natgillin/translations-raw huggingface dataset:
Vedblivende steroidfri remission a Reduktion i CDAI ≥ 25% og ≥ 70 point.
Sustained Steroid-Free Remission b a Reduction in CDAI ≥ 25% and ≥ 70 points.
Yderligere doser
Further doses
b Baseret på patienter med PASI > 2.5 ved baseline for IMPACT, og patienter med > 3% BSA psoriasis hud påvirkning ved baseline af IMPACT 2.
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.
• Lægen vil bestemme din dosis, og hvor ofte du skal have Inflectra.
• The doctor will decide your dose and how often you will be given Inflectra.
• Din læge skal teste dig for hepatitis B-virus.
• Your doctor should test you for hepatitis B virus.
Tidligere behandling med PUVA, methotrexat, ciclosporin eller acitretin var modtaget af 71,4% af patienterne, selv om de ikke nødvendigvis var behandlingsresistente.
Prior therapy with PUVA, methotrexate, ciclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Patienter i begge studier havde plaque psoriasis (Body Surface Area [BSA] ≥ 10% og Psoriasis Area and Severity Index [PASI] score ≥ 12).
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
Inflectra er et biosimilært lægemiddel.
Inflectra is a biosimilar medicinal product.
Inflectra-infusioner skal administreres af kvalificeret sundhedspersonale, som er trænet i at detektere infusionsrelaterede problemer.
Inflectra infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Inflectra bør administreres
Inflectra should be administered
Du må ikke få Inflectra, hvis noget af ovenstående passer på dig.
Do not use Inflectra if any of the above applies to you.
Inflectra, i kombination med methotrexat, er indiceret til reduktion af sygdomstegn og symptomer samt forbedring af fysisk funktionsevne hos:
Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Før rekonstitution:
Before reconstitution
Rester af den ikke anvendte infusionsopløsning må ikke opbevares til fornyet brug.
Any unused portion of the infusion solution should not be stored for reuse.
Tidlig erkendelse af atypiske kliniske forekomster af alvorlige infektioner og typiske kliniske forekomster af sjældne og usædvanlige infektioner er afgørende for at begrænse forsinkelse i diagnosticering og behandling.
Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment.
Inflectra bruges også til voksne og børn fra 6 år og opefter til behandling af:
Inflectra is also used in adults and children 6 years of age or older for:
Inflectra tilhører en medicingruppe kaldet ”TNF-blokkere”.
Inflectra belongs to a group of medicines called ‘TNF blockers'.
• Hos nogle patienter, som får infliximab, kan kroppen måske ikke lave nok af de blodlegmer, der skal hjælpe med at bekæmpe infektioner eller stoppe blødninger.
• In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Virkningen af infliximab i uge 54 blev undersøgt i ACT 1 studiet.
The efficacy of infliximab through week 54 was assessed in the ACT 1 study.
Infliximab passerer placenta og er blevet sporet i i serum hos spædbørn op til 6 måneder efter fødslen.
Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
placebo infliximab placebo Infliximab placebo infliximab placebo infliximab
placebo inflixim ab placebo inflixim ab placebo inflixim ab placebo inflixim ab
Sikkerhed og virkning ved fornyet administration efter en infliximab-fri periode på over 16 uger er ikke klarlagt.
The safety and efficacy of re-administration after an infliximab-free interval of more than 16 weeks has not been established.
Patienter, der ikke havde responderet på infliximab i uge 8 (n=15) fik ikke yderligere doser og gik tilbage til sikkerhedsopfølgning.
Patients who did not respond to infliximab at week 8 (n=15) received no further medicinal product and returned for safety follow-up.
Der er set stigninger i ALAT ≥ 5 x øvre grænse for normalområdet (ULN) (se tabel 2).
Elevations of ALT ≥5 x Upper Limit of Normal (ULN) have been observed (see Table 2).
Bivirkninger kan også opstå efter ophør af din behandling med Inflectra.
Side effects may also occur after your treatment with Inflectra has stopped.
Der konstateredes en virkning inden for 2 uger med maksimal virkning efter 4 uger.
A response was observed within 2 weeks, with a maximum response at 4 weeks.
17,5% af de randomiserede patienter i REACH oplevede 1 eller flere infusionsreaktioner.
In REACH, 17.5% of randomised patients experienced 1 or more infusion reactions.
Denne indlægsseddel blev senest ændret i {MM/YYYY}.
This leaflet was last revised in {MM/YYYY}.
Det beskedne antal prospektivt indsamlede graviditeter eksponeret for infliximab, som resulterede i levendefødsel med kendte resultater, inklusive ca. 1.100 graviditeter, der blev eksponeret under første trimester, tyder ikke på en stigning i hyppigheden af misdannelser hos den nyfødte.
The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1,100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
START var et randomiseret, multicenter, dobbelblindet, 3-armet, parallel-gruppe sikkerhedsstudie.
START was a randomised, multicentre, double-blind, 3-arm, parallel-group safety study.
46% af patienterne fortsatte på stabile doser methotrexat (≤ 25 mg/uge).
Forty-six percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
Der kendes ikke til nogen bivirkninger efter at have fået for meget Inflectra.
There are no known side effects of having too much of Inflectra.
Kortet fungerer både som en påmindelse om at registrere datoer for og resultater af specifikke test og gør det lettere for patienten at dele særlige oplysninger med de sundhedspersoner, der behandler patienten, om den igangværende behandling med lægemidlet.
The card is aimed at both serving as a reminder to record the dates and outcomes of specific tests and to facilitate the patient sharing of special information with healthcare professionals (HCPs) treating the patient about on-going treatment with the product.
Det påkrævede samlede volumen rekonstitueret Inflectraopløsning beregnes.
The required total volume of reconstituted Inflectra solution has to be calculated.
Infliximab skal administreres intravenøst over en 2-timers periode.
Infliximab should be administered intravenously over a 2 hour period.
Cirka 3% af patienterne afbrød behandlingen på grund af infusionsrelaterede reaktioner, og alle patienter kom sig med eller uden behandling.
Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy.
I alle situationer beskrevet nedenfor bør benefit/risk-balancen af infliximab-behandling vurderes meget nøje.
In all situations described below, the benefit/risk balance of infliximab therapy should be very carefully considered.
Den potentielle risiko ved kombinationen af AZA eller 6-MP og infliximab skal overvejes omhyggeligt.
The potential risk with the combination of AZA or 6-MP and infliximab should be carefully considered.
Foreliggende data tyder på, at det kliniske respons sædvanligvis nås inden for 12 ugers behandling.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Størstedelen af patienterne (67%) behøvede ingen dosisjustering.
The majority (67%) of these patients did not require any dose titration.
5 år ved 2°C - 8°C.
5 years at 2 °C - 8 °C.
• du er allergisk over for infliximab eller et af de øvrige indholdsstoffer i Inflectra (angivet i punkt 6),
• you are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6),
Pakningsstørrelser på 1, 2, 3, 4, 5 hætteglas.
Pack sizes of 1, 2, 3, 4, 5 vials.
** 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.
** PASI 75 response for IMPACT not included due to low N; p<0.001 for infliximab vs. placebo at week 24 for IMPACT 2.
• sænke antallet af unormale åbninger (fistler) mellem din tarm og hud, der ikke har kunnet behandles tilfredsstillende med andre lægemidler eller operation.
• reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery.
I et fertilitets- og generelt reproduktionsfunktionsstudie var antallet af drægtige mus reduceret efter administration af det samme analoge antistof.
In a fertility and general reproductive function study, the number of pregnant mice was reduced following administration of the same analogous antibody.
Da humane immunglobuliner udskilles i mælk, må kvinder ikke amme i mindst 6 måneder efter infliximab-behandling.
Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after infliximab treatment.
Inflectra opbevares af sundhedspersonalet på hospitalet eller klinikken.
Inflectra will generally be stored by the health professionals at the hospital or clinic.
Inflectra bør kun anvendes til børn, hvis de behandles for Crohns sygdom eller colitis ulcerosa.
Inflectra should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Før initiering af behandling med infliximab skal alle patienter vurderes for både aktiv og inaktiv (“latent”) tuberkulose.
Before starting treatment with infliximab, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Den normale dosis er 5 mg for hver kg legemsvægt.
The usual dose is 5 mg for every kg of body weight.
Infusionsrelaterede reaktioner efter fornyet administration af infliximab
Infusion reactions following re-administration of infliximab
Ved spontan rapportering efter markedsføring er infektioner den mest almindelige alvorlige bivirkning.
In post-marketing spontaneous reporting, infections are the most common serious adverse reaction.
Kombinationen af infliximab og abatacept anbefales ikke.
The combination of infliximab and abatacept is not recommended.
Af de 573 randomiserede patienter, opnåede 335 (58%) klinisk respons ved uge 2.
Of the 573 patients randomised, 335 (58%) achieved clinical response by week 2.
• Din læge eller sygeplejerske vil klargøre medicinen før infusionen.
• Your doctor or nurse will prepare the medicine for infusion.
Dette skal tages med i overvejelserne for patienter på kontrolleret natriumdiæt (se pkt.
This should be taken into consideration for patients on a controlled sodium diet (see section 6.6).
Vedvarende remission (i remission både i uge 8 og uge 30)
Sustained remission(in remission at both week 8 and week 30)
• Hvis du oplever reaktivering af hepatitis B, kan det blive nødvendigt, at lægen stopper din behandling og giver dig medicin som fx effektiv antiviral terapi med understøttende behandling.
• If you experience reactivation of hepatitis B, your doctor may need to stop your treatment and may give you medicines such as effective antiviral therapy with supportive treatment.
• Du vil få Inflectra af din læge eller sygeplejerske på et hospital eller en klinik.
• Inflectra will be given to you by your doctor or nurse, in a hospital or clinic.
I alle tilfælde blev infliximab seponeret og/eller anden behandling igangsat med fuldstændigt ophør af tegn og symptomer.
In all cases, infliximab treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Hos nøje udvalgte voksne patienter, som har tålt mindst 3 initiale 2-timers infusioner med infliximab (induktionsfase) og får vedligeholdelsesterapi, kan det overvejes at indgive de efterfølgende infusioner over en periode på ikke mindre end 1 time.
In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of infliximab (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Opbevaring ud over 24 timer ved 2C - 8C gælder kun for tilberedning af Inflectra i infusionspose.
Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Inflectra in the infusion bag only.
Øvre luftvejsinfektion (7/60 [12%]) og faryngitis (5/60 [8%]) var de hyppigst rapporterede luftvejsinfektioner.
Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections.
Hos børn (i alderen 6 år eller derover), der behandles for Crohns sygdom eller colitis ulcerosa, er den anbefalede dosis den samme som for voksne.
In children (6 years of age or older) treated for Crohn's disease or ulcerative colitis, the recommended dose is the same as for adults.
Der blev registreret signifikante forbedringer fra baseline i DLQI (p < 0,001) og de fysiske og mentale del-scorer af SF 36 (p < 0,001 for hver enkelt delsammenligning).
Significant improvements from baseline were demonstrated in DLQI (p<0.001) and the physical and mental component scores of the SF 36 (p<0.001 for each component comparison).
Hvis der observeres synligt uigennemsigtige partikler, misfarvning eller fremmedlegemer må det ikke anvendes.
If visibly opaque particles, discolouration or foreign particles are observed it should not be used.
Ved baseline havde 87% af patienterne perianale fistler, 14% havde abdominale fistler, 9% havde rektovaginale fistler.
At baseline, 87% of the patients had perianal fistulae, 14% had abdominal fistulae, 9% had rectovaginal fistulae.
Inflectra indeholder det aktive stof infliximab, der stammer fra mennesker og mus.
Inflectra contains the active substance infliximab, which is of human and mouse origin.
Andelen af patienter med klinisk respons i uge 8 var 73,3% (44/60).
The proportion of patients in clinical response at week 8 was 73.3% (44/60).
Alle patienter havde haft utilstrækkelig virkning af tidligere konventionel behandling.
All patients had experienced an inadequate response to prior conventional therapies.
Rheumatoid artritis Den normale dosis er 3 mg for hver kg legemsvægt.
Rheumatoid arthritis The usual dose is 3 mg for every kg of body weight.
Din læge kan anbefale en midlertidig pause med Inflectra.
Your doctor may recommend temporarily stopping Inflectra.
Foreliggende data tyder på, at det kliniske respons sædvanligvis opnås inden for 14 ugers behandling, svarende til tre doser.
Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. three doses.
I de fleste patienter med fistulerende Crohns sygdom blev infliximab påvist i serum i 12 uger (interval 4-28 uger) efter administration af regimen.
In most fistulising Crohn's disease patients, infliximab was detected in serum for 12 weeks (range 4-28 weeks) after administration of the regimen.
Behandling med infliximab må ikke fortsættes, hvis en patient udvikler en alvorlig infektion eller sepsis.
Further treatment with infliximab must not be given if a patient develops a serious infection or sepsis.
Derfor kan kombination af infliximab og anakinra ikke anbefales.
Therefore, the combination of infliximab and anakinra is not recommended.
Passende screeningundersøgelser (f.eks. tuberkulintest, røntgen af thorax og/eller Interferon Gamma Release Assay), bør udføres hos alle patienter (lokale vejledninger kan være gældende).
Appropriate screening tests (e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
• En påmindelse til patienterne om, at de skal vise patientinformationskortet til alle behandlende sundhedspersoner, herunder i nødstilfælde, og en besked til sundhedspersoner om, at patienten anvender Inflectra.
• A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Inflectra
Det er vigtigt, at du fortæller dit barns læger og andet sundhedspersonale, at du får Inflectra, så de kan finde frem til, hvornår dit barn skal vaccineres; det gælder også levende vacciner som BCG (bruges til at forebygge tuberkulose).
It is important that you tell your baby's doctors and other healthcare professionals about your Inflectra use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
b N = 292. c Analysen var baseret på patienter med neglepsoriasis ved baseline (81,8% af patienterne).
b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Opbevar dette kort på dig i 4 måneder efter du har fået din sidste dosis Inflectra, eller i tilfælde af graviditet i mindst 6 måneder, efter du har født.
Keep this card with you for 4 months after your last dose of Inflectra, or in case of pregnancy, for at least 6 months after the birth of your baby.
Inflectra fremstilles i pakninger med 1, 2, 3, 4 eller 5 hætteglas.
Inflectra is produced in packs of 1, 2, 3, 4, or 5 vials.
Klinisk remission i uge 8 var 33,3% (17/51) målt ved pædiatrisk colitis ulcerosa aktivitets-indeks (PUCAI) scoren.
Clinical remission at week 8 was 33.3% (17/51) as measured by the Paediatric Ulcerative Colitis Activity Index (PUCAI) score.
Fortæl det til lægen, hvis du får en diæt med lavt saltindhold.
Talk to your doctor if you are on a low salt diet.
Inflectra påvirker sandsynligvis ikke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
Inflectra is not likely to affect your ability to drive or use tools or machines.
• Hvis du har holdt pause i behandlingen med infliximab i over 16 uger, er der en højere risiko for at få en allergisk reaktion, når du starter Inflectra-behandlingen igen.
• If you have had a break in your treatment with infliximab of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
• du har tuberkulose (TB) eller en anden alvorlig infektion, såsom lungebetændelse eller blodforgiftning (sepsis, en alvorlig bakterieinfektion i blodet),
• you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis(serious bacterial infection of the blood),
Fornyet administration ved Crohns sygdom og reumatoid arthritis Hvis tegn og symptomer på sygdom vender tilbage, kan infliximab indgives på ny inden for 16 uger efter den seneste infusion.
Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last infusion.
Inden du får Inflectra, bliver det imidlertid blandet med en opløsning, der indeholder natrium.
However, before Inflectra is given to you, it is mixed with a solution that contains sodium.
• du har hjertesvigt i moderat eller svær grad.
• you have heart failure that is moderate or severe.
Patienter, som udvikler en ny infektion, imens de er under behandling med infliximab, bør monitoreres tæt og gennemgå en komplet diagnostisk evaluering.
Patients who develop a new infection while undergoing treatment with infliximab, should be monitored closely and undergo a complete diagnostic evaluation.
Kortere infusionstid ved doser > 6 mg/kg er ikke blevet undersøgt (se pkt.
Shortened infusions at doses >6 mg/kg have not been studied (see section 4.8).
178 af de 580 inkluderede patienter (30,7%) blev defineret som havende svær sygdom (CDAI score > 300 og samtidig kortikoid og/eller immunsupprimerende behandling) svarende til populationen defineret i indikationen (se pkt.
178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Samtidig brug af stabile doser af konventionel behandling var tilladt, og 83% af patienterne fortsatte brugen af mindst en af disse behandlinger.
Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies.
Hvis disse lægemidler eller behandlinger ikke virker godt nok, vil du få Inflectra for at reducere tegn og symptomer på din sygdom.
If these medicines or treatments do not work well enough, you will be given Inflectra to reduce the signs and symptoms of your disease.
Det bør overvejes at afbryde infliximab-behandlingen, hvis disse sygdomme udvikles.
Discontinuation of infliximab should be considered if these disorders develop.
* P-værdier repræsenterer hver infliximab-behandlingsgruppe vs. AZA monoterapi.
* p-values represent each infliximab treatment group vs. AZA monotherapy.
Der forekom én alvorlig infusionsrelateret reaktion (< 1%) hos en patient på infliximab monoterapi.
One serious infusion reaction (< 1%) occurred in a patient on infliximab monotherapy.
Republikken Korea
Republic of Korea
• Hvis din læge tror, at du har risiko for at få TB, kan du blive behandlet med lægemidler mod TB, inden du får Inflectra.
• If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Inflectra.
Plastiklåget fra hætteglasset fjernes og toppentørres med en 70% alkoholvatpind.
The flip-top from the vial has to be removed and the top has to be wiped with a 70% alcohol swab.
• Din læge vil også udlevere et patientinformationskort til dig, som indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under din behandling med
• Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Inflectra.
Kvinder i den fertile alder skal overveje at anvende sikker kontraception for at undgå graviditet og fortsætte med anvendelsen heraf i mindst 6 måneder efter den sidste behandling med infliximab.
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last infliximab treatment.
Af de patienter som behøvede dosisjustering opnåede 80% klinisk respons og størstedelen af disse (64%) behøvede kun en justering med 1,5 mg/kg.
Of the patients who required a dose titration, 80% achieved clinical response and the majority (64%) of these required only one adjustment of 1.5 mg/kg.
• forsinke skaden i dit led
• slow down the damage in your joints,
Immunogenicitet Antistoffer over for infliximab blev påvist hos 4 (7,7%) patienter i uge 54.
Immunogenicity Antibodies to infliximab were detected in 4 (7.7%) patients through week 54.
Kun et infusionssæt med et in-line, sterilt, ikke-pyrogent, minimalt proteinbindende filter (porestørrelse 1,2 mikrometer eller derunder) bør anvendes.
Only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less) should be used.
Alle patienter, der har fået infliximab, skal observeres i mindst 1-2 timer efter infusionen for akutte infusionsrelaterede reaktioner.
All patients administered infliximab are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Deres læge vil teste dig for at se, om du har haft TB.
Your doctor will test you to see if you have TB.
PASI 75 respons** * ITT-analyser med forsøgspersoner med manglende data blev inkluderet som ikke-responderende.
* ITT-analysis where subjects with missing data were included as non-responders.
Hvis inaktiv (“latent”) tuberkulose diagnosticeres, skal behandling for latent tuberkulose påbegyndes med behandling mod tuberkulose før initiering af infliximab-behandling i henhold til lokale vejledninger.
If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of infliximab, and in accordance with local recommendations.