FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Ozurdex (which may affect more than 1 in 10 people) are increased intraocular pressure (the pressure inside the eye), conjunctival haemorrhage (bleeding from the membrane over the white of the eye) and cataract (clouding of the lens - in patients with uveitis and with diabetes).
Danish: De hyppigste bivirkninger ved Ozurdex (som kan forekomme hos mere end 1 ud af 10 personer) er øget intraokulært tryk (trykket inde i øjet), conjunktival blødning (blødning fra membranen over det hvide i øjet) og grå stær (tilsløring af linsen - hos patienter med uveitis og med diabetes).
English: The European Medicines Agency decided that Ozurdex's benefits are greater than its risks in patients with uveitis or macular oedema related to blocked veins, and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Ozurdex opvejer risiciene hos patienter med uveitis eller makulært ødem i forbindelse med blokerede vener, og at det kan godkendes til anvendelse i EU.
English: It is used to treat adults with impaired vision due to macular oedema associated with:
Danish: Det anvendes til behandling af voksne med nedsat syn på grund af makulært ødem i forbindelse med:
English: Ozurdex must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes) and in patients with advanced glaucoma (damage to the nerve of the eye usually caused by high pressure inside the eye) that is not adequately controlled with medicines alone.
Danish: Ozurdex må ikke anvendes hos patienter, der har eller menes at have infektioner i eller omkring øjnene, og hos patienter med fremskreden glaukom (beskadigelse af øjets nerve, normalt pga. højt tryk i øjet), som ikke er tilstrækkeligt kontrolleret med lægemidler alene.
English: Ozurdex is an implant that is injected into the eye.
Danish: Ozurdex er et implantat, der injiceres i øjet.
English: Macular oedema is swelling in the macula, the central part of the retina (the light-sensing layer at the back of the eye), which can reduce the central part of a person's vision and affect tasks such as reading and driving.
Danish: Makulært ødem er hævelse i den gule plet (makula), den centrale del af nethinden (det lysfølsomme lag bagest i øjet), som kan reducere den centrale del af en persons syn og påvirke evnen til at læse og køre bil.
English: Two main studies involving 1,048 patients compared the effects of a 700 microgram or a 350 microgram implant of Ozurdex.
Danish: To hovedstudier med 1.048 patienter sammenlignede virkningerne af et implantat på 700 mikrogram Ozurdex og et på 350 mikrogram Ozurdex.
English: In the first study, around 23% of the patients receiving Ozurdex had increased BCVA of at least 15 letters after 180 days compared with 17% of the patients receiving the sham treatment.
Danish: I det første studie havde ca. 23 % af de patienter, der fik Ozurdex, fået forøget BCVA med mindst 15 bogstaver efter 180 dage sammenlignet med 17 % af de patienter, der fik skinbehandlingen.
English: What are the risks associated with Ozurdex?
Danish: Hvilke risici er der forbundet med Ozurdex?
English: Ozurdex can only be obtained with a prescription and must be given by an ophthalmologist (eye specialist) who has experience in giving intravitreal injections (injections into the vitreous humour, the jelly-like fluid in the eye).
Danish: Ozurdex fås kun på recept og skal indgives af en oftalmolog (øjenspecialist), som har erfaring med at give intravitreale injektioner (injektioner i øjets glaslegeme, det geleagtige materiale i øjet).
English: In patients in whom other types of treatment had not worked or were unsuitable, there was an average improvement in BCVA over both studies of 3.2 letters after Ozurdex 700 micrograms, compared with 1.5 letters after sham treatment.
Danish: Hos de patienter, hos hvem andre behandlingsformer ikke havde virket eller ikke var egnede, var der i begge undersøgelser en gennemsnitlig forbedring i BCVA på 3,2 bogstaver efter 700 mikrogram Ozurdex sammenlignet med 1,5 bogstaver efter skinbehandling.
English: Macular oedema related to diabetes
Danish: Diabetesrelateret makulært ødem
English: In patients whose lens had already been surgically replaced, there was an average improvement in BCVA over both studies of 6.5 letters after Ozurdex 700 micrograms, compared with 1.7 letters after sham treatment.
Danish: Hos patienter, hvis linse allerede var blevet erstattet kirurgisk, var der en gennemsnitlig forbedring i BCVA i begge undersøgelser på 6,5 bogstaver efter 700 mikrogram Ozurdex sammenlignet med 1,7 bogstaver efter skinbehandlingen.
English: Patients receive one Ozurdex implant at a time, injected directly into the vitreous humour.
Danish: Patienterne får ét Ozurdex-implantat ad gangen, der injiceres direkte i glaslegemet.
English: Macular oedema related to blocked veins of the retina
Danish: Makulært ødem i forbindelse med blokerede vener i nethinden
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ozurdex have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ozurdex.
English: How is Ozurdex used?
Danish: Hvordan anvendes Ozurdex?
English: For the full list of side effects of Ozurdex, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Ozurdex fremgår af indlægssedlen.
English: For the full list of restrictions with Ozurdex, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Ozurdex fremgår af indlægssedlen.
English: How does Ozurdex work?
Danish: Hvordan virker Ozurdex?
English: What benefits of Ozurdex have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ozurdex?
English: Ozurdex implants are injected directly into the vitreous humour of the eye.
Danish: Ozurdex-implantater injiceres direkte i øjets glaslegeme.
English: Ozurdex is also used to treat adults with non-infectious uveitis at the back of the eye. Uveitis is inflammation of the uvea, the middle layer of the eye.
Danish: Ozurdex anvendes også til behandling af voksne med ikkeinfektiøs uveitis i den bagerste del af øjet.
English: In one main study involving 229 adults with uveitis, 8 weeks after injection, around 47% of patients treated with 700 micrograms of Ozurdex achieved a vitreous haze score of zero, compared with 36% of patients treated with 350 micrograms of Ozurdex and 12% of patients who received the sham treatment.
Danish: Ozurdex var mere effektivt end skinbehandling til at mindske betændelse hos patienter med uveitis, målt ved en forbedring af patienternes glaslegemescore, der angiver betændelsesgraden, og hvor nul svarer til, at der ingen betændelse er. I et hovedstudie, der omfattede 229 voksne med uveitis, opnåede ca. 47 % af de patienter, der blev behandlet med 700 mikrogram Ozurdex, en glaslegemescore på nul sammenlignet med 36 % af de patienter, der blev behandlet med 350 mikrogram Ozurdex, og 12 % af de patienter, der fik skinbehandlingen.
English: However, in those with an artificial lens in the affected eye or who previously have not responded to or are unsuitable for other non-corticosteroid treatments, the benefits of Ozurdex were considered to outweigh the risks.
Danish: Fordelene ved Ozurdex blev imidlertid anset for at opveje risiciene hos patienter, som har en kunstig linse i det berørte øje, eller som ikke tidligere har reageret på eller ikke er egnede til andre behandlinger uden kortikosteroider.
English: Strength Pharmaceutical Form Route of Administration Packaging
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage
English: HR=High Risk.
Danish: HR=Høj risiko.
English: Some of these reactions have been severe.
Danish: Nogle af disse reaktioner har været svære.
English: Frequencies are reported as:
Danish: Hyppighed rapporteres som:
English: In this study, a durable protection was statistically demonstrated to approximately 10 years.
Danish: I dette studie blev varig beskyttelse statistisk påvist i ca. 10 år.
English: See sections 4.4 and 5.1 for important information on the data that support these indications.
Danish: 4.4 og 5.1 for vigtig information om de data, der understøtter disse indikationer.
English: Allergic reactions have been reported.
Danish: Der er blevet rapporteret om allergiske reaktioner.
English: p-value <0.001.
Danish: p-værdi<0,001.
English: • suffer from an illness with high fever.
Danish: • lider af en sygdom med høj feber.
English: Paediatric population (children <9 years of age)
Danish: Pædiatrisk population (børn < 9 år)
English: The duration of protection is not yet known.
Danish: Beskyttelsens varighed kendes ikke.
English: Long-term effectiveness studies
Danish: Langsigtede effektstudier
English: It is important that procedures are in place to avoid injury from fainting.
Danish: Det er vigtigt, at der findes procedurer til at undgå kvæstelse ved besvimelse.
English: Number of cases*
Danish: n Antal tilfælde*
English: Gardasil 9 should be administered as soon as possible after being removed from the refrigerator.
Danish: Gardasil 9 skal administreres så hurtigt som muligt, efter det er taget ud af køleskabet.
English: Therefore, vaccinees should be observed for approximately 15 minutes after vaccination.
Danish: Derfor skal vaccinerede mennesker observeres i ca. 15 minutter efter vaccinationen.
English: No cases of overdose have been reported.
Danish: Der er ikke rapporteret om nogen tilfælde af overdosering.
English: mMU=milli-Merck units.
Danish: mMU=milli-Merck-enheder.
English: Date of first authorisation: 10 June 2015 Date of latest renewal: {DD month YYYY}
Danish: Dato for første markedsføringstilladelse: 10. juni 2015 Dato for seneste fornyelse: {DD måned ÅÅÅÅ}
English: • has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia;
Danish: • har en blødersygdom (en sygdom som gør, at du bløder mere end normalt), f.eks. hæmofili;
English: These adverse reactions usually were mild or moderate in intensity.
Danish: Disse bivirkninger var som regel lette eller moderate i intensitet.
English: qHPV vaccine was also known as Silgard in some countries.
Danish: qHPV-vaccine var også kendt under navnet Silgard i nogle lande.
English: Use with other vaccines
Danish: Anvendelse med andre vacciner
English: CI=Confidence Interval.
Danish: CI=Konfidensinterval.
English: Please speak to your doctor for more information.
Danish: Tal med din læge, hvis du ønsker flere oplysninger.
English: Vaccination should be postponed in individuals suffering from an acute severe febrile illness.
Danish: Man bør udsætte vaccination hos personer, som lider af en akut alvorlig febril sygdom.
English: • is allergic to any of the active substances or any of the other ingredients of this vaccine (listed under “other ingredients”, in section 6).
Danish: • er allergisk over for et af de aktive stoffer eller et af de øvrige indholdsstoffer i denne vaccine (angivet under “andre indholdsstoffer” i punkt 6).
English: The minimum anti-HPV titre that confers protective efficacy has not been determined.
Danish: Den minimale anti-HPV titer, som giver en beskyttende effekt, er ikke fastlagt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. reelt set “natriumfri”.
English: The vaccine should not be mixed in the same syringe with any other vaccines and solution.
Danish: Vaccinen må ikke blandes i samme sprøjte med andre vacciner og opløsninger.
English: The need for a booster dose has not been established.
Danish: Behovet for en boosterdosis er ikke blevet fastlagt.
English: However, these data are considered insufficient to recommend use of Gardasil 9 during pregnancy.
Danish: Disse data anses dog for utilstrækkelige til at anbefale brugen af Gardasil 9 under graviditeten.
English: A repeat dose toxicity study in rats, which included an evaluation of single-dose toxicity and local tolerance, revealed no special hazards to humans.
Danish: Et studie med gentagen dosistoksicitet i rotter, som inkluderede en evaluering af enkelt-dosis toksicitet og lokal tolerance, viste ikke nogen speciel fare for mennesker.
English: Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure.
Danish: Da disse hændelser blev indberettet frivilligt fra en population af ukendt størrelse, er det ikke muligt at anslå hyppigheden pålideligt eller, for alle hændelser, at fastslå en årsagssammenhæng med eksponering for vaccinen.
English: The CD4% or plasma HIV RNA was not affected by vaccination.
Danish: CD4% eller plasma-hiv-RNA blev ikke påvirket af vaccination.
English: The vaccine has not been shown to have a therapeutic effect.
Danish: Det er ikke blevet påvist, at vaccinen har en terapeutisk effekt.
English: A. Summary of the safety profile
Danish: A. Oversigt over sikkerhedsprofilen
English: Fainting, sometimes accompanied by shaking or stiffening, has been reported.
Danish: Besvimelse, nogle gange ledsaget af rysten eller stivhed, er blevet rapporteret.
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 gå til lægen på det planlagte tidspunkt, skal du spørge lægen til råds.
English: The VLPs cannot infect cells, reproduce or cause disease.
Danish: VLP'er kan ikke inficere celler, reproducere sig eller forårsage sygdom.
English: • Choose an appropriate needle to ensure an intramuscular (IM) administration depending on your patient's size and weight.
Danish: • Vælg den rigtige nål til intramuskulær (IM) administration afhængigt af patientens størrelse og vægt.
English: Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
Danish: Bivirkninger, som anses for at være som minimum sandsynligt forbundet med vaccination, er kategoriseret efter hyppighed.
English: Longer term follow-up studies are ongoing to determine whether a booster dose is needed.
Danish: Langvarige opfølgningsstudier pågår for at fastslå, om det er nødvendigt med en boosterdosis.
English: The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity (see section 4.5).
Danish: De observerede forskelle var < 10% og hos størstedelen af forsøgspersonerne blev de uønskede hændelser rapporteret som værende let til moderat i intensitet (se pkt.
English: These data are intended to guide healthcare professionals in case of temporary temperature excursion only.
Danish: Disse data er kun beregnet til at hjælpe sundhedspersoner i tilfælde af midlertidige temperaturudsving.
English: At the end of this period Gardasil 9 should be used or discarded.
Danish: Efter denne periode skal Gardasil 9 bruges eller bortskaffes.
English: • Genital warts (Condyloma acuminata) caused by specific HPV types.
Danish: • Kondylomer (Condyloma acuminata) forårsaget af specifikke HPV-typer.
English: Acute disseminated encephalomyelitis, Guillain-Barré syndrome, syncope sometimes accompanied by tonic-clonic movements
Danish: Akut dissemineret encephalomyelitis, Guillain-Barrés syndrom, synkope, nogle gange ledsaget af toniske-kloniske bevægelser
English: Pharmacotherapeutic group: Vaccines, Papillomavirus vaccines, ATC code: J07BM03
Danish: Farmakoterapeutisk klassifikation: Vacciner, papillomavirus vacciner, ATC-kode: J07BM03
English: The vaccine should be administered by intramuscular injection.
Danish: Vaccinen bør administreres som intramuskulær injektion.
English: If you are pregnant, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine.
Danish: Hvis du er gravid, 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: If you are a woman, you should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Danish: Hvis du er kvinde, skal du fortsætte med at følge din læges råd om cervikale screeningsprøver/Pap-tests og forebyggende og beskyttende foranstaltninger
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Danish: Som med alle injicerbare vacciner skal relevant medicinsk behandling og overvågning altid være tilgængelig i tilfælde af, at der opstår sjældne anafylaktiske reaktioner efter administration af vaccinen.
English: Evidence of anamnestic (Immune Memory) response
Danish: Evidens for anamnestisk respons (immunologisk hukommelse)
English: Adjuvants are included to improve the immune response of vaccines.
Danish: Adjuvanser tilsættes for at forbedre vacciners immunreaktion.
English: If a scheduled injection is missed, your doctor will decide when to give the missed dose.
Danish: Hvis du ikke får en planlagt dosis, vil din læge afgøre, hvornår du skal have den manglende dosis.
English: Vaccination should be postponed until completion of pregnancy (see section 5.1).
Danish: Vaccinationen skal udsættes til efter endt graviditet (se pkt.
English: Safety and immunogenicity in individuals who have received immunoglobulin or blood-derived products during the 3 months prior to vaccination have not been studied in clinical trials.
Danish: Sikkerheden og immunogeniciteten hos personer, som har fået immunoglobulin eller produkter, der er deriveret fra blod, i 3 måneder før vaccinationen, er ikke blevet undersøgt i kliniske forsøg.
English: Therefore tell the doctor or nurse if fainting occurred with a previous injection.
Danish: Derfor skal du fortælle det til lægen eller sygeplejersken, hvis du besvimede ved en tidligere injektion.
English: The efficacy of L1 VLP vaccines is thought to be mediated by the development of a humoral immune response.
Danish: Effekten af L1 VLP-vacciner menes at blive medieret af udviklingen af humoralt immunrespons.
English: Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
Danish: Derfor skal man fortsætte med at tage passende forholdsregler mod seksuelt overførte sygdomme.
English: ASC-US=Atypical squamous cells of undetermined significance.
Danish: ASC-US=Atypiske pladeceller af ubestemt signifikans.
English: Demonstration of non-inferiority required that the lower bound of the 95% CI of the GMT ratio be greater than
Danish: Demonstration af non-inferioritet krævede, at den lavere grænse på 95% CI af GMT forholdet skal være højere end 0,67.
English: Duration of protection of a 2-dose schedule of Gardasil 9 has not been established.
Danish: Varighed af beskyttelse ved en 2-dosis tidsplan af Gardasil 9 er ikke fastsat.
English: Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du eller dit barn tager eller måske vil tage anden medicin eller har gjort det for nylig, inklusive ikke-receptpligtig medicin.
English: Gardasil 9 is given as an injection by your doctor.
Danish: Gardasil 9 gives som en injektion af din læge.
English: Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you or your child. - Keep this leaflet.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn vaccineres, da den indeholder vigtige oplysninger for dig eller dit barn.
English: Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Danish: Selv om besvimelse er ualmindeligt, skal patienter observeres i 15 minutter, efter de har fået HPV-vaccine.
English: Type-specific immunoassays with type-specific standards were used to assess immunogenicity to each vaccine HPV type.
Danish: Type-specifikke immunanalyser med type-specifikke standarder blev brugt til at vurdere immunogenicitet for hver vaccine-HPV-type.
English: The clinical significance of this observation is not known.
Danish: Den kliniske signifikans af denne observation kendes ikke.
English: cLIA= Competitive Luminex Immunoassay.
Danish: cLIA= Kompetitiv Luminex-baseret immunanalyse.
English: %Efficacy** (95% CI)
Danish: % Effekt** (95% CI)
English: Stability data indicate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 25°C or from 0°C to 2°C.
Danish: Stabilitetsdata indikerer, at vaccinens komponenter er stabile i 72 timer, når den opbevares ved temperaturer på mellem 8 °C og 25 °C eller mellem 0 °C og 2 °C.
English: In the long-term extensions of clinical studies Protocols 001 and 002, effectiveness was observed in the PPE population.
Danish: I de langsigtede forlængelser af de kliniske studier Protokol 001 og 002 blev effektiviteten observeret i PPE-populationen.
English: Use with hormonal contraceptives
Danish: Brug sammen med hormonelle præventionsmidler
English: All three doses should be given within a 1-year period.
Danish: Alle tre doser skal gives inden for en periode på 1 år.
English: There were no vaccine-related serious adverse experiences reported in infants who were breast-feeding during the vaccination period.
Danish: Der blev ikke rapporteret om vaccinerelaterede alvorlige uønskede hændelser hos spædbørn, som blev ammet i vaccinationsperioden.
English: The qHPV vaccine was used as an active control during the clinical development program for Gardasil 9.
Danish: qHPV-vaccinen blev brugt som en aktiv kontrol under det kliniske udviklingsprogram for Gardasil 9.
English: Table 1: Adverse reactions following administration of Gardasil 9 occurring with a frequency of at least 1.0% from clinical trials*
Danish: Tabel 1: Bivirkninger efter administration af Gardasil 9, der opstod med en hyppighed på mindst 1,0 % i kliniske forsøg*
English: Specific studies of Gardasil 9 in pregnant women were not conducted.
Danish: Specifikke studier af Gardasil 9 hos gravide kvinder er ikke blevet udført.
English: The clinical relevance of the lower response is unknown.
Danish: Den kliniske relevans af det lavere respons er ukendt.
English: Individuals with hypersensitivity after previous administration of Gardasil 9 or Gardasil/Silgard should not receive Gardasil 9.
Danish: Personer med overfølsomhed efter tidligere administration af Gardasil 9 eller Gardasil/Silgard bør ikke få Gardasil 9.
English: Syncope (fainting), sometimes associated with falling, can occur following, or even before, any vaccination, especially in adolescents as a psychogenic response to the needle injection.
Danish: Synkope (besvimelse), nogle gange ledsaget af fald, kan forekomme efter eller endog før en vaccination, især hos unge som en psykogen reaktion på injektionen.
English: Efficacy and/or immunogenicity of Gardasil 9 were assessed in ten clinical studies.
Danish: Effekt og/eller immunogenicitet af Gardasil 9 blev vurderet i ti kliniske studier.
English: Gardasil 9 will not protect against every type of Human Papillomavirus.
Danish: Gardasil 9 beskytter ikke mod alle typer Human papillomavirus.
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: Man skal udvise forsigtighed, hvis vaccinen gives til personer med trombocytopeni eller andre koagulationsforstyrrelser, da der kan opstå blødning efter intramuskulær administration hos disse personer.
English: Pyrexia, fatigue, At the injection site: pruritus, bruising
Danish: Pyreksi, træthed På injektionsstedet: pruritus, hæmatom