Israel - English - Ministry of Health

csl behring ltd., israel - c - 1 esterase inhibitor human - powder for solution for inj/inf - c - 1 esterase inhibitor human 500 iu/vial - c1- inhibitor,plasma derived - c1- inhibitor,plasma derived - hereditary angioedema type i and ii (hae).treatment and pre-procedure (prior to oral, dental, and upper respiratory tract procedures) prevention of acute episodes

Israel - English - Ministry of Health

csl behring ltd., israel - albumin human - solution for infusion - albumin human 200 mg/ml - albumin - albumin - hypoalbuminemia (liver cirrhosis nephrosis) toxic processes ( pregnancy toxicosis, hyperbilirubinemia ) ,volume substitution therapy.

Israel - English - Ministry of Health

csl behring ltd., israel - anti-d immunoglobulins - solution for injection - anti-d immunoglobulins 150 mcg/ml - anti-d (rh) immunoglobulin - anti-d (rh) immunoglobulin - prophylaxis of rh (d) immunisation in rh (d)-negative women: anti-d immune globulin is administered for the prevention of rh (d) immunization if it has been demonstrated or if it is suspected that fetal erythrocytes have entered the circulation of the mother. treatment is not necessary when it is assured that the child or the father are rh (d)- negative. criteria for a rhesus-incompatible pregnancy and the administration of anti-d immune globulin are : a) the mother is rh (d) -negative b) the child is either rh (d)-positive rh (d)weak - positive or its rhesus type is not known. routine antepartum prophylaxis : to prevent rh (d) immunisation due to spontaneous fetomaternal haemorrhage (fmh) during the last trimester of pregnancy. postpartum prophylaxis to prevent rh (d) immunisation of the rh (d)-negative mother following delivery of a rh (d)-positive child. complications of pregnancy: interventions during pregnancy such as invasive prenatal diagnosis (e.g. amniocentesis chorionic villus sampling fetal blood sampling) or other intrauterine procedures (e.g. insertion of shunts embryo reduction) external version of the fetus and therapeutic abortion. incidents during pregnancy such as antepartum haemorrhage spontaneous abortion ruptured tubal pregnancy ectopic pregnancy stillbirths intrauterine death and abdominal trauma. treatment of rh (d) -negative persons after incompatible transfusions of rh (d)-positive blood or erythrocyte concentrate: prevention of rh (d) immunisation in rh (d)-negative persons who for any reason have been given blood or blood components containing rh (d)-positive red cells.

Israel - English - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 200 mg / 1 ml - immunoglobulins, normal human, for extravascular adm. - replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency and wiskott-aldrich syndrome - igg subclass deficiencies with recurrent infectionsreplacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

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

csl behring australia pty ltd - hepatitis b immunoglobulin, quantity: 400 iu; human immunoglobulin g, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; hepatitis b immunoglobulin, quantity: 100 iu - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - indications as at 8 august 2002 : hepatitis b immunoglobulin is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive material or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin is also indicated for prophylaxis in infants born to hbsag-positive mothers. hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

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

csl behring australia pty ltd - anti-d rho immunoglobulin, quantity: 250 iu; anti-d rho immunoglobulin, quantity: 10 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - rh(d) immunoglobulin is indicated for the prevention of rh sensitisation in rh(d)negative females at or below child bearing age.

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

csl behring australia pty ltd - anti-d rho immunoglobulin, quantity: 625 iu; anti-d rho immunoglobulin, quantity: 30 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - indications as at 6 august 2002 : rh(d) immunoglobulin is indicated for the prevention of rh sensitisation in rh(d) negative females at or below child bearing age.

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; zoster immunoglobulin, quantity: 200 iu - injection, solution - excipient ingredients: water for injections; glycine; human immunoglobulin a - indications as at 8 august 2002 : zoster immunoglobulin 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 history of chickenpox. 4. if zoster immunoglobulin can be administered within 96 hours after exposure. zoster immunoglobulin, normal immunoglobulin (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 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.

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.