New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - immunoglobulin g 0.06 g/ml - solution for injection - 0.06 g/ml - active: immunoglobulin g 0.06 g/ml excipient: maltose water for injection - intragam® p is indicated for replacement igg therapy in primary immunodeficiency diseases (pid).

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 1000 [iu] (100iu/ml when reconstituted with 10ml water for injection) - injection with diluent - 1000 iu - active: factor ix 1000 [iu] (100iu/ml when reconstituted with 10ml water for injection) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - monofix®-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix®-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix®-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 500 [iu] (human coagulation 100iu/ml when reconstituted with 5ml water for injections) - injection with diluent - 500 iu - active: factor ix 500 [iu] (human coagulation 100iu/ml when reconstituted with 5ml water for injections) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - monofix®-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix®-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix®-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 500 [iu] (50 iu/ml when reconstituted with 10 ml water for injections) - injection with diluent - 50 iu/ml - active: factor ix 500 [iu] (50 iu/ml when reconstituted with 10 ml water for injections) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - monofix®-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix®-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix®-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

New Zealand - English - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ii 500 [iu] (approx.); factor ix 500 [iu]; factor x 500 [iu] (approx.) - powder for injection with diluent - active: factor ii 500 [iu] (approx.) factor ix 500 [iu] factor x 500 [iu] (approx.) excipient: antithrombin iii heparin sodium water for injection - treatment and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required. treatment and prophylaxis of bleeding in patients with single or multiple congenital deficiency of factor ix, ii or x when purified specific coagulation factor product is not available.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - tetanus immunoglobulin, human 250 [iu] (immunoglobulin ex nz =160mg/ml) - solution for injection - 250 iu - active: tetanus immunoglobulin, human 250 [iu] (immunoglobulin ex nz =160mg/ml) excipient: glycine - tetanus immunoglobulin-vf 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 vaccine dose. in all the above instances, active immunisation with a tetanus vaccine should be commenced at the same time according to current datasheet recommendations.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - antithrombin iii 1000 [iu] (aust) - powder for injection - 1000 iu - active: antithrombin iii 1000 [iu] (aust) excipient: chlorine citric acid monohydrate sodium water for injection - thrombotrol(r)-vf is indicated in patients with hereditary deficiency of atiii under the following circumstances: · prophylactic administration for the prevention of thrombosis and pulmonary embolism in surgery, pregnancy and childbirth · therapeutic administration in thrombosis or pulmonary embolism

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - zoster immunoglobulin, human 100 iu/ml (immunoglobulin ex nz) - solution for injection - 200 iu/2ml - active: zoster immunoglobulin, human 100 iu/ml (immunoglobulin ex nz) excipient: glycine - zoster immunoglobulin-vf is indicated for prophylaxis against varicella in patients who meet all four of the criteria listed below: 1. one of the following underlying illnesses or conditions: a. neoplastic disease (leukaemia or lymphoma) b. congenital or acquired immunodeficiency c. immunosuppressive therapy with steroids or antimetabolites. 2. one of the following types of exposure to chickenpox or shingles patients: a. household contact b. playmate contact (> 1 hour play indoors) c. hospital contact (in same 2 to 4 bedroom or adjacent beds in a large ward) d. newborn contact (newborn of mother who had onset of chickenpox < 5 days before delivery or within 48 hours after delivery) e. premature infant (> 28 weeks gestation) whose mother lacks a prior history of chickenpox f. premature infant (< 28 weeks gestation or < 1000g) regardless of maternal history. 3. negative or unknown prior history of chickenpox. 4. if zoster immunoglobulin-vf can be administered within 96 hours after exposure. zoster immunoglobulin-vf, normal immunoglobulin-vf (immunoglobulin for intramuscular use) or plasma are of no value in the treatment of established varicella or zoster infection. high levels of circulating antibody do not prevent dissemination of infection. zoster immunoglobulin-vf is not indicated for prophylactic use in immunodeficient children or adults when there is a history of varicella, unless the patient's immunosuppressed status is that which is associated with bone marrow transplantation.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pusat darah negara - factor ix fraction,dried; factor x/stuart factor; factor ii/prothrombin -