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

aptevo biotherapeutics llc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 312 [iu] in 1 ml - hepagam b [hepatitis b immune globulin intravenous (human)] is an intravenous immune globulin indicated for the following: including - acute exposure to hbsag-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc), - perinatal exposure of infants born to hbsag-positive mothers, - sexual exposure to hbsag-positive persons, and - household exposure to persons with acute hbv infection. - individuals known to have anaphylactic or severe systemic reactions to the parenteral administration of human globulin preparations should not receive hepagam b. - individuals who are deficient in iga may have the potential to develop anti-iga antibodies and have an anaphylactoid reaction. hepagam b contains less than 40 micrograms per milliliter of iga. - hepagam b contains less than 40 micrograms per milliliter of iga. - for postexposure prophylaxis indications, hepagam b must be administered intramuscularly only. in patients who have severe thrombocytopenia or any coagulat

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

saol therapeutics inc. - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - hepagam b [hepatitis b immune globulin intravenous (human)] is an intravenous immune globulin indicated for the following: including - acute exposure to hbsag-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc.), - perinatal exposure of infants born to hbsag-positive mothers, - sexual exposure to hbsag-positive persons, and - household exposure to persons with acute hbv infection. - individuals known to have anaphylactic or severe systemic reactions to the parenteral administration of human globulin preparations should not receive hepagam b. - individuals who are deficient in iga may have the potential to develop anti-iga antibodies and have an anaphylactoid reaction. hepagam b contains less than 40 micrograms per milliliter of iga. - hepagam b contains less than 40 micrograms per milliliter of iga. - for postexposure prophylaxis indications, hepagam b must be administered intramuscularly only. in patients who have severe thrombocytopenia or any coagulat

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

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 5 g in 50 ml - flebogamma 10% dif is an immune globulin intravenous (human) solution indicated for the treatment of: flebogamma 10% dif is indicated as replacement therapy in primary immunodeficiency (pi) including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and wiskott-aldrich syndrome. flebogamma 10% dif is indicated for the treatment of patients 2 years of age and older with chronic primary immune thrombocytopenia to raise platelet count. - flebogamma 10% dif is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin. - flebogamma 10% dif is contraindicated in iga deficient patients with antibodies to iga and a history of hypersensitivity. (see warnings and precautions (5.1)) risk summary there are no studies of flebogamma 10% dif use in pregnant women. animal reproduction studies have not been performed with flebogamma 10% dif. it is

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

emergent biosolutions canada inc. - human vaccinia virus immune globulin (unii: 7ub4j759td) (human vaccinia virus immune globulin - unii:7ub4j759td) - human vaccinia virus immune globulin 1 [iu] in 1 ml - vigiv (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: vigiv is not considered to be effective in the treatment of postvaccinial encephalitis. vigiv is contraindicated in: risk summary there are no data on the use of vigiv in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted with vigiv. risk summary there are no data to assess the presence or absence of vigiv in human milk, the effects on the breastfed child or the effects on milk production/excretion. safety and effectiveness in the pediatric population (<16 yrs of age) has not been established for vigiv. safety and effectiveness in the geriatric population (>65 yrs of age) has not been established for vigiv.

Canada - English - Health Canada

talecris biotherapeutics inc - immunoglobulin (human) - solution - 5g - immunoglobulin (human) 5g - serums

Canada - English - Health Canada

talecris biotherapeutics inc - immunoglobulin (human) - solution - 10g - immunoglobulin (human) 10g - serums

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

adma biologics, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - bivigam is an immune globulin intravenous (human), 10% liquid, indicated for the treatment of adults and pediatric patients 2 years of age and older 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. no human data are available to indicate the presence or absence of drug-associated risk. animal reproductive 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. immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. bivigam should be given to pregnant women only if clearly needed. 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. no human data are available to indicate the presence or absence of drug-associated risk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bivigam and any potential adverse effects on the breastfed infant from bivigam or from the underlying maternal condition. bivigam was evaluated in 25 pediatric patients (3 children ages 2 to <6, 9 children ages 6 to <12, and 13 adolescents ages 12 to 16 years) with pi. the safety and effectiveness of bivigam for the treatment of pi has been established in pediatric patients 2 years of age and older, based on data from 2 prospective, open-label, single-arm, multi-center studies, supported by evidence from a population pk analysis of adult and pediatric pk data ( see adverse reactions [ 6.1], clinical pharmacology [ 12.3], and clinical studies [ 14.1] ). pk, safety and efficacy were similar to those in adults. no specific dose requirements were necessary to achieve the targeted serum igg levels in the pediatric subjects. the safety and effectiveness of bivigam has not been established in pediatric patients with pi who are under the age of 2 ( see clinical studies [ 14] ). bivigam should be used with caution in patients age 65 and over who are judged to be at increased risk of developing renal insufficiency or thrombotic events (see boxed warning, warnings and precautions [5.1, 5.3] ). do not exceed recommended doses and administer bivigam at the minimum infusion rate practicable. bivigam was evaluated in 9 patients age 65 and older with pi. this number of geriatric patients is not sufficient to determine whether they respond differently from younger patients ( see clinical studies [14] ).

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

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

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

csl behring ag - human cytomegalovirus immune globulin (unii: 129l90a25n) (human cytomegalovirus immune globulin - unii:129l90a25n) - human cytomegalovirus immune globulin 50 mg in 1 ml - cytomegalovirus immune globulin intravenous (human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. in transplants of these organs other than kidney from cmv seropositive donors into seronegative recipients, prophylactic cmv-igiv should be considered in combination with ganciclovir. cytogam should not be used in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. persons with selective immunoglobulin a deficiency have the potential for developing antibodies to immunoglobulin a and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin a, including cytogam.

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

california department of public health - human botulinum neurotoxin a/b immune globulin (unii: x641y30oa7) (human botulinum neurotoxin a/b immune globulin - unii:x641y30oa7) - human botulinum neurotoxin a/b immune globulin 50 mg in 1 ml - babybig® , botulism immune globulin intravenous (human), is indicated for the treatment of infant botulism caused by toxin type a or b in patients below one year of age. - as with other immunoglobulin preparations, babybig should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations.[1-4] - individuals with selective immunoglobulin a deficiency have the potential for developing antibodies to immunoglobulin a and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin a. babybig has been studied for safety and efficacy only in patients below one year of age [see adverse reactions (6) and clinical studies (14) ]. it has not been tested in other populations. ndc 68403-1100-7 rx only 100 mg igg, 100 mg sucrose 20 mg albumin (human) lyophilized solvent detergent treated botulism immune globulin intravenous (human) (big-iv) babybig® store between 2°c and 8°c (35.6°f and 46.4°f).