? Gastrointestinal infections e.g. intra-abdominal sepsis, peritonitis.,? Skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess,? Other Infections e.g. septic abortion, puerperal sepsis, post-surgical infections.,? CURAM is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastrointestinal surgery.
Visual Identification: Type II colourless glass vials with a nominal capacity of 20 ml closed with rubber stopper and a flip-off cap.; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-09-20
Curam 1 CURAM ® _ AMOXICILLIN AND CLAVULANIC ACID POWDER FOR INJECTION_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Curam injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. In deciding to give you. Curam, your doctor has weighed the risks of you taking Curam against the benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT CURAM IS USED FOR This product contains two active ingredients. One of these is a penicillin called amoxicillin and the other is clavulanic acid. Curam injection belongs to the penicillin group of antibiotics. This product is used to treat a wide range of infections caused by bacteria. These infections may affect the respiratory tract (bronchitis, pneumonia, tonsillitis, sinusitis), genito- urinary tract (cystitis, urethritis, pyelonephritis, gonorrhoea), gastrointestinal tract (peritonitis, intra-abdominal sepsis) the ears (otitis media) and the skin. This product can also be used to prevent infections in major surgical procedures. Amoxicillin/ clavulanic acid injection works by killing the bacteria that cause these infections. This medicine will not work against infections caused by viruses such as colds or the flu. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE IT _WHEN YOU MUST NOT USE _ _CURAM_ _ _ 1. DO NOT USE CURAM IF YOU ARE ALLERGIC TO PENICILLINS AND CEPHALOSPORINS OR CLAVULANIC ACID. 2. DO NOT USE CURAM IF YOU HAVE A PREVIOUS HISTORY OF AMOXICILLIN/ CLAVULANIC ACID ASSOCIATED JAUNDICE / HEPATIC DYSFUNCTION. 3. YOU HAVE HAD AN ALLERGIC REACTION TO CEPHALOSPORIN ANTIBIOTICS. YOU MAY HAVE AN INCREASED CHANCE OF BEING ALLERGIC TO CURA อ่านเอกสารฉบับเต็ม
20180322-Curam-pi Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION CURAM ® POWDER FOR INJECTION ( AMOXICILLIN / CLAVULANIC ACID ) 1 NAME OF THE MEDICINE Amoxicillin sodium/Potassium clavulanate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Curam 500/100 powder for injection consists of vials of sterile white to off-white powder providing amoxicillin sodium equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 100 mg clavulanic acid. Each vial contains 0.5 mmoL (19.6 mg) of potassium and 1.4 mmoL (31.4 mg) of sodium. Curam 1000/200 powder for injection consists of vials of sterile white to off-white powder providing amoxicillin sodium equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg clavulanic acid. Each vial contains 1.0 mmoL (39.3 mg) of potassium and 2.7 mmoL (62.9 mg) of sodium. Curam 2000/200 powder for injection consists of vials of sterile white to off-white powder providing amoxicillin sodium equivalent to 2000 mg amoxicillin and potassium clavulanate equivalent to 200 mg clavulanic acid. Each vial contains 1.0 mmoL (39.3 mg) of potassium and 5.5 mmoL (125.9 mg) of sodium. Curam powder for injection is a combination product containing the semisynthetic antibiotic, amoxicillin sodium and the β-lactamase inhibitor, potassium clavulanate (as the potassium salt of clavulanic acid). Amoxicillin sodium is a white or almost white, crystalline powder, very hygroscopic, very soluble in water. A 1% solution in water has a pH of 8.0 to 10.0. Potassium clavulanate is a white or almost white, hygroscopic, crystalline powder and is freely soluble in water. A 1% solution in water has a pH of 5.5 to 8.0. Curam contains no other excipients. 3 PHARMACEUTICAL FORM Curam 500 mg/100 mg, 1000 mg/200 mg and 2000 mg/200 mg powder for injection consists of vials of sterile white to off-white powder 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Curam is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especia อ่านเอกสารฉบับเต็ม