FrancophonIA/ELRC3.0 huggingface dataset:
English: • In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Danish: • Hos nogle patienter, som får Remsima, kan kroppen måske ikke lave nok af de blodlegemer, der skal hjælpe med at bekæmpe infektioner eller stoppe blødning.
English: • Ask your healthcare provider how often you will need to give an injection.
Danish: • Spørg sundhedspersonalet, hvor ofte du skal injicere.
English: EGIS Bulgaria EOOD
Danish: EGIS Bulgaria EOOD Teл.
English: a. After the syringe is empty, slowly lift your thumb from the plunger until needle is completely covered by the automatic needle guard.
Danish: a. Når sprøjten er tom, løftes langsomt tommelfingeren fra stemplet, indtil nålen er helt dækket af den automatiske nålebeskyttelse.
English: Remsima subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.
Danish: Remsima subkutan formulering er ikke beregnet til intravenøs administration og bør udelukkende administreres via en subkutan injektion.
English: Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Danish: Gennemsnitlig NAPSI-score ved baseline var hhv. 4,6 og 4,3 i infliximab- og placebogruppen.
English: There are no known side effects of having too much of Remsima.
Danish: Der kendes ikke til nogen bivirkninger efter at have fået for meget Remsima.
English: • Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Remsima treatment again.
Danish: • Fortæl din læge, hvis du tidligere har været i behandling med lægemidler, der indeholder infliximab og nu starter behandling med Remsima igen.
English: ACR response (% of patients) N
Danish: ACR respons (% af patienter) N
English: a. Leave the pen at room temperature for 30 minutes to allow it to naturally warm up.
Danish: a. Efterlad pennen ved stuetemperatur i 30 minutter for at lade den varme naturligt op.
English: AZA Monotherapy
Danish: AZA Monoterapi
English: It is important that you tell your baby's doctors and other health care professionals about your Remsima use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Danish: Det er vigtigt, at du fortæller dit barns læger og andet sundhedspersonale, at du får Remsima, så de kan finde frem til, hvornår dit barn skal vaccineres; det gælder også levende vacciner som BCG (bruges til at forebygge tuberkulose).
English: Each new injection site should be at least 3 cm away from the previous injection site.
Danish: Hvert nyt injectionssted skal være mindst 3 cm fra det foregående injektionssted.
English: At baseline, 87% of the patients had perianal fistulae, 14% had abdominal fistulae, 9% had rectovaginal fistulae.
Danish: Ved baseline havde 87 % af patienterne perianale fistler, 14 % havde abdominale fistler, 9 % havde rektovaginale fistler.
English: Remsima is not likely to affect your ability to drive or use tools or machines.
Danish: Remsima påvirker sandsynligvis ikke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
English: However, before Remsima is given to you, it is mixed with a solution that contains sodium.
Danish: Inden du får Remsima, bliver det imidlertid blandet med en opløsning, der indeholder natrium.
English: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis)
Danish: Interstitiel lungesygdom (inklusive hurtigt fremadskridende sygdom, lungefibrose og pneumonitis).
English: Note: After you remove the pen from the injection site, the needle will be automatically covered (see Figure I).
Danish: Bemærk: Når du har fjernet pennen fra injektionsstedet, dækkes kanylen automatisk (se Figur I).
English: Mucosal healing at Week 8a
Danish: Slimhindeheling i uge 8a
English: They are administered 2 weeks apart via intravenous infusion.
Danish: Disse administreres med 2 ugers mellemrum via intravenøs infusion.
English: TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Danish: TNF-alfa er involveret i kroppens betændelsesprocesser, så blokering af dette kan mindske betændelsen i din krop.
English: a. Select an injection site.
Danish: a. Vælg et injektionssted.
English: Keep this card with you for 4 months after your last dose of Remsima, or in case of pregnancy, for at least 6 months after the birth of your baby.
Danish: Opbevar dette kort på dig i 4 måneder efter du har fået din sidste dosis Remsima, eller i tilfælde af graviditet i mindst 6 måneder, efter du har født.
English: ≥90% improvement ≥75% improvement ≥50% improvement
Danish: N ≥ 90 % forbedring ≥ 75 % forbedring ≥ 50 % forbedring
English: If these medicines or treatments do not work well enough, you will be given Remsima to reduce the signs and symptoms of your disease.
Danish: Hvis disse lægemidler eller behandlinger ikke virker godt nok, vil du få Remsima for at reducere tegn og symptomer på din sygdom.
English: About the Remsima pen Parts of the pen (see Figure A):
Danish: Om Remsima pen Pennens dele (se Figur A):
English: • Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Remsima.
Danish: • Din læge vil også udlevere et patientinformationskort til dig, som indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under din behandling med Remsima.
English: All randomised patients
Danish: Alle randomiserede patienter
English: c. With a quick and “dart-like” motion, insert the needle completely into the fold of the skin at a 45-degree angle.
Danish: c. Med en hurtig og ”dart-lignende” bevægelse føres kanylen helt ind i hudfolden i en 45graders vinkel.
English: If you have used more Remsima than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor, pharmacist or nurse immediately.
Danish: Hvis du har taget for meget Remsima (enten ved at injicere for meget ved en enkelt lejlighed eller ved at bruge det for hyppigt) skal du straks tale med lægen, apotekspersonalet eller sygeplejersken.
English: The safety population consisted of 168 patients in the Remsima subcutaneous group and 175 patients in the Remsima intravenous group.
Danish: Sikkerhedspopulationen bestod af 168 patienter i gruppen med subkutan Remsima og 175 patienter i gruppen med intravenøs Remsima.
English: After the injection 12.
Danish: Efter injektionen 12.
English: Systemic injection reaction and localised injection site reaction in adult patients administered with Remsima subcutaneous formulation
Danish: Systemisk injektionsreaktion og lokaliseret reaktion på injektionsstedet hos voksne patienter administreret med Remsima subkutan formulering
English: • Do not remove the cap until you are ready to inject.
Danish: • Hætten må ikke fjernes før du er klar til at injicere.
English: The mean scores for DAS28 (CRP) and DAS28 (ESR) gradually decreased from baseline at each time point until Week 54 in each treatment arm (see Table 5 and Table 6, respectively).
Danish: De gennemsnitlige scorer for DAS28 (CRP) og DAS28 (ESR) faldt gradvist fra baseline på hvert tidspunkt indtil uge 54 i hver behandlingsarm (se hhv. tabel 5 og 6).
English: Remsima contains sorbitol
Danish: Remsima indeholder sorbitol
English: If these medicines do not work well enough, you will be given Remsima which you will take with another medicine called methotrexate to:
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Remsima, som du skal tage sammen med et andet lægemiddel, der hedder methotrexat, for at:
English: Remsima works by selectively attaching to TNF alpha and blocking its action.
Danish: Remsima virker ved selektivt at binde sig til TNF-alfa og blokere dets virkning.
English: Tachycardia, palpitation
Danish: Takykardi, palpitation.
English: Almost all patients had also received medicines containing azathioprine or mercaptopurine in addition to TNF-blockers.
Danish: Næsten alle patienterne havde også fået medicin, der indeholder azathioprin eller mercaptopurin ud over den TNF-blokerende behandling.
English: • able to close with a tight-fitting, puncture-resistant lid, without sharps being able to come out;
Danish: • Kan lukkes med et tætsluttende, punkteringsbestandigt låg, så skarpe genstande ikke kan falde ud;
English: HAQ change from baseline over timee (patients evaluated)
Danish: HAQ ændring fra baseline over tidene (patienter evalueret) Gennemsnit ±
English: b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Danish: b N = 292. c Analysen var baseret på patienter med neglepsoriasis ved baseline (81,8 % af patienterne).
English: A damaged syringe may not function properly.
Danish: En beskadiget injektionssprøjte fungerer muligvis ikke korrekt.
English: After the injection 13.
Danish: Efter injektionen 13.
English: c. When your sharps disposal container is almost full, it should be disposed of in accordance with local requirements.
Danish: c. Når din beholder til bortskaffelse af skarpe genstande næsten er fuld, skal den bortskaffes i henhold til lokale retningslinjer.
English: ACCENT I (Week-2 responders) % of Patients
Danish: ACCENT I (uge-2 responderende) % Patienter
English: Clinical Responsea
Danish: Klinisk responsa
English: Proportions of Patients Achieving Clinical Response According to the ACR Criteria ACR20
Danish: Tabel 6 Andel af patienter, der opnåede klinisk respons i henhold til ACR-kriterier ACR20
English: Do not warm the pen using heat sources such as hot water or a microwave.
Danish: Pennen må ikke opvarmes ved hjælp af varmekilder såsom varmt vand eller mikrobølgeovn.
English: • Most of these reactions are mild to moderate and resolve on their own within a day.
Danish: • De fleste af disse reaktioner er milde til moderate og løser sig selv inden for et døgn.
English: After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection).
Danish: Efter 4 uger fra sidste intravenøse infusion vil du få Remsima via injektion under huden (subkutan injektion).
English: One serious infusion reaction (<1%) occurred in a patient on infliximab monotherapy.
Danish: Der forekom én alvorlig infusionsrelateret reaktion (< 1 %) hos en patient på infliximab monoterapi.
English: The physician should ensure appropriate follow-up of patients for any systemic injection reaction and localised injection site reaction after the initial subcutaneous injection is administered.
Danish: Lægen skal sikre passende opfølgning af patienter med henblik på eventuel systemisk injektionsreaktion og lokaliseret reaktion på injektionsstedet efter administration af den første subkutane injektion.
English: The incidence of anti-infliximab antibodies following the subcutaneous infliximab was demonstrated to be not higher than that of the intravenous infliximab and had no significant impact on efficacy (determined by disease activity score in 28 joints [DAS28] and American College of Rheumatology criteria 20 [ACR20]) and the safety profile.
Danish: Forekomsten af anti-infliximab-antistoffer efter subkutan infliximab påvistes til ikke at være højere end for den intravenøse infliximab og havde ingen signifikant indvirkning på virkning (bestemt ved en sygdomsaktivitetsscore i 28 led [DAS28] og American College of Rheumatology criteria 20 [ACR20]) samt sikkerhedsprofilen.
English: The safety profile of Remsima subcutaneous formulation in combination with methotrexate was evaluated in a Phase I/III parallel group study in patients with active rheumatoid arthritis.
Danish: Sikkerhedsprofilen for Remsima subkutan formulering i kombination med methotrexat blev evalueret i et fase I/III parallelgruppestudie hos patienter med aktiv reumatoid artrit.
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 Remsima
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 Remsima.
English: Remove the pen from the injection site.
Danish: Fjern pennen fra injektionsstedet.
English: Information regarding switching patients from the subcutaneous formulation to the intravenous formulation of Remsima is not available.
Danish: Der foreligger ingen oplysninger om at skifte patienter fra den subkutane formulering til den intravenøse formulering af Remsima.
English: The flip-top from the vial has to be removed and the top has to be wiped with a 70% alcohol swab.
Danish: Plastiklåget fra hætteglasset fjernes og toppentørres med en 70 % alkoholvatpind.
English: If jaundice and/or ALT elevations ≥5 times the upper limit of normal develop(s), infliximab should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Danish: Hvis der opstår gulsot og/eller ALAT-forhøjelser ≥ 5 gange øvre grænse af normalområdet, bør infliximab seponeres, og et omhyggelig studie af hændelsen bør foretages.
English: No major age-related differences in clearance or volume of distribution were observed in clinical studies with infliximab intravenous formulations and the same is expected for subcutaneous formulation.
Danish: Der er ikke iagttaget større aldersrelaterede forskelle i clearance eller fordelingsvolumen i kliniske studier med infliximab intravenøse formuleringer, og det samme forventes for den subkutane formulering.
English: The analysis of other efficacy endpoints showed that efficacy profile of Remsima subcutaneous formulation compared to Remsima intravenous formulation in RA patients was generally comparable in terms of disease activity measured by DAS28 (CRP and ESR) and ACR response up to Week 54.
Danish: Analysen af andre virkningsendepunkter viste, at virkningsprofilen for Remsima subkutan formulering sammenlignet med Remsima intravenøs formulering hos RA-patienter generelt var sammenlignelig med hensyn til sygdomsaktivitet målt ved DAS28 (CRP og ESR) og ACR-respons op til uge 54.
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Remsima.
Danish: • Hvis din læge tror, at du har risiko for at få TB, kan du blive behandlet med lægemidler mod TB, inden du får Remsima.
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferon γ.
Danish: Analyse af lamina propria mononukleære celler udtaget ved biopsi fra den intestinale mucosa viste, at infliximab-behandling forårsagede en reduktion i antallet af celler, som var i stand til at udtrykke TNFα og interferonγ.
English: • If you received Remsima while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth.
Danish: • Hvis du har fået Remsima, mens du var gravid, kan dit barn også have en større risiko for at få en infektion med levende vacciner i op til 6 måneder efter fødslen.
English: • Cancer
Danish: • Kræft
English: Your doctor will start your treatment with two Remsima intravenous infusion doses of 3 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours).
Danish: Din læge vil påbegynde din behandling med to Remsima intravenøse infusionsdoser af 3 mg for hver kg kropsvægt (givet i en blodåre, som regel i armen, over en periode på 2 timer).
English: • Remsima will be given to you by your doctor or nurse.
Danish: • Du vil få Remsima af din læge eller sygeplejerske.
English: b. If you do not have an approved sharps disposal container, you may use a household container that is:
Danish: b. Hvis du ikke har en godkendt beholder til bortskaffelse af skarpe genstande, kan du bruge en husholdningsbeholder som:
English: For storage conditions up to 25°C before reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold op til 25 °C før rekonstitution af lægemidlet, se pkt.
English: Infliximab has not been studied in these patient populations.
Danish: Infliximab er ikke undersøgt hos disse patientpopulationer.
English: Ask your doctor to record the type and date of your last screening(s) for TB on the card.
Danish: Du skal bede din læge om at notere type og dato for din(e) seneste screening(er) for TB på kortet
English: • Tell your surgeon or dentist that you are having treatment with Remsima by showing them your patient reminder card.
Danish: • Fortæl kirurgen eller tandlægen, at du er i behandling med Remsima ved at vise dem dit patientinformationskort.
English: For subsequent injections and after proper training in subcutaneous injection technique, patients may self-inject with Remsima if their physician determines that it is appropriate and with medical followup as necessary.
Danish: Ved efterfølgende injektioner og efter tilstrækkelig egnet træning i subkutan injektionsteknik kan patienter selv-injicere med Remsima, hvis behandlende læge finder det passede og med medicinsk opfølgning efter behov.
English: • Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Danish: • Tal med din læge, hvis du fornylig har fået eller det er planlagt, at du skal have behandling med et terapeutisk smitstof (f.eks. instillation af BCG til behandling af kræft).
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE
Danish: Tabel 4 Virkninger på ACRn, strukturel ledskade og fysisk funktion ved uge 54, ASPIRE
English: Single intravenous doses up to 20 mg/kg have been administered without toxic effects and repeated doses of Remsima subcutaneous formulation up to 240 mg have been administered without toxic effects.
Danish: Enkelte intravenøse doser på op til 20 mg/kg har været indgivet uden toksiske virkninger, og gentagne doser af Remsima subkutan formulering på op til 240 mg er blevet administreret uden toksiske virkninger.
English: Periodic screening should continue in women treated with infliximab, including those over 60 years of age.
Danish: Periodisk screening bør fortsætte hos kvinder, der er blevet behandlet med Remsima, inklusive kvinder over 60 år.
English: Table 7 Effects on response rate, data from ACCENT II (Week-14 responders)
Danish: Tabel 7 Virkninger på responshastighed, data fra ACCENT II (uge-14 responderende)
English: Children may receive some vaccines during treatment with Remsima but should not receive live vaccines while using Remsima.
Danish: Børn kan få visse vacciner under behandlingen med Remsima, men må ikke få levende vacciner, mens de får Remsima.
English: The required volume of reconstituted Remsima solution should slowly be added to the 250-mL infusion bottle or bag and gently be mixed.
Danish: Det påkrævede volumen af rekonstitueret Remsima-opløsning tilføjes langsomt til 250 ml infusionsflasken eller -posen og blandes forsigtigt.
English: Table 5 Effects on response and remission rate, data from ACCENT I (Week-2 responders)
Danish: Tabel 5 Virkninger på respons og remissionshastighed, data fra ACCENT I (uge-2 responderende)
English: If the dose is delayed by 8 days or more, the patients should be instructed to skip the missed dose, wait until their next scheduled dose, and then remain on their original bi-weekly dosing schedule.
Danish: Hvis dosis er forsinket med 8 dage eller mere, skal patienterne instrueres i at springe den glemte dosis over, vente til den næste planlagte dosis og derefter forblive på deres oprindelige doseringsplan hver anden uge.
English: Remsima must be given concomitantly with methotrexate.
Danish: Remsima skal anvendes sammen med methotrexat.
English: The mean terminal half-life ranged from 11.3 days to 13.7 days for 120, 180 and 240 mg of subcutaneous infliximab administered to healthy subjects.
Danish: Den gennemsnitlige terminale halveringstid varierede fra 11,3 dage til 13,7 dage for 120, 180 og 240 mg subkutant infliximab administreret til raske forsøgspersoner.
English: Appropriate screening tests, (e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
Danish: Passende screeningundersøgelser, (fx tuberkulintest, røntgen af thorax og/eller Interferon Gamma Relase Assay, bør udføres hos alle patienter (lokale vejledninger kan være gældende).
English: 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
Danish: I 102. uge var 49 patienter stadig på infliximab-behandling, og blandt disse var 30 (61 %) BASDAI 50 responderende.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common
Danish: Inden for systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥ 1/10); almindelig
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last infliximab treatment.
Danish: Fertile kvinder skal overveje at anvende sikker kontraception for at undgå graviditet og fortsætte med anvendelsen heraf i mindst 6 måneder efter den sidste behandling med infliximab.
English: The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.
Danish: Den anbefalede dosis for Remsima subkutan formulering er 120 mg én gang hver 2. uge.
English: Your doctor may recommend temporarily stopping Remsima.
Danish: Din læge kan anbefale en midlertidig pause med Remsima.
English: • If you received Remsima during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Hvis du fik Remsima under graviditeten, kan dit barn have en øget risiko for at få en infektion.
English: The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of <150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose >6 mg/day.
Danish: Studiets primære endepunkt var kortikosteroidfri klinisk remission i uge 26, defineret som patienter i klinisk remission (CDAI < 150), som i mindst 3 uger ikke havde taget orale systemiske kortikosteroider (prednison eller lignende) eller budesonid i en dosis på > 6 mg/dag.
English: b. Push the plunger down slowly and as far as it will go until the syringe is empty.
Danish: b. Skub stemplet langsomt ned og så langt det kan komme, indtil injektionssprøjten er tom.
English: Gather the supplies for the injection.
Danish: Saml delene til injektionen.
English: • The outer area of the upper arms (caregiver ONLY).
Danish: • Ydersiden af overarmene (KUN omsorgsperson).
English: If you are given too much Remsima
Danish: Hvis du får for meget Remsima
English: Talk to your doctor before or during treatment with Remsima if you have:
Danish: Kontakt lægen, før eller under behandlingen med Remsima, hvis du har:
English: Remsima should only be used during pregnancy if your doctor feels it is necessary for you.
Danish: Du må kun få Remsima under graviditeten, hvis lægen finder det nødvendigt.
English: If patients miss an injection of Remsima subcutaneous formulation, they should be instructed to take the missed dose immediately in case this happens within 7 days from the missed dose, and then remain on their original bi-weekly dosing schedule.
Danish: Hvis patienter glemmer en injektion af Remsima subkutan formulering, skal de instrueres i at tage den glemte dosis øjeblikkeligt, hvis dette sker inden for 7 dage efter den glemte dosis, og derefter forblive på deres oprindelige doseringsplan hver anden uge.
English: Remsima may have a minor influence on the ability to drive and use machines.
Danish: Remsima påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.