Malta - englanti - Malta Medicines Authority

baxter healthcare limited - albumin, human 200 g/l - solution for infusion

Yhdysvallat - englanti - 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.

Yhdysvallat - englanti - NLM (National Library of Medicine)

csl behring llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 2.5 g in 50 ml

Yhdistynyt kuningaskunta - englanti - MHRA (Medicines & Healthcare Products Regulatory Agency)

biotest (uk - albumin solution human - solution for infusion - 200mg/1ml

Yhdistynyt kuningaskunta - englanti - MHRA (Medicines & Healthcare Products Regulatory Agency)

biotest (uk - albumin solution human - solution for infusion - 200mg/1ml

Australia - englanti - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - albumin, quantity: 40 g/l - injection, solution - excipient ingredients: chloride; water for injections; sodium; octanoate - indications as at 27 january 2000 : hypovolaemia/shock: preservation of an adequate circulating blood volume should be the primary aim of therapy. the initial resuscitating fluid should not be a human blood product, but rather an alternative plasma volume expander should be used as a first-line replacement. albumex 4 may, however, be the initial plasma expander of choice if shock is associated with significant hypoalbuminaemia (albumin concentration less than 25g/litre), or if it is clinically desirable to avoid the infusion of large volumes of crystalloid solutions. albumex 4 may also be useful following initial resuscitation with crystalloid or synthetic colloid solutions in patients in whom extended support of the intravascular volume is required, such as seriously ill patients with multiple organ failure or the systemic capillary leak syndrome. cardiopulmonary bypass: albumex 4 may be used for priming the pump for cardiopulmonary bypass surgery for patients with poor left ventricular function, and other complicating factors such as long bypass time, anaemia or repeat surgery. for post-operative hypovolaemia albumex 4 may be used if further colloid is required after a moderate amount of synthetic colloid (1-2l) has been given, or there is ongoing bleeding or anaemia, until cross-matched blood is available. plasma exchange: albumex 4 is indicated as a replacement solution in plasma exchange procedures, particularly when the volume exchanged exceeds 20ml/kg body weight. in patients with thrombotic thrombocytopenic purpura, fresh frozen plasma may be a preferred replacement.,albumex 4 is a plasma volume expander for restoration and maintenance of circulating blood volume. albumex 4 may be used for priming the pump for cardiopulmonary bypass surgery. albumex 4 is indicated as a replacement solution in plasma exchange procedures.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - albumin, quantity: 40 g/l - injection, solution - excipient ingredients: water for injections; sodium; chloride; octanoate - indications as at 27 january 2000: hypovolaemia/shock: preservation of an adequate circulating blood volume should be the primary aim of therapy. the initital resuscitating fluid should not be a human blood product, but rather an alternative plasma volume expander should be used as a first-line replacement. albumex 4 may, however, be the initial plasma expander of choice if shock is associated with significant hypoalbuminaemia (albumin concentration less than 25g/litre), or it is clinically desirable to avoid the infusion of large volumes of crystalloid solutions. albumex 4 may also be useful following initital resuscitation with crystalloid or synthetic colloid solutions in patients in whom extended support of the intravascular volume is required, such as seriously ill patients with multiple organ failure or the systemic capillary leak syndrome. cardiopulmonary bypass: albumex 4 may be used for priming the pump for cardiopulmonary bypass surgery for patients with poor left ventricular function, and other complicating factors such as long bypass time, anaemia or repeat surgery. for post-operative hypovolaemia albumex 4 may be used if further colloid is required after a moderate amount of synthetic colloid (1-2l) has been given, or there is ongoing bleeding or anaemia, until cross-matched blood is available. plasma exchange: albumex 4 is indicated as a replacement solution in plasma exchange procedures, particularly when the volume exchanged exceeds 20ml/kg body weight. in patients with thrombotic thrombocytopenic purpura, fresh frozen plasma may be preferred replacement.,albumex 4 is a plasma volume expander for restoration and maintenance of circulating blood volume. albumex 4 may be used for priming the pump for cardiopulmonary bypass surgery. albumex 4 is indicated as a replacement solution in plasma exchange procedures.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - albumin, quantity: 40 g/l - injection, solution - excipient ingredients: chloride; octanoate; water for injections; sodium - indications as at 27 january 2000 :hypovolaemia/shock: preservation of an adequate cirulating blood volume should be the primary aim of therapy. the initial resuscitating fluid should not be a human blood product, but rather an alternative plasma volume expander should be used as a first-line replacement. albumex 4 may, however, be the initial plasma expander of choice if shock is associated with significant hypoalbuminaemia (albumin concentration less than 25g/litre) or if it is clinically desirable to avoid the infusion of large volumes of crystalloid solutions. albumex 4 may also be useful following initial resuscitation with crystalloid or synthetic colloid solutions in patients in whom extended support of the intravascular volume is required, such as seriously ill patients with multiple organ failure or the systemic capillary leak syndrome. cardiopulmonary bypass: albumex 4 may be used for priming the pump for cardiopulmonary bypass surgery for patients with poor left ventricular function, and other complicating factors such as long bypass time, aneamia or repeat surgery. for post-operative hypovolaemia albumex 4 may be used if further colloid is required after a moderate amount of synthetic colloid (1-2l) has been given, or there is ongoing bleeding or anaemia, until cross-matched blood is available. plasma exchange: albumex 4 is indicated as a replacement solution in plasma exchange procedures, particularly when the volume exchanged exceeds 20ml/kg body weight. in patients with thrombotic thrombocytopenic purpura, fresh frozen plasma may be preferred replacement.,albumex 4 is a plasma volume expander for restoration and maintenance of circulating blood volume. albumex 4 may be used for priming the pump for cardiopulmonary bypass surgery. albumex 4 is indicated as a replacement solution in plasma exchange procedures.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - albumin, quantity: 0.2 g/ml - injection, intravenous infusion - excipient ingredients: octanoate; sodium; water for injections - indications as at 27 january 2000: hypoproteinaemia in the acutely ill patient: albumex 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy. shock: albumex 20 may be used for the resuscitation of patients in shock due to acute loss of blood or plasma, but 4-5% human albumin is preferred when available. burns: extensive burns are followed by sequential shifts in the distribution of body water, salt and proteins, resulting in hypovolaemic shock and circulatory failure. inititally (during the first 24 hours) there is an increased vascular permeability leading to loss of water and proteins into the extravascular compartment, and haemoconcentration. large volumes of crystalloid solutions should be infused to restore the constricted intravascular fluid space, and smaller amounts of albumex 20 are required to maintain adequate plasma volume and colloid osmotic pressure. adult respiratory distress syndrome

Australia - englanti - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - albumin, quantity: 0.2 g/ml - injection, intravenous infusion - excipient ingredients: water for injections; sodium; octanoate - indications as at 27 january 2000: hypoproteinaemia in the acutely ill patient: albumex 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy. shock: albumex 20 may be used for the resuscitation of patients in shock due to acute loss of blood or plasma, but 4-5% human albumin is preferred when available. burns: extensive burns are followed by sequential shifts in the distribution of body water, salt and proteins, resulting in hypovolaemic shock and circulatory failure. inititally (during the first 24 hours) there is an increased vascular permeability leading to loss of water and proteins into the extravascular compartment, and haemoconcentration. large volumes of crystalloid solutions should be infused to restore the constricted intravascular fluid space, and smaller amounts of albumex 20 are required to maintain adequate plasma volume and colloid osmotic pressure. adult respiratory distress syndrome