Malta - English - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - immunoglobulin antihepatitis - solution for injection - immunoglobulin antihepatitis b 100 iu/ml - immune sera and immunoglobulins

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - hepatitis b immunoglobulin, human 220 iu/ml (from us plasma) - solution for injection - 220 iu/ml - active: hepatitis b immunoglobulin, human 220 iu/ml (from us plasma) excipient: glycine water for injection - hepatitis b immunoglobulin (human) is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete or when the antibody level is inadequate i.e. (human) with hepatitis b vaccine will provide both short and long-term protection. this post exposure prophylaxis should be considered following either parenteral exposure, direct mucous membrane contact, oral ingestion, sexual exposure to an hbsag-positive person and for infants hepatitis b immunoglobulin (human) can also be considered for haemodialysis patients and receptors of certain blood products unable to develop adequate immune protection.

European Union - English - EMA (European Medicines Agency)

biotest pharma gmbh - human hepatitis b immunoglobulin - immunization, passive; hepatitis b; liver transplantation - immune sera and immunoglobulins, - prevention of hepatitis b virus (hbv) re-infection in hbsag and hbv-dna negative adult patients at least one week after liver transplantation for hepatitis b induced liver failure. hbv-dna negative status should be confirmed within the last 3 months prior to olt. patients should be hbsag negative before treatment start. the concomitant use of adequate virostatic agents should be considered as standard of hepatitis b re-infection prophylaxis.,

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

csl behring australia pty ltd - hepatitis b immunoglobulin, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine - 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 (< 10 iu/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 - hepatitis b immunoglobulin, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine - 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 (< 10 iu/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.

United States - English - NLM (National Library of Medicine)

adma biologics, inc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 1560 [iu] in 5 ml - indications and usage nabi-hb, hepatitis b immune globulin (human), is indicated for treatment of acute exposure to blood containing hbsag, perinatal exposure of infants born to hbsag-positive mothers, sexual exposure to hbsag-positive persons and household exposure to persons with acute hbv infection in the following settings: acute exposure to blood containing hbsag following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving hbsag-positive materials such as blood, plasma, or serum. perinatal exposure of infants born to hbsag-positive mothers infants born to mothers positive for hbsag with or without hbeag12. sexual exposure to hbsag-positive persons sexual partners of hbsag-positive persons. household exposure to persons with acute hbv infection infants less than 12 months old whose mother or primary caregiver is positive for hbsag. other household contacts with an identifiable blood exposure to the i

United States - English - NLM (National Library of Medicine)

adma biologics, inc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 312 [iu] in 1 ml - indications and usage nabi-hb, hepatitis b immune globulin (human), is indicated for treatment of acute exposure to blood containing hbsag, perinatal exposure of infants born to hbsag-positive mothers, sexual exposure to hbsag-positive persons and household exposure to persons with acute hbv infection in the following settings: acute exposure to blood containing hbsag following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving hbsag-positive materials such as blood, plasma, or serum. perinatal exposure of infants born to hbsag-positive mothers infants born to mothers positive for hbsag with or without hbeag12. sexual exposure to hbsag-positive persons sexual partners of hbsag-positive persons. household exposure to persons with acute hbv infection infants less than 12 months old whose mother or primary caregiver is positive for hbsag. other household contacts with an identifiable blood exposure to the i

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

immunoglobulin g - human; immunoglobulin - hepatitis b; hepatitis b immunoglobulin -

Singapore - English - 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

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - zoster immunoglobulin, human 100 iu/ml (immunoglobulin ex nz) - granules 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.