Europska Unija - engleski - EMA (European Medicines Agency)

instituto grifols s.a. - human normal immunoglobulin - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - immune sera and immunoglobulins, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - normal immunoglobulin, quantity: 30 g - injection, solution - excipient ingredients: glycine; water for injections - kiovig administered intravenously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid);,? symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,2. immunomodulation indications,? idiopathic thrombocytopenia purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;,? guillain barr? syndrome;,? kawasaki disease;,? chronic inflammatory demyelinating polyradiculoneuropathy (cidp) in adults.,? multifocal motor neuropathy (mmn).,kiovig administered subcutaneously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid).

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

cangene biopharma inc. - 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

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

cangene biopharma, llc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 50 mg in 1 ml

Sjedinjene Američke Države - engleski - 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.

Sjedinjene Američke Države - engleski - 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

Sjedinjene Američke Države - engleski - 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)

Sjedinjene Američke Države - engleski - 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

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

emergent biosolutions canada inc. - anthrax immune globulin human (unii: vkz83s945z) (anthrax immune globulin human - unii:vkz83s945z) - anthrax immune globulin human 60 [iu] in 35 ml - anthrasil is an anthrax immune globulin intravenous (human) indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs. the effectiveness of anthrasil is based solely on efficacy studies conducted in animal models of inhalational anthrax [see 13.2 animal toxicology and/or pharmacology]. limitations: risk summary there are no human data to establish the presence or absence of anthrasil associated risk. risk summary there are no data to assess the presence or absence of anthrasil in human milk, the effects on the breastfed child or the effects on milk production/excretion. safety and effectiveness of anthrasil in the pediatric population (≤16 yrs of age) have not been studied. allometric scaling was used to derive dosing regimens to provide pediatric patients with exposure comparable to the observed exposure in adults receiving 420 units and 840 units. the dose for pediatric patients is based on body weight. safety and effectiveness of

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 2.5 g in 50 ml - treatment of shock — plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. it is also effective in the emergency treatment of shock due to hemorrhage.(3,4) following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss. in infants and small children, plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection. plasmanate is contraindicated for use in patients on cardiopulmonary bypass. severe hypotension has been reported in such patients when given plasma protein fraction.(4) plasma protein fraction is contraindicated in patients with severe anemia, congestive heart failure, or increased blood volume.