FrancophonIA/ELRC3.0 huggingface dataset:
English: However, before Inflectra is given to you, it is mixed with a solution that contains sodium.
Danish: Inden du får Inflectra, bliver det imidlertid blandet med en opløsning, der indeholder natrium.
English: • you have heart failure that is moderate or severe.
Danish: • du har hjertesvigt i moderat eller svær grad.
English: Patients who develop a new infection while undergoing treatment with infliximab, should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, som udvikler en ny infektion, imens de er under behandling med infliximab, bør monitoreres tæt og gennemgå en komplet diagnostisk evaluering.
English: Shortened infusions at doses >6 mg/kg have not been studied (see section 4.8).
Danish: Kortere infusionstid ved doser > 6 mg/kg er ikke blevet undersøgt (se pkt.
English: 178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Danish: 178 af de 580 inkluderede patienter (30,7%) blev defineret som havende svær sygdom (CDAI score > 300 og samtidig kortikoid og/eller immunsupprimerende behandling) svarende til populationen defineret i indikationen (se pkt.
English: Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies.
Danish: Samtidig brug af stabile doser af konventionel behandling var tilladt, og 83% af patienterne fortsatte brugen af mindst en af disse behandlinger.
English: If these medicines or treatments do not work well enough, you will be given Inflectra to reduce the signs and symptoms of your disease.
Danish: Hvis disse lægemidler eller behandlinger ikke virker godt nok, vil du få Inflectra for at reducere tegn og symptomer på din sygdom.
English: Discontinuation of infliximab should be considered if these disorders develop.
Danish: Det bør overvejes at afbryde infliximab-behandlingen, hvis disse sygdomme udvikles.
English: * p-values represent each infliximab treatment group vs. AZA monotherapy.
Danish: * P-værdier repræsenterer hver infliximab-behandlingsgruppe vs. AZA monoterapi.
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: Republic of Korea
Danish: Republikken Korea
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Inflectra.
Danish: • Hvis din læge tror, at du har risiko for at få TB, kan du blive behandlet med lægemidler mod TB, inden du får Inflectra.
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: • 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 Inflectra.
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
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: Kvinder i den fertile alder 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: Of the patients who required a dose titration, 80% achieved clinical response and the majority (64%) of these required only one adjustment of 1.5 mg/kg.
Danish: Af de patienter som behøvede dosisjustering opnåede 80% klinisk respons og størstedelen af disse (64%) behøvede kun en justering med 1,5 mg/kg.
English: • slow down the damage in your joints,
Danish: • forsinke skaden i dit led
English: Immunogenicity Antibodies to infliximab were detected in 4 (7.7%) patients through week 54.
Danish: Immunogenicitet Antistoffer over for infliximab blev påvist hos 4 (7,7%) patienter i uge 54.
English: Only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less) should be used.
Danish: Kun et infusionssæt med et in-line, sterilt, ikke-pyrogent, minimalt proteinbindende filter (porestørrelse 1,2 mikrometer eller derunder) bør anvendes.
English: All patients administered infliximab are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Danish: Alle patienter, der har fået infliximab, skal observeres i mindst 1-2 timer efter infusionen for akutte infusionsrelaterede reaktioner.
English: Your doctor will test you to see if you have TB.
Danish: Deres læge vil teste dig for at se, om du har haft TB.
English: * ITT-analysis where subjects with missing data were included as non-responders.
Danish: PASI 75 respons** * ITT-analyser med forsøgspersoner med manglende data blev inkluderet som ikke-responderende.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of infliximab, and in accordance with local recommendations.
Danish: Hvis inaktiv (“latent”) tuberkulose diagnosticeres, skal behandling for latent tuberkulose påbegyndes med behandling mod tuberkulose før initiering af infliximab-behandling i henhold til lokale vejledninger.
English: • Children and adults taking Inflectra may have an increased risk of developing lymphoma or another cancer.
Danish: • Børn og voksne i behandling med Inflectra kan have en øget risiko for at udvikle lymfom eller anden form for kræft.
English: a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension.
Danish: a Uge 98 data for IMPACT inkluderer kombineret placebo cross-over og infliximab-patienter, der deltog i den åbne undersøgelse.
English: Concurrent use of stable doses of conventional therapies was permitted, and 92% of patients continued to receive these therapies.
Danish: Samtidig brug af stabile doser af konventionel behandling var tilladt, og 92% af patienterne fortsatte brugen af disse behandlinger.
English: In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of infliximab.
Danish: Hos patienter, der har adskillige eller signifikante risikofaktorer for tuberkulose og har en negativ test for latent tuberkulose, bør anti-tuberkulosebehandling overvejes før initieringen af infliximab.
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 omhyggeligt studie af hændelsen bør foretages.
English: Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with infliximab is not established, the risk and benefits of continued therapy to the individual patients should be carefully considered by the clinician.
Danish: Da muligheden for øget risiko for udvikling af cancer hos patienter med nydiagnosticeret dysplasi behandlet med infliximab ikke er klarlagt, bør risiko og gavn af fortsat behandling for de individuelle patienter nøje overvejes af lægen.
English: Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer.
Danish: Aktuelle data tyder ikke på, at infliximab-behandling påvirker risikoen for at udvikle dysplasi eller coloncarcinom.
English: At the last evaluation, 57% of infliximab-treated patients remained anti-dsDNA positive.
Danish: Ved den sidste vurdering var 57% af infliximab-behandlede patienter fortsat anti-dsDNA positive.
English: • Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Inflectra treatment again.
Danish: • Fortæl din læge, hvis du tidligere har været i behandling med lægemidler, der indeholder infliximab og nu starter behandling med Inflectra igen.
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 .
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: Patients who discontinue immunosuppressants prior to or during infliximab treatment are at greater risk of developing these antibodies.
Danish: Patienter, der får seponeret immunsuppressiva før eller under infliximab-behandling, har større risiko for at udvikle disse antistoffer.
English: The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%].
Danish: Median opfølgningsperioden var 0,8 år (incidens 5,7% [95% CI 2,65%-10,6%].
English: • Tell your doctor if you have hepatitis B or if you know or suspect you are a carrier of the hepatitis B virus.
Danish: • Fortæl din læge, hvis du har hepatitis B, eller hvis du ved eller har mistanke om, at du er bærer af hepatitis B virus.
English: During Inflectra treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Danish: Under Inflectrabehandling bør anden samtidig behandling såsom kortikosteroider og immunsuppressiva optimeres.
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: If these medicines do not work well enough, you will be given Inflectra which you will take with another medicine called methotrexate to:
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Inflectra, som du skal tage sammen med et andet lægemiddel, der hedder methotrexat, for at:
English: What you need to know before you use Inflectra
Danish: Det skal du vide, før du begynder at bruge Inflectra
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with infliximab.
Danish: Patienter skal følges tæt for infektioner, inklusive tuberkulose før, under og efter behandling med infliximab.
English: In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines.
Danish: Hos patienter, der får anti-TNF-behandling er der utilstrækkelige data vedrørende respons på vaccinationer med levende vacciner og vedrørende sekundære overførsel af infektion forårsaget af levende vacciner.
English: EU/1/13/854/001 1 vial EU/1/13/854/002 2 vials EU/1/13/854/003 3 vials EU/1/13/854/004 4 vials EU/1/13/854/005 5 vials
Danish: EU/1/13/854/001 1 hætteglas EU/1/13/854/002 2 hætteglas EU/1/13/854/003 3 hætteglas EU/1/13/854/004 4 hætteglas EU/1/13/854/005 5 hætteglas
English: In addition, bone fracture (6.8%) was reported, however, a causal association has not been established.
Danish: Derudover er knoglebrud (6,8%) rapporteret.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts handelsnavn og batchnumrer tydeligt registreres.
English: All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Danish: Alle patienterne skulle være på en stabil dosis af 6-MP, AZA eller MTX (35% fik også kortiokosteroid ved baseline).
English: • If you received Inflectra 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 Inflectra, mens du var gravid, kan dit barn også have en større risiko for at få en infektion, som skyldes levende vacciner, i op til 6 måneder efter fødslen.
English: The infusion solution has to be administered over a period of not less than the infusion time recommended (see section 3).
Danish: Infusionsvæsken skal administreres over en periode på ikke mindre end den anbefalede infusionstid (se pkt.
English: For more information see section on Pregnancy and breast-feeding.
Danish: For yderligere information henvises til afsnittet om Graviditet, amning og frugtbarhed.
English: • Tell your surgeon or dentist that you are having treatment with Inflectra by showing them your patient reminder card.
Danish: • Fortæl kirurgen eller tandlægen, at du er i behandling med Inflectra ved at vise dem dit patientinformationskort.
English: Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Infliximab bør anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/II).
English: In a 1-year clinical study with repeated infusions in patients with Crohn's disease (ACCENT I study), the incidence of serum sickness-like reactions was 2.4%.
Danish: I et 1-års klinisk studie med gentagne infusioner hos patienter med Crohns sygdom (ACCENT I studie) var hyppigheden af serumsygdoms-lignende reaktioner 2,4%.
English: N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
Danish: ≥ 90% forbedring ≥ 75% forbedring ≥ 50% forbedring
English: Use of anti-tuberculosis therapy should also be considered before the initiation of infliximab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Anvendelsen af anti-tuberkulosebehandling bør også overvejes før initieringen af infliximab hos patienter med en tidligere sygdomshistorie med latent eller aktiv tuberkulose, hos hvem et passende behandlingsprogram ikke kan bekræftes.
English: Inflectra must be given concomitantly with methotrexate.
Danish: Inflectra skal anvendes sammen med methotrexat.
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: At baseline 27.4% of patients were receiving systemic corticosteroids, 14.2% of patients were receiving budesonide, and 54.3% of patients were receiving 5-ASA compounds.
Danish: Ved baseline fik 27,4% af patienterne systemiske kortikosteroider, 14,2% af patienterne fik budesonid, og 54,3% af patienterne fik 5-ASA-stoffer.
English: You may receive some vaccines during treatment with Inflectra but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Inflectra because they may cause infections.
Danish: Under Inflectra behandlingen kan du få nogle vaccinationer, men du må ikke få levende vacciner (vacciner der indeholder et levende men svækket smitstof), da de kan give infektioner.
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 cancer).
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 seneste screening(er) for TB på kortet
English: Patients with fistulising Crohn's disease with acute suppurative fistulas must not initiate infliximab therapy until a source for possible infection, specifically abscess, has been excluded (see section 4.3).
Danish: Patienter med fistulerende Crohns sygdom med akut pusdannende fistler må ikke påbegynde infliximab-behandling, før en kilde til mulig infektion, specielt abscesser, er blevet udelukket (se pkt.
English: The ATTRACT study evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate.
Danish: ATTRACT studiet evaluerede responset ved ugerne 30, 54 og 102 i et placebokontrolleret studie hos 428 patienter med aktiv reumatoid arthritis på trods af behandling med methotrexat.
English: Had treatment with any medicine containing infliximab before
Danish: Været i behandling med lægemidler, der indeholder infliximab tidligere
English: For volumes greater than 250 mL, either use a larger infusion bag (e.g. 500 mL, 1000 mL) or use multiple 250 mL infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/mL.
Danish: Brug enten en større infusionspose (fx 500 ml, 1.000 ml) til volumener over 250 ml eller brug flere 250 ml infusionsposer for at sikre, at koncentrationen af infusionsvæsken ikke overstiger 4 mg/ml.
English: It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Inflectra therapy.
Danish: Det anbefales, at patienterne, om muligt, bringes up to date med alle vaccinationer i overensstemmelse med gældende vaccinationsvejledninger før initiering af behandling med Inflectra.
English: Patients may be pre-treated with e.g. an antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects.
Danish: Patienter kan forbehandles med for eksempel et antihistamin, hydrocortison og/eller paracetamol, for at forebygge lette og forbigående reaktioner.
English: At week 2, all patients were assessed for clinical response and randomised to one of 3 treatment groups; a placebo maintenance group, 5 mg/kg maintenance group and 10 mg/kg maintenance group.
Danish: I uge 2 blev alle patienter bedømt til klinisk respons og randomiseret til en af 3 behandlingsgrupper; en placebo-vedligeholdelsesgruppe, en 5 mg/kg vedligeholdelsesgruppe og en 10 mg/kg vedligeholdelsesgruppe.
English: In Crohn's disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Danish: I Crohns sygdom er erfaring med fornyet administration efter recidiverende sygdomstegn og symptomer begrænset og sammenlignende data vedrørende gavn versus risici på de forskellige strategier savnes.
English: N/A 60 N/A 49.4 N/A 6.7% N/A 1.7%
Danish: N/A 6,7% N/A 1,7%
English: The required volume of reconstituted Inflectra solution should slowly be added to the 250-mL infusion bottle or bag and gently be mixed.
Danish: Det påkrævede volumen af rekonstitueret Inflectra-opløsning tilføjes langsomt til 250 ml infusionsflasken eller -posen og blandes forsigtigt.
English: If you received Inflectra 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 Inflectra 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: SPIRIT evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy.
Danish: SPIRIT vurderede virkningen af infliximab induktionsbehandling hos 249 patienter med plaque psoriasis, som tidligere havde fået PUVA eller systemisk behandling.
English: * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Danish: *Infliximab er et kimærisk monoklonalt humant-murint IgG1-antistof fremstillet i murine hybridomaceller ved rekombinant DNA-teknologi.
English: Table 7 Effects on response rate, data from ACCENT II (Week-14 responders) ACCENT II (Week-14 responders)
Danish: Tabel 7 Virkninger på responshastighed, data fra ACCENT II (uge-14 responderende)
English: The median time to onset of response in the infliximab-treated group was 2 weeks.
Danish: Median tiden til der registreredes en virkning i gruppen behandlet med infliximab var 2 uger.
English: Inflectra should only be used during pregnancy if your doctor feels it is necessary for you.
Danish: Du må kun få Inflectra under graviditeten, hvis lægen finder det nødvendigt.
English: Table 8 Effects on clinical response, clinical remission and mucosal healing at Weeks 8 and 30.
Danish: Tabel 8 Virkninger på klinisk respons, klinisk remission og slimhindeheling i uge 8 og 30.
English: In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever,
Danish: I C0168T72 var de almindeligste bivirkninger øvre luftvejsinfektion, faryngitis, abdominalsmerter, feber og hovedpine.
English: The solution should be colourless to light yellow and opalescent.
Danish: Opløsningen bør være farveløs til lysegul og opaliserende.
English: Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C - 8 °C and for an additional 24 hours at 25 C after removal from refrigeration.
Danish: Den fortyndede opløsnings kemiske og fysiske stabilitet efter anbrud er påvist i op til 28 dage ved 2C - 8C og i yderligere 24 timer ved 25°C efter udtagning fra køleskab.
English: If you are not sure, talk to your doctor before you are given Inflectra.
Danish: Hvis du er i tvivl, så tal med din læge, før du får Inflectra.
English: • If you received Inflectra during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Hvis du fik Inflectra under graviditeten, kan dit barn have en øget risiko for at få en infektion.
English: If you are 65 years of age or older, you have a greater risk.
Danish: Du har en højere risiko, hvis Du er 65 år eller derover.
English: Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50.
Danish: Tabel 10 Resumé af PASI respons, PGA-respons og andel patienter, hvis negle alle var fri for psoriasis i uge 10, 24 og 50.
English: Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period.
Danish: Af de patienter, som ikke fik en infusionsreaktion under induktionsfasen, fik 9% en infusionsreaktion under vedligeholdelsesfasen.
English: In one of the study arms (group 2, n=329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Danish: I en af armene (gruppe 2, n=329) blev patienter med utilstrækkeligt respons tilladt dosisjustering med 1,5 mg/kg intervaller fra 3 op til 9 mg/kg.
English: The pooled data analysis from the ACT 1 and ACT 2 studies and their extensions, analysed from baseline through 54 weeks, demonstrated a reduction of ulcerative colitis-related hospitalisations and surgical procedures with infliximab treatment.
Danish: Den samlede dataanalyse for ACT 1 og ACT 2 studierne og deres forlængelser, som blev analyseret fra baseline til uge 54, viste en reduktion af colitis ulcerosa-relaterede hospitalsindlæggelser og kirurgiske indgreb med infliximab-behandling.