FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Efter infliximabbehandling udviste patienter nedsat niveau af serum interleukin 6 (IL-6) og C-reaktivt protein (CRP).
English: Inflectra 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 (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: Inflectra 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.
English: Mean ± SDd a p <0.001, for each infliximab treatment group vs control.
Danish: Gennemsnit ± SD a p < 0,001, for hver infliximab-behandlingsgruppe mod kontrol.
English: It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating infliximab therapy.
Danish: Det anbefales, at pædiatriske patienter bliver vaccineret i overensstemmelse med gældende vaccinationsvejledninger, før infliximab-behandling påbegyndes, hvis dette er muligt.
English: Carriers of HBV who require treatment with infliximab should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Hos patienter med positiv test for HBV-infektion, anbefales det at rådføre sig med en læge med erfaring i behandling af hepatitis B. Bærere af HBV, hvor behandling med infliximab er nødvendig, skal følges nøje under behandlingen og i adskillige måneder efter afslutning af behandlingen for at registrere tegn og symptomer på aktiv HBV-infektion.
English: Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p<0.001).
Danish: Endepunkt blev målt ved ændring fra baseline i samlet modificeret vdH-S score (middel ± SD score var 0,82 ± 2,62 i placebogruppen sammenlignet med -0,70 ± 2,53 i infliximab-gruppen; p < 0,001).
English: Other medicines and Inflectra
Danish: Brug af anden medicin sammen med Inflectra
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind studies: SPIRIT and EXPRESS.
Danish: Virkningen af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblindede studier:
English: Inflectra 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.
Danish: Inflectra 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.
English: • Tell your doctor before you are given Inflectra if you have an infection, even if it is a very minor one.
Danish: • Før du får Inflectra, skal du fortælle det til din læge, hvis du har en infektion, også selvom det er en meget let infektion.
English: The proportion of subjects achieving clinical remission at week 10 was 58.9% (66/112).
Danish: Andelen af personer med klinisk respons i uge 10 var 88,4% (99/112), og andelen af personer, som opnåede klinisk remission i uge 10, var 58,9% (66/112).
English: • Tell your doctor before you are given Inflectra if you are a carrier of hepatitis B or have ever had it.
Danish: • Før du får Inflectra, skal du fortælle din læge, hvis du er bærer af, eller nogensinde har haft hepatitis B.
English: Placebo Maintenance (n=99)
Danish: Placebovedligeholdelse (n=110)
English: • 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 Inflectra over 1 hour.
Danish: • Lægemidlet vil blive givet som en infusion (drop) (i løbet af 2 timer) i en af dine blodårer
English: Excipients: sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate
Danish: Hjælpestoffer: Saccharose, polysorbat 80, natriumdihydrogen-phosphatmonohydrat og dinatriumphosphatdihydrat.
English: During the 24-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22 (100 patients in each group).
Danish: Under den 24 uger dobbeltblindede fase modtog patienterne enten 5 mg/kg infliximab eller placebo i ugerne 0, 2, 6, 14 og 22 (100 patienter i hver gruppe).
English: • Fungal infections such as yeast infection or fungal infection of the nails
Danish: • Svampeinfektioner, såsom gærsvampeinfektion eller svampeinfektion i neglene
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: Inflectra and Kineret should not be used together.
Danish: Du må ikke få Inflectra og Kineret samtidig.
English: During the 16-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, and 14 (52 patients in each group).
Danish: Under den 16 uger lange dobbeltblindede fase fik patienterne enten 5 mg/kg infliximab eller placebo i uge 0, 2, 6 og 14 (52 patienter i hver gruppe).
English: Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Danish: Inflectra er indiceret til behandling af svær, aktiv colitis ulcerosa hos børn og unge i alderen 6 til 17 år, som har responderet utilstrækkeligt på konventionel behandling, inklusive kortikosteroider og 6-MP eller AZA, eller som er intolerante over for eller hvor der er kontraindikationer mod disse behandlinger.
English: Also at week 4, 13/27 (48%) of infliximab-treated patients achieved a clinical remission (CDAI < 150) vs. 1/25 (4%) of placebo-treated patients.
Danish: I uge 4 opnåede endvidere 13/27 (48%) af infliximab-behandlede patienter en klinisk remission
English: Children may receive some vaccines during treatment with Inflectra but should not receive live vaccines while using Inflectra.
Danish: • Børn skal have de anbefalede vaccinationer, før behandling med Inflectra påbegyndes.Børn kan få visse vacciner under behandlingen med Inflectra, men må ikke få levende vacciner, mens de får Inflectra.
English: Inflectra 100 mg powder for concentrate for solution for infusion infliximab
Danish: Inflectra 100 mg pulver til koncentrat til infusionsvæske, opløsning infliximab
English: Placebo Maintenance
Danish: Placebo
English: What Inflectra looks like and contents of the pack Inflectra is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Danish: Inflectra leveres som et hætteglas (glasflaske) indeholdende et pulver til koncentrat til infusionsvæske, opløsning.
English: Infliximab b
Danish: Infliximab
English: Patients should be tested for HBV infection before initiating treatment with infliximab.
Danish: Før behandlingen med infliximab påbegyndes, skal patienten testes for HBV-infektion.
English: Table 1 Adverse reactions in clinical studies and from post-marketing experience Infections and infestations Very common:
Danish: Tabel 1 Bivirkninger i kliniske studier og efter markedsføring
English: In patients who develop HBV reactivation, infliximab should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.
Danish: Der foreligger ingen data om antiviral behandling profylaktisk mod HBV-reaktivering i forbindelse med TNF-antagonist-behandling hos patienter, som er bærere af HBV. Infliximab bør seponeres hos patienter, hvor HBV reaktiveres, og effektiv antiviral behandling med passende understøttende behandling bør igangsættes.
English: It is recommended that therapeutic infectious agents not be given concurrently with infliximab (see section 4.4).
Danish: Terapeutiske smitstoffer bør ikke gives samtidig med infliximab (se pkt.
English: Week 30 Clinical Response a
Danish: Uge 30 Klinisk respons
English: Percentage of subjects in clinical remission and sustained remission Clinical remission at week 8
Danish: Procent forsøgspersoner i klinisk remission og vedvarende remission
English: It is recommended that therapeutic infectious agents not be given concurrently with infliximab.
Danish: Terapeutiske smitstoffer bør ikke gives samtidig med infliximab.
English: • Chills, a build-up of fluid under the skin causing swelling
Danish: • Kulderystelser, hævelse på grund af ophobning af væske under huden
English: Infliximab (Week 16)
Danish: Infliximab (uge 16)
English: The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Danish: Fornyet administration ved ankyloserende spondylitis Sikkerhed og virkning ved fornyet administration, udover hver 6. til 8. uge, er ikke klarlagt (se pkt.
English: Infliximab (Week 98)
Danish: Infliximab (uge 98)
English: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease,
Danish: • Alvorlige lidelser i nervesystemet såsom transversel myelitis, multipel sklerose-lignende sygdom, optisk neuritis og Guillain-Barré syndrom
English: • Tell your doctor straight away if you get signs of TB during treatment with Inflectra.
Danish: • Fortæl straks din læge, hvis du får tegn på TB under behandlingen med Inflectra.
English: Infliximab (Week 54)
Danish: Infliximab (uge 54)
English: Administration of live vaccines (e.g. BCG vaccine) to infants exposed to infliximab in utero is not recommended for at least 6 months after birth (see sections 4.4 and 4.5).
Danish: (fx BCG vaccine) til spædbørn eksponeret for infliximab i uterus, i mindst 6 måneder efter fødslen (se pkt.
English: Infliximab (Week 24)
Danish: Infliximab (uge 24)
English: Subjects randomised
Danish: Forsøgspersoner randomiseret
English: How to store Inflectra
Danish: Sådan får du Inflectra
English: Overall, 8 (13.3%) of 60 treated patients experienced one or more infusion reactions, with 4 of 22 (18.2%) in the q8 week and 3 of 23 (13.0%) in the q12 week treatment maintenance group.
Danish: Det drejede sig om 4 ud af 22 (18,2%) i 8-ugers vedligeholdelsesbehandlingsgruppen og 3 ud af 23 (13,0%) i 12-ugers vedligeholdelsesbehandlingsgruppen.
English: • Tell your doctor straight away if you get symptoms of low blood counts during treatment with Inflectra.
Danish: • Fortæl det straks til lægen, hvis du får symptomer på lave blodtal under behandlingen med Inflectra.
English: 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
Danish: Der var designet et klinisk studie med patienter med moderat til svær psoriasis for at undersøge virkning og sikkerhed af langtidsvedligeholdelsesbehandling i forhold til fornyet administration med et induktionsregime med infliximab (højst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom.
English: among patients who were receiving corticosteroids at baseline.
Danish: De patienter, der fik kortikosteroider ved baseline, fik ikke kortikosteroider i de 3 måneder forud for uge 54.
English: Tell your doctor if you are using, have recently used or might use any other medicines, including any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Danish: Dette gælder også medicin til behandling af Crohns sygdom, colitis ulcerosa, reumatoid arthritis, ankyloserende spondylitis, psoriasisarthritis eller psoriasis eller medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
English: After reconstitution each mL contains 10 mg of infliximab.
Danish: Efter rekonstitution indeholder hver ml 10 mg infliximab.
English: • Tell your doctor straight away if you get signs of infection during treatment with Inflectra.
Danish: • Fortæl straks din læge, hvis du får tegn på infektion under behandling med Inflectra.
English: Patients received either 3 or 5 mg/kg infliximab or placebo infusions at weeks 0, 2 and 6.
Danish: 5 mg/kg infliximab eller placeboinfusioner i uge 0, 2 og 6.
English: Patients treated with Inflectra should be given the patient reminder card.
Danish: Indlægssedlen og patientinformationskortet skal gives til patienter, som behandles med Inflectra.
English: • Tell your doctor straight away if you develop symptoms of lupus during treatment with Inflectra.
Danish: • Fortæl det straks til lægen, hvis du får symptomer på lupus under behandlingen med Inflectra.
English: All infliximab b
Danish: Alle infliximab
English: It is recommended that live vaccines not be given concurrently with infliximab.
Danish: Levende vacciner bør ikke gives samtidig med Inflectra.
English: Each Inflectra vial contains 100 mg infliximab.
Danish: Hvert Inflectra-hætteglas indeholder 100 mg infliximab.
English: After reconstitution one mL contains 10 mg of infliximab.
Danish: Efter rekonstitution indeholder 1 ml 10 mg infliximab.
English: a a p <0.001, for each infliximab treatment group vs. placebo.
Danish: Slimhindeheling i uge 30 a p < 0,001, for hver infliximab-behandlingsgruppe mod placebo.
English: • Tell your doctor straight away if you get symptoms of liver problems during treatment with Inflectra.
Danish: • Fortæl det straks til lægen, hvis du får symptomer på leverproblemer under behandlingen med Inflectra.
English: a p <0.001, for each infliximab treatment group vs. control.
Danish: Uge50 a p < 0,001, for hver infliximab-behandlingsgruppe versus kontrol.
English: While using Inflectra you should not receive live vaccines.
Danish: De må ikke få levende vacciner, mens De får Inflectra.
English: The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Danish: Fornyet administration ved psoriasis arthritis Sikkerhed og virkning ved fornyet administration, udover hver 8. uge, er ikke klarlagt (se pkt.
English: b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or
Danish: b Alle infliximab doser er givet i kombination med methotrexat og folat samt eventuelt kortikosteroider og/eller NSAIDs c p < 0,001, for hver infliximab-behandlingsgruppe versus kontrol d Større værdier indikerer mere uarbejdsdygtighed.
English: • Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Inflectra.
Danish: Fortæl straks din læge, hvis du får symptomer på en nervesygdom under behandlingen med Inflectra.
English: Inflectra 100 mg powder for concentrate for solution for infusion
Danish: Inflectra 100 mg pulver til koncentrat til infusionsvæske, opløsning.
English: What Inflectra is and what it is used for What you need to know before you use Inflectra How Inflectra will be given Possible side effects
Danish: Det skal du vide, før du begynder at bruge Inflectra Sådan vil du få Inflectra
English: Powder for concentrate for solution for infusion.
Danish: Pulver til koncentrat til infusionsvæske, opløsning
English: België/Belgique/Belgien Pfizer SA/NV
Danish: België/Belgique/Belgien Pfizer SA/NV Tél/Tel: + 32 2 554 62 11
English: One vial contains 100 mg of infliximab.
Danish: Et hætteglas indeholder 100 mg infliximab.
English: ‘Re-administration' below and section 4.4).
Danish: 4.4 og 4.5).
English: The procedures are independent and no data will be brought into one or the other procedure.
Danish: Procedurerne er uafhængige, og der bringes ikke nogen data ind i den ene eller den anden procedure.
English: - Paediatric information currently exists in the Member States, and this has been harmonised and included.
Danish: - Der er i øjeblikket pædiatriske oplysninger i medlemsstaterne, og disse er harmoniseret og inkluderet.
English: Developmental safety data in this population have not been evaluated.'
Danish: Udviklingsmæssige sikkerhedsdata i denne patientgruppe er ikke evalueret."
English: The pooled dataset included a total of 16,066 patients, treated for a median period of 53 weeks.
Danish: Det poolede datasæt omfattede i alt 16 066 patienter, som har været behandlet i en medianperiode på 53 uger.
English: Overall summary of the scientific evaluation of Lipitor and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Lipitor og relaterede navne (se bilag I)
English: A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks.
Danish: Terapeutisk virkning ses inden for 2 uger, og maksimal respons opnås normalt inden for 4 uger.
English: Efficacy and safety in patients older than 70 using recommended doses are similar to those seen in the general population.
Danish: Virkning og sikkerhed hos patienter på over 70 år, som anvender de anbefalede doser, svarer til den, der ses i befolkningen generelt.
English: Only limited data are available (see section 5.1).
Danish: Der er kun begrænsede data til rådighed (se pkt.
English: • Efficacy and safety issues
Danish: • Aspekter vedrørende sikkerhed og virkning
English: Section 4.7 - Effects on ability to drive and use machines The majority of markets currently have the proposed harmonised wording, which is in line with the SmPC guideline dated September 2009.
Danish: Punkt 4.7 - Virkning på evnen til at føre motorkøretøj eller betjene maskiner De fleste markeder har i øjeblikket den foreslåede harmoniserede formulering, som er i overensstemmelse med produktresumévejledningen fra september 2009.
English: The indication proposed by the MAH for the prevention of cardiovascular disease is in line with the wording agreed upon by the CHMP on 20-23 March 2006 (CHMP/76062/2006) during the Article 6(12) referral.
Danish: Den indikation, som af indehaveren af markedsføringstilladelsen foreslår til forebyggelse af kardiovaskulær sygdom, er på linje med den formulering, som CHMP vedtog den 20.-23. marts 2006 (CHMP/76062/2006) under indbringelsen i henhold til artikel 6, stk. 12.
English: This was not endorsed by the CHMP due to the fact that low HDL-levels is not accepted as a surrogate marker for cardiovascular disease.
Danish: Dette er ikke godkendt af CHMP, da lave HDL-niveauer ikke accepteres som surrogatmarkør for kardiovaskulær sygdom.
English: Following agreement of the Statin Class wording by the PhVWP in November 2009, the agreed text has been included.
Danish: Efter at arbejdsgruppen vedrørende lægemiddelovervågning blev enig om statinklasseformuleringen i november 2009, er den aftalte tekst medtaget.
English: Data were reviewed for all doses combined (10-80mg) vs placebo, and adverse events were grouped by categories of organ systems.
Danish: Dataene blev gennemgået for alle doser (10-80 mg) kontra placebo, og bivirkningerne blev grupperet efter kategorier af organsystemer.
English: As current guidelines for lipid lowering therapy are subject to constant change, the CHMP agreed that it would not seem to be helpful to fix such an advice in the informative texts.
Danish: Da de nuværende retningslinjer for lipidsænkende behandling ændres hele tiden, accepterede CHMP, at det ikke ville virke nyttigt at fastsætte en sådan vejledning i de informative tekster.
English: Changes to the wording of certain terms as well as justifications for retaining some others were accepted by the CHMP.
Danish: Ændringer i visse formuleringer samt dokumentation for at bevare andre blev accepteret af CHMP.
English: Myopathy has not been included in the list of contraindications since no contraindication regarding myopathy was agreed for previous Art 30 procedures for pravastatin, simvastatin and fluvastatin.
Danish: Myopati er ikke medtaget på listen over kontraindikationer, da der ikke var aftalt nogen kontraindikation med hensyn til myopati for tidligere artikel 30-procedurer for pravastatin, simvastatin og fluvastatin.
English: The following wording was agreed by the CHMP: ‘Prevention of cardiovascular disease
Danish: Følgende formulering er godkendt af CHMP: "Forebyggelse af kardiovaskulær sygdom
English: In line with the SmPC guidance, dated September 2009, brief and qualitative statement covering the nonclinical safety profile of atorvastatin have been included.
Danish: I overensstemmelse med produktresumévejledningen fra september 2009 er der medtaget korte og kvalitative udsagn om atorvastatins ikke-kliniske sikkerhedsprofil.
English: Doses should be individualised and adjusted every 4 weeks to 40 mg daily.
Danish: Dosis bør individualiseres og justeres hver 4. uge op til 40 mg dagligt.
English: Adjustment of dose should be made at intervals of 4 weeks or more.
Danish: Dosis bør justeres med intervaller på 4 uger eller mere.
English: - with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal
Danish: - med aktiv leversygdom eller uforklarlig vedvarende stigning i serumtransaminaserne svarende til mere end 3 gange den øvre referenceværdi
English: The similarities between the two clinical trials as well as the timing of completion of the studies allowed for a joint review in support of an indication for atorvastatin in the prevention of cardiovascular disease.
Danish: Lighederne mellem de to kliniske undersøgelser samt timingen af undersøgelsernes afslutning tillod en samlet vurdering til støtte for en indikation for atorvastatin til forebyggelse af kardiovaskulær sygdom.
English: The temporary suspension of atorvastatin during fusidic acid therapy has been included in line with the Type II MRP variation (DE/H/0109/001- 004/II/094).
Danish: Den midlertidige suspension af atorvastatin under behandling med fusidinsyre er medtaget i overensstemmelse med type II-ændringen i det gensidigt anerkendte produktresumé (DE/H/0109/001- 004/II/094).
English: The following wording was agreed by the CHMP:
Danish: Følgende formulering er godkendt af CHMP:
English: There is evidence from animal studies that HMG-CoA reductase inhibitors may influence the development of embryos or foetuses.
Danish: Der er fra dyreforsøg dokumentation for, at HMG-CoA-reduktasehæmmere kan påvirke den embryoføtale udvikling.
English: Discontinuation due to adverse reactions occurred in 5.2% of patients on atorvastatin compared to 4.0% of the patients on placebo.
Danish: Seponering på grund af bivirkninger forekom hos 5,2 % af de patienter, som fik atorvastatin, og hos 4,0 % af de patienter, som fik placebo.
English: This review identified a number of new adverse events that have been added to the atorvastatin CDS and hence also to the SmPC, as well as some changes to the frequencies of existing adverse events.
Danish: Denne gennemgang identificerede en række nye bivirkninger, som er tilføjet i atorvastatin-CDS og derfor også i produktresuméet, samt nogle ændringer i hyppigheder af eksisterende bivirkninger.
English: - with hypersensitivity to the active substance or to any of the excipients of this medicinal product
Danish: - med overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne i dette lægemiddel