New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) - solution for injection - 400 iu - active: hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) excipient: glycine water for injection - 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

biotest pharma gmbh - human plasma protein >96% immunoglobulins - solution for infusion - 50 gram(s)/litre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - varicella-zoster immunoglobulin human - solution for injection - 250mg

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma limited - human plasma protein - solution for infusion - %v/v - blood substitutes and plasma protein fractions

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human plasma protein - solution for infusion - . percent volume/volume - blood substitutes and plasma protein fractions

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human plasma protein - powder and solvent for solution for infusion - blood substitutes and plasma protein fractions

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

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.

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - human cytomegalovirus immunoglobulin in 50mg/ml human plasma protein (igg ≥ 96%) - injection - 100 u/ml - human cytomegalovirus immunoglobulin in 50mg/ml human plasma protein (igg ≥ 96%) 100 u/ml

Israel - English - Ministry of Health

kamada ltd, israel - cytomegalovirus antibody; human plasma protein; immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 96 %; human plasma protein 50 mg/ml; cytomegalovirus antibody 100 u/ml - cytomegalovirus immunoglobulin - prophylaxis of clinical manifestations of cytomegalovirus infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.the concomitant use of adequate virostatic agents should be considered for cmv-prophylaxis.