FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 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 eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Do not remove before instructed.
Danish: Undlad at fjerne den før instruktion herom.
English: Throughout this section, median duration of follow-up (approximately 4 years) is generally presented for all golimumab use.
Danish: Overalt i dette punkt er den mediane opfølgningsperiode (ca. 4 år) generelt opført for al brug af golimumab.
English: Table 7 Key efficacy outcomes from PURSUIT - Induction and PURSUIT - Maintenance PURSUIT-Induction
Danish: Tabel 7 Nøgleresultater vedrørende virkning fra PURSUIT - Induction og PURSUIT - Maintenance PURSUIT-Induction
English: Do not administer a second dose without speaking to your doctor.
Danish: Tag ikke en ny dosis uden at have spurgt din læge.
English: In GO-BEFORE, major clinical response, defined as the maintenance of an ACR 70 response over a continuous 6-month period, was measured.
Danish: I GO-BEFORE blev et major klinisk respons, defineret som vedligeholdelse af ACR 70 over en sammenhængende 6-måneders periode, målt.
English: Ulcerative colitis • The table below shows how you will usually use this medicine.
Danish: Colitis ulcerosa: • Af nedenstående tabel fremgår det, hvordan du sædvanligvis skal anvende lægemidlet.
English: The pre-filled pen is a manual injection pen that allows you to set a specific, prescribed dose.
Danish: Den fyldte pen er en manuel injektionspen, der giver dig mulighed for at indstille en specifik, ordineret dosis.
English: Marketing Authorisation Holder and Manufacturer Janssen Biologics B.V.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Janssen Biologics B.V.
English: • At the start, your doctor or nurse may inject Simponi.
Danish: • I begyndelsen vil din læge eller sygeplejerske indsprøjte Simponi.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction and development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, reproduktions- og udviklingstoksicitet.
English: The majority of the injection site reactions were mild and moderate and the most frequent manifestation was injection site erythema.
Danish: Hovedparten af reaktionerne på injektionsstedet var milde og moderate, og det hyppigste tegn var erytem på injektionsstedet.
English: Each pre-filled pen is for single use in a single patient, and should be discarded immediately after use.
Danish: Hver fyldt pen er til engangsbrug hos en enkelt patient og skal kasseres umiddelbart efter brug.
English: Approximately forty-eight percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
Danish: Ca. 48% af patienterne forsatte på stabile methotrexatdoser (≤ 25 mg/uge).
English: At week 54, the clinical outcomes observed in these patients were similar to the clinical outcomes reported for the patients achieving clinical response at week 6.
Danish: Ved uge 54 var de observerede kliniske resultater hos disse patienter sammenlignelige med de kliniske resultater, som blev indberettet for patienterne, der opnåede klinisk respons ved uge 6.
English: It is important that you and your doctor record the brand name and batch number of your medicine.
Danish: Det er vigtigt, at du og din læge registrerer produktnavn og lot-nummer på din medicin.
English: Almost all of these patients had also received medicines known as azathioprine or 6-mercaptopurine.
Danish: Næsten alle disse patienter havde også fået medicin kendt som azathioprin eller 6-mercaptopurin.
English: Responders, % of patients ACR 20
Danish: Respondenter, % af patienterne ACR 20
English: Patients taking TNF-blockers are more susceptible to serious infections.
Danish: Patienter, der er i behandling med TNF-blokkere, er mere modtagelige over for alvorlige infektioner.
English: There are no adequate data on the use of golimumab in pregnant women.
Danish: Der er ikke tilstrækkeligt datagrundlag for brug af golimumab hos gravide kvinder.
English: Tell your doctor if you develop symptoms of a disease called lupus.
Danish: Fortæl det til din læge, hvis du udvikler symptomer på en sygdom kaldet lupus.
English: • If you have mild heart failure and you are being treated with Simponi, you must be closely monitored by your doctor.
Danish: • Hvis du har let hjertesvigt og er i behandling med Simponi, skal du nøje overvåges af din læge.
English: At week 14, 28% of these patients achieved response defined by partial Mayo score (decreased by ≥ 3 points compared with start of induction).
Danish: Ved uge 14 opnåede 28% af disse patienter respons defineret ud fra partiel Mayo-score (fald på ≥ 3 point sammenlignet med induktionsstart).
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Simponi is indicated.
Danish: Behandling skal initieres og overvåges af kvalificerede læger med erfaring i diagnosticering og behandling af de sygdomme, som Simponi er indiceret til.
English: The baseline median number of active joints was 12, and median CRP was 0.17 mg/dL.
Danish: Det gennemsnitlige antal aktive led ved baseline var 12, og det mediane CRP var 0,17 mg/dl.
English: Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Studier hos dyr indikerer ikke direkte eller indirekte skadelige virkninger med hensyn til graviditet, embryo/foster-udvikling, fødsel eller udvikling efter fødslen (se pkt.
English: The card is aimed at both serving as a reminder to record the dates and outcomes of specific tests and to facilitate the patient sharing of special information with healthcare professional(s) treating the patient about ongoing treatment with the product.
Danish: Kortet fungerer både som en påmindelse om at registrere datoer for og resultater af specifikke test og gør det lettere for patienten at dele særlige oplysninger med de sundhedspersoner, der behandler patienten, om den igangværende behandling med lægemidlet.
English: Operations or dental procedures
Danish: Operationer eller tandbehandling
English: Potential for medication errors
Danish: Risiko for medicineringsfejl
English: • If you have moderate or severe heart failure.
Danish: • Hvis du har hjertesvigt i moderat eller svær grad.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: I hver hyppighedsgruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: The radiographic effects observed at week 52 were maintained through week 104.
Danish: De radiografiske effekter, som blev observeret i uge 52, blev opretholdt frem til uge 104.
English: Pregnancy and vaccinations
Danish: Graviditet og vaccinationer
English: In addition, levels of TNF- were reduced in RA and AS patients and levels of IL-8 were reduced in PsA patients.
Danish: Derudover var TNFα niveauet reduceret hos patienter med RA og AS og niveauet af IL-8 var reduceret i PsA-patienter.
English: The concomitant use of golimumab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Danish: Samtidig brug af golimumab og disse biologiske lægemidler anbefales ikke på grund af øget risiko for infektion og andre potentielle farmakologiske interaktioner.
English: Simponi is for subcutaneous use.
Danish: Simponi er til subkutan anvendelse.
English: • Contact details of the prescriber.
Danish: • Kontaktoplysninger på den ordinerende læge.
English: • You usually inject the medicine into the front of the middle thighs.
Danish: • Du kan som regel indsprøjte medicinen på oversiden af lårene.
English: Do not inject if the perforations on the carton are broken.
Danish: Undlad at indsprøjte, hvis perforeringen på kartonen er brudt.
English: See the package leaflet for further information.
Danish: Læs indlægssedlen for mere information.
English: Ask your doctor to record the type and date of the last screening(s) for TB below: Test _______________
Danish: Du skal bede din læge om at notere type og dato for din(e) seneste undersøgelse(r) for TB nedenfor:
English: In this case you will get training on how to inject Simponi.
Danish: I dette tilfælde vil du blive trænet i, hvordan Simponi skal indsprøjtes.
English: Patients in this study had a diagnosis of PsA for at least 6 months and had at least mild psoriatic disease.
Danish: Patienter i dette studie har haft diagnosen PsA i mindst 6 måneder og har som minumum haft mild psoriasissygdom.
English: • Check the expiration date and the security seal
Danish: • Tjek udløbsdato og sikkerhedsforseglingen
English: *: Observed with other TNF-blocking agents.
Danish: * Observeret med andre TNF-blokerende midler.
English: It will lock, and you will not receive the dose.
Danish: Den låses på plads, og du vil ikke få dosis.
English: Eight malignancies in the combined golimumab treatment group (n = 230) and none in the placebo treatment group (n = 79) were reported.
Danish: Der blev rapporteret 8 tilfælde af malign sygdom i den kombinerede golimumab-behandlingsgruppe (n = 230) og ingen i placebo-behandlingsgruppen (n = 79).
English: Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate.
Danish: Patienter bør efter behov informeres om og undgå potentielle risikofaktorer for infektion.
English: INSIDE OF CARTON
Danish: INDENI KARTON
English: At week 104, X-ray data were available for 114 patients, and 77% showed no progression from baseline.
Danish: Ved uge 104 var røntgendata tilgængelige for 114 patienter, og 77% viste ingen progression i forhold til baseline.
English: The first ‘click' means that the needle has been inserted and the injection has started.
Danish: Det første “klik” betyder, at nålen er ført ind, og indsprøjtningen er startet.
English: • A statement that the brand name and batch number should be recorded.
Danish: • En meddelelse om, at produktnavn og lot-nummer skal registreres.
English: Do not fan or blow on the clean area.
Danish: Lad være med at vifte eller blæse på det rene område.
English: Tell your doctor straight away if you notice any of the above symptoms.
Danish: Fortæl det straks til din læge, hvis du bemærker nogen af ovennævnte symptomer.
English: • If you are allergic (hypersensitive) to golimumab or any of the other ingredients of this medicine (listed in Section 6).
Danish: • Hvis du er allergisk over for golimumab eller et af de øvrige indholdsstoffer i Simponi (angivet i punkt 6).
English: Colon dysplasia/carcinoma
Danish: Colon dysplasi/karcinom
English: Simponi has not been studied in these patient populations.
Danish: Simponi er ikke undersøgt hos denne patientpopulation.
English: • nervous system disease such as multiple sclerosis (rare).
Danish: • Sygdom i nervesystemet såsom multipel sklerose (sjælden).
English: ACR 70 Week 14 4% 14% p = 0.008
Danish: ACR 70 Uge 14 4% 14% p = 0,008
English: In this case you will get training on how to inject
Danish: I dette tilfælde vil du blive trænet i, hvordan
English: In general these elevations were asymptomatic and the abnormalities decreased or resolved with either continuation or discontinuation of golimumab or modification of concomitant medicinal products.
Danish: Generelt var stigningerne asymptomatiske og reduceredes eller normaliseredes ved ophør eller under fortsat behandling med golimumab eller med ændring af samtidig medicin.
English: Injecting without pinching the skin is recommended (Figure 5a).
Danish: Det anbefales at foretage indsprøjtningen uden at klemme huden sammen (figur 5a).
English: Radiographic response:
Danish: Radiografisk respons
English: Table 1: Simponi dose in millilitres (mL) by height and weight of patients with pJIA Total Body Weight (kg)
Danish: Tabel 1: Simponi-dosis i milliliter (ml) ud fra højde og vægt hos patienter med pJIA Total kropsvægt (kg)
English: • A reminder to patients to show the Patient Reminder Card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Simponi.
Danish: • En påmindelse til patienterne om, at de skal vise patientinformationskortet til alle behandlende sundhedspersoner, herunder i nødstilfælde, og en besked til sundhedspersoner om, at patienten anvender Simponi.
English: It is not known if golimumab treatment influences the risk for developing dysplasia or colon cancer.
Danish: Det er ukendt, om golimumab-behandling har indvirkning på risikoen for udvikling af dysplasi eller coloncancer.
English: If any changes in the appearance of the skin or growths on the skin occur during or after therapy, tell your doctor.
Danish: Hvis der opstår forandringer i hudens udseende eller svulster på huden under eller efter behandlingen, skal du fortælle det til lægen.
English: When to inject your next dose:
Danish: Hvornår skal den næste dosis indsprøjtes:
English: • Place the needle at approximately a 45-degree angle to the pinched skin.
Danish: • Placer nålen i en vinkel på ca. 45° i forhold til den klemte hud.
English: Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
Danish: Kasser lægemidlet, hvis det ikke er brugt før den nye udløbsdato eller den udløbsdato, der er trykt på pakningen, alt efter, hvilken dato der kommer først.
English: • Keep this card with you for 6 months after the last Simponi dose, since side effects may occur a long time after your last dose of Simponi.
Danish: • Du skal gemme dette kort i 6 måneder efter seneste Simponi-indsprøjtning, da bivirkninger kan optræde lang tid efter din sidste Simponi indsprøjtning.
English: Need help?
Danish: Hvis du har brug for hjælp
English: All patients had a history of heavy smoking.
Danish: Alle patienter havde tidligere røget meget.
English: • reactivation of hepatitis B virus if you are a carrier or have had hepatitis B before (rare).
Danish: • Tilbagevendende hepatitis B-infektion, hvis du er smittebærer af hepatitis B-virus eller tidligere har haft hepatitis B (sjælden).
English: Sorbitol intolerance
Danish: Sorbitol-intolerans
English: For paediatric patients < 40 kg
Danish: Til pædiatriske patienter < 40 kg
English: Wipe your chosen injection site with an alcohol swab and allow it to dry.
Danish: Aftør det valgte indsprøjtningssted med en spritserviet, og lad det tørre.
English: Do not touch the plunger while you do this.
Danish: Rør ikke ved stemplet mens du gør det.
English: You will not be able to press in the button unless the pre-filled pen is pushed firmly against your skin and the Safety Sleeve slides into the Clear Cover.
Danish: Du vil ikke kunne trykke knappen ind, medmindre den fyldte pen er presset fast mod huden, og sikkerhedskraven glider ind i clear cover.
English: Do not warm any other way.
Danish: Undlad at opvarme pennen på nogen anden måde.
English: It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion.
Danish: Det vides ikke, om golimumab udskilles i human mælk eller optages systemisk efter indtagelse.
English: Before starting treatment with golimumab, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Danish: Før behandling med golimumab påbegyndes, skal alle patienter evalueres for både aktiv og inaktiv (“latent”) tuberkulose.
English: Within the designated system organ classes, the ARs are listed under headings of frequency and using the following convention: 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); not known (cannot be estimated from the available data).
Danish: Inden for systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: 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 forhåndenværende data).
English: Use the space above to record your prescribed dose.
Danish: Brug ovennævnte felt til at notere din ordinerede dosis.
English: In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment be instituted immediately.
Danish: Ved tilfælde af overdosering anbefales det, at patienten bliver overvåget for sygdomstegn eller symptomer på bivirkninger, og at passende symptomatisk behandling igangsættes med det samme.
English: Remove air bubbles*
Danish: Fjern luftbobler*
English: In case you have received Simponi while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Danish: Hvis du har fået Simponi, mens du var gravid, er det vigtigt, at du informerer dit barns læge om det, før dit barn bliver vaccineret.
English: There was no specific clustering of any type of malignancy.
Danish: Der var ingen specifikke grupperinger af maligne sygdomme.
English: • Continue to hold the pre-filled pen down firmly against your skin until you hear a second ‘click'.
Danish: • Fortsæt med at holde den fyldte pen fast mod huden, indtil du hører et nyt ”klik”.
English: Patients should be instructed not to inject a double dose to make up for the forgotten dose.
Danish: Patienterne skal instrueres i, at de ikke skal injicere en dobbeltdosis som erstatning for den glemte dosis.
English: The educational programme consists of a Patient Reminder Card to be held by the patient.
Danish: Uddannelsesprogrammet består af et patientinformationskort, som patienten skal have på sig.
English: Lymphoma was reported in 1 patient, non-melanoma skin cancer in 2 patients, and other malignancies in 5 patients.
Danish: Der blev set lymfom hos 1 patient, non-melanom hudkræft hos 2 patienter og andre maligne sygdomme hos 5 patienter.
English: Structural damage in both hands and feet was assessed radiographically by the change from baseline in the vdH-S score, modified for PsA by addition of hand distal interphalangeal (DIP) joints.
Danish: Strukturel ødelæggelse i både hænder og fødder blev vurderet radiografisk ved ændring fra baseline i vdH-S score, modificeret for PsA ved tilføjelse af distale interfalangeale (DIP) led i hænderne.
English: Care should be taken to ensure that patients are not underdosed or overdosed.
Danish: Der skal udvises omhu for at sikre, at patienterne ikke bliver underdoserede eller overdoserede.
English: Vaccinations Talk to your doctor if you have had, or are due to have a vaccine.
Danish: Vaccinationer Tal med din læge, hvis du er blevet eller planlægger at blive vaccineret.
English: Once Simponi has been stored at room temperature, it should not be returned to refrigerated storage.
Danish: Når Simponi har været opbevaret ved stuetemperatur, må det ikke sættes tilbage på køl igen.
English: The combination of golimumab and anakinra is not recommended.
Danish: Kombinationen af golimumab og anakinra anbefales ikke.
English: • You should not receive certain (live) vaccines while using Simponi.
Danish: • Du må ikke få visse (levende) vacciner, mens du tager Simponi.
English: Previous treatment with an anti-TNF agent was not allowed.
Danish: Tidligere behandling med anti-TNF midler var ikke tilladt.
English: Do not use Simponi:
Danish: Tag ikke Simponi:
English: The Patient Reminder Card shall contain the following key messages:
Danish: Patientinformationskortet skal indeholde følgende væsentlige elementer:
English: Percentage of patients Maintenance of response (Patients in clinical response through week 54) Sustained remission (Patients in clinical remission at both week 30 and week 54)
Danish: Procentdel af patienter Vedligeholdelse af respons (patienter med klinisk respons til og med uge 54) Vedvarende remission (patienter med klinisk remission i både uge 30 og uge 54)
English: Some cases have had fatal outcome.
Danish: Nogle tilfælde har haft dødeligt udfald.
English: Because immunogenicity analyses are product- and assay-specific, comparison of antibody rates with those from other products is not appropriate.
Danish: Da analyser af immunogenicitet er produkt- og assayspecifikke er det ikke hensigtsmæssigt at sammenligne disse data med data fra andre produkter.
English: GO-AFTER evaluated 445 patients who were previously treated with one or more of the anti-TNF agents adalimumab, etanercept, or infliximab.
Danish: GO-AFTER evaluerede 445 patienter, som tidligere var behandlet med en eller flere af anti-TNF-midlerne adalimumab, etanercept eller infliximab.
English: Do not touch, fan, or blow on the injection site after you have cleaned it.
Danish: Undlad at berøre, vifte henover eller puste på indsprøjtningsstedet, efter at du har rengjort det.
English: GO-AFTER Active RA, previously treated with one or more anti-TNF agent(s)
Danish: GO-AFTER Aktiv RA, tidligere behandlet med en eller flere anti-TNF-midler
English: • Read the Simponi package leaflet carefully before you start using this medicine.
Danish: • Læs indlægssedlen for Simponi grundigt, inden du begynder at tage medicinen.
English: • Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og pakningen efter ”EXP”.
English: Simponi should be given concomitantly with MTX.
Danish: Simponi skal anvendes sammen med MTX.
English: Prepare for your injection
Danish: Gør dig klar til indsprøjtningen
English: Inject Simponi
Danish: Indsprøjt Simponi
English: • Patients with severe rheumatoid arthritis and other inflammatory diseases, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Danish: • Patienter med alvorlig reumatoid artrit og andre betændelsessygdomme, og som har haft sygdommen i lang tid, kan have en større risiko end gennemsnittet for at udvikle lymfom.
English: There may be a small amount of blood or liquid at the injection site.
Danish: Der kan være en smule blod eller væske på indsprøjtningsstedet.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende læggemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: • Melanoma (a type of skin cancer)
Danish: • Melanom (en type hudkræft)
English: Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
Danish: Fortæl det til lægen, hvis du tager azathioprin eller 6-mercaptopurin sammen med Simponi.
English: The combination of golimumab and abatacept is not recommended.
Danish: Kombinationen af golimumab og abatacept anbefales ikke.
English: • Tell your doctor if you have an infection.
Danish: • Fortæl det til din læge, hvis du har en infektion.
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Danish: Hos patienter med positiv test for HBV-infektion, anbefales det at rådføre sig med en læge med erfaring i behandling af hepatitis B.
English: d MRI sacroiliac joint score n reflects randomised and treated patients
Danish: d MRI-score for led med sakroiliit n afspejler randomiserede og behandlede patienter
English: • If your doctor feels that you are at risk of TB, you may be treated with medicines for TB before you begin using Simponi.
Danish: • Hvis din læge tror, at du har risiko for at få TB, kan du blive behandlet med lægemidler mod TB, inden du får Simponi.