Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - amoxicillin sodium 530.1mg equivalent to amoxicillin 500 mg;  ; potassium clavulanate 119.13mg equivalent to clavulanic acid 100 mg;  ;  ;   - powder for injection - 600 mg - active: amoxicillin sodium 530.1mg equivalent to amoxicillin 500 mg   potassium clavulanate 119.13mg equivalent to clavulanic acid 100 mg       - augmentin 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 augmentin is indicated for 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.

Israel - anglès - Ministry of Health

glaxo smith kline (israel) ltd - amoxicillin as trihydrate; clavulanic acid as potassium salt - film coated tablets - amoxicillin as trihydrate 875 mg; clavulanic acid as potassium salt 125 mg - 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.

Israel - anglès - Ministry of Health

glaxo smith kline (israel) ltd - amoxicillin as trihydrate; clavulanic acid as potassium salt - film coated tablets - amoxicillin as trihydrate 500 mg; clavulanic acid as potassium salt 125 mg - amoxicillin and enzyme inhibitor - amoxicillin 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.

Unió Europea - anglès - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. 

Estats Units - anglès - NLM (National Library of Medicine)

dr reddys laboratories inc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 600 mg in 5 ml - augmentin es-600 powder for oral suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to s. pneumoniae (penicillin mics ≤ 2 mcg/ml), h. influenzae (including β-lactamase–producing strains), or m. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: - antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 years daycare attendance - age ≤ 2 years - daycare attendance [see clinical pharmacology, microbiology.] note: acute otitis media due to s. pneumoniae alone can be treated with amoxicillin. augmentin es-600 powder for oral suspension is not indicated for the treatment of acute otitis media due to s. pneumoniae with penicillin mic ≥ 4 mcg/ml. therapy may be instituted prior to obtaining the

Israel - anglès - Ministry of Health

glaxo smith kline (israel) ltd - amoxicillin as trihydrate; clavulanic acid as potassium salt - film coated tablets - amoxicillin as trihydrate 500 mg; clavulanic acid as potassium salt 125 mg - amoxicillin 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.

Israel - anglès - Ministry of Health

trima israel pharmaceutical products maabarot ltd - digoxin - tablets - digoxin 0.25 mg - digoxin - cardiac failure:digoxin kern pharma is indicated for the treatment of chronic cardiac failure where the principal cause is systolic dysfunction. the greatest therapeutic benefit is achieved in patients with ventricular dilatation.digoxin kern pharma is specifically indicated where cardiac failure is accompanied by atrial fibrilation.supraventricular arrhythmias:digoxin kern pharma is indicated for the treatment of certain supraventricular arrhythmias, particularly atrial fibrillation and flutter, where its principal beneficial effect is to reduce the ventricular rate.

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - dexmedetomidine hydrochloride 0.1182 mg/ml equivalent to dexmedetomidine 0.1mg/ml - concentrate for injection - active: dexmedetomidine hydrochloride 0.1182 mg/ml equivalent to dexmedetomidine 0.1mg/ml excipient: sodium chloride water for injection - for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine hydrochloride ever pharma by continuous intubation in these patents should not exceed 24 hours. for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Estats Units - anglès - NLM (National Library of Medicine)

allegis holdings, llc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - augmentin 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, augmentin should not be used. usage to reduce the development of drug‑resistant bacteria and maintain the effectiveness of augmentin and other antibacterial drugs, augmentin 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. augmentin 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). augmentin is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with augmentin. teratogenic effects : pregnancy category b. reproduction studies performed in pregnant rats and mice given augmentin (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 augmentin. 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 augmentin for oral suspension and chewable tablets have been established in pediatric patients. use of augmentin in pediatric patients is supported by evidence from studies of augmentin tablets in adults with additional data from a study of augmentin 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 augmentin, 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.

Egipte - anglès - EDA (Egyptian Drug Authority)

aug pharma - coated tablet - 20 mg