Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM SALT
GLAXO SMITH KLINE (ISRAEL) LTD
J01CR01
FILM COATED TABLETS
AMOXICILLIN AS TRIHYDRATE 875 MG; CLAVULANIC ACID AS POTASSIUM SALT 125 MG
PER OS
Required
SMITHKLINE BEECHAM PHARMACEUTICALS, UK
AMPICILLIN AND ENZYME INHIBITOR
AMPICILLIN AND ENZYME INHIBITOR
Augmentin is indicated for the treatment of the following infections in adults and children :• Acute bacterial sinusitis (adequately diagnosed)• Acute otitis media• Acute exacerbations of chronic bronchitis (adequately diagnosed)• Community acquired pneumonia• Cystitis• Pyelonephritis• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.• Bone and joint infections, in particular osteomyelitis.
2012-09-30
62000000047669 GSK_MAYENNE_FRANCE PAGE 1 OF 1 Project: CO-0028544 Site Code: 62000000047669 Document: PPC-3300328 Version: 2 Operator: SRM58890 Date/Time Created: 03.Feb.2020 13:46 GMT e-Banner Прочитайте повний документ
Page 1 of 15 Augmentin 500 mg Tablets SUMMARY OF PRODUCT CHARACTERISTICS Augmentin 500 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, oval film-coated tablets debossed with ‘AC’ and a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): • Acute bacterial sinusitis (adequately diagnosed) • Acute otitis media • Acute exacerbations of chronic bronchitis (adequately diagnosed) • Community acquired pneumonia • Cystitis • Pyelonephritis • Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis • Bone and joint infections, in particular osteomyelitis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component. The dose of Augmentin that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) Page 2 of 15 • The severity and the site of the infection • The age, weight and renal function of the patient as shown below. The use of alternative presentations of Augmentin (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1). For adults and children ≥ 40 kg, Прочитайте повний документ