natgillin/translations-raw huggingface dataset:
• Børn og voksne i behandling med Inflectra kan have en øget risiko for at udvikle lymfom eller anden form for kræft.
• Children and adults taking Inflectra may have an increased risk of developing lymphoma or another cancer.
a Uge 98 data for IMPACT inkluderer kombineret placebo cross-over og infliximab-patienter, der deltog i den åbne undersøgelse.
a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension.
Samtidig brug af stabile doser af konventionel behandling var tilladt, og 92% af patienterne fortsatte brugen af disse behandlinger.
Concurrent use of stable doses of conventional therapies was permitted, and 92% of patients continued to receive these therapies.
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.
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.
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.
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.
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.
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.
Aktuelle data tyder ikke på, at infliximab-behandling påvirker risikoen for at udvikle dysplasi eller coloncarcinom.
Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer.
Ved den sidste vurdering var 57% af infliximab-behandlede patienter fortsat anti-dsDNA positive.
At the last evaluation, 57% of infliximab-treated patients remained anti-dsDNA positive.
• Fortæl din læge, hvis du tidligere har været i behandling med lægemidler, der indeholder infliximab og nu starter behandling med Inflectra igen.
• Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Inflectra treatment again.
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.
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 .
Patienter, der får seponeret immunsuppressiva før eller under infliximab-behandling, har større risiko for at udvikle disse antistoffer.
Patients who discontinue immunosuppressants prior to or during infliximab treatment are at greater risk of developing these antibodies.
Median opfølgningsperioden var 0,8 år (incidens 5,7% [95% CI 2,65%-10,6%].
The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%].
• Fortæl din læge, hvis du har hepatitis B, eller hvis du ved eller har mistanke om, at du er bærer af hepatitis B virus.
• Tell your doctor if you have hepatitis B or if you know or suspect you are a carrier of the hepatitis B virus.
Under Inflectrabehandling bør anden samtidig behandling såsom kortikosteroider og immunsuppressiva optimeres.
During Inflectra treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
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.
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.
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:
If these medicines do not work well enough, you will be given Inflectra which you will take with another medicine called methotrexate to:
Det skal du vide, før du begynder at bruge Inflectra
What you need to know before you use Inflectra
Patienter skal følges tæt for infektioner, inklusive tuberkulose før, under og efter behandling med infliximab.
Patients must be monitored closely for infections including tuberculosis before, during and after treatment with infliximab.
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.
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.
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
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
Derudover er knoglebrud (6,8%) rapporteret.
In addition, bone fracture (6.8%) was reported, however, a causal association has not been established.
For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts handelsnavn og batchnumrer tydeligt registreres.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Alle patienterne skulle være på en stabil dosis af 6-MP, AZA eller MTX (35% fik også kortiokosteroid ved baseline).
All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
• 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.
• 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.
Infusionsvæsken skal administreres over en periode på ikke mindre end den anbefalede infusionstid (se pkt.
The infusion solution has to be administered over a period of not less than the infusion time recommended (see section 3).
For yderligere information henvises til afsnittet om Graviditet, amning og frugtbarhed.
For more information see section on Pregnancy and breast-feeding.
• Fortæl kirurgen eller tandlægen, at du er i behandling med Inflectra ved at vise dem dit patientinformationskort.
• Tell your surgeon or dentist that you are having treatment with Inflectra by showing them your patient reminder card.
Infliximab bør anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/II).
Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II).
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%.
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%.
≥ 90% forbedring ≥ 75% forbedring ≥ 50% forbedring
N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
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.
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.
Inflectra skal anvendes sammen med methotrexat.
Inflectra must be given concomitantly with methotrexate.
I 102. uge var 49 patienter stadig på infliximab-behandling, og blandt disse var 30 (61%) BASDAI 50 responderende.
102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
Ved baseline fik 27,4% af patienterne systemiske kortikosteroider, 14,2% af patienterne fik budesonid, og 54,3% af patienterne fik 5-ASA-stoffer.
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.
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.
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.
• 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).
• 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).
Du skal bede din læge om at notere type og dato for din seneste screening(er) for TB på kortet
Ask your doctor to record the type and date of your last screening(s) for TB on the card.
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.
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).
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.
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.
Været i behandling med lægemidler, der indeholder infliximab tidligere
Had treatment with any medicine containing infliximab before
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.
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.
Det anbefales, at patienterne, om muligt, bringes up to date med alle vaccinationer i overensstemmelse med gældende vaccinationsvejledninger før initiering af behandling med Inflectra.
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.
Patienter kan forbehandles med for eksempel et antihistamin, hydrocortison og/eller paracetamol, for at forebygge lette og forbigående reaktioner.
Patients may be pre-treated with e.g. an antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects.
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.
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.
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.
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.
Det påkrævede volumen af rekonstitueret Inflectra-opløsning tilføjes langsomt til 250 ml infusionsflasken eller -posen og blandes forsigtigt.
The required volume of reconstituted Inflectra solution should slowly be added to the 250-mL infusion bottle or bag and gently be mixed.
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.
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.
SPIRIT vurderede virkningen af infliximab induktionsbehandling hos 249 patienter med plaque psoriasis, som tidligere havde fået PUVA eller systemisk behandling.
SPIRIT evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy.
*Infliximab er et kimærisk monoklonalt humant-murint IgG1-antistof fremstillet i murine hybridomaceller ved rekombinant DNA-teknologi.
* Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Tabel 7 Virkninger på responshastighed, data fra ACCENT II (uge-14 responderende)
Table 7 Effects on response rate, data from ACCENT II (Week-14 responders) ACCENT II (Week-14 responders)
Median tiden til der registreredes en virkning i gruppen behandlet med infliximab var 2 uger.
The median time to onset of response in the infliximab-treated group was 2 weeks.
Du må kun få Inflectra under graviditeten, hvis lægen finder det nødvendigt.
Inflectra should only be used during pregnancy if your doctor feels it is necessary for you.
Tabel 8 Virkninger på klinisk respons, klinisk remission og slimhindeheling i uge 8 og 30.
Table 8 Effects on clinical response, clinical remission and mucosal healing at Weeks 8 and 30.
I C0168T72 var de almindeligste bivirkninger øvre luftvejsinfektion, faryngitis, abdominalsmerter, feber og hovedpine.
In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever,
Opløsningen bør være farveløs til lysegul og opaliserende.
The solution should be colourless to light yellow and opalescent.
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.
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.
Hvis du er i tvivl, så tal med din læge, før du får Inflectra.
If you are not sure, talk to your doctor before you are given Inflectra.
• Hvis du fik Inflectra under graviditeten, kan dit barn have en øget risiko for at få en infektion.
• If you received Inflectra during your pregnancy, your baby may have a higher risk for getting an infection.
Du har en højere risiko, hvis Du er 65 år eller derover.
If you are 65 years of age or older, you have a greater risk.
Tabel 10 Resumé af PASI respons, PGA-respons og andel patienter, hvis negle alle var fri for psoriasis i uge 10, 24 og 50.
Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50.
Af de patienter, som ikke fik en infusionsreaktion under induktionsfasen, fik 9% en infusionsreaktion under vedligeholdelsesfasen.
Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period.
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.
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.
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.
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.
TNF-alfa er involveret i kroppens betændelsesprocesser, og blokering af proteinet kan herved mindske betændelsen i din krop.
TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
• Hvis du har fået Inflectra, mens du var gravid, er det vigtigt, at du informerer dit barns læge om det, før dit barn bliver vaccineret.
• In case you have received Inflectra while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Lymfom, non-Hodgkins lymfom, Hodgkins sygdom, leukæmi, melanom.
Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
• Det er meget vigtigt, at du fortæller du læge, hvis du nogensinde har haft TB, eller hvis du har været i tæt kontakt med en person, som har eller har haft TB.
• It is very important that you tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.
> 54 uger
>54 weeks
Der var en rapporteret malign sygdom blandt 77 kontrolpatienter (median opfølgningsperiode 0,8 år; incidens 1.3% [95% CI 0,03%-7,0%]).
There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]).
Behandling med infliximab bør seponeres, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling bør initieres, indtil infektionen er under kontrol.
Administration of infliximab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Inflectra er indiceret til behandling af aktiv og progressiv psoriasis arthritis hos voksne patienter, hvor respons på tidligere DMARD-behandling har været utilstrækkelig.
Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Næsten alle patienterne havde fået behandling med AZA eller 6-MP, samtidig med eller umiddelbart før TNF-blokerende midler.
Almost all patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to a TNF-blocker.
Anden anvendelse af terapeutiske smitstoffer såsom levende svækkede bakterier (f.eks. instillation af BCG i blæren ved behandling af cancer) kan medføre kliniske infektioner herunder disseminerede infektioner.
Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g. BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Dette patientinformationskort indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Inflectra.
This patient reminder card contains important safety information that you need to be aware of before and during treatment with Inflectra.
I et uddybende klinisk studie omfattende patienter, som havde moderat til svær KOL og var enten nuværende eller tidligere rygere, var 157 voksne patienter behandlet med infliximab i doser svarende til dem, der anvendes ved reumatoid arthritis og Crohns sygdom.
In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Der blev rapporteret om infektioner hos 31 (51,7%) af 60 behandlede patienter i C0168T72, og 22 (36,7%) krævede oral eller parenteral antimikrobiel behandling.
Infections were reported in 31 (51.7%) of 60 treated patients in C0168T72 and 22 (36.7%) required oral or parenteral antimicrobial treatment.
På basis af et observationsstudie fra Nordeuropa blev der observeret øget risiko (OR, 95% CI; pværdi) for kejsersnit (1,50; 1,14-1,96; p = 0,0032), for tidligt fødte børn (1,48; 1,05-2,09; p = 0,024), børn født små i forhold til gestationsalder (2,79; 1,54-5,04; p = 0,0007) og lav fødselsvægt (2,03; 1,41-2,94; p = 0,0002) hos kvinder, som blev eksponeret for infliximab under graviditeten (med eller uden immunmodulatorer/kortikosteroider, 270 graviditeter) sammenlignet med kvinder, som udelukkende blev eksponeret for immunmodulatorer/kortikosteroider (6.460 graviditeter).
Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Patienter med ACR20 respons /Patienter evalueret (%)
Patients with ACR20 response/Patients evaluated (%) Total score d
Inflectra påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
Inflectra may have a minor influence on the ability to drive and use machines.
Hos patienter behandlet med infliximab bør en invasiv svampeinfektion såsom aspergillose, candidiasis, pneumocystose, histoplasmose, kokcidioidomykose eller blastomykose mistænkes, hvis en alvorlig systemisk sygdom udvikles, og en læge med ekspertise i diagnosticering og behandling af invasive svampeinfektioner bør konsulteres på et tidligt stadie, når disse patienter undersøges.
In patients treated with infliximab, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
• Leverproblem, der giver gulfarvning af hud eller øjne (gulsot)
• Liver problem that causes yellowing of the skin or eyes (jaundice)
I uge 16 blev 47 placebopatienter med < 10% forbedring fra udgangspunktet i både hævede og ømme led flyttet til infliximab induktion (tidlig overflytning).
At week 16, 47 placebo patients with < 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
• Alvorlige allergiske reaktioner (f.eks. anafylaktisk shock), en sygdom i immunsystemet kaldet lupus, allergiske reaktioner over for fremmede proteiner
• Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins