FrancophonIA/ELRC3.0 huggingface dataset:
English: At study completion, there were no cases of infection or histopathological lesions associated with HPV-16 or HPV-18 in the vaccine group in study HPV-023.
Danish: Ved afslutningen af studie HPV-023 var der ingen tilfælde af infektion eller histopatologiske celleforandringer associeret med HPV-16 eller HPV-18 i vaccinegruppen.
English: 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl).
Danish: 1 ml suspension i hætteglas (type I-glas) med prop (butylgummi) til 2 doser.
English: • itching, red skin rash, hives (urticaria)
Danish: • kløe, rødt hududslæt, nældefeber
English: ATP cohort(1) End of study analysis(3)
Danish: ATP -kohorte(1) End-of-study analyse(3)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/419/001 - pack of 1
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/419/001 - Pakningstørrelse på 1
English: Human Papillomavirus1 type 16 L1 protein2,3,4
Danish: Humant papillomvirus1 type 16 L1-protein2,3,4
English: In two clinical trials (HPV-012 & -013) performed in girls aged 10 to 14 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7) with GMTs at least 2-fold higher as compared to women aged 15 to 25 years.
Danish: I to kliniske studier (HPV-012 og -013) med piger i alderen fra 10 til 14 år serokonverterede alle personer for både HPV-type 16 og 18 efter den 3. dosis (ved måned 7), og GMT var mindst 2 gange højere i forhold til kvinder i alderen fra 15 til 25 år.
English: • gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
Danish: • mave-tarm-symptomer herunder kvalme, opkast, diaré og mavesmerter
English: ATP cohort(1) End of study analysis(2)
Danish: ATP -kohorte(1) End-of-study analyse(2)
English: 0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl).
Danish: 0,5 ml suspension i hætteglas (type I-glas) med prop (butylgummi) til 1 dosis.
English: Human Papillomavirus1 type 18 L1 protein2,3,4
Danish: Humant papillomvirus1 type 18 L1-protein2,3,4
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT Fritaget fra krav om blindeskrift.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/419/010 - pack of 1
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/419/010 - Pakningstørrelse på 1
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MONODOSE VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Vaccine-induced IgG GMTs for both HPV-16 and HPV-18 peaked at month 7 and then declined to reach a plateau from month 18 up to the [M107-M113] interval with ELISA GMTs for both HPV-16 and HPV-18 at least still 10-fold higher than the ELISA GMTs observed in women who cleared a natural HPV infection.
Danish: Vaccineinduceret IgG GMT for både HPV-16 og HPV-18 var højest ved måned 7, hvorefter det faldt og nåede et plateau fra måned 18 til M107-M113-tidsintervallet målt ved ELISA.
English: This post-hoc analysis excluded cases (in the vaccine group and in the control group) which were not considered to be causally associated with HPV-16 or HPV-18 infections acquired during the trial.
Danish: Denne post-hoc-analyse ekskluderede de tilfælde, som ikke blev anset for at være kausalt forbundet med HPV-16- eller HPV18-infektioner opstået i løbet af studiet (både i vaccinegruppen og i kontrolgruppen).
English: If not used within 6 hours it should be discarded.
Danish: Vaccinen skal kasseres, hvis den ikke er anvendt inden 6 timer.
English: Vaccine efficacy against virological endpoints (6-month and 12-month persistent infection) associated with HPV-16/18 observed in the ATP cohort at the end of study is presented in Table 2.
Danish: Effekten af vaccinen mod virologiske endepunkter (6- og 12-måneders persisterende infektion) associeret med HPV-16/18 set i ATP-kohorten ved slutningen af studiet er anført i tabel 2.
English: A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe.
Danish: Et fint hvidt bundfald med et klart, farveløst væskelag ovenpå kan ses efter opbevaring af injektionssprøjten.
English: Except for asymptomatic human immunodeficiency virus (HIV) infected subjects for whom limited immunogenicity data are available (see section 5.1), there are no data on the use of Cervarix in subjects with impaired immune responsiveness such as patients receiving immunosuppressive treatment.
Danish: 5.1) findes der ingen data vedrørende brugen af Cervarix til personer med svækket immunforsvar, såsom patienter i immunsuppresiv behandling.
English: 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive or use machines have been performed.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner
English: Vaccine efficacy against high grade cervical lesions associated with HPV-16/18 observed in TVC at end of study is presented in Table 3.
Danish: Effekten af vaccinen mod high-grade celleforandringer associeret med HPV-16/18 i TVC-kohorten ved slutningen af studiet er anført i tabel 3.
English: In the TVC and TVC-naïve cohorts, the vaccine's efficacy was demonstrated against high-grade cervical lesions at end of study (Table 5).
Danish: Effekten af vaccinen mod high-grade celleforandringer blev vist i TVC-kohorten og i kohorten TVC-naive ved slutningen af studiet (tabel 5).
English: An anamnestic immune response to HPV-16 and HPV-18 (by ELISA) was observed one week and one month after the challenge dose, GMTs one month after the challenge dose exceeded those observed one month after the primary 3-dose vaccination.
Danish: Et anamnestisk respons mod HPV-16 og HPV-18 (målt ved ELISA) blev set en uge og en måned efter den administrerede belastningsdosis.
English: Suspension for injection
Danish: Beskyttelseshætte for injektionssprøjten
English: Vaccine efficacy against virological endpoints (6-month and 12-month persistent infection) associated with HPV-16/18 observed in TVC at end of study is presented in Table 4.
Danish: Effekten af vaccinen mod virologiske endepunkter (6- og 12-måneders persisterende infektion) associeret med HPV-16/18 i TVC-kohorten ved slutningen af studiet er anført i tabel 4.
English: In clinical trials, oral contraceptives (e.g. the pill) did not reduce the protection obtained by Cervarix.
Danish: Kliniske undersøgelser har vist, at Cervarix' beskyttende virkning ikke svækkes ved samtidig indtagelse af orale præventionsmidler (f.eks. p-piller).
English: Women who are pregnant or trying to become pregnant, are advised to postpone or interrupt vaccination until completion of pregnancy.
Danish: Det anbefales at udsætte vaccination af / afbryde vaccinationsprogrammet hos gravide kvinder eller kvinder, som forsøger at blive gravide, til graviditeten er afsluttet.
English: In the event-triggered analysis, vaccine efficacy against CIN1 associated with HPV 16/18 observed in the ATP cohort was 94.1% (96.1% CI: 83.4;98.5).
Danish: I den hændelsesudløste analyse var effekten af vaccinen mod CIN1 associeret med HPV-16/18 94,1 % (96,1 % CI: 83,4; 98,5) i ATP-kohorten.
English: A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.
Danish: Et fint hvidt bundfald med et klart, farveløst væskelag ovenpå kan ses efter opbevaring af hætteglasset.
English: Table 5: Vaccine efficacy against high-grade cervical lesions irrespective of the HPV DNA type in the lesion
Danish: Effekt af vaccinen mod high-grade cervikale celleforandringer uanset HPV-DNA-type i celleforandringerne
English: Vaccine efficacy against CIN1+ associated with HPV 16/18 observed in the ATP cohort was 91.7% (96.1% CI: 82.4;96.7).
Danish: Effekten af vaccinen mod CIN1+ associeret med HPV-16/18 var 91,7 % (96,1 % CI: 82,4; 96,7) i ATP-kohorten.
English: Multidose vial
Danish: Flerdosis hætteglas
English: Not known* Syncope or vasovagal responses to injection, sometimes accompanied by tonic-clonic movements (see section 4.4) *Because these events were reported spontaneously, it is not possible to reliably estimate their frequency
Danish: Synkope eller vasovagalt respons på injektionen, til tider ledsaget af tonisk-kloniske bevægelser (se pkt.
English: Cervarix is available in 2 dose vials (1 ml) in packs of 1, 10 and 100.
Danish: Cervarix fås i pakninger med 1, 10 og 100 hætteglas hver indeholdende 2 doser (1 ml).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE WITH OR WITHOUT NEEDLE, PACK OF 1, 10
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FYLDT INJEKTIONSSPRØJTE MED OG UDEN KANYLER, PAKNINGSSTØRRELSER PÅ
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: Kløende hududslæt, åndenød og hævelse af ansigt og tunge kan være tegn på en overfølsomhedsreaktion.
English: Cervarix is available in 1 dose vials (0.5 ml) in packs of 1, 10 and 100.
Danish: Cervarix fås i pakninger med 1, 10 og 100 hætteglas hver indeholdende 1 dosis (0,5 ml).
English: At the end of study analysis, vaccine efficacy against CIN1 associated with HPV 16/18 observed in the ATP cohort was 92.8% (95% CI: 87.1;96.4).
Danish: I analysen ved afslutningen af studiet var effekten af vaccinen mod CIN1 associeret med HPV-16/18 92,8 % (95 % CI: 87,1; 96,4) i ATP-kohorten.
English: Third injection: 6 months after first injection
Danish: Anden injektion: 1 måned efter den første injektion Tredje injektion: 6 måneder efter den første injektion Hvis det er nødvendigt, kan man afvige fra vaccinationsprogrammet.
English: Uncommon Upper respiratory tract infection
Danish: Ikke almindelig Infektion i øvre luftveje
English: DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni. - The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate
Danish: celler fra insektet Trichoplusia ni. - Øvrige indholdsstoffer: Natriumchlorid (NaCl), natriumdihydrogenphosphatdihydrat
English: These diseases include: - cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb) and anal cancer, - precancerous cervical, vulvar, vaginal and anal lesions (changes in genital or anal cells that have a risk of turning into cancer).
Danish: Disse sygdomme inkluderer: - livmoderhalskræft (kræft i livmoderhalsen, dvs. den nederste del af livmoderen) og analkræft (kræft ved endetarmsåbningen og analkanalen, som er de nederste få cm af tarmkanalen mellem endetarmen og endetarmsåbningen).
English: 10 multidose vials 10 x 2 doses (1 ml)
Danish: 10 flerdosis hætteglas 10 x 2 doser (1 ml)
English: The efficacy against CIN3 was only demonstrated for HPV-31 and there was no evidence of protection against AIS for any of the HPV types.
Danish: Der er ikke evidens for beskyttelse mod AIS for nogen af HPV-typerne.
English: Cervarix can be given with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa -IPV vaccines), with a combined hepatitis A and hepatitis B vaccine (Twinrix) or a hepatitis B vaccine (Engerix B), or with a meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT), at a separate injection site (another part of your body, e.g. the other arm) during the same visit.
Danish: Cervarix kan gives samtidig med en kombineret boostervaccine mod difteri (d), stivkrampe (tetanus, T) og kighoste [acellulær] (pa) og eventuelt polio (inaktiveret polio-virus, IPV), (dTpa-, dTpa-IPVvacciner), samtidig med en kombinationsvaccine mod hepatitis A og hepatitis B (Twinrix) eller en hepatitis B-vaccine (Engerix-B), eller med meningokokserogrupperne A, C, W-135, Y tetanustoksoid konjugeret vaccine (MenACW,Y-TT).
English: 100 multidose vials 100 x 2 doses (1 ml)
Danish: 100 flerdosis hætteglas 100 x 2 doser (1 ml)
English: These measures will help to protect the environment.
Danish: Nødvendige forholdsregler skal tages for at undgå kontaminering.
English: It is also not intended to prevent progression of other established HPV-related lesions or existing HPV infections with vaccine or non-vaccine types (see section 5.1 “Efficacy against HPV-16/18 in women with evidence of HPV-16 or HPV-18 infection at study entry.”).
Danish: Den er heller ikke beregnet til forebyggelse af progression af andre manifeste HPV-relaterede celleforandringer eller eksisterende HPV-infektioner forårsaget af enten HPV-typerne i vaccinen eller af andre ikke-vaccine-HPV-typer (se pkt.
English: Breast-feeding
Danish: Lymfadenopati
English: This leaflet was last revised in {month YYYY} Other sources of information
Danish: Denne indlægsseddel blev senest ændret
English: Suspension for injection in pre-filled syringe 1 pre-filled syringe
Danish: Injektionsvæske, suspension i fyldt injektionssprøjte 1 fyldt injektionssprøjte
English: EU/1/07/419/012 - pack of 100
Danish: EU/1/07/419/012 - Pakningstørrelse på 100
English: Table 4: Vaccine efficacy against virological endpoints associated with HPV-16/18 (TVC)
Danish: Tabel 4 Effekt af vaccinen mod virologiske endepunkter associated med HPV-16/18 (TVCkohorten)
English: 100 vials 100 x 1 dose (0.5 ml)
Danish: 100 hætteglas 100 x 1 dosis (0,5 ml)
English: EU/1/07/419/011 - pack of 10
Danish: EU/1/07/419/011 - Pakningstørrelse på 10
English: For adjuvants, see section 2.
Danish: Vedrørende adjuvans, se pkt.
English: Table 1: Vaccine efficacy against high grade cervical lesions associated with HPV-16/18 (ATP cohort)
Danish: Tabel 1: Effekt af vaccinen mod high-grade cervikale celleforandringer associeret med HPV-16/18 (ATP-kohorte)
English: 10 vials 10 x 1 dose (0.5 ml)
Danish: 10 hætteglas 10 x 1 dosis (0,5 ml)
English: EU/1/07/419/003 - pack of 100
Danish: EU/1/07/419/003 - Pakningstørrelse på 100
English: CIN2+ associated with HPV-16 and HPV-18 individually was demonstrated.
Danish: Herudover blev vist, at vaccinens effekt mod CIN2+ associeret med hhv. HPV-16 og HPV-18 var statistisk signifikant.
English: 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
Danish: 10 fyldte injektionssprøjter + 20 kanyler 10 x 1 dosis (0,5 ml)
English: Table 3: Vaccine efficacy against high grade cervical lesions associated with HPV-16/18 (TVC) HPV
Danish: Tabel 3: Effekt af vaccinen mod high-grade cervikale celleforandringer associeret med HPV-16/18 (TVC-kohorten)
English: Table 2: Vaccine efficacy against virological endpoints associated with HPV-16/18 (ATP cohort) HPV-16/18 endpoint
Danish: Tabel 2: Effekt af vaccinen mod virologiske endepunkter associeret med HPV-16/18 (ATP-kohorte)
English: ГлаксоСмитКлайн ЕООД Тел.
Danish: България ГлаксоСмитКлайн ЕООД
English: 10 pre-filled syringes 10 x 1 dose (0.5 ml)
Danish: 10 fyldte injektionssprøjter 10 x 1 dosis (0,5 ml)
English: 1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
Danish: 1 fyldt injektionssprøjte + 2 kanyler 1 dosis (0,5 ml)
English: Cervarix suspension for injection, multidose container Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Danish: Cervarix injektionsvæske, suspension, flerdosisbeholder Human papillomvirusvaccine [type 16, 18] (rekombinant, adjuveret, adsorberet)
English: 1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
Danish: 1 fyldt injektionssprøjte + 1 kanyle 1 dosis (0,5 ml)
English: Posology
Danish: Endepunkt
English: Suspension for injection 1 vial
Danish: Injektionsvæske, suspension 1 hætteglas
English: All subjects were seropositive in the ELISA assay to both HPV 16 and 18 one month after the third dose (at Month 7) and the seropositivity for HPV 16 and 18 was maintained up to Month 12.
Danish: En måned efter tredje dosis (ved måned 7) var alle personer seropositive for både HPV-16 og -18 ved ELISA analysen.
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
Danish: 10 fyldte injektionssprøjter + 10 kanyler 10 x 1 dosis (0,5 ml)
English: Needle protector
Danish: Beskyttelseshætte for kanyle
English: Suspension for injection in pre-filled syringe
Danish: Injektionssprøjte Beskyttelseshætte for injektionssprøjten
English: EU/1/07/419/002 - pack of 10
Danish: EU/1/07/419/002 - Pakningstørrelse på 10
English: Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Danish: Cervarix injektionsvæske, suspension i hætteglas Human papillomvirusvaccine [type 16, 18] (rekombinant, adjuveret, adsorberet)
English: • tiredness
Danish: • ledsmerter
English: Use with systemic immunosuppressive medicinal products See section 4.4.
Danish: Anvendelse sammen med systemiske immunsuppressive lægemidler
English: GlaxoSmithKline S.p.A. Tel:+ 39 (0)45 9218 111
Danish: Tel: + 39 (0)45 9218 111
English: 4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant
Danish: 4L1-protein i form af ikke-smitsom viruslignende partikel (VLP) produceret ved hjælp af rekombinant DNA-teknologi med brug af et Baculovirussystem, som anvender Hi-5 Rix4446
English: Syringe cap
Danish: Mave-tarm-kanalen
English: Remove the needle protector, which on occasion can be a little stiff.
Danish: Den kan være lidt stram.
English: NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Danish: Cervarix injektionsvæske, suspension i fyldt injektionssprøjte Human papillomvirusvaccine [type 16, 18] (rekombinant, adjuveret, adsorberet)
English: It starts working in about a week.
Danish: Det begynder at virke efter ca. 1 uge.
English: • it looks damaged
Danish: • den ser beskadiget ud
English: Before You Get Started
Danish: Inden du starter
English: Handle it carefully.
Danish: Håndtér den med forsigtighed.
English: Patients > 65 years of age were also excluded.
Danish: Patienter > 65 år blev også udelukket.
English: • At the request of the European Medicines Agency;
Danish: • På anmodning fra Det Europæiske Lægemiddelagentur
English: Commonly Asked Questions
Danish: Ofte stillede spørgsmål
English: Elderly (> 65 years)
Danish: Ældre (> 65 år)
English: • the medicine is frozen
Danish: • medicinen er frosset
English: Date of first authorisation: 14 November 2018
Danish: Dato for første markedsføringstilladelse: 14. november 2018
English: 279 patients were exposed for 12 months.
Danish: 279 patienter blev behandlet i 12 måneder.
English: Make sure you have the right medicine.
Danish: Sørg for, at du har den rette medicin.
English: Such signs are listed under “Serious side effects” in section 4.
Danish: Sådanne tegn er anført under ”alvorlige bivirkninger” i afsnit 4.
English: The treatment benefit should be assessed within 3 months after initiation of treatment.
Danish: Behandlingsfordelen bør vurderes inden for 3 måneder efter start af behandlingen.
English: • The pen contains glass parts.
Danish: • Pennen indeholder dele af glas.
English: You will hear a second click in about 5 to 10 seconds after the first one.
Danish: Du vil høre endnu et klik ca. 5-10 sekunder efter det første.
English: Most of the reactions were mild or moderate in severity.
Danish: De fleste reaktioner var lette eller moderate i sværhedsgrad.
English: Look out for allergic reactions
Danish: Hold øje med allergiske reaktioner
English: This medicine should not be given to children and adolescents under 18 years of age because it has not been studied in this age group.
Danish: Dette lægemiddel bør ikke gives til børn og unge under 18 år, da det ikke er blevet undersøgt i denne aldersgruppe.
English: This is normal.
Danish: Det er helt normalt.
English: Do not remove the pen from your skin until you hear the second loud click.
Danish: Tag ikke pennen væk fra huden, før du hører det andet høje klik.
English: Age, sex, weight, race, ethnicity
Danish: Alder, køn, vægt, race, etnicitet
English: Sesto Fiorentino (FI) Italy
Danish: Sesto Fiorentino (FI) Italien
English: No safety data are available in these patients.
Danish: Der foreligger ingen sikkerhedsdata for disse patienter.
English: 77.8 % of patients completed the treatment period.
Danish: 77,8 % af patienterne gennemførte behandlingsperioden.
English: Emgality can potentially cause serious allergic reactions.
Danish: Emgality kan potentielt forårsage alvorlige allergiske reaktioner.
English: The medicine inside should be clear.
Danish: Medicinen indeni skal være klar.
English: • Periodic Safety Update Reports (PSURs)
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: No drug interaction studies were conducted.
Danish: Der er ikke udført nogen lægemiddelinteraktionsstudier.
English: • Do not inject in the same spot as before.
Danish: • Foretag ikke indsprøjtning på samme sted som før.
English: Important Information
Danish: Vigtige oplysninger
English: • Insert the needle at a 45 degree angle.
Danish: • Stik nålen ind i en vinkel på 45 grader.
English: You will also see the grey plunger at the top of the clear base.
Danish: Du vil også se det grå stempel i toppen af det klare bundstykke.
English: For example, if your first injection was in your abdomen, your next injection could be in another area of your abdomen.
Danish: Hvis den første indsprøjtning for eksempel var i abdomen, kan den næste indsprøjtning være i et andet området af abdomen.
English: Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine.
Danish: Behandlingen bør igangsættes af læger med erfaring inden for diagnose og behandling af migræne.
English: Any further decision to continue treatment should be taken on an individual patient basis.
Danish: Beslutning om at fortsætte behandlingen skal træffes individuelt for den enkelte patient.
English: Make sure the pen is locked.
Danish: Sørg for at pennen er 'låst'.
English: If the plunger is stuck or damaged:
Danish: Hvis stemplet sidder fast eller er beskadiget:
English: It is preferable to avoid the use of Emgality in pregnancy as the effects of this medicine in pregnant women are not known.
Danish: Det er bedst at undgå brug af Emgality under graviditet, da virkningerne af dette lægemiddel hos gravide kvinder ikke kendes.
English: The MSQ measures impact of migraine on work or daily activities, relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness.
Danish: MSQ måler indvirkningen af migræne på arbejde eller daglige aktiviteter, forhold til familie og venner, fritid, produktivitet, koncentration, energi og træthed.
English: Otherwise, you may give or get an infection.
Danish: Ellers kan du give, eller selv få en infektion.
English: Evaluation of the need to continue treatment is recommended regularly thereafter.
Danish: Herefter anbefales det regelmæssigt at vurdere behovet for at fortsætte behandlingen.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • Når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: • the expiration date printed on the label has passed
Danish: • udløbsdatoen på etiketten er overskredet
English: Scoring ranges from 0 to 100, with higher scores indicating less impairment , that is, patients experience fewer restrictions on the performance of day-to-day activities.
Danish: Der scores fra 0 - 100, hvor højere scorer angiver mindre svækkelse, dvs. at patienterne oplever færre begrænsninger på udførelsen af de daglige aktiviteter.
English: Across the 3 studies, patients were predominantly female (> 83 %) with a mean age of 41 years, and an average migraine history of 20 to 21 years.
Danish: På tværs af de 3 studier var patienterne hovedsageligt kvinder (> 83 %) med en middelalder på 41 år og en migrænehistorie på gennemsnitligt 20-21 år.
English: Percentage, %
Danish: Procentdel, %