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kedrion biopharma, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 10 g in 100 ml - gammaked is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: gammaked is indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.(1-4) gammaked is indicated for the treatment of adults and children with idiopathic thrombocytopenic purpura to raise platelet counts to prevent bleeding or to allow a patient with itp to undergo surgery.(5,6) gammaked is indicated for the treatment of cidp in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. gammaked is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. gammaked is contraindicated in iga deficient patients with antibodies against iga and history of hyperse

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grifols usa, llc - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - human rabies virus immune globulin 150 [iu] in 1 ml - rabies vaccine and hyperrab s/d should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. hyperrab s/d should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the u.s. public health service advisory committee on immunization practices (acip). [19] every exposure to possible rabies infection must be individually evaluated. the following factors should be considered before specific antirabies treatment is initiated: carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies

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grifols usa, llc - human rho(d) immune globulin (unii: 48w7181flp) (human rho(d) immune globulin - unii:48w7181flp) - human rho(d) immune globulin 250 [iu] - hyperrho s/d mini-dose is recommended to prevent the isoimmunization of rho (d) negative women at the time of spontaneous or induced abortion of up to 12 weeks’ gestation provided the following criteria are met: - the mother must be rho (d) negative and must not already be sensitized to the rho (d) antigen.  the mother must be rho (d) negative and must not already be sensitized to the rho (d) antigen.  - the father is not known to be rho (d) negative. the father is not known to be rho (d) negative. - gestation is not more than 12 weeks at termination. gestation is not more than 12 weeks at termination. note: rho (d) immune globulin (human) prophylaxis is not indicated if the fetus or father can be determined to be rh negative. if the rh status of the fetus is unknown, the fetus must be assumed to be rho (d) positive, and hyperrho s/d mini-dose should be administered to the mother. for abortions or miscarriages occurring after 12 weeks’ gestation, a standard dose of rho (d) immune globulin (human) is i

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grifols usa, llc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 220 [iu] in 1 ml - recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future hbv exposure for the person requiring treatment. in all exposures, a regimen combining hepatitis b immune globulin (human) with hepatitis b vaccine will provide both short- and long-term protection, will be less costly than the two-dose hepatitis b immune globulin (human) treatment alone, and is the treatment of choice.(9) hyperhep b  is indicated for post-exposure prophylaxis in the following situations: after either parenteral exposure, e.g., by accidental “needlestick” or direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident) involving hbsag-positive materials such as blood, plasma or serum. for inadvertent percutaneous exposure, a regimen of two doses of hepatitis b immune globulin (human), one given after exposure and one a month later, is about 75% effective in preventing hepatitis b in this setting. infants born to hbsag-positive mothers are at risk of be

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adma biologics, inc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 5 g in 50 ml - bivigam is an immune globulin intravenous (human), 10% liquid, indicated for the treatment of patients with primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. - bivigam is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. - bivigam is contraindicated in iga deficiency patients with antibodies to iga and a history of hypersensitivity. pregnancy category c. animal reproduction studies have not been conducted with bivigam. it is not known whether bivigam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. bivigam should be given to pregnant women only if clearly needed.17,18 use of bivigam in nursing mothers has not been evaluated. bivigam should be giv

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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 - gammagard liquid is indicated as replacement therapy for primary humoral immunodeficiency (pi) in adult and pediatric patients two years of age or 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 gammagard liquid is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with multifocal motor neuropathy (mmn). gammagard liquid is indicated as a therapy to improve neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy (cidp). limitation of use gammagard liquid has not been studied in immunoglobulin-naive patients with cidp. gammagard liquid maintenance therapy in cidp has not been studied for periods longer than 6 months. after responding during an initial treatment period, not all patients require indefinite maintenance therapy with gammagard liquid in order to remain free of cidp symptoms. individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy. gammagard liquid is contraindicated in patients who have a history of anaphylactic or severe systemic hypersensitivity reactions to administration of human immune globulin. gammagard liquid is contraindicated in iga-deficient patients with antibodies to iga and a history of hypersensitivity. anaphylaxis has been reported with intravenous use of gammagard liquid and is theoretically possible following subcutaneous administration [see warnings and precautions (5.1)] . risk summary animal reproduction studies have not been conducted with gammagard liquid. it is not known whether gammagard liquid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. gammagard liquid should be given to a pregnant woman only if clearly indicated. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. risk summary there is no information regarding the presence of gammagard liquid in human milk, its effects on the breastfed infant or its effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gammagard liquid and any potential adverse effects on the breastfed infant from gammagard liquid or from the underlying maternal condition. treatment of primary immunodeficiency (pi) gammagard liquid administered intravenously was evaluated in 15 pediatric subjects with pi (7 subjects aged 2 to <12 years and 8 subjects aged 12 to <16 years) in a multicenter clinical study. gammagard liquid administered subcutaneously was evaluated in 18 pediatric subjects with pi (14 subjects aged 2 to <12 years and 4 subject aged 12 to <16 years) in another multicenter clinical study. the safety and efficacy profiles were similar to adult subjects. no pediatric-specific dose requirements were necessary to achieve the desired serum igg levels. safety and efficacy of gammagard liquid in pediatric patients below the age of 2 have not been established. treatment of multifocal motor neuropathy (mmn) and chronic inflammatory demyelinating polyneuropathy (cidp) safety and effectiveness in pediatric patients with mmn and cidp have not been established. treatment of primary immunodeficiency (pi) limited information is available for the geriatric use of gammagard liquid. gammagard liquid administered intravenously and subcutaneously was evaluated in two pi studies with a total of 8 subjects over the age of 65 years. no differences in safety or efficacy were observed for this group. monitor patients who are at an increased risk for developing renal failure or thrombotic events. do not exceed the recommended dose. infuse at the minimum intravenous infusion rate practicable [see boxed warning, warnings and precautions (5.2, 5.4) and dosage and administration (2.5)] . treatment of multifocal motor neuropathy (mmn) gammagard liquid was administered intravenously for treatment of mmn in 5 subjects aged 65 years and above. there was an insufficient number of subjects aged 65 years and above to determine whether they respond differently from younger subjects [see boxed warning, warnings and precautions (5.2, 5.4) and dosage and administration (2.5)] . treatment of chronic inflammatory demyelinating polyneuropathy (cidp) gammagard liquid was administered intravenously for the treatment of cidp in 5 subjects aged 65 years and above and 15 subjects aged below 65 years. there was an insufficient number of subjects aged 65 years and above to determine whether they respond differently from younger subjects. [see boxed warning, warnings and precautions (5.2, 5.4) and dosage and administration (2.5)] .

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kedrion biopharma, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 1 g in 10 ml - bivigam is an immune globulin intravenous (human), 10% liquid, indicated for the treatment of patients with primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. - bivigam is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. - bivigam is contraindicated in iga deficiency patients with antibodies to iga and a history of hypersensitivity. pregnancy category c. animal reproduction studies have not been conducted with bivigam. it is not known whether bivigam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. bivigam should be given to pregnant women only if clearly needed.17,18 use of bivigam in nursing mothers has not been evaluated. bivigam should be given to nursing m

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apotheca company - human chorionic gonadotropin (unii: 20ed16gheb) (human chorionic gonadotropin - unii:20ed16gheb) - human chorionic gonadotropin 60 [hp_x] in 1 ml - indications:   supports weight loss by facilitating hormone functions and temporarily decreasing appetite. indications:   supports weight loss by facilitating hormone functions and temporarily decreasing appetite.

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mannkind corporation - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 4 - afrezza® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: - afrezza is not recommended for the treatment of diabetic ketoacidosis [see warning and precautions (5.6)] . - the safety and effectiveness of afrezza in patients who smoke have not been established. the use of afrezza is not recommended in patients who smoke or who have recently stopped smoking. afrezza is contraindicated: - during episodes of hypoglycemia [see warning and precautions (5.3)]. - chronic lung disease, such as asthma or chronic obstructive pulmonary disease (copd), because of the risk of acute bronchospasm [see warnings and precautions (5.1)] - hypersensitivity to regular human insulin or any of the excipients in afrezza [see warnings and precautions (5.7)] risk summary limited available data with afrezza use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. available information from published studies with human insulin use during pregnancy has not reported a clear association with human insulin and adverse developmental outcomes (see data ). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations ). in animal reproduction studies, there were no adverse developmental outcomes with subcutaneous administration of carrier particles (vehicle without insulin) to pregnant rats during organogenesis at doses 21 times the human daily dose of 99 mg afrezza, based on auc (see data) . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with hba1c >7 and has been reported to be as high as 20-25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. 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 disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia- related morbidity. data human data there are limited data with afrezza use in pregnant women. published data do not report a clear association with human insulin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when human insulin is used during pregnancy. however, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and lack of blinding. animal data in pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 6 through 17 (organogenesis), no major malformations were observed at doses up to 100 mg/kg/day (21 times the human systemic exposure at a daily dose of 99 mg afrezza, based on auc). in pregnant rabbits given subcutaneous doses of 2, 10, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through 19 (organogenesis), adverse maternal effects were observed in all dose groups (at human systemic exposure following a daily dose of 99 mg afrezza, based on auc). in pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through lactation day 20 (weaning), decreased epididymis and testes weights were observed in f1 male offspring, however, no decrease in fertility was noted, and impaired learning were observed in f1 pups at ³ 30 mg/kg/day (6 times the human systemic exposure at a daily dose of 99 mg afrezza, based on auc). risk summary there are no data on the presence of afrezza in human milk, the effects on the breastfed infant, or the effects on milk production. one small published study reported that exogenous subcutaneous insulin was present in human milk. no adverse effects in infants were noted. the carrier particles are present in rat milk (see data ). potential adverse reactions that are related to inhalational administration of afrezza are unlikely to be associated with potential exposure of afrezza through breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for afrezza and any potential adverse effects on the breastfed infant from afrezza or from the underlying maternal condition. data subcutaneous administration of the carrier particle in lactating rats resulted in excretion of the carrier particle in rat milk at levels that were approximately 10% of the maternal exposure. given the results of the rat study, it is highly likely that the insulin and carrier in afrezza are excreted in human milk. the safety and effectiveness of afrezza to improve glycemic control in pediatric patients with diabetes mellitus has not been established. afrezza has not been studied in pediatric patients. in the afrezza clinical studies, 671 (12%) patients were 65 years of age or older, of which 42 (0.8%) were 75 years of age or older. in these studies, 381 (13%) of afrezza-treated patients were 65 years of age or older, of which 20 (0.7%) were 75 years of age or older. no overall differences in effectiveness of afrezza have been observed between patients 65 years of age and older and younger adult patients [see clinical studies (14)] . clinical studies of afrezza did not include sufficient numbers of patients 65 years of age and older to determine whether there were differences in safety between these patients and younger adult patients. pharmacokinetic and pharmacodynamic studies to assess the effect of age on pharmacokinetics or pharmacodynamics on insulin human, respectively, have not been conducted. the effect of hepatic impairment on the pharmacokinetics of afrezza has not been studied. frequent glucose monitoring and a lower dosage may be necessary in afrezza-treated patients with hepatic impairment [see warnings and precautions (5.3)] . the effect of renal impairment on the pharmacokinetics of afrezza has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. frequent glucose monitoring and a lower dosage may be necessary in afrezza-treated patients with renal impairment [see warnings and precautions (5.3)] . instructions for use afrezza® (uh-frezz-uh) (insulin human) inhalation powder, for oral inhalation use this “instructions for use” contains information on how to use afrezza® (insulin human) inhalation powder. read this instructions for use before you start using afrezza and each time you get a new afrezza inhaler. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. your healthcare provider should show you how to use your afrezza inhaler the right way before you use it for the first time. important information about afrezza: - afrezza comes in 3 strengths (see figure a): 4 units (blue cartridge) 8 units (green cartridge) 12 units (yellow cartridge) - 4 units (blue cartridge) - 8 units (green cartridge) - 12 units (yellow cartridge) - if your prescribed afrezza dose is higher than 12 units, you will need to use more than 1 cartridge. - if you need to use more than 1 cartridge for your dose, throw away the used cartridge before getting a new one. you can tell when a cartridge has been used, because the cup has moved to the center. - do not try to open the afrezza cartridges. the afrezza inhaler opens the cartridge automatically during use. - afrezza cartridges should only be used with the afrezza inhaler. do not try to breathe in the afrezza insulin powder in any other way. do not put cartridges in your mouth and do not swallow cartridges. - use only 1 afrezza inhaler at a time. the same inhaler should be used for the 4 unit, 8 unit or 12 unit cartridges. - store the inhaler in a clean, dry place with the mouthpiece cover on until your next dose. - throw away your afrezza inhaler after 15 days and get a new one. if you are having problems with your afrezza inhaler or if it breaks and you need a new one, call 1-877-323-8505. know your afrezza inhaler: know your afrezza cartridges: manufactured by: mannkind corporation danbury, ct 06810 us license no. #2190 © 2016 – 2023 mannkind corporation this instructions for use has been approved by the u.s. food and drug administration. revised: 02/2023 afrezza is a registered trademark of mannkind corporation patent: www.mannkindcorp.com/patent-notices

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baxter healthcare corporation - human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g), fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - human thrombin 2.0 [usp'u] - tachosil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. limitations for use do not use tachosil for: risk summary a review of available data suggests that major birth defects occur in 2-4% of the u.s. general population and that miscarriage occurs in 15-20% of clinically recognized pregnancies, regardless of drug exposure. animal reproduction studies have not been conducted with tachosil. there are no adequate and well-controlled studies in pregnant women. it is also not known whether tachosil can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. tachosil should be administered to pregnant women only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, ca