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

allergan, inc. - linaclotide (unii: n0txr0xr5x) (linaclotide - unii:n0txr0xr5x) - linaclotide 145 ug - linzess is indicated for the treatment of: • irritable bowel syndrome with constipation (ibs-c) in adults • chronic idiopathic constipation (cic) in adults • functional constipation (fc) in pediatric patients 6 to 17 years of age linzess is contraindicated in: - patients less than 2 years of age due to the risk of serious dehydration [see warnings and precautions ( 5.1 ), use in specific populations ( 8.4 )] . - patients with known or suspected mechanical gastrointestinal obstruction.  risk summary linaclotide and its active metabolite are negligibly absorbed systemically following oral administration [see clinical pharmacology ( 12.3 )] , and maternal use is not expected to result in fetal exposure to the drug. the available data on linzess use in pregnant women are not sufficient to inform any drug-associated risk for major birth defects and miscarriage. in animal developmental studies, no effects on embryo-fetal development were observed with oral administration of linaclotide in rats and rabbits during o

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

amgen inc - blinatumomab (unii: 4fr53sif3a) (blinatumomab - unii:4fr53sif3a) - blinatumomab 12.5 ug in 1 ml - blincyto is indicated for the treatment of cd19-positive b-cell precursor acute lymphoblastic leukemia (all) in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1% in adult and pediatric patients. blincyto is indicated for the treatment of relapsed or refractory cd19-positive b-cell precursor acute lymphoblastic leukemia (all) in adult and pediatric patients. blincyto is contraindicated in patients with known hypersensitivity to blinatumomab or to any component of the product formulation. risk summary based on its mechanism of action, blincyto may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of blincyto in pregnant women to evaluate for a drug-associated risk. in animal reproduction studies, a murine surrogate molecule administered to pregnant mice crossed the placental barrier (see data) . blinatumomab causes t-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. in addition, based on expression of cd19 on b-cells and the finding of b-cell depletion in non-pregnant animals, blinatumomab can cause b-cell lymphocytopenia in infants exposed to blinatumomab in-utero. advise pregnant women of the potential risk to a fetus. 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. clinical considerations fetal/neonatal adverse reactions due to the potential for b-cell lymphocytopenia in infants following exposure to blincyto in utero , the infant's b lymphocytes should be monitored before the initiation of live virus vaccination [see warnings and precautions (5.11)] . data animal data animal reproduction studies have not been conducted with blinatumomab. in embryo-fetal developmental toxicity studies, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis. the surrogate molecule crossed the placental barrier and did not cause embryo-fetal toxicity or teratogenicity. the expected depletions of b and t cells were observed in the pregnant mice, but hematological effects were not assessed in fetuses. risk summary there is no information regarding the presence of blinatumomab in human milk, the effects on the breastfed infant, or the effects on milk production. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from blincyto, including b-cell lymphocytopenia, advise patients not to breastfeed during treatment with blincyto and for 48 hours after the last dose. blincyto may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating blincyto treatment. contraception females advise females of reproductive potential to use effective contraception during treatment with blincyto and for 48 hours after the last dose. minimal residual disease (mrd)-positive b-cell precursor all the safety and efficacy of blincyto for the treatment of cd19-positive b-cell precursor acute lymphoblastic leukemia (all) in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1% have been established in pediatric patients. use of blincyto is supported by evidence from two randomized, controlled trials (study aall1331 nct02101853 and study 20120215 nct02393859) in pediatric subjects with first relapsed b-cell precursor all. both studies included pediatric patients with mrd-positive b-cell precursor all. the studies included pediatric patients treated with blincyto in the following age groups: 6 infants (1 month up to less than 2 years), 165 children (2 years up to less than 12 years), and 70 adolescents (12 years to less than 17 years). in general, the adverse reactions in blincyto-treated pediatric patients were similar in type to those seen in adult patients with mrd-positive all [see adverse reactions (6.1)] , and no differences in safety were observed between the different pediatric age subgroups. relapsed or refractory b-cell precursor all the safety and efficacy of blincyto have been established in pediatric patients with relapsed or refractory b-cell precursor all. use of blincyto is supported by a single-arm trial in pediatric patients with relapsed or refractory b-cell precursor all. this study included pediatric patients in the following age groups: 10 infants (1 month up to less than 2 years), 40 children (2 years up to less than 12 years), and 20 adolescents (12 years to less than 18 years). no differences in efficacy were observed between the different age subgroups [see clinical studies (14.2)] . in general, the adverse reactions in blincyto-treated pediatric patients with relapsed or refractory all were similar in type to those seen in adult patients with relapsed or refractory b-cell precursor all [see adverse reactions (6.1)] . adverse reactions that were observed more frequently (≥ 10% difference) in the pediatric population compared to the adult population were pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs. 24%), infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%), leukopenia (24% vs. 11%), and weight increased (17% vs. 6%). in pediatric patients less than 2 years old (infants) with relapsed or refractory all, the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (17%). benzyl alcohol toxicity in neonates serious and fatal adverse reactions, including "gasping syndrome," can occur in very low birth weight (vlbw) neonates born weighing less than 1500 g, and early preterm neonates (infants born less than 34 weeks gestational age) treated with benzyl alcohol-preserved drugs intravenously. the "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high concentrations of benzyl alcohol and its metabolite in the blood and urine (blood concentration of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. the minimum amount of benzyl alcohol at which serious adverse reactions may occur in neonates is not known [see warnings and precautions (5.12)] . use the preservative-free formulations of blincyto where possible in neonates. when prescribing blincyto (with preservative) in neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including blincyto (with preservative). the blincyto 7-day bag (with preservative) contains 7.4 mg of benzyl alcohol per ml [see warnings and precautions (5.12)] . benzyl alcohol administration may contribute to metabolic acidosis in pediatric patients, particularly those with immaturity of the metabolic pathway for alcohol, or those with underlying conditions or receiving concomitant medications that could predispose to acid base imbalance. monitor these patients during use of blincyto (with preservative) for new or worsening metabolic acidosis. of the total number of patients with all treated in clinical studies of blincyto, approximately 12% were 65 and over, while 2% were 75 and older. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. however, elderly patients experienced a higher rate of serious infections and neurological toxicities, including cognitive disorder, encephalopathy, and confusion [see warnings and precautions (5.2, 5.3)] .

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

bausch & lomb incorporated - benoxinate hydrochloride (unii: 0ve4u49k15) (benoxinate - unii:axq0jym303), fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir) - benoxinate hydrochloride 4 mg in 1 ml - for procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures. known hypersensitivity to any component of this product. prolonged use of a topical ocular anesthetic is not recommended. it may produce permanent corneal opacification with accompanying visual loss.

Canada - English - Health Canada

aa pharma inc - pinaverium bromide - tablet - 50mg - pinaverium bromide 50mg - miscellaneous gi drugs

Canada - English - Health Canada

aa pharma inc - pinaverium bromide - tablet - 100mg - pinaverium bromide 100mg - miscellaneous gi drugs

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

altaire pharmaceuticals inc. - benoxinate hydrochloride (unii: 0ve4u49k15) (benoxinate - unii:axq0jym303), fluorescein sodium (unii: 93x55pe38x) (fluorescein - unii:tpy09g7xir) - benoxinate hydrochloride 4 mg in 1 ml - altafluor benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. altafluor benox is contraindicated in patients with known hypersensitivity to any component of this product. risk summary   there are no available data on the use of altafluor benox in pregnant women to inform any drug associated risk. adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. altafluor benox should be given to a pregnant woman only if clearly needed. risk summary    there are no data on the presence of fluorescein sodium or benoxinate hydrochloride in human milk after ocular administration of altafluor benox, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for altafluor benox a

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

amgen australia pty ltd - blinatumomab, quantity: 38.5 microgram/g - injection, solution - excipient ingredients: citric acid monohydrate; lysine hydrochloride; polysorbate 80; sodium hydroxide; water for injections - blincyto is indicated for the treatment of relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).,blincyto is indicated for the treatment of minimal residual disease (mrd) positive b-cell precursor acute lymphoblastic leukaemia (all) in patients in complete haematological remission.,note to indication: the indications in philadelphia positive, mrd positive and paediatric patients were approved based on phase ii, non-randomised evidence. an improvement in clinical outcomes by direct prospective comparison in a randomised setting relative to other standard-of-care salvage therapies has not been established.

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

merz australia pty ltd - incobotulinumtoxina, quantity: 100 u - injection, powder for - excipient ingredients: albumin; sucrose - xeomin is indicated in adults for the treatment of:,? cervical dystonia (spasmodic torticollis),? blepharospasm,? spasticity of the upper limb,? chronic sialorrhea due to neurological disorders,? upper facial lines,- glabellar frown lines,- lateral periorbital lines (crow?s feet),- horizontal forehead lines,xeomin is indicated in children and adolescents aged 2 years to 17 years for the symptomatic treatment of:,? chronic sialorrhea due to neurological/neurodevelopmental disorders,? spasticity of the lower and/or upper limbs

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

merz australia pty ltd - incobotulinumtoxina, quantity: 50 u - injection, powder for - excipient ingredients: albumin; sucrose - xeomin is indicated in adults for the treatment of:,? cervical dystonia (spasmodic torticollis),? blepharospasm,? spasticity of the upper limb,? chronic sialorrhea due to neurological disorders,? upper facial lines,- glabellar frown lines,- lateral periorbital lines (crow?s feet),- horizontal forehead lines,xeomin is indicated in children and adolescents aged 2 years to 17 years for the symptomatic treatment of:,? chronic sialorrhea due to neurological/neurodevelopmental disorders,? spasticity of the lower and/or upper limbs

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

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 1000 mg - solution - excipient ingredients: monobasic sodium phosphate; alanine; water for injections - prolastin? c liquid is an alpha-1-proteinase inhibitor indicated to increase serum alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1-antitrypsin and with clinically significant emphysema (fev1 <80%).,the data for clinical efficacy of prolastin? c liquid is derived from changes in the biomarkers alpha-1 anti-protease level and ct lung density. efficacy on fev1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials.,clinical trials have only included patients who were not smoking.