Riik: Malta
keel: inglise
Allikas: Medicines Authority
AMOXICILLIN, CLAVULANIC ACID
Elpen Pharmaceutical Co. Inc. 95 Marathonos Ave., 190 09 Pikermi, Attica, Greece
J01CR02
AMOXICILLIN 250 mg/5ml CLAVULANIC ACID 62.5 mg/5ml
POWDER FOR ORAL SUSPENSION
AMOXICILLIN 250 mg/5ml CLAVULANIC ACID 62.5 mg/5ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2006-11-14
1 PATIENT INFORMATION LEAFLET FUGENTIN ® (AMOXICILLIN – CLAVULANIC ACID) BROAD SPECTRUM ANTIBIOTIC 5503700.1 1. CHARACTERISTICS OF THE PHARMACEUTICAL PRODUCT 1.1 NAME FUGENTIN ® FUGENTIN ® Powder for oral suspension (125+31.25)mg/5ml and (250+62.5)mg/5ml. FUGENTIN ® Film coated tablets (500+125)mg/tab. 1.2 COMPOSITION ACTIVE INGREDIENTS: Amoxicillin Trihydrate and Clavulanate Potassium. EXCIPIENTS: FUGENTIN ® POWDER FOR ORAL SUSPENSION: Xanthan gum, hypromellose, aspartame, silicon dioxide colloidal, silicon dioxide anhydrous, strawberry flavour, peach flavour, lemon flavour, succinic acid. FUGENTIN ® FILM COATED TABLETS: Magnesium stearate, colloidal anhydrous silica, sodium starch glycollate (type A), cellulose microcrystalline. Coating: Talc, titanium dioxide E171, hypromellose, diethylphthalate, dimeticone. 1.3 PHARMACEUTICAL FORM Powder for oral suspension, film coated tablets. 1.4 CONTENT OF ACTIVE INGREDIENT FUGENTIN ® POWDER FOR ORAL SUSPENSION (125+31.25)MG/5ML: When reconstituted it contains 125mg amoxicillin as the trihydrate and 31.25mg clavulanic acid as the potassium salt per 5ml. FUGENTIN ® POWDER FOR ORAL SUSPENSION (250+62.5)MG/5ML: When reconstituted it contains 250mg amoxicillin as the trihydrate and 62.5mg clavulanic acid as the potassium salt per 5ml. FUGENTIN ® FILM COATED TABLETS (500+125)MG/TAB.: Each tablet contains 500mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. 1.5 DESCRIPTION- PACKAGE FUGENTIN ® POWDER FOR ORAL SUSPENSION (125+31.25)MG/5ML AND (250+62.5)MG/5ML: White to off-white powder in dark brown glass bottles which are marked for correct volume (60ml or 100ml) during reconstitution. Pack of one bottle. FUGENTIN ® FILM COATED TABLETS (500+125)MG/TAB.: Oval, white, bisected, biconvex tablets, in packs of 12 tablets (3 blisters Al-Al x 4 tablets). 1.6. Lugege kogu dokumenti
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT FUGENTIN ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FUGENTIN ® film-coated tablets (500 + 125) mg/tab: Each tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate). FUGENTIN ® powder for oral suspension (125 + 31.25) mg/5 ml: Each dosimetric spoonful (5 ml of the suspension) contain 125 mg amoxicillin (as amoxicillin trihydrate) and 31.25 mg clavulanic acid (as potassium clavulanate)._ _ FUGENTIN ® powder for oral suspension (250 + 62.5) mg/5 ml: Each dosimetric spoonful (5 ml of the suspension) contain 250 mg amoxicillin (as amoxicillin trihydrate) and 62.5 mg clavulanic acid (as potassium clavulanate)._ _ 3. PHARMACEUTICAL FORM A. Film-coated tablets B. Powder for oral suspension 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS FUGENTIN ® is indicated for short period treatment of bacterial infections, caused by beta-lactamase producing organisms, which are susceptible to this drug. The duration of treatment depends on the therapeutic indication and it must not exceed 14 days. • Upper Respiratory Tract Infections (including ear, nose and throat infections), i.e. recurrent tonsillitis, sinusitis, otitis media (especially in recurrence or in severe cases). • Lower Respiratory Tract Infections i.e. acute exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia. • Genitourinary Tract Infections i.e. cystitis, urethritis (not prostatitis), pyelonephritis, infections of the female genital organs (excluding infections caused by chlamydia). • Skin and Soft Tissue Infections. • Bone and Joint Infections i.e. osteomyelitis. • Other Infections i.e. septic abortion, puerperal sepsis, Lugege kogu dokumenti