オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - itraconazole, quantity: 50 mg - capsule - excipient ingredients: sodium starch glycollate type a; titanium dioxide; brilliant blue fcf; hypromellose phthalate; silicon dioxide; magnesium stearate; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - superficial mycoses: lozanoc is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and pityriasis versicolor. systemic mycoses: lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see pharmacology).

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - fluconazole, quantity: 50 mg - capsule, hard - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; silicon dioxide; magnesium stearate; maize starch; titanium dioxide; potable water; gelatin; brilliant scarlet 4r; patent blue v; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note: data suggests that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of acute phase cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal canidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oesophageal canidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note: it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks. (see adverse reactions).

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - fluconazole, quantity: 150 mg - capsule, hard - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; silicon dioxide; magnesium stearate; maize starch; titanium dioxide; potable water; gelatin; propylene glycol; purified water; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; potassium hydroxide; iron oxide black - treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note: data suggests that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of acute phase cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal canidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oesophageal canidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note: it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea crur

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - metronidazole, quantity: 400 mg - tablet, uncoated - excipient ingredients: magnesium stearate; povidone; hypromellose; calcium hydrogen phosphate; maize starch; purified talc; macrogol 400 - anaerobic infections: treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly bacteroides fragilis and other species of bacteroides, and other species such as fusobacteria, eubacteria, clostridia and anaerobic streptococci. metronide has been used successfully in septicaemia; bacteraemia; brain abscess; necrotising pneumonia; osteomyelitis; puerperal sepsis; pelvic abscess; pelvic cellulitis; postoperative wound infections. note: metronidazole is inactive against aerobic and facultative anaerobic bacteria. other indications: oral treatment of urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male, and for the treatment of bacterial vaginosis. the male consort of females suffering from urogenital trichomoniasis should be treated concurrently; all forms of amoebiasis (intestinal and extraintestinal disease and that of symptomless cyst passers); giardiasis; acute ulcerative gingivitis.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - metronidazole, quantity: 400 mg - tablet, uncoated - excipient ingredients: hypromellose; magnesium stearate; purified talc; calcium hydrogen phosphate; macrogol 400; maize starch; povidone - anaerobic infections: treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly bacteroides fragilis and other species of bacteroides, and other species such as fusobacteria, eubacteria, clostridia and anaerobic streptococci. flagyl has been used successfully in septicaemia; bacteraemia; brain abscess; necrotising pneumonia; osteomyelitis; puerperal sepsis; pelvic abscess; pelvic cellulitis; postoperative wound infections. note: metronidazole is inactive against aerobic and facultative anaerobic bacteria. other indications: oral treatment of urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male, and for the treatment of bacterial vaginosis. the male consort of females suffering from urogenital trichomoniasis should be treated concurrently; all forms of amoebiasis (intestinal and extraintestinal disease and that of symptomless cyst passers); giardiasis; acute ulcerative gingivitis.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - metronidazole, quantity: 200 mg - tablet, uncoated - excipient ingredients: povidone; macrogol 400; magnesium stearate; maize starch; calcium hydrogen phosphate; hypromellose - anaerobic infections: treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly bacteroides fragilis and other species of bacteroides, and other species such as fusobacteria, eubacteria, clostridia and anaerobic streptococci. metronide has been used successfully in septicaemia; bacteraemia; brain abscess; necrotising pneumonia; osteomyelitis; puerperal sepsis; pelvic abscess; pelvic cellulitis; postoperative wound infections. note: metronidazole is inactive against aerobic and facultative anaerobic bacteria. other indications: oral treatment of urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male, and for the treatment of bacterial vaginosis. the male consort of females suffering from urogenital trichomoniasis should be treated concurrently; all forms of amoebiasis (intestinal and extraintestinal disease and that of symptomless cyst passers); giardiasis; acute ulcerative gingivitis.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

major pharmaceuticals - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole 50 mg - voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive apergillosis (ia). in clinical trials, the majority of isolates recovered were aspergillus fumigatus . there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus [see clinical studies (14.1, 14.5) and microbiology (12.4)].   voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see clinical studies (14.2, 14.5) and microbiology (12.4)]. voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (ec) in adults and pediatric patients 2 years of age and older [see clinical studies (14.3, 14.5) and microbiology (12.4)]. voricona

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

zydus lifesciences limited - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole 50 mg - voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (ia). in clinical trials, the majority of isolates recovered were aspergillus fumigatus . there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus [see clinical studies (14.1, 14.5) and microbiology (12.4)].   voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see clinical studies (14.2, 14.5) and microbiology (12.4)]. voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (ec) in adults and pediatric patients 2 years of age and older [see clinical studies (14.3, 14.5) and microbiology (12.4)]. voriconazole tablets are indicated for the treatment of serious fungal infections caused by scedosporium apiospermum (asexual form of pseudallescheria boydii ) and fusarium spp. including fusarium solani , in adults and pediatric patients 2 years of age and older intolerant of, or refractory to, other therapy [see clinical studies (14.4) and microbiology (12.4)]. specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). therapy may be instituted before the results of the cultures and other laboratory studies are known. however, once these results become available, antifungal therapy should be adjusted accordingly. - voriconazole tablets are contraindicated in patients with known hypersensitivity to voriconazole or its excipients. there is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. caution should be used when prescribing voriconazole to patients with hypersensitivity to other azoles. - coadministration of pimozide , quinidine or ivabradine with voriconazole is contraindicated because increased plasma concentrations of these drugs can lead to qt prolongation and rare occurrences of torsade de pointes [see drug interactions(7) ]. - coadministration of voriconazole with sirolimus is contraindicated because voriconazole significantly increases sirolimus concentrations [see drug interactions (7) and clinical pharmacology (12.3) ]. - coadministration of voriconazole with rifampin, carbamazepine, long-acting barbiturates, and st john's wort is contraindicated because these drugs are likely to decrease plasma voriconazole concentrations significantly [see drug interactions (7) and clinical pharmacology (12.3) ]. - coadministration of standard doses of voriconazole with efavirenz doses of 400 mg every 24 hours or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. voriconazole also significantly increases efavirenz plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3) ]. - coadministration of voriconazole with high-dose ritonavir (400 mg every 12 hours) is contraindicated because ritonavir (400 mg every 12 hours) significantly decreases plasma voriconazole concentrations. coadministration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole [see drug interactions (7) and clinical pharmacology (12.3) ]. - coadministration of voriconazole with rifabutin is contraindicated since voriconazole significantly increases rifabutin plasma concentrations and rifabutin also significantly decreases voriconazole plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3) ]. - coadministration of voriconazole with ergot alkaloids (ergotamine and dihydroergotamine) is contraindicated because voriconazole may increase the plasma concentration of ergot alkaloids, which may lead to ergotism [see drug interactions (7) ]. - coadministration of voriconazole with naloxegol is contraindicated because voriconazole may increase plasma concentrations of naloxegol which may precipitate opioid withdrawal symptoms [see drug interactions (7)] . - coadministration of voricoazole with tolvaptan is contraindicated because voriconazole may increase tolvaptan plasma concentrations and increase risk of adverse reactions [see drug interactions (7) ]. - coadministration of voriconazole with venetoclax at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) due to the potential for increased risk of tumor lysis syndrome [see drug interactions(7) ]. - coadministration of voriconazole with lurasidone is contraindicated since it may result in significant increases in lurasidone exposure and the potential for serious adverse reactions [see drug interactions(7) ]. risk summary voriconazole can cause fetal harm when administered to a pregnant woman. there are no available data on the use of voriconazole in pregnant women. in animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits. cleft palates and hydronephrosis/hydroureter were observed in rat pups exposed to voriconazole during organogenesis at and above 10 mg/kg (0.3 times the rmd of 200 mg every 12 hours based on body surface area comparisons). in rabbits, embryomortality, reduced fetal weight and increased incidence of skeletal variations, cervical ribs and extrasternal ossification sites were observed in pups when pregnant rabbits were orally dosed at 100 mg/kg (6 times the rmd based on body surface area comparisons) during organogenesis. rats exposed to voriconazole from implantation to weaning experienced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose [see data]. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus [see warnings and precautions (5.9)]. the background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20% respectively. data animal data voriconazole was administered orally to pregnant rats during organogenesis (gestation days 6-17) at 10, 30, and 60 mg/kg/day. voriconazole was associated with increased incidences of the malformations hydroureter and hydronephrosis at 10 mg/kg/day or greater, approximately 0.3 times the recommended human dose (rmd) based on body surface area comparisons, and cleft palate at 60 mg/kg, approximately 2 times the rmd based body surface area comparisons. reduced ossification of sacral and caudal vertebrae, skull, pubic, and hyoid bone, supernumerary ribs, anomalies of the sternebrae, and dilatation of the ureter/renal pelvis were also observed at doses of 10 mg/kg or greater. there was no evidence of maternal toxicity at any dose. voriconazole was administered orally to pregnant rabbits during the period of organogenesis (gestation days 7-19) at 10, 40, and 100 mg/kg/day. voriconazole was associated with increased post-implantation loss and decreased fetal body weight, in association with maternal toxicity (decreased body weight gain and food consumption) at 100 mg/kg/day (6 times the rmd based on body surface area comparisons). fetal skeletal variations (increases in the incidence of cervical rib and extra sternebral ossification sites) were observed at 100 mg/kg/day. in a peri-and postnatal toxicity study in rats, voriconazole was administered orally to female rats from implantation through the end of lactation at 1, 3, and 10 mg/kg/day. voriconazole prolonged the duration of gestation and labor and produced dystocia with related increases in maternal mortality and decreases in perinatal survival of f1 pups at 10 mg/kg/day, approximately 0.3 times the rmd. risk summary no data are available regarding the presence of voriconazole in human milk, the effects of voriconazole on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for voriconazole and any potential adverse effects on the breastfed child from voriconazole or from the underlying maternal condition. contraception advise females of reproductive potential to use effective contraception during treatment with voriconazole. the coadministration of voriconazole with the oral contraceptive, ortho-novum® (35 mcg ethinyl estradiol and 1 mg norethindrone), results in an interaction between these two drugs, but is unlikely to reduce the contraceptive effect. monitoring for adverse reactions associated with oral contraceptives and voriconazole is recommended [see drug interactions (7) and clinical pharmacology (12.3)]. the safety and effectiveness of voriconazole have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. a total of 105 pediatric patients aged 2 to less than 12 [n=26] and aged 12 to less than 18 [n=79] from two, non-comparative phase 3 pediatric studies and eight adult therapeutic trials provided safety information for voriconazole use in the pediatric population [see adverse  reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . safety and effectiveness in pediatric patients below the age of 2 years has not been established. therefore, voriconazole is not recommended for pediatric patients less than 2 years of age. a higher frequency of liver enzyme elevations was observed in the pediatric patients [see dosage and administration (2.5), warnings  and precautions (5.1), and adverse reactions (6.1)] . the frequency of phototoxicity reactions is higher in the pediatric population. squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. stringent measures for photoprotection are warranted. sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation [see warnings and precautions (5.6)]. voriconazole has not been studied in pediatric patients with hepatic or renal impairment [see dosage and administration (2.5, 2.6)] . hepatic function and serum creatinine levels should be closely monitored in pediatric patients [see dosage and administration (2.6) and warnings and precautions (5.1, 5.10)] . in multiple dose therapeutic trials of voriconazole, 9.2% of patients were ≥65 years of age and 1.8% of patients were ≥75 years of age. in a study in healthy subjects, the systemic exposure (auc) and peak plasma concentrations (cmax ) were increased in elderly males compared to young males. pharmacokinetic data obtained from 552 patients from 10 voriconazole therapeutic trials showed that voriconazole plasma concentrations in the elderly patients were approximately 80% to 90% higher than those in younger patients after either iv or oral administration. however, the overall safety profile of the elderly patients was similar to that of the young so no dosage adjustment is recommended [see clinical pharmacology (12.3) ].

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole 50 mg - voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive apergillosis (ia). in clinical trials, the majority of isolates recovered were aspergillus fumigatus . there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus [see clinical studies (14.1, 14.5) and microbiology (12.4)].   voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see clinical studies (14.2, 14.5) and microbiology (12.4)]. voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (ec) in adults and pediatric patients 2 years of age and older [see clinical studies (14.3, 14.5) and microbiology (12.4)]. voricon

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - fluconazole, quantity: 100 mg - capsule, hard - excipient ingredients: lactose monohydrate; maize starch; sodium lauryl sulfate; silicon dioxide; magnesium stearate; titanium dioxide; potable water; gelatin; patent blue v; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note: data suggests that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of acute phase cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal canidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oesophageal canidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note: it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks. (see adverse reactions).