FrancophonIA/ELRC3.0 huggingface dataset:
English: A reduction in signs and symptoms was defined to be at least a 20% improvement (ACR20) in both tender and swollen joint counts, and in 3 of the following 5 criteria: (1) evaluator's global assessment, (2) patient's global assessment, (3) functional/disability measure, (4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
Danish: Et fald i tegn og symptomer var defineret som værende mindst en 20 % forbedring (ACR20) i antallet af både ømme og hævede led og i 3 af de følgende 5 kriterier: (1) Evaluators samlede vurdering, (2) patientens samlede vurdering, (3) funktions/handicap mål, (4) visuel analog smerteskala og (5) erytrocytsedimentationshastighed eller C-reaktivt protein.
English: Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p=0.001).
Danish: Det lykkedes desuden at lukke alle fistler hos 55 % af infliximabbehandlede patientersammenlignet med 13 % af patienter behandlet med placebo (p = 0,001).
English: • Low blood counts, including a severely decreased number of white blood cells
Danish: • Lave blodtal, herunder svært nedsat antal hvide blodlegemer.
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2°C - 8°C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Danish: Hvis opløsningen er klargjort under aseptiske betingelser, kan den dog opbevares i køleskab ved 2°C - 8°C i op til 28 dage og i yderligere 24 timer ved 25 °C efter udtagning fra køleskab.
English: The efficacy of subcutaneous infliximab in rheumatoid arthritis patients was assessed in a randomised, parallel-group pivotal Phase I/III study consisting of two parts: Part 1 to determine the optimal dose of subcutaneous infliximab and Part 2 to demonstrate non-inferiority in terms of efficacy of subcutaneous infliximab compared to intravenous infliximab treatment.
Danish: Virkningen af subkutan infliximab hos reumatoid artritpatienter blev vurderet i et randomiseret, parallelgruppe, pivotalt fase I/III-studie bestående af to dele: del 1 til bestemmelse af den optimale dosis af subkutan infliximab og del 2 for at påvise noninferioritet med hensyn til virkningen af subkutan infliximab sammenlignet med intravenøs infliximab-behandling.
English: Treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 3 mg/kg given 2 weeks apart.
Danish: Behandling med Remsima administreret subkutant skal påbegyndes som vedligeholdelsesbehandling 4 uger efter sidste administratoin af to intravenøse infusioner af infliximab 3 mg/kg givet med 2 ugers mellemrum.
English: a. After the needle is inserted, let go of the pinched skin.
Danish: a. Efter at kanylen er indført, gives der slip på den sammenknebne hud.
English: Dispose of the pen (see Figure J).
Danish: Bortskaf pennen (se Figur J).
English: • Cotton ball or gauze*
Danish: • Vatrondel eller gaze*
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with infliximab and is positive for antibodies against double-stranded DNA, further treatment with infliximab must not be given (see section 4.8).
Danish: Hvis en patient udvikler symptomer, der viser tegn på et lupus-lignende syndrom efter behandling med Remsima og er positiv over for antistoffer mod dobbeltstrenget DNA, må behandling med Remsima ikke fortsættes (se pkt.
English: If you miss a dose of Remsima for up to 7 days, after the original scheduled dose, you should take the missed dose immediately.
Danish: Hvis du glemmer en dosis Remsima i op til 7 dage efter den oprindeligt planlagte dosis, skal du straks tage den glemte dosis.
English: If you forget or miss your Remsima infusion
Danish: Hvis du har glemt eller kommer for sent til din Remsima-infusion
English: Sodium acetate trihydrate Sorbitol
Danish: Natriumacetattrihydrat Sorbitol
English: a. Hold the syringe by its body in one hand between your thumb and index finger.
Danish: a. Hold fast om injektionssprøjtens hoveddel med den ene hånd mellem tommel- og pegefinger.
English: The reduction in incidence of colectomy was also examined in another randomised, double-blind study (C0168Y06) in hospitalised patients (n=45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy.
Danish: Reduktionen i hyppigheden af kolektomi blev også undersøgt i et anden randomiseret, dobbelblindet studie (C0168Y06) af hospitaliserede patienter (n=45) med moderat til svær aktiv colitis ulcerosa, som ikke responderede på intravenøse kortikosteroider, og som derfor havde større risiko for kolektomi.
English: Patients with no deterioration/patients evaluated (%)c
Danish: Medianc (Interkvartilt interval) Patienter uden forværring/pati enter evalueret (%)c
English: Read carefully these instructions before using the Remsima pen.
Danish: Læs disse instruktioner grundigt, inden du begynder at bruge Remsima pen.
English: In the RA patients, the mean (± standard deviation) clearance of Remsima 120 mg subcutaneously was 18.8 ± 8.3 mL/hr at steady state.
Danish: Hos RA-patienterne var den gennemsnitlige (± standard afvigelse) clearance af Remsima 120 mg subkutant på 18,8 ± 8,3 ml/time ved steady state.
English: It is used in adults for the following inflammatory disease:
Danish: Det bruges til voksne til behandling af følgende betændelsessygdom:
English: d p = 0.030 and <0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Danish: d p = 0,030 og < 0,001 for henholdsvis 3 mg/kg og 6 mg/kg behandlingsgruppen mod placebo + MTX.
English: • Do not breast-feed when you are being treated with Remsima or for 6 months after your last treatment with Remsima.
Danish: • Du må ikke amme, mens du er i behandling med Remsima og i mindst 6 måneder efter din sidste behandling med Remsima.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, d.v.s. den er i det væsentlige natriumfri.
English: 3.4 (1.3)b a Two-sided 95% CI for difference in the mean change from baseline for DAS28 (CRP) at Week 22 was well above the pre-defined non-inferiority margin of -0.6 b Remsima IV was switched to Remsima SC at Week 30
Danish: 3,4 (1,3)b a Tosidet 95 % CI for forskel i gennemsnitlig ændring fra baseline for DAS28 (CRP) i uge 22 lå langt over den prædefinerede noninferioritetsmargen på -0.6 b Remsima i.v.
English: A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
Danish: Der var designet et klinisk studie med patienter med moderat til svær psoriasis for at undersøge virkning og sikkerhed af langtidsvedligeholdelsesbehandling i forhold til fornyet administration med et induktionsregime med infliximab (højst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom.
English: • You should avoid getting pregnant when you are being treated with Remsima and for 6 months after you stop being treated with it.
Danish: • Du skal undgå at blive gravid, mens Du er i behandling med Remsima, og i mindst 6 måneder efter du er stoppet med behandlingen.
English: • A rare blood cancer affecting mostly young men (hepatosplenic T-cell lymphoma)
Danish: • En sjælden blodkræft, som hovedsageligt rammer unge mænd (hepatosplenisk T-celle-lymfom)
English: b. Remove the syringe from the carton stored in your refrigerator by holding the middle of the syringe body.
Danish: b. Fjern injektionssprøjten fra kartonen, som er opbevaret i dit køleskab, ved at holde fast om injektionssprøjtens hoveddel.
English: Before treatment with Remsima
Danish: Før behandling med Remsima
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of infliximab treatment should be carefully considered before initiation of infliximab therapy.
Danish: Hos patienter, der har boet i eller rejst til områder, hvor invasive svampeinfektioner såsom histoplasmose, kokcidioidomykose eller blastomykose er endemiske, skal fordele og risici ved infliximab-behandling overvejes omhyggeligt, før infliximab-behandling initieres.
English: Do not blow on or touch the injection site again before giving the injection.
Danish: Du må ikke puste på eller røre injektionsstedet igen, før du injicerer.
English: Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Remsima bør anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/II).
English: After single doses of 120, 180 and 240 mg of subcutaneous infliximab administered to healthy subjects, the mean Cmax values were 10.0, 15.1 and 23.1 µg/mL, respectively, and for all doses infliximab could be detected in the serum for at least 12 weeks thereafter.
Danish: Efter en enkelt dosis på 120, 180 og 240 mg subkutan infliximab administreret til raske forsøgspersoner, var de gennemsnitlige Cmax-værdier på hhv. 10,0; 15,1 og 23,1 µg/ml, og for alle doser kunne der påvises infliximab i serum i mindst 12 uger efter.
English: Upon removal from refrigerated storage, Remsima must not be returned to refrigerated storage.
Danish: Når Remsima er taget ud af køleskabet, må det ikke sættes tilbage på køl igen.
English: Clinical response at Week 8a Clinical response at Week 30a Sustained response (clinical response at both Week 8 and Week 30)
Danish: Klinisk respons i uge 8a Klinisk respons i uge 30a Vedvarende respons (klinisk respons både i uge 8 og uge 30)a
English: Endoscopic studies of intestinal mucosa have shown evidence of mucosal healing in infliximab-treated patients.
Danish: Endoskopiske studier af tarm-mucosa har vist tegn på heling af mucosa hos infliximabbehandlede patienter.
English: For this reason, the initial intravenous administrations should take place where emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway is immediately available.
Danish: Af denne grund skal de første intravenøse administrationer foregå, hvor nødudstyr såsom adrenalin, antihistaminer, kortikosteroider, tungeholder og Rubens ballon er umiddelbart tilgængeligt.
English: For women taking Remsima including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Danish: Lægen kan tilråde, at kvinder, der får Remsima, herunder kvinder over 60 år, regelmæssigt screenes for livmoderhalskræft.
English: b. Using your other hand, gently pinch a fold of skin you cleaned.
Danish: b. Brug din anden hånd til forsigtigt at knibe en hudfold på et stykke af den rensede hud.
English: Anaphylactic shock, vasculitis, sarcoid-like reaction
Danish: Anafylaktisk shock, vasculitis, sarkoid-lignende reaktioner.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), lichenoid reactions, acute generalised exanthematous pustulosis (AGEP).
Danish: Toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, erythema multiforme, furunkulose, lineær IgA bulløs dermatose (LABD), lichenoide reaktioner, akut generaliseret eksantematøs pustulose (AGEP).
English: There are insufficient data on the incidence of delayed hypersensitivity reactions after infliximab-free intervals of more than 1 year but limited data from clinical studies suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval (see section 4.4).
Danish: Der er utilstrækkelige data vedrørende forekomst af forsinkede overfølsomhedsreaktioner efter infliximab-fri perioder på mere end 1 år, men begrænsede data fra kliniske studier tyder på en øget risiko for forsinket overfølsomhed med stigende infliximab-fri periode (se pkt.
English: Clean the injection site.
Danish: Rens injektionsstedet.
English: More signs of allergic side effects that may happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, sore throat or headache.
Danish: Andre tegn på en allergisk bivirkning, som kan opstå op til 12 dage efter din injektion, inkluderer muskelsmerter, feber, led- eller kæbesmerter, ondt i halsen eller hovedpine.
English: Patients should be closely monitored and infliximab must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Danish: Patienter bør følges nøje, og Remsima må ikke fortsættes hos patienter, som udvikler nye eller forværrede symptomer på hjerteinsufficiens (se pkt.
English: The ASPIRE study evaluated responses at 54 weeks in 1,004 methotrexate naive patients with early (≤3 years disease duration, median 0.6 years) active rheumatoid arthritis (median swollen and tender joint count of 19 and 31, respectively).
Danish: ASPIRE studiet evaluerede respons ved uge 54 hos 1.004 methotrexat naive patienter med tidlig (≤ 3 års sygdomsvarighed, median 0,6 år) aktiv reumatoid arthritis (median antallet af hævede og ømme led var henholdsvis 19 og 31).
English: Do not use the syringe if:
Danish: Injektionssprøjten må ikke bruges, hvis:
English: Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Danish: Remsima er indiceret til behandling af svær, aktiv ankyloserende spondylitis hos voksne patienter, som har responderet utilstrækkeligt på konventionel behandling.
English: If you received Remsima while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Danish: Hvis du har fået Remsima under graviditeten, kan vaccination af dit barn med BCG-vaccine (bruges til at forebygge tuberkulose) inden for 6 måneder efter fødslen medføre infektion med alvorlige komplikationer, herunder død.
English: After use, place the pre-filled syringe/ pre-filled syringe with automatic needle guard/ pre-filled pen into a puncture resistant container and discard as required by local regulations.
Danish: Efter brug lægges den fyldte injektionssprøjte/fyldte injektionssprøjte med automatisk kanylebeskyttelse/fyldte pen i en beholder til skarpe genstande og bortskaffes i henhold til lokale retningslinjer.
English: If these medicines do not work well enough, you will be given Remsima to:
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Remsima for at:
English: • Rotate the injection site each time you give an injection.
Danish: • Skift injektionssted hver gang du injicerer.
English: During treatment with Remsima
Danish: Under behandling med Remsima
English: • Use the pen ONLY if your healthcare provider has trained you on the right way to prepare for and to give an injection.
Danish: • Brug KUN pennen hvis dit sundhedspersonale har trænet dig på den rigtige måde til at forberede dig på og i at give en injektion.
English: During Remsima treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Danish: Under Remsimabehandling bør anden samtidig behandling såsom kortikosteroider og immunsuppressiva optimeres.
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/mL (0.9%) solution for infusion from the 250-mL glass bottle or infusion bag equal to the volume of reconstituted Remsima.
Danish: Fortyndingen kan opnås ved at udtrække et volumen af natriumchlorid 9 mg/ml (0,9 %) infusionsvæske fra 250 ml glasflasken eller infusionsposen svarende til voluminet af det rekonstituerede Remsima.
English: • Some patients who have received TNF-blockers, including infliximab have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Danish: • Nogle patienter, som har fået TNF-blokerende behandling, herunder infliximab, har udviklet en sjælden kræftform kaldet hepatosplenisk T-celle-lymfom.
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as a decrease in CDAI by ≥70 points from baseline at the 4-week evaluation and without an increase in the use of medicinal products or surgery for Crohn's disease.
Danish: Det primære endepunkt var andelen af patienter, der oplevede en klinisk virkning, bestemt som en nedgang i CDAI på ≥ 70 point fra baseline ved 4-ugers evalueringen og uden stigning i brugen af lægemidler eller kirurgiske indgreb for Crohns sygdom.
English: From a microbiological point of view, the infusion solution should be administered immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Danish: Ud fra et mikrobiologisk synspunkt skal infusionsvæsken administreres straks, opbevaringstider og -forhold efter anbrud indtil anvendelse er brugerens ansvar, og de vil normalt ikke overskride 24 timer ved 2 °C - 8 °C, medmindre rekonstitution/fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: • After the first two intravenous infusions, the first dose of Remsima will be administered under the supervision of your doctor.
Danish: • Efter de første to infusioner i en blodåre, gives den første dosis Remsima under overvågning af din læge.
English: In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses.
Danish: I en undergruppe med 90 voksne patienter med reumatoid arthritis fra ASPIRE-studiet kom en tilsvarende andel af patienterne i hver behandlingsgruppe (methotrexat plus: placebo [n=17], 3 mg/kg [n=27 eller 6 mg/kg infliximab [n=46]) op på en effektiv fordobling i titer med en polyvalent pneumokokvaccine, som indikerer, at infliximab ikke påvirkede det T-celle uafhængige humorale immunrespons.
English: Suitability of the patient for subcutaneous home use should be assessed and patients should be advised to inform their healthcare professional if they experience symptoms of an allergic reaction before administering the next dose.
Danish: Patientens egnethed til subkutan selv-injecering skal vurderes, og patienter skal rådes til at informere sundhedspersonalet, hvis de oplever symptomer på en allergisk reaktion,
English: Significantly fewer colectomies occurred within 3 months of study infusion in patients who received a single dose of 5 mg/kg infliximab compared to patients who received placebo (29.2% vs. 66.7% respectively, p=0.017).
Danish: Der forekom signifikant færre kolektomier indenfor 3 måneder fra studieinfusion hos patienter, der fik en enkelt dosis 5 mg/kg infliximab sammenlignet med patienter, der fik placebo (hhv. 29,2 % versus 66,7 %, p=0,017).
English: Do not dilute the reconstituted Remsima solution with any other diluent.
Danish: Fortynd ikke det rekonstituerede Remsimakoncentrat med andre fortyndingsmidler'.
English: Table 2 Proportion of patients with increased ALT activity in clinical studies using intravenous infliximab
Danish: Tabel 2 Andel patienter med øget ALAT-aktivitet i kliniske studier med intravenøs infliximab
English: If these medicines do not work well enough, you will be given Remsima to treat your disease.
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Remsima til behandling af din sygdom.
English: The dose and the number of Remsima vials have to be calculated.
Danish: Dosis og antal af de nødvendige Remsima-hætteglas beregnes.
English: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02
Danish: Farmakoterapeutisk klassifikation: Immunosuppressiva, tumornekrosefaktor-alfa (TNFα)-hæmmere, ATC-kode: L04AB02.
English: A patient who requires surgery while on infliximab should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som kræver operation under Remsimabehandling, bør følges nøje for infektioner, og passende forholdsregler bør tages.
English: The primary endpoints were the reduction of signs and symptoms as assessed by the ACR criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function.
Danish: De primære endepunkter var reduktionen af sygdomstegn og symptomer, i henhold til ACR-kriterier (ACR20 for ATTRACT, grænsebestemt ACR-N for ASPIRE), forebyggelsen af strukturel ledskade og forbedringen af fysisk funktionsevne.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remsima treatment.
Danish: • Patienter med KOL og patienter, som er storrygere, kan have en øget risiko for at udvikle kræft under behandling med Remsima.
English: The medicinal product may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: Lægemidlet kan opbevares ved temperaturer op til max. 25 °C i en periode på op til 14 dage.
English: a. Put the used syringe in an approved sharps disposal container immediately after use.
Danish: a. Læg den brugte injektionssprøjte i en godkendt beholder til bortskaffelse af skarpe genstande straks efter brug.
English: In studies in healthy subjects, the mean (± standard deviation) apparent clearance of Remsima 120 mg administered subcutaneously was 19.3 ± 6.9 mL/hr.
Danish: I studier med raske forsøgspersoner var den gennemsnitlige (± standard afvigelse) clearance af Remsima 120 mg administreret subkutant på 19,3 ± 6,9 ml/time.
English: Patient Reminder Card
Danish: Patient informationskort
English: c. Apply an adhesive bandage, if necessary.
Danish: c. Sæt et plaster på efter behov.
English: If you were using Remsima during pregnancy, tell your baby's doctor and other health care professionals caring for your baby about your Remsima use before the baby receives any vaccines.
Danish: Hvis du har fået Remsima, mens du var gravid, skal du fortælle dit barns læge og andet sundhedspersonale, der tager sig af dit barn, at du har fået Remsima, før barnet bliver vaccineret.
English: • That treatment with Remsima may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP
Danish: • Information om at behandling med Remsima kan øge risikoen for alvorlige infektioner/sepsis, opportunistiske infektioner, tuberkulose, reaktivering af hepatitis B og BCGgennembrudsinfektion hos spædbørn, der i uterus er blevet eksponeret for infliximab, samt information om, hvornår patienten skal søge hjælp hos en sundhedsperson.
English: Among patients in the infliximab 5 mg/kg group who crossed over because of loss of fistula response after week 22, 57% (12/21) responded to re-treatment with infliximab 10 mg/kg every 8 weeks.
Danish: Blandt patienter i infliximab-gruppen 5 mg/kg, der krydsede over på grund af tab af fistel respons efter uge 22, responderede 57 % (12/21) på genbehandling med infliximab 10 mg/kg hver 8. uge.
English: Remsima treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Danish: Behandling med Remsima skal initieres og holdes under opsyn af kvalificerede læger med erfaring i diagnostik og behandling af reumatoid arthritis, inflammatoriske tarmsygdomme, ankyloserende spondylitis, psoriasis arthritis eller psoriasis.