אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 1000 mg - diluent, not applicable - excipient ingredients: - prolastin-c is an alpha-1-proteinase inhibitor (human, alpha1-pi) indicated to increase serum alpha1-pi levels in adults with congenital deficiency of alpha-1 antitrypsin and with clinically significant emphysema (fev1 less than 80%). the data for clinical efficacy of prolastin-c is derived from changes in the biomarkers alpha-1 anti-protease level and ct lung density. efficacy on fev1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials. clinical trials have only included patients who were not smoking.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - immunoglobulin g 160 mg/ml (immunoglobulin ex nz 16% igg) - solution for injection - 160 mg/ml - active: immunoglobulin g 160 mg/ml (immunoglobulin ex nz 16% igg) excipient: glycine - normal immunoglobulin-vf is indicated in the management of congenital and acquired forms of primary hypogammaglobulinaemia. it may also be of value in treating secondary forms of this disorder as in leukaemia, nephrosis and acute protein-losing enteropathy, particularly when there is a tendency to recurrent infection. in susceptible contacts of hepatitis a, measles and poliomyelitis, normal immunoglobulin-vf may be of value in preventing or modifying the disease. in general, the earlier in the incubation period of these diseases normal immunoglobulin-vf is given, the greater its effectiveness.

ישראל - אנגלית - Ministry of Health

kamada ltd, israel - human plasma coagulation factor viii - powder for solution for injection - human plasma coagulation factor viii 50 iu/ml - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding: in patients with haemophilia a (congenital factor viii deficiency) in patient with acquired factor viii deficiency. haemoctin is not effective in controlling the bleeding of patients with von willebrond`s disease.

ישראל - אנגלית - Ministry of Health

kamada ltd, israel - human plasma coagulation factor viii - powder and solvent for solution for injection - human plasma coagulation factor viii 50 iu/ml - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding: in patients with haemophilia a (congenital factor viii deficiency) in patient with acquired factor viii deficiency.haemoctin is not effective in controlling the bleeding of patients with von willebrond`s disease.

ישראל - אנגלית - Ministry of Health

kamada ltd, israel - human plasma coagulation factor viii - powder and solvent for solution for injection - human plasma coagulation factor viii 100 iu/ml - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding: in patients with haemophilia a (congenital factor viii deficiency) in patient with acquired factor viii deficiency.haemoctin is not effective in controlling the bleeding of patients with von willebrond`s disease.

ישראל - אנגלית - Ministry of Health

kamada ltd, israel - human normal immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, and children and adolescents (0-18 years) in:- primary immunodeficiency syndromes (pid) with impaired antibody production- secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of <4 g/l* psaf= failure to mount at least a 2-fold rise in igg antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccinesimmunomodulation in adults, and 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 (in conjunction with acetylsalicylic acid)- chronic inflammatory demyelinating polyradiculoneuropathy (cidp)- multifocal motor neuropathy (mmn)

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >90% gamma globulin - solution for injection - 0.8g/5ml %w/v

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

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

סינגפור - אנגלית - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - human hepatitis b immunoglobulin in 50mg/ml human plasma protein (igg ≥ 96%) - infusion, solution - 50 iu/ml - human hepatitis b immunoglobulin in 50mg/ml human plasma protein (igg ≥ 96%) 50 iu/ml

מלטה - אנגלית - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - human plasma, protein - solution for infusion - human plasma protein 200 g/l - blood substitutes and perfusion solutions