Stany Zjednoczone - angielski - NLM (National Library of Medicine)

par pharmaceutical, inc. - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole is indicated for the prophylaxis of invasive aspergillus and candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (hsct) recipients with graft-versus-host disease (gvhd) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see clinical studies (14.1)] as follows: - posaconazole injection : adults pediatric use information is approved for merck sharp & dohme corp.’s noxafil (posaconazole) injection. however, due to merck sharp & dohme corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. posaconazole is contraindicated with sirolimus. concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirol

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole is indicated for the prophylaxis of invasive aspergillus and candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (hsct) recipients with graft-versus-host disease (gvhd) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see clinical studies ( 14.2 )] as follows: posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and older. posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. posaconazole is contraindicated with sirolimus. concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity [see drug interactions (7.1) a

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

westminster pharmaceuticals, llc - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole delayed-release tablets are indicated for prophylaxis of invasive aspergillus and candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (hsct) recipients with graft-versus-host disease (gvhd) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see clinical studies (14.2) ] as follows: - posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older. additional pediatric use information is approved for merck sharp & dohme corp.’s noxafil (posaconazole) delayed-release tablets. however, due to merck sharp & dohme corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. posaconazole is contraindicated with sirolimus. concomitant administration of posaconaz

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

pharmacor pty ltd - posaconazole, quantity: 100 mg - tablet, enteric coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; hyprolose; colloidal anhydrous silica; hypromellose acetate succinate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - 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 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.

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

pharmacor pty ltd - posaconazole, quantity: 100 mg - tablet, enteric coated - excipient ingredients: hyprolose; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; hypromellose acetate succinate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - 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 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.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

bryant ranch prepack - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. posaconazole is indicated for the prophylaxis of invasive aspergillus and candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (hsct) recipients with graft-versus-host disease (gvhd) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see clinical studies (14.1)] as follows: posaconazole delayed-release tablets : adults and pediatric patients 2 years of age and older who weigh greater than 40 kg posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. posaconazole is contraindicated with sirolimus. concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity [see drug interactions (7.1) and clinical pharmacology (12.3)] . posaconazole is contraindicated with cyp3a4 substrates that prolong the qt interval. concomitant administration of posaconazole with the cyp3a4 substrates, pimozide and quinidine may result in increased plasma concentrations of these drugs, leading to qtc prolongation and cases of torsades de pointes [see warnings and precautions (5.2) and drug interactions (7.2)] . coadministration with the hmg-coa reductase inhibitors that are primarily metabolized through cyp3a4 (e.g., atorvastatin, lovastatin, and simvastatin) is contraindicated since increased plasma concentration of these drugs can lead to rhabdomyolysis [see drug interactions (7.3) and clinical pharmacology (12.3)] . posaconazole may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism [see drug interactions (7.4)] . coadministration of posaconazole 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 warnings and precautions (5.9) and drug interactions (7.15)]. risk summary based on findings from animal data, posaconazole may cause fetal harm when administered to pregnant women. available data for use of noxafil in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, skeletal malformations (cranial malformations and missing ribs) and maternal toxicity (reduced food consumption and reduced body weight gain) were observed when posaconazole was dosed orally to pregnant rats during organogenesis at doses ≥1.4 times the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations of noxafil in healthy volunteers. in pregnant rabbits dosed orally during organogenesis, increased resorptions, reduced litter size, and reduced body weight gain of females were seen at doses 5 times the exposure achieved with the 400 mg twice daily oral suspension regimen. doses of ≥ 3 times the clinical exposure caused an increase in resorptions in these rabbits (see data) . based on animal data, advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data posaconazole resulted in maternal toxicity (reduced food consumption and reduced body weight gain) and skeletal malformations (cranial malformations and missing ribs) when given orally to pregnant rats during organogenesis (gestational days 6 through 15) at doses ≥27 mg/kg (≥1.4 times the 400 mg twice daily oral suspension regimen based on steady-state plasma concentrations of drug in healthy volunteers). the no-effect dose for malformations and maternal toxicity in rats was 9 mg/kg, which is 0.7 times the exposure achieved with the 400 mg twice daily oral suspension regimen. no malformations were seen in rabbits dosed during organogenesis (gestational days 7 through 19) at doses up to 80 mg/kg (5 times the exposure achieved with the 400 mg twice daily oral suspension regimen). in the rabbit, the no-effect dose was 20 mg/kg, while high doses of 40 mg/kg and 80 mg/kg (3 or 5 times the clinical exposure) caused an increase in resorptions. in rabbits dosed at 80 mg/kg, a reduction in body weight gain of females and a reduction in litter size were seen. risk summary there are no data on the presence of posaconazole in human milk, the effects on the breastfed infant, or the effects on milk production. posaconazole is excreted in the milk of lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for posaconazole and any potential adverse effects on the breastfed child from posaconazole or from the underlying maternal condition. the safety and effectiveness of posaconazole oral suspension and posaconazole delayed-release tablets for the prophylaxis of invasive aspergillus and candida infections have been established in pediatric patients aged 2 and older who are at high risk of developing these infections due to being severely immunocompromised, such as hsct recipients with gvhd or those with hematologic malignancies with prolonged neutropenia from chemotherapy. the safety and effectiveness of posaconazole injection and posaconazole delayed-release tablets for the treatment of invasive aspergillosis have been established in pediatric patients aged 13 years and older. use of posaconazole in these age groups is supported by evidence from adequate and well-controlled studies of noxafil in adults and pediatric patients and additional pharmacokinetic and safety data in pediatric patients 2 years of age and older [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the safety and effectiveness of posaconazole have not been established in pediatric patients younger than 2 years of age. no overall differences in the safety of noxafil delayed-release tablets and noxafil oral suspension were observed between geriatric patients and younger adult patients in the clinical trials; therefore, no dosage adjustment is recommended for any formulation of posaconazole in geriatric patients. no clinically meaningful differences in the pharmacokinetics of noxafil were observed in geriatric patients compared to younger adult patients during clinical trials [see clinical pharmacology (12.3)] . of the 230 patients treated with noxafil delayed-release tablets, 38 (17%) were greater than 65 years of age. of the 605 patients randomized to noxafil oral suspension in noxafil oral suspension study 1 and study 2, 63 (10%) were ≥65 years of age. in addition, 48 patients treated with greater than or equal to 800-mg/day noxafil oral suspension in another indication were ≥65 years of age. of the 288 patients randomized to noxafil injection/noxafil delayed-release tablets in the aspergillosis treatment study, 85 (29%) were ≥65 years of age. no overall differences in the pharmacokinetics and safety were observed between elderly and young subjects during clinical trials, but greater sensitivity of some older individuals cannot be ruled out. following single-dose administration of 400 mg of the noxafil oral suspension, there was no significant effect of mild (egfr: 50-80 ml/min/1.73 m2 , n=6) or moderate (egfr: 20-49 ml/min/1.73 m2 , n=6) renal impairment on posaconazole pharmacokinetics; therefore, no dose adjustment is required in patients with mild to moderate renal impairment. in subjects with severe renal impairment (egfr: <20 ml/min/1.73 m2 ), the mean plasma exposure (auc) was similar to that in patients with normal renal function (egfr: >80 ml/min/1.73 m2 ); however, the range of the auc estimates was highly variable (cv=96%) in these subjects with severe renal impairment as compared to that in the other renal impairment groups (cv<40%). due to the variability in exposure, patients with severe renal impairment should be monitored closely for breakthrough fungal infections [see dosage and administration (2)] . similar recommendations apply to posaconazole delayed-release tablets; however, a specific study has not been conducted with the posaconazole delayed-release tablets. after a single oral dose of noxafil oral suspension 400 mg, the mean auc was 43%, 27%, and 21% higher in subjects with mild (child-pugh class a, n=6), moderate (child-pugh class b, n=6), or severe (child-pugh class c, n=6) hepatic impairment, respectively, compared to subjects with normal hepatic function (n=18). compared to subjects with normal hepatic function, the mean cmax was 1% higher, 40% higher, and 34% lower in subjects with mild, moderate, or severe hepatic impairment, respectively. the mean apparent oral clearance (cl/f) was reduced by 18%, 36%, and 28% in subjects with mild, moderate, or severe hepatic impairment, respectively, compared to subjects with normal hepatic function. the elimination half-life (t½ ) was 27 hours, 39 hours, 27 hours, and 43 hours in subjects with normal hepatic function and mild, moderate, or severe hepatic impairment, respectively. it is recommended that no dose adjustment of posaconazole is needed in patients with mild to severe hepatic impairment (child-pugh class a, b, or c) [see dosage and administration (2) and warnings and precautions (5.4)] . similar recommendations apply to posaconazole delayed-release tablets; however, a specific study has not been conducted with the posaconazole delayed-release tablets. the pharmacokinetics of posaconazole are comparable in males and females. no adjustment in the dosage of posaconazole is necessary based on gender. the pharmacokinetic profile of posaconazole is not significantly affected by race. no adjustment in the dosage of posaconazole is necessary based on race. pharmacokinetic modeling suggests that patients weighing greater than 120 kg may have lower posaconazole plasma drug exposure. it is, therefore, suggested to closely monitor for breakthrough fungal infections particularly when using posaconazole oral suspension [see clinical pharmacology (12.3)] .

Izrael - angielski - Ministry of Health

ofek pharma ltd, israel - posaconazole - tablets delayed release - posaconazole 100 mg - posaconazole - 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 patient intolerant to itraconazole.- coccidioidomycosis in patients with disease refractory to amphotericin b, itraconazole or fludonazole or in patient intolerant to these medicinal products.- zygomycosis in patients intolerant of or with disease that is refractory to alternative therapy.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.these are also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukemia (aml) or myelodysplatic syndrome (mds) expected to result in prolonged neutropenia 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.

Belgia - angielski - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - posaconazol 100 mg - gastro-resistant tablet - 100 mg - posaconazole 100 mg - posaconazole

Belgia - angielski - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva b.v. - posaconazol 100 mg - gastro-resistant tablet - 100 mg - posaconazole 100 mg - posaconazole

Izrael - angielski - Ministry of Health

inovamed ltd - posaconazole - tablets delayed release - posaconazole 100 mg - posaconazole - posaconazole inovamed delayed-release tablets are 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.- zygomycosis in patients intolerant of or with disease that is refractory to alternative therapy.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.noxafil gastro-resistant tablets are 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.