natgillin/translations-raw huggingface dataset:
Monobasisk natriumphosphatmonohydrat Dibasisk natriumphosphatheptahydrat 
Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate
Juvenil idiopatisk arthritis, psoriasis arthritis og ankyloserende spondylitis Infliximabs sikkerhed og virkning hos børn og unge under 18 år for indikationerne juvenil idiopatisk arthritis, psoriasis arthritis og ankyloserende spondylitis er ikke klarlagt. 
Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Der bør udvises forsigtighed, når brug af Flixabi overvejes hos patienter med kronisk infektion eller med en sygdomshistorie med tilbagevendende infektioner, inklusive samtidig behandling med immunsuppressive lægemidler. 
Caution should be exercised when considering the use of Flixabi in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Fortyndingen kan opnås ved at udtrække et volumen af natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning, fra 250 ml glasflasken eller infusionsposen svarende til voluminet af den rekonstituerede Flixabi-opløsning. 
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 Flixabi.
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 Flixabibehandling overvejes omhyggeligt, før Flixabibehandling initieres. 
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 Flixabi treatment should be carefully considered before initiation of Flixabi therapy.
Infusionsrelaterede reaktioner efter fornyet indgift af infliximab Der var designet et klinisk studie med patienter med moderat til svær psoriasis for at undersøge effekt og sikkerhed af langtidsvedligeholdelsesbehandling i forhold til fornyet indgift med et induktionsregimen med infliximab (højst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom. 
Infusion reactions following re-administration of infliximab 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.
Eksisterende resultater støtter ikke fortsat Flixabi-behandling hos patienter, der ikke responderer inden for 6 uger efter den første infusion. 
Available data do not support further Flixabi treatment, in patients not responding within 6 weeks of the initial infusion.
Begrænset erfaring fra fornyet indgift med en enkelt infliximab dosis ved psoriasis efter et interval på 20 uger tyder på nedsat effekt og en højere incidens af lette til moderate infusionsreaktioner sammenlignet med det initiale induktionsregimen (se pkt. 
Limited experience from re-treatment with one single infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Beregn dosis og det nødvendige antal Flixabi-hætteglas. 
Calculate the dose and the number of Flixabi vials needed.
Af de infliximab- behandlede patienter, som fik en infusionsreaktion under induktionsfasen til og med uge 6, fik 27 % en infusionsreaktion i vedligeholdelsesfasen uge 7 til og med uge 54. 
Of infliximab-treated patients who had an infusion reaction during the induction period, through week 6, 27% experienced an infusion reaction during the maintenance period, week 7 through week 54.
Hepatitis, hepatocellulær skade, kolecystitis. 
Hepatitis, hepatocellular damage, cholecystitis.
Myokardieiskæmi/myokardieinfarkt. 
Myocardial ischaemia/myocardial infarction.
Ved psoriasis arthritis reducerede korttidsbehandling med infliximab antallet af T-celler og blodkar i synovium og hud med psoriasis. 
In psoriatic arthritis, short term treatment with infliximab reduced the number of T-cells and blood vessels in the synovium and psoriatic skin.
Patienter i begge studier havde plaque psoriasis (Body Surface Area [BSA] ≥ 10 % og 
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
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 kke påvirkede det T-celle uafhængige humorale immunrespons. 
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.
Amnesi, uro, forvirring, søvnighed, nervøsitet. 
Amnesia, agitation, confusion, somnolence, nervousness.
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). 
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).
Klinisk remission i uge 30a 
Clinical remission at week 30
• Mulige tegn på kræft, inklusive men ikke begrænset til hævede lymfeknuder, vægttab, feber, usædvanlige knuder i huden, ændringer i modermærker eller hudfarven eller usædvanlig blødning fra skeden. 
• Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding
Meningitis, opportunistiske infektioner (såsom invasive svampeinfektioner [pneumocystose, histoplasmose, aspergillose, kokcidioidomykose, kryptokokkose, blastomykose], bakterielle infektioner [atypiske mykobakterier, listeria, salmonella] og virale infektioner [cytomegalovirus]), parasitære infektioner, reaktivering af hepatitis B. 
Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
I kliniske studier har forsinkede overfølsomhedsreaktioner været usædvanlige og er forekommet efter infliximab-fri perioder på mindre end 1 år. 
In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year.
(patienter evalueret) Gennemsnit ± SDc a Kontrol = Alle patienter havde aktiv RA på trods af behandling med stabile methotrexat doser i 6 måneder før inklusion og skulle fortsætte på stabile doser gennem studiet. 
c a control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Flixabi leveres som et hætteglas (glasflaske) indeholdende et pulver til koncentrat til infusionsvæske, opløsning. 
Flixabi is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Hvis opløsningen er klargjort under aseptiske betingelser, kan den dog opbevares i køleskab ved 2 °C - 8 °C i 24 timer. 
However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2°C to 8°C for 24 hours.
• Børn skal have de anbefalede vaccinationer, før behandling med Flixabi påbegyndes. 
• Children should receive recommended vaccinations before starting Flixabi treatment.
Hvis du har fået Flixabi, mens du var gravid, skal du fortælle dit barns læge og andet sundhedspersonale, der tager sig af dit barn, at du har fået Flixabi, før barnet bliver vaccineret. 
If you were using Flixabi during pregnancy, tell your baby's doctor and other healthcare professionals caring for your baby about your Flixabi use before the baby receives any vaccines.
I et uddybende klinisk studie, der vurderede anvendelsen af infliximab hos patienter med moderat til svær kronisk obstruktiv lungesygdom (COPD), blev der rapporteret flere maligne sygdomme hos patienter behandlet med infliximab sammenlignet med kontrolpatienter. 
In an exploratory clinical study evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximab-treated patients compared with control patients.
• Information om at behandling med Flixabi 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. 
• That treatment with Flixabi 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
De bivirkninger, som børn og unge i behandling med infliximab mod Crohns sygdom fik, var forskellige fra de bivirkninger, som voksne i behandling med infliximab mod Crohns sygdom fik. 
Children and adolescents who took infliximab for Crohn's disease showed some differences in side effects compared with adults who took infliximab for Crohn's disease.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet, som indeholder infliximab, i alle undergrupper af den pædiatriske population med reumatoid arthritis, juvenil idiopatisk arthritis, psoriasis arthritis, ankyloserende spondylitis, psoriasis og Crohns sygdom (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Unormale hudåbninger • Fortæl din læge, hvis du har nogen unormale hudåbninger (fistler), før du får Flixabi. 
Abnormal skin openings • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Flixabi.
Blandt patienter i infliximabgruppen 5 mg/kg, der krydsede over på grund af tab af fistula respons efter uge 22, responderede 57 % (12/21) på genbehandling med infliximab 10 mg/kg hver 8. uge. 
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.
Børn kan få visse vacciner under behandlingen med Flixabi, men må ikke få levende vacciner, 
Children may receive some vaccines during treatment with Flixabi but should not receive live vaccines while using Flixabi.
Bland forsigtigt opløsningen ved at slynge hætteglasset rundt for at opløse det lyofiliserede pulver. 
Gently swirl the solution by rotating the vial to dissolve the lyophilised powder.
• Fortæl din læge, før du får Flixabi, hvis du er bærer af hepatitis B, eller hvis du nogensinde har haft det. 
• Tell your doctor before you are given Flixabi if you are a carrier of hepatitis B or have ever had it.
• Nogle patienter, der får infliximab, har udviklet alvorlige leverproblemer. 
• Some patients receiving infliximab have developed serious liver problems.
Det er blevet påvist, at infliximab fremmer fysisk funktion hos patienter med psoriasis arthritis samt reducerer udviklingshastigheden af perifere ledskader målt med røntgen hos patienter med polyartikulære symmetriske undertyper af sygdommen (se pkt. 
Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1).
Der er set tilfælde af aktiv tuberkulose hos patienter behandlet med infliximab. 
There have been reports of active tuberculosis in patients receiving infliximab.
I SPIRIT var andelen af patienter, der opnåede PASI 75 i uge 10 71,7 % i 3 mg/kg infliximab- gruppen, 87,9 % i 5 mg/kg infliximab-gruppen og 5,9 % i placebogruppen (p < 0,001). 
In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p < 0.001).
Flixabi kan opbevares ved temperaturer på maksimalt 25 °C i en enkelt periode på op til 6 måneder, som ikke overskrider den oprindelige udløbsdato. 
Flixabi may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date.
• hvis du er allergisk over for infliximab (det aktive indholdsstof i Flixabi) eller et af de øvrige indholdsstoffer i Flixabi (angivet i punkt 6), 
• You are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6).
Antallet af patienter i hver undergruppe er for lille til at drage definitive konklusioner om alderens indflydelse på bivirkninger, men der var en større andel af patienter med alvorlige bivirkninger og patienter, som stoppede behandlingen på grund af bivirkninger, i den yngre aldersgruppe end i den ældre aldersgruppe. 
While the numbers of patients in each subgroup are too small to make any definitive conclusions about the effect of age on safety events, there were higher proportions of patients with serious adverse events and discontinuation due to adverse events in the younger age group than in the older age group.
Sikkerhed og effekt ved infliximab blev vurderet i to (ACT 1 og ACT 2) randomiserede, dobbeltblinde, placebokontrollerede kliniske studier hos voksne patienter med moderat til svær, aktiv colitis ulcerosa (Mayo-score 6 til 12; Endoskopi subscore ≥ 2) med et utilstrækkeligt respons på konventionel behandling [orale kortikosteroider, aminosalicylater og/eller immunmodulatorer (6-MP, AZA)]. 
The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Flixabi er indiceret til behandling af svær, aktiv ankyloserende spondylitis hos voksne patienter, som har responderet utilstrækkeligt på konventionel behandling. 
Flixabi is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
• behandling af fistulerende, aktiv Crohns sygdom hos voksne patienter, som ikke har responderet på trods af en fuldstændig og adækvat behandlingsperiode med konventionel behandling (inklusive antibiotika, drænage og immunsuppressiv behandling). 
 treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Tabel 3 Virkninger på ACR20, strukturel ledskade og fysisk funktionsevne ved uge 54, ATTRACT infliximab b 
Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT
I et 6-måneders flerdosis toksicitetsstudie hos mus, ved brug af det samme analoge antistof mod muse TNFα, sås krystalaflejringer på linsekapslerne hos nogle af de behandlede hanmus. 
In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNFα, crystalline deposits were observed on the lens capsule of some of the treated male mice.
Det skal du vide, før du begynder at bruge Flixabi 
What you need to know before you use Flixabi
• hvis du er allergisk over for proteiner, som stammer fra mus, 
• You are allergic (hypersensitive) to proteins that come from mice.
Transversel myelitis, demyeliniseringsforstyrrelser i centralnervesystemet (dissemineret sklerose-lignende sygdom og optisk neuritis), perifere demyeliniseringsforstyrrelser (såsom Guillain-Barré syndrom, kronisk inflammatorisk demyeliniserende polyneuropati og multifokal motorisk neuropati). 
Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy).
Lægen kan tilråde, at kvinder, der får infliximab, herunder kvinder over 60 år, bliver regelmæssigt screenet for livmoderhalskræft. 
For women taking infliximab including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Patienterne fik 3 eller 6 mg/kg infliximab som et induktionsregimen med 3 doser (hhv. uge 0, 2, 6 eller uge 14, 16, 20) fulgt af vedligeholdelsesbehandling hver 8. uge i kombination med methotrexat. 
Patients received 3 or 6 mg/kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20, respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Alle patienter skal informeres om at søge læge, hvis sygdomstegn/symptomer, der tyder på tuberkulose (fx vedvarende hoste, skranten/vægttab, let feber), forekommer under eller efter Flixabibehandling. 
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after Flixabi treatment.
I begge studier var samtidig brug af konstante doser af folinsyre, orale kortikosteroider (≤ 10 mg/dag) og/eller nonsteroide anti-inflammatoriske stoffer (NSAIDs) tilladt. 
In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted.
Der er ikke gennemført biokemiske forligelighedsstudier for at vurdere samtidig indgivelse af Flixabi med andre midler. 
No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Flixabi with other agents.
I kliniske studier af reumatoid arthritis var hyppigheden af alvorlige infektioner højere hos infliximabplus methotrexatbehandlede patienter på 65 år og derover (11,3 %) sammenlignet med patienter under 65 år (4,6 %). 
In rheumatoid arthritis clinical studies, the incidence of serious infections was greater in infliximab plus methotrexate-treated patients 65 years and older (11.3%) than in those under 65 years of age (4.6%).
Hvis disse lægemidler ikke virker godt nok, vil du få Flixabi for at: 
If these medicines do not work well enough, you will be given Flixabi to:
Trombocytopeni, lymfopeni, lymfocytose. 
Thrombocytopenia, lymphopenia, lymphocytosis.
Dato for start af Flixabi-behandling: 
Date of Flixabi therapy initiation:
Efter markedsføring er der rapporteret maligniteter, hvoraf nogle har været letale, hos børn, unge og unge voksne (op til 22 år), som er behandlet med TNF-blokkere inklusive infliximab (behandlingsstart før 18-års alderen). 
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including infliximab in the post-marketing setting.
Tumor nekrose faktor alfa (TNFα) frembringer betændelse og modulerer cellulært immunrespons. 
Tumour necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune responses.
Der er begrænset erfaring med sikkerheden af infliximab-behandling hos patienter, som har gennemgået kirurgiske indgreb inklusive atroplastik. 
There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty.
Uge 50 
Week 50
Hos patienter med allerede eksisterende eller nyligt opståede demyeliniseringssygdomme skal vurdering af forventet gavn og risiko ved anti-TNF-behandlingen overvejes omhyggeligt før initiering af behandling med Flixabi. 
In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of Flixabi therapy.
Ved aktiv tuberkulose, må Flixabibehandling ikke påbegyndes (se pkt. 
If active tuberculosis is diagnosed, Flixabi therapy must not be initiated (see section 4.3).
Effekt og sikkerhed blev vurderet i to dobbeltblinde, placebokontrollerede multicenterstudier hos patienter med aktiv psoriasis arthritis. 
Efficacy and safety were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
I et toksicitetsstudie vedrørende udvikling udført på mus ved brug af et analogt antistof, der selektivt hæmmer den funktionelle aktivitet af muse TNFα, var der ingen tegn på maternal toksicitet, embryotoksicitet eller teratogenicitet. 
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.
De alvorligste bivirkninger forbundet med brugen af TNF-blokkere, som er blevet rapporteret for infliximab, inkluderer HBV-reaktivering, CHF (kongestivt hjertesvigt), alvorlige infektioner (inklusive sepsis, opportunistiske infektioner og TB), serumsygdom (forsinkede overfølsomhedsreaktioner), hæmatologiske reaktioner, systemisk lupus erythematosus/lupus-lignende syndrom, demyeliniserende sygdomme, hepatobiliære bivirkninger, lymfomer, HSTCL, leukæmi, Merkelcellekarcinom, melanom, pædiatrisk malignitet, sarkoidose/sarkoid-lignende reaktion, byld i tarmen eller ved endetarmen (ved Crohns sygdom) og alvorlige infusionsreaktioner (se pkt. 
The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Samtidig administration af levende vacciner og Flixabi frarådes. 
The concurrent administration of live vaccines with Flixabi is not recommended.
• Fortæl din læge, før du får Flixabi, hvis du har en lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL, rygerlunger), eller hvis du er storryger. 
• Tell your doctor before you are given Flixabi if you have a lung disease called Chronic Obstructive Pulmonary Disease (COPD) or if you are a heavy smoker.
Gastrointestinal blødning, diarré, dyspepsi, gastroøsofageal refluks, forstoppelse. 
Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
• Hvis din læge tror, at du har risiko for at få TB, kan du blive behandlet med lægemidler mod TB, 
• If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Flixabi.