国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
potassium clavulanate, Quantity: 7.45 mg/mL (Equivalent: clavulanic acid, Qty 6.25 mg/mL); amoxicillin trihydrate, Quantity: 28.7 mg/mL (Equivalent: amoxicillin, Qty 25 mg/mL)
Sandoz Pty Ltd
amoxicillin trihydrate,potassium clavulanate
Suspension, powder for
Excipient Ingredients: sodium citrate; purified talc; Guar Gum; silicon dioxide; aspartame; citric acid; Flavour
Oral
100 mL bottles
(S4) Prescription Only Medicine
Treatment of the following infections when caused by CURAM 125/31.25 sensitive, beta-lactamase producing organisms: Skin and skin structure infections, including cases caused by beta-lactamase producing Staph. aureus, E. coli and Klebsiella sp. (only some strains may be sensitive). Urinary tract infections, including cases caused by beta-lactamase producing E. coli, P. mirabilis and Klebsiella sp. Upper respiratory tract infections, such as sinusitis, including cases caused by beta-lactamase producing H. influenzae and M. catarrhalis, and otitis media, especially cases caused by beta-lactamase producing H. influenzae, M. catarrhalis and Staph. aureus. Lower respiratory tract infections, especially cases caused by beta-lactamase producing H. influenzae and M. catarrhalis. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to CURAM 125/31.25. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in Microbiology, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to CURAM 125/31.25 should not require the addition of another antibiotic due to the amoxycillin content of CURAM 125/31.25.
Visual Identification: Off-white powder; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2009-03-06
CURAM ® 125/31.25 1 CURAM ® 125/31.25 _amoxicillin (as trihydrate) and clavulanic acid (as potassium clavulanate) 125 mg+31.25 mg/5 mL powder _ _for oral suspension _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Curam 125/31.25. 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. Your doctor has weighed the risks of your child taking this medicine against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CURAM 125/31.25 IS USED FOR This medicine is used to treat a wide range of infections caused by bacteria. These infections may affect: • the chest (bronchitis or pneumonia) • the bladder (cystitis) • the sinuses (sinusitis) • the ears (otitis media) • or the skin. It works by killing the bacteria that cause these infections. This medicine contains the active ingredients amoxicillin (as trihydrate) and clavulanic acid (as potassium clavulanate). Amoxicillin belongs to the penicillin group of antibiotics. Clavulanic acid is used to increase the effectiveness of amoxicillin against certain types of bacteria. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOUR CHILD. Your doctor may have prescribed it for another reason. There is no evidence that this medicine is addictive. This medicine is available only with a doctor's prescription. BEFORE YOU GIVE CURAM 125/31.25 _WHEN YOU MUST NOT GIVE IT _ DO NOT GIVE THIS MEDICINE IF YOUR CHILD HAS AN ALLERGY TO: • amoxicillin trihydrate or potassium clavulanate, the active ingredients, or to any of the other ingredients listed at the end of this leaflet under Product description • any other similar medicines (such as penicillins, cephalosporins, carbapenems, monobactams or any other types of antibi 完全なドキュメントを読む
200511-curam-pi Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION CURAM 125/31.25 (AMOXICILLIN TRIHYDRATE/POTASSIUM CLAVULANATE) POWDER FOR SUSPENSION 1. NAME OF THE MEDICINE Amoxicillin trihydrate/Potassium clavulanate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL of reconstituted suspension contains 125 mg amoxicillin and 31.25 mg potassium clavulanate. When reconstituted as directed, Curam 125/31.25 contains aspartame 8.5 mg/5 mL. Each 5 mL of suspension contains 0.16 mmol of potassium. For the full list of excipients, see Section 6.1 List of excipients 3. PHARMACEUTICAL FORM Curam 125/31.25 amoxicillin 125 mg/5 mL (as trihydrate) & clavulanic acid 31.25 mg/5 mL (as potassium clavulanate) powder for suspension: off-white powder and off-white suspension. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Curam 125/31.25 (amoxicillin and clavulanic acid) is indicated for the treatment of the following infections when caused by Curam 125/31.25 sensitive, beta-lactamase producing organisms: skin and skin structure infections, including cases caused by beta-lactamase producing _Staph. aureus, E. coli_ and _Klebsiella sp._ (only some strains may be sensitive). urinary tract infections, including cases caused by beta-lactamase producing _E. coli, P. _ _mirabilis_ and _Klebsiella sp._ upper respiratory tract infections, such as sinusitis, including cases caused by beta- lactamase producing _H. influenzae_ and M _. catarrhalis_ , and otitis media, especially cases caused by beta-lactamase producing _H. influenzae_ , _M. catarrhalis_ and _Staph. _ _aureus_ . lower respiratory tract infections, especially cases caused by beta-lactamase producing _H. influenzae_ and _M. catarrhalis_ . Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to Curam 125/31.25 (amoxicillin and clavulanic acid). However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in 完全なドキュメントを読む