FrancophonIA/ELRC3.0 huggingface dataset:
English: Carriers of HBV who require treatment with Flixabi should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Hos patienter med positiv test for HBV-infektion, anbefales det at rådføre sig med en læge med erfaring i behandling af hepatitis B. Bærere af HBV, hvor behandling med Flixabi er nødvendig, skal følges nøje under behandlingen og i adskillige måneder efter afslutning af behandlingen for at registrere tegn og symptomer på aktiv HBV-infektion.
English: Urinary tract infection.
Danish: Urinvejsinfektion.
English: It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Flixabi therapy.
Danish: Det anbefales, at pædiatriske patienter bliver vaccineret i overensstemmelse med gældende vaccinationsvejledninger, før Flixabi-behandling påbegyndes, hvis dette er muligt.
English: Complete fistula response (%)
Danish: Uge 54 Fistula respons (%)a
English: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Danish: Lungeødem, bronkospasme, pleuritis, pleural effusion.
English: If you are not sure if any of the above applies to you, talk to your doctor before you are given Flixabi.
Danish: Hvis du er i tvivl, om noget af ovenstående passer på dig, skal du kontakte lægen, før du får Flixabi.
English: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis.
Danish: Nedre luftvejsinfektion (fx bronchitis, pneumoni), dyspnø, næseblod.
English: VIAL LABEL
Danish: HÆTTEGLAS-ETIKET
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside.http://www.ema.europa.eu.
English: Other medicines and Flixabi
Danish: Brug af anden medicin sammen med Flixabi
English: Flixabi 100 mg powder for concentrate infliximab
Danish: Flixabi 100 mg pulver til koncentrat, opløsning infliximab
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind studies: SPIRIT and EXPRESS.
Danish: Psoriasis hos voksne Effekten af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblinde studier: SPIRIT og
English: In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year (see sections 4.4 and 4.8).
Danish: I kliniske studier har forsinkede overfølsomhedsreaktioner været usædvanlige og er forekommet efter infliximab-fri perioder på mindre end 1 år (se pkt.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.However, before Flixabi is given to you, it is mixed with a solution that contains sodium.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis.
Danish: Tarmperforation, tarmstenose, diverticulitis, pancreatitis, keilitis.
English: Flixabi is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Danish: Flixabi er indiceret til behandling af svær, aktiv colitis ulcerosa hos børn og unge i alderen 6 til 17 år, som har responderet utilstrækkeligt på konventionel behandling, inklusive kortikosteroider og 6-MP eller AZA, eller som er intolerante over for eller hvor der er kontraindikationer mod disse behandlinger.
English: Dizziness may occur following administration of Flixabi (see section 4.8).
Danish: Der kan opstå svimmelhed under behandling med Flixabi (se pkt.
English: It is recommended that live vaccines not be given concurrently with Flixabi.
Danish: Levende vacciner bør ikke gives samtidig med Flixabi.
English: Flixabi should be administered  in combination with methotrexate  or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Danish: • eller alene hos patienter, der udviser intolerance over for methotrexat, eller for hvem methotrexat er kontraindiceret
English: Hepatobiliary disorders Common:
Danish: Vaskulære sygdomme Almindelig:
English: Efficacy and safety of infliximab were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
Danish: Infliximabs effekt og sikkerhed blev undersøgt i to multicenter, dobbeltblinde, placebokontrollerede studier hos patienter med aktiv ankyloserende spondylitis (Bath Ankylosing Spondylitis Disease
English: Signs include a fever, feeling tired, (persistent) cough, shortness of breath, weight loss, night sweats, diarrhea, wounds, dental problems, burning when urinating or ‘flulike' signs.
Danish: Tegn inkluderer feber, træthedsfølelse, (vedvarende) hoste, åndenød, vægttab, natlig svedtendens, diarré, sår, tandproblemer, en brændende smerte, når du lader vandet, eller influenzalignende symptomer.
English: Flixabi 100 mg powder for concentrate for solution for infusion infliximab
Danish: Flixabi 100 mg pulver til koncentrat til infusionsvæske, opløsning infliximab
English: If a patient does not respond after 3 doses, no additional treatment with Flixabi should be given.
Danish: Hvis en patient ikke responderer efter 3 doser, bør der ikke gives yderligere behandling med Flixabi.
English: Headache.
Danish: Leversvigt.
English: Administration of live vaccines (e.g. BCG vaccine) to infants exposed to infliximab in utero is not recommended for at least 6 months after birth (see sections 4.4 and 4.5).
Danish: Der bør ikke indgives levende vacciner (fx BCG-vaccine) til spædbørn, eksponeret for infliximab i uterus, i mindst 6 måneder efter fødslen (se pkt.
English: Median time to loss of response through
Danish: Median tid til tab af respons efter uge 54
English: Pyelonephritis.
Danish: Pyelonefritis.
English: Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Danish: Brystsmerte, træthed, feber, reaktioner på injektionsstedet, kulderystelser, ødem.
English: Flixabi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:  adult patients with active disease when the response to disease-modifying antirheumatic drugs
Danish: Flixabi, i kombination med methotrexat, er indiceret til reduktion af sygdomstegn og symptomer samt forbedring af fysisk funktionsevne hos:
English: Impaired healing.
Danish: Forringet heling.
English: Flixabi 100 mg powder for concentrate for solution for infusion.
Danish: Flixabi 100 mg pulver til koncentrat til infusionsvæske, opløsning.
English: If a patient does not respond by 6 weeks (i.e. after 2 doses), no additional treatment with Flixabi should be given.
Danish: Hvis en patient ikke responderer ved uge 6 (det vil sige efter 2 doser), bør der ikke gives yderligere behandling med Flixabi.
English: b CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54 among patients who were receiving corticosteroids at baseline.
Danish: De patienter, der fik kortikosteroider ved baseline, fik ikke kortikosteroider i de 3 måneder forud for uge 54.
English: For more information about the safety of infliximab in elderly patients (see sections 4.4 and 4.8).
Danish: 4.4 og 4.8 for mere information omkring sikkerhed ved brug af infliximab hos ældre patienter.
English: Additional side effects in children and adolescents
Danish: Hos børn og unge kan endvidere ses følgende bivirkninger:
English: The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leucopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Danish: Følgende bivirkninger forekom hyppigere hos børn: nedsat antal røde blodlegemer (anæmi), blod i afføringen, nedsat samlet indhold af hvide blodlegemer (leukopeni), anfaldsvis ansigtsrødme,
English: Table 1 Undesirable effects in clinical studies and from post-marketing experience Infections and infestations Very Common:
Danish: Tabel 1 Bivirkninger i kliniske studier og efter markedsføring Infektioner og parasitære sygdomme Meget almindelig: Virusinfektion (fx influenza, herpes virus infektioner).
English: Adult Crohn's disease Flixabi is indicated for:  treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Danish: • behandling af moderat til svært aktiv Crohns sygdom hos voksne patienter, som ikke har responderet på trods af en fuldstændig og adækvat behandling med et kortikosteroid og/eller et immunsuppressivum, eller som er intolerante over for eller har kliniske kontraindikationer for sådanne behandlinger.
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: ≤ 3 års sygdomsvarighed, median 0,6 år) aktiv reumatoid arthritis (median antallet af hævede og ømme led var henholdsvis 19 og 31).
English: In responding patients, the alternative strategies for continued treatment are:  Maintenance: Additional infusions of 5 mg/kg every 8 weeks or  Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see ‘Re-administration' below and section 4.4).
Danish: • Fornyet indgift: Doser på 5 mg/kg, hvis sygdomstegn og symptomer på sygdommen kommer igen, efterfulgt af infusionsdoser på 5 mg/kg hver 8. uge (se "Fornyet indgift" nedenfor samt pkt.
English: It is recommended that therapeutic infectious agents not be given concurrently with Flixabi.
Danish: Terapeutiske smitstoffer bør ikke gives samtidig med Flixabi.
English: Sustained response (clinical response at both week
Danish: Vedvarende respons (klinisk respons både i uge 8 og uge 30)a
English: Overall, 8 (13.3%) of 60 treated patients experienced one or more infusion reactions, with 4 of 22 (18.2%) in the q8 week and 3 of 23 (13.0%) in the q12 week treatment maintenance group.
Danish: Det drejede sig om 4 ud af 22 (18,2 %) i 8-ugers vedligeholdelsesbehandlingsgruppen og 3 ud af 23 (13,0 %) i 12-ugers vedligeholdelsesbehandlingsgruppen.
English: Each Flixabi vial contains 100 mg infliximab.
Danish: Hvert Flixabi-hætteglas indeholder 100 mg infliximab.
English: Tell your doctor straight away if you get signs of TB during treatment with Flixabi.
Danish: Fortæl straks din læge, hvis du får tegn på TB under behandlingen med Flixabi.
English: One vial contains 100 mg of infliximab*.
Danish: Et hætteglas indeholder 100 mg infliximab*.
English: In patients who develop HBV reactivation, Flixabi should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.
Danish: Der er ikke tilgængelige data om antiviral behandling profylaktisk mod HBV-reaktivering i forbindelse med TNF-antagonist-behandling hos patienter, som er bærere af HBV. Flixabi bør seponeres hos patienter, hvor HBV reaktiveres, og effektiv antiviral behandling med passende understøttende behandling bør igangsættes.
English: Nervous system disorders Very common:
Danish: Psykiske forstyrrelser Almindelig:
English: Transient visual loss occurring during or within 2 hours of infusion.
Danish: Kortvarigt synstab under infusionen eller inden for 2 timer efter infusionen.
English: DENMARK
Danish: DANMARK
English: Tell your doctor straight away if you get signs of infection during treatment with Flixabi.
Danish: Fortæl straks din læge, hvis du får tegn på infektion under behandling med Flixabi.
English: • Chills, a build up of fluid under the skin causing swelling
Danish: • Kulderystelser, hævelse på grund af ophobning af væske under huden
English: The safety and efficacy of infliximab were assessed in a multicentre, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Danish: Infliximabs sikkerhed og virkning blev vurderet i et multicenter, randomiseret, open-label, parallelgruppe klinisk studie (C0168T72) hos 60 pædiatriske patienter i alderen 6 til 17 år (medianalder
English: The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Danish: Fornyet indgift ved ankyloserende spondylitis Sikkerhed og virkning ved fornyet indgift, udover hver 6. til 8. uge, er ikke klarlagt (se pkt.
English: Tell your doctor straight away if you get symptoms of low blood counts during treatment with Flixabi.
Danish: Fortæl det straks til lægen, hvis du får symptomer på lave blodtal under behandlingen med Flixabi.
English: After reconstitution, each ml contains 10 mg of infliximab.
Danish: Efter rekonstitution indeholder hver ml 10 mg infliximab.
English: After preparation each mL contains 10 mg of infliximab.
Danish: Efter klargøring indeholder hver ml 10 mg infliximab.
English: It is recommended that therapeutic infectious agents not be given concurrently with Flixabi (see section 4.4).
Danish: Terapeutiske smitstoffer bør ikke gives samtidig med Flixabi (se pkt.
English: In clinical studies, mild or moderate elevations of ALT and AST have been observed in patients receiving infliximab without progression to severe hepatic injury.
Danish: Lever- og galdevejshændelser I kliniske studier er let til moderate stigninger i ALAT og ASAT set hos patienter, der fik infliximab,
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Flixabi use before your baby is given any vaccine.
Danish: Det er vigtigt, at du fortæller dit barns læger og andet sundhedspersonale, at du har fået Flixabi, før barnet bliver vaccineret (for mere information, se afsnit om vaccination).
English: a a p < 0.001, for each infliximab treatment group vs. placebo
Danish: Slimhindeheling i uge 30a a p < 0,001 for hver infliximab-behandlingsgruppe mod placebo.
English: Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Flixabi.
Danish: Fortæl straks din læge, hvis du får symptomer på en nervesygdom under behandlingen med Flixabi.
English: Mean ± SD
Danish: Gennemsnit ± SDa
English: How much Flixabi is given
Danish: Så meget Flixabi vil du få
English: After reconstitution one mL contains 10 mg infliximab.
Danish: Efter rekonstitution indeholder 1 ml 10 mg infliximab.
English: Mean ± SDd a p < 0.001, for each infliximab treatment group vs control b greater values indicate more joint damage.
Danish: Gennemsnit ± SDd a p < 0,001, for hver infliximab-behandlingsgruppe mod kontrol.
English: If a patient does not respond after 2 doses, no additional treatment with Flixabi should be given.
Danish: Hvis patienten ikke responderer efter 2 doser, bør der ikke behandles yderligere med Flixabi.
English: Sími: + 354 800 9836
Danish: Icepharma hf Sími: + 354 800 9836
English: (DMARDs), including methotrexate, has been inadequate.
Danish: • voksne patienter med aktiv sygdom, når responset til sygdomsmodulerende antireumatiske lægemidler (DMARDs), inklusive methotrexat, har været utilstrækkeligt.
English: Tell your doctor straight away if you develop symptoms of lupus during treatment with Flixabi.
Danish: Fortæl det straks til lægen, hvis du får symptomer på lupus under behandlingen med Flixabi.
English: * ITT-analysis where subjects with missing data were included as non-responders a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension b Based on patients with PASI ≥ 2.5 at baseline for IMPACT, and patients with ≥ 3% BSA psoriasis skin involvement at baseline in IMPACT 2 ** PASI 75 response for IMPACT not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for IMPACT 2
Danish: ** PASI 75 respons for IMPACT ikke inkluderet som følge af lav N; p < 0,001 for infliximab vs. placebo i uge 24 for IMPACT 2.
English: Common: may affect up to 1 10 people
Danish: Almindelig: kan forekomme hos op til 1 ud af 10 personer
English: In the second clinical study (IMPACT 2), efficacy and safety of infliximab were studied in 200 patients with active psoriatic arthritis (≥ 5 swollen joints and ≥ 5 tender joints).
Danish: I det andet kliniske studie (IMPACT 2) blev effekt og sikkerhed af infliximab undersøgt hos 200
English: Respiratory, thoracic and mediastinal disorders Very common:
Danish: Luftveje, thorax og mediastinum Meget almindelig: Øvre luftvejsinfektion, sinuitis.
English: (furunculosis)
Danish: • Leversvigt
English: Patients should be tested for HBV infection before initiating treatment with Flixabi.
Danish: Før behandlingen med Flixabi påbegyndes, skal patienten testes for HBV-infektion.
English: Flixabi and Kineret should not be used together.
Danish: Du må ikke få Flixabi og Kineret samtidig.
English: AZA Monotherapy
Danish: Brug ikke Flixabi
English: Tell your doctor straight away if you get symptoms of liver problems during treatment with Flixabi.
Danish: Fortæl det straks til lægen, hvis du får symptomer på leverproblemer under behandlingen med Flixabi.
English: Patients treated with Flixabi should be given the patient reminder card.
Danish: Patientinformationskortet skal udleveres til patienter, som er i behandling med Flixabi.
English: Uncommon: may affect up to1 in 100 people
Danish: Ikke almindelig: kan forekomme hos op til 1 ud af 100 personas
English: Olof Palmestraat 10
Danish: Mave-tarm-kanalen
English: Keratitis, periorbital oedema, hordeolum.
Danish: Keratitis, periorbitalt ødem, bygkorn.
English: How Flixabi is given
Danish: Flixabi bør administreres
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥ 50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
Danish: drænet ved forsigtigt tryk, ved mindst to på hinanden følgende besøg (med 4 ugers mellemrum) uden øget brug af lægemidler eller kirurgisk indgreb for Crohns sygdom.
English: HAQ change from baseline over timee (patients evaluated) Mean ± SD
Danish: HAQ ændring fra baseline over tiden e
English: The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Danish: Fornyet indgift ved psoriasis arthritis Sikkerhed og virkning ved fornyet indgift, udover hver 8. uge, er ikke klarlagt (se pkt.
English: 3 mg/kg q 8 wks
Danish: Kontrol a 3 mg/kg hver 8. uge
English: Patients with ACR20 response/ Patients evaluated (%) Total scored (van der Heijde-modified Sharp score) Change from baseline (Mean ± SD
Danish: (van der Heijdemodified Sharp score) Ændring fra baseline (Gennemsnit ± SD
English: Percentage of subjects with mucosal healing Mucosal healing at week 8
Danish: Procent forsøgspersoner med slimhindeheling Slimhindeheling i uge 8a
English: Apathy.
Danish: Flixabi.
English: How to store Flixabi
Danish: Sådan skal du bruge Flixabi
English: Indication
Danish: Opbevaring
English: (anaphylactic shock)
Danish: (hepatosplenisk T-celle- lymfom)
English: Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNFblocking agents including infliximab.
Danish: Ydermere er der efter markedsføring blevet rapporteret tilfælde af hepatosplenisk T-celle- lymfom hos patienter i behandling med infliximab.
English: Arthralgia, myalgia, back pain.
Danish: Artralgi, myalgi, rygsmerter.
English: In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with infliximab with the vast majority of cases occurring in Crohn's disease and ulcerative colitis, and most of whom were adolescent or young adult males (see section 4.4).
Danish: Hos patienter, som fik infliximab, er langt de fleste tilfælde forekommet hos patienter med Crohns sygdom eller colitis ulcerosa, og de fleste blev rapporteret hos unge og unge voksne mænd.
English: Instructions for use and handling - reconstitution, dilution and administration In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Danish: Instruktion i anvendelse og håndtering - rekonstitution, fortynding og administration
English: 5 mg/kg
Danish: 5 mg/kg (i uge 24)
English: In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Danish: behandlet med 3 infusioner infliximab 5 mg/kg, 10 mg/kg eller placebo i løbet af 6 uger.
English: Patients received placebo, 3 mg/kg or 10 mg/kg infliximab at weeks 0, 2
Danish: Patienterne fik placebo, 3 mg/kg eller 10 mg/kg infliximab i ugerne 0, 2 og 6, samt hver 4. eller 8. uge herefter.
English: Rheumatoid arthritis1
Danish: Reumatoid arthritis Crohns sygdom2
English: Autoimmune processes
Danish: Lever- og galdevejshændelser
English: • Swelling of small blood vessels (vasculitis)
Danish: (anafylaktisk shock) • Hævelse af små blodkar (blodkarbetændelse)
English: a p < 0.001, for each infliximab treatment group vs. control b n = 292 c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Danish: Analysen var baseret på patienter med neglepsoriasis ved baseline (81,8 % af patienterne).
English: Bottle (HDPE) 1 bottle of 180 tablets without outer carton
Danish: 1 glas med 180 tabletter uden ydre pakning
English: Package sizes
Danish: Pakningsstørrelse
English: Invented name Strengths Pharmaceutical Forms Route of Administration Packaging
Danish: Lægemiddelform Indgivelsesvej
English: Talk to your doctor if you are over 65.
Danish: Tal med Deres læge, hvis De er over 65 år.
English: If you miss a dose
Danish: Hvis De glemmer en dosis
English: Date of opening:___________
Danish: Dato for åbning: ___________
English: Date of first authorisation: 8 December 2016
Danish: Dato for første markedsføringstilladelse: 8. december 2016
English: - Risk Management Plan (RMP)
Danish: - Risikostyringsplan (RMP)
English: Get tested for HIV regularly.
Danish: Bliv testet for HIV regelmæssigt.
English: - Reminders for evaluations/counselling at the initial visit and follow-up.
Danish: - Påmindelser om evaluering/rådgivning ved det indledende besøg og ved opfølgning.
English: - The other ingredients are:
Danish: - Øvrige indholdsstoffer er:
English: Not recommended for use in this population.
Danish: Anbefales ikke til brug i denne population.
English: NC = not calculated.
Danish: IB = ikke beregnet.
English: Always take the dose recommended by your doctor.
Danish: Tag altid den dosis, Deres læge har anbefalet.
English: → Tell your doctor if you are taking any of these medicines.
Danish: → Fortæl Deres læge, hvis De tager nogen af disse lægemidler.
English: - Reminders on what the individual should know before and while taking
Danish: - Påmindelse om, hvad den pågældende skal vide før og under indtagelse af
English: Subjects were followed for 4,237 personyears.
Danish: Forsøgspersonerne blev fulgt i 4.237 personår.
English: - Additional risk minimisation measures
Danish: - Yderligere risikominimerende foranstaltninger