FrancophonIA/ELRC3.0 huggingface dataset:
English: The percentage of the maternal certolizumab pegol dose reaching an infant during a 24 hour period was estimated to 0.04% to 0.30 %.
Danish: Procentdelen af den maternelle dosis af certolizumab pegol, som når spædbarnet i løbet af en periode på 24 timer, blev estimeret til at være 0,04 % til 0,30 %.
English: Approximately one-third of antibody-positive patients had antibodies with neutralising activity in vitro.
Danish: Omkring en tredjedel af de antistof-positive patienter havde antistoffer med neutraliserende aktivitet in vitro.
English: Because the elimination of certolizumab pegol may take up to 5 months, monitoring should be continued throughout this period (see section 4.3).
Danish: Da eliminationen af certolizumab pegol kan tage op til 5 måneder, bør patienterne fortsat følges i denne periode (se pkt.
English: No serious infections were reported in the placebo-treated patients.
Danish: Der blev ikke rapporteret alvorlige infektioner for placebobehandlede patienter.
English: Non-radiographic AxSpA
Danish: Non-radiografisk AxSpA
English: The maximum duration of the study was 216 weeks.
Danish: Studiets maksimale varighed var 216 uger.
English: - Position ava as shown so that you can comfortably reach the (Start/Pause button) without moving ava.
Danish: - Anbring ava som vist, så du let kan nå (start/pause-knappen) uden at bevæge ava.
English: If you take Cimzia, your risk of getting lymphoma or other cancers may increase.
Danish: Hvis du tager Cimzia, kan risikoen for at få lymfekræft eller andre former for kræft øges.
English: CIMPASI-1 and CIMPASI-2 evaluated 234 patients and 227 patients respectively.
Danish: CIMPASI-1 og CIMPASI-2 evaluerede henholdsvis 234 patienter og 227 patienter.
English: • headaches (including migraines)
Danish: • hovedpine (herunder migræne)
English: (d) Full Analysis Set
Danish: (d) Komplet analysesæt
English: Patients should be given the special reminder card.
Danish: Patienterne bør få udleveret det særlige patient-påmindelseskort.
English: Signs and symptoms
Danish: Fund og symptomer
English: Patients had ≥ 9 swollen and tender joints each and had active RA for at least 6 months prior to baseline.
Danish: Patienterne havde hver ≥ 9 hævede eller ømme led og havde aktiv RA i mindst 6 måneder før baseline.
English: Active tuberculosis or other severe infections such as sepsis or opportunistic infections (see section 4.4).
Danish: Aktiv tuberkulose eller andre alvorlige infektioner, såsom sepsis eller opportunistiske infektioner (se pkt 4.4).
English: Major clinical response is defined as achieving ACR 70 response at every assessment over a continuous 6-month period
Danish: Overordnet klinisk respons er defineret som opnåelse af ACR70-respons ved hver vurdering over en sammenhængende 6-måneders periode
English: - If you are at risk of or are a carrier of or have active HEPATITIS B VIRUS (HBV) infection, Cimzia may increase the risk of reactivation in people who carry this virus.
Danish: - Hvis du har risiko for at få, er bærer af eller har aktiv HEPATITIS B VIRUS (HBV)-infektion, kan Cimzia forøge risikoen for reaktivering, hos personer der bærer denne virus.
English: • Additional risk minimisation measures The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Cimzia are provided with a physician information pack containing the following:
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen skal før frigivelse sikre, at alle læger, som forventes at ordinere/anvende Cimzia, er forsynet med en informationspakke til læger, som indeholder følgende:
English: Medicines that bind to TNFα are also called TNF blockers.
Danish: Medicin, som bindes til TNF-α, kaldes også TNF-blokkere.
English: • You can now remove the used pen by pulling the pen straight up carefully from the skin.
Danish: • Du kan nu fjerne den brugte pen ved forsigtig at trække pennen lige op fra huden.
English: Always take the Patient Reminder Card and the outer carton from the Cimzia package with you, even if it is empty.
Danish: Tag altid patient-påmindelseskortet og den ydre æske fra Cimzia-emballagen med dig, også selvom den er tom.
English: PASI75 and PGA at Week 16 were key secondary endpoints.
Danish: PASI 75 og PGA i uge 16 var vigtige sekundære effektmål.
English: RA-I (52 weeks)
Danish: RA-I (52 uger)
English: The most frequent serious infections included pneumonia, tuberculosis infections.
Danish: De hyppigste alvorlige infektioner inkluderede pneumoni og tuberkulose.
English: Randomised, double-blind treatment regimen week 18 to 34
Danish: Randomiseret, dobbeltblindt behandlingsregime uge 18-34
English: Contact with natural rubber latex may cause severe allergic reactions in individuals sensitive to latex.
Danish: Kontakt med naturlig gummilatex kan forårsage svære allergiske reaktioner hos personer, der er overfølsomme over for latex.
English: Check the red medication level indicator is at the bottom of the cartridge - this shows you have had all of your injection.
Danish: Kontroller at den røde medicinniveau-indikator er i bunden af kassetten - dette viser, at du har fået hele injektionen.
English: The 14-day half-life of certolizumab pegol should be taken into consideration if a surgical procedure is planned.
Danish: Certolizumab pegols halveringstid på 14 dage bør tages i betragtning, hvis der planlægges kirurgi.
English: • Stevens-Johnson syndrome (a serious skin condition which early symptoms include malaise,
Danish: • Stevens-Johnson syndrom (en alvorlig hudtilstand med tidlige symptomer såsom utilpashed,
English: Choosing and preparing an injection site
Danish: Valg og forberedelse af injektionssted
English: Inhibition of radiographic progression was further maintained up to Week 216 for the patients who remained in the study.
Danish: Hæmning af radiografisk progression blev yderligere opretholdt frem til uge 216 hos de patienter, som forblev i studiet.
English: Patients who were ‘primary' non-responders on any prior biologic therapy (defined as no response within the first 12 weeks of treatment) were excluded from the phase III studies (CIMPASI-1, CIMPASI-2 and CIMPACT).
Danish: Patienter, som var ”primære” non-respondenter på en forudgående biologisk behandling (defineret som ingen respons i løbet af de første 12 ugers behandling) blev udelukket fra fase III studierne (CIMPASI-1, CIMPASI-2 og CIMPACT).
English: • Continue to hold the pre-filled pen in place firmly against the skin until a second “click” is heard and the viewing window turns orange.
Danish: • Fortsæt med at holde den fyldte pen mod huden indtil det andet ”klik” lyder, og kontrolvinduet bliver orange.
English: Spinal mobility was assessed in the double-blind, placebo-controlled period by using BASMI at several time points including Baseline, Week 12 and Week 24.
Danish: Den spinale mobilitet blev vurderet i den dobbeltblinde, placebokontrollerede periode ved brug af BASMI ved flere tidspunkter, herunder baseline, uge 12 og uge 24.
English: Following subcutaneous administration, peak plasma concentrations of certolizumab pegol were attained between 54 and 171 hours post-injection.
Danish: Efter subkutan administration, blev peakplasmakoncentration af certolizumab pegol opnået 54 til 171 timer efter injektion.
English: There is no experience with Cimzia in combination with DMARDs other than MTX.
Danish: Der er ingen erfaring med Cimzia i kombination med DMARDs udover MTX.
English: Nevertheless, a potential risk of hypersensitivity reactions cannot be completely excluded in latex-sensitive individuals.
Danish: En potentiel risiko for overfølsomhedsreaktioner kan imidlertid ikke fuldstændigt udelukkes hos personer, der er overfølsomme over for latex.
English: Almost all of these patients had received treatment with the immunosuppressants azathioprine and/or 6-mercaptopurine concomitantly with a TNF-antagonist at or prior to diagnosis.
Danish: Næsten alle disse patienter havde fået behandling med de immunsupprimerende lægemidler azathioprin og/eller 6-mercaptopurin samtidig med en TNF-antagonist ved eller før diagnosticering.
English: After Use
Danish: Efter anvendelse
English: Patients treated with Cimzia may receive vaccinations, except for live vaccines.
Danish: Patienter i behandling med Cimzia kan vaccineres undtagen med levende vacciner.
English: • Hold the pre-filled pen firmly with one hand around the black handle.
Danish: • Hold den fyldte pen fast med den ene hånd omkring det sorte håndtag.
English: • Find a comfortable position and sit down for your injection.
Danish: • Find en behagelig stilling at sidde i før injektionen.
English: • Let go of the needle cap - this allows ava to check if the medication is usable.
Danish: • Slip nålehætten - dette tillader, at ava kan kontrollere om medicinen er anvendelig.
English: Of these, 427 completed 2 years of open-label follow-up and thus had a total exposure to Cimzia of 148 weeks overall.
Danish: Af disse gennemførte 427 de 2 års åbne opfølgningsstudier og havde således total eksponering over for Cimzia i 148 uger i alt.
English: Caution should be exercised when treating the elderly patients, and particular attention paid with respect to occurrence of infections.
Danish: Der bør udvises forsigtighed ved behandling af ældre patienter samt udvises særlig opmærksomhed i forhold til udvikling af infektioner.
English: For the above indications, available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Danish: Tilgængelige data for de ovennævnte indikationer indikerer, at der sædvanligvis opnås klinisk respons inden for 12 ugers behandling.
English: Of the 850 patients, 14% had received at least one TNF-antagonist, 13% had received an anti-IL-17, and 5% had received an anti-IL 12/ 23.
Danish: Af de 850 patienter, havde 14 % fået mindst én TNF-antagonist, 13 % havde fået en anti-IL-17, og 5 % havde fået en anti-IL 12/23.
English: There is limited experience with Cimzia in pregnant women.
Danish: Der er begrænset erfaring med brug af Cimzia til gravide kvinder.
English: Cancer - It is uncommon, but cases of certain types of CANCER have been reported in patients treated with Cimzia or other TNF blockers.
Danish: Kræft - Det er ualmindeligt, men tilfælde af visse former for KRÆFT er blevet set hos patienter behandlet med Cimzia eller andre TNF-blokkere.
English: This is so that the doctor can determine if Cimzia is working for you or if another treatment needs to be considered.
Danish: Det er for at give lægen mulighed for at vurdere, om Cimzia virker for dig, eller om der skal overvejes en anden behandling.
English: Rare sexual dysfunction
Danish: Sjælden seksuel dysfunktion
English: - Keep the needle cap - you will need it to remove the used medication from ava later.
Danish: - Gem nålehætten - du skal bruge den til at fjerne den tomme medicin fra ava senere.
English: Skin sensor (the skin sensor detects when the injection port is fully in contact with your skin).
Danish: Hudsensor (hudsensoren registrerer, når injektionsporten er i fuld kontakt med din hud) 5.
English: •two alcohol wipes (for cleansing the areas chosen for injection).
Danish: • To alkoholservietter (til rensning af det valgte injektionsområde).
English: • fungal infections (occur when the ability to fight off infection is lessened)
Danish: • svampeinfektioner (forekommer når evnen til at bekæmpe infektioner er nedsat)
English: The pivotal non-clinical safety studies were conducted in the cynomolgus monkey.
Danish: De pivotale nonkliniske sikkerhedsstudier blev udført i cynomolgus aben.
English: Concomitant use with other biologics
Danish: Samtidig brug med andre biologiske lægemidler
English: There have been rare reports of other immunemediated conditions; the causal relationship to Cimzia is not known.
Danish: Der har været rapporter om tilfælde af andre immunmedierede tilstande; årsagssammenhængen med Cimzia er ikke kendt.
English: The difference from placebo tended to be greater in nr-axSpA than in the AS subpopulation which may be due to less chronic structural damage in nr-axSpA patients.
Danish: Forskellen i forhold til placebo tenderede til at blive større i nr-axSpA-subpopulationen end i AS-subpopulationen, hvilket kan skyldes mindre kronisk strukturskade hos patienterne med nr-axSpA.
English: Cimzia does not contain a fragment crystallisable (Fc) region, which is normally present in a complete antibody, and therefore does not fix complement or cause antibody-dependent cell-mediated cytotoxicity in vitro.
Danish: Cimzia indeholder ikke en krystalliserbar-fragment (Fc)-region, som normalt er til stede i et komplet antistof, og som derfor ikke binder komplement eller forårsager antistofafhængig cellemedieret cytotoxicitet in vitro.
English: - After a short pause, ava will automatically pull the cartridge in further.
Danish: - Efter en kort pause vil ava automatisk trække kassetten længere ind.
English: Data from more than 500 prospectively collected pregnancies exposed to Cimzia with known pregnancy outcomes, including more than 400 pregnancies exposed during the first trimester, does not indicate a malformative effect of Cimzia.
Danish: Prospektive data fra mere end 500 graviditeter med kendt graviditetsudfald, som var eksponeret for Cimzia, herunder mere end 400 graviditeter eksponeret i første trimester, indikerer ikke, at Cimzia forårsager misdannelser.
English: Week 52 p-values were < 0.001 for both mTSS and erosion score and ≤ 0.01 for JSN score.
Danish: Uge 52 p-værdier var < 0,001 for både mTSS og erosion score og ≤ 0,01 for JSN-score.
English: - If ava is accidentally removed from your skin during the injection, the injection will automatically stop and the needle will go back into ava.
Danish: - Hvis ava fjernes fra huden ved et uheld under injektionen, vil injektionen automatisk stoppe og nålen vil trækkes ind i ava.
English: Uncommo tinnitus, vertigo
Danish: Tinnitus, vertigo
English: No data are available on the response to live vaccinations or the secondary transmission of infection by live vaccines in patients receiving Cimzia.
Danish: Der foreligger ingen data for respons på levende vacciner eller for sekundær overførsel af infektion via levende vacciner hos patienter, som får Cimzia.
English: Not known multiple sclerosis*, Guillain-Barré syndrome*
Danish: Ikke kendt multipel sclerose*, Guillain-Barré syndrom*
English: This will help to reduce discomfort when injecting.
Danish: Dette vil være medvirkende til at mindske ubehag under injektionen.
English: RA-II (24 weeks)
Danish: RA-II (24 uger)
English: It does not induce apoptosis in vitro in human peripheral blood-derived monocytes or lymphocytes, or neutrophil degranulation.
Danish: Det inducerer ikke apoptose in vitro i humane perifere blodderiverede monocyter eller lymfocyter eller neutrophil degranulation.
English: Plaque psoriasis is an inflammatory disease of the skin, and can also affect your scalp and nails.
Danish: Plaque psoriasis er en inflammatorisk sygdom i huden og kan også påvirke din hovedbund og negle.
English: It is recommended to wait a minimum of 5 months following the mother's last Cimzia administration during pregnancy before administration of live or live-attenuated vaccines (e.g. BCG vaccine), unless the benefit of the vaccination clearly outweighs the theoretical risk of administration of live or liveattenuated vaccines to the infants.
Danish: Det anbefales, at der ventes mindst 5 måneder efter moderens sidste Cimzia dosis under graviditeten, inden der administreres levende eller levende svækkede vacciner (f.eks. BCG vaccine), med mindre fordelene af vaccinationen klart opvejer den teoretiske risiko, der er forbundet med administrationen af levende eller levende svækkede vacciner til spædbørnene.
English: • The current injection speed (medication flow rate) is shown.
Danish: • Den aktuelle injektionshastighed (medicinens flowhastished) vises.
English: Results are from the Randomized Set.
Danish: Resultaterne er fra det randomiserede sæt.
English: The data above reflect the percentage of patients whose test results were considered positive for antibodies to Cimzia in an ELISA, and are highly dependent on the sensitivity and specificity of the assay.
Danish: Ovenstående data afspejler andelen af patienter, hvis testresultater blev betragtet som positive for antistoffer mod Cimzia i en ELISA-analyse, og afhænger i høj grad af analysens sensitivitet og specificitet.
English: No dose-limiting toxicity was observed during clinical trials.
Danish: Der blev ikke observeret dosisbegrænset toksicitet under de kliniske studier.
English: Operations or dental procedures - Talk to your doctor if you are going to have any operations or dental procedures.
Danish: Operationer eller tandbehandling - Tal med lægen hvis du skal have foretaget operationer eller tandbehandling.
English: Specific clinical trials have not been performed in elderly patients subjects.
Danish: Der er ikke udført specifikke kliniske studier hos ældre patienter.
English: Cimzia will be given to you by your doctor or nurse, in hospital or clinic.
Danish: Du vil få Cimzia af din læge eller sygeplejerske på et hospital eller en klinik.
English: Infections - If you have had RECURRENT or OPPORTUNISTIC INFECTIONS or other conditions that increase the risk of infections (such as treatment with immunosuppressants, which are medicines that could reduce your ability to fight infections).
Danish: Infektioner - Hvis du har haft TILBAGEVENDENDE eller OPPORTUNISTISKE INFEKTIONER (infektioner som kun fremkommer, hvis du er særligt disponeret) eller andre tilstande, som øger infektionsrisikoen (såsom behandling med immunsuppressive lægemidler, som er medicin, der kan nedsætte din evne til at bekæmpe infektioner).
English: Active dose regimen
Danish: Aktivt doseringsregime
English: Please remove from skin" - you can then remove ava from you skin.
Danish: Fjern anordningen fra huden.” - herefter kan du fjerne ava fra huden.
English: Appropriate screening tests, e.g. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Danish: Egnede screeningsundersøgelser, dvs. tuberkulintest og røntgen af thorax, bør udføres hos alle patienter (lokale vejledninger kan være gældende).
English: • Remove the following items from the Cimzia pack and set them up on a clean flat surface:
Danish: • Tag følgende ting fra Cimzia-pakningen og læg dem på et rent, jævnt underlag:
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Cimzia is indicated.
Danish: Behandling bør initieres og superviseres af specialister med erfaring i diagnosticering og behandling af sygdomme, for hvilke Cimzia er indiceret.
English: A dose of 400 mg every 2 weeks can be considered in patients with insufficient response (see section 5.1).
Danish: En dosis på 400 mg hver 2. uge kan overvejes hos patienter med utilstrækkeligt respons (se afsnit 5.1).
English: The results of clinical trials RA-I and RA-II are shown in Table 3.
Danish: Resultaterne af de kliniske studier RA-I og RA-II er vist i Tabel 3.
English: • Place the orange skin sensor against the injection site where you are going to inject.
Danish: • Anbring den orange hudsensor mod det sted på huden, hvor du ønsker at injicere.
English: In cases of overdose, it is recommended that patients are monitored closely for any adverse reactions or effect, and appropriate symptomatic treatment initiated immediately.
Danish: I tilfælde af overdosering anbefales det, at patienter overvåges nøje med henblik på bivirkninger eller påvirkninger, og at passende symptomatisk behandling indledes omgående.
English: • muscle problems including increased muscle enzymes
Danish: • muskelproblemer herunder øgning af niveauet af muskelenzymer
English: 47% had received prior phototherapy or chemophototherapy, and 30% had received prior biologic therapy for the treatment of psoriasis.
Danish: 47 % havde fået forudgående lysterapi eller kemolysterapi, og 30 % havde fået forudgående biologisk terapi til behandling af deres psoriasis.
English: The improvement in BASMI linear score achieved at Week 24 was maintained through Week 204 for patients who remained in the study.
Danish: Forbedringen i BASMI liniær score nået i uge 24, blev opretholdt til og med uge 204 hos patienter, som forblev i studiet.
English: Both doses of Cimzia demonstrated efficacy compared to placebo regardless of age, gender, body weight, BMI, psoriasis disease duration, previous treatment with systemic therapies and previous treatment with biologics.
Danish: Begge doser Cimzia påviste effekt sammenlignet med placebo uanset alder, køn, kropsvægt, BMI, varighed af psoriasis-sygdommen, tidligere behandling med systemiske terapier og tidligere behandling med biologiske lægemidler.
English: • Do not use the medication if it has been dropped after taking it out of the pack.
Danish: • Brug ikke medicinen, hvis den har været tabt, efter den er taget ud af pakningen.
English: Cimzia is used to reduce skin inflammation and other signs and symptoms of your disease.
Danish: Cimzia bruges til at reducere hudinflammation og andre tegn og symptomer på din sygdom.
English: • azoospermia (lack of sperm production).
Danish: • azoospermi (manglende sædproduktion).
English: If you received Cimzia while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy.
Danish: Hvis du har fået Cimzia, mens du var gravid, kan dit barn have øget risiko for at få en sådan infektion i op til ca. fem måneder efter den sidste dosis, du fik under din graviditet.
English: Before initiation of therapy with Cimzia, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
Danish: Før behandling med Cimzia initieres, skal alle patienter vurderes for både aktiv og inaktiv (latent) tuberkulose.
English: If you experience these symptoms, contact your doctor.
Danish: Hvis du får disse symptomer, skal du kontakte lægen.
English: - Once the needle cap has been removed, you must give the injection within 5 minutes.
Danish: - Når nålehætten er taget af, skal injektionen udføres inden for 5 minutter.
English: Multiple doses of up to 800 mg subcutaneously and 20 mg/kg intravenously have been administered.
Danish: Der er indgivet gentagne doser på op til 800 mg ved subkutan administration og 20 mg/kg ved intravenøs administration.
English: This difference in exposure is primarily due to patients on placebo being more likely to withdraw early.
Danish: Denne forskel i eksponering skyldes primært, at patienter, som fik placebo, havde større tendens til at trække sig fra studierne før tid.
English: If severe reactions occur, administration of Cimzia should be discontinued immediately and appropriate therapy instituted.
Danish: Hvis der opstår alvorlige reaktioner, skal administration af Cimzia omgående afbrydes og passende behandling iværksættes.
English: If inactive (‘latent') tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Danish: Hvis der er mistanke om inaktiv (latent) tuberkulose, bør en læge med erfaring i behandling af tuberkulose konsulteres.
English: - It is uncommon, but symptoms of a disease called lupus (for example persistent rash, fever, joint pain and tiredness) may occur.
Danish: - Det er ualmindeligt, men symptomer på en sygdom som kaldes lupus (f.eks. vedvarende udslæt, feber, ledsmerter og træthed) kan forekomme.
English: There are insufficient data to provide a dosing recommendation in moderate and severe renal impairment.
Danish: Der er ikke tilstrækkelig dokumentation til at foreskrive en dosisanbefaling ved moderat og alvorlig nedsat nyrefunktion.
English: Sustained inhibition of progression of structural damage was demonstrated in a subset of 449 of these patients who completed at least 2 years of treatment with Cimzia (RA-I and open-label extension study) and had evaluable data at the 2-year timepoint.
Danish: Vedvarende progressionshæmning af strukturel ødelæggelse blev set i en undergruppe med 449 af disse patienter, som gennemførte mindst 2 års behandling med Cimzia (RA-I og åbent forlængelsesstudie) og havde evaluerbare data ved det 2-årige tidspunkt.