Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
potassium clavulanate, Quantity: 13.58 mg/mL (Equivalent: clavulanic acid, Qty 11.4 mg/mL); amoxicillin trihydrate, Quantity: 91.84 mg/mL (Equivalent: amoxicillin, Qty 80 mg/mL)
Sandoz Pty Ltd
amoxicillin trihydrate,potassium clavulanate
Suspension, powder for
Excipient Ingredients: citric acid; Guar Gum; sodium citrate; purified talc; aspartame; silicon dioxide; Flavour
Oral
120 mL bottles, 150 mL bottles, 60 mL bottles
(S4) Prescription Only Medicine
Short-term treatment of the following bacterial infections when caused by sensitive organisms: skin and skin structure infections; urinary tract infections (complicated and uncomplicated); upper respiratory tract infections including sinusitis and otitis media; lower respiratory tract infections including acute exacerbations of chronic bronchitis and community acquired pneumonia. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to CURAM DUO 400/57. 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 DUO 400/57 should not require the addition of another antibiotic due to the amoxycillin content of CURAM DUO 400/57.
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
Licence status A
2009-03-06
CURAM ® DUO 400/57 1 CURAM ® DUO 400/57 _amoxicillin (as trihydrate) and clavulanic acid (as potassium clavulanate) 400 mg+57 mg/5 mL powder _ _for oral suspension _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Curam Duo 400/57. 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 DUO 400/57 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 DUO 400/57 _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 anti Preberite celoten dokument
220930-Curam Duo-pi Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION CURAM DUO 400/57 (AMOXICILLIN TRIHYDRATE/ POTASSIUM CLAVULANATE) POWDER FOR SUSPENSION 1. NAME OF THE MEDICINE Amoxicillin Trihydrate and Potassium Clavulanate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Curam Duo 400/57 contains amoxicillin 400 mg/5 mL (as trihydrate) and clavulanic acid 57 mg/5 mL (as potassium clavulanate). _Excipients with known effect: _ When reconstituted as directed, Curam Duo 400/57 contains aspartame 8.5 mg/5 mL. Each 5 mL of suspension contains 0.29 mmol of potassium. Also contains sulfites. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for Suspension: off-white powder and off-white suspension. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Curam Duo 400/57 (amoxicillin and clavulanic acid) is indicated for the short-term treatment of the following bacterial infections when caused by sensitive organisms (see Section 5.1 Pharmacodynamic properties – Microbiology): skin and skin structure infections; urinary tract infections (complicated and uncomplicated); upper respiratory tract infections including sinusitis and otitis media; lower respiratory tract infections including acute exacerbations of chronic bronchitis and community acquired pneumonia. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to Curam Duo 400/57 _ _ (amoxicillin and clavulanic acid). 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 amoxicillin susceptible organisms and beta- lactamase producing organisms susceptible to Curam Duo 400/57 _ _ (amoxicillin and clavulanic acid) should Preberite celoten dokument