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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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kedrion biopharma inc. - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - kedrab is a human rabies immune globulin (hrig) indicated for passive, transient post-exposure prophylaxis (pep) of rabies infection to persons of all ages when given immediately after contact with a rabid or possibly rabid animal. kedrab should be administered concurrently with a full course of rabies vaccine. none. risk summary kedrab has not been studied in pregnant women. therefore, the risk of major birth defects and miscarriage in pregnant women who are exposed to kedrab is unknown. animal developmental or reproduction toxicity studies have not been conducted with kedrab. it is not known whether kedrab can cause harm to the fetus when administered to a pregnant woman or whether kedrab can affect reproductive capacity. in the u.s. general population, the estimated background of major birth defects occurs in 2-4% of the general population and miscarriage occurs in 15-20% of clinically recognized pregnancies. risk summary there is no information regarding the presence of kedrab 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 kedrab and any potential adverse effects on the breastfed infant from kedrab or from the underlying maternal condition. safety and effectiveness have been established in children. in a pediatric study of 30 patients ranging in age from 0.5 to 14.9 years, kedrab presented no serious adverse reactions through day 84. of the 30 patients, 28 (93.3%) achieved a day-14 rvna titer ≥0.5 iu/ml, the who recommended level. none of the patients who were followed until the end of the study (28/30 patients) developed rabies infection through day 84. [see clinical trials ( 14)] adverse reactions that occurred in ≥3.3% of patients within the first 14 days of kedrab and the first rabies vaccination administration are listed in section 6.1. the clinical trial conducted in the pediatric population is described in section 14. additional evidence to support the use of kedrab in children comes from real world evidence. based on claims data, 172 u.s. children (≤17 years) were treated with kedrab between 2018-2020. based on center for disease control data, no children in the u.s. treated with post-exposure prophylaxis have been reported to have had rabies between 2018-april 2021. clinical studies of kedrab did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. clinical experience with hrig products has not identified differences in effectiveness between elderly and younger patients (acip) 1 .

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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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kedrion biopharma, inc. - antihemophilic factor human (unii: 839moz74gk) (antihemophilic factor human - unii:839moz74gk) - antihemophilic factor human 250 [iu] in 5 ml - koĀte® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia a (hereditary factor viii deficiency). limitation of use koĀte is not indicated for the treatment of von willebrand disease. koĀte is contraindicated in patients who have had hypersensitivity reactions, including anaphylaxis, to koĀte or its components. [see description (11) ] risk summary there are no data with koĀte use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using koĀte. it is not known whether koĀte can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. koĀte should be given to a pregnant woman 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. risk summary there is no information regarding the presence of koĀte 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 koĀte and any potential adverse effects on the breast-fed infant from koĀte or from the underlying maternal condition. safety and efficacy studies have been performed in 20 previously treated pediatric patients aged 2.5 to 16 years. subjects received 208 infusions of koĀte for treatment or control of bleeding episodes, including perioperative management, and routine prophylaxis.  children have shorter half-life and lower recovery of factor viii than adults. because clearance of factor viii (based on per kilogram body weight) is higher in children, higher or more frequent dosing may be needed. clinical studies of koĀte did not include any subjects aged 65 and over to determine whether they respond differently from younger subjects. individualize dose selection for geriatric patients.

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

kedrion biopharma, inc. - antihemophilic factor human (unii: 839moz74gk) (antihemophilic factor human - unii:839moz74gk) - antihemophilic factor human 250 [iu] in 5 ml - koĀte® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia a (hereditary factor viii deficiency). limitation of use koĀte is not indicated for the treatment of von willebrand disease. koĀte is contraindicated in patients who have had hypersensitivity reactions, including anaphylaxis, to koĀte or its components. [see description (11) ] risk summary there are no data with koĀte use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using koĀte. it is not known whether koĀte can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. koĀte should be given to a pregnant woman 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. risk summary there is no information regarding the presence of koĀte 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 koĀte and any potential adverse effects on the breast-fed infant from koĀte or from the underlying maternal condition. safety and efficacy studies have been performed in 20 previously treated pediatric patients aged 2.5 to 16 years. subjects received 208 infusions of koĀte for treatment or control of bleeding episodes, including perioperative management, and routine prophylaxis. children have shorter half-life and lower recovery of factor viii than adults. because clearance of factor viii (based on per kilogram body weight) is higher in children, higher or more frequent dosing may be needed. clinical studies of koĀte did not include any subjects aged 65 and over to determine whether they respond differently from younger subjects. individualize dose selection for geriatric patients.

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kedrion biopharma, inc. - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 10 g in 50 ml - emergency treatment of hypovolemic shock albuked 20 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema.(1) if the patient is dehydrated, additional crystalloids must be given,(4) or alternatively, albumin (human) 5%, usp (albuked™ 5) should be used. the patient’s hemodynamic response should be monitored and the usual precautions against circulatory overload observed. the total dose should not exceed the level of albumin found in the normal individual; i.e., about 2 g per kg body weight in the absence of active bleeding. although albuked 5 is to be preferred for the usual volume deficits, albuked 20 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.(2) removal of ascitic fluid from a

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

kedrion biopharma, inc. - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - emergency treatment of hypovolemic shock albuked 25 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema.(1) if the patient is dehydrated, additional crystalloids must be given,(4) or alternatively, albumin (human) 5%, usp (albuked™ 5) should be used. the patient’s hemodynamic response should be monitored and the usual precautions against circulatory overload observed. the total dose should not exceed the level of albumin found in the normal individual, i.e., about 2 g per kg body weight in the absence of active bleeding. although albuked 5 is to be preferred for the usual volume deficits, albuked 25 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.(2) removal of ascitic fluid from a

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

kedrion biopharma, inc. - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 2.5 g in 50 ml - emergency treatment of hypovolemic shock albuked 5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused. in conditions associated mainly with a volume deficit, albumin is best administered as a 5% solution (albuked 5); but where there is an oncotic deficit, albumin (human) 25%, usp (albuked™ 25) may be preferred. this is also an important consideration where the treatment of the shock state has been delayed. if albuked 25 is used, appropriate additional crystalloid should be administered.(1) crystalloid solutions in volumes several times greater than that of albuked 5 may be effective in treating shock in younger individuals who have no preexisting illness at the time of the incident. older patients, especially those with preexisting debilitating conditions, or those in whom the shock is caused by a medical disorder, or where the state of shock has existed for some time before active therapy could be insti

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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

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kedrion s.p.a - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin (human) 12.5 g in 50 ml - for restoration and maintenance of circulating blood volume where volume deficiency is demonstrated and colloid use is appropriate. kedbumin® is indicated for severe albumin deficiency caused by illness or active bleeding. when albumin deficiency results from excessive protein loss, the effect of albumin administration will be temporary unless the underlying disorder is reversed. kedbumin® is indicated for maintenance of cardiovascular function following the removal of large volumes of ascitic fluid due to cirrhosis [1, 2]. kedbumin® is indicated as a plasma expander in the fluid management of severe forms of ovarian hyperstimulation syndrome (ohss) [3, 4]. kedbumin® is indicated in conjunction with diuretics to correct fluid volume overload associated with ards [5]. kedbumin® is indicated after > 24 hours post burn in patients experiencing severe albumin depletion in order to favor edema re-absorption [6]. kedbumin® is indicated in patients undergoing long term dialysis or for those patients who are fl