natgillin/translations-raw huggingface dataset:
Hvordan virker Firdapse? 
How does Firdapse work?
Alternative vaccinationsprogrammer: 
Alternative vaccination schedules:
AFLUNOV skal anvendes i overensstemmelse med de officielle anbefalinger. 
AFLUNOV should be used in accordance with official recommendations.
I sådanne tilfælde vil Western Blot-metoden være negativ. 
In such cases, the Western Blot method is negative.
Dato for første markedsføringstilladelse: 29. november 2010 Dato for seneste fornyelse: 17. juli 2015 
Date of first authorisation: 29 November 2010 Date of latest renewal: 17 July 2015
Der blev observeret tilsvarende tendenser for seroprotektionsrater i begge studier. 
Similar trends were observed for seroprotection rates in both studies.
Hvis dette gælder for dig, vil din vaccination som regel blive udsat, indtil du har det bedre. 
If this applies to you then your vaccination will usually be postponed until you are feeling better.
Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italien. 
Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy.
Der foreligger ingen data vedrørende human fertilitet. 
There are no data concerning human fertility.
I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil. 
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be taken by a state laboratory or a laboratory designated for that purpose.
Andre sjældne bivirkninger, som er set efter rutinemæssig brug: 
Other rare side effects observed after routine use:
- Øvrige indholdsstoffer: 
- Other ingredients:
Når en person får vaccinen, vil immunsystemet (kroppens naturlige forsvar) skabe sin egen beskyttelse (antistoffer) mod sygdommen. 
When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
HI-resultater for de to kliniske studier viste lavere værdier end de, der er rapporteret i tidligere studier. 
HI results for the two clinical studies revealed lower values than those reported in previous studies.
1105BJ Amsterdam Holland 
1105BJ Amsterdam Netherlands
Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) 
Periodic Safety Update Reports (PSURs)
Infektioner hos mennesker opstår primært ved kontakt med inficerede dyr og spredes ikke let mellem mennesker. 
Human infections are primarily caused by contact with infected animals, but do not spread easily between people.
Disse forbigående falsk positive resultater kan skyldes IgM-produktion som respons på vaccinen. 
These transitory false positive results may be due to IgM production in response to the vaccine.
- Italien 
- Italy
Inspicér suspensionen visuelt inden administration. 
Visually inspect the suspension prior to administration.
• hvis du har en alvorlig infektion og feber (temperatur over 38 °C). 
• if you have a severe infection with a high temperature (over 38°C).
Ingen af ingredienserne i vaccinen kan give influenza. 
None of the ingredients in the vaccine can cause flu.
Forsøgspersoner med underliggende medicinske eller immunsuppressive tilstande: 
Subjects with underlying medical or immunosuppressive conditions:
SP = seroprotektion SC = serokonvertering 
SP= seroprotection SC= seroconversion
I tilfælde af eventuelle partikler og/eller abnormt udseende skal vaccinen kasseres. 
In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Enhver anden utilsigtet hændelse 
Any Other Adverse Event
• Stikkende eller pulserende smerte langs en eller flere nerver 
• Severe stabbing or throbbing pain along one or more nerves
Feber ≥ 38 °C (≥ 40 °C) 
Fever ≥ 38°C (≥ 40°C)
Krydsreaktivitetsdata for voksne 
Cross reactivity data in adults
Vaccinering anbefales i øjeblikket ikke hos denne aldersgruppe. 
Vaccination is currently not recommended in this age group.
Det immunologiske respons kan blive nedsat, hvis patienten er i immunsuppressiv behandling. 
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Fortæl lægen, hvis du har et svagt immunforsvar eller et underliggende langvarigt medicinsk problem. 
Tell your doctor if you have a weak immune system or an underlying long term medical problem.
Udløbsdatoen (efter Exp) er den sidste dag i den nævnte måned. 
The expiry date refers to the last day of that month.
For at forbedre sporbarheden af biologiske lægemidler skal navn og batchnummer på det administrerede præparat registreres tydeligt. 
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
BILAG II A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET 
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Lokale Systemiske 
Local Systemic
Resultaterne er vist ved SRH. 
Results are shown by SRH.
AFLUNOV er også beregnet til at blive givet, når der er forventning om en mulig pandemi som følge af den samme eller en tilsvarende stamme. 
AFLUNOV is intended also to be given when there is anticipation of a possible pandemic due to the same or a similar strain.
Kliniske studier i specielle populationer 
Clinical trials in special populations
Det er vigtigt at træffe sikkerhedsforanstaltninger for at undgå kvæstelser ved besvimelse. 
It is important that procedures are in place to avoid injury from faints
Immunisering skal udskydes hos patienter med febril sygdom eller akut infektion. 
Immunization shall be postponed in patients with febrile illness or acute infection.
Der bør gives endnu en dosis på 0,5 ml efter et interval på mindst 3 uger. 
A second dose of 0.5 ml should be given after an interval of at least 3 weeks.
Lægerne kender til denne risiko, og de har derfor udstyr til akut behandling til brug i disse tilfælde. 
Doctors are aware of this possibility and have emergency treatment available for use in such cases.
I et lignende studie blev intranasal challenge udskudt til ca. 4 måneder efter administration af den anden dosis vaccine. 
In a similar study, intranasal challenge was delayed until approximately 4 months after the second dose of vaccine was administered.
- Adjuvans MF59C.1: 
- Adjuvant MF59C.1:
Yderligere oplysninger) 
Further information);
Langsigtet booster-immunhukommelse: 
Long term booster immune memory:
Pædiatrisk population AFLUNOVs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt. 
Paediatric population The safety and efficacy of AFLUNOV in subjects under 18 years of age have not yet been established.
En sådan situation kræver hurtig indberetning af sikkerhedsoplysninger, der i høj grad kan påvirke balancen mellem risici og fordele under en pandemi. 
Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler. 
In the absence of compatibility trials, this medicinal product must not be mixed with other medicinal products.
• hvis du skal have taget en blodprøve for at afgøre, om du har bestemte virusinfektioner. 
• if you are having a blood test to look for evidence of infection with certain viruses.
Det skal bemærkes, at bivirkningerne kan intensiveres. 
It should be noted that the adverse reactions may be intensified.
Procentdelen af forsøgspersoner, der rapporterede om lokale reaktioner, var højere i de ældste aldersgrupper, hovedsagelig pga. flere rapporter om smerte. 
The percentages of subjects reporting local reactions were higher in the older age groups, mainly due to the higher reports for pain.
Uanset antigendosis blev næsten alle systemiske reaktioner indberettet på vaccinationsdagen (dag 1) eller i løbet af de efterfølgende 3 dage. 
Irrespective of antigen dose, almost all systemic reactions were reported on the day of vaccination (day 1) or during the 3 days immediately following.
Lægen eller sygeplejersken vil give dig vaccinen i overensstemmelse med de officielle retningslinjer. 
Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Immunogeniciteten blev vurderet hos 182 forsøgspersoner. 
Immunogenicity was assessed in 182 subjects.
Endvidere er opkastning hyppigt rapporteret. 
In addition, vomiting was commonly reported.
Der foreligger ingen data for børn under 6 måneder. 
No data are available in children aged less than 6 months.
Vaccination beskyttede dyrene mod letal challenge, selv når HI-antistoftitrene var lave eller ikke kunne detekteres. 
Vaccination protected animals from lethal challenge even when HI antibody titres were low or undetectable.
Børn fra 6 måneder til 17 år 
Children from 6 months to 17 years of age
Lungeskader var mindre hos de vaccinerede grupper. 
Lung damage was reduced in vaccinated groups.
Børn under 6 måneder Vaccinering anbefales i øjeblikket ikke hos denne aldersgruppe. 
Children aged less than 6 months of age Vaccination is currently not recommended in this age group.
Herudover er bivirkningerne i listen nedenfor set i dagene eller ugerne efter vaccination med vacciner, som gives rutinemæssigt hvert år for at forebygge sæsoninfluenza. 
In addition, the side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent seasonal flu.
Virkning mod challenge med det heterologe virus A/Indonesia/5/2005 blev også testet. 
Efficacy against challenge with the heterologous virus A/Indonesia/5/2005 was also tested.
Under en pandemisk situation vil den hyppighed, hvormed PSUR'er skal indsendes i henhold til artikel 24 i forordning 726/2004/EF, ikke være tilstrækkelig til sikkerhedsovervågning af en pandemisk vaccine, for hvilken der forventes høje eksponeringsniveauer inden for et kort tidsrum. 
During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation 726/2004/EC will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
I sådanne tilfælde skal du være opmærksom på, at bivirkningerne kan være mere intense. 
In such cases, you should be aware that the side effects may be more intense.
Din læge må vurdere fordelene og de mulige risici ved at give dig vaccinen. 
Your doctor needs to assess the benefits and potential risks of giving you the vaccine.
Disse bivirkninger forsvinder som regel inden for 1-2 dage uden behandling. 
These side effects usually disappear within 1-2 days without treatment.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du får vaccinen. 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before receiving this vaccine.
Spontant rapporterede utilsigtede hændelser efter markedsføring og et interventionsstudie tyder ikke på direkte eller indirekte skadelige virkninger af Focetria-ekponering på graviditet. 
Post-marketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
• Neuritis (nervebetændelse) 
• Neuritis (inflammation of nerves)
Farmakoterapeutisk klassifikation: Influenzavaccine, ATC-kode J07BB02. 
Pharmacotherapeutic group: Influenza vaccine ATC Code J07BB02.
Efter omrystning er det normale udseende af AFLUNOV en mælkehvid suspension. 
After shaking, the normal appearance of AFLUNOV is a milky-white suspension.
En dosis på 0,5 ml på en udvalgt dato. 
One dose of 0.5 ml at an elected date.
I dette studie var 100 % af dyrene beskyttet mod homolog challenge, og 81 % af dyrene var beskyttet mod heterolog challenge. 
In this study 100% of animals were protected against homologous challenge, and 81% of animals were protected against heterologous challenge.
Hovedparten af disse bivirkninger forsvinder som regel inden for 1-2 dage uden behandling. 
The majority of these side effects usually disappear within 1-2 days without treatment.
Vaccinen må under ingen omstændigheder administreres intravaskulært eller intradermalt. 
The vaccine should under no circumstances be administered intravascularly or intradermally.
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).