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

forest pharmaceuticals, inc. - flunisolide hemihydrate (unii: qk4dys664x) (flunisolide - unii:qk4dys664x) - aerosol, metered - 80 ug - aerospan inhalation aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. aerospan inhalation aerosol is also indicated for asthma patients requiring oral corticosteroid therapy, where adding aerospan inhalation aerosol may reduce or eliminate the need for oral corticosteroids. aerospan inhalation aerosol is not indicated for the relief of acute bronchospasm. aerospan inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. hypersensitivity to flunisolide or any of the ingredients of this preparation contraindicates the use of aerospan inhalation aerosol.

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

baxalta us inc. - pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - pegaspargase 750 [iu] in 1 ml - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with all. oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of l-asparaginase. oncaspar is contraindicated in patients with a: - history of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients [see warnings and precautions (5.1)] . - history of serious thrombosis with prior l-asparaginase therapy [see warnings and precautions (5.2)] . - history of pancreatitis, including pancreatitis related to prior l-asparaginase therapy [see warnings and precautions (5.3)] . - history of serious hemorrhagic events with prior l-asparaginase therapy [see warnings and precautions (5.5)] . - severe hepatic impairment [see warnings and precautions (5.6)] . risk summary there are no available data on the use of oncaspar i

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

servier pharmaceuticals llc - pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with all. oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of l-asparaginase. oncaspar is contraindicated in patients with a: - history of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients [see warnings and precautions (5.1)] . - history of serious thrombosis with prior l-asparaginase therapy [see warnings and precautions (5.2)] . - history of pancreatitis, including pancreatitis related to prior l-asparaginase therapy [see warnings and precautions (5.3)] . - history of serious hemorrhagic events with prior l-asparaginase therapy [see warnings and precautions (5.5)] . - severe hepatic impairment [see warnings and precautions (5.6)] . risk summary based on published literature studies with l-asparaginase in pregnant animals, oncaspar can cause fetal harm when administered to a pregnant woman. there are no available data on oncaspar use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. published literature studies in pregnant animals suggest asparagine depletion may cause harm to the animal offspring (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. data animal data animal reproduction studies have not been conducted with oncaspar to evaluate its effect on reproduction and fetal development. published literature studies in which pregnant rabbits were administered l-asparaginase or pregnant rats were deprived of dietary asparagine suggested harm to the animal offspring. risk summary there are no data on the presence of pegaspargase in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with oncaspar and for 1 month after the last dose. oncaspar can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy pregnancy testing is recommended in females of reproductive potential prior to initiating oncaspar. contraception advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with oncaspar and for 3 months after the last dose. the safety and effectiveness of oncaspar in the treatment of all have been established in pediatric patients. use of oncaspar in these age groups is supported by evidence of efficacy as first-line treatment from one adequate and well-controlled trial, and evidence of efficacy for treatment of patients with hypersensitivity to asparaginase from four adequate and well-controlled trials [see clinical studies (14.1)] , and safety data from 7 total trials. the pediatric patients treated with oncaspar 2,500 international units/m2 on these trials included 26 infants (1 month to <2 years old), 165 children (2 years to <12 years old), and 39 adolescents (12 to 17 years old). clinical studies of oncaspar did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.

European Union - English - EMA (European Medicines Agency)

les laboratoires servier - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

European Union - English - EMA (European Medicines Agency)

astellas pharma europe b.v. - gilteritinib fumarate - leukemia, myeloid, acute - antineoplastic agents - xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (aml) with a flt3 mutation.,

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

zydus pharmaceuticals (usa) inc. - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd). the efficacy of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in the treatment of adhd was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met dsm-iv® criteria for adhd [see clinical studies (14)]. a diagnosis of adhd (dsm-iv®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accou

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

bryant ranch prepack - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd). the efficacy of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules in the treatment of adhd was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met dsm-iv® criteria for adhd [see clinical studies (14)]. a diagnosis of adhd (dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better a

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - luspatercept - powder for solution for injection - luspatercept 25 mg - luspatercept - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non-transfusion-dependent beta-thalassaemia

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - luspatercept - powder for solution for injection - luspatercept 75 mg - luspatercept - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non-transfusion-dependent beta-thalassaemia

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

mylan pharmaceuticals inc. - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate (unii: h527kap6l5) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate 1.25 mg - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful.