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

cvs - petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u) - petrolatum 600 mg in 1 g

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

henry schein, inc. - petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u) - petrolatum 1 g in 1 g - purpose: skin protectant temporarily protects minor cuts, scrapes, and burns. temporarily protects and helps chapped or cracked skin and lips.  helps protect lips from drying effects fo wind and cold weather.

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

cvs - petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u), lanolin (unii: 7ev65eaw6h) (lanolin - unii:7ev65eaw6h) - petrolatum 534 mg in 1 g

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

riteaid - petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u), lanolin (unii: 7ev65eaw6h) (lanolin - unii:7ev65eaw6h) - petrolatum .534 g in 1 g

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

cvs - petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u), lanolin (unii: 7ev65eaw6h) (lanolin - unii:7ev65eaw6h) - petrolatum .534 g in 1 g

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)] .

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.

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

eli lilly and company - olaratumab (unii: tt6hn20mvf) (olaratumab - unii:tt6hn20mvf) - olaratumab 10 mg in 1 ml - lartruvo™ is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (sts) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. this indication is approved under accelerated approval [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. none. risk summary based on animal data and its mechanism of action, lartruvo can cause fetal harm [see clinical pharmacology (12.1)]. there are no available data on lartruvo use in pregnant women. no animal studies using olaratumab have been conducted to evaluate its effect on female reproduction and embryo-fetal development. animal knockout models link disruption of platelet-derived growth factor receptor alpha (pdgfr-α) signaling to adverse effects on embryo-fetal development. administration of an anti-

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

eli lilly and company - necitumumab (unii: 2bt4c47rui) (necitumumab - unii:2bt4c47rui) - necitumumab 16 mg in 1 ml - portrazza™ is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. portrazza is not indicated for treatment of non-squamous non-small cell lung cancer [see warnings and precautions (5.6) and clinical studies (14.2)] . none risk summary based on animal data and its mechanism of action, portrazza can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. disruption or depletion of egfr in animal models results in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development. the absence of egfr signaling has resulted in embryolethality as well as post-natal death in animals (see data) . no animal reproduction studies have been conducted with necitumumab. there are no available data for portrazza exposure in pregnant women. advise pregnant women of the potential risk to a fetus, and the risk to postnatal development. 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. data animal data no animal studies have been conducted to evaluate the effect of necitumumab on reproduction and fetal development; however, based on its mechanism of action, portrazza can cause fetal harm or developmental anomalies. in mice, egfr is critically important in reproductive and developmental processes including blastocyst implantation, placental development, and embryo-fetal/postnatal survival and development. reduction or elimination of embryo-fetal or maternal egfr signaling can prevent implantation, can cause embryo-fetal loss during various stages of gestation (through effects on placental development) and can cause developmental anomalies and early death in surviving fetuses. adverse developmental outcomes were observed in multiple organs in embryos/neonates of mice with disrupted egfr signaling. human igg1 is known to cross the placenta; therefore, necitumumab has the potential to be transmitted from the mother to the developing fetus. in monkeys, administration of a chimeric anti-egfr antibody that binds to an epitope overlapping that of necitumumab during the period of organogenesis resulted in detectable exposure of the antibody in the amniotic fluid and in the serum of embryos from treated dams. while no fetal malformations or other clear teratogenic effects occurred in offspring, there was an increased incidence of embryolethality and abortions. risk summary there is no information regarding the presence of necitumumab in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions in breastfed infants from portrazza, advise a nursing woman not to breastfeed during treatment with portrazza and for three months following the final dose. contraception females based on its mechanism of action, portrazza can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with portrazza and for three months following the final dose. the safety and effectiveness of portrazza have not been established in pediatric patients. of the 545 patients in the portrazza plus gemcitabine and cisplatin arm in study 1, 213 (39%) were 65 years and over, while 108 (20%) were 70 years and over. in an exploratory subgroup analysis of study 1, the hazard ratio for overall survival in patients 70 years or older was 1.03 (95% ci: 0.75, 1.42). of the adverse reactions listed in table 1 [see adverse reactions (6.1)] , there was a higher incidence (≥3%) of venous thromboembolic events including pulmonary embolism in patients age 70 and over compared to those who were younger than age 70. no formal studies have been conducted to evaluate the effect of renal impairment on the exposure to necitumumab. renal function has no influence on the exposure to necitumumab based on the population pharmacokinetic analysis of data from clinical trials [see clinical pharmacology (12.3)] . no formal studies have been conducted to evaluate the effect of hepatic impairment on the exposure to necitumumab. mild or moderate hepatic impairment has no influence on the exposure to necitumumab based on the population pharmacokinetic analysis. no patients with severe hepatic impairment were enrolled in the clinical trials with portrazza [see clinical pharmacology (12.3)] .

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

wal-mart stores, inc. - petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u) - petrolatum 100 g in 100 g - skin protectant - helps treat and prevent diaper rash - protects chafed skin due to diaper rash - helps seal out wetness - deep or puncture wounds - animal bites - serious burns - condition worsens - symptoms longer than 7 days or clear up and occur again within a few days