Армения - английски - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

serum institute of india pvt ltd. - hepatitis b surface antigene - suspension for injection - 20mcg/dose

Армения - английски - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

serum institute of india pvt ltd. - hepatitis b surface antigene - suspension for injection - 20mcg/dose

САЩ - английски - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p) - hepatitis b virus subtype adw2 hbsag surface protein antigen 10 ug in 0.5 ml - engerix-b is indicated for immunization against infection caused by all known subtypes of hepatitis b virus. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis b-containing vaccine, or to any component of engerix-b, including yeast, is a contraindication to administration of engerix-b [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 engerix-b 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 engerix-b during pregnancy (see data) . there are no animal studies with engerix-b to inform use during pregnancy. a developmental toxicity study was performed in female rats administered a vaccine with the same hepatitis b surface antigen component and quantity as engerix-b prior to mating and during gestation (0.2 ml at each occasion). this study revealed no adverse effects on fetal or pre-weaning development (see data ). data human data: in an evaluation of pre- and post-licensure clinical trials of engerix-b, 58 pregnant women were inadvertently administered engerix-b following their last menstrual period. after excluding elective terminations (n = 6), those with an unknown outcome (n = 3), those with exposure in the third trimester (n = 1), and those with an unknown exposure timing (n = 22), there were 26 pregnancies with known outcomes with exposure in the first or second trimester. miscarriage was reported in 11.5% of pregnancies with exposure prior to 20 weeks of gestation (3/26) and major birth defects were reported in 0% (0/23) of live births born to women with exposure during the first or second trimester. the rates of miscarriage and major birth defects were consistent with estimated background rates. no pregnancy registry for engerix-b was conducted. twinrix [hepatitis a & hepatitis b (recombinant) vaccine] is a bivalent vaccine containing the same hepatitis b surface antigen component and quantity as used in engerix-b. therefore, clinical data accrued with twinrix are relevant to engerix-b. a pregnancy exposure registry was maintained for twinrix from 2001 to 2015. the registry prospectively enrolled 245 women who received a dose of twinrix during pregnancy or within 28 days prior to conception. after excluding induced abortions (n = 6, including one of a fetus with congenital anomalies), those lost to follow-up (n = 142), those with exposure in the third trimester (n = 1), and those with an unknown exposure timing (n = 9), there were 87 pregnancies with known outcomes with exposure within 28 days prior to conception, or in the first or second trimesters. miscarriage was reported for 9.6% of pregnancies with exposure to twinrix prior to 20 weeks gestation (8/83). major birth defects were reported for 3.8% of live born infants whose mothers were exposed within 28 days prior to conception or during the first or second trimester (3/80). the rates of miscarriage and major birth defects were consistent with estimated background rates. animal data: in a developmental toxicity study, female rats were administered twinrix, which contains the same hepatitis b surface antigen component and quantity as engerix-b, by intramuscular injection on day 30 prior to mating and on gestation days 6, 8, 11, and 15. the total dose was 0.2 ml (divided) at each occasion (a single human dose is 1 ml). no adverse effects on pre-weaning development up to post-natal day 25 were observed. there were no fetal malformations or variations. risk summary there is no information regarding the presence of engerix-b 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 engerix-b and any potential adverse effects on the breastfed child from engerix-b or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of engerix-b have been established in all pediatric age-groups. maternally transferred antibodies do not interfere with the active immune response to the vaccine. [see adverse reactions (6), clinical studies (14.1, 14.3, 14.4).] the timing of the first dose in infants weighing less than 2,000 g at birth depends on the hbsag status of the mother. [see warnings and precautions ( 5.2).] clinical studies of engerix-b used for licensure did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. however, in later studies it has been shown that a diminished antibody response and seroprotective levels can be expected in persons older than 60 years.5 [see clinical studies (14.2).]

САЩ - английски - NLM (National Library of Medicine)

a-s medication solutions - hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p) - hepatitis b virus subtype adw2 hbsag surface protein antigen 10 ug in 0.5 ml - engerix-b® is indicated for immunization against infection caused by all known subtypes of hepatitis b virus. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis b-containing vaccine, or to any component of engerix-b, including yeast, is a contraindication to administration of engerix-b [see description (11)]. pregnancy category c animal reproduction studies have not been conducted with engerix-b. it is also not known whether engerix-b can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. engerix-b should be given to a pregnant woman only if clearly needed. it is not known whether engerix-b is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when engerix-b is administered to a nursing woman. safety and effectiveness of engerix-b have been established in all pediatric age-groups. maternally transferred antibodies do not interfere with the active immune response to the vaccine. [see adver

Европейски съюз - английски - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vaccines - twinrix adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis a and hepatitis b infection.

Израел - английски - Ministry of Health

scivac ltd, israel - hepatitis b vaccines - suspension for injection - hepatitis b vaccines 10 mcg/ml - hepatitis b, purified antigen - hepatitis b, purified antigen - for active immunization against hepatitis b virus. in high dose: it is indicated for imunization of neonates & children in highly endemic areas.

Израел - английски - Ministry of Health

scivac ltd, israel - hepatitis b vaccines - suspension for injection - hepatitis b vaccines 2.5 mcg / 0.5 ml - hepatitis b, purified antigen - hepatitis b, purified antigen - for active immunization against hepatitis b virus. in high dose: it is indicated for immunization of neonates & children in highly endemic areas.

Израел - английски - Ministry of Health

scivac ltd, israel - hepatitis b vaccines - suspension for injection - hepatitis b vaccines 5 mcg / 0.5 ml - hepatitis b, purified antigen - hepatitis b, purified antigen - for active immunization against hepatitis b virus. in high dose: it is indicated for immunization of neonates & children in highly endemic areas.

Европейски съюз - английски - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vaccines - ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-a and hepatitis-b infection.protection against hepatitis-b infections may not be obtained until after the second dose.therefore:ambirix should be used only when there is a relatively low risk of hepatitis-b infection during the vaccination course;it is recommended that ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.

Европейски съюз - английски - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hepatitis b, recombinant surface antigen - hepatitis b; immunization - vaccines - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. the specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis-b infection. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. the specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis-b infection. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.,