Australien - Englisch - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - amoxicillin trihydrate, quantity: 1012.617 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149.774 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: dichloromethane; isopropyl alcohol; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type a; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose - clavamox 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 clavamox 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to clavamox tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - amoxicillin trihydrate, quantity: 1012.617 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149.774 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type a; dichloromethane; magnesium stearate; isopropyl alcohol; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose - alkem-amoxiclav 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 alkem-amoxiclav 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to alkem-amoxiclav tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - amoxicillin trihydrate, quantity: 1012.617 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149.774 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; dichloromethane; sodium starch glycollate type a; magnesium stearate; isopropyl alcohol; colloidal anhydrous silica; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose - pharmaclav 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 pharmaclav 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to pharmaclav tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - amoxicillin trihydrate, quantity: 1012.617 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149.774 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: isopropyl alcohol; magnesium stearate; dichloromethane; colloidal anhydrous silica; sodium starch glycollate type a; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose - pharmacor clavam 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 pharmacor clavam 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to pharmacor clavam tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - amoxicillin trihydrate, quantity: 1012.617 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149.774 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; dichloromethane; magnesium stearate; sodium starch glycollate type a; colloidal anhydrous silica; isopropyl alcohol; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose - pharmacor clavam 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 pharmacor clavam 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to pharmacor clavam tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Nigeria - Englisch - NAFDAC (National Agency for Food and Drugs Administration and Control)

dafra pharma gmbh - amoxicillin + clavulanic acid - amoxicillin 400mg,clavulanic acid 57mg - dafraclav is indicated in the treatment of the following infections caused by the microorganisms indicated below. - upper respiratory tract infections (including otitis media and sinusitis), due to beta-lactamase producing strains of haemophilus influenzae and moraxella catarrhalis. - lower respiratory tract infections, due to beta-lactamase producing strains of haemophilus influenzae and moraxella catarrhalis. - skin and skin structure infections, due to beta-lactamase producing strains of staphylococcus aureus, escherichia coli and klebsiella spp. - urinary tract infections. since dafraclav contains amoxicillin, it can be used in the treatment of infections caused by bacteria susceptible to ampicillin. additionally, if in a mixed infection a microorganisms is susceptible to ampicillin and the other which is a beta-lactamase producer is susceptible to dafraclav, such an infection can be treated by the administration of dafraclav alone, addition of another antibiotic is not required.

Vereinigte Staaten - Englisch - 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.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

sandoz inc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), amoxicillin sodium (unii: 544y3d6myh) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 562.5 mg - amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients with due to confirmed, or suspected β-lactamase-producing pathogens (i.e., h. influenzae, m. catarrhalis, h. parainfluenzae, k. pneumoniae , or methicillin-susceptible s. aureus ) and s. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin mics equal to 2 mcg/ml). limitations of use amoxicillin and clavulanate potassium extended-release tablets is not indicated for the treatment of infections due to s. pneumoniae with penicillin mics greater than or equal to 4 mcg/ml. data are limited with regard to infections due to s. pneumoniae with penicillin mics greater than or equal to 4 mcg/ml [see clinical studies (14)] . usage to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium extended-release tablets and other antibacterial drugs, amoxicillin and clavulanate potassium extended-releas

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

northstar rx llc - 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 tablets. 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 tablets 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.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

northstar rxllc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 250 mg - 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: 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 con