Austrália - inglês - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen-cilag pty ltd - azaconazole - unknown - azaconazole triazole active 0.0 - active constituent

Austrália - inglês - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen-cilag pty ltd - azaconazole - fungicide - mushroom crop - adhesion control | control of penetration | control of adhesion

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: hyprolose; triacetin; titanium dioxide; microcrystalline cellulose; hypromellose acetate succinate; macrogol 400; croscarmellose sodium; purified talc; iron oxide red; magnesium stearate; silicon dioxide; hypromellose - posaconazole arx (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ,? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ,? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. ,posaconazole arx is also indicated for the: ,? prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: hypromellose acetate succinate; microcrystalline cellulose; hyprolose; croscarmellose sodium; silicon dioxide; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - posaconazole sandoz (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:,? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,posaconazole sandoz is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; triethyl citrate; microcrystalline cellulose; croscarmellose sodium; propyl gallate; methacrylic acid - ethyl acrylate copolymer (1:1); xylitol; sodium stearylfumarate; hyprolose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - posaconazole juno is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:,? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy.,? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,posaconazole juno is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Estados Unidos - inglês - NLM (National Library of Medicine)

jubilant cadista pharmaceuticals inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg - itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: - blastomycosis, pulmonary and extrapulmonary - histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and - aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin b therapy. specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: - onychomycosis of the toenail, with or without fingernail involvement

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - itraconazole, quantity: 100 mg - capsule - excipient ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - apo-itraconazole indicated for use in adults for the treatment of: ? superficial dermatomycoses not responding to topical treatment. ? fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. ? pityriasis versicolor not responding to any other treatment. ? vulvovaginal candidiasis not responding to topical treatment. ? oral candidiasis in immunocompromised patients. ? onychomycosis caused by dermatophytes. ? systemic mycoses: - systemic aspergillosis, histoplasmosis, sporotrichosis. - treatment and maintenance therapy in aids patients with disseminated or chronic pulmonary histoplasmosis infection. - treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. this may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

União Europeia - inglês - EMA (European Medicines Agency)

schering-plough europe - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimycotics for systemic use - posaconazole sp is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.posaconazole sp is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who areat high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

União Europeia - inglês - EMA (European Medicines Agency)

accord healthcare s.l.u. - posaconazole - mycoses - antimycotics for systemic use - posaconazole ahcl oral suspension is indicated for use in the treatment of the following fungal infections in adults:invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.posaconazole ahcl oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:patients receiving remission-induction chemotherapy for acute myelogenous leukemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

Estados Unidos - inglês - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg - itraconazole capsules    are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. blastomycosis, pulmonary and extrapulmonary 2. histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non- meningeal histoplasmosis, and 3. aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin b therapy. specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. itraconazole capsules    are also indicated for the treatment of the following fungal infections in non-immunocompromised patients:  1. onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and 2. onychomycosis of the fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (see clinical pharmacology: special populations, contraindications, warnings, and adverse reactions: post-marketing experience for more information.) description of clinical studies: blastomycosis: analyses were conducted on data from two open-label, non-concurrently controlled studies (n=73 combined) in patients with normal or abnormal immune status. the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. histoplasmosis: analyses were conducted on data from two open-label, non-concurrently controlled studies (n=34 combined) in patients with normal or abnormal immune status (not including hiv-infected patients). the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. histoplasmosis in hiv-infected patients: data from a small number of hiv-infected patients suggested that the response rate of histoplasmosis in hiv-infected patients is similar to that of non-hiv-infected patients. the clinical course of histoplasmosis in hiv-infected patients is more severe and usually requires maintenance therapy to prevent relapse. aspergillosis: analyses were conducted on data from an open-label, “single-patient-use” protocol designed to make itraconazole available in the u.s. for patients who either failed or were intolerant of amphotericin b therapy (n=190). the findings were corroborated by two smaller open-label studies (n=31 combined) in the same patient population. most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin b therapy. onychomycosis of the toenail: analyses were conducted on data from three double-blind, placebo-controlled studies (n=214 total; 110 given itraconazole capsules    in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules   once daily for 12 consecutive weeks. results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative koh plus negative culture, in 54% of patients. thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). the mean time to overall success was approximately 10 months. twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of koh or culture from negative to positive). onychomycosis of the fingernail: analyses were conducted on data from a double-blind, placebo-controlled study (n=73 total; 37 given itraconazole capsules   in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules   b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules   b.i.d. results demonstrated mycologic cure in 61% of patients. fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. the mean time to overall success was approximately 5 months. none of the patients who achieved overall success relapsed. congestive heart failure: itraconazole capsules   should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (chf) or a history of chf. (see boxed warnings, warnings, precautions: drug interactions-calcium channel blockers, adverse reactions: post-marketing experience, and clinical pharmacology: special populations.) drug interactions: coadministration of a number of cyp3a4 substrates are contraindicated with itraconazole. some examples of drugs for which plasma concentrations increase are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride,naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. in addition, coadministration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of cyp2d6 and in subjects taking strong or moderate cyp2d6 inhibitors. (see precautions: drug interactions section for specific examples.) this increase in drug concentrations caused by coadministration with itraconazole may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs. for example, increased plasma concentrations of some of these drugs can lead to qt prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes , a potentially fatal arrhythmia. some specific examples are listed in precautions: drug interactions. coadministration with venetoclax is contraindicated in patients with cll/sll during the dose initiation and ramp-up phase of venetoclax due to the potential for an increased risk of tumor lysis syndrome.   itraconazole should not be administered for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy. itraconazole are contraindicated for patients who have shown hypersensitivity to itraconazole. there is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. caution should be used when prescribing itraconazole to patients with hypersensitivity to other azoles.