Malta - English - Medicines Authority

stada arzneimittel ag stadastraße 2-18, 61118 bad vilbel, germany - dutasteride - capsule - dutasteride 0.5 mg - urologicals

United States - English - NLM (National Library of Medicine)

alkermes, inc. - aripiprazole lauroxil (unii: b786j7a343) (aripiprazole lauroxil - unii:b786j7a343) - aristada initio, in combination with oral aripiprazole, is indicated for the initiation of aristada when used for the treatment of schizophrenia in adults. aristada initio is contraindicated in patients with a known hypersensitivity reaction to aripiprazole. hypersensitivity reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aristada initio during pregnancy. for more information, contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. limited published data on aripiprazole use in pregnant women are not sufficient to inform any drug-associated risks for birth defects or miscarriage. no teratogenicity was observed in animal reproductive studies with intramuscular administration of aripiprazole lauroxil to rats and rabbits during organogenesis at doses up to 8 and 23 times, respectively, the maximum recommended human dose (mrhd) of 675 mg based on body surface area (mg/m2 ). however, aripiprazole caused developmental toxicity and possible teratogenic effects in rats and rabbits [see data]. the background risk of major birth defects and miscarriage for the indicated population are 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. advise pregnant women of the potential risk to a fetus. clinical considerations fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. these symptoms have varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. some neonates recover within hours or days without specific treatment; others required prolonged hospitalization. data animal data for aristada (aripiprazole lauroxil) aripiprazole lauroxil did not cause adverse developmental or maternal effects in rats or rabbits when administered intramuscularly during the period of organogenesis at doses of 18, 49, or 144 mg/animal in pregnant rats which are approximately 1 to 8 times the mrhd of 675 mg based on mg/m2 , and at doses of 241, 723, and 2893 mg/animal in pregnant rabbits which are approximately 2 to 23 times the mrhd based on mg/m2 . however, aripiprazole caused developmental toxicity and possible teratogenic effects in rats and rabbits [see data below] . animal data for aripiprazole pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day which are approximately 1 to 10 times the oral mrhd of 30 mg/day based on mg/m2 of aripiprazole during the period of organogenesis. treatment at the highest dose caused a slight prolongation of gestation and delay in fetal development, as evidenced by decreased fetal weight, and undescended testes. delayed skeletal ossification was observed at 3 and 10 times the oral mrhd based on mg/m2 . at 3 and 10 times the oral mrhd based on mg/m2 , delivered offspring had decreased body weights. increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed in offspring from the highest dose group (the other dose groups were not examined for these findings). a low incidence of diaphragmatic hernia was also seen in the fetuses exposed to the highest dose. postnatally, delayed vaginal opening was seen at 3 and 10 times the oral mrhd based on mg/m2 and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) along with some maternal toxicity were seen at the highest dose; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. in pregnant rabbits treated with oral doses of 10, 30, and 100 mg/kg/day which are 2 to 11 times human exposure at the oral mrhd based on auc and 6 to 65 times the oral mrhd based on mg/m2 of aripiprazole during the period of organogenesis decreased maternal food consumption and increased abortions were seen at the highest dose as well as increased fetal mortality. decreased fetal weight and increased incidence of fused sternebrae were observed at 3 and 11 times the oral mrhd based on auc. in rats treated with oral doses of 3, 10, and 30 mg/kg/day which are 1 to 10 times the oral mrhd based on mg/m2 of aripiprazole perinatally and postnatally (from day 17 of gestation through day 21 postpartum), slight maternal toxicity and slightly prolonged gestation were seen at the highest dose. an increase in stillbirths and decreases in pup weight (persisting into adulthood) and survival were also seen at this dose. risk summary aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for aristada initio and any potential adverse effects on the breastfed infant from aristada initio or from the underlying maternal condition. safety and effectiveness of aristada initio in pediatric patients have not been established. safety and effectiveness of aristada initio in patients >65 years of age have not been evaluated. elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. aristada initio is not approved for the treatment of patients with dementia-related psychosis [see warnings and precautions (5.1, 5.2)]. approximately 8% of caucasians and 3-8% of black/african americans cannot metabolize cyp2d6 substrates and are classified as poor metabolizers (pm). avoid use of aristada initio in these patients because dosage adjustments are not possible (it is only available in one strength in a single-dose pre-filled syringe) [see dosage and administration (2.3), clinical pharmacology (12.3)] . no dosage adjustment for aristada initio is required based on a patient's hepatic function (mild to severe hepatic impairment, child-pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 ml/minute) [see clinical pharmacology (12.3)] . no dosage adjustment for aristada initio is required on the basis of a patient's sex, race, or smoking status [see clinical pharmacology (12.3)] .

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

stada pharmaceuticals australia pty ltd - anastrozole -

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

stada pharmaceuticals australia pty ltd - sildenafil citrate; sildenafil (as citrate) -

United States - English - NLM (National Library of Medicine)

alkermes, inc. - aripiprazole lauroxil (unii: b786j7a343) (aripiprazole lauroxil - unii:b786j7a343) - aripiprazole lauroxil 441 mg in 1.6 ml - aristada is indicated for the treatment of schizophrenia in adults [see clinical studies (14)]. aristada is contraindicated in patients with a known hypersensitivity reaction to aripiprazole. hypersensitivity reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aristada during pregnancy. for more information, contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. limited published data on aripiprazole use in pregnant women are not sufficient to inform any drug-associated risks for birth defects or miscarriage. no teratogenicity was observed in animal reproductive studies with intramuscular administration of aripiprazole lauroxil to rats and rabbits during organogenesis at doses up to 5 and 15 times, respectively, the maximum recommended human dose (mrhd) of 1064 mg based on body surface area (mg/m2 ). however, aripiprazole caused developmental toxicity and possible teratogenic effects in rats and rabbits [see data]. the background risk of major birth defects and miscarriage for the indicated population are 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. advise pregnant women of the potential risk to a fetus. clinical considerations fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. these symptoms have varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. some neonates recover within hours or days without specific treatment; others required prolonged hospitalization. data animal data for aripiprazole lauroxil aripiprazole lauroxil did not cause adverse developmental or maternal effects in rats or rabbits when administered intramuscularly during the period of organogenesis at doses of 18, 49, or 144 mg/animal in pregnant rats which are approximately 0.6 to 5 times the mrhd of 1064 mg on mg/m2 basis, and at doses of 241, 723, and 2893 mg/animal in pregnant rabbits which are approximately 1 to 15 times the mrhd on mg/m2 basis. however, aripiprazole caused developmental toxicity and possible teratogenic effects in rats and rabbits [see data below] . animal data for aripiprazole pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day which are approximately 1 to 10 times the oral mrhd of 30 mg/day on mg/m2 basis of aripiprazole during the period of organogenesis. treatment at the highest dose caused a slight prolongation of gestation and delay in fetal development, as evidenced by decreased fetal weight, and undescended testes. delayed skeletal ossification was observed at 3 and 10 times the oral mrhd on mg/m2 basis. at 3 and 10 times the oral mrhd on mg/m2 basis, delivered offspring had decreased body weights. increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed in offspring from the highest dose group (the other dose groups were not examined for these findings). a low incidence of diaphragmatic hernia was also seen in the fetuses exposed to the highest dose. postnatally, delayed vaginal opening was seen at 3 and 10 times the oral mrhd on mg/m2 basis and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) along with some maternal toxicity were seen at the highest dose; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. in pregnant rabbits treated with oral doses of 10, 30, and 100 mg/kg/day which are 2 to 11 times human exposure at the oral mrhd based on auc and 6 to 65 times the oral mrhd on mg/m2 basis of aripiprazole during the period of organogenesis decreased maternal food consumption and increased abortions were seen at the highest dose as well as increased fetal mortality. decreased fetal weight and increased incidence of fused sternebrae were observed at 3 and 11 times the oral mrhd based on auc. in rats treated with oral doses of 3, 10, and 30 mg/kg/day which are 1 to 10 times the oral mrhd on mg/m2 basis of aripiprazole perinatally and postnatally (from day 17 of gestation through day 21 postpartum), slight maternal toxicity and slightly prolonged gestation were seen at the highest dose. an increase in stillbirths and decreases in pup weight (persisting into adulthood) and survival were also seen at this dose. risk summary aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for aristada and any potential adverse effects on the breastfed infant from aristada or from the underlying maternal condition. safety and effectiveness of aristada in patients <18 years of age have not been evaluated. safety and effectiveness of aristada in patients >65 years of age have not been evaluated. elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. aristada is not approved for the treatment of patients with dementia-related psychosis [see warnings and precautions ( 5.1,  5.2)]. dosage adjustment is recommended in known cyp2d6 poor metabolizers due to high aripiprazole concentrations. approximately 8% of caucasians and 3-8% of black/african americans cannot metabolize cyp2d6 substrates and are classified as poor metabolizers (pm) [see dosage and administration ( 2.4), clinical pharmacology ( 12.3)] . no dosage adjustment for aristada is required based on a patient's hepatic function (mild to severe hepatic impairment, child-pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 ml/minute) [see clinical pharmacology ( 12.3)] . no dosage adjustment for aristada is required on the basis of a patient's sex, race, or smoking status [see clinical pharmacology ( 12.3)] .

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - nintedanib esylate - capsule, soft - nintedanib

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - nintedanib esylate - capsule, soft - nintedanib

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

medis pharma pty ltd - hydrochlorothiazide, quantity: 25 mg; irbesartan, quantity: 300 mg - tablet - excipient ingredients: colloidal anhydrous silica; hydrogenated castor oil; microcrystalline cellulose; maize starch; magnesium stearate; lactose monohydrate; croscarmellose sodium; povidone - stada irbesartan hct is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

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

medis pharma pty ltd - hydrochlorothiazide, quantity: 12.5 mg; irbesartan, quantity: 150 mg - tablet - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; povidone; microcrystalline cellulose; magnesium stearate; hydrogenated castor oil; maize starch; lactose monohydrate - stada irbesartan hct is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

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

medis pharma pty ltd - hydrochlorothiazide, quantity: 12.5 mg; irbesartan, quantity: 300 mg - tablet - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; povidone; hydrogenated castor oil; maize starch; magnesium stearate; lactose monohydrate; croscarmellose sodium - stada irbesartan hct is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.