Israel - English - Ministry of Health

kamada ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 5 g / 100 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, and children and adolescents in:- primary immunodeficiency syndromes with impaired antibody production - hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed- hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation- congenital aids with recurrent bacterial infectionsimmunomodulation in adults, and children and adolescents 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

Israel - English - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 100 g/l - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in• primary immunodeficiency syndromes (pid) such as: – congenital agammaglobulinaemia and hypogammaglobulinaemia – common variable immunodeficiency – severe combined immunodeficiency – wiskott-aldrich syndrome• myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections• children with congenital aids and recurrent infectionsimmunomodulation• immune thrombocytopenic purpura (itp) in children or adults at high risk of bleeding or prior to surgical interventions to correct the platelet count• guillain-barré syndrome• kawasaki disease• chronic inflammatory demyelinating polyneuropathy (cidp)allogeneic bone marrow transplantation

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - immunoglobulin (polyvalent) (human) - injection - 160 mg/ml - immunoglobulin (polyvalent) (human) 160 mg/ml

Malta - English - Malta Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - immunoglobulin rabies, human - solution for injection - immunoglobulin rabies, human 150 iu/ml - immune sera and immunoglobulins

United States - English - 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.

Malta - English - Malta Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - albumin, human - solution for infusion - albumin, human 200 g/l - blood substitutes and perfusion solutions

Malta - English - Malta Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - albumin, human - solution for infusion - albumin, human 50 g/l - blood substitutes and perfusion solutions

Malta - English - Malta Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - albumin, human - solution for infusion - albumin, human 200 g/l - blood substitutes and perfusion solutions

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

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - for restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3 acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. human albumin grifols® 20% can be used in such cases.1 human albumin grifols 20% may be of value in the treatment of shock or hypotension in renal dialysis patients.1 preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. albumin also may be used in the priming fluid.4,5,6 human albumin grifols 20% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.1,2,7 human albumin grifols 20% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. when albumin deficit is the result of excessive protein loss, the effect of human albumin grifols 20% administration will be temporary unless the underlying disorder is reversed.8,9,10 septic patients and patients undergoing major surgery may lose more than half of their circulating plasma volume.1,11 treatment with human albumin grifols 20% may be of value in such cases, especially when plasma colloid oncotic pressure is abnormally low.1 in the first 24 hours after thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. beyond 24 hours, human albumin grifols 20% can be used to maintain plasma colloid osmotic pressure.2,12,13 protein loss from the third space due to infection (acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis) may require treatment with an infusion of albumin.14,15 human albumin grifols 20% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.16,17 human albumin grifols 20% is indicated for the treatment of neonatal hyperbilirubinemia. it may be used prior to or during an exchange procedure in an attempt to bind free bilirubin and enhance its excretion.18,19,20 human albumin grifols 20% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ards.6,21 human albumin grifols 20% may be used to maintain cardiovascular function following removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites.2,22,23,24 - hypersensitivity to albumin preparations or to any of the excipients. - severe anemia or cardiac failure with normal or increased intravascular volume. pregnancy category c. animal reproduction studies have not been conducted with human albumin grifols 20%. it is also not known whether human albumin grifols 20% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. human albumin grifols 20% should be given to a pregnant woman only if clearly needed. no human or animal data. use only if clearly needed. no human or animal data. use only if clearly needed. no human or animal data. use only if clearly needed. no human or animal data. use only if clearly needed.

Israel - English - Ministry of Health

cts ltd - human fibrinogen; thrombin - sealant matrix - thrombin 2 iu/cm2; human fibrinogen 5.5 mg/cm2 - human fibrinogen - human fibrinogen - tachosil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for sutute support in vascular surgery where standard techniques are insufficient.