Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
amoxicillin trihydrate, Quantity: 575 mg; potassium clavulanate, Quantity: 148.875 mg
Medreich Australia Pty Ltd
amoxicillin trihydrate,potassium clavulanate
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; isopropyl alcohol; microcrystalline cellulose; propylene glycol; purified talc; dichloromethane; hypromellose; ethylcellulose; magnesium stearate; titanium dioxide; hyprolose; industrial methylated spirit
Oral
60, 2, 10
(S4) Prescription Only Medicine
APO-Amoxy/Clav 500/125 and APO-Amoxy/Clav 875/125 tablets are indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to Microbiology):,Urinary Tract Infections (uncomplicated and complicated),Lower Respiratory Tract Infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis,Upper Respiratory Tract Infections, such as sinusitis, otitis media and recurrent tonsillitis.,Skin and Skin Structure Infection,Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to Amoxicillin and clavulanic acid tablets. However, when there is 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 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 Amoxicillin and clavulanic acid tablets should not require the addition of another antibiotic due to the amoxicillin content of these products.
Visual Identification: A white oval shaped film coated tablets with marking 'CA625' on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-01-17
APO-AMOXY/CLAV TABLETS 1 APO-AMOXY/CLAV 500/125 & APO- AMOXY/CLAV 875/125 _Amoxicillin trihydrate & Potassium clavulanate _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you take APO- AMOXY/CLAV 500/125 or APO- AMOXY/CLAV 875/125 tablets. This leaflet answers some common questions about APO- AMOXY/CLAV 500/125 and APO- AMOXY/CLAV 875/125 tablets. It does not contain all of the available information. It does not take the place of talking to your 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 doctor has weighed the expected benefits of you taking APO- AMOXY/CLAV tablets against the risks this medicine could have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT ARE APO- AMOXY/CLAV 500/125 AND APO- AMOXY/CLAV 875/125 TABLETS USED FOR? APO-AMOXY/CLAV tablets contain two active ingredients. One of these is a penicillin called amoxycillin and the other is clavulanic acid. APO-AMOXY/CLAV tablets belong to the penicillin group of antibiotics. APO-AMOXY/CLAV tablets are 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. APO-AMOXY/CLAV tablets work by killing the bacteria that causes these infections. APO- AMOXY/CLAV tablets will not work against infections caused by viruses such as colds or the flu. Your doctor may prescribe APO- AMOXY/CLAV tablets for another use. If you want more information, ask your doctor. There is no evidence that APO- AMOXY/CLAV tablets are addictive. BEFORE YOU TAKE APO- AMOXY/CLAV 500/125 OR APO-AMOXY/CLAV 875/125 DO NOT TAKE APO-AMOXY/CLAV TABLETS IF: • you have had an allergic reaction to penicillin or similar types of antibiotics (su Đọc toàn bộ tài liệu
1 AUSTRALIAN PRODUCT INFORMATION – APO-AMOXY/CLAV 500/125 AND APO-AMOXY/CLAV 875/125 (AMOXICILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE) TABLETS 1 NAME OF THE MEDICINE Amoxicillin trihydrate and potassium clavulanate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION APO ‐ AMOXY/CLAV 500/125 and APO ‐ AMOXY/CLAV 875/125 tablets (amoxicillin and clavulanic acid tablets) are combination products containing the semisynthetic antibiotic, amoxicillin (as the trihydrate) and the β-lactamase inhibitor, potassium clavulanate (as the potassium salt of clavulanic acid). Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each film coated tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM APO ‐ AMOXY/CLAV 500/125 Tablets: A white, oval shaped, film coated tablet with marking “CA625” on one side. APO ‐ AMOXY/CLAV 875/125 Tablets: A white elongated capsule shaped film coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO ‐ AMOXY/CLAV 500/125 and APO ‐ AMOXY/CLAV 875/125 tablets are indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to Microbiology): • Urinary tract infections (uncomplicated and complicated). • Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. • Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. • Skin and skin structure infection. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin and clavulanic acid tablets. 2 However, when there is reason to believe an infection may involve any of the β-lactamase producing organisms listed above, therapy may be instituted prior to obtainin Đọc toàn bộ tài liệu