Israel - Inggeris - Ministry of Health

merck sharp & dohme israel ltd - posaconazole - suspension - posaconazole 40 mg/ml - posaconazole - posaconazole - noxafil 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

Kanada - Inggeris - Health Canada

glenmark pharmaceuticals canada inc. - posaconazole - tablet (delayed-release) - 100mg - posaconazole 100mg

Kanada - Inggeris - Health Canada

jamp pharma corporation - posaconazole - suspension - 40mg - posaconazole 40mg

Kanada - Inggeris - Health Canada

sandoz canada incorporated - posaconazole - tablet (delayed-release) - 100mg - posaconazole 100mg - azoles

Kanada - Inggeris - Health Canada

apotex inc - posaconazole - tablet (delayed-release) - 100mg - posaconazole 100mg - azoles

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

arrotex pharmaceuticals pty ltd - posaconazole, quantity: 40 mg/ml - oral liquid, suspension - excipient ingredients: peg-40 hydrogenated castor oil; sodium benzoate; citric acid monohydrate; glycerol; purified water; liquid glucose; xanthan gum; sodium citrate dihydrate; titanium dioxide; peg-40 stearate; benzoic acid; glyceryl monostearate; methylcellulose; polysorbate 65; simethicone; sorbic acid; sulfuric acid; flavour - 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: ? treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole. ? 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.

Israel - Inggeris - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - posaconazole - suspension - posaconazole 40 mg/ml - posaconazole - posaconazole - noxafil 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. noxafil 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 prologed 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. zygomycosis in patients intolerant of or with disease that is refractory to alternative therapy

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

eugia us llc - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole injection 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 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 (5.10) and drug interactions (7.16)] . risk summary based on findings from animal data, posaconazole may cause fetal harm when administered to pregnant women. available data for use of posaconazole 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 posaconazole 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 have not been established in pediatric patients younger than 2 years of age. 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. no overall differences in the safety of posaconazole injection 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 posaconazole were observed in geriatric patients compared to younger adult patients during clinical trials [see clinical pharmacology (12.3)] . of the 279 patients treated with posaconazole injection in the posaconazole injection study, 52 (19%) were greater than 65 years of age. of the 288 patients randomized to posaconazole injection 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. posaconazole injection should be avoided in patients with moderate or severe renal impairment (egfr <50 ml/min), unless an assessment of the benefit/risk to the patient justifies the use of posaconazole injection. in patients with moderate or severe renal impairment (egfr <50 ml/min), receiving the posaconazole injection, accumulation of the intravenous vehicle, sbecd, is expected to occur. serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to changing to oral noxafil therapy [see dosage and administration (2.9) and warnings and precautions (5.5)] . 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 noxafil oral suspension, noxafil delayed-release tablets, noxafil powdermix for delayed-release oral suspension, and posaconazole injection 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) ] . however, a specific study has not been conducted with, noxafil delayed-release tablets, noxafil powdermix for delayed-release oral suspension,  and posaconazole injection. 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.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole injection 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: 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 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 (5.10) and drug interactions (7.16) ]. risk summary based on findings from animal data, posaconazole may cause fetal harm when administered to pregnant women. available data for use of posaconazole 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 posaconazole 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 have not been established in pediatric patients younger than 2 years of age. 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. no overall differences in the safety of posaconazole injection was 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 posaconazole were observed in geriatric patients compared to younger adult patients during clinical trials [see clinical pharmacology (12.3) ]. of the 279 patients treated with posaconazole injection in the posaconazole injection study, 52 (19%) were greater than 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. posaconazole injection should be avoided in patients with moderate or severe renal impairment (egfr <50 ml/min), unless an assessment of the benefit/risk to the patient justifies the use of posaconazole injection. in patients with moderate or severe renal impairment (egfr <50 ml/min), receiving the posaconazole injection, accumulation of the intravenous vehicle, sbecd, is expected to occur. serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to changing to oral posaconazole therapy [see dosage and administration (2.9) and warnings and precautions (5.5) ]. 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 injection 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) ]. however, a specific study has not been conducted with posaconazole injection. the pharmacokinetics of posaconazole are comparable in males and females. no adjustment in the dosage of posaconazole injection is necessary based on gender. the pharmacokinetic profile of posaconazole is not significantly affected by race. no adjustment in the dosage of posaconazole injection 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 [see clinical pharmacology (12.3)].

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

i3 pharmaceuticals, llc - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole delayed-release tablets are 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 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 adm