Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - amoxicillin, quantity: 1 g - injection, powder for - excipient ingredients: - ibiamox is intended for use where the patient?s condition precludes the administration of the oral form of amoxicillin. it is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms.,note: therapy should be guided by bacteriological studies, including sensitivity tests, and clinical response. however, in emergency cases where the causative organism has not been identified, therapy with amoxicillin sodium may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.,septicaemia: (bacterial) h. influenzae; e. coli (see section 5.1 pharmacodynamic properties - microbiology); p. mirabilis; streptococcus; strep. pneumoniae; strep. faecalis and salmonella typhi.,skin and skin structure: staphylococcus (non-penicillinase-producing), streptococcus; e. coli (see section 5.1 pharmacodynamic properties - microbiology).,respiratory, acute and chronic: h. influenzae; streptococcus; strep. pneumoniae; staphylococcus (non-penicillinase producing); e. coli (see section 5.1 pharmacodynamic properties - microbiology).,genitourinary tract (complicated and uncomplicated), acute and chronic: e. coli (see section 5.1 pharmacodynamic properties - microbiology); p. mirabilis and strep. faecalis.,gonorrhoea: n. gonorrhoeae (nonpenicillinase producing),prophylaxis of endocarditis: amoxicillin sodium may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with prosthetic heart valves or those who have previously had endocarditis.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.32 mg (equivalent: estradiol, qty 2.25 mg) - drug delivery system, transdermal - excipient ingredients: polyethylene terephthalate; isopropyl palmitate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. lifestyle modifications and the risk-benefit profile of estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing (see section 4.4 special warnings and precautions for use and section 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide; water for injections; nitrogen - daptomycin is indicated for:,the treatment of adults and paediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,daptomycin is also indicated in adults for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates. the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy,- daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be coadministered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: water for injections; sodium hydroxide; nitrogen - daptomycin is indicated for:,the treatment of adults and paediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,daptomycin is also indicated in adults for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates. the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy,- daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be coadministered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

avallon pharmaceuticals pty ltd - allopurinol, quantity: 300 mg - tablet, uncoated - excipient ingredients: powdered cellulose; povidone; macrogol 4000; crospovidone; purified talc; magnesium stearate; microcrystalline cellulose - main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy; certain enzyme disorders which lead to overproduction of urate and involve hypoxanthine guanine phosphoribosyltransferase including lesch-nyhan syndrome, glucose-6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. management of 2,8-dihydroxyadenine (2,8-dha) renal stones relate to deficient activity of adenine phosphoribosyl transferase. management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

avallon pharmaceuticals pty ltd - allopurinol, quantity: 100 mg - tablet, uncoated - excipient ingredients: powdered cellulose; povidone; macrogol 4000; crospovidone; purified talc; magnesium stearate; microcrystalline cellulose - main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy; certain enzyme disorders which lead to overproduction of urate and involve hypoxanthine guanine phosphoribosyltransferase including lesch-nyhan syndrome, glucose-6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. management of 2,8-dihydroxyadenine (2,8-dha) renal stones relate to deficient activity of adenine phosphoribosyl transferase. management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - sodium valproate, quantity: 400 mg - injection, solution - excipient ingredients: water for injections - sodium valproate juno is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

sunshine lake pharma co., ltd. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral olanzapine is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13-17), efficacy was established in one 6-week trial [see clinical studies ( 14.1)] . when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions ( 5.5] . monotherapy — oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disord

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

sunshine lake pharma co., ltd. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin tablets are indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]) , haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies ( 14.3 )] . mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and sk

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

sunshine lake pharma co., ltd. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral olanzapine is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 years to 17 years), efficacy was established in one 6-week trial [see clinical studies ( 14.1)] . when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions ( 5.5)] . monotherapy — oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of