Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
amoxicillin trihydrate, Quantity: 574 mg (Equivalent: amoxicillin, Qty 500 mg); potassium clavulanate, Quantity: 149 mg (Equivalent: amoxicillin, Qty 500 mg; Equivalent: clavulanic acid, Qty 125 mg)
Apotex Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose
Oral
10 tablets
(S4) Prescription Only Medicine
Short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. Skin and skin structure infections. Urinary tract infections (uncomplicated and complicated). Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to AMOXYCILLIN/CLAVULANIC ACID tablets. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, 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
Visual Identification: OFF-WHITE, OVAL BICONVEX, FILM-COATED TABLETS, SCORED ON BOTH SIDES.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2019-07-16
AMOXYCILLIN AND CLAVULANIC ACID 500MG/125MG APOTEX TABLETS 1 AMOXYCILLIN AND CLAVULANIC ACID 500MG/125MG APOTEX TABLETS _Amoxicillin trihydrate and potassium clavulanate _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about amoxycillin and clavulanic acid. 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 you using this medicine against the benefits they expect it will 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Amoxycillin and clavulanic acid is used to treat a wide range of infections caused by bacteria. These infections may affect the chest (bronchitis or pneumonia), bladder (cystitis), sinuses (sinusitis), ears (otitis media) or skin. _HOW IT WORKS _ Amoxycillin is a type of penicillin antibiotic. Clavulanic acid is used to help the amoxycillin work better against certain types of bacteria. Amoxycillin and clavulanic acid works by killing the bacteria that cause these infections. It will not work against viral infections such as colds or the flu, which are caused by viruses. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. These tablets are not recommended for children weighing less than 40 kg. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • amoxicillin • other penicillins or cephalosporins • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing Prečítajte si celý dokument
1 0AUSTRALIAN PRODUCT INFORMATION AMOXYCILLIN/CLAVULANIC ACID 500 /125 APOTEX (AMOXICILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE) TABLETS 1 NAME OF THE MEDICINE Amoxicillin trihydrate and potassium clavulanate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains the following ingredients: Active Ingredients: Amoxicillin (as trihydrate) Clavulanic acid (as potassium clavulanate) Amoxycillin/Clavulanic Acid 500 /125 APOTEX tablets 500 mg 125 mg For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM Amoxycillin/Clavulanic Acid 500 /125 APOTEX tablets: Off-white, oval, biconvex, film-coated and scored on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxicillin and Clavulanic Acid tablets are indicated for short term treatment of bacterial infections at the following sites when caused by amoxicillin/clavulanic acid sensitive, beta- lactamase producing organisms (refer to section 5.1 PHARMACODYNAMIC PROPERTIES - MICROBIOLOGY): • Skin and skin structure infections. • Urinary Tract Infections (complicated and uncomplicated). • Upper Respiratory Tract Infections, such as sinusitis, otitis media and recurrent tonsillitis • Lower Respiratory Tract Infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis 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 in section 5.1 PHARMACODYNAMIC PROPERTIES - 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. 2 The treatment of mixed infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to Amoxicillin and Clavulanic Acid tablets shoul Prečítajte si celý dokument