Philippines - English - FDA (Food And Drug Administration)

euro-health care exponents, inc.; importer: n/a; distributor: n/a - zinc (as gluconate) - chewable tablet (equivalent to 70 mg zinc gluconate) - 10 mg

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.2).,

Israel - English - Ministry of Health

amgen europe b.v. - blinatumomab - powder for concentrate for solution for infusion - blinatumomab 35 mcg / 1 vial - blinatumomab - • blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b- precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options.• blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b-cell precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b precursor all as part of the consolidation therapy.limitations of use: after failure of two previous treatments and with no cns involvement.

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

maia pharmaceuticals, inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults to: - stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. sincalide for injection is contraindicated in patients with: - a history of a hypersensitivity reaction to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)]. - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide for inj

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

fosun pharma usa inc - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults to: - stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. sincalide for injection is contraindicated in patients with: - a history of a hypersensitivity reaction to sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)]. - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide for

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)] .

Philippines - English - FDA (Food And Drug Administration)

euro-med labs phils inc - 0.9% sodium chloride - solution for intravenous infusion

Philippines - English - FDA (Food And Drug Administration)

euro-med labs phils inc - 10% dextrose in water parenteral solution - solution - 100mg

Philippines - English - FDA (Food And Drug Administration)

euro-med labs phils inc - 25% dextrose monohydrate - solution for injection iv

Philippines - English - FDA (Food And Drug Administration)

euro-med labs phils inc - 5% dextrose in lactated ringer's - solution for iv infusion