País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
clavulanic acid, Quantity: 11.4 mg/mL; amoxicillin, Quantity: 80 mg/mL
Aspen Pharmacare Australia Pty Ltd
Oral Liquid, powder for
Excipient Ingredients: silicon dioxide; succinic acid; colloidal anhydrous silica; aspartame; xanthan gum; hypromellose; Flavour
Oral
125ml, 60ml, 50mL, 1 x single dose (starter pack)
(S4) Prescription Only Medicine
Augmentin Duo 400 oral suspension is indicated in the short term treatment of the following bacterial infections when caused by sensitive organisms (see Microbiology). Skin and skin structure infections: Urinary tract infections (complicated and uncomplicated): Upper respiratory tract infections including sinusitis, 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 Augmentin. However, when there is good reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptible 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 Augmentin Duo 400, should not require the addition of another antibiotic due to the amoxycillin content of Augmentin Duo 400.
Visual Identification: Off- white free flowing powder with a characteristic. Off white suspension is formed which slowly deposits a slight white sediment on standing .; Container Type: Bottle; Container Material: Glass Type III Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
1999-02-12
1 AUGMENTIN ® DUO 400 SUSPENSION _Amoxicillin trihydrate & Potassium clavulanate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you give AUGMENTIN DUO 400 SUSPENSION. This leaflet answers some common questions about AUGMENTIN DUO 400 SUSPENSION. It does not contain all of the available information. It does not take the place of talking to your child’s doctor or pharmacist. All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your child’s doctor has weighed the expected benefits of your child taking AUGMENTIN DUO 400 SUSPENSION against the risks this medicine could have for your child. If you have any concerns about your child taking this medicine, ask your child’s doctor or pharmacist. Keep this leaflet until your child has finished the course of AUGMENTIN DUO 400 SUSPENSION. You may need to read it again. WHAT IS AUGMENTIN DUO 400 SUSPENSION USED FOR? AUGMENTIN DUO 400 SUSPENSION contains two active ingredients. One of these is a penicillin called amoxicillin and the other is clavulanate. AUGMENTIN DUO 400 SUSPENSION belongs to the penicillin group of antibiotics. AUGMENTIN DUO 400 SUSPENSION is used for the short term treatment of a wide range of infections caused by bacteria. These infections may affect the chest (e.g. bronchitis or pneumonia), bladder (e.g. cystitis), sinuses (e.g. sinusitis), the ears (e.g. otitis media) or the skin. AUGMENTIN DUO 400 SUSPENSION works by killing the bacteria that cause these infections. AUGMENTIN DUO 400 SUSPENSION is used for the treatment of the infections listed. However, the doctor may prescribe these medicines for another use. If you want more information ask the doctor. There is no evidence that AUGMENTIN DUO 400 SUSPENSION is addictive. BEFORE YOU GIVE AUGMENTIN DUO 400 SUSPENSION _ _ _AUGMENTIN DUO 400 _ _SUSPENSION MUST NOT BE _ _GIVEN IF: _ • your child is allergic to penicillin or similar types of antibiotics (such as cephalosporins) or a Leer el documento completo
Augmentin-Duo-400-pi 1 AUSTRALIAN PRODUCT INFORMATION AUGMENTIN ® DUO 400 (AMOXICILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE) POWDER FOR SUSPENSION 1 NAME OF THE MEDICINE Amoxicillin Trihydrate and Potassium Clavulanate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AUGMENTIN ® DUO 400 is a combination product containing the semisynthetic antibiotic, amoxicillin (as the trihydrate) and the β -lactamase inhibitor, potassium clavulanate (as the potassium salt of clavulanic acid). AUGMENTIN DUO 400 Oral Suspension: Each 5mL of reconstituted off-white mixed fruit flavoured suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt. NOTE: AUGMENTIN DUO 400 oral suspension contains aspartame 12.5mg per 5mL. Each 125 mg of potassium clavulanate is equivalent to 0.63 mmol of potassium. Excipients with known effect: aspartame. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM An off-white dry powder for reconstitution in water to form an off-white mixed-fruit flavoured suspension. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS AUGMENTIN DUO 400 oral suspension is indicated in the 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 AUGMENTIN. However, when there is reason to believe an infection may involve any of the β -lactamase producing Augmentin-Duo-400-pi 2 organisms listed above, 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 treatme Leer el documento completo