Filipine - engleză - FDA (Food And Drug Administration)

euro-health care exponents, inc.; distributor: vitalink health product inc. - vitamin b-complex - solution for injection (im/iv) - formulation each 2ml amploule contains: thiamine hydrochloride (vitamin b1) bp..100mg pyridoxine hydrochloride (vitamin b5) bp...100mg cyanocobalamin (vitamin b12) bp...1000mcg nicotinamide bp..100mg dexpanthenol bp..50mg

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

parke-davis div of pfizer inc - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - neurontin® is indicated for: neurontin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as neurontin, during pregnancy. encourage women who are taking neurontin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of neurontin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically [see data]. in the u.s. general population, the estimated background

Uniunea Europeană - engleză - 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 - engleză - 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.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

bracco diagnostics inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide 5 ug in 5 ml - kinevac is indicated in adults to: - 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; - to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - to 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. kinevac is contraindicated in patients with: - a history of hypersensitivity 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 may cause preterm labor or spontaneous

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

laboratoire aguettant - zinc gluconate trihydrate (unii: f2f0xu34wq) (zinc cation - unii:13s1s8sf37) - zinc cation 1 mg in 1 ml

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

moberg pharma north america llc - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) - zinc oxide .113 g in 1 g - - helps relieve and prevent rashes and irritation due to wetness from incontinence - protects chafed skin due to irritation and helps seal out wetness

Statele Unite ale Americii - engleză - 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)] .

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

nature's care manufacture pty limited - natural fish oil, quantity: 1000 mg (equivalent: eicosapentaenoic acid, qty 180 mg; equivalent: docosahexaenoic acid, qty 120 mg); euphausia superba oil, quantity: 50 mg - capsule, soft - excipient ingredients: purified water; glycerol; gelatin - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support healthy eye function ; maintain/support eye health ; maintain/support general health and wellbeing ; anti-inflammatory/relieve inflammation ; decrease/reduce/relieve symptoms of mild arthritis/mild osteoarthritis ; maintain/support joint health ; decrease/reduce/relieve mild joint inflammation/swelling ; helps in the maintenance of healthy blood lipids/blood fats ; maintain/support cardiovascular system health ; maintain/support brain function ; maintain/support brain health ; maintain/support nervous system health

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

nature's care manufacture pty limited - manganese amino acid chelate, quantity: 40 mg (equivalent: manganese, qty 4 mg); colecalciferol, quantity: 0.0025 mg; pyridoxine hydrochloride, quantity: 50 mg (equivalent: pyridoxine, qty 41 mg); heavy magnesium oxide, quantity: 440 mg (equivalent: magnesium, qty 265 mg); calcium ascorbate dihydrate, quantity: 250 mg; magnesium phosphate pentahydrate, quantity: 175 mg (equivalent: magnesium, qty 35 mg) - capsule, hard - excipient ingredients: colloidal anhydrous silica; povidone; magnesium stearate; microcrystalline cellulose; maize starch; silicon dioxide; dl-alpha-tocopherol; sucrose; hydrolysed gelatin; hydrogenated soya oil; purified water; gelatin - maintain/support energy production ; maintain/support cardiovascular system health ; decrease/reduce/relieve muscle cramps ; helps decrease/reduce/relieve mild muscle spasms/twitches ; maintain/support muscle health ; maintain/support muscle function ; enhance/improve/promote/increase muscle relaxation ; maintain/support healthy neuromuscular system/function ; helps enhance/promote/increase absorption of dietary (state vitamin/mineral/nutrient) ; enhance/improve/promote/increase (state vitamin/mineral/nutrient) levels in the body ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; helps enhance/promote/increase body utilisation of (state mineral/vitamin/nutrient) ; maintain/support neuromuscular function ; maintain/support nervous system health ; maintain/support nervous system function