Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

bio products laboratory limited - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 5 g in 50 ml - gammaplex 10% is an immune globulin intravenous (human), 10% liquid indicated for replacement therapy in 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 common variable immunodeficiency, x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. gammaplex 10% is indicated for the treatment of chronic immune thrombocytopenic purpura (itp) in adults to raise platelet counts. - gammaplex 10% is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin - gammaplex 10% is contraindicated in iga-deficient patients with antibodies to iga and a history of hypersensitivity risk summary animal reproduction studies have not been conducted with gammaplex 10%. it is also not known whether gammaplex 10% can cause fetal harm when administered to a pregnant woman or can af

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

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

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

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

Ameerika Ühendriigid - inglise - 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)

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

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.

Malta - inglise - Medicines Authority

bio products laboratory limited - anti, d immunoglobulin, human - solution for injection - anti-d immunoglobulin, human 250 international unit(s)/millilitre - immune sera and immunoglobulins

Euroopa Liit - inglise - EMA (European Medicines Agency)

cangene europe limited - human hepatitis b immunoglobulin - immunization, passive; hepatitis b - specific immunoglobulins - immunoprophylaxis of hepatitis b - in case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown).- in haemodialysed patients, until vaccination has become effective.- in the newborn of a hepatitis b virus carrier-mother.- in subjects who did not show an immune response (no measurable hepatitis b antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis b.consideration should also be given to other official guidance on the appropriate use of human hepatitis b immunoglobulin for intramuscular use.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - human immunoglobulin g, quantity: 40 g - injection, intravenous infusion - excipient ingredients: proline - privigen is an immune globulin intravenous (human), 10% liquid indicated for the treatment of the following conditions. 1.1 primary humoral immunodeficiency privigen indicated as replacement therapy for primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. 1.2 chronic immune thrombocytopenic purpura privigen is indicated for the treatment of patients with chronic immune thrombocytopenic purpura (itp) to raise platelet counts. 1.3 chronic inflammatory demyelinating polyneuropathy privigen is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (cidp) to improve neuromuscular disability and impairment. limitation of use: privigen 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 privigen 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.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - human immunoglobulin g, quantity: 10 g - injection, intravenous infusion - excipient ingredients: proline - privigen is an immune globulin intravenous (human), 10% liquid indicated for the treatment of the following conditions. 1.1 primary humoral immunodeficiency privigen indicated as replacement therapy for primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. 1.2 chronic immune thrombocytopenic purpura privigen is indicated for the treatment of patients with chronic immune thrombocytopenic purpura (itp) to raise platelet counts. 1.3 chronic inflammatory demyelinating polyneuropathy privigen is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (cidp) to improve neuromuscular disability and impairment. limitation of use: privigen 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 privigen 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.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - human immunoglobulin g, quantity: 5 g - injection, intravenous infusion - excipient ingredients: proline - privigen is an immune globulin intravenous (human), 10% liquid indicated for the treatment of the following conditions. 1.1 primary humoral immunodeficiency privigen indicated as replacement therapy for primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. 1.2 chronic immune thrombocytopenic purpura privigen is indicated for the treatment of patients with chronic immune thrombocytopenic purpura (itp) to raise platelet counts. 1.3 chronic inflammatory demyelinating polyneuropathy privigen is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (cidp) to improve neuromuscular disability and impairment. limitation of use: privigen 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 privigen 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.