Moldova - rumensk - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

glaxosmithkline biologicals s.a. - vaccin împotriva hepatitei virale b - suspensie injectabila in seringa preumpluta - 10 mcg/1 doza

Moldova - rumensk - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

glaxosmithkline biologicals s.a. - vaccin împotriva hepatitei virale b - suspensie injectabila in seringa preumpluta - 20 mcg/1 doza

Romania - rumensk - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

glaxosmithkline biologicals s.a. - belgia - vaccin hepatitic b - susp. inj. - 10µg/0,5ml - vaccinuri virale vaccinuri hepatitice

Romania - rumensk - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

glaxosmithkline biologicals s.a. - belgia - vaccin hepatitic b - susp. inj. - 20µg/ml - vaccinuri virale vaccinuri hepatitice

Tyskland - tysk - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

axicorp pharma gmbh (8055874) - hepatitis b-oberflächenantigen (hbsag), rekombinant - suspension zur injektion - teil 1 - suspension zur injektion; hepatitis b-oberflächenantigen (hbsag), rekombinant (31424) 10 mikrogramm

Tyskland - tysk - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

axicorp pharma b.v. (8140835) - hepatitis b-oberflächenantigen (hbsag), rekombinant - suspension zur injektion - teil 1 - suspension zur injektion; hepatitis b-oberflächenantigen (hbsag), rekombinant (31424) 20 mikrogramm

Brasil - portugisisk - ANVISA (Agência Nacional de Vigilância Sanitária)

glaxosmithkline brasil ltda - antígeno de superfície da hepatite b - vacinas

USA - engelsk - 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) - 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 (5.3).] 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).]

USA - engelsk - 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

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

laboratoire glaxosmithkline - antigène de surface de l'hépatite b recombinant 20 microgrammes - suspension - 20 microgrammes - pour une dose de 1 ml > antigène de surface de l'hépatite b recombinant 20 microgrammes - vaccin contre l’hépatite b - classe pharmacothérapeutique - code atc :sans objet.engerix b 20 microgrammes/1 ml est un vaccin utilisé pour prévenir l'infection par le virus de l'hépatite b. il peut également aider à prévenir l’infection par le virus de l’hépatite d.ce vaccin peut être administré aussi bien aux adultes qu’aux adolescents âgés de 16 ans et plus. dans certaines conditions exceptionnelles, il peut également être administré aux enfants et adolescents âgés de 11 à 15 ans (voir rubrique 3).l'hépatite b est une maladie infectieuse du foie causée par un virus. certaines personnes portent le virus de l'hépatite b dans leur organisme, mais ne peuvent pas s’en débarrasser. elles peuvent toujours infecter d’autres personnes et sont considérées comme porteuses du virus. la maladie est propagée par le virus qui pénètre dans l'organisme après un contact avec des fluides corporels, le plus souvent par le sang d'une personne infectée.si la mère est porteuse du virus ; elle peut le transmettre à son bébé à la naissance. il est également possible d'attraper le virus d’un porteur, par exemple, par le biais de rapports sexuels non protégés, de partage d’aiguilles d'injection ou lors d’un traitement par un équipement médical n’ayant pas été correctement stérilisé.les principaux signes de la maladie incluent maux de tête, fièvre, nausées et jaunisse (jaunissement de la peau et des yeux) mais, chez environ 3 patients sur 10 il n'y a aucun signe de maladie.chez les personnes infectées par l'hépatite b, 1 adulte sur 10 et jusqu’à 9 bébés sur 10 deviendront porteurs du virus et seront susceptibles de continuer à développer des lésions hépatiques graves et, dans certains cas un cancer du foie.comment engerix b 20 microgrammes/1 ml fonctionne :engerix b 20 microgrammes/1 ml contient une petite quantité de « l’enveloppe externe » du virus de l'hépatite b. cette « enveloppe externe » n'est pas contagieuse et ne peut pas vous rendre malade. lorsque l’on vous administrera le vaccin, il va déclencher le système immunitaire de votre corps pour le préparer à se protéger contre ces virus dans le futur. engerix b 20 microgrammes/1 ml ne vous protègera pas si vous êtes déjà infecté par le virus de l'hépatite b. engerix b 20 microgrammes/1 ml peut seulement vous aider à vous protéger contre l'infection par le virus de l'hépatite b.