Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - human plasma, protein - solution for infusion or injection - human plasma protein 50 mg/ml - immune sera and immunoglobulins

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - human hepatitis, b immunoglobulin, human plasma, protein - solution for injection - human hepatitis b immunoglobulin 200 iu human plasma protein 100-170 mg - immune sera and immunoglobulins

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - clottable protein (human fibrinogen); human thrombin - solution - 50-90 mg/ml - clottable protein (human fibrinogen) 50-90 mg/ml; human thrombin 800-1200 iu/ml

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

octapharma australia pty ltd - plasma proteins, quantity: 45 mg/ml - injection, solution - excipient ingredients: octoxinol 9; glycine; tributyl phosphate; monobasic sodium phosphate; sodium citrate dihydrate - complex deficiencies of coagulation factors such as coagulopathy due to severe hepatic failure or massive transfusion. substitution therapy in coagulation factor deficiencies, in emergency situations, when a specific coagulation factor concentrate, e.g. factor v or factor xi, is not available or when a precise laboratory diagnosis is not possible.treatment of overdosage of oral anticoagulants (coumarin or indanedione type), when rapid reversal of anticoagulant effects is required, in combination with intravenous vitamin k and a prothrombin complex concentrate.thrombotic thrombocytopenic purpura (ttp), usually in conjunction with plasma exchange. haemorrhage due to coagulation abnormalities resulting from intensive plasma exchange procedures.

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

csl behring australia pty ltd - tetanus immunoglobulin, quantity: 4000 iu; human immunoglobulin g, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: maltose; water for injections; human immunoglobulin a - tetanus immunoglobulin-vf (for intravenous use) is used in the management of clinical tetanus.

Australia - English - 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.

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

csl behring australia pty ltd - tetanus immunoglobulin, quantity: 250 iu; human immunoglobulin g, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine; human immunoglobulin a - tetanus immunoglobulin is indicated for the passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful. it should also be given to the fully immunised patient with a tetanus-prone wound if more than 10 years have elapsed since the last dose of toxoid. in all the above instances, active immunisation with tetanus toxoid, adsorbed or adt vaccine should be commenced at the same time [in accordance with details specified in table 1 (guide to tetanus prophylaxis in wound management) in indication section of the approved product information provided as attachment 1]. although tetanus immunoglobulin and vaccine should be given at the same time, they should be administered in opposite limbs, using separate syringes.

Israel - English - Ministry of Health

kamada ltd, israel - plasma protein fraction - solution for infusion - plasma protein fraction 200 mg/ml - protein c - protein c - restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. the choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendation.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >95% immunoglobulins - solution for injection - 160 g/l

Ireland - English - HPRA (Health Products Regulatory Authority)

csl behring gmbh - human plasma protein - solution for injection - 250 international unit(s)/millilitre - specific immunoglobulins; tetanus immunoglobulin