Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
potassium clavulanate, Quantity: 151.917 mg; amoxicillin trihydrate, Quantity: 1004.31 mg
Micro Labs Pty Ltd
amoxicillin trihydrate,potassium clavulanate
Tablet, film coated
Excipient Ingredients: dichloromethane; isopropyl alcohol; microcrystalline cellulose; sodium starch glycollate; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; propylene glycol; purified talc; ethylcellulose
Oral
Alu/Alu strip packs of 10 tablets packed in monocarton
(S4) Prescription Only Medicine
AMOXYCLAV MLabs 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 (complicated and uncomplicated),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 preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.
Visual Identification: White colored capsule shaped film coated tablet debossed with 'I 07' on one side and plain on other side.; Container Type: Strip Pack; Container Material: Al/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
2017-08-07
AMOXYCLAV MLABS TABLETS 1 AUSTRALIAN PRODUCT INFORMATION- AMOXYCLAV MLABS 875/125 AND AMOXYCLAV MLABS 500/125 (AMOXICILLIN AND CLAVULANIC ACID) FILM-COATED TABLETS 1. NAME OF THE MEDICINE Amoxicillin (as trihydrate) and clavulanic acid (as potassium). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AMOXYCLAV MLabs 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). AMOXYCLAV MLabs 875/125 & AMOXYCLAV MLabs 500/125 tablets also contain the inactive ingredients: Microcrystalline cellulose, magnesium stearate, sodium starch glycollate Type A and colloidal anhydrous silica. The tablet coating contains hypromellose, titanium dioxide, propylene glycol, purified talc, ethylcellulose. 3. PHARMACEUTICAL FORM AMOXYCLAV MLabs 500 /125 tablets contain amoxicillin (as trihydrate) 500 mg and clavulanic acid (as potassium clavulanate) 125 mg. White colored capsule shaped film coated tablet debossed with ‘Ɩ 06’ on one side and plain on other side. AMOXYCLAV MLabs 875 /125 tablets contain amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium clavulanate) 125 mg. White colored capsule shaped film coated tablet debossed with ‘Ɩ 07’ on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AMOXYCLAV MLabs 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 ac Läs hela dokumentet