Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 g - injection, solution - excipient ingredients: human immunoglobulin a; water for injections; sorbitol - replacement therapy indications: - primary immunodeficiency (pi) diseases - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,immunomodulation indications: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - guillain barr? syndrome - kawasaki disease.

Írország - angol - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >90% gamma globulin human tetanus immunoglobulin ph. eur. - solution for injection

Izrael - angol - 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

Írország - angol - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human plasma protein >95% immunoglobulins - solution for injection - 160 gram(s)/litre - immunoglobulins, normal human; immunoglobulins, normal human, for extravascular adm. - immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration - replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency - igg subclass deficiencies with recurrent infections

Kanada - angol - Health Canada

grifols therapeutics llc - immunoglobulin (human) - solution - 18% - immunoglobulin (human) 18% - serums

Egyesült Államok - angol - NLM (National Library of Medicine)

csl behring ag - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 5 g in 50 ml - privigen is an immune globulin intravenous (human), 10% liquid indicated for the treatment of the following conditions. privigen is 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. privigen is indicated for the treatment of patients age 15 years and older with chronic immune thrombocytopenic purpura (itp) to raise platelet counts. 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

Egyesült Államok - angol - NLM (National Library of Medicine)

grifols usa, llc - human clostridium tetani toxoid immune globulin (unii: v4swi4rf4j) (human clostridium tetani toxoid immune globulin - unii:v4swi4rf4j) - human clostridium tetani toxoid immune globulin 250 [iu] in 1 ml - hypertet is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). it is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus.(8,9,16) a thorough attempt must be made to determine whether a patient has completed primary vaccination. patients with unknown or uncertain previous vaccination histories should be considered to have had no previous tetanus toxoid doses. persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.(3) the following table is a summary guide to tetanus prophylaxis in wound management: none known.

Egyesült Államok - angol - NLM (National Library of Medicine)

aptevo biotherapeutics llc - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - human varicella-zoster immune globulin 125 [iu] - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. - there is no convincing evidence that varizig reduces the incidence of chickenpox infection after exposure to vzv. - there is no convincing evidence that established infections with vzv can be modified by varizig administration. - there is no indication for the prophylactic use of varizig in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone m

Egyesült Államok - angol - NLM (National Library of Medicine)

cangene biopharma - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - human varicella-zoster immune globulin 1.25 [iu] in 1 ml - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. pregnancy category c. animal reproduction studies have not been conducted with varizig. it also is not known whether varizig can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. varizig should be given to a pregnant woman only if clearly needed. the safety and effectiveness of varizig have been evaluated for post-exposure prophylaxis in clinical trials in 166 pregnant women [see 6 adverse reactions and 14 clinical studies]. it is not known whether varizig is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when varizig is administered to a nursing moth

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 20 g - injection, solution - excipient ingredients: glycine; water for injections - intragam? 10 is indicated for replacement igg therapy in: ?primary immunodeficiency diseases (pid) ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. intragam? 10 is indicated for immunomodulatory therapy in: ?idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?kawasaki disease ?guillain-barre syndrome (gbs) ?chronic inflammatory demyelinating polyneuropathy (cidp) ?multifocal motor neuropathy (mmn) ?myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects ?short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients ?treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.