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octapharma ab - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 50 mg in 1 ml - octagam is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (pi), such as congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome and severe combined immunodeficiencies. octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin. octagam 5% liquid contains trace amounts of iga (not more than 0.2 mg/ml in a 5% solution). it is contraindicated in iga deficient patients with antibodies against iga and history of hypersensitivity (see description [11]). octagam 5% liquid is contraindicated in patients with acute hypersensitivity reaction to corn. octagam 5% liquid contains maltose, a disaccharide sugar which is derived from corn. patients known to have corn allergies should avoid using octagam 5% liquid. pregnancy category c. animal reproduction studies have not been conducted with octagam 5% liquid. it is also not known whether o

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csl behring llc - coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t) - coagulation factor ix human 500 [iu] in 5 ml - mononine is indicated for the prevention and control of bleeding in factor ix deficiency, also known as hemophilia b or christmas disease. mononine is not indicated in the treatment or prophylaxis of hemophilia a patients with inhibitors to factor viii. mononine contains non-detectable levels of factors ii, vii and x (<0.0025 iu per factor ix unit using standard coagulation assays) and is, therefore, not indicated for replacement therapy of these clotting factors. mononine is also not indicated in the treatment or reversal of coumarin-induced anticoagulation or in a hemorrhagic state caused by hepatitis-induced lack of production of liver dependent coagulation factors. known hypersensitivity to mouse protein is a contraindication to mononine.

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csl behring ag - human rho(d) immune globulin (unii: 48w7181flp) (human rho(d) immune globulin - unii:48w7181flp) - human rho(d) immune globulin 1500 [iu] in 2 ml - rhophylac is a rh(d) immune globulin intravenous (human) (anti-d) product that is indicated for the suppression of rh isoimmunization in non-sensitized rh(d)-negative patients and for the treatment of immune thrombocytopenic purpura (itp) in rh(d)-positive patients. pregnancy and obstetric conditions rhophylac is indicated for suppression of rhesus (rh) isoimmunization in non-sensitized rh(d)-negative women with an rh-incompatible pregnancy, including: - routine antepartum and postpartum rh prophylaxis - rh prophylaxis in cases of: – obstetric complications (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage) – invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma) an rh-incompatible pregnancy is assumed if the fetus/baby is either rh(d)-positive or rh(d)-unknown or if the father is either rh(d)-positive or r

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merck sharp & dohme llc - human papillomavirus type 6 l1 capsid protein antigen (unii: 61746o90dy) (human papillomavirus type 6 l1 capsid protein antigen - unii:61746o90dy), human papillomavirus type 11 l1 capsid protein antigen (unii: z845vhq61p) (human papillomavirus type 11 l1 capsid protein antigen - unii:z845vhq61p), human papillomavirus type 16 l1 capsid protein antigen (unii: 6lte2dnx63) (human papillomavirus type 16 l1 capsid protein antigen - unii:6lte2dnx63), human papillomavirus type 18 l1 capsid protein antigen (unii: - human papillomavirus type 6 l1 capsid protein antigen 20 ug in 0.5 ml - gardasil® is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by human papillomavirus (hpv) types included in the vaccine: - cervical, vulvar, vaginal, and anal cancer caused by hpv types 16 and 18 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following precancerous or dysplastic lesions caused by hpv types 6, 11, 16, and 18: - cervical intraepithelial neoplasia (cin) grade 2/3 and cervical adenocarcinoma in situ (ais) - cervical intraepithelial neoplasia (cin) grade 1 - vulvar intraepithelial neoplasia (vin) grade 2 and grade 3 - vaginal intraepithelial neoplasia (vain) grade 2 and grade 3 - anal intraepithelial neoplasia (ain) grades 1, 2, and 3 gardasil is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by hpv types included in the vaccine: - anal cancer caused by hpv types 16 and 18 - genital warts (condyloma acuminata) caused by hpv types 6 and

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adma biologics, inc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 1560 [iu] in 5 ml - indications and usage nabi-hb, hepatitis b immune globulin (human), is indicated for treatment of acute exposure to blood containing hbsag, perinatal exposure of infants born to hbsag-positive mothers, sexual exposure to hbsag-positive persons and household exposure to persons with acute hbv infection in the following settings: acute exposure to blood containing hbsag following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving hbsag-positive materials such as blood, plasma, or serum. perinatal exposure of infants born to hbsag-positive mothers infants born to mothers positive for hbsag with or without hbeag12. sexual exposure to hbsag-positive persons sexual partners of hbsag-positive persons. household exposure to persons with acute hbv infection infants less than 12 months old whose mother or primary caregiver is positive for hbsag. other household contacts with an identifiable blood exposure to the i

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takeda pharmaceuticals america, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 100 mg in 1 ml - hyqvia is an immune globulin infusion 10% (human) with a recombinant human hyaluronidase (rhuph20) indicated for the treatment of primary immunodeficiency (pi) in adults and pediatric patients two years of age and older. this includes, but is not limited to, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.1,2 hyqvia is indicated for the treatment of chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. hyqvia is contraindicated in: - patients who have had a history of anaphylactic or severe systemic reactions to the administration of igg. - iga deficient patients with antibodies to iga and a history of hypersensitivity. - patients with known systemic hypersensitivity to hyaluronidase including rhuph20 of hyqvia. - patients with known systemic hypersensitivity to human albumin (in the hyaluronidase solution)]. risk summary limited human data are available to assess the presence or absence of drug-associated risk in pregnancy. in a postmarketing pregnancy study, two out of 5 infants born to mothers taking hyqvia during pregnancy had congenital abnormalities (1 cleft lip and 1 talipes calcaneovalgus). animal reproduction studies have not been conducted with the immune globulin infusion 10% (human) component of hyqvia. immune globulins increasingly cross the placenta from maternal circulation after 30 weeks of gestation. there was no evidence of teratogenicity in animal studies for rhuph20, (a component of hyqvia). the effects of antibodies to the rhuph20 on the human embryo or fetal development are unknown. it is not known whether hyqvia can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. hyqvia should be given to a pregnant woman only if clearly needed. the estimated 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data: nine women treated with hyqvia were enrolled in a prospective, uncontrolled, open-label, multicenter post-authorization pregnancy registry. seven mothers continued hyqvia, and two mothers were treated with immune globulin other than hyqvia during the pregnancy. one mother discontinued from the registry before the expected delivery. of the eight pregnancies with known outcomes, there were eight live births. there were no specified labor or delivery complications. two out of 5 infants whose mothers took hyqvia during pregnancy had congenital abnormalities (cleft lip without cleft palate and talipes calcaneovalgus). data from the hyqvia pregnancy registry are insufficient to establish causality. the interpretation of the registry findings is limited by the small sample size, by the potential that selection bias may have increased enrollment of mothers of infants with congenital abnormalities, the absence of fetal outcomes in some exposed maternal-fetal pairs, and incomplete data on other potential etiologies. the following adverse events were identified in post-approval reports: spontaneous abortions and fetal deaths. the following congenital anomalies were identified in post-approval reports in infants whose mothers took hyqvia during pregnancy: cleft palate, atrial septal defect, ventricular septal defect, cleft lip, hypoplastic left heart syndrome (aortic atresia, mitral valve atresia), endocardial fibroelastosis, and tricuspid valve incompetence. because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. animal data: animal reproduction studies have not been conducted with immune globulin infusion 10% (human) component of hyqvia. development and reproductive toxicology studies have been conducted with rhuph20 in mice and rabbits [see nonclinical toxicology (13.2)] . no adverse effects on pregnancy were associated with anti-rhuph20 antibodies at a dose of 3 mg/kg rhuph20 in mice, which is 4800 times higher than the typical monthly human dose. no teratogenicity or signs of maternal toxicity were observed at doses up to 18 mg/kg, which is 28,800 times higher than the typical monthly human dose. doses of 9 and 18 mg/kg (14,400 and 28,800 times higher than the typical monthly human dose) in mice were associated with reduced fetal weight and an increased number of fetal resorptions. in these studies, maternal antibodies to rhuph20 were transferred to offspring in utero. the effects of antibodies to the rhuph20 component of hyqvia on the human embryo or on human fetal development are unknown. risk summary it is not known whether hyqvia can cause harm to the breastfed infant when administered to a lactating woman. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hyqvia and any potential adverse effects on the breastfed infant from hyqvia or from the underlying maternal condition. data from the hyqvia pregnancy registry are insufficient to predict effects on the breastfed child from exposure to hyqvia through human milk. data animal data: in animal studies, maternal antibodies binding to rhuph20 were transferred to offspring during lactation. no adverse effects on pregnancy or offspring development were associated with anti-rhuph20 antibodies. the effects of antibodies that bind to rhuph20 of hyqvia transferred during human lactation are unknown. risk summary animal studies do not indicate direct or indirect harmful effects of (rhuph20) with respect to reproductive potential at the doses used for facilitating administration of ig 10% [see nonclinical toxicology (13.1)]. primary immunodeficiency (pi) the safety and effectiveness of hyqvia for the treatment of primary immunodeficiency have been established in pediatric patients 2 years and older. use of hyqvia for this indication is supported by evidence from the pivotal efficacy and safety study in 44 pediatric subjects (aged 2 to 16 years of age). results from pre-specified interim data analysis, where all subjects completed 12 months of participation (one year of observation period) in the study, indicated similar safety profiles to adults. no pediatric-specific dose requirements were necessary to achieve the desired serum igg levels. [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)]. safety and effectiveness of hyqvia has not been evaluated in patients <2 years of age. chronic inflammatory demyelinating polyneuropathy (cidp) the safety and effectiveness of hyqvia for the treatment of cidp have not been established in pediatric patients under the age of 18 years. primary immunodeficiency (pi) hyqvia was evaluated in 7 subjects over age 65 in the pi clinical trial. the available data are too limited to draw safety conclusions. chronic inflammatory demyelinating polyneuropathy hyqvia was evaluated in 13 subjects over age 65 in the pivotal clinical trial. no clinically significant differences in safety were observed between those 13 elderly subjects and the subjects 18 to 65 years of age. use caution when administering hyqvia to patients age 65 and over who are judged to be at increased risk of developing thrombosis and acute renal insufficiency [see boxed warning, warnings and precautions (5.2, 5.6)] . do not exceed recommended doses and administer hyqvia at the minimum dose and infusion rate practicable.

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aptevo biotherapeutics llc - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - human varicella-zoster immune globulin 125 [iu] - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. - there is no convincing evidence that varizig reduces the incidence of chickenpox infection after exposure to vzv. - there is no convincing evidence that established infections with vzv can be modified by varizig administration. - there is no indication for the prophylactic use of varizig in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone m

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sandoz inc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - vienvatm (levonorgestrel and ethinyl estradiol tablets, usp) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table ii lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year3 method (1) typical use1 (2) perfect use2 (3) (4) chance 4 85 85 spermicides 5 26 6 40 periodic abstinence 25 63 calendar 9 ovulation method 3 sympto-thermal 6 2 post-ovulation 1 cap7 parous women 40 26 42 nulliparous women 20 9 56 sponge parous women 40 20 42 nulliparous women 20 9 56 diaphragm7 20 6 56 withdrawal 19 4 c

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grifols usa, llc - factor ix complex (unii: fw411qxd5m) (factor ix complex - unii:fw411qxd5m) - factor ix complex 500 [iu] in 5 ml - profilnine, factor ix complex, is indicated for the prevention and control of bleeding in patients with factor ix deficiency (hemophilia b). profilnine contains non-therapeutic levels of factor vii and is not indicated for use in the treatment of factor vii deficiency. none known.

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ge healthcare inc. - human albumin microspheres (unii: t8c6w1n6nw) (human albumin microspheres - unii:t8c6w1n6nw), perflutren (unii: ck0n3wh0sr) (perflutren - unii:ck0n3wh0sr) - human albumin microspheres 10 mg in 1 ml - optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. do not administer optison to patients with known or suspected hypersensitivity to perflutren or albumin [see warnings and precautions (5.5)] . risk summary there are no data with optison use in pregnant women to inform any drug-associated risks. no adverse developmental outcomes were observed in animal reproduction studies with intravenous administration of optison to pregnant rats and rabbits during organogenesis at doses up to at least 5 and 10 times the recommended human dose based on body surface area (see data ). 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 optison was administered intravenously to rats at doses of 0.25, 5 and 10 ml/kg/day (approximately 0.2, 5 and 10 times the recommended maximum human dose of 8.7 ml, respectively, based on body surface area) and to rabbits at 0.25, 2.5 and 5 ml/kg/day (approximately 0.5, 5 and 10 times the recommended maximum human dose, respectively, based on body surface area) during organogenesis. no significant findings attributable solely to a direct effect on the fetus were detected in the studies. there are no data on the presence of perflutren protein-type a microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for optison and any potential adverse effects on the breastfed infant from optison or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the total number of subjects in a clinical study of optison, 35% were 65 and over, while 14% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.