FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection site pain and headache were common in the elderly.
Danish: Smerter på injektionsstedet og hovedpine var almindeligt hos ældre.
English: Very common
Danish: Meget almindelige
English: Adverse reactions are listed according to the following frequency:
Danish: Bivirkningerne er anført i henhold til nedenstående hyppigheder:
English: If you need a blood test to look for evidence of infection with certain viruses in the first few weeks after vaccination with Optaflu, the result of the test may not be correct.
Danish: Hvis De får taget en blodprøve til kontrol for visse virusinfektioner de første par uger efter vaccination med Optaflu, vil prøven måske give et forkert resultat.
English: Optaflu is a vaccine against flu (influenza).
Danish: Optaflu er en vaccine mod influenza.
English: A multinational (US, Finland, and Poland), randomized, observer-blinded, placebo-controlled trial was performed to assess clinical efficacy and safety of Optaflu during the 2007-2008 influenza season in adults aged 18 to 49 years.
Danish: Et multinationalt (udført i USA, Finland og Polen), randomiseret, observatørblindet, placebokontrolleret studie blev udført for at vurdere Optaflus kliniske virkning og sikkerhed hos voksne i alderen 18 til 49 år i løbet af influenzasæsonen 2007-2008.
English: Visually inspect the contents of each Optaflu syringe for particulate matter and/or change in colour prior to administration.
Danish: Kontrollere indholdet af hver sprøjte med Optaflu visuelt for partikelindhold og/eller farveændring før administration.
English: Organ class
Danish: Organklasse
English: Do not use this vaccine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke vaccinen efter den udløbsdato, der står på etiketten og på æsken efter EXP. Udløbsdatoen er
English: Overall 7253 single doses of Optaflu were administered to 6180 adults aged 18 - 60 years of age and to 1073 elderly (aged 61 years or older).
Danish: Der blev i alt administreret 7.253 enkeltdoser af Optaflu til 6.180 voksne i alderen 18-60 år og til 1.073 ældre (61 år og derover).
English: Common ≥ 1/100 to
Danish: Almindelige ≥ 1/100 til
English: Seroconversion/Significant increase rate
Danish: Serumbeskyttelse Serokonvertering/ signifikant stigning i %
English: Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02
Danish: Farmakoterapeutisk klassifikation: Influenzavaccine, ATC-kode: J07BB02
English: Optaflu is given to you by your doctor or nurse.
Danish: Optaflu gives af Deres læge eller sygeplejerske.
English: Note that the side effects of the vaccines may be intensified.
Danish: Bemærk, at bivirkningerne af vaccinerne kan forstærkes.
English: The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for
Danish: Vaccinen opfylder WHO's anbefalinger for den nordlige halvkugle samt EU's bestemmelser for
English: * propagated in Madin Darby Canine Kidney (MDCK) cells
Danish: * opformeret i Madin Darby Canine Kidney (MDCK)-celler
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Danish: De skal derfor fortælle det til lægen eller sygeplejersken, hvis De tidligere er besvimet i forbindelse med en injektion.
English: A total of 11,404 subjects were enrolled to receive Optaflu (N=3828), Agrippal (N=3676) or placebo (N=3900) in a 1:1:1 ratio.
Danish: I alt indgik 11.404 forsøgspersoner, der fik enten Optaflu (N=3.828), Agrippal (N=3.676) eller placebo (N=3.900) i forholdet 1:1:1.
English: Number of Subjects with Influenza
Danish: Antal forsøgspersoner med influenza
English: Date of latest renewal: 01 June 2012
Danish: Dato for første markedsføringstilladelse: 01. juni 2007 Dato for seneste fornyelse: 01. juni 2012
English: 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, HTLV-1.
Danish: Efter influenzavaccination kan serologitest målt ved ELISA-metoden give falsk positive resultater for antistoffer mod human immundefekt virus 1 (HIV-1), hepatitis C virus og navnlig HTLV-1.
English: The safety of Optaflu in pregnancy and breast-feeding has not been assessed in clinical trials.
Danish: Sikkerheden af Optaflu under graviditet og amning er ikke blevet vurderet i kliniske studier.
English: Very serious side effects
Danish: Ikke alvorlige bivirkninger
English: • Fainting can occur following, or even before, any needle injection.
Danish: • besvimelse kan opstå efter, eller endda før, enhver injektion med en kanyle.
English: If either condition exists, do not administer the vaccine.
Danish: Hvis et af disse forhold gør sig gældende, må vaccinen ikke administreres.
English: The limited data from influenza vaccinations in pregnant women do not indicate that there are negative effects for the unborn child.
Danish: De begrænsede oplysninger om influenzavaccination af gravide kvinder tyder ikke på, at det har nogen negative virkninger på det ufødte barn.
English: Therefore, Optaflu is not recommended for use in children and adolescents less than 18 years of age (see section 5.1).
Danish: Optaflu bør derfor ikke anvendes til børn og unge under 18 år (se pkt 5.1).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant
Danish: Det immunologiske respons kan reduceres, hvis patienten behandles med immunsuppressiva.
English: If you take any medicines against cancer (chemotherapy), corticosteroid medicines (such as cortisone) or other medicines affecting the immune system, the immune response of your body may be weakened.
Danish: Hvis De tager medicin mod kræft (kemoterapi), medicin, som indeholder kortikosteroid (såsom kortison) eller andet lægemiddel, som påvirker immunforsvaret, kan Deres krops immunrespons være svækket.
English: - Vasculitis, possibly associated with transient renal involvement
Danish: - Vaskulit, muligvis forbundet med forbigående nyrepåvirkning
English: Vaccine Efficacy = (1 - Relative Risk) x 100 %; ** There were too few cases of influenza due to vaccine-matched influenza A/H3N2 or B to adequately assess vaccine efficacy.
Danish: Vaccinens virkning = (1 - relativ risiko) x 100 %; ** Der var for få influenzatilfælde forårsaget af influenza A/H3N2 eller B, der matchede vaccinen, til at foretage en adækvat vurdering af vaccinens virkning.
English: Not known (cannot be estimated from the available data) • swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other
Danish: Hyppighed ikke kendt (kan ikke vurderes ud fra tilgængelige data): • hævelse, der er mest tydelig på hoved og nakke, inklusive ansigt, læber, tunge, hals eller andre
English: Across all three influenza strains, for the egg-derived vaccine seroprotection rates ranged between 85% and 98%, seroconversion or significant increase rates ranged between 62% and 73% and GMRs ranged between 5.52- and 8.76-fold over baseline HI titers.
Danish: For den ægderiverede vaccine lå serumbeskyttelsen for alle tre influenzastammers vedkommende på mellem 85 % og 98 %, serokonvertering eller signifikant stigning lå på mellem 62 % og 73 %, og GMR-værdierne var mellem 5,52 og 8,76 gange højere end HI-titrene ved baseline.
English: Safety and reactogenicity evaluations were performed for all subjects during the first 3 weeks following vaccination and SAEs have been collected for approximately 6700 vaccinees during six
Danish: Sikkerhed og reaktogenicitet blev vurderet hos alle forsøgspersoner i løbet af de første 3 uger efter vaccinationen, og alvorlige bivirkninger blev indsamlet hos cirka 6.700 vaccinerede i løbet af seks måneders followup.
English: * Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy of each influenza vaccine relative to placebo based on the Sidak-corrected score confidence intervals for the two relative risks.
Danish: * Samtidige ensidige konfidensintervaller på 97,5 % for vaccinens virkning for hver influenzavaccine i forhold til placebo baseret på Sidak-korrigerede konfidensintervaller for scoren for de to relative risici.
English: The European Medicines Agency has deferred the obligation to submit the results of studies withOptaflu in one or more subsets of the paediatric population in the prevention of influenza (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Optaflu i en eller flere undergrupper af den pædiatriske population til forebyggelse af influenza (se pkt.
English: 15 micrograms HA**
Danish: 15 mikrogram HA**
English: Not known (cannot be estimated from the available data) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Non-clinical data reveal no special hazard for humans based on conventional repeat dose toxicity studies.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser.
English: • if you are allergic to influenza vaccine or any of the other ingredients of this vaccine (listed in
Danish: • hvis De er allergisk over for influenzavaccine eller et af de øvrige indholdsstoffer i denne
English: Seroprotection is generally obtained within 3 weeks, as shown by the pivotal phase III clinical study V58P4 for the adult and elderly population.
Danish: Immunitet opnås generelt inden for 3 uger som vist i det pivotale, kliniske fase III-studie V58P4 for
English: ILI was defined according to Centers for Disease Control and Prevention (CDC) case definition, i.e., a fever (oral temperature ≥ 100.0°F / 38°C) and cough or sore throat.
Danish: Influenzalignende sygdomme blev defineret i henhold til definitionen fra Centers for Disease Control and Prevention (CDC), dvs. feber (oral temperatur ≥ 38 °C) og hoste eller ondt i halsen.
English: Data for elderly were as follows (values in brackets show the 95% confidence intervals):
Danish: Data for ældre var som følger (værdier i parentes viser 95 % konfidensintervallerne):
English: No case of overdose has been reported for Optaflu.
Danish: Der er ikke indberettet tilfælde af overdosering med Optaflu.
English: Your doctor will decide if you should receive Optaflu.
Danish: Deres læge vil afgøre, om De bør vaccineres
English: There is no human data on use of Optaflu during lactation.
Danish: Der er ingen humane data fra anvendelse af Optaflu under amning.
English: In this comparative trial against an egg-derived influenza vaccine the seroprotection* rate, seroconversion or significant increase rate** and the geometric mean ratio (GMR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
Danish: I denne komparative undersøgelse ved sammenligning med en ægderiveret influenzavaccine blev serumbeskyttelse*, serokonvertering eller signifikant stigning** og geometrisk middelværdi (GMR) for anti-HA-antistof (målt ved hæmagglutination-inhibition-assay, HI) vurderet ifølge prædefinerede kriterier.
English: No evidence of reproductive or developmental toxicity was seen in a study where the human dose of Optaflu was administered prior to and during gestatioin to female rabbits.
Danish: Der blev ikke påvist reproduktions- eller udviklingstoksicitet i et studie, hvor den humane dosis Optaflu blev administreret til hunkaniner inden og i løbet af drægtighedsperioden.
English: Data for adults were as follows (values in brackets show the 95% confidence intervals):
Danish: Data for voksne var som følger (værdier i parentes viser 95 % konfidensintervallerne):
English: • you should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see Section 2, “Taking other medicines”).
Danish: • skal De fortælle det til Deres læge, hvis Deres immunforsvar er nedsat, eller hvis De er i behandling med medicin, som påvirker immunforsvaret, f.eks. medicin mod kræft (kemoterapi) eller medicin, der indeholder kortikosteroid (se punkt 2 ”Brug af anden medicin sammen med Optaflu”).
English: The safety and efficacy of Optaflu in children and adolescents less than 18 years of age have not yet been established.
Danish: Optaflus sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: All pack sizes are available with or without needle(s).
Danish: Alle pakningsstørrelser findes med eller uden
English: No human fertility data are available.
Danish: Der er ingen tilgængelige data vedrørende human fertilitet.
English: Table 1: Frequency in adults (18-60 years of age)
Danish: Følgende bivirkninger er blevet observeret: Tabel 1: Hyppighed hos voksne (18 - 60 år)
English: Immunisation should be carried out by intramuscular injection into the deltoid muscle.
Danish: Immunisering skal udføres ved intramuskulær injektion i musculus deltoideus.
English: Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI).
Danish: Influenzatilfældene blev identificeret gennem aktivt og passivt opsyn med influenzalignende sygdom.
English: Due to the kind of manufacturing Optaflu is free of When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus.
Danish: Når en person får vaccinen, vil immunsystemet (kroppens naturlige forsvarssystem) danne sin egen beskyttelse mod influenzavirus.
English: One dose of 0.5 ml
Danish: Én dosis på 0,5 ml
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Danish: Hos patienter med endogen eller iatrogen immunsuppression kan antistofresponset være utilstrækkeligt.
English: This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free'.
Danish: Denne vaccine indeholder mindre end 1 mmol kalium (39 mg) pr. dosis, dvs. den er i det væsentlige ”kaliumfri”.
English: Optaflu efficacy was defined as the prevention of culture-confirmed symptomatic influenza illness caused by viruses antigenically matched to those in the vaccine compared to placebo.
Danish: Optaflus virkning blev defineret som forebyggelse af kulturbekræftet, symptomatisk influenzasygdom forårsaget af virus, hvor antigenerne matchede dem, der indgår i vaccinen, sammenlignet med placebo.
English: The vaccine should be allowed to reach room temperature before use.
Danish: Vaccinen skal opnå stuetemperatur inden brug.
English: Optaflu contains sodium chloride and potassium chloride This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Optaflu indeholder natriumchlorid og kaliumchlorid Denne vaccine indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. den er i det væsentlige ”natriumfri”.
English: No differences were observed between the cell-culture and the comparator egg-derived vaccine.
Danish: Der var ingen forskel imellem vaccinen udviklet i cellekultur og den ægderiverede komparator.
English: The use of Optaflu may be considered from the second trimester of pregnancy.
Danish: Anvendelse af Optaflu kan overvejes fra graviditetens andet trimester.
English: Optaflu may be given at the same time as other vaccines.
Danish: Optaflu kan gives samtidigt med andre vacciner.
English: Optaflu should under no circumstances be administered intravascularly.
Danish: Optaflu må under ingen omstændigheder administreres intravaskulært.
English: What you need to know before you receive OPTAFLU
Danish: Det skal De vide, før De får Optaflu
English: Prophylaxis of influenza for adults, especially in those who run an increased risk of associated
Danish: Forebyggelse af influenza hos voksne, især hos personer med øget risiko for komplikationer
English: • painful disorders of the nerves, e.g. attacks of extreme pain in the face, throat or ear fits
Danish: • smertefulde nervelidelser, f.eks. anfald af ekstrem smerte i ansigt, hals eller ører, kramper
English: Very Rare (affects less than 1 user in 10,000): • bleeding or bruising which are symptoms of a low platelet count in the blood
Danish: Meget sjældne (forekommer hos mindre end 1 bruger ud af 10.000): • blødning eller blodudtrædninger, hvilket er symptomer på et lavt antal blodplader.
English: Shake before use.
Danish: Omrystes inden brug.
English: The use of this vaccine may be considered from the second trimester of pregnancy.
Danish: Brugen af denne vaccine kan overvejes fra graviditetens 4 måned.
English: Dispose of in accordance with local requirements.
Danish: Bortskaffes i henhold til lokale retningslinjer.
English: In a repeated-dose toxicity study in rabbits there was no evidence of systemic toxicity and the vaccine was locally well tolerated.
Danish: Et studie af toksicitet efter gentagne doser hos kaniner viste ingen tegn på systemisk toksicitet, og vaccinen var
English: Talk to your doctor, pharmacist or nurse before receiving Optaflu.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De får Optaflu.
English: % Lower Limit of One-Sided 97.5% CI
Danish: % Nederste grænse for en - sidigt CI på 97,5 %
English: Ask you pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan De skal bortskaffe medicinrester.
English: - Local lymphadenopathy
Danish: - Lokal lymfadenopati
English: So far there is limited post-marketing experience with Optaflu.
Danish: Erfaringerne med Optaflu efter markedsføring er foreløbig begrænsede.
English: Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect - you may need urgent medical attention or hospitalisation:
Danish: Søg omgående læge eller skadestue på det nærmeste hospital, hvis De får følgende bivirkningerDe kan have brug for omgående lægehjælp eller indlæggelse:
English: A/Switzerland/9715293/2013 (H3N2) - like strain
Danish: A/Switzerland/9715293/2013 (H3N2) -lignende stamme
English: This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information
English: Optaflu is injected into the muscle on the top of the upper arm (deltoid muscle).
Danish: Optaflu indsprøjtes i musklen på overarmen (deltoideus).
English: After an episode of ILI, nose and throat swab samples were collected for analysis.
Danish: Efter et tilfælde af influenzalignende sygdom blev der foretaget podning fra næse og hals til analyse.
English: Not known (cannot be estimated from available data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhånden værende data)
English: A/California/7/2009 (H1N1)pdm09 - like strain
Danish: A/California/7/2009 (H1N1)pdm09-lignende stamme
English: In this case the vaccines should be injected into separate limbs.
Danish: I sådanne tilfælde skal vaccinerne injiceres i forskellige arme og ben.
English: Healthcare professionols are asked to report any suspected adverse reactions via the national reporting sytem listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V. 4.9 Overdosering
English: (convulsions) (only observed with egg-derived influenza vaccines)
Danish: (er kun observeret ved vacciner dyrket på æg)
English: Vaccine Efficacy* % Lower Limit of OneSided 97.5% CI
Danish: Vaccinens virkning* % Nederste grænse for ensidigt CI på 97,5 %
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK - Inner Carton Box for 10 pre-filled syringes with needles - Inner Carton Box for 10 pre-filled syringes without needles Inner carton box will not include “Blue Box”.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FLERSTYKSPAKNING - Indre kartonæske til 10 injektionssprøjter med kanyler - Indre kartonæske til 10 injektionssprøjter uden kanyler Den ydre karton vil ikke inkludere ”Blå Boks”.
English: Optaflu has minor influence on the ability to drive and use machines.
Danish: Optaflu påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: In the elderly frequencies were similar, except for myalgia, headache and injection site pain which were classified as ‘common'.
Danish: Hyppighederne var de samme blandt ældre, dog var myalgi, hovedpine og smerter på injektionsstedet 'almindelige'.
English: Optaflu is not recommended for use in children below 18 years of age since there is no information available.
Danish: Brug til børn og unge Brug af Optaflu anbefales ikke til børn under 18 år, da der ikke foreligger nogen oplysninger.
English: - Angioedema
Danish: - Angioødem
English: • your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration.
Danish: • sørger Deres læge eller sygeplejerske for, at De kan få den rette behandling og overvågning i tilfælde af, at vaccinen skulle fremkalde en meget stærk allergisk reaktion (anafylaktisk reaktion, med symptomer som vejrtrækningsbesvær, svimmelhed, svag og hurtig puls og udslæt).
English: Optaflu is used to prevent flu in adults, especially in those who run an increased risk of experiencing associated complications in case they fall ill with flu.
Danish: Optaflu anvendes til at forebygge influenza hos voksne, særligt til personer, som har en øget risiko for at få komplikationer i forbindelse med influenza.
English: 0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber).
Danish: 0,5 ml suspension i fyldt injektionssprøjte (type I-glas) med en stempelprop (brombutylgummi).
English: In general data from influenza vaccinations in pregnant women do not indicate adverse foetal and maternal outcomes attributable to the vaccine.
Danish: Generelt tyder data fra influenzavaccination af gravide kvinder ikke på, at uønskede hændelser hos fosteret og moderen skyldes vaccinen.
English: • difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)
Danish: • vejrtrækningsbesvær, svimmelhed, en svag og hurtig puls og udslæt, hvilket er symptomer på en meget alvorlig allergisk reaktion (anafylaktisk reaktion)
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs
English: A single syringe contains 0.5 ml of suspension for injection.
Danish: Optaflu er en En enkelt sprøjte indeholder 0,5 ml injektionsvæske, suspension.
English: It should be noted that adverse reactions may be intensified.
Danish: Bemærk, at bivirkninger kan forstærkes.
English: For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
Danish: Til gravide kvinder med sygdomme, som øger risikoen for komplikationer i forbindelse med influenza, anbefales vaccination uanset graviditetstrimester.