Australia - Kiingereza - 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 - Kiingereza - 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.

Marekani - Kiingereza - NLM (National Library of Medicine)

a-s medication solutions - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) (unii: 5bfc8lz6lq) (hepatitis a virus strain hm175 antigen (formaldehyde inactivated) - unii:5bfc8lz6lq) - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) 1440 [iu] in 1 ml - havrix is indicated for active immunization against disease caused by hepatitis a virus (hav). havrix is approved for use in persons 12 months of age and older. primary immunization should be administered at least 2 weeks prior to expected exposure to hav. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis a-containing vaccine, or to any component of havrix, including neomycin, is a contraindication to administration of havrix [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there are no adequate and well-controlled studies of havrix in pregnant women in the u.s. available data do not suggest an increased risk of major birth defects and miscarriage in women who received havrix during pregnancy (see data) . there are no animal studies with havrix to inform use during pregnancy. data human data: in pre- and post-licensure clinical studies of havrix, 175 pregnant women (177 outcomes, including two sets of twins) were inadvertently administered havrix following their last menstrual period. after excluding ectopic pregnancies (n = 2), molar pregnancies (n = 1), elective terminations (n = 22, including one of a fetus with a birth defect), those that were lost to follow-up (n = 9), and those with an unknown exposure timing (n = 5), there were 138 known pregnancy outcomes with exposure during the first or second trimester. of these, miscarriage was reported in 11% of pregnancies exposed prior to 20 weeks gestation (15/136) and major birth defects were reported in 3.3% (4/123) of live births. the rates of miscarriage and major birth defects were consistent with estimated background rates. risk summary there is no information regarding the presence of havrix in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for havrix and any potential adverse effects on the breastfed child from havrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. the safety and effectiveness of havrix, doses of 360 el.u. or 720 el.u., have been evaluated in more than 22,000 subjects aged 1 to 18 years. the safety and effectiveness of havrix have not been established in subjects younger than 12 months. clinical studies of havrix did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects. subjects with chronic liver disease had a lower antibody response to havrix than healthy subjects [see clinical studies (14.3)] .

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

dynavax gmbh - hepatitis b surface antigen - hepatitis b - vaccines - heplisav b is indicated for the active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes of hepatitis b virus in adults 18 years of age and older. the use of heplisav b should be in accordance with official recommendations.it can be expected that hepatitis d will also be prevented by immunisation with heplisav b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

Israeli - Kiingereza - Ministry of Health

sanofi israel ltd - hepatitis a vaccines - suspension for injection - hepatitis a vaccines 80 units / 0.5 ml - hepatitis a, inactivated, whole virus - hepatitis a, inactivated, whole virus - avaxim 80 u pediatric is indicated for active immunisation against infection caused by hepatitis a virus in children aged from 12 months to 15 years inclusive, who are at risk either of contaminating or spreading infection or of a life threatening disease if infected.

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

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

Israeli - Kiingereza - Ministry of Health

padagis israel agencies ltd, israel - hepatitis b immunoglobulin - solution for injection - hepatitis b immunoglobulin 220 iu/ml - hepatitis b immunoglobulin - hepatitis b immunoglobulin - for post-exposure prophylaxis such as: - acute exposure to blood containing hbsag, - perinatal exposure of infants born to hbsag-positive mothers, - sexual exposure to hbsag positive persons, - household exposure to persons with acute hbv infections.

Israeli - Kiingereza - Ministry of Health

tzamal bio-pharma ltd - hepatitis b immunoglobulin - solution for injection - hepatitis b immunoglobulin 312 iu/ml - hepatitis b immunoglobulin - hepatitis b immunoglobulin - prevention of hepatitis b recurrence following liver transplantation : hepagam b is indicated for the prevetion of hepatitis b recurrence following liver transplantation in hbsag-positive liver transplant patients. hepagam b should be administered intravenously for this indication.postexposure prophylaxis : hepagam b is indicated for the 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 hbeag. perinatal exposure of infants born 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 index patient. hepagam b is indicated for intramuscular use only for these post-exposure prophylaxis indications.

Israeli - Kiingereza - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - hepatitis a virus antigen, inactivated - suspension for injection - hepatitis a virus antigen, inactivated 25 units / 0.5 ml - hepatitis a, inactivated, whole virus - hepatitis a, inactivated, whole virus - vaqta is indicated for active pre-exposure prophylaxis against disease caused by hepatitis a virus in children and adolescents 12 months of age and older .

Israeli - Kiingereza - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - hepatitis a virus antigen, inactivated - suspension for injection - hepatitis a virus antigen, inactivated 50 u/ml - hepatitis a, inactivated, whole virus - hepatitis a, inactivated, whole virus - vaqta is indicated for active pre-exposure prophylaxis against disease caused by hepatitis a virus in persons 2 years of age and older.