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

united therapeutics corporation - dinutuximab (unii: 7sqy4zud30) (dinutuximab - unii:7sqy4zud30) - dinutuximab 3.5 mg in 1 ml - unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (gm-csf), interleukin-2 (il-2), and 13-cis-retinoic acid (ra), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see clinical studies (14)]. unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. risk summary based on its mechanism of action, unituxin may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk. monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. risk summary there is no information available on the presence of dinutuximab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. however, human igg is present in human milk. because of the potential for serious adverse reactions in a breastfed infant, advise a nursing woman to discontinue breastfeeding during treatment with unituxin. contraception females unituxin may cause fetal harm [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of unituxin. the safety and effectiveness of unituxin as part of multi-agent, multimodality therapy have been established in pediatric patients with high-risk neuroblastoma based on results of an open-label, randomized (1:1) trial conducted in 226 patients aged 11 months to 15 years (median age 3.8 years) (study 1). prior to enrollment, patients achieved at least a partial response to prior first-line therapy for high-risk neuroblastoma consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and received radiation therapy to residual soft tissue disease. patients randomized to the unituxin/13-cis-retinoic acid (ra) arm (unituxin/ra) received up to 5 cycles of unituxin in combination with alternating cycles of granulocyte-macrophage colony-stimulating factor (gm-csf) and interleukin-2 (il-2) plus ra, followed by 1 cycle of ra alone. patients randomized to the ra arm received up to 6 cycles of ra monotherapy. study 1 demonstrated an improvement in event-free survival (efs) and overall survival (os) in patients in the unituxin/ra arm compared to those in the ra arm [see adverse reactions (6), clinical pharmacology (12), and clinical studies (14)] . juvenile animal toxicity data juvenile monkeys (13 to 18 months of age at study start) received dinutuximab daily via intravenous infusion for 4 consecutive days over five 28-day cycles at doses of 1, 3, or 10 mg/kg. monkeys also received morphine during infusion for pain management. at the high dose of 10 mg/kg (approximately equal to the 17.5 mg/m2 clinical dose), mild degeneration of nerve fibers in the brain (medulla oblongata) and moderate degeneration of nerve fibers in the spinal cord (cervical, thoracic, and lumbar) were present. mild neuronal and nerve fiber degeneration were also present in the dorsal root ganglia (cervical, thoracic, and lumbar). nerve fiber degeneration in the spinal cord and neuronal degeneration in dorsal root ganglia persisted 6 months after the end of dosing, though at lower severity. at the 10 mg/kg dose level, nerve conduction velocity (ncv) analysis showed motor and sensory ncv decreases of less than 10% compared to vehicle controls, starting on day 27 and continuing to day 83. sensory ncv decreases were still present at the end of the dosing period but were on a trend towards recovery 6 months after the end of dosing. the safety and effectiveness of unituxin in geriatric patients have not been established. unituxin has not been studied in patients with renal impairment. unituxin has not been studied in patients with hepatic impairment.

European Union - English - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastoma - antineoplastic agents - unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (asct). it is administered in combination with granulocyte-macrophage colony-stimulating factor (gm-csf), interleukin-2 (il-2), and isotretinoin.

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

united airlines - sodium monofluorophosphate (unii: c810jcz56q) (fluoride ion - unii:q80vpu408o) - fluoride ion 7.6 mg in 1 g - anticavity helps protect against cavities

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

united laboratories inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - anti-microbial hand sanitizer - helps reduce bacteria that potentially can cause disease - helps prevent cross contamination by hand contact - recommended for repeated use

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

unique biotech.,co.ltd - silicon dioxide (unii: etj7z6xbu4) (silicon dioxide - unii:etj7z6xbu4), .alpha.-tocopherol acetate (unii: 9e8x80d2l0) (.alpha.-tocopherol - unii:h4n855pnz1) - purpose: antibacterial and anticavity uses: - delivering all features including anti-plague, anti-septic & anti-bacterial properties, gingivitis, cavities reduction and mouth & gums.

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

star valley research, llc dba united sanitizer - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic health care personnel hand rub to help reduce bacteria that potentially can cause disease.

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

m d c care medicine trading l.l.c united states of america - 1 device unit (7314p) - device - device - n/a

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

m d c care medicine trading l.l.c united states of america - 1 device unit (7314p) - device - device - n/a

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

m d c care medicine trading l.l.c united states of america - 1 device unit (7314p) - device - device - n/a

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

m d c care medicine trading l.l.c united states of america - 1 device unit (7325p) - device - device - n/a