USA - engelsk - NLM (National Library of Medicine)

aptevo biotherapeutics llc - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - human varicella-zoster immune globulin 125 [iu] - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. - there is no convincing evidence that varizig reduces the incidence of chickenpox infection after exposure to vzv. - there is no convincing evidence that established infections with vzv can be modified by varizig administration. - there is no indication for the prophylactic use of varizig in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone m

USA - engelsk - NLM (National Library of Medicine)

cangene biopharma - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - human varicella-zoster immune globulin 1.25 [iu] in 1 ml - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. pregnancy category c. animal reproduction studies have not been conducted with varizig. it also is not known whether varizig can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. varizig should be given to a pregnant woman only if clearly needed. the safety and effectiveness of varizig have been evaluated for post-exposure prophylaxis in clinical trials in 166 pregnant women [see 6 adverse reactions and 14 clinical studies]. it is not known whether varizig is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when varizig is administered to a nursing moth

USA - engelsk - NLM (National Library of Medicine)

kamada ltd. - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - varizig ® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. - there is no convincing evidence that varizig reduces the incidence of chickenpox infection after exposure to vzv. - there is no convincing evidence that established infections with vzv can be modified by varizig administration. - there is no indication for the prophylactic use of varizig in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone marrow transplantation. - individuals known to have anaphylactic or severe systemic (hypersensitivity) reactions to human immune globulin preparations should not receive varizig. - iga-deficient patients with antibodies against iga and a history of hypersensitivity may have an anaphylactoid reaction. - varizig contains less than 40 micrograms per milliliter of iga. animal reproduction studies have not been conducted with varizig. it also is not known whether varizig can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. varizig should be given to a pregnant woman only if clearly needed. the safety and effectiveness of varizig have been evaluated for post-exposure prophylaxis in clinical trials in 166 pregnant women [see 6adverse reactions and 14clinical studies ]. it is not known whether varizig is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when varizig is administered to a nursing mother. the dosing recommendations in the treatment of pediatric patients are by body weight [see 2dosage and administration ]. the safety and effectiveness of varizig have been evaluated for post-exposure prophylaxis in the varizig expanded access clinical trial in 374 pediatric patients, including immunocompromised pediatric patients: - 94 preterm newborns and infants, - 53 term newborns, - 45 infants and toddlers, - 176 children and, - 43 adolescents. in the eap, follow up data were available for 110 varizig treatments in infants (including newborns, pre-term infants, and infants less than 1 year old). three severe infections were reported, all three with pox count greater than 100, one of which also had pneumonia and another one also developed probable varicella encephalitis. clinical studies of varizig administered intramuscularly for post-exposure prophylaxis did not include sufficient numbers of geriatric subjects (aged 65 and over) to determine whether they respond differently from younger subjects. use caution when administering varizig to patients aged 65 and over who are judged to be at increased risk of thrombotic events [see 5warnings and precautions ]. do not exceed recommended doses and administer varizig intramuscularly only. in the eap, both adult (n=37) and pediatric immunocompromised subjects (n=235) were treated. twelve immunocompromised subjects developed clinical varicella and none developed varicella pneumonitis; however at least five are reported to have received concomitant acyclovir and due to incomplete reporting, it is not known if others also received acyclovir.

USA - engelsk - NLM (National Library of Medicine)

saol therapeutics - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. - there is no convincing evidence that varizig reduces the incidence of chickenpox infection after exposure to vzv. - there is no convincing evidence that established infections with vzv can be modified by varizig administration. - there is no indication for the prophylactic use of varizig in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone m

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

msd france - virus de la varicelle souche oka (vivant - poudre - supérieur ou égal 1350 ufp - pour une dose de 0,5 ml de suspension reconstituée > virus de la varicelle souche oka (vivant, atténué supérieur ou égal 1 350 ufp solvant > pas de substance active. - vaccins viraux – virus de la varicelle - classe pharmacothérapeutique : vaccins viraux – virus de la varicelle, code atc : j07bk01.varivax est un vaccin qui permet la protection contre la varicelle des adultes et des enfants. les vaccins sont utilisés pour vous protéger, vous ou votre enfant, contre les maladies infectieuses.varivax peut être administré aux personnes âgées de 12 mois ou plus.varivax peut être administré aux nourrissons à partir de l'âge de 9 mois dans certaines circonstances, conformément au calendrier vaccinal national ou lors de situations épidémiques.il peut aussi être administré aux personnes n'ayant pas d'antécédent de varicelle, mais ayant été exposées à la varicelle.une vaccination dans les 3 jours suivant l'exposition peut aider à prévenir la varicelle ou à diminuer sa sévérité résultant en des lésions cutanées moindres et une durée plus courte de la maladie. de plus, il existe des données limitées montrant qu'une vaccination dans les 5 jours suivant l'exposition peut réduire la sévérité de la maladie.comme tout autre vaccin, varivax ne protège pas complètement tous les individus contre les formes naturellement acquises de varicelle.

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

laboratoire glaxosmithkline - virus de la varicelle souche oka (vivant - poudre - au minimum 10^^3.3 ufp - pour une dose de 0,5 ml > virus de la varicelle souche oka (vivant, atténué au minimum 10^^3.3 ufp solvant > pas de substance active. - vaccins viraux - classe pharmacothérapeutique : vaccins viraux, vaccins contre varicelle-zona, code atc : j07bk01.varilrix est un vaccin qui peut être utilisé chez les sujets âgés de 12 mois et plus afin de les protéger de la varicelle. dans certaines circonstances, varilrix peut également être administré aux nourrissons à partir de 9 mois.une vaccination dans les 3 jours suivant l’exposition à un patient ayant la varicelle peut aider à éviter la varicelle ou à diminuer la sévérité de la maladie.comment agit varilrixlorsqu’une personne est vaccinée avec varilrix, le système immunitaire (le système de défense naturelle de l’organisme) fabrique des anticorps pour protéger la personne contre l’infection par le virus de la varicelle.varilrix contient des virus atténués qui sont très peu susceptibles de provoquer la varicelle chez des sujets en bonne santé.comme pour tous les vaccins, varilrix peut ne pas protéger complètement tous les sujets vaccinés.

Canada - engelsk - Health Canada

cangene corporation a subsidiary of emergent biosolutions inc. - varicella zoster immunoglobulin (human) - kit - 125unit - varicella zoster immunoglobulin (human) 125unit - serums

Den europeiske union - kroatisk - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - tip osobe papillomavirus1 16 Л1 sirutke papilloma virus tipa 18 Л1 proteina - papillomavirus infections; uterine cervical dysplasia; immunization - cjepiva - cervarix je cjepivo namijenjeno u dobi od 9 godina za prevenciju premaligne ano-genitalnih lezija (vrata maternice, vulve, vaginalni i analni) i raka vrata maternice i analni uzročno povezan s određene onkogenih tipova humanog papiloma virusa (hpv). pogledajte odjeljke 4. 4 i 5. 1 za važne informacije o podacima koji podržavaju ovu oznaku. primjena Церварикс mora biti u skladu sa službenim preporukama.

Den europeiske union - tysk - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - menschliche papillomavirus1 typ 16 l1-protein hpv-typ 18 l1-protein - papillomavirus infections; uterine cervical dysplasia; immunization - impfstoffe - cervarix ist ein impfstoff für den einsatz ab dem alter von 9 jahren zur vorbeugung von prämaligne ano-genitale läsionen (gebärmutterhalskrebs, vulva, vaginal und anal) und gebärmutterhalskrebs und analem krebs ursächlich im zusammenhang mit bestimmter onkogene humane papillomavirus (hpv). siehe abschnitte 4. 4 und 5. 1 für wichtige informationen zu den daten, die diese indikation unterstützen. die verwendung der impfstoffe sollten in übereinstimmung mit den offiziellen empfehlungen.

Den europeiske union - rumensk - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - omului papillomavirus1 tip 16 proteina l1, papilomavirus uman tip 18 proteina l1 - papillomavirus infections; uterine cervical dysplasia; immunization - vaccinuri - cervarix este un vaccin pentru utilizare la vârsta de 9 ani pentru prevenirea premaligne leziunile ano-genitale (col uterin, vulvare, vaginal şi anal) şi tipuri de cancer de col uterin şi anal cauzal legate de anumite tipuri de papilomavirus uman (hpv) oncogenic. vezi secțiunile 4. 4 și 5. 1 pentru informații importante privind datele care susțin această indicație. utilizarea cervarix trebuie să fie în conformitate cu recomandările oficiale.