natgillin/translations-raw huggingface dataset:
I et toksicitetsstudie vedrørende udvikling udført på mus med et analogt antistof, som selektivt hæmmer den funktionelle aktivitet af muse- TNFα, var der ingen tegn på maternal toksicitet, embryotoksicitet eller teratogenicitet (se pkt.
In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity (see section 5.3).
Neutropeni, leukopeni, anæmi, lymfadenopati.
Neutropenia, leucopenia, anaemia, lymphadenopathy.
Infliximabvedligeholdelse 5 mg/kg (n = 113) (p-værdi)
Infliximab Maintenance 5 mg/kg (n=113) (p value)
Under overvågning efter markedsføring er der rapporteret tilfælde af gulsot og hepatitis, nogle med tegn på autoimmun hepatitis, hos patienter, der fik infliximab (se pkt.
In post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving infliximab (see section 4.4).
Fortynd ikke det rekonstituerede Flixabi-koncentrat med andre infusionsvæsker.
Do not dilute the reconstituted Flixabi solution with any other diluent.
• Hudproblemer såsom blæredannelse, vorter, unormal hudfarve eller pigmentering, eller hævede læber, eller fortykkelse af huden eller rød, skællende hud og afskalning af huden
• Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen lips, or thickening of the skin, or red, scaly and flaky skin
De patienter, som af investigator blev vurderet til at have et klinisk respons i uge 10, blev randomiseret og fik 5 mg/kg infliximab enten hver 8. eller hver 12. uge som et vedligeholdelsesbehandlingsregimen.
Patients assessed by the investigator to be in clinical response at week 10 were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Klinisk responsa Klinisk remission
Clinical Remission
(p < 0,001)* * P-værdier repræsenterer hver infliximab-behandlingsgruppe vs. AZA monoterapi.
* P-values represent each infliximab treatment group vs. AZA monotherapy
Infliximabvedligeholdelse 10 mg/kg (n = 112) (p-værdi)
Infliximab Maintenance 10 mg/kg (n=112) (p value)
Unormal leverfunktion, forhøjede leveraminotransferaser.
Hepatic function abnormal, transaminases increased.
Der er rapporteret om enkelte tilfælde af aktiv tuberkulose under og efter behandling for latent tuberkulose hos patienter i behandling med Flixabi.
Some cases of active tuberculosis have been reported in patients treated with Flixabi during and after treatment for latent tuberculosis.
• Lungehindebetændelse, der giver skarpe smerter, som forværres ved vejrtrækning (pleuritis)
• Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing (pleurisy)
Infliximabs sikkerhed og virkning hos børn og unge under 18 år for indikationen juvenil reumatoid arthritis er ikke klarlagt.
The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established.
Spontane alvorlige bivirkninger hos børn efter markedsføring af infliximab inkluderer maligniteter inklusive hepatosplenisk T-celle-lymfom, forbigående leverenzymabnormaliteter, lupus lignende syndromer og positive autoantistoffer (se pkt.
Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
• Tegn på en sygdom i immunsystemet såsom ledsmerter, udslæt på kinderne eller arme, som er følsomme over for solen (lupus) eller hoste, åndenød, feber eller hududslæt (sarkoidose)
• Signs of an immune system disorder such as joint pain or a rash on cheeks or arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash (sarcoidosis)
De mest almindeligt rapporterede infektioner var øvre luftvejsinfektioner og faryngitis.
The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess.
Andelen af patienter med slimhindeheling i uge 26 var signifikant større i grupperne, der fik infliximab plus AZA (43,9 %; p < 0,001) eller infliximab-monoterapi (30,1 %; p = 0,023) sammenlignet med AZAmonoterapigruppen (16,5 %).
The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p < 0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Antallet af hospitalsindlæggelser relateret til colitis ulcerosa var signifikant lavere i 5 og 10 mg/kg infliximab-behandlingsgrupperne end i placebogruppen (gennemsnitligt antal hospitalsindlæggelser per 100 forsøgsperson-år: 21 og 19 versus 40 i placebogruppen; hhv. p = 0,019 og p = 0,007).
The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p=0.019 and p=0.007, respectively).
Infliximabs sikkerhed og virkning hos børn og unge under 18 år for indikationen psoriasis er ikke klarlagt.
The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of psoriasis have not been established.
Der er set tilfælde af kortvarigt synstab under infusion eller inden for 2 timer efter infusion af infliximab.
Cases of transient visual loss occurring during or within 2 hours of infliximab infusion have been reported.
Hvis du er i tvivl, om noget af ovenstående passer på dig, skal du kontakte lægen eller apotekspersonalet, før du får Flixabi.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Flixabi.
Der blev observeret alvorlige infektioner og neutropeni i kliniske studier ved samtidig anvendelse af anakinra og et andet TNFα -blokerende middel, etanercept, uden nogen øget klinisk fordel sammenlignet med etanercept indgivet alene.
Concurrent administration of TNF-alpha inhibitor and anakinra Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNFα-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
• Fortæl din læge, før du får Flixabi, hvis du har en infektion, også selvom det er en meget let infektion.
Infections • Tell your doctor before you are given Flixabi if you have an infection even if it is a very minor one.
Antallet af kirurgiske indgreb relateret til colitis ulcerosa var også lavere i 5 og 10 mg/kg infliximab-behandlingsgrupperne end i placebogruppen (gennemsnitligt antal kirurgiske indgreb per 100 forsøgsperson-år: 22 og 19 versus 34; hhv. p = 0,145 og p = 0,022).
The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs. 34; p=0.145 and p=0.022, respectively).
• Tegn på hjerteproblemer såsom ubehag i brystkassen eller brystsmerter, armsmerter, mavesmerter, åndenød, angst, ørhed, svimmelhed, besvimelse, svedtendens, kvalme, (utilpashed) opkastning, flakkende hjerte eller trykken i brystet, et hurtigt eller langsomt hjerteslag og hævelse af dine fødder.
• Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick), vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet.
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 eller unge voksne mænd.
The vast majority of infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and most were reported in adolescent or young adult males.
Graviditet, amning og frugtbarhed
Pregnancy and breast-feeding, and fertility
• Tegn på infektion (inklusive tuberkulose (TB)) såsom feber, træthedsfølelse, hoste, der kan være vedvarende, åndenød, influenzalignende symptomer, vægttab, natlig svedtendens, diarré, sår, ansamling af pus i tarmen eller omkring anus (absces), tandproblemer eller brændende smerte, når du lader vandet
• Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating
Hjælpestoffer: Saccharose, polysorbat 80, monobasisk natriumphosphatmonohydrat og dibasisk natriumphosphatheptahydrat.
Excipients: sucrose, polysorbate 80, monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate.
Debuterende eller forværring af allerede eksisterende psoriasis, inklusive pustuløs psoriasis (primært palmoplantaris), urticaria, udslæt, pruritus, øget svedtendens, tør hud, svampedermatitis, eksem, alopeci.
New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis,
Klinisk remission og slimhindeheling forekom i en større andel af patienterne i den kombinerede infliximabbehandlingsgruppe sammenlignet med placebobehandlingsgruppen i uge 54 (henholdsvis 34,6 % mod 16,5 %, p < 0,001 og 46,1 % mod 18,2 %, p < 0,001).
Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p < 0.001 and 46.1% vs. 18.2%, p < 0.001, respectively).
Der er rapporteret om melanom og Merkelcellekarcinom hos patienter, der har fået TNF-blokerende behandling, herunder infliximab (se pkt.
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab (see section 4.8).
Fortæl straks din læge, hvis du får nye eller forværrede tegn på hjertesvigt under behandlingen med Flixabi.
Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Flixabi.
Perifer iskæmi, tromboflebitis, hæmatom.
Peripheral ischaemia, thrombophlebitis, haematoma.
Opløsningen må ikke anvendes, hvis det indeholder uigennemsigtige partikler, er misfarvet eller indeholder andre fremmedlegemer.
Do not use if opaque particles, discolouration, or other foreign particles are present.
Ved uge 8 blev 45 patienter randomiseret og fik 5 mg/kg infliximab enten hver 8. eller hver 12. uge som et vedligholdelsesregimen.
At week 8, 45 patients were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Det skal du vide, før du begynder at bruge Flixabi Sådan skal du bruge Flixabi Bivirkninger
What Flixabi is and what it is used for What you need to know before you use Flixabi How Flixabi will be given Possible side effects
Du må ikke få Flixabi og Orencia samtidig.
Flixabi and Orencia should not be used together.
Alle infliximab b
All infliximab b
Hvis en patient ikke viser respons efter 14 uger (det vil sige efter 4 doser), bør der ikke gives yderligere behandling med Flixabi.
If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment with Flixabi should be given.
Cyanose, perikardieeffusion.
Cyanosis, pericardial effusion.
Kredsløbssvigt, petekkier, vasospasme.
Circulatory failure, petechia, vasospasm.
Patienter i gruppe 2, som havde en BASDAI ≥ 3 ved 2 på hinanden følgende konsultationer, fik 7,5 mg/kg infliximab hver 6. uge startende med uge 36 og frem til uge 96.
In Group 2, starting with the week 36 infusion, patients who had a BASDAI ≥ 3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
Infliximab med eller uden AZA blev vurderet i et randomiseret, dobbeltblind studie med aktiv komparator (SONIC) hos 508 voksne patienter med moderat til svær Crohns sygdom (CDAI ≥ 220 ≤
Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Infliximabs sikkerhed og virkning hos børn under 6 år med colitis ulcerosa er ikke undersøgt.
The safety and efficacy of infliximab have not been studied in children with ulcerative colitis below the age of 6 years.
I tilfælde heraf må lægemidlet ikke sættes tilbage på køl.
In this situation, do not return to refrigerated storage again.
Almindelig: Vertigo, svimmelhed, hypæstesi, paræstesi.
Vertigo, dizziness, hypoaesthesia, paraesthesia.
• Infektioner i skeden.
• Infections of the vagina.
Der er set pancytopeni, leukopeni, neutropeni og trombocytopeni hos patienter, der fik TNF- hæmmere, herunder infliximab.
There have been reports of pancytopenia, leucopenia, neutropenia, and thrombocytopenia in patients receiving TNF-blockers, including infliximab.
• Fortæl din læge, hvis du har eller nogensinde har haft en lidelse, som påvirker dit nervesystem,
• Tell your doctor if you have or have ever had a problem that affects your nervous system before you are given Flixabi.
Efter infliximab- behandling udviste patienter nedsat niveau af serum interleukin 6 (IL-6) og C-reaktiv protein (CRP).
After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
• Disse infektioner kan være alvorlige og indbefatter tuberkulose, infektioner forårsaget af virus, svampe, bakterier eller andre organismer i miljøet samt blodforgiftning, som kan være livstruende.
• These infections may be serious and include tuberculosis, infections caused by viruses, fungi,
Bivirkninger
IMPACT
Flixabi er indiceret til behandling af moderat til svær, aktiv colitis ulcerosa hos voksne patienter, som har haft utilstrækkelig respons af konventionel behandling inklusive kortikosteroider og 6-mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kliniske kontraindikationer for sådanne behandlinger.
Flixabi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Flixabi er indiceret til behandling af svær, aktiv Crohns sygdom hos børn og unge mellem 6 og 17 år, som ikke har responderet på konventionel behandling inklusive kortikosteroid, immunmodulator og primær ernæringsbehandling, eller som er intolerante over for eller hvor der er kontraindikationer mod sådanne behandlinger.
Flixabi is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
• Medicinenvil blive givet som en infusion (drop) (over 2 timer) i en af dine blodårer (vener),
• The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Flixabi over 1 hour.
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.
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.
Urinvejsinfektion.
Urinary tract infection.
Det anbefales, at pædiatriske patienter bliver vaccineret i overensstemmelse med gældende vaccinationsvejledninger, før Flixabi-behandling påbegyndes, hvis dette er muligt.
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.
Uge 54 Fistula respons (%)a
Complete fistula response (%)
Lungeødem, bronkospasme, pleuritis, pleural effusion.
Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Hvis du er i tvivl, om noget af ovenstående passer på dig, skal du kontakte lægen, før du får Flixabi.
If you are not sure if any of the above applies to you, talk to your doctor before you are given Flixabi.
Nedre luftvejsinfektion (fx bronchitis, pneumoni), dyspnø, næseblod.
Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis.
HÆTTEGLAS-ETIKET
VIAL LABEL
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside.http://www.ema.europa.eu.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Brug af anden medicin sammen med Flixabi
Other medicines and Flixabi
Flixabi 100 mg pulver til koncentrat, opløsning infliximab
Flixabi 100 mg powder for concentrate infliximab
Psoriasis hos voksne Effekten af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblinde studier: SPIRIT og
The efficacy of infliximab was assessed in two multicentre, randomised, double-blind studies: SPIRIT and EXPRESS.
I kliniske studier har forsinkede overfølsomhedsreaktioner været usædvanlige og er forekommet efter infliximab-fri perioder på mindre end 1 år (se pkt.
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).
Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
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.
Tarmperforation, tarmstenose, diverticulitis, pancreatitis, keilitis.
Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis.
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.
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.
Der kan opstå svimmelhed under behandling med Flixabi (se pkt.
Dizziness may occur following administration of Flixabi (see section 4.8).
Levende vacciner bør ikke gives samtidig med Flixabi.
It is recommended that live vaccines not be given concurrently with Flixabi.
• eller alene hos patienter, der udviser intolerance over for methotrexat, eller for hvem methotrexat er kontraindiceret
Flixabi should be administered  in combination with methotrexate  or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Vaskulære sygdomme Almindelig:
Hepatobiliary disorders Common:
Infliximabs effekt og sikkerhed blev undersøgt i to multicenter, dobbeltblinde, placebokontrollerede studier hos patienter med aktiv ankyloserende spondylitis (Bath Ankylosing Spondylitis Disease
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).
Tegn inkluderer feber, træthedsfølelse, (vedvarende) hoste, åndenød, vægttab, natlig svedtendens, diarré, sår, tandproblemer, en brændende smerte, når du lader vandet, eller influenzalignende symptomer.
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.
Flixabi 100 mg pulver til koncentrat til infusionsvæske, opløsning infliximab
Flixabi 100 mg powder for concentrate for solution for infusion infliximab
Hvis en patient ikke responderer efter 3 doser, bør der ikke gives yderligere behandling med Flixabi.
If a patient does not respond after 3 doses, no additional treatment with Flixabi should be given.
Leversvigt.
Headache.
Der bør ikke indgives levende vacciner (fx BCG-vaccine) til spædbørn, eksponeret for infliximab i uterus, i mindst 6 måneder efter fødslen (se pkt.
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).
Median tid til tab af respons efter uge 54
Median time to loss of response through
Pyelonefritis.
Pyelonephritis.
Brystsmerte, træthed, feber, reaktioner på injektionsstedet, kulderystelser, ødem.
Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Flixabi, i kombination med methotrexat, er indiceret til reduktion af sygdomstegn og symptomer samt forbedring af fysisk funktionsevne hos:
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
Forringet heling.
Impaired healing.
Flixabi 100 mg pulver til koncentrat til infusionsvæske, opløsning.
Flixabi 100 mg powder for concentrate for solution for infusion.
Hvis en patient ikke responderer ved uge 6 (det vil sige efter 2 doser), bør der ikke gives yderligere behandling med Flixabi.
If a patient does not respond by 6 weeks (i.e. after 2 doses), no additional treatment with Flixabi should be given.
De patienter, der fik kortikosteroider ved baseline, fik ikke kortikosteroider i de 3 måneder forud for uge 54.
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.
4.4 og 4.8 for mere information omkring sikkerhed ved brug af infliximab hos ældre patienter.
For more information about the safety of infliximab in elderly patients (see sections 4.4 and 4.8).
Hos børn og unge kan endvidere ses følgende bivirkninger:
Additional side effects in children and adolescents
Følgende bivirkninger forekom hyppigere hos børn: nedsat antal røde blodlegemer (anæmi), blod i afføringen, nedsat samlet indhold af hvide blodlegemer (leukopeni), anfaldsvis ansigtsrødme,
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.
Tabel 1 Bivirkninger i kliniske studier og efter markedsføring Infektioner og parasitære sygdomme Meget almindelig: Virusinfektion (fx influenza, herpes virus infektioner).
Table 1 Undesirable effects in clinical studies and from post-marketing experience Infections and infestations Very Common: