United States - English - NLM (National Library of Medicine)

a-s medication solutions - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 ml 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. amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 ml 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 results from bacteriological studies when there is reason to believe th

United States - English - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of pediatric patients with - recurrent or persistent acute otitis media due to s. pneumoniae (penicillin mics less than or equal to 2 mcg/ml), h. influenzae (including β-lactamase-producing strains), or m. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors: - antibacterial drug exposure for acute otitis media within the preceding 3 months, and  either of the following: 1) age 2 years, or younger or 2) day care attendance [see microbiology (12.4)] . limitations of use acute otitis media due to s. pneumoniae alone can be treated with amoxicillin. amoxicillin and clavulanate potassium for oral suspension is not indicated for the treatment of acute otitis media due to s. pneumoniae with penicillin mic greater than or equal to 4 mcg/ml. therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may invol

United States - English - NLM (National Library of Medicine)

a-s medication solutions - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of pediatric patients with - recurrent or persistent acute otitis media due to s. pneumoniae (penicillin mics less than or equal to 2 mcg/ml), h. influenzae (including β-lactamase-producing strains), or m. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors: - antibacterial drug exposure for acute otitis media within the preceding 3 months, and  either of the following: 1) age 2 years, or younger or 2) day care attendance [see microbiology (12.4)] . limitations of use acute otitis media due to s. pneumoniae alone can be treated with amoxicillin. amoxicillin and clavulanate potassium for oral suspension is not indicated for the treatment of acute otitis media due to s. pneumoniae with penicillin mic greater than or equal to 4 mcg/ml. therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both s. pneumoniae (penicillin mic less than or equal to 2 mcg/ml) and the β-lactamase-producing organisms listed above. usage to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension 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 for oral suspension 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 for oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin and clavulanate potassium. pregnancy category b.  there are 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. reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral dosages up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. the amoxicillin doses in rodents (based on body surface area and assuming a 20 kg child) were approximately 2 times (rats) or equal to (mice) the recommended clinical amoxicillin and clavulanate potassium for oral suspension dose of 90/6.4 mg/kg/day. for clavulanate, these dose multiples were approximately 15 times and 7.5 times the recommended daily dose of amoxicillin and clavulanate potassium for oral suspension. oral ampicillin-class antibacterial drugs are generally poorly absorbed during labor. studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions, and duration of contractions. however, it is not known whether the 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 that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary. in a single study in women with premature rupture of fetal membranes, it was reported that prophylactic treatment with amoxicillin and clavulanate potassium may be associated with an increased risk of necrotizing enterocolitis in neonates. ampicillin-class antibacterial drugs are excreted in human milk; therefore, caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman. safety and efficacy of amoxicillin and clavulanate potassium for oral suspension in infants younger than 3 months have not been established. safety and efficacy of amoxicillin and clavulanate potassium for oral suspension have been demonstrated for treatment of acute otitis media in infants and children 3 months to 12 years [see clinical studies (14)]. the safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established for the treatment of pediatric patients (3 months to 12 years) with acute bacterial sinusitis. this use is supported by evidence from adequate and well-controlled studies of amoxicillin and clavulanate potassium extended-release tablets in adults with acute bacterial sinusitis, studies of amoxicillin and clavulanate potassium for oral suspension in pediatric patients with acute otitis media, and by similar pharmacokinetics of amoxicillin and clavulanate in pediatric patients taking amoxicillin and clavulanate potassium for oral suspension [see clinical pharmacology (12)] and adults taking amoxicillin and clavulanate potassium extended-release tablets.

United States - English - NLM (National Library of Medicine)

usantibiotics, llc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - augmentin es-600 is indicated for the treatment of pediatric patients with - recurrent or persistent acute otitis media due to s. pneumoniae (penicillin mics less than or equal to 2 mcg/ml), h. influenzae (including β-lactamase-producing strains), or m. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors:      - antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) daycare attendance [s ee microbiology (12.4) ]. limitations of use acute otitis media due to s. pneumoniae alone can be treated with amoxicillin. augmentin es-600 is not indicated for the treatment of acute otitis media due to s. pneumoniae with penicillin mic greater than or equal to 4 mcg/ml. therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both s. pneumoniae (penicillin mic less than or equal to 2 mcg/ml) and the

United States - English - 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 pediatric patients with - recurrent or persistent acute otitis media due to s. pneumoniae (penicillin mics less than or equal to 2 mcg/ml), h. influenzae (including β-lactamase-producing strains), or m. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors:      - antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2)  daycare attendance  [ see microbiology (12.4)] limitations of use acute otitis media due to s. pneumoniae alone can be treated with amoxicillin. amoxicillin and clavulanate potassium for oral suspension is not indicated for the treatment of acute otitis media due to s. pneumoniae with penicillin mic greater than or equal to 4 mcg/ml. therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both s. pneum

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - dantrolene sodium hemiheptahydrate, quantity: 50 mg - capsule - excipient ingredients: sodium lauryl sulfate; maize starch; lactose monohydrate; titanium dioxide; sunset yellow fcf; gelatin; iron oxide yellow; iron oxide red; magnesium stearate; purified talc; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - dantrium is indicated in controlling the manifestations of clinical spasticity resulting from serious chronic disorders such as spinal cord injury, stroke, cerebral palsy, or multiple sclerosis. it is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. there is no evidence that patients with contractures will benefit. dantrium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders or electroconvulsive therapy. if improvement occurs, it will ordinarily occur within the dosage titration schedule (see dosage and administration), as manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrium. occasionally, subtle but meaningful improvements in spasticity may occur with dantrium therapy. in such instances informat

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - dantrolene sodium hemiheptahydrate, quantity: 25 mg - capsule - excipient ingredients: titanium dioxide; sunset yellow fcf; purified talc; gelatin; iron oxide red; magnesium stearate; maize starch; sodium lauryl sulfate; lactose monohydrate; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; simethicone - dantrium is indicated in controlling the manifestations of clinical spasticity resulting from serious chronic disorders such as spinal cord injury, stroke, cerebral palsy, or multiple sclerosis. it is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. there is no evidence that patients with contractures will benefit. dantrium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders or electroconvulsive therapy. if improvement occurs, it will ordinarily occur within the dosage titration schedule (see dosage and administration), as manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrium. occasionally, subtle but meaningful improvements in spasticity may occur with dantrium therapy. in such instances inf

Australia - English - Department of Health (Therapeutic Goods Administration)

templeton wholesale pty ltd - 31161 - disability vehicle, - a mobility aid used to provide a disabled user with a means of transportation, typically without attendance from another person, but not in all cases. the device is designed to be used and/or operated by a disabled person. this device will enhance the user's independence to convey themselves from one place to another.

Australia - English - Department of Health (Therapeutic Goods Administration)

sunrise medical pty ltd - 31110 - walking aid, - a mobility aid used to assist a disabled or infirm user in walking by providing a means of support and increasing their ability to move around without attendance from another person. it can be collapsible or non-collapsible.

Australia - English - Department of Health (Therapeutic Goods Administration)

sunrise medical pty ltd - 31110 - walking aid, - a mobility aid used to assist a disabled or infirm user in walking by providing a means of support and increasing their ability to move around without attendance from another person. it can be collapsible or non-collapsible