natgillin/translations-raw huggingface dataset:
Denne vaccine kan administreres samtidigt med hepatitis B immunglobulin, men på separate injektionssteder.
82 This vaccine can be administered simultaneously with hepatitis B immunoglobulin, at a separate injection site.
77 Denne vaccine kan anvendes til at fuldføre en primærimmunisering eller som revaccinering hos personer der tidligere har modtaget en anden hepatitis B vaccine.
This vaccine can be used to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine.
HVORDAN DE ANVENDER HBVAXPRO 40 mikrogram/ ml
HOW TO USE HBVAXPRO 40 micrograms/ ml
Den anbefalede dosis pr. injektion (1 ml) er 40 mikrogram til voksne prædialyse - og dialysepatienter.
The recommended dose for each injection (1 ml) is 40 micrograms for predialysis and dialysis adult patients
Skemaet omfatter 2 injektioner med 1 måneds interval efterfulgt af en tredje injektion 6 måneder efter første administration (0, 1, 6 måneder).
The schedule is two injections with an interval of one month followed by a third injection 6 months after the first administration (0,1,6 months).
En boosterdosis til disse patienter skal overvejes, hvis antistofniveauet mod hepatitis B virus overflade- antigen er mindre end 10 IE/ l.
A booster dose must be considered in these vaccinees if the antibody level against hepatitis B virus surface antigen is less than 10 IU/ l.
Hvis De glemmer at tage en dosis HBVAXPRO 40 mikrogram/ ml:
If you forget one dose of HBVAXPRO 40 micrograms/ ml:
HVILKE MULIGE BIVIRKNINGER HBVAXPRO 40 mikrogram/ ml HAR
POSSIBLE SIDE EFFECTS
78 opkastning, kvalme, diaré, mavepine, hudreaktioner såsom eksem, udslæt, hårtab, kløe, nældefeber og vabler i huden, ledsmerter, ledbetændelse, muskelsmerter, smerter i arm eller ben, træthed, feber, utilpashed, influenzalignende symptomer og forhøjede leverenzymer.
83 Other side effects are reported very rarely: low platelet count, lymph node disease, allergic reactions, nervous system disorders such as pins and needles, facial paralysis, nerve inflammations including Guillain-Barre Syndrome, inflammation of the nerve of the eye that leads to impaired vision, brain inflammation, exacerbation of multiple sclerosis, multiple sclerosis, convulsions, headache, dizziness and fainting, low blood pressure, blood vessel inflammation, asthma-like symptoms, vomiting, nausea, diarrhoea, abdominal pain, skin reactions such as eczema, rash, hair loss, itching, hives and skin blistering, joint pain, arthritis, muscle pain, pain in extremity, fatigue, fever, vague illness, flu-like symptoms and elevations of liver enzymes.
HVORDAN DE OPBEVARER HBVAXPRO 40 mikrogram/ ml
HOW TO STORE HBVAXPRO 40 micrograms/ ml
Hvad HBVAXPRO 40 mikrogram/ ml indeholder
What HBVAXPRO 40 micrograms/ ml contains
Produktets udseende og pakningsstørrelse
What HBVAXPRO 40 micrograms/ ml looks like and contents of the pack
79 For yderligere oplysninger om dette lægemiddel bedes henvendelse rettet til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
HBVAXPRO er en vaccine, der inducerer specifik humoral og cellulær immunrespons mod HBsAg, hvilket resulterer i aktiv immunisering mod infektion med hepatitis B- virus.
HBVAXPRO is a vaccine inducing a specific humoral and cellular immune response against HBsAg, which results in an active immunisation against Hepatitis B virus infection.
Fordelene ved HBVAXPRO er, at den giver effektiv beskyttelse mod Hepatitis B i alle aldersgrupper og ikke indeholder thiomersal i det færdige Spørgsmålene vedrørende den relativt lave immunogenicitet af Hepatitis B- komponenten (HepB) i produkt. vacciner indeholdende den rekombinante Hepatitis B- komponent fra SPMSD er blevet gennemgået og tilbundsgående drøftet af CHMP og dettes arbejdsgrupper (arbejdsgruppen vedrørende bioteknologi og arbejdsgruppen vedrørende vacciner).
Issues pertaining to the relatively low immunogenicity of the Hepatitis B (HepB) component contained in the vaccines containing the recombinant Hepatitis B component from SPMSD have been assessed and extensively discussed by the CHMP and its Working Parties (Biotechnology Working Party, Vaccines Working Party).
Den 26. maj 2005 vedtog CHMP at indkalde en ad hoc- ekspertgruppe vedrørende hepatitis til et møde vedrørende den langtids - og korttidsbeskyttelse, der ydes af rekombinante Hepatitis B- vacciner.
On 26 May 2005, the CHMP agreed on the need to convene an Ad Hoc Expert Group Meeting on Hepatitis short and long-term protection afforded by recombinant Hepatitis B vaccines.
CHMP gav udtryk for betænkelighed ved tegnene på en uforudsigelig variabilitet i antistof- responsen over for Hepatitis B efter vaccination med Hexavac.
The CHMP expressed concerns that there is evidence of unpredictable variability in Hepatitis B antibody response following vaccination with Hexavac.
Denne variabilitet synes at hænge sammen med de på nuværende tidspunkt ukontrollable afvigelser i fremstillingsprocessen for den rekombinante HepB- vaccinekomponent.
This variability seems to be related to currently uncontrollable variances in the manufacturing process of the recombinant HepB vaccine component.
Der blev udtrykt betænkelig ved den ringe immunogenicitet af HepB - komponenten i Hexavac og de mulige konsekvenser for den langsigtede beskyttelse mod infektion med Hepatitis B og for muligheden af senere boosting, når den vaccinerede har gennemgået det første vaccinationsprogram med denne vaccine.
Concerns were expressed on the low immunogenicity of the HepB component of Hexavac and the potential consequences on long-term protection against Hepatitis B infection and boostability post primary course of vaccination with this vaccine.
Efter suspenderingen af Hexavac på grund af reduceret immunogenicitet af Hep B- komponenten i vaccinen blev indehaveren af markedsføringstilladelsen (Sanofi Pasteur MSD) i september 2005 anmodet om at fremlægge yderligere oplysninger og afklaring vedrørende den langsigtede immunologiske hukommelse og beskyttelse med Hep B- virusinfektion, der ydes af HBVAXPRO og PROCOMVAX, og tidsplaner for, hvornår yderligere oplysninger ville blive til rådighed.
Following the suspension of Hexavac due to reduced immunogenicity of the Hep B component in the vaccine, the MAH (Sanofi Pasteur MSD) was requested in September 2005 to provide further data and clarification on long-term immunological memory and protection against Hep B viral infection afforded by HBVAXPRO and PROCOMVAX, and the timelines of availability of further data.
På plenarmødet i januar 2006 bekræftede CHMP sine betænkeligheder ved den aftagende immunogenicitet af den rekombinante Hep B- komponent i HBVAXPRO og PROCOMVAX.
In their January 2006 plenary meeting, the CHMP confirmed their concerns regarding the decreasing immunogenicity of the recombinant Hep B component contained in HBVAXPRO and PROCOMVAX.
De hidtidige resultater må derfor tolkes med varsomhed, da er opnået med den pædiatriske (5 µg) Hep B- vaccine, der var produceret før 2001.
As a consequence the data obtained so far must be interpreted with caution since they were generated using the paediatric (5µg) dose of Hep B vaccine produced before 2001.
Der er visse tegn på, at den nu producerede Hep B- vaccine er mindre immunogen end den, der blev produceret sidst i 1990' erne.
There are some indications that the Hep B vaccine currently produced is less immunogenic than the vaccine produced in the 1990’ s.
726/ 2004, efter at CHMP havde udtrykt betænkelighed vedrørende den lave immunogenicitet af HepB- komponenten i HBVAXPRO.
On 13 February 2006, the European Commission (EC) triggered the procedure under Article 20 of Regulation (EC) No 726/ 2004, after the CHMP expressed concerns on the low immunogenicity of the HepB component of HBVAXPRO.
CHMP blev anmodet om at afgive en udtalelse om, hvorvidt markedsføringstilladelsen for HBVAXPRO burde opretholdes, ændres, suspenderes eller inddrages ved en procedure i henhold til artikel 20 i forordning (EF) nr.
The CHMP was requested to give an opinion as to whether the marketing authorisation for HBVAXPRO should be maintained, varied, suspended or withdrawn in the context of an Article 20 of Regulation (EC) No.
1 DISKUSSION
DISCUSSION
Fra et kvalitetsmæssigt synspunkt kan immunogeniciteten af rekombinante hepatitis B- komponenter hos mennesker ikke forudsiges ad teknisk eller analytisk vej eller ved dyreforsøg.
From the quality point of view, there are no technical, analytical or animal tools able to predict immunogenicity of recombinant hepatitis B components in man.
Analytiske redskaber kan anvendes som kriterier for konsistens, men ikke som korrelater for sikkerhed og virkning (immunogenicitet) af Hepatitis B- lots produceret hos SPMSD.
Analytical tools can be used as consistency criteria, but not as correlates for safety and efficacy (immunogenicity) of Hepatitis B batches produced at SPMSD.
Da der ikke findes noget in vitro eller in vivo system, der er egnet til at forudsige tilfredsstillende immunogenicitet hos mennesker, er det vigtigt, at man på dette trin noterer sig, at den C3H- musemodel, der foreslås af indehaveren af markedsføringstilladelsen, synes at kunne skelne mellem de Hepatitis B- lots, der er tilfredsstillende, og dem, der ikke er det.
As there is no in vitro or in vivo system suitable to predict acceptable immunogenicity in man, it is important to note at this stage that the C3H mouse model suggested by the MAH appears to be able to discriminate between Hepatitis B lots which are acceptable and those who are not.
Det foreløbige resultat af en klinisk undersøgelse med de "procesopgraderede" Hepatitis B- lots bekræfter, at immunogeniciteten af den nuværende HBVAXPRO- vaccine er af den tidligere standard, og giver vidnesbyrd om en ensartet tendens i retning af højere gennemsnitlige antistoftitre (GMT) med HBVAXPRO fremstillet med den ændrede proces.
The interim outcome of a clinical trial with the ‘ process upgraded’ recombinant Hepatitis B batches confirms that the immunogenicity of the current HBVAXPRO vaccine is at the historic standard, and provides evidence for a consistent trend to higher GMTs with HBVAXPRO manufactured with the process modification.
De af CHMP gennemgåede oplysninger omfatter data fra syv undersøgelser med HBVAXPRO og Procomvax, hvoraf en er i gang på nuværende tidspunkt, Disse undersøgelser er udført hos forskellige risikogrupper og alderskategorier, dvs. børn født af Hepatitis B- positive mødre, spædbørn, raske unge, og raske i alderen 16- 35 år.
These trials were carried out in different risk groups and age categories, i. e. children born to Hepatitis B positive mothers, infants, healthy young adults and healthy subjects between 16-35 years of age.
Der er hverken vidnesbyrd om, at korttids - eller langtidsbeskyttelsen er forringet.
There is no evidence that either short or long term protection has been impacted.
Skønt der i visse af undersøgelserne fra de sidste fem år er opnået lavere antistoftiter med hepatitis B - vacciner end i begyndelsen af 1990' erne, viser de kliniske data, der er genereret af sponsoren i de ovenfor beskrevne undersøgelser, et ensartet højt beskyttelsesniveau af anti- HBs i serum, som er det anerkendte korrelat for virkning.
Although in some of the trials conducted in the past 5 years, the GMTs of the hepatitis B vaccines were lower than responses observed in the early 1990’ s, the clinical data generated by the sponsor in the trials described above, demonstrate consistent, high anti-HBs seroprotective rates, which is the established correlate of effectiveness.
En gennemgang af den kliniske virkning, vurderet på den opnåede beskyttelse mod sygdom som anført i V121- 018- undersøgelsen, giver desuden støtte for den konklusion, at hepatitis B- vaccinerne fortsat er effektive til at reducere infektion med hepatitis B og de svære sequelae heraf.
In addition, a review of clinical performance as assessed by protection against disease as noted in the V121-018 trial supports the conclusion that the hepatitis B vaccines remain effective in decreasing hepatitis B infection and its serious sequelae.
Den mest følsomme population over for en eventuel utilstrækkelig immunogenicitet af vaccinen vil være spædbørn født af Hepatitis B- positive mødre, da de har en høj infektionsrisiko.
Due to the relatively high risk of infection, the group of infants born to Hepatitis B positive mothers represents the population, which would be most vulnerable to a possible insufficient immunogenicity of the vaccine.
Da der aktuelt ikke findes indberetninger om et stigende antal Hepatitis B- gennembrud efter vaccination med HBVAXPRO, og i betragtning af, at EU er et område med lav endemisk forekomst af sygdommen, har CHMP ikke fundet noget umiddelbart faresignal vedrørende sikkerheden.
As there are currently no reports on increased numbers of Hepatitis B breakthrough cases after HBVAXPRO vaccination, considering that the EU is a low endemic region, no immediate safety signal could be identified by the CHMP.
De nyeste oplysninger om immunogenicitet kommer fra interimanalysen af undersøgelsenV232- 054, som er den tredje undersøgelse, der inden for de seneste få år er foretaget af det nuværende produkt (fra BTMC- produktionsanlægget) hos unge voksne med anvendelse af samme doseringsplan (de to andre undersøgelser er V501- 011 og V232- 052).
The most recent immunogenicity data comes from the interim analysis of the V232-054 trial, this is the third trial in the past few years to study the current product (from the BTMC manufacturing facility) in young adults using the same dosing schedule (the other two trials are V501-011 and V232- 052).
Resulta - terne af denne undersøgelse er derfor et vidnesbyrd om, at det aktuelle produkt giver det forventede niveau af beskyttende antistoffer hos alle de populationer, det er indiceret til.
Therefore, the results of this study provide evidence that the currently available product is providing the expected level of protective antibodies in all populations for which it is indicated.
Foruden af de immunogenicitetsdata, der de seneste 5 år er genereret i kliniske undersøgelser med HBVAXPRO og PROCOMVAX, bekræftes vaccinernes tilfredsstillende virkning af overvågningsresultater vedrørende hepatitis B i USA og New Zealand og af en trend- analyse af tilfælde
In addition to the immunogenicity data generated in the past 5 years from clinical trials with the HBVAXPRO and PROCOMVAX data, the acceptable performance of these vaccines are supported from findings of surveillance for hepatitis B cases in the United States and New Zealand and from an analysis of the trend in vaccine failures reported to the MAH safety database.
2 CHMP anmodede indehaveren af markedsføringstilladelsen om at udføre undersøgelser vedrørende nyfødte, spædbørn, ældre voksne, dialysepatienter, dosisfastlæggelse og en booster- undersøgelse med den aktuelle formulering og det proces- opgraderede produkt for at tilvejebringe yderligere sikkerhed for, at vaccinen giver tilstrækkelig langsigtet beskyttelse mod Hepatitis B.
The CHMP requested the MAH to conduct studies regarding neonates, infants, older adults, renal dialysis patients, dose ranging and a booster study with the current formulation and the process upgraded product to further ensure that the vaccine provides a sufficient level of long-term protection against Hepatitis B.
På baggrund af de manglende analytiske muligheder for at forudsige immunogeniciteten hos mennesker blev det overvejet, om rekombinante HepB- lots regelmæssigt bør testes i kliniske undersøgelser for at sikre vedholdende høj immunogenicitet af HBVAXPRO, specielt de lots, der er produceret med den nye opdaterede/ forbedrede proces.
In view of the lack of analytical tools to predict immunogenicity in man, the need for regular testing of recombinant HepB batches in clinical trials was considered, in order to ensure consistent high immunogenicity of HBVAXPRO produced in particular according to the new updated/ improved process.
CHMP aftalte med indehaveren af markedsføringstilladelsen, at denne – hvis der om 4 år ikke er igangværende kliniske undersøgelser af immunogeniciteten med det anvendte hepatitis B- antigen – fremover mindst hvert fjerde år udfører en undersøgelse af vaccinens immunogenicitet til bekræftelse af, at erfaringerne med det fremstillede produkt fortsat er gyldige, og at den kliniske virkning opfylder forventningerne.
The CHMP agreed with the MAH that in 4 years time, in the absence of ongoing clinical studies of immunogenicity with the MAH’ s hepatitis B antigen, the MAH will conduct a study of vaccine immunogenicity no less frequently than every four years to confirm that experience with manufactured product remains current and that clinical performance meets expectations.
Mens resultatet af undersøgelserne afventes, forpligter indehaveren af markedsføringstilladelsen sig til at ændre produktresuméets afsnit 4. 2, 4. 4, 4. 5 (når det er relevant) og 5. 1 som følger:
Pending the outcome of the studies, the MAH committed to amend the SPC sections 4.2, 4.4, 4.5 (where relevant) and 5.1 as follows:
• Det er blevet yderligere understreget, at det er nødvendigt at give den fjerde dosis ved 12 måneder, når det komprimerede program (0, 1, 2 og 12 måneder) anvendes. • Der er indført skærpede anbefalinger vedrørende serologisk testning og administration af supplerende doser efter behov hos immunkompromitterede patienter, ikke- responderende patienter i andre højrisikogrupper og ved formodet eksponering for hepatitis B. • Sideløbende administration af pneumokok- konjugatvaccine anbefales ikke, da dette ikke er undersøgt tilstrækkeligt med henblik på HBVAXPRO. • Hos de dialysepatienter, som ikke opnår tilstrækkelig antistoftiter efter boosting, bør brug af andre hepatitis B- vacciner overvejes.
• The need of the 4th dose at 12 months has been reinforced, when the compressed administration schedule 0, 1, 2 and 12 months is used • The recommendations for serologic testing, and administration of additional doses if needed, in immunocompromised patients, in non-responders of other high risk groups, and in the case of presumed exposure to hepatitis B, have been strengthened. • The concomitant administration of pneumococcal conjugate vaccine is not recommended since this has not been sufficiently studied for HBVAXPRO. • In renal dialysis patients in whom insufficient antibody titre is achieved after boosting, the use of alternative hepatitis B vaccines should be considered.
CHMP har desuden taget hensyn til de forpligtelser, som indehaveren af markedsføringstilladelsen har påtaget sig for at imødekomme CHMP' s anmodninger om fremtidig minutiøs kontrol af virkningen af HBVAXPRO i en bred vifte af kliniske undersøgelser hos alle alders - og risikokategorier.
The CHMP also considered the commitments given by the MAH in response to CHMP’ s requests to meticulously control the performance of HBVAXPRO from now on in a broad array of appropriate clinical trials including all age and risk categories.
Oplysningerne vil blive formidlet til sundhedspersoner og vil sikre, at vaccinen anvendes korrekt hos de forskellige alders - og risikogrupper.
Information will be provided to health care professionals and will ensure that the vaccine will be correctly used in the different age and risk categories.
CHMP godkendte de nye produktoplysninger og vedtog at afslutte artikel 20- proceduren uden yderligere indgreb.
The CHMP endorsed the new product information and agreed to finalise the article 20 procedure without any further regulatory action.
1, i forordning (EF) nr.
Considering all points raised, including time lines required to fully explore all issues related to low HepB immunogenicity following vaccination with HBVAXPRO and further to the assessment of the data provided by the MAH, the CHMP concluded that the MA of HBVAXPRO should be varied in accordance with Article 5(1) of Regulation (EC) No.
3 BEGRUNDELSE FOR ÆNDRING AF MARKEDSFØRINGSTILLADELSEN FOR HBVAXPRO
GROUNDS FOR THE VARIATION OF THE MARKETING AUTHORISATION OF HBVAXPRO
Ud fra følgende betragtninger:
WHEREAS
• CHMP fandt, at den nedsatte immunogenicitet af den HepB- komponent, der frigives af indehaveren af markedsføringstilladelsen, synes at skyldes variabilitet i produktionsprocessen for denne komponent, og at indehaveren af markedsføringstilladelsen efter en tilbundsgående gennemgang af produktionsprocessen har udpeget den nuværende adjuveringsproces som en mulig grundårsag til nedsat immunogenicitet af HepB- vaccinekomponenten.
• The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component and that following extensive review of the manufacturing process the MAH has identified the current adjuvantation process as a potential root cause for decreased immunogenicity of the HepB vaccine component.
• CHMP fandt, at benefit/ risk forholdet for HBVAXPRO fortsat er positivt til beskyttelse mod infektion med Hepatitis B virus forårsaget af alle kendte undertyper i alle aldersgrupper, som anses for at have en risiko for at blive eksponeret for hepatitis B virus,
• The CHMP considered that the benefit/ risk balance of HBVAXPRO concerning protection against hepatitis B virus infection caused by all known subtypes in all age categories considered at risk of exposure to hepatitis B virus remains favourable.
2, i forordning (EF) nr.
The CHMP has recommended the variation of the Marketing Authorisations for HBVAXPRO in accordance with Article 5(2) of Regulation (EC) No.
Pulveret er det aktive stof 13C- urea (45 mg til børn eller 75 mg til voksne).
The powder is the active substance 13C-urea (45 mg for children or 75 mg for adults).
Helicobacter Test INFAI kan anvendes til at teste voksne, unge, der er disponeret for peptisk ulcus, og børn i alderen 3- 11 år.
Helicobacter Test INFAI can be used to test adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years.
Herefter skal patienten indtage et 'testmåltid' (enten 200 ml ren appelsinjuice eller 1 g citronsyre opløst i 200 ml vand) efterfulgt af Helicobacter Test INFAI opløst i vand.
The patient then takes a ‘ test meal’ (either 200 ml of pure orange juice or 1 g of citric acid dissolved in 200 ml water), followed by the solution of Helicobacter Test INFAI dissolved in water.
Hos børn i alderen 3- 11 år skal 'testmåltidet' bestå af 100 ml ren appelsinjuice.
In children aged three to 11 years, the ‘ test meal’ should be 100 ml of pure orange juice.
De nærmere oplysninger om, hvordan testen udføres, fremgår af indlægssedlen.
The active substance in Helicobacter Test INFAI, 13C-urea, is the natural chemical urea that has been labelled with carbon-13 (13C).
Det aktive stof i Helicobacter Test INFAI, 13C- urea, er det naturlige kemikalie urea, der er blevet mærket med kulstof- 13 (13C).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged H. pylori contain enzymes called ureases that make it able to break down urea into carbon dioxide, which is then removed in the breath.
Når patienten tager Helicobacter Test INFAI, nedbrydes 13C- ureaet i testen af H. pylori til kuldioxid, der også indeholder 13C.
When the patient takes Helicobacter Test INFAI, the 13C-urea contained in the test is broken down by H Pylori into carbon dioxide that also contains 13C.
De fik alle 75 mg 13C- urea, med undtagelse af 204 børn under 11 år, som fik 45 mg.
All received 75 mg of 13C-urea, except 204 children under the age of 11 who received 45 mg.
I alle undersøgelser stemte resultaterne af testen udført med Helicobacter Test INFAI i over 95% af tilfældene overens med resultaterne fra endoskopien med den histologiske undersøgelse.
In all studies, the results of the test done using Helicobacter Test INFAI agreed with the results obtained with the endoscopy and histology in over 95% of cases.