캐나다 - 영어 - Health Canada

genzyme corporation - alemtuzumab - solution - 10mg - alemtuzumab 10mg - antineoplastic agents

미국 - 영어 - NLM (National Library of Medicine)

genzyme corporation - autologous cultured chondrocytes (unii: d5p3k3v822) (autologous cultured chondrocytes - unii:d5p3k3v822) - autologous cultured chondrocytes 1.2e+007

미국 - 영어 - NLM (National Library of Medicine)

genzyme corporation - alglucosidase alfa (unii: dti67o9503) (alglucosidase alfa - unii:dti67o9503) - alglucosidase alfa 5 mg in 1 ml

미국 - 영어 - NLM (National Library of Medicine)

genzyme corporation - alglucosidase alfa (unii: dti67o9503) (alglucosidase alfa - unii:dti67o9503) - alglucosidase alfa 5 mg in 1 ml - lumizyme® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with pompe disease (acid α-glucosidase [gaa] deficiency). none. risk summary data from postmarketing reports and published case reports with alglucosidase alfa use in pregnant women have not identified a lumizyme-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. the continuation of treatment for pompe disease during pregnancy should be individualized to the pregnant woman. untreated pompe disease may result in worsening disease symptoms in pregnant women [see clinical considerations] . reproduction studies performed in mice and rabbits at doses resulting in exposures up to 0.4 or 0.5 times the human steady-state auc (area under the plasma concentration-time curve), respectively, during the period of organogenesis revealed no evidence of effects on embryo-fetal development. in mice there was an increase in pup mortality during lactation at maternal exposures 0.4 times the human steady-state auc [see data] . the background risk of major birth defects and miscarriage in the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. pregnant women and women of reproductive potential should be encouraged to enroll in the pompe patient registry. the registry will monitor the effect of lumizyme on pregnant women and their offspring. for more information, visit www.registrynxt.com or call 1-800-745-4447, extension 15500. clinical considerations disease-associated maternal and/or embryo-fetal risk untreated pompe disease has been associated with worsening respiratory and musculoskeletal symptoms in some pregnant women. data animal data all reproductive studies included pretreatment with diphenhydramine to prevent or minimize hypersensitivity reactions. the effects of alglucosidase alfa were evaluated based on comparison to a control group treated with diphenhydramine alone. daily intravenous administration of alglucosidase alfa up to 40 mg/kg in mice and rabbits (0.4 and 0.5 times the human steady-state auc, respectively, at the recommended biweekly dose) during the period of organogenesis had no effects on embryo-fetal development. administration of 40 mg/kg intravenously every other day in mice (0.4 times the human steady-state auc at the recommended biweekly dose) during the period of organogenesis through lactation produced an increase in mortality of offspring during the lactation period. risk summary available published literature suggests the presence of alglucosidase alfa in human milk. there are no reports of adverse effects of alglucosidase alfa on the breastfed infant. there is no information on the effects of alglucosidase alfa on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lumizyme and any potential adverse effects on the breastfed child from lumizyme or from the underlying maternal condition. lactating women with pompe disease treated with lumizyme should be encouraged to enroll in the pompe disease registry [see use in specific populations (8.1)] . clinical considerations a lactating woman may consider interrupting breastfeeding, pumping and discarding breast milk during treatment and for 24 hours after lumizyme administration in order to minimize drug exposure to a breastfed infant. the safety and effectiveness of alglucosidase alfa have been established in pediatric patients with pompe disease [see adverse reactions (6.2)] . the safety and effectiveness of alglucosidase alfa were assessed in 57 treatment-naive infantile-onset pompe disease patients, aged 0.2 month to 3.5 years at first infusion, in three separate clinical trials [see clinical studies (14.1)] . the safety and effectiveness of alglucosidase alfa were assessed in pediatric patients with late (non-infantile) onset pompe disease in a randomized, double-blind, placebo-controlled study in 90 patients, including 2 patients 16 years of age or less [see clinical studies (14.2)] . anaphylaxis, hypersensitivity reactions, and acute cardiorespiratory failure have occurred in pediatric patients [see boxed warning, warnings and precautions (5.1, 5.3)] . additionally, cardiac arrhythmia and sudden cardiac death have occurred in pediatric patients during general anesthesia for central venous catheter placement [see warnings and precautions (5.4)] . the randomized, double-blind, placebo-controlled study of alglucosidase alfa did not include sufficient numbers (n=4) of patients aged 65 years and over to determine whether they respond differently from younger patients [see clinical studies (14.1)] .

미국 - 영어 - NLM (National Library of Medicine)

genzyme corporation - alemtuzumab (unii: 3a189dh42v) (alemtuzumab - unii:3a189dh42v) - alemtuzumab 30 mg in 1 ml - campath is indicated as a single agent for the treatment of b-cell chronic lymphocytic leukemia (b-cll). none. risk summary based on findings from animal studies, campath may cause fetal harm when administered to a pregnant woman. available data from published cohort studies in pregnant women are insufficient to establish a campath-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. alemtuzumab was embryolethal in pregnant hucd52 transgenic mice when administered during organogenesis (see data) . human igg antibodies are known to cross the placental barrier; therefore, campath may be transmitted from the mother to the developing fetus. advise women of the potential risk to the fetus. infants born to pregnant women treated with campath may be at increased risk of infection (see clinical considerations) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other

미국 - 영어 - NLM (National Library of Medicine)

genzyme corporation - agalsidase beta (unii: rzd65tsm9u) (agalsidase beta - unii:rzd65tsm9u) - agalsidase beta 5 mg in 1 ml - fabrazyme® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed fabry disease. none. risk summary available data from a pregnancy sub-study within the fabry disease registry, post-marketing case reports, and case series with fabrazyme use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (see data). reproduction studies performed in rats at doses up to 68 times the human dose have revealed no evidence of effects on embryo-fetal development (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data available data from a pregnancy sub-study within the fabry disease registry, post-marketing case reports, and case series with fabrazyme use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in the fabry disease registry pregnancy sub-study, 33 pregnancies exposed to fabrazyme prior to or during pregnancy had a known outcome; 5 were reported as exposed in the first trimester. animal data the effects of agalsidase beta on embryo-fetal development in rats were evaluated at doses of 3, 10, and 30 mg/kg/day (up to 68 times the human dose of 1 mg/kg every 2 weeks on a body surface area basis) during gestation days 7 to 17. hepatocellular necrosis consistent with accumulation of test article was evident in maternal livers in the 10 and 30 mg/kg/day groups (23 and 68 times the human dose on a body surface area basis). there were no adverse effects of agalsidase beta on embryo-fetal development in rats. risk summary the available human data detected small amounts of agalsidase beta in human milk. available data from the clinical study, global pharmacovigilance database, and published scientific literature are insufficient to determine the effects of fabrazyme on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fabrazyme and any potential adverse effects on the breastfed child from fabrazyme or from the underlying maternal condition. the safety and effectiveness of fabrazyme have been established in pediatric patients based on adequate and well-controlled studies in adults, a single-arm, open-label study in 16 pediatric patients with fabry disease aged 8 to 16 years, and additional data in 24 patients with fabry disease aged 2 to 7 years [see clinical pharmacology (12.2) and clinical studies (14)] . the overall safety profile of fabrazyme was similar between the pediatric and the adult population [see adverse reactions (6.1) and clinical studies (14)] . clinical studies of fabrazyme did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

미국 - 영어 - NLM (National Library of Medicine)

genzyme corporation - lapine t-lymphocyte immune globulin (unii: d7rd81he4w) (lapine t-lymphocyte immune globulin - unii:d7rd81he4w) - lapine t-lymphocyte immune globulin 5 mg in 1 ml - thymoglobulin is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. thymoglobulin is to be used in conjunction with concomitant immunosuppression. thymoglobulin is contraindicated in patients with history of allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or who have active acute or chronic infections that contraindicate any additional immunosuppression [see warnings and precautions (5.2, 5.5) and adverse reactions (6.2)] . risk summary animal reproduction studies have not been conducted with thymoglobulin. it is also not known whether thymoglobulin can cause fetal harm. thymoglobulin should be given to a pregnant woman only if the benefit outweighs the risk. risk summary thymoglobulin has not been studied in nursing women. it is not known whether this drug is excreted in human milk. because other immunoglobulins are excreted in human milk, breastfeeding should be discontinued during thymoglobulin therapy. contracepti

미국 - 영어 - NLM (National Library of Medicine)

genzyme corporation - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine 1 mg in 1 ml

미국 - 영어 - NLM (National Library of Medicine)

genzyme corporation - plerixafor (unii: s915p5499n) (plerixafor - unii:s915p5499n) - plerixafor 24 mg in 1.2 ml

미국 - 영어 - NLM (National Library of Medicine)

genzyme corporation - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate 800 mg - renvela ® (sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. renvela is contraindicated in patients with bowel obstruction. renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. data animal data in pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin d, occurred in mid and