FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, duration 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 varigheden af pandemien, nødvendige ressourcer til en tilbundsgående vurdering af PSUR i det format, der er defineret i bind 9a af EU's lægemiddellovgivning, måske ikke tilstrækkelig til en hurtig identifikation af nye sikkerhedsproblemer.
English: The active substances and other ingredients in Daronrix are listed at the end of the leaflet.
Danish: Det aktive stof og andre indholdsstoffer i Daronrix er anført til sidst i indlægssedlen.
English: - Periodicity will be reviewed by the MAH and the (Co-)Rapporteur at 3 monthly intervals.
Danish: - Indehaveren af markedsføringstilladelsen og (Co-)Rapporteur evaluerer hyppigheden med 3 måneders mellemrum.
English: Like all medicines, Daronrix can cause side effects, although not everybody gets them.
Danish: Daronrix kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Data from vaccinations with interpandemic trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Danish: Data fra vaccinationer med interpandemiske, trivalente vacciner til gravide kvinder tyder ikke på, at utilsigtede foster- eller moderhændelser skyldtes vaccinen.
English: From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse events have been reported:
Danish: I forbindelse med opfølgning efter markedsføringen med interpandemiske, trivalente vacciner er der indberettet følgende bivirkninger:
English: Pharmacovigilance During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Danish: Farmakovigilance Under pandemien gennemfører ansøgeren en prospektiv kohorteundersøgelse som nævnt i farmakovigilanceplanen.
English: • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated,
Danish: • Allergiske reaktioner, der kan føre til farligt blodtryksfald, og som kan ende med kollaps,
English: Seroconversion factor
Danish: Serokonversionsfaktor
English: Read all of this leaflet carefully before you start receiving this vaccine.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage medicinen.
English: The incidence of symptoms observed in subjects >60 years of age was lower as compared to the 18-60 years old population.
Danish: Forekomsten af symptomer hos forsøgspersoner >60 år var lavere end i den 18-60 årige population.
English: • Narrowing or blockage of blood vessels with kidney problems
Danish: • Indsnævring eller blokering af blodkar med nyreproblemer til følge
English: Proportional reporting ratio [PRR], Information Component [IC)] or the Empirical Bayesian Geometric Mean [EBMG]; this is not mandatory as all MAHs do not yet have this capability.
Danish: - Et mål for relativ rapportering af hændelser for hvert enkelt foretrukket term skal om muligt angives (fx "Proportional Reporting Ratio" [PRR], "Information Component" (IC)] eller "Empirical Bayesian Geometric Mean [EBMG]); dette er ikke obligatorisk, da det ikke er alle indehavere af markedsføringstilladelser, der på nuværende tidspunkt kan gøre dette.
English: 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.
Danish: Hurtig analyse af de kumulative sikkerhedsoplysninger er i lyset af smitte afgørende for myndighedernes beslutning og beskyttelse af den population, der skal vaccineres.
English: General disorders and administration site conditions Very common: pain and redness at the site of injection, fatigue Common: swelling and induration at the site of injection, shivering, fever Uncommon: injection site pruritis
Danish: Generelle symptomer og forstyrrelser ved applikationssted Meget almindelig: smerter og rødme på injektionsstedet, træthed Almindelig: hævelse og induration på injektionsstedet, kulderystelser, feber Ikke almindelig: pruritis på injektionsstedet
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 ved en pandemi.
English: A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (if the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.
Danish: Der skal også udarbejdes et kort resume over PSUR, hvor alle problemstillinger markeres, udredningen over hændelserne prioriteres (hvis der er flere hændelser), og hvor passende tidslinjer for indsendelse af en fuldstændig evalueringsrapport over hændelserne angives.
English: - Reporting to be fortnightly for the first 3 months of the pandemic.
Danish: - Rapportering sker derefter hver 14. dag i de første 3 måneder af pandemien.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt/revideret den {MM/ÅÅÅÅ}
English: • Temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face.
Danish: • Forbigående betændelse i nerverne, der giver smerter, mathed og lammelser i armene, som ofte går videre til bryst og ansigt
English: EXPIRY DATE EXP: MM/YYYY
Danish: UDLØBSDATO EXP: MM/ÅÅÅÅ
English: During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Danish: Kliniske aspekter Under en pandemi indsamler ansøgerne data om klinisk sikkerhed og effektivitet for den pandemiske vaccine og indsender disse oplysninger til CHMP til vurdering.
English: Adverse Events of Special Interest (PTs) 3.
Danish: Særlige bivirkninger af speciel interesse (foretrukne termer) 3.
English: Adverse reactions from clinical trials with different formulations (H5N1, H2N2 and H9N2) (N=941) of the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up vaccines).
Danish: Bivirkninger i kliniske forsøg med forskellige formuleringer (H5N1, H2N2 og H9N2) (N=941) af mockup-vaccinen findes nedenfor (se afsnit 5.1 med yderligere oplysninger om mockup-vacciner).
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Danish: Neurologiske sygdomme, fx encefalomyelitis, neuritis og Guillain-Barré-syndrom.
English: - The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, thiomersal, water for injections
Danish: - Øvrige indholdsstoffer: natriumchlorid, dinatriumphosphatdodecadydrat, kaliumdihydrogenphosphat, kaliumchlorid, magnesiumchloridhexahydrat, thiomersal, vand til injektionsvæsker
English: Daronrix is a vaccine used in adults aged 18 to 60 years to prevent influenza (flu) in an officially declared pandemic.
Danish: Daronrix er en vaccine, som anvendes til voksne i alderen 18-60 år mod influenza ved en officiel, udbrudt pandemi.
English: An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Danish: CHMP's retningslinjer for risikohåndteringssystemer i forbindelse med lægemidler til mennesker.
English: The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Danish: Det europæiske lægemiddelagentur (EMEA) vurderer hvert år ny information vedrørende produktet, og denne indlægsseddel vil om nødvendigt blive opdateret.
English: Therefore health care providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
Danish: Sundhedspersonalet skal derfor vurdere fordele og ulemper ved indgift af vaccinen til gravide kvinder under hensyntagen til de officielle anbefalinger.
English: • Swelling at the injection site, hard lump
Danish: • Hævelser på injektionsstedet, hård klump
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: Som ved alle andre injicerbare vacciner, bør passende medicinsk behandling og overvågning være til stede for det tilfælde at der opstår en sjælden anafylaktisk reaktion efter indgift af vaccinen.
English: Very rare (<1/10,000):
Danish: Meget sjælden (< 1/10.000):
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2 °C - 8 °C) Må ikke nedfryses.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug
English: • Shivering, fever
Danish: • Kulderystelser, feber
English: 0.45 milligrams Al3+
Danish: 0,45 milligram Al3+
English: Daronrix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Daronrix takes due account of the officially declared pandemic strain.
Danish: Daronrix må kun markedsføres når der er udstedt en officiel WHO/EU-erklæring om en pandemisk influenza og på de betingelser som markedsføringstilladelsesindehaveren skal opfylde som følge af den officielt erklærede pandemiske vaccinestamme:
English: The vaccine is unlikely to produce an effect on the ability to drive and use machines.
Danish: Det er ikke sandsynligt, at vaccinen påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: 0.05 milligrams Al3+
Danish: 0,05 milligram Al3+
English: Immunisation should be carried out by intramuscular injection.
Danish: Vaccinationen skal gives som intramuskulær injektion.
English: Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are below the age of 18 years.
Danish: Din læge vil derfor vurdere fordele og ulemper ved at give dig vaccinen, hvis du er under 18 år.
English: However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Danish: Men under en pandemi kan det være relevant at give vaccinen under forudsætning af, at genoplivningsudstyr er inden for rækkevidde.
English: anti-HA antibody
Danish: anti-HA-antistof
English: * propagated in eggs ** haemagglutinin *** adjuvanted by aluminium phosphate
Danish: * opformeret i æg ** hæmagglutinin *** adjuveret med aluminiumphosphat
English: Frequency of submission - The clock will start from the first Monday after shipment of the first batch of vaccine.
Danish: Hyppighed af indsendelse - Uret startes fra den første mandag efter afsendelse af den første vaccinebatch - Første data-lock point er 14 dage senere.
English: • Low blood platelet count
Danish: • Lavt tal af blodplader
English: Fatal and/or life-threatening reactions - for each Preferred Term (PT), including the proportion of fatal reports 2.
Danish: Dødelige og/eller livstruende reaktioner - hver foretrukket term for sig, inkl.
English: The seroprotection rate, the seroconversion rate and seroconversion factor for anti-HA antibody were as follows 21 days after the first dose:
Danish: Seroprotektionsværdi, serokonversionstal og serokonversionsfaktor for anti-HA-antistof var som følger 21 dage efter den første dosis:
English: However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Danish: Men hvis det er nødvendigt med samtidig indgift af andre vacciner, skal det ske i separate lemmer.
English: Musculoskeletal and connective tissue disorders Common: myalgia, arthralgia
Danish: Muskuloskeletale-, bindevævs- og knoglelidelser Almindelig: myalgi, artralgi
English: 100 x 1 dose
Danish: 100 x 1 dosis
English: See section 6.5 for the number of doses per vial.
Danish: Dette er en flerdosisbeholder, se afsnit 6.5, der oplyser om antal doser pr. glas.
English: Suspension for injection Prefilled syringe 1 dose
Danish: Injektionsvæske, suspension Fyldt injektionssprøjte 1 dosis
English: The persistence of antibodies for the mock-up vaccines varies.
Danish: Varigheden af antistofferne i mockup-vaccinen varierer.
English: There is no information on the use of Daronrix in pregnant women.
Danish: Der er ingen oplysninger om anvendelse af Daronrix til gravide kvinder.
English: No clinical data have been generated in subjects below 18 years of age.
Danish: Der foreligger ingen kliniske data fra forsøgspersoner under 18 år.
English: The doctor will give Daronrix as an injection into your upper arm muscle.
Danish: Lægen giver Daronrix som en indsprøjtning i overarmsmusklen.
English: WHAT DARONRIX IS AND WHAT IT IS USED FOR
Danish: DARONRIX' VIRKNING OG HVAD DU SKAL BRUGE DET TIL
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: En allergisk reaktion kan vise sig ved følgende symptomer: kløende hududslæt, stakåndethed og opsvulmen af ansigt eller tunge.
English: per 0.5 ml dose * propagated in eggs ** haemagglutinin *** adjuvanted by aluminium phosphate
Danish: pr. 0,5 ml dosis * opformeret i æg ** hæmagglutinin *** adjuveret med aluminiumphosphat
English: 21 days after 1st dose
Danish: 21 dage efter første dosis
English: Daronrix should under no circumstances be administered intravascularly.
Danish: Daronrix må under ingen omstændigheder gives intravaskulært.
English: Although no clinical data have been generated with Daronrix in subjects >60 years of age, the immunogenicity of a mock up formulation with different antigen doses of an aluminium-adjuvanted whole virus vaccine (A/H9N2) administered at 0, 21 days was evaluated in a clinical trial in this population.
Danish: Selvom der ikke foreligger kliniske data med Daronrix til personer over 60 år er immunogeniciteten af mockup-formuleringen med forskellige antigendoser af en aluminiumsadjuveret hel virusvaccine (A/H9N2) indgivet på dag 0 og dag 21 vurderet i et klinisk forsøg med denne population.
English: B-1330 Rixensart Belgium
Danish: B-1330 Rixensart
English: Therefore health care providers need to assess the benefits and potential risks of administering the vaccine in that population.
Danish: Sundhedspersonalet skal derfor vurdere fordele og ulemper ved at give vaccinen til denne population.
English: In a clinical study where a mock-up formulation of aluminium-adjuvanted whole virus vaccine (AH9/N2) containing 3.8 µg HA was evaluated following a 0, 10 day schedule, it has been shown that a faster onset of protection could be reached as compared to the recommended 0, 21 day schedule.
Danish: I et klinisk forsøg, hvor en mockup-formulering af alminimumsadjuveret hel virusvaccine (AH9/N2) med 3,8 µg HA blev evalueret efter indgift på dag 0 og dag 10, er det påvist, at en hurtigere beskyttelse kan nås sammenlignet med indgift på dag 0 og dag 21.
English: Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant.
Danish: Din læge vil vurdere fordele og ulemper ved at give dig vaccinen, hvis du er gravid.
English: • Sore nose and throat and discomfort when swallowing, runny nose
Danish: • Dårlig næse og hals og ubehag ved synkning, løbende næse
English: The MAH commits to performing the studies and pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Danish: Indehaveren af markedsføringstilladelsen skal foretage de undersøgelser og øvrige farmakovigilanceaktiviteter, som er beskrevet i farmakovigilance-planen.
English: per 0.5 ml dose
Danish: pr. 0,5 ml dosis
English: • Inflammation of the brain and spinal column
Danish: • Betændelse i hjernen og rygsøjlen
English: Daronrix has been evaluated with a haemagglutinin content of 15 µg HA per dose in adults aged 18-60 years following a 0, 21 day schedule.
Danish: Daronrix er vurderet med et hæmagglutininindhold på 15 µg HA pr. dosis til voksne i alderen 18-60 år efter indgift på dag 0 og dag 21.
English: Vasculitis with transient renal involvement.
Danish: Vaskulitis med forbigående nyreinvolvering.
English: • Painful swelling in the arms or legs
Danish: • Smerter og opsvulmede arme eller ben
English: Nervous system disorders Very common: headache
Danish: Lidelser i det centrale og perifere nervesystem Meget almindelig: hovedpine
English: The seroprotection rate, the seroconversion rate and seroconversion factor for anti-HA antibody were as follows:
Danish: Seroprotektionsværdi, serokonversionstal og serokonversionsfaktor for anti-HA-antistof er som følger:
English: Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: Ikke almindelig (≥ 1/1.000, < 1/100) Sjælden (≥ 1/10.000, < 1/1.000) Meget sjælden (< 1/10.000)
English: • Pain and redness at the injection site
Danish: • Smerter og rødme på injektionsstedet
English: Daronrix is a white, slightly milky liquid and is presented as follows: - in an ampoule (5 ml) for 10 doses in a pack of 50 - in a vial (5 ml) for 10 doses in a pack of 50 - in a vial (10 ml) for 20 doses in a pack of 50
Danish: Daronrix er en hvid, let mælkeagtig væske, der leveres som følger: - i en ampul (5 ml) til 10 doser i en pakning med 50 - i et hætteglas (5 ml) til 10 doser i en pakning med 50 - i et hætteglas (10 ml) til 20 doser i en pakning med 50
English: • Post-marketing surveillance
Danish: • Erfaring efter markedsføringen
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues e.g. eggs, chicken protein, gentamicin sulphate.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Der skal udvises forsigtighed, når vaccinen gives til personer med kendt overfølsomhed (ud over anafylaktisk reaktion) over for det aktive stof eller over for et eller flere af hjælpestofferne, over for thiomersal og over for sporstoffer fx af æg, kyllingeprotein, gentamicinsulfat.
English: PHARMACEUTICAL FORM AND CONTENTS Ampoule
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Ampul
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent to: A/Vietnam/1194/2004 (H5N1)***
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hele virion influenzavaccine af pandemisk stamme, inaktiveret, med antigen* svarende til: A/Vietnam/1194/2004 (H5N1) ***
English: Common (≥1/100 to <1/10)
Danish: Almindelig (≥ 1/100, < 1/10)
English: Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent to: A/Vietnam/1194/2004 (H5N1)***
Danish: Hele virion influenzavaccine af pandemisk stamme, inaktiveret, med antigen* svarende til: A/Vietnam/1194/2004 (H5N1) ***
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Daronrix, suspension for injection.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Daronrix, injektionsvæske, suspension
English: There is no information on the use of Daronrix below 18 years of age.
Danish: Der findes ingen oplysninger om brugen af Daronrix til børn og unge under 18 år.
English: Seroconversion rate
Danish: Serokonversionstal
English: Take special care with Daronrix:
Danish: Vær ekstra forsigtig med at tage Daronrix:
English: History of an anaphylactic reaction (i.e. life-threatening) to any of the constituents or trace residues (e.g. eggs, chicken protein, gentamicin sulphate) of this vaccine.
Danish: Tidligere anafylaktisk reaktion (dvs. livstruende) over for blot et af stofferne eller sporstofferne (fx æg, kyllingeprotein, gentamicinsulfat) i denne vaccine.
English: Daronrix may be used during lactation.
Danish: Daronrix kan anvendes under amning.
English: • Fatigue
Danish: • Træthed
English: Skin and subcutaneous tissue disorders Common: sweating increase, ecchymosis
Danish: Dermatologiske lidelser Almindelig: øget svedtendens, ekkymose
English: and aluminium hydroxide, hydrated
Danish: og aluminiumhydroxidhydrat
English: Intramuscular use Shake before use
Danish: Intramuskulær anvendelse Omrystes før brug
English: ♦ Uncommon (less than 1 per 100 but more than 1 per 1000 doses of vaccine): • Generalised skin reactions such as itching, hives or rash
Danish: ♦ Ikke almindelig (forekommer hos mellem 1 og 10 ud af 1.000 patienter): • Udbredte hudreaktioner, fx kløe, nældefeber eller udslæt
English: Two hundred and one subjects received the monovalent aluminium-adjuvanted whole virus vaccine (A/H5N1).
Danish: 201 forsøgspersoner fik den monovalente aluminiumsadjuverede, hele virusvaccine (A/H5N1).
English: MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a. rue de l'Institut 89
Danish: Indehaveren af markedsføringstilladelsen GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89
English: Adults from the age of 18 to 60 years will receive two doses of Daronrix, the first administered at an elected date, the second at least three weeks after the first dose for maximum efficacy.
Danish: Voksne i alderen 18-60 år får to doser Daronrix, den første på en given dato, og den anden mindst 3 uger efter den første dosis, hvilket giver maksimal effekt.
English: Adults from the age of 18 to 60 years will receive two injections of Daronrix, the first injection will be administered at an elected date, the second at least three weeks after the first injection.
Danish: Voksne i alderen 18-60 år får to injektioner med Daronrix, den første på en given dato, og den anden mindst 3 uger efter den første injektion.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Danish: Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Rare (≥1/10,000 to <1/1,000):
Danish: Sjælden (≥ 1/10.000, < 1/1.000):
English: The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Danish: Resultaterne af undersøgelserne vil danne grundlaget for den årlige vurdering af risk/benefit-forholdet.
English: Daronrix is a white, slightly milky liquid and is presented as follows in an ampoule (0.5 ml) for 1 dose in a pack of 100
Danish: Daronrix er en hvid, let mælkeagtig væske, og den leveres i en ampul (0,5 ml) til 1 dosis i en pakning med 100.
English: No data have been generated with Daronrix in pregnant women.
Danish: Der foreligger ingen data fra Daronrix til gravide kvinder.
English: • Itching at the injection site
Danish: • Smerter på injektionsstedet
English: All signal evaluation reports should be provided, including those that were subsequently not identified as being signals.
Danish: dem, der efterfølgende ikke blev identificeret som hændelser.
English: A clinical study has evaluated the immunogenicity of the monovalent aluminium-adjuvanted whole virus vaccine (A/H5N1) with a haemagglutinin content of 15 µg HA per dose in adults aged 18-60 years (N=48) following a 0, 21 day schedule.
Danish: Et klinisk forsøg har vurderet immunogeniciteten af den monovalente, aluminiumsadjuverede, hele virusvaccine (A/H5N1) med et hæmagglutininindhold på 15 µg HA pr. dosis til voksne i alderen 1860 år (N=48), der har fået vaccinen på dag 0 og dag 21.
English: PREFILLED SYRINGE X 1 AND X 10 WITH AND WITHOUT NEEDLE
Danish: FYLDT INJEKTIONSSPRØJTE, 1 OG 10 DOSER, MED OG UDEN KANYLE
English: Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Potassium chloride Magnesium chloride hexahydrate Thiomersal
Danish: Dinatriumphosphatdodecahydrat Kaliumdihydrogenphosphat Kaliumchlorid