Bacterial skin and soft tissues infections (SSTI) are one of the most common 1. infections among different age groups

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1 Bacterial skin and soft tissues infections (SSTI) are one of the most common 1 infections among different age groups Gram-positive bacteria are the most frequently isolated pathogens from SSTI, with a predominance of 1 S. aureus and S. pyogenes The clinical evaluation of patients with SSTI must take into account pathogen-specific and local antibiotic 2 resistance patterns

2 In the treatment of SSTI, Experience backed by surveillance data Cefuroxime axetil is active in vitro against pathogens relevant in dermatology such as S. aureus (methicillin susceptible) * 3,4 and S. pyogenes A large surveillance study (106 centers, 19 countries) reported susceptibility rates for methicillin-susceptible S. aureus (MSSA) of 98.3% (N=479) towards cefuroxime3* * In vitro data; susceptibility patterns may vary with time and geography, refer local antibiotic susceptibility trends.

3 Experience clinical success with cefuroxime axetil in SSTI Established clinical and bacteriological efficacy in treating SSTI in historical clinical trials in adults and children 5-8 Significantly more effective than cephalexin in mild to moderate infections of skin and skin structure 7 Comparable efficacy to cefadroxil in resolving SSTIs in children % 89% 96% 85% % 90.3% 97.1% 94.3% % of patients n=92 n=90 n=72 n=71 Satisfactory clinical response # (p=0.047) Satisfactory bacteriological response* (p=0.026) # cure (resolution of clinical symptoms and healed lesions; no further antibacterial therapy required) + improvement (resolution of clinical symptoms but incomplete lesion healing) at visit 1-3 days after treatment * cure (initial pathogen eradicated) + presumed cure (initial pathogen presumed to be eradicated as follow up cultures not obtainable due to healed lesions). % of patients n=138 n=72 n=138 n=70 Satisfactory clinical response ## (p=0.009) Satisfactory bacteriological response*(p=0.242) ## cure(resolution of clinical signs and symptoms of infection) + improvement (resolution of signs and symptoms with incomplete lesion healing;further antibacterial therapy required). Cefuroxime axetil (250 mg bid x 10 days) Cephalexin (500 mg bid x 10 days) Cefuroxime axetil (30 mg/kg/day x 10 days) Cefadroxil (30 mg/kg/day x 10 days) Adapted from: Gooch III WM, Kaminester L, Cole GW, et al. Clinical comparison of Cefuroxime Axetil, Cephalexin and Cefadroxil in the treatment of patients with primary infections of the skin or skin structures. Dermatology 1991;183(1): Adapted from: Jacobs RF, Brown WD, Chartrand S, et al. Evaluation of cefuroxime axetil and cefadroxil suspensions for treatment of pediatric skin infections. Antimicrobial Agents and Chemotherapy. 1992;36(8):

4 Summary Cefuroxime axetil is active in vitro against pathogens relevant in SSTI such as S. aureus (methicillin susceptible) and S. pyogenes*3,4 Cefuroxime axetil is significantly more effective than cephalexin in mild to moderate infections of skin and skin structure7 Cefuroxime axetil has comparable efficacy to cefadroxil in resolving SSTIs in children8 * In vitro data; susceptibility patterns may vary with time and geography, refer local antibiotic susceptibility trends

5 Zinnat main safety information 9,10 Contraindicated in patients with known hypersensitivity to cephalosporin antibiotics, and special care must be taken in patients with previous allergic reaction to penicillins or other beta-lactams. Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Prolonged use may result in overgrowth of Candida and other non-susceptible organisms (e.g. enterococci and C. difficile).

6 Zinnat main safety information 9,10 The most commonly reported adverse drug reactions ( 1/100 to <1/10) are headache, dizziness, eosinophilia, overgrowth of Candida, gastrointestinal disturbances including diarrhoea, nausea and abdominal pain; and transient increases of hepatic enzyme levels. In patients with renal impairment the dosage will need to be adjusted. Consideration should be given to local susceptibility data (where available) and official guidance on the appropriate use of antibacterial agents.

7 Dosage and administration The usual course of therapy is seven days (range five to ten days)9,10 Tablet9 Suspension10 Cefuroxime axetil tablets should be taken after food for optimum absorption. For optimal absorption cefuroxime axetil suspension should be taken with food. Adults and children ( 40 kg) Adults and children ( 40 kg) MOST INFECTIONS: 250 mg twice daily. MOST INFECTIONS: 250 mg twice daily. Children (<40 kg) Children (<40 kg) Most infections: 15 mg/kg twice daily to a maximum of 250 mg twice daily. The usual dose of Zinnat Suspension is 10 mg/kg (a maximum of 125 mg) to 15 mg/kg (a maximum of 250 mg) twice daily depending on the severity and type of infection and the weight and age of the child.

8 GlaxoSmithKline. 25 Basel street, P.O. Box 10283, Petach-Tikva Israel, Tel: Medical information service: Adverse events reporting service: Tel: ל- PI המלא נא ללחוץ כאן הינך מוזמן להיכנס לאתר IL/CFA/0005/16 Date of Preparation January 2017 The images shown are for representational purposes only and are copyright compliant.

9 References: 1. Tognetti L, Martinelli C, Berti S, et al. Bacterial skin and soft tissue infections: Review of the epidemiology, microbiology, aetiopathogenesis and treatment. Journal of the European Academy of Dermatology and Venereology. 2012;26(8): Stevens DL, Bisno AL, Chambers HF, Dellinger EP, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clinical Infectious Diseases. 2014;59(2):e10 e Morrissey I, Leakey A, Northwood JB. In vitro activity of ceftaroline and comparator antimicrobials against European and middle east isolates from complicated skin and skin-structure infections collected in International Journal of Antimicrobial Agents. 2012;40(3): Sunderkötter C, Herrmann M, Jappe U. Antimicrobial therapy in Dermatology. Journal der Deutschen Dermatologischen Gesellschaft. 2006;4(1): Parish LC, Cocchetto DM, Werner K, Jungkind DL, et al. Cefuroxime axetil in the treatment of Cutaneous infections. International Journal of Dermatology 1987;26(6): Bucko AD, Hunt BJ, Kidd SL, Hom R. Randomized, double-blind, multicenter comparison of oral cefditoren 200 or 400 mg BID with either cefuroxime 250 mg BID or cefadroxil 500 mg BID for the treatment of uncomplicated skin and skin-structure infections. Clinical Therapeutics 2002;24(7): Gooch III WM, Kaminester L, Cole GW, et al. Clinical comparison of Cefuroxime Axetil, Cephalexin and Cefadroxil in the treatment of patients with primary infections of the skin or skin structures. Dermatology. 1991;183(1): Jacobs RF, Brown WD, Chartrand S, et al. Evaluation of cefuroxime axetil and cefadroxil suspensions for treatment of pediatric skin infections. Antimicrobial Agents and Chemotherapy 1992;36(8): Zinnat Tablets MOH approved Prescribing Information. 10. Zinnat Suspension MOH approved Prescribing Information.

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