FrancophonIA/ELRC3.0 huggingface dataset:
English: This vaccine may contain traces of formaldehyde, benzonase, sucrose, trypsin and Vero host cell protein, which are used during the manufacturing process.
Danish: Denne vaccine kan indeholde spor af formaldehyd, benzonase, saccharose, trypsin og vero-værtscelleprotein, som anvendes under fremstillingsprocessen.
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Danish: Endnu en dosis på 0,5 ml skal gives efter et interval på mindst tre uger.
English: • allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated,
Danish: • allergiske reaktioner, der fører til et faretruende fald i blodtryk, der, hvis det ikke behandles,
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 updates of the RMP.
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: Pandemic and Pre-pandemic vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Danish: Pandemiske og præpandemiske vacciner indeholder influenza-antigener, som er anderledes end antigenerne i de aktuelt cirkulerende influenzavira.
English: VEPACEL should not be given at the same time as immunoglobulins.
Danish: VEPACEL må ikke gives på samme tid som immunoglobuliner.
English: neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome
Danish: nervebetændelse (neuritis) og en type lammelse (paralyse), der er kendt som Guillain-Barré syndrom
English: b) Tabulated list of adverse reactions Adverse reactions are listed according to the following frequency:
Danish: b) Tabel over bivirkninger Bivirkninger er angivet i henhold til følgende hyppighed:
English: Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Danish: Sådanne situationer kræver hurtige sikkerhedsoplysninger, som kan have stor betydning for afvejning af fordele og ulemper i forbindelse med en pandemi.
English: Prepandemic influenza vaccine (H5N1)
Danish: Præpandemisk influenzavaccine (H5N1)
English: Seroneutralization rate* 52.6% 85.4% 17.1% 72.9% 3.0% 68.8% Seroconversion rate** 9.1% 31.8% 16.4% 72.2% 9.1% 65.6% Seroconversion factor***
Danish: 2. dosis Seroneutraliseringsværdi* 52,6 % 85,4 % 17,1 % 72,9 % 3,0 % 68,8 % Serokonverteringsværdi** 9,1 % 31,8 % 16,4 % 72,2 % 9,1 % 65,6 % Serokonversionsfaktor*** 1,6
English: 60 years and above Strain A/Indonesia/05/2005 21 Days after 2nd Dose
Danish: 60 år og derover Stamme A/Indonesia/05/2005 21 dage efter 2. dosis
English: The adverse reactions observed are shown in the table below.
Danish: De observerede bivirkninger er anført i tabellen herunder.
English: Please tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, or if you have recently received any other vaccine.
Danish: Fortæl altid lægen eller sygeplejersken, hvis du bruger, for nylig har taget eller muligvis kan tage anden medicin, inklusive håndkøbsmedicin og naturlægemidler eller hvis du for nylig har fået indgivet anden vaccine.
English: Data obtained with the H5N1 vaccines will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with H5N1 vaccines are relevant for the pandemic and pre-pandemic vaccines.
Danish: Data fra H5N1-vacciner støtter den vaccinationsstrategi, der sandsynligvis vil blive anvendt med den pandemiske vaccine: Klinisk immunogenicitets-, sikkerheds- og reaktogenicitetsdata fra H5N1-vacciner er relevante i forbindelse med de pandemiske og præpandemiske vacciner.
English: If necessary, VEPACEL may be given at the same time as normal or specific immunoglobulin into separate limbs.
Danish: Om nødvendigt kan der gives VEPACEL samtidig med normal eller specifik immunoglobulin ved injektion i separate ekstremiteter.
English: Adults, older people, and special risk groups
Danish: Voksne, ældre og særlige risikogrupper
English: Uncommon (affects 1 to 10 users in 1,000): • generalised skin reactions including urticaria (hives)
Danish: Ikke almindelig (forekommer hos 1 til 10 brugere ud af 1.000): • generaliserede hudreaktioner, herunder nældefeber (urticaria)
English: The use of VEPACEL during pregnancy and lactation may be considered in a pre-pandemic situation, taking into account official recommendations.
Danish: Anvendelsen af VEPACEL under graviditet og amning kan overvejes i en præpandemisk situation, i overensstemmelse med officielle anbefalinger.
English: Animal reproductive and developmental toxicology studies do not indicate harmful effects in regard to female fertility, embryo-foetal and pre- and post-natal toxicity.
Danish: Dyrestudier af reproduktions- og udviklingstoksicitet i dyr indikerer ikke skadelige virkninger på fertilitet hos hunner, embryonal/føtal og præ- eller postnatal toksicitet.
English: There is no information on the use of VEPACEL under the skin.
Danish: Der findes ingen oplysninger om indgift af VEPACEL under huden.
English: This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1).
Danish: Denne indikation er baseret på immunogenicitetsdata fra personer i alderen 6 måneder og derover efter administration af to vaccinedoser, der er fremstillet med H5N1-subtypestammer (se pkt.
English: • hardness, redness, swelling or bruising at the injection site b) The following side effects have been reported in clinical studies in children aged 3 to 8 years.
Danish: • hårdhed, rødme, hævelse eller blåt mærke på injektionsstedet b) Der er set følgende bivirkninger i kliniske forsøg med børn i alderen fra 3 til 8 år.
English: The side effects are generally similar to those related to the flu vaccine.
Danish: Bivirkningerne ligner generelt bivirkningerne af influenzavaccinen.
English: VEPACEL has minor influence on the ability to drive and use machines.
Danish: VEPACEL påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: • Infants, children, and adolescents
Danish: • Spædbørn, børn og unge
English: However, if this cannot be avoided, the other vaccine should not be injected into the same arm used for VEPACEL.
Danish: Hvis dette imidlertid ikke kan undgås, bør den anden vaccine ikke injiceres i den samme arm, som den der anvendes til VEPACEL.
English: No case of overdose has been reported for VEPACEL.
Danish: Der er ikke rapporteret tilfælde af overdosering for VEPACEL.
English: You should not receive VEPACEL
Danish: Du må ikke få VEPACEL
English: The safety of VEPACEL in pregnancy and lactation has not been assessed in clinical trials.
Danish: Sikkerhed ved VEPACEL under graviditet og amning er ikke vurderet i kliniske forsøg.
English: Seroneutralisation rate* Tested against
Danish: Seroneutraliseringsværdi* Testet imod
English: In the clinical studies conducted in adults and older people most side effects were mild in nature and short term.
Danish: I kliniske forsøg udført med voksne og ældre personer var de fleste bivirkninger milde og kortvarige.
English: Clinically significant alterations in liver enzymes and calcium levels have not been seen to date in human clinical studies.
Danish: Klinisk væsentlige forandringer i leverenzymer og calciumniveauer er til dato ikke iagttaget i kliniske forsøg med mennesker.
English: Very Common (≥1/10) Common (≥1/100 - <1/10) Uncommon (≥1/1,000 - <1/100) Rare (≥1/10,000 - <1/1,000)
Danish: Meget almindelig (≥1/10) Almindelig (≥1/100 - <1/10) Ikke almindelig (≥1/1.000 - <1/100) Sjælden (≥1/10.000 - <1/1.000)
English: 12 - 24 months booster
Danish: 12-24 måneders booster
English: Immunogenicity in immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123)
Danish: Immunogenicitet hos immunokompromitterede personer (N=122) og hos patienter med kroniske sygdomme (N=123)
English: Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte vacciner samt affald heraf skal bortskaffes i henhold til lokale bestemmelser.
English: However, if this cannot be avoided, the immunoglobulins should not be injected into the same arm used for VEPACEL.
Danish: Hvis dette imidlertid ikke kan undgås, bør immunoglobulinerne ikke injiceres i den samme arm, som den der anvendes til VEPACEL.
English: • Adults, older people, and special risk groups
Danish: • Voksne, ældre og særlige risikogrupper
English: The A/Vietnam/1203/2004 vaccine afforded protection against homologous challenge as evidenced by full survival, reduced weight loss, a less pronounced and shorter increase in temperature, a less marked reduction in lymphocyte counts and in reduction of inflammation and necrosis in brain and olfactory bulb in the vaccinated cohorts as compared to control animals.
Danish: A/Vietnam/1203/2004-vaccinen gav beskyttelse ved homolog eksponering, hvilket manifesterede sig ved fuld overlevelse, reduceret vægttab, en mindre udtalt og mere kortvarig temperaturforøgelse, en mindre markant reduktion af lymfocyttallet samt reduktion af inflammation og nekrose i hjerne og bulbus olfactorius hos den vaccinerede kohorte sammenlignet med kontroldyrene.
English: • feeling cold c) The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years.
Danish: • kuldefølelse c) Der er set følgende bivirkninger i kliniske forsøg med unge i alderen fra 9 til 17 år.
English: If vaccination is considered necessary, facilities for resuscitation should be immediately available in case of need (see section 4.4).
Danish: Hvis en vaccination vurderes at være nødvendig, skal genoplivningsudstyr være umiddelbart tilgængeligt (se pkt.
English: Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Danish: Immunisering bør foretages ved intramuskulær injektion i musculus deltoideus eller anterolateralt i låret afhængigt af muskelmasse.
English: In addition, during a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports 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.
Danish: Desuden er de ressourcer, der er nødvendige for en tilbundsgående vurdering af PSUR i det format, der er defineret i bind 9a af EU's lægemiddellovgivning (Volume 9a of the Rules Governing Medicinal Product in the European Union), måske ikke tilstrækkelige til hurtig identifikation af nye sikkerhedsproblemer under en pandemi.
English: Date of latest renewal: 04/01/2017
Danish: Dato for første markedsføringstilladelse: 17. februar 2012 Dato for seneste fornyelse: 04. januar 2017
English: From post-marketing surveillance with a whole virion, Vero cell derived, H1N1 vaccine, the following adverse reactions have been reported (the frequency of these adverse reactions is not known as it cannot be estimated from the available data):
Danish: I forbindelse med bivirkningsovervågning efter markedsføringen af hel virion, verocelle-afledt H1N1-vaccine er følgende alvorlige bivirkninger indberettet (hyppigheden af disse bivirkninger er ikke kendt og kan ikke vurderes ud fra de tilgængelige data):
English: • allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock
Danish: • allergiske reaktioner, herunder anafylaktiske reaktioner, der fører til et faretruende fald i blodtryk, der, hvis det ikke behandles, kan føre til chok
English: Adverse Reactions (adults and older people)
Danish: Bivirkninger (voksne og ældre personer)
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 der ses falske positive resultater i serologiske ELISA- test ved undersøgelse af antistoffer mod humant immundefektvirus-1 (HIV-1), hepatitis C-virus og især HTLV-1.
English: Sensory disturbance (paresthesia, dysesthesia, oral dysesthesia, hypoesthesia, dysgeusia, and burning sensation)
Danish: Sensoriske forstyrrelser (paræstesi, dysæstesi, oral dysæstesi, hypæstesi, dysguesi og brændende fornemmelse) Synkope
English: Neurological disorders, such as encephalomyelitis, neuritis, and Guillain Barré syndrome.
Danish: Neurologiske sygdomme, f.eks. encefalomyelitis, neuritis og Guillain-Barré syndrom.
English: • fits due to fever
Danish: • anfald pga. feber
English: • insomnia (difficulty sleeping)
Danish: • søvnløshed (svært ved at falde i søvn)
English: • low blood platelet count which can result in bleeding or bruising
Danish: • lavt blodpladetal, hvilket kan resultere i blødning eller blå mærker
English: Do not use this medicine after the expiry date which is stated on the carton and the label.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og etiketten efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: You should be aware that side effects may be intensified.
Danish: Vær opmærksom på, at bivirkningerne herved kan forstærkes.
English: What VEPACEL contains
Danish: VEPACEL indeholder:
English: ACTIVE SUBSTANCE A/Vietnam/1203/2004 (H5N1)
Danish: AKTIVT STOF A/Vietnam/1203/2004 (H5N1)
English: Celvapan (H1N1)v
Danish: Celvapan (H1N1)
English: All ferrets were challenged intranasally on day 35 with a high dose of the highly virulent H5N1 virus strain A/Vietnam/1203/2004 and monitored for 14 days.
Danish: Alle fritter blev eksponeret intranasalt på dag 35 med en stor dosis af den stærkt virulente H5N1-virusstamme A/Vietnam/1203/2004 og overvåget i 14 dage.
English: - if you have a weakened immune system as for example because of immunosuppressive therapy, e.g. taking of corticosteroids or treatment for cancer.
Danish: - hvis du har et svækket immunforsvar (det kan være på grund af immunhæmmende behandling som f.eks. indtagelse af binyrebarkhormoner (kortikosteroider) eller behandling for kræft).
English: • itching where the injection was given
Danish: • kløe på det sted, hvor injektionen blev givet
English: Side effects observed with a similar influenza vaccine (Celvapan) The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme:
Danish: Bivirkninger, der er iagttaget med lignende influenzavacciner (Celvapan) Bivirkningerne, der er anført herunder, er forekommet med en lignende influenzavaccine (Celvapan) hos voksne og børn under H1N1 pandemisk influenzavaccinationsprogram.
English: Animal studies with H5N1 strain vaccines (A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Danish: Ved dyrestudier med H5N1-vaccinestammer (A/Vietnam/1203/2004 og A/Indonesia/05/2005) er der ikke påvist direkte eller indirekte bivirkninger, hvad angår fertilitet, drægtighed, embryonal/føtal udvikling, fødsel eller postnatal udvikling (se pkt.
English: • neurological disorders such as encephalomyelitis (inflammation of the central nervous system),
Danish: • Neurologiske sygdomme, som f.eks. betændelse i centralnervesystemet (encefalomyelitis),
English: 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.
Danish: I lighed med andre injicerbare vacciner skal adækvat overvågning og medicinsk behandling og altid være tilgængelig i tilfælde af sjælden anafylaktisk reaktion.
English: After first opening, the vaccine should be used immediately (within a maximum period of 3 hours).
Danish: Efter åbning skal vaccinen bruges omgående (inden for maksimalt tre timer).
English: The incidence and nature of symptoms after the first and second vaccination were similar to those observed in the healthy adults and older people.
Danish: Forekomsten og arten af bivirkninger efter den første og anden vaccination svarede til dem, der blev set hos raske voksne og ældre personer.
English: In addition, the immunogenicity has also been evaluated in a Phase 3 study in specified risk groups of immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123) following a 0, 21 day schedule.
Danish: Immunogeniciteten er desuden vurderet i et fase 3-studie blandt specificerede risikogrupper af immunkompromitterede personer (N=122) og patienter med kroniske sygdomme (N=123), der blev vaccineret på dag 0 og dag 21.
English: A protective immune response may not be induced in all individuals receiving the vaccine (see section 5.1).
Danish: Et beskyttende immunrespons opnås ikke med sikkerhed blandt alle vaccinerede (se pkt.
English: Trivalent seasonal influenza vaccines
Danish: Trivalente, årstidsbestemte influenzavacciner
English: Once the needle is attached, the vaccine must be administered immediately.
Danish: Efter påsætning af nålen skal vaccinen administreres straks.
English: a) The following side effects have been reported in a clinical study in infants aged 6 to 35 months.
Danish: a) Der er set følgende bivirkninger i kliniske forsøg med spædbørn i alderen fra 6 til 35 måneder.
English: If you get any side effects talk to your doctor or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: The vaccine should never be given into a blood vessel.
Danish: Vaccinen må aldrig gives i blodkar.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu/
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: After shaking, the vaccine is a clear to opalescent suspension.
Danish: Efter rystning er vaccinen en klar til opaliserende suspension.
English: Sodium chloride Water for injections Polysorbate 80.
Danish: Natriumchlorid Vand til injektionsvæsker Polysorbat 80.
English: The protective efficacy of VEPACEL against morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian influenza H5N1 virus was assessed non-clinically in a ferret challenge model.
Danish: Den beskyttende virkning af VEPACEL mod sygdom og død påført af en infektion med dødelige doser af en svært patogen aviær Influenza H5N1-virus er blevet evalueret præklinisk i en dyre undersøgelse, ved anvendelse af fritter.
English: • injection-site reaction such as irritation, itching, bruising or stiff arm
Danish: • reaktioner på injektionsstedet, såsom irritation, kløe, blåt mærke eller stiv arm
English: Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period.
Danish: Overfølsomhedsreaktioner, herunder anafylaksi, er rapporteret efter brug af tilsvarende hel virion, verocelle-producerede H1N1-influenzavaccine administreret under en pandemisk periode.
English: Seroneutralisation rate* Seroconversion rate** Seroconversion factor*** * MN titre ≥ 20 ** ≥ 4-fold increase in MN titre *** geometric mean increase
Danish: Seroneutraliseringsværdi* Serokonverteringsværdi** Serokonverteringsfaktor*** * MN-titer ≥20 ** ≥4-dobbelt stigning i MN-titer *** geometrisk middelstigning
English: EXP After first opening, use immediately (within 3 hours max)
Danish: EXP Anvendes omgående efter første åbning (inden for maksimalt 3 timer)
English: Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine demonstrated a high rate of seroconversion.
Danish: De fritter, der var vaccineret med 7,5 µg dosen af A/Vietnam/1203/2004-vaccinen havde en høj serokonverteringsværdi.
English: The observed adverse reactions from a paediatric clinical trial with the H5N1 vaccine are listed below.
Danish: De observerede bivirkninger fra et pædiatrisk klinisk forsøg med H5N1-vaccinen er anført herunder.
English: What VEPACEL looks like and contents of the pack
Danish: Hvad VEPACEL udseende og pakningsstørrelse
English: The vaccine should never be given into a vein.
Danish: Vaccinen må aldrig gives i en vene.
English: • conjunctivitis (an inflammation of the eye), eye irritation
Danish: • øjenbetændelse (konjunktivitis), øjenirritation
English: Seroneutralisation rate* Seroconversion rate** Seroconversion factor***
Danish: Seroneutraliseringsværdi* Serokonverteringsværdi** Serokonverteringsfaktor***
English: Adverse Reactions (Infants, children and adolescents)
Danish: Bivirkninger (spædbørn, børn og unge)
English: There is no information on administration of VEPACEL with other vaccines.
Danish: Der foreligger ingen oplysninger om indgivelse af VEPACEL sammen med andre vacciner.
English: Each dose of 0.5 ml is withdrawn into a syringe for injection.
Danish: Hver dosis på 0,5 ml trækkes op i en injektionssprøjte.
English: Adults and children from 6 months onwards:
Danish: Voksne og børn fra 6-månedersalderen og ældre:
English: Sixteen ferrets were divided into two cohorts and were vaccinated on days 0 and 21 with 7.5 µg of the A/Vietnam/1203/2004 vaccine or were sham vaccinated.
Danish: Seksten fritter blev opdelt i to kohorter og enten vaccineret på dag 0 og dag 21 med 7,5 µg af A/Vietnam/1203/2004-vaccinen, eller vaccination blev imiteret.
English: After first opening, the vial is to be used within a maximum of 3 hours.
Danish: Efter åbning skal indholdet i hætteglasset bruges i løbet af højst tre timer.
English: Allergic reactions, including sudden life-threatening allergic reactions (anaphylaxis) have been reported following use of a similar vaccine for H1N1 influenza during a pandemic period.
Danish: Allergiske reaktioner, der omfatter pludselig livstruende allergiske reaktioner (anafylaksi) er rapporteret efter brug af en tilsvarende vaccine mod H1N1-influenza, der er administreret under en pandemisk periode.
English: • sudden hearing loss
Danish: • pludseligt høretab
English: The vaccine will be injected into the muscle of the upper arm (deltoid muscle) or upper thigh, depending on the muscle mass.
Danish: Vaccinen vil blive injiceret i musklen i overarmen eller øverst på låret afhængigt af muskelmassen.
English: • vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney problems)
Danish: • betændelse i blodkar (vasculitis), som kan forårsage hududslæt, ledsmerter og nyreproblemer
English: VEPACEL is presented as a suspension for injection in multidose vial (10 doses of 0.5 ml per vial) in pack size of 20 vials.
Danish: VEPACEL leveres som en suspension til injektion (i flerdosis hætteglas (10 doser af 0,5 ml)pakningsstørrelse på 20 hætteglas).
English: In the clinical studies conducted in infants, children and adolescents, the incidence and nature of symptoms after the first and second vaccination were similar to those occurred in adults and older people.
Danish: I de kliniske forsøg, der blev udført hos spædbørn, børn og unge, svarede forekomsten og arten af bivirkninger efter den første og anden vaccination til dem, der blev set hos voksne og ældre personer.
English: What you need to know before you receive VEPACEL
Danish: Det skal du vide, før du vaccineres med VEPACEL
English: VEPACEL may affect your ability to drive and use machines.
Danish: VEPACEL kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: The suspension is clear to opalescent.
Danish: Suspensionen er klar til opaliserende.