natgillin/translations-raw huggingface dataset:
Endvidere viste to store observationsstudier, der var rettet mod vurdering af sikkerheden af Focetriaeksponering under graviditet, ingen stigning i forekomsten af gestationel diabetes, præeklampsi, aborter, dødfødsler, lav fødselsvægt, præmaturitet, neonatal død og medfødte misdannelser blandt næsten 10.000 vaccinerede gravide kvinder og deres børn sammenlignet med ikke-vaccinerede kontroller.
In addition, two large observational studies designed to assess the safety of Focetria exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10,000 vaccinated pregnant women and their offspring compared with unvaccinated controls.
Efter en influenzavaccination kan der forekomme falsk positive serologiske resultater opnået ved ELISA-metoden for antistof mod human immundefektvirus-1 (HIV-1), hepatitis C-virus og især humant T-lymfotropt virus type 1 (HTLV-1).
Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, human T-lymphotropic virus type 1 (HTLV-1).
** geometriske middelratioer af SRH
** geometric mean ratios of SRH
Der kan opstå allergiske reaktioner efter vaccinationen, som i sjældne tilfælde kan medføre shock.
Allergic reactions may occur following vaccination, in rare cases leading to shock.
Ikke anvendt vaccine samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
Any unused vaccine and waste material should be disposed of in accordance with local requirements.
De potentielle fordele for moderen og risici for barnet skal overvejes, før AFLUNOV administreres under amning.
The potential benefits to the mother and risks to the infant should be considered before administering AFLUNOV during breast-feeding.
Data for børn og unge antyder et svagt fald i bivirkninger efter den anden dosis af vaccinen, uden øgning i forekomsten af feber.
Data in children and adolescents suggest a slight decrease in side effects after the second dose of the vaccine, with no increase in rates of fever.
AFLUNOV indeholder natrium og kalium
AFLUNOV contains sodium and potassium.
AFLUNOV kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, AFLUNOV can cause side effects, although not everybody gets them.
Immunresponset var lavere i gruppen, der fik den 2. dosis efter 1 uge og højere i grupper med længere intervaller i programmet.
The magnitude of immune response was lower in the group who received the 2nd dose 1 week later and higher in the groups with longer interval schedules.
Sundhedspersonalet må vurdere fordele og potentielle risici ved administration af vaccinen til gravide kvinder under hensyntagen til de officielle anbefalinger.
Healthcare providers need to assess the benefit and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
Fritter fik én eller to doser vaccine (A/Vietnam/1194/2004).
Ferrets received one or two doses of vaccine (A/Vietnam/1194/2004).
Som med alle vacciner er det ikke sikkert, at AFLUNOV beskytter alle vaccinerede personer fuldstændigt.
As with all vaccines, AFLUNOV may not fully protect all persons who are vaccinated.
En mindre infektion, såsom en forkølelse, er normalt ikke nogen hindring, men din læge eller sygeplejerske afgør, om du alligevel kan vaccineres med AFLUNOV
A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with AFLUNOV;
Sundhedspersonalet må derfor afveje fordele og potentielle risici ved administration af vaccinen til personer med trombocytopeni eller enhver blødningsforstyrrelse, der ville kontraindicere intramuskulær injektion, medmindre den potentielle fordel opvejer risikoen for blødning.
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Hos immunsvækkede forsøgspersoner i alderen 18 til 60 år blev der imidlertid rapporteret lidt højere forekomst af kvalme (13,0 %).
However, in immunocompromised subjects 18 through 60 years of age, slightly higher rates of nausea (13.0%) were reported.
• Generelle hudreaktioner inklusive
• Generalised skin reactions including
Advarsel: Må ikke injiceres intravaskulært eller intradermalt.
Warning: Do not inject intravascularly or intradermally.
Den leveres i en injektionssprøjte klar til brug med en enkelt dosis på 0,5 ml til injektion.
It is provided in a ready-to-use pre-filled syringe, containing a single dose of 0.5 ml for injection.
Voksne år)*
Adults years)*
Uanset alder var procentdelen af forsøgspersoner, der indberettede feber, lav.
Across all ages, low percentages of subjects reported fever.
Derfor skal indehaveren af markedsføringstilladelsen, så snart pandemien erklæres, og den zoonotiske vaccine anvendes, indsende hyppigere, forenklede PSUR'er i det format og efter den tidsplan, der er defineret i ”CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context” (EMEA/49993/2008), og eventuelle efterfølgende opdateringer.
In consequence, as soon as the pandemic is declared and the zoonotic vaccine is used, the Marketing Authorisation Holder (MAH) shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the “CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context” (EMEA/49993/2008), and any subsequent update.
Som med alle injicerbare vacciner skal relevant medicinsk behandling og mulighed for overvågning altid være let tilgængelig i tilfælde af en sjælden anafylaktisk reaktion efter indgift af vaccinen.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Viral shedding og virustiter i lungerne var også mindre, hvilket tyder på, at vaccination kan mindske risikoen for virusoverførsel.
Viral shedding and viral titres in lungs were also reduced, suggesting that vaccination may reduce the risk of viral transmission.
AFLUNOV giver muligvis ikke fuld beskyttelse til alle, der vaccineres, især ældre personer, og personer med svækket immunforsvar, såsom HIV-patienter, eller personer med underliggende langvarige medicinske problemer, såsom diabetes, lungesygdom eller hjerteproblemer.
AFLUNOV may not fully protect everyone who is vaccinated, especially elderly subjects and those with weakened immune systems, such as HIV patients, or those with underlying long term medical problems, such as diabetes, lung disease or heart problems.
Endvidere blev der rapporteret højere forekomst af artralgi (op til 23,3 %) hos både voksne og ældre forsøgspersoner, der var immunsvækkede eller havde underliggende medicinske tilstande.
In addition, higher rates of arthralgia (up to 23.3%) were reported in both adult and elderly subjects, who were immunocompromised or with underlying medical conditions.
Voksne og ældre (18 år og derover):
Adults and elderly (18 years of age and above):
Derudover vil de ressourcer, som er nødvendige for en dybtgående evaluering af PSUR'er i det format, der er defineret i bind 9a af The Rules Governing Medicinal Product in the European Union, måske ikke være tilstrækkelige under en pandemi til hurtig at kunne identificere et nyt sikkerhedsproblem.
In addition, duration a pandemic, resources needed for an in-depth evaluation of PSURs in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med AFLUNOV i en eller flere undergrupper af den pædiatriske population til aktiv immunisering mod influenza A-H5N1-virus.
The European Medicines Agency has deferred the obligation to submit the results of studies with AFLUNOV in one or more subsets of the paediatric population in active immunisation against H5N1 subtype of Influenza A virus.
Adjuvans: MF59C.1-olie-i-vand-emulsion, der indeholder squalen, som oliefasen stabiliseret med polysorbat 80 og sorbitantrioleat.
Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate.
Følgende forespurgte bivirkninger blev endvidere indsamlet i disse to studier og rapporteret med følgende hyppigheder hos forsøgspersoner, der fik AFLUNOV, uanset alder og helbredsstatus: diarré (op til 11,9 %), appetitløshed (op til 10,9 %) og opkastning (op til 1,7 %).
The following solicited adverse reactions were additionally collected in these two studies and reported with the following frequencies across subjects who received AFLUNOV irrespective of age or health status: diarrhoea (up to 11.9%), loss of appetite (up to 10.9%) and vomiting (up to 1.7%).
Uanset alder var reaktogeniciteten højere efter den første dosis end efter den anden vaccination.
Regardless of age, reactogencity was higher after the first dose than after the second vaccination.
To doser vaccine beskyttede 92 % af dyrene, og en enkelt dosis vaccine beskyttede 50 % af dyrene mod challenge med A/Indonesia/5/2005-virussen.
Two doses of vaccine protected 92% of animals, and a single dose of vaccine protected 50% of animals against challenge with the A/Indonesia/5/2005 virus.
Da 2 doser anbefales, skal det bemærkes, at der ikke foreligger data om sikkerhed, immunogenicitet og virkning, der understøtter muligheden for at erstatte AFLUNOV med andre monovalente H5N1-vacciner.
Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of AFLUNOV with other H5N1 monovalent vaccines.
Nogle af de virkninger, som er nævnt under pkt.
Some effects mentioned under section 4.
Immunogeniciteten blev vurderet hos en subgruppe (N=197) af forsøgspopulationen.
Immunogenicity was assessed in a subset (n=197) of subjects .
Zoonotiske influenzavira inficerer af og til mennesker og kan forårsage sygdom, der spænder fra en let infektion i de øvre luftveje (feber og hoste) til hurtig udvikling til kraftig lungebetændelse, akut respiratorisk distress syndrom, shock og endog dødsfald.
Zoonotic influenza viruses occasionally infect humans, and can cause disease ranging from mild upper respiratory infection (fever and cough) to rapid progression to severe pneumonia, acute respiratory distress syndrome, shock and even death.
Et studie med kaniner viste ingen reproduktions- eller udviklingstoksicitet for AFLUNOV (se pkt.
A study in rabbits did not indicate reproductive or developmental toxicity of AFLUNOV (see section 5.3).
Der var 3.872 forsøgspersoner i alderen 18-60 år, 365 forsøgspersoner i alderen 61-70 år og 89 forsøgspersoner over 70 år.
There were 3872 subjects 18-60 years of age, 365 subjects 61-70 years of age, and 89 subjects greater than 70 years of age.
MN-resultater viste i lighed med SRH-resultater et stærkt immunrespons efter gennemførelse af priming-vaccinationsserien hos en population af ældre forsøgspersoner.
MN results, similar to SRH results, demonstrated strong immune response after completion of priming vaccination series in a population of elderly subjects.
Anti-HA antistof (SRH)
Anti-HA antibody (SRH)
AFLUNOV indeholder mindre end 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) per 0,5 ml dosis, dvs. at det i det væsentlige er natrium- og kaliumfrit.
AFLUNOV contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium-free.
MN-resultaterne gav en GMR mod A/turkey/Turkey/2005 i området fra 1,59 til 2,95.
MN results yielded a GMR against A/turkey/Turkey/2005 ranging from 1.59 to 2.95.
Det skal du vide, før du får AFLUNOV Få ikke AFLUNOV:
What you need to know before you receive AFLUNOV You should not receive AFLUNOV:
* formeret i befrugtede hønseæg fra sunde hønsehold ** udtrykt som mikrogram hæmagglutinin.
* propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
Dyrene fik én eller to doser vaccine indeholdende 3,75 eller 7,5 mikrogram antigen, efterfulgt af challenge med en letal dosis A/Vietnam/1203/04-virus.
Animals received one or two doses of vaccine containing 3.75 or 7.5 micrograms of antigen, followed by challenge with a lethal dose of A/Vietnam/1203/04 virus.
Medicinske tilstande
Medical conditions
Adjuvans MF59C.1 indeholdende: squalen
Adjuvant MF59C.1 containing: squalene
I en pandemisk situation kan det dog være hensigtsmæssigt for dig at blive vaccineret med AFLUNOV under forudsætning af, at der er adgang til passende, akut medicinsk behandling, hvis det skulle blive nødvendigt i tilfælde af en allergisk reaktion.
However, in a pandemic situation, it may be appropriate for you to be vaccinated with AFLUNOV provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Suspensionen er en mælkehvid væske.
The suspension is a milky-white liquid.
• Allergiske reaktioner, muligvis med åndenød, hivende vejrtrækning, hævelse af svælget eller førende til et farligt fald i blodtrykket, som kan føre til shock, hvis det ikke behandles.
• Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Virkning mod challenge med vira, der er homologe og heterologe med virusstammer, blev evalueret i frittemodellen.
Efficacy against challenge with virus homologous and heterologous to vaccine strains was evaluated in the ferret model.
Eksponeringsomfanget taget i betragtning er hurtig analyse af de samlede sikkerhedsoplysninger afgørende for lovmæssige beslutninger og beskyttelse af befolkningen, som skal vaccineres.
Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Disse studier tilvejebragte begrænsede immunogenicitetsdata for forsøgspersoner med visse underliggende medicinske (især nedsat nyrefunktion og perifer kardiovaskulær sygdom) og immunsuppressive tilstande (især transplantatmodtagere og patienter i cancerbehandling).
These studies provided limited immunogenicity data in subjects with some underlying medical (in particular, renal impairment and peripheral cardiovascular disease) and immunosuppressive conditions (in particular, transplant recipients and patients under cancer treatment).
Brug ikke AFLUNOV efter den udløbsdato, der står på pakningen.
Do not use AFLUNOV after the expiry date which is stated on the carton and the label.
Meget almindelige bivirkninger i aldersgruppen 36 måneder til 17 år var smerter, hovedpine og træthed.
Very commonly reported reactions in the 36 months to 17 years of age group were pain, headache and fatigue.
Forekomster af bivirkninger, der blev indberettet efter en hvilken som helst vaccinationsdosis (dvs. 1., 2. eller booster-), var sammenlignelige og er anført efter følgende hyppighed i henhold til MedDRA-konventionen og systemorganklasse:
The adverse reaction rates reported after any vaccination doses (i.e. 1st, 2nd or booster) were similar and are listed according to the following MedDRA frequency convention and system organ class:
I begge studier blev immunogeniciteten af AFLUNOV vist ved hjælp af HI-, SRH- og MN-analyser efter både den første og anden dosis.
In both trials, immunogenicity of AFLUNOV was shown by HI, SRH and MN assays following both the first and second dose.
• i tilfælde af immundefekter kan der gives AFLUNOV, men det er ikke sikkert, at der fremkaldes et beskyttende immunrespons.
• in the presence of immune deficiencies AFLUNOV may be administered but a protective immune response may not be elicited.
I overensstemmelse med data fra studier for at observere bestemte reaktioner var der en generel tendens til, at antallet af rapporter om lokale reaktioner efter den anden vaccination var mindre end efter den første vaccination.
Consistent with the data observed by trial for solicited reactions, there was a general trend towards decreased reports of local reactions after the second vaccination compared with the first injection.
Besvimelse kan opstå efter, eller endda før, enhver injektion med en kanyle.
Fainting can occur following, or even before, any needle injection.
Foreliggende data fra pædiatrisk population
Available data in paediatric population
Bivirkningerne nedenfor er opstået under kliniske studier med AFLUNOV hos voksne, inklusive ældre:
The side effects listed below have occurred with AFLUNOV in clinical studies in adults, including the elderly:
Endvidere kan patienter med endogen eller iatrogen immunsuppression have et utilstrækkeligt antistofrespons til tilvejebringelse af beskyttelse.
In addition, antibody responses in patients with endogenous or iatrogenic immunosuppression may be insufficient to provide protection.
Da AFLUNOV ikke forventes anvendt i akutte situationer, kan administrationen af vaccinen under graviditet eventuelt udskydes af forsigtighedshensyn.
Since AFLUNOV is expected not to be used in an emergency situation, its administration during pregnancy might be deferred as a precautionary approach.
Graden af beskyttelse, der muligvis fremkaldes mod H5N1-stammer af andre clader, er dog ukendt.
However, the degree of protection that may be elicited to H5N1 strains of other clades is unknown (see section 5.1).
Indsendelse af periodiske sikkerhedsopdateringsrapporter (PSUR'er), når AFLUNOV anvendes under en influenzapandemi:
PSUR submission when AFLUNOV is used during an influenza pandemic:
Alle dyr, der fik 2 doser AFLUNOV, var beskyttet, og 94 % af de dyr, der fik en enkelt dosis AFLUNOV, var beskyttet.
All animals receiving 2 doses of AFLUNOV were protected, and 94% of animals receiving a single dose of AFLUNOV were protected.
En tredje (booster-) dosis AFLUNOV blev administreret 6 måneder og derefter efter den primære vaccination.
A third (booster) dose of AFLUNOV was administered 6 months onwards after the primary vaccination.
Ældre år)*
Elderly years)*
I en pandemisk situation forårsaget af den stamme, der indgår i denne vaccine, kan det dog være hensigtsmæssigt at give denne vaccine til personer med anafylaksi i anamnesen som defineret ovenfor, forudsat at der kan skaffes øjeblikkelig adgang til genoplivningsudstyr, hvis behovet skulle opstå.
However, in a pandemic situation caused by the strain included in this vaccine, it may be appropriate to give this vaccine to individuals with a history of anaphylaxis as defined above, provided that facilities for resuscitation are immediately available in case of need.
De prækliniske data opnået med AFLUNOV og med sæsoninfluenzavaccine indeholdende MF59C.1-adjuvans viser ingen særlig risiko for mennesker ud fra konventionelle undersøgelser af toksicitet efter gentagne doser, lokal tolerance, kvindelig fertilitet og reproduktionstoksicitet og udvikling (til og med slutningen af amningsperioden).
Non-clinical data obtained with AFLUNOV and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
• Hævelse, smerter og rødme på injektionsstedet, der dækker mere end 10 cm og varer mere end én uge (cellulitislignende reaktion på injektionstedet)
• swelling, pain and redness at the injection site extending to more than 10 cm and lasting more than one week (Injection site cellulitis-like reaction)
Fortæl venligst din læge eller sundhedspersonalet, hvis du har blødningsproblemer eller nemt får blå mærker.
Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Hos børn og unge var smerte den hyppigst rapporterede forventelige lokale reaktion, og træthed og hovedpine var de mest almindeligt rapporterede forventelige systemiske reaktioner.
In children and adolescents, pain was the most frequently reported solicited local reaction, and fatigue and headache were the most commonly reported solicited systemic reactions.
Blod og lymfesystem Trombocytopeni (i visse tilfælde med reversibelt fald i trombocyttal til under 5.000/mm³)
Blood and lymphatic system disorders Thrombocytopenia (in some cases reversible platelet counts less than 5000 mm3).
Erfaringerne hos ældre over 70 år er begrænsede.
There is limited experience in elderly over 70 years of age.
Der er ikke fastlagt noget immunkorrelat for beskyttelse mod influenza A (H5N1).
Protection against influenza There is no immune correlate of protection established for influenza A (H5N1).
*faktisk aldersinterval for inkluderet population
*actual age range of population enrolled
Systemorganklasse i henhold til MedDRA
MedDRA System Organ class Very common
EU/1/10/658/001 1 fyldt sprøjte EU/1/10/658/002 10 fyldte sprøjter
EU/1/10/658/001 1 prefilled syringe EU/1/10/658/002 10 prefilled syringes
• Feber og kvalme
• Fever and nausea
87 % af de dyr, der blev inficeret med en virus, der var heterolog til vaccinestammen, var beskyttet efter 2 doser vaccine og en enkelt dosis heterolog vaccine beskyttede 56 % af dyrene.
87% of animals challenged with virus heterologous to the vaccine strain after 2 doses of vaccine were protected, and a single dose of heterologous vaccine protected 56% of the animals.
Persistens af antistoffer efter primær vaccination i denne population blev vurderet med hæmagglutinationsinhiberings (HI)-, SRH- og MN-analyser.
Persistence of antibodies after primary vaccination in this population was assessed by hemagglutination inhibition (HI), SRH, and MN assays.
Forekomsten af bivirkninger er blevet evalueret i syv kliniske studier hos raske forsøgspersoner omfattende over 4.300 voksne og ældre, der fik AFLUNOV (mindst 7,5 µg HA, adjuveret).
The incidence of adverse reactions has been evaluated in seven clinical trials in healthy subjects involving over 4300 adults and elderly receiving AFLUNOV (at least 7.5 µg HA, adjuvanted).
Der er observeret en vis grad af krydsreaktiv immunitet mod H5N1-vira af andre clader end vaccinestammen.
Some degree of cross-reactive immunity has been observed against H5N1 viruses of clades different to that of the vaccine strain.
Bivirkningsovervågning efter markedsføring Der foreligger ingen data fra overvågning efter markedsføring efter administration af AFLUNOV.
Post-marketing surveillance No post-marketing surveillance data are available following AFLUNOV administration.
Injektion 1
Injection 1
I sammenligning med antistofniveauer dag 43 efter gennemførelse af det primære vaccinationsprogram var antistofniveauerne ved dag 202 reduceret med 1/5 til ½ i forhold til de tidligere niveauer.
Compared to the antibody levels obtained at day 43 after completion of primary vaccination schedules, antibody levels at day 202 were reduced by 1/5 to 1/2 from their prior levels.
Vaccinen skal have stuetemperatur før brug.
The vaccine should be allowed to reach room temperature before use.
Injektion 2
Injection 2
I begge studier rapporterede forsøgspersoner med underliggende medicinske og immunsuppressive tilstande højere hyppigheder af diarré, appetitløshed og opkastning sammenlignet med raske forsøgspersoner (uanset alder).
In both studies, subjects with underlying medical and immunosuppressive conditions reported higher frequencies of diarrhoea, loss of appetite and vomiting compared to healthy subjects (irrespective of age).