FrancophonIA/ELRC3.0 huggingface dataset:
English: If abnormal liver function tests or clinical symptoms consistent with liver disease occur, treatment with <Product Name> must be discontinued.
Danish: Hvis der opstår unormale leverfunktionstests eller kliniske symptomer, der tyder på leversygdom, skal {X} seponeres.
English: Liver function tests must be performed at weekly intervals during treatment with <Product Name> because increased liver enzyme levels, hepatitis and liver failure have been reported in association with flupirtine therapy.
Danish: Der skal udføres ugentlige leverfunktionstests under behandling med {X}, da der i forbindelse med behandling med flupiritin er rapporteret stigning i leverenzymniveauerne, hepatitis og leversvigt.
English: Use in children and adolescents
Danish: {X} bør ikke anvendes til børn og unge under 18 år.
English: Flupirtine should be used for the shortest duration necessary to achieve adequate pain relief.
Danish: Flupirtine skal anvendes i så kort tid som muligt for at opnå en passende smertelindring.
English: Flupirtine should be administered for the shortest duration necessary to achieve adequate analgesia.
Danish: Flupirtin bør anvendes i så kort tid som muligt for at opnå tilstrækkelig analgesi.
English: Section 4.5 Interaction with other medicinal products and other forms of interaction [The wording below should be inserted in this section]
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: [Oral pharmaceutical forms and suppositories] Do not <take><use><Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Danish: [Orale formuleringer og suppositorier] Tag ikke {X}, hvis du: - har en leversygdom - misbruger alkohol - samtidig anvender andre lægemidler, der vides at kunne give leverskade.
English: Your doctor will test liver function every week during treatment with <Product Name> because increased liver enzyme levels, hepatitis and liver failure have been reported in association with flupirtine therapy.
Danish: Din læge vil kontrollere din leverfunktion hver uge, så længe du er i behandling med {X}, da der er rapporteret om forhøjede leverenzymer, leverbetændelse og leversvigt i forbindelse med behandling med flupirtine.
English: <Product name > must only be used if treatment with other analgesics is contraindicated.
Danish: {X} må kun anvendes, hvis andre analgetika er kontraindicerede.
English: Do not use <Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Danish: Du må ikke få {X}, hvis du: - har en leversygdom - misbruger alkohol - samtidig anvender andre lægemidler, der vides at kunne give leverskade.
English: [Oral pharmaceutical forms and suppositories] Patients with pre-existing liver disease or alcohol abuse must not take <Product Name>.
Danish: [Orale lægemiddelformer og suppositorier] {X} må ikke anvendes til patienter med præeksisterende leversygdom eller alkoholmisbrug.
English: [The wording below should be inserted in this section]
Danish: [Nedenstående skal indsættes i de relevante afsnit]
English: Concomitant use of flupirtine with other drugs known to cause drug induced liver injury must be avoided (see Section 4.3).
Danish: Samtidig anvendelse af flupiritine og andre lægemidler, der vides at kunne forårsage lægemiddelinduceret leverskade, skal undgås (se pkt.
English: Warnings and precautions
Danish: Advarsler og forsigtighedsregler [Alle lægemiddelformer]
English: Not known: Hepatitis, liver failure.
Danish: Meget almindelig: Forhøjede leverenzymer Ikke kendt: Leverbetændelse (hepatitis), leversvigt.
English: Some of these reactions have been severe.
Danish: Visse af disse reaktioner har været alvorlige.
English: Number of cases Number of individuals*
Danish: Antal tilfælde Antal personer*
English: See sections 4.4 and 5.1 for important information on the data that support this indication.
Danish: Se afsnit 4.4 og 5.1 for vigtig information om de data, der understøtter denne indikation.
English: The results are summarised in Table 3.
Danish: Resultaterne er opsummeret i tabel 3.
English: Silgard should be administered as soon as possible after being removed from the refrigerator.
Danish: Silgard skal administreres så hurtigt som muligt, efter det er taget ud af køleskabet.
English: Headache was also seen.
Danish: Hovedpine er også set.
English: In this study, a durable protection was statistically demonstrated to approximately 10 years.
Danish: I dette studie blev varig beskyttelse i op til cirka 10 år påvist statistisk.
English: The primary time point analysis after 3 years did not reach statistical significance for all pre-specified endpoints.
Danish: Den primære analyse efter 3 år nåede ikke statistisk signifikans for alle præspecificerede endepunkter.
English: Use with hormonal contraceptives
Danish: Anvendelse med hormonale kontraceptionsmidler
English: Afterwards, the GMTs declined through Month 24 - 48 and then generally stabilized.
Danish: Efterfølgende faldt GMT'erne i måned 24-48 og stabiliseredes herefter generelt.
English: What other important information should you or your child know about Silgard
Danish: Hvilke andre vigtige ting, skal du eller dit barn vide om Silgard
English: Fever and nausea have also been reported.
Danish: Der er også indberettet feber og kvalme.
English: Data from stability studies demonstrate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 42°C.
Danish: Data fra stabilitetsstudier påviser, at vaccinens komponenter er stabile i 72 timer, når de opbevares ved temperaturer på mellem 8 °C og 42 °C.
English: However, these data are insufficient to recommend use of Silgard during pregnancy.
Danish: Disse data er dog ikke tilstrækkelige til at anbefale brug af Silgard under graviditet.
English: Specific studies of the vaccine in pregnant women were not conducted.
Danish: Der er ikke udført specifikke studier af vaccinen hos gravide kvinder.
English: Results of individual studies support the results from the combined analysis.
Danish: Resultater fra de individuelle studier understøtter resultaterne fra den kombinerede analyse.
English: The other ingredients in the vaccine suspension are:
Danish: De øvrige ingredienser i vaccinesuspensionen er følgende:
English: * Post-Marketing adverse events (frequency cannot be estimated from the available data).
Danish: * Bivirkninger efter markedsføring (hyppigheden kan ikke estimeres ud i fra forhåndenværende data).
English: Clinical Studies
Danish: Kliniske studier
English: HIV infection was an exclusion criterion (see also section 4.4).
Danish: Hiv-infektion var eksklusionskriterium (se også pkt.
English: The following side effects can be seen after the use of Silgard:
Danish: Følgende bivirkninger kan ses efter brug af Silgard:
English: Rare: urticaria.
Danish: Sjælden: Urticaria
English: The exact duration of immunity following a 3-dose series has not been established and is currently being studied.
Danish: Den præcise immunitetsvarighed efter en serie på 3 doser er endnu ikke blevet fastlagt og undersøges for øjeblikket.
English: • you or your child suffer from an illness with high fever.
Danish: • Hvis du eller dit barn har en sygdom med høj feber.
English: Therefore, it is important that the same vaccine should be prescribed for the whole dose regimen.
Danish: Det er derfor vigtigt, at den samme vaccine ordineres til hele doseringsregimet.
English: Date of first authorisation: 20 September 2006
Danish: Dato for første markedsføringstilladelse: 20. september 2006 Dato for seneste fornyelse: 20. juli 2011
English: • The vaccine should be used as supplied.
Danish: • Vaccinen skal bruges som leveret.
English: These adverse reactions usually were mild or moderate in intensity.
Danish: Disse bivirkninger var oftest lette eller moderate i intensitet.
English: Administer the entire dose as per standard protocol.
Danish: Administrér hele dosen i henhold til standard protokol.
English: % Efficacy
Danish: % Effekt
English: The duration of protection is currently unknown.
Danish: Varigheden af beskyttelse er for nuværende ikke kendt.
English: Silgard is a vaccine.
Danish: Silgard er en vaccine.
English: Few individuals (0.2%) discontinued due to adverse reactions.
Danish: Kun få personer (0,2 %) udgik på grund af bivirkninger/uønskede reaktioner.
English: Longer term follow-up studies are ongoing to determine whether a booster dose is needed.
Danish: Længerevarende opfølgningsstudier pågår med henblik på at fastlægge, hvorvidt en booster dosis behøves.
English: If you are from 9 to and including 13 years of age
Danish: Hvis du er fra 9 til og med 13 år gammel
English: If you miss a scheduled injection, your doctor will decide when to give the missed dose.
Danish: Hvis du glemmer en planlagt injektion, vil din læge beslutte, hvornår den manglende dosis skal tages.
English: Consequently, the frequency of these adverse events is
Danish: Derfor er hyppigheden af disse bivirkninger
English: • has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia
Danish: • har en forstyrrelse i blodets størkning (en sygdom, der gør, at du bløder mere end normalt), for eksempel hæmofili
English: For the 10 individual HPV types, statistical significance was only reached for HPV 31.
Danish: For de 10 individuelle HPV-typer var der alene statistisk signifikans for HPV 31.
English: The median duration of follow-up was 2.9 years.
Danish: Median opfølgningstid var 2,9 år.
English: The need for a booster dose has not been established.
Danish: Behovet for en boosterdosis er ikke fastlagt.
English: Read all of this leaflet carefully before you or your child are vaccinated.
Danish: Læs hele denne indlægsseddel grundigt, før du eller dit barn vaccineres.
English: Efficacy results are presented for the combined analysis of study protocols.
Danish: Effektresultaterne præsenteres for den kombinerede analyse af studieprotokollerne.
English: Efficacy was measured starting after the Month 7 visit.
Danish: Måling af effekt blev påbegyndt efter kontrolbesøget i måned 7.
English: If you forget or are not able to go back to your doctor at the scheduled time, ask your doctor for advice.
Danish: Hvis du glemmer eller ikke er i stand til at besøge din læge på det planlagte tidspunkt, skal du spørge din læge til råds.
English: A subset of individuals enrolled in the Phase III studies was followed up for a long-term period for safety, immunogenicity and effectiveness.
Danish: En undergruppe af personer rekrutteret i fase III-studier blev fulgt i en længere periode med hensyn til sikkerhed, immunogenicitet og effektivitet.
English: The vaccine should be used as supplied; no dilution or reconstitution is necessary.
Danish: Vaccinen skal anvendes som den leveres; der er hverken behov for fortynding eller rekonstitution.
English: It is important that you follow the instructions of your doctor or nurse regarding return visits for the follow-up doses.
Danish: Det er vigtigt, at du følger din læges eller sygeplejerskes instrukser vedrørende ekstra besøg med henblik på supplerende doser.
English: The primary analysis was done in type-specific populations that required women to be negative for the type being analyzed, but who could be positive for other HPV types (96% of the overall population).
Danish: Den primære analyse blev udført på type-specifikke populationer, hvor det var et krav, at kvinder var negative for den type, der blev analyseret for, men kunne være positive for andre HPV-typer (96 % af den samlede population).
English: Silgard is intended to prevent these diseases.
Danish: Silgard er beregnet til at forebygge disse sygdomme.
English: *Number of individuals with at least one follow-up visit after 30 days after Day 1 **Percent efficacy is calculated from the combined protocols.
Danish: *Antal personer med mindst et opfølgningsbesøg efter 30 dage efter dag 1 **Procentuel effekt beregnes ud fra de kombinerede protokoller.
English: These data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity.
Danish: Disse data for gravide kvinder (flere end 1.000 kvinder eksponeret) indikerer hverken misdannelser eller føto/neonatal toksicitet.
English: Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Danish: Eftersom disse bivirkninger er indberettet frivilligt fra en population af ukendt størrelse, er det ikke altid muligt at bestemme hyppigheden pålideligt eller at fastlægge en årsagssammenhæng med eksponering for vaccinen.
English: Table 4: Results for CIN 2/3 or AIS in Type-Specific HPV-Naïve Individuals
Danish: Tabel 4: Resultater for CIN 2/3 eller AIS hos type-specifikke HPV-naive personer
English: Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Silgard should not receive further doses of Silgard.
Danish: Personer, som udvikler symptomer, der indikerer overfølsomhed, efter at have modtaget en dosis Silgard, bør ikke modtage yderligere doser Silgard.
English: Note: point estimates and confidence intervals are adjusted for person-time of follow-up.
Danish: Bemærk: Punktestimater og konfidensintervaller er justeret for person-opfølgningstidspunkt.
English: 1 dose (0.5 ml) contains approximately:
Danish: 1 dosis (0,5 ml) indeholder ca.:
English: • you or your child developed an allergic reaction after receiving a dose of Silgard.
Danish: • Hvis du eller dit barn har udviklet en allergisk reaktion efter at have modtaget en dosis Silgard
English: Cross-protective efficacy
Danish: Effekt af krydsbeskyttelse
English: These data are intended to guide healthcare professionals in case of temporary temperature excursion only.
Danish: Disse data er kun beregnet til at vejlede sundhedspersonale i tilfælde af midlertidige temperaturudsving.
English: n % of seropositive subjects
Danish: % af seropositive forsøgspersoner
English: The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity.
Danish: De observerede forskelle var < 10 %, og for flertallet af forsøgspersonerne var intensiteten af bivirkningerne rapporteret som mild til moderat.
English: The data on Silgard administered during pregnancy did not indicate any safety signal.
Danish: Data på Silgard indgivet under graviditet indikerede ingen sikkerhedsrisiko.
English: The requirement for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for
English: Therefore, vaccinees should be observed for approximately 15 minutes after vaccine administration.
Danish: Derfor skal den vaccinerede overvåges nøje i cirka 15 minutter efter indgivelse af vaccinen.
English: Fainting, sometimes accompanied by shaking or stiffening, has been reported.
Danish: Besvimelse, som sommetider er ledsaget af rystelser eller rigiditet, er blevet rapporteret.
English: Pharmacotherapeutic group: Viral Vaccine, ATC code: J07BM01
Danish: Farmakoterapeutisk klassifikation: Viral vaccine, ATC-kode: J07BM01
English: Silgard has not been shown to have a therapeutic effect.
Danish: Det er ikke blevet påvist, at Silgard har en terapeutisk effekt.
English: What you need to know before you receive Silgard
Danish: Det skal du vide, før du får Silgard
English: It is important that procedures are in place to avoid injury from faints.
Danish: Det er vigtigt at træffe sikkerhedsforanstaltninger for at undgå kvæstelser ved besvimelse.
English: Long-term follow-up studies are currently ongoing to determine the duration of protection (see
Danish: Langtids opfølgningsstudier pågår for at fastslå beskyttelsens varighed (se pkt.
English: How Silgard is given
Danish: Sådan gives Silgard
English: At the end of this period Silgard should be used or discarded.
Danish: Derefter skal Silgard bruges eller bortskaffes.
English: 16- to 26-Year-Old Women (Protocols 013 and 015) GMT (95% CI)
Danish: 16- til 26-årige kvinder (Protokol 013 og 015) GMT (95 % CI)
English: 16- to 26-Year-Old Men
Danish: 16-26-årige mænd
English: The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination.
Danish: Beslutningen om at vaccinere den enkelte bør ske under hensyntagen til risiko for tidligere eksponering for HPV og potentielle fordele ved vaccination.
English: Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
Danish: Derfor bør relevante forebyggende forholdsregler imod seksuelt overførte sygdomme fortsat tages.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får denne vaccine.
English: In all clinical trials, individuals who had received immunoglobulin or blood-derived products during the 6 months prior to the first vaccine dose were excluded.
Danish: I samtlige kliniske studier blev personer, som havde modtaget immunoglobulin eller produkter afledt af blod i 6 måneder forud for den første vaccinedosis, udelukket.
English: Vaccination is not a substitute for routine cervical screening.
Danish: Vaccination er ikke en erstatning for rutinemæssig cervikal screening.
English: Impact on Definitive Cervical Therapy Procedures
Danish: Virkning på definitive cervikale behandlingsprocedurer
English: CIN 3 and AIS have been accepted as immediate precursors of invasive cervical
Danish: CIN 3 og AIS er blevet accepteret som umiddelbare forstadier til invasiv cervixcancer.
English: [Very Common (≥1/10); Common (≥1/100 to 1/10); Uncommon (≥1/1,000 to 1/100); Rare (≥1/10,000 to 1/1,000); Very Rare (1/10,000)]
Danish: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra
English: GMT- Geometric mean titre in mMU/ml (mMU = milli-Merck units)
Danish: GMT- Geometrisk gennemsnitstiter i mMU/ml (mMU = milli-Merck-enheder)
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg viser ikke direkte eller indirekte skadelige påvirkninger med hensyn til reproduktionstoksicitet (se pkt.
English: • has a weakened immune system, for example due to a genetic defect, HIV infection or medicines that affect the immune system.
Danish: • har et svækket immunsystem, f.eks. som følge af en genetisk fejl, hiv-infektion eller medicin, der påvirker immunsystemet.
English: This vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Danish: Denne vaccine bør gives med forsigtighed til personer med trombocytopeni eller koagulationsforstyrrelser, da der kan opstå blødning efter en intramuskulær indgivelse i disse personer.
English: Since no vaccine is 100% effective and Silgard will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
Danish: Eftersom ingen vaccine er 100 % effektiv, og Silgard ikke vil yde beskyttelse mod alle HPV typer eller mod eksisterende HPVinfektioner, er rutinemæssig cervikal screening fortsat af yderste vigtighed og skal udføres i overensstemmelse med lokale retningslinjer.
English: They are ranked under headings of frequency using the following convention:
Danish: Bivirkningerne er anført efter hyppighed i henhold til konventionen:
English: Silgard may be given to women who are breast-feeding or intend to breast-feed.
Danish: Silgard kan gives til kvinder, som ammer eller planlægger at amme.
English: After thorough agitation, it
Danish: Efter grundig omrystning bliver det
English: Antibodies against all four HPV types were transferred to the offspring during gestation and possibly during lactation.
Danish: Antistoffer over for alle fire HPV-typer overførtes til afkommet under drægtighedsperioden og muligvis under diegivningen.
English: Table 1 also includes additional adverse events which have been spontaneously reported during the post-marketing use of Silgard worldwide.
Danish: Tabel 1 indeholder desuden bivirkninger, der er indberettet spontant under anvendelse af Silgard efter markedsføring over hele verden.
English: Silgard may not have an optimal effect if: • used with medicines that suppress the immune system.
Danish: Silgard vil muligvis ikke have en optimal virkning hvis: • det anvendes sammen med medicin, der hæmmer immunsystemet.
English: Neither subcutaneous nor intradermal administration has been studied.
Danish: Hverken subkutan eller intradermal indgivelse er blevet undersøgt.
English: Total IgG Luminex Immunoassay (IgG LIA) was used to assess the persistence of immune response in addition to cLIA.
Danish: Total IgG Luminex Immunanalyse (IgG-LIA) blev brugt til at vurdere persistensen af immunrespons som supplement til cLIA.
English: 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 safety of
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Silgard is intended for adolescents and adults from 9 years of age onwards.
Danish: Silgard er beregnet til unge og voksne fra 9-års alderen og ældre.
English: All three doses should be given within a 1-year period.
Danish: Alle tre doser bør gives inden for en periode på 1 år.
English: Impact on Biopsy and Definitive Therapy Procedures
Danish: Virkningen på biopsi- og definitive behandlingsprocedurer