Hoa Kỳ - Tiếng Anh - 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.

Hoa Kỳ - Tiếng Anh - 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.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 0.05 g in 1 ml - flebogamma 5% dif is an immune globulin intravenous (human) solution indicated in adults and pediatric patients 2 years of age and older for the treatment of primary immunodeficiency (pi), including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and wiskott-aldrich syndrome. - flebogamma 5% 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 5% 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 5% dif use in pregnant women. animal reproduction studies have not been performed with flebogamma 5% dif. it is also not known whether flebogamma 5% dif can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. flebogamma 5% dif should be given to a pregnant woman only if clearly needed. risk summary there is no information regarding the presence of flebogamma 5% dif 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 flebogamma 5% dif and any potential adverse effects on the breastfed infant from flebogamma 5% dif or from the underlying maternal condition. flebogamma 5% dif was studied in a multicenter clinical trial for the treatment of pi in 24 subjects aged 2-16 years (seven were 2-5 years of age, seven were 6-11 years, and ten were 12-16 years), and found to be efficacious for the prevention of acute serious bacterial infections. no pediatric-specific dose requirements were necessary to achieve the desired serum igg levels. twenty subjects (83.3%) had at least one adverse reaction at some time during the study that was considered product-related. there were no deaths or serious adverse reactions. treatment-related adverse reactions that occurred with an incidence of at least 5% on a per-subject basis included headache (42%), pyrexia (29%), hypotension (25%), tachycardia (25%), diastolic hypotension (21%), nausea (8%), abdominal pain (8%), diarrhea (8%), pain (8%), and vomiting (8%). safety and efficacy of flebogamma 5% dif in pediatric patients below the age of 2 years have not been established. limited information is available for the geriatric use of flebogamma 5% dif. clinical studies of flebogamma 5% dif did not include sufficient numbers of subjects over the age of 65 to determine whether they respond differently from younger subjects. use caution when administering flebogamma 5% dif to patients age 65 and over who are judged to be at increased risk for developing thrombosis or renal insufficiency. do not exceed recommended dose, and administer flebogamma 5% dif at the minimum dose and infusion rate practicable, and at less than 0.06 ml per kg per minute (3 mg per kg per min). (see boxed warning, warning and precautions [5.2, 5.4], and dosage and administration [2.3] )

Hoa Kỳ - Tiếng Anh - 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

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

kedrion biopharma inc - human rho(d) immune globulin (unii: 48w7181flp) (human rho(d) immune globulin - unii:48w7181flp) - human rho(d) immune globulin 300 ug - rhogam and micrhogam are indicated for administration to rh-negative women not previously sensitized to the rho(d) factor, unless the father or baby are conclusively rh-negative, in case of: - delivery of an rh-positive baby irrespective of the abo groups of the mother and baby - antepartum prophylaxis at 26 to 28 weeks gestation - antepartum fetal-maternal hemorrhage (suspected or proven) as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma - actual or threatened pregnancy loss at any stage of gestation - ectopic pregnancy rhogam and micrhogam are indicated for prevention of rh immunization in any rh-negative person after incompatible transfusion of rh-positive blood or blood products (e.g., red blood cells, platelet concentrates, granulocyte concentrates). pregnancy and other obstetrical conditions in the case of postpartum use, rhogam and micrhogam are intended for matern

Hoa Kỳ - Tiếng Anh - 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).

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 1 g in 5 ml - cuvitru is an immune globulin subcutaneous (human) (igsc), 20% solution indicated as replacement therapy for primary humoral immunodeficiency (pi) in adult 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 immunodeficiencies1,2 . - cuvitru is contraindicated in patients who have had an anaphylactic or severe systemic hypersensitivity reaction to the subcutaneous administration of human immune globulin. - cuvitru is contraindicated in iga-deficient patients with antibodies against iga and a history of hypersensitivity to human immune globulin treatment. risk summary no human data are available to indicate the presence or absence of drug-associated risk. animal reproduction studies have not been conducted with cuvitru. it is also not known whether cuvitru can cause fetal harm when administered to a pregnant woman or can affect r

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

csl behring ag - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 0.2 g in 1 ml - hizentra is an immune globulin subcutaneous (human) (igsc), 20% liquid indicated for the treatment of the following conditions: hizentra is indicated as replacement therapy for primary humoral immunodeficiency (pi) in adults and pediatric patients 2 years of age and older. this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. hizentra is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. limitations of use: hizentra maintenance therapy in cidp has been systematically studied for 6 months and for a further 12 months in a follow-up study. maintenance therapy beyond these periods should be individualized based upon the patient's response and need for continued therapy [see dosage and administration (2)

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

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 30 ug in 0.5 ml - gardasil® 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases: - cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (hpv) types 16, 18, 31, 33, 45, 52, and 58 - 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, 18, 31, 33, 45, 52, and 58: - 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 9 is indicated in boys and men 9 through 45 years of age for the prevention of the following diseases: - anal, oropharyngeal and other head and neck cancers caused by hpv types 16, 18, 31, 33, 45, 52, and 58 - genital war

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 10 g in 100 ml - gamunex-c is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: gamunex-c 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) gamunex-c 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) gamunex-c is indicated for the treatment of cidp in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. gamunex-c is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. gamunex-c is contraindicated in iga deficient patients with antibodies against iga and history of h