Armēnija - angļu - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

smithkline beecham limited - amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate) - powder for oral suspension - 125mg/5ml+ 31,25mg/5ml

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

devatis limited - amoxicillin trihydrate 57.4 mg/ml equivalent to amoxicillin 50 mg/ml; potassium clavulanate 29.776 mg/ml (1:1 silicon dioxide. equivalent to clavulanic acid 12.5 mg/ml. +5% overage);   - powder for oral suspension - active: amoxicillin trihydrate 57.4 mg/ml equivalent to amoxicillin 50 mg/ml potassium clavulanate 29.776 mg/ml (1:1 silicon dioxide. equivalent to clavulanic acid 12.5 mg/ml. +5% overage)   excipient: citric acid colloidal silicon dioxide dispersible cellulose mannitol sodium citrate sucralose tutti frutti flavour 051880 ap0551 vanilla xanthan gum - amoxiclav should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data. amoxiclav is indicated for the short term treatment of common bacterial infections such as: upper respiratory tract infections (including ent): e.g. tonsillitis, sinusitis, otitis media lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar and broncho-pneumonia genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections skin and soft tissue infections bone and joint infections: e.g. osteomyelitis other infections: e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis, post-surgical infections. susceptibility to amoxiclav will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. infections caused by amoxicillin susceptible organisms are amenable to amoxiclav treatment due to its amoxicillin content. mixed infections caused by amoxicillin susceptible organism in conjunction with amoxiclav susceptible betalactamase-producing organisms may therefore be treated by amoxiclav.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

putney, inc. - amoxicillin anhydrous (unii: 9em05410q9) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 50 mg - indications: amoxicillin trihydrate and clavulanate potassium tablets are indicated in the treatment of: dogs: skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: β-lactamase-producing staphylococcus aureus , non-β-lactamase-producing staphylococcus aureus , staphylococcus spp., streptococcus spp., and e. coli . periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria. amoxicillin trihydrate and clavulanate potassium tablets have been shown to be clinically effective for treating cases of canine periodontal disease. cats: skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: β-lactamase-producing staphylococcus aureus , non-β-lactamase-producing staphylococcus aureus , staphylococcus spp., streptococcus spp., e. coli , and pasteurella spp. urinary tract infections (cystitis)

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

micro labs limited - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 250 mg - amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: • lower respiratory tract infections - caused by beta‑lactamase‑producing isolates of haemophilus influenzae and moraxella catarrhalis . • acute bacterial otitis media - caused by beta‑lactamase‑producing isolates of h. influenzae and m. catarrhalis . • sinusitis - caused by beta‑lactamase‑producing isolates of h. influenzae and m. catarrhalis . • skin and skin structure infections - caused by beta‑lactamase‑producing isolates of staphylococcus aureus, escherichia coli and klebsiella species. • urinary tract infections - caused by beta‑lactamase‑producing isolates of e. coli, klebsiella species, and enterobacter species. limitations of use when susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used. usage to reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. amoxicillin and clavulanate potassium tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or stevens-johnson syndrome) to amoxicillin, clavulanate or to other beta‑lactam antibacterial drugs (e.g., penicillins and cephalosporins). amoxicillin and clavulanate potassium tablets are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium. teratogenic effects: reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. the amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). for clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. oral ampicillin‑class antibacterials are poorly absorbed during labor. it is not known whether use of amoxicillin and clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. amoxicillin has been shown to be excreted in human milk. amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants. caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman. the safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and chewable tablets have been established in pediatric patients. use of amoxicillin and clavulanate potassium in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see clinical studies ( 14.2)] . because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. dosing of amoxicillin and clavulanate potassium should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [see dosage and administration ( 2.3)] . of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (gfr less than 30 ml/min). see patients with renal impairment [see dosage and administration ( 2.4)] for specific recommendations in patients with renal impairment.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 500 mg - amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: - lower respiratory tract infections – caused by beta–lactamase–producing isolates of haemophilus influenzae and moraxella catarrhalis . - acute bacterial otitis media – caused by beta–lactamase–producing isolates of h. influenzae and m. catarrhalis . - sinusitis – caused by beta–lactamase–producing isolates of h. influenzae and m. catarrhalis . - skin and skin structure infections – caused by beta–lactamase–producing isolates of staphylococcus aureus , escherichia coli , and klebsiella species. - urinary tract infections – caused by beta–lactamase–producing isolates of e. coli , klebsiella species, and enterobacter species. limitations of use when susceptibility te

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

dr. reddy's laboratories inc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 250 mg - to reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. amoxicillin and clavulanate potassium is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: caused by beta‑lactamase–producing isolates of haemophilus influenzae and moraxella catarrhalis . caused by beta‑lactamase–producing isolates of h. influenzae and m. catarrhalis . caused by beta‑lactamase–pro

Armēnija - angļu - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

sandoz gmbh - amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate) - powder for oral suspension - 125mg/5ml+ 31,25mg/5ml

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

usantibiotics, llc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: - lower respiratory tract infections - caused by beta‑lactamase–producing isolates of haemophilus influenzae and moraxella catarrhalis . - acute bacterial otitis media - caused by beta‑lactamase–producing isolates of h. influenzae and m. catarrhalis . - sinusitis - caused by beta‑lactamase–producing isolates of h. influenzae and m. catarrhalis . - skin and skin structure infections - caused by beta‑lactamase–producing isolates of staphylococcus aureus , escherichia coli , and klebsiella species. - urinary tract infections - caused by beta‑lactamase–producing isolates of e. coli , klebsiella species, and enterobacter species. limitations of use when susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used. usage to reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. amoxicillin and clavulanate potassium is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or stevens-johnson syndrome) to amoxicillin, clavulanate or to other beta‑lactam antibacterial drugs (e.g., penicillins and cephalosporins). amoxicillin and clavulanate potassium is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium. teratogenic effects : pregnancy category b. reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. the amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). for clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. oral ampicillin‑class antibacterials are poorly absorbed during labor. it is not known whether use of amoxicillin and clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. amoxicillin has been shown to be excreted in human milk. amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants. caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman. the safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and chewable tablets have been established in pediatric patients. use of amoxicillin and clavulanate potassium in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see clinical studies (14.2)] . because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. dosing of amoxicillin and clavulanate potassium should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [see dosage and administration (2.3)]. of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (gfr less than 30 ml/min). see patients with renal impairment [see dosage and administration (2.4)] for specific recommendations in patients with renal impairment.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - amoxicillin, quantity: 500 mg; clavulanic acid, quantity: 125 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; purified talc; ethylcellulose - augmentin 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 infections. appropriate culture and susceptibility studies should be performed to identify the causative organisms(s) and its (their) susceptibility to augmentin tablets. however, when there is reason to believe an infection may involve any of the b-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 amoxycillin susceptible organisms and b-lactamase producing organisms susceptible to augmentin tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - amoxicillin trihydrate 287mg equivalent to amoxycillin 250 mg;  ; potassium clavulanate 149mg equivalent to clavulanic acid 125 mg - film coated tablet - 250mg/125mg - active: amoxicillin trihydrate 287mg equivalent to amoxycillin 250 mg   potassium clavulanate 149mg equivalent to clavulanic acid 125 mg excipient: croscarmellose sodium ethylcellulose hypromellose magnesium stearate microcrystalline cellulose povidone purified talc   purified water titanium dioxide triethyl citrate - short term treatment of common bacterial infections such as: upper respiratory tract infections (including ent): e.g. tonsillitis, sinusitis, otitis media lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar and broncho-pneumonia genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections skin and soft tissue infections bone and joint infections: e.g. osteomyelitis other infections: e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis and post-surgical infections. prophylaxis against infection which may be associated with major surgical procedures such as gastro-intestinal, pelvic, head and neck, cardiac, renal, joint replacement and biliary tract surgery. infections caused by amoxycillin susceptible organisms are amenable to amoxycillin/clavulanic acid treatment due to its amoxycillin content. mixed infections caused by amoxycillin susceptible organisms in conjunction with amoxycillin/clavulanic acid susceptible beta-lactamase-producing organisms may therefore be treated by amoxycillin/clavulanic acid.