FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with Arava, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Arava fremgår af indlægssedlen.
English: How has Arava been studied?
Danish: Hvordan blev Arava undersøgt?
English: What is Arava used for?
Danish: Hvad anvendes Arava til?
English: What benefit has Arava shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Arava?
English: How does Arava work?
Danish: Hvordan virker Arava?
English: How is Arava used?
Danish: Hvordan anvendes Arava?
English: In rheumatoid arthritis, Arava has been studied in four main studies involving over 2,000 patients, in which it was compared with placebo (a dummy treatment), or with methotrexate or sulphasalazine (other medicines used to treat rheumatoid arthritis).
Danish: I disse undersøgelser blev det sammenlignet med placebo (en virkningsløs behandling) eller med methotrexat eller sulfasalazin (andre lægemidler, der anvendes til behandling af rheumatoid arthritis).
English: poor bone marrow function or low blood cell counts (red cells, white cells or platelets) caused by conditions other than rheumatoid or psoriatic arthritis;
Danish: leverlidelser svære immundefekttilstande såsom erhvervet immundefektsyndrom (aids) ringe knoglemarvsfunktion eller lavt antal blodlegemer (røde blodlegemer, hvide blodlegemer eller trombocytter) forårsaget af andre lidelser end rheumatoid arthritis eller arthritis psoriatica svære infektioner moderat til svært nedsat nyrefunktion svær hypoproteinæmi (lavt indhold af proteiner i blodet).
English: Adopted at the 29-31 October 2018 PRAC
Danish: Vedtaget på PRAC's møde 29.-31. oktober 2018
English: Talk to your doctor or pharmacist before using <Product name>
Danish: Kontakt lægen eller apotekspersonalet, før du tager <produktnavn>
English: What you need to know before you use <Product name>
Danish: Det skal du vide, før du begynder at tage <produktnavn>
English: These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating hepatic or renal function or neurological symptoms.
Danish: Disse infektioner er ofte forbundet med en høj total immunsuppressiv belastning og kan føre til alvorlige eller fatale tilstande, som lægerne bør overveje i differentialdiagnosticeringen af immunsupprimerede patienter med forringet lever- eller nyrefunktion eller neurologiske symptomer.
English: if you suffer from a heart disease (e.g. long QT syndrome)
Danish: hvis du lider af en hjertesygdom (f.eks. langt QT-syndrom)
English: Tacrolimus systemic formulation - Hepatitis E infection (EPITT no 19246)
Danish: Systemisk formulering af tacrolimus - Hepatitis Einfektion (EPITT nr. 19246)
English: Among these conditions are such as BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
Danish: Blandt disse tilstande ersåsom BK-virus associeret nefropati og JC-virus associeret progressiv multifokal leukoencefalopati (PML).
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/758155/2018
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/790415/2018
English: Note: in the package leaflet the text ‘(e.g. long QT syndrome)' should be added to the bullet point mentioning heart disease, taking into account the already existing wording for nationally authorised medicinal products.
Danish: Bemærk: I indlægssedlen bør teksten "(f.eks. langt QT-syndrom)" tilføjes under det listepunkt, hvor hjertesygdom nævnes, under hensyntagen til den allerede eksisterende ordlyd for nationalt godkendte lægemidler.
English: Xylometazoline - Serious ventricular arrhythmia in patients with long QT syndrome (EPITT no 19242)
Danish: Xylometazolin - Alvorlig ventrikulær arytmi hos patienter med langt QT-syndrom (EPITT nr. 19242)
English: Patients treated with immunosuppressants, including tacrolimus are at increased risk for infections including opportunistic infections (bacterial, fungal, viral and protozoal).
Danish: Patienter behandlet med immunsuppressiva, herunder tacrolimus, har en øget risiko for infektioner, herunder opportunistiske infektioner (bakteriel, fungal, viral og protozoal).
English: For package leaflets which do not mention ‘heart disease', a bullet point on ‘heart disease (e.g. long QT syndrome)' should be added, in line with the wording above.
Danish: I indlægssedler, hvor "hjertesygdom" ikke er nævnt, bør der tilføjes et listepunkt med "hjertesygdom (f.eks. langt QT-syndrom)" i overensstemmelse med ordlyden ovenfor.
English: Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Patienter med langt QT-syndrom, som får behandling med xylometazolin, kan have en øget risiko for alvorlige ventrikulære arytmier.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: JANSSEN-CILAG S.A. Paseo de las Doce Estrellas 5-7, 28042 Madrid, España
Danish: JANSSEN-CILAG S.A. Paseo de las Doce Estrellas 5-7, 28042 Madrid, Spain
English: Janssen-Cilag Oy Vaisalantie 2, FI02130 Espoo, FINLAND
Danish: Janssen-Cilag Oy Vaisalantie 2, FI-02130 Espoo, Suomi
English: Turnhoutseweg 30, Beerse, Belgium
Danish: Janssen-Cilag International N.V Turnhoutseweg 30, Beerse, Belgium
English: [To be filled in nationally]
Danish: [Udfyldes nationalt]
English: If necessary, they can be diluted in water (see above).
Danish: Om nødvendigt kan de fortyndes i vand (se ovenfor).
English: Do not touch the dropper.
Danish: Undgå at røre dråbetælleren.
English: Please interrupt treatment, temporarily.
Danish: Stop behandlingen midlertidigt.
English: Efficacy and safety beyond 8 weeks have not been studied.
Danish: Virkningen og sikkerheden ud over 8 uger er ikke undersøgt.
English: These reactions usually disappear within a few days even if treatment is continued.
Danish: Disse reaktioner svinder normalt i løbet få dage, selv om behandlingen fortsættes.
English: If appropriate, speak to your doctor.
Danish: Om nødvendigt kan du tale med lægen.
English: You can also report side effects directly via the national reporting system: [to be filled in nationally]
Danish: Du kan desuden indberette bivirkninger direkte gennem det nationale indberetningssystem: [Udfyldes nationalt]
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Præparatoplysningerne kan efterfølgende opdateres efter behov af medlemsstatens kompetente myndighed i samarbejde med referencemedlemsstaten, hvor det er passende, i overensstemmelse med procedurerne, som er beskrevet i kapitel 4 titel III i direktiv 2001/83/EU.
English: By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Ved at indrapportere bivirkninger kan du hjælpe med skaffe mere information om sikkerheden af dette lægemiddel.
English: The recommended dose is:
Danish: Den sædvanlige dosis er:
English: Overall, there is a shift in activity in favour of Th1 helper cells, accompanied by inhibition of the Th2 helper cells.
Danish: Alt i alt er der et skift i aktivitet til fordel for Th1-hjælperceller ledsaget af hæmning af Th2hjælpercellerne.
English: In a non-interventional study with 203 children aged 4-18 years no undesirable effects were reported.
Danish: I en ikke-interventionsundersøgelse med 203 børn i alderen 4-18 år blev der ikke meldt om bivirkninger.
English: If and to what extend these results are applicable for the use in patients is not yet known.
Danish: Hvorvidt disse resultater er gyldige for anvendelse hos patienter, vides endnu ikke.
English: However, based on these limited data the safety profile for children and adolescents is considered to be comparable to that of adults.
Danish: På baggrund af disse begrænsede data anses sikkerhedsprofilen hos børn og unge dog for at være sammenlignelig med sikkerhedsprofilen hos voksne.
English: This can be prevented by opening the bottle for a short time only when using this product, and by dispensing the drops carefully.
Danish: Det kan man undgå ved kun at åbne flasken kortvarigt, når man bruger produktet, og ved at lade dråberne løbe ud forsigtigt.
English: The drops are taken orally during the meals.
Danish: Dråberne indtages oralt sammen med måltiderne.
English: Only limited experience of adverse reactions in children from pharmacovigilance data is available.
Danish: Der foreligger kun begrænsede erfaringer med bivirkninger hos børn fra lægemiddelovervågningsdata.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system (details see below).
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem (se nærmere nedenfor).
English: Antibiotics may inhibit the Escherichia coli bacteria and thus reduce the efficacy of this medicine.
Danish: Antibiotika kan hæmme Escherichia coli-bakterierne og derved nedsætte virkningen af dette lægemiddel.
English: Not known: flatulence, nausea, diarrhoea.
Danish: Ikke kendt: flatulens, kvalme, diarré
English: The speed at which the drops come out can be changed by varying the angle at which the bottle is held.
Danish: Dråbehastigheden kan ændres ved at variere den vinkel, man holder flasken i.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Common: abdominal pain (including upper abdominal pain and abdominal discomfort).
Danish: Almindelig: abdominalsmerter (herunder smerter i øvre abdomen og abdominalt ubehag)
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare not known (cannot be estimated from the available data) The following undesirable effects may occur: Immune system disorders Common: urticaria
Danish: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1 000 til <1/100), sjælden (≥1/10 000 til <1/1 000), meget sjælden (<1/10 000), ikke kendt (kan ikke beregnes af forhåndenværende data).
English: No recommendation on a posology can be made as the efficacy and safety in children and adolescents have not been established.
Danish: Der kan ikke gives anbefalinger om dosis, da virkningen og sikkerheden hos børn og unge ikke er blevet fastslået.
English: Release of the drops is started by holding the bottle at an angle and tapping lightly on the bottom.
Danish: Dråberne frigøres ved at holde flasken i en vinkel og banke let mod bunden.
English: Not known (cannot be estimated from the available data): - Flatulence - Nausea - Diarrhoea
Danish: ikke kendt (kan ikke estimeres ud fra forhåndenværende data): - rigelig tarmluft - kvalme - diarré
English: The efficacy and safety in children and adolescents have not been established.
Danish: Virkningen og sikkerheden hos børn og unge er ikke undersøgt.
English: The most common undesirable effects observed in the clinical trial, predominantly observed within the first 4 weeks of treatment, were abdominal pain and urticaria.
Danish: De hyppigste bivirkninger, der blev iagttaget i den kliniske undersøgelse og hovedsagelig observeret inden for de første 4 ugers behandling, var abdominalsmerter og urticaria.
English: Do not take Symbioflor E. coli during acute illnesses with fever.
Danish: Tag ikke Symbioflor E. coli under akut sygdom med feber.
English: Overall, Symbioflor E. coli was well tolerated in the clinical trial with no significant differences in the tolerability compared to placebo regarding vital functions, body weight and all laboratory parameters tested.
Danish: Som helhed var Symbioflor E. coli veltolereret i den kliniske undersøgelse uden væsentlige forskelle i tolerabilitet i forhold til placebo hvad angår vitale funktioner, legemsvægt og alle undersøgte laboratorieparametre.
English: Duration of use of 8 weeks is recommended.
Danish: Det anbefales, at behandlingen varer i 8 uger.
English: Amendments to relevant sections of the Product Information
Danish: Ændringer af relevante punkter i produktinformation
English: Available data are described in sections 4.8 and 5.1.
Danish: 4.8 og 5.1.
English: In a human whole-blood culture model, Symbioflor E. coli exerts strong modulating effects on the physiologically induced synthesis and release of cytokines and chemokines.
Danish: I en human dyrkningsmodel med helblod har Symbioflor E. coli stærke modulerende virkninger på den fysiologisk inducerede syntese og frigivelse af cytokiner og kemokiner.
English: During acute febrile diseases, Symbioflor E. coli should be temporarily discontinued.
Danish: Under akut febril sygdom skal anvendelsen af Symbioflor E. coli midlertidigt ophøre.
English: The investigator's global assessment of tolerability was predominantly good to very good and balanced between Symbioflor E. coli and placebo.
Danish: Undersøgerens samlede vurdering af tolerabiliteten var overvejende god til meget god med jævn fordeling mellem Symbioflor E. coli og placebo.
English: Because of the high surface tension of Symbioflor E. coli, problems with starting and stopping release of the drops of solution cannot be completely avoided.
Danish: På grund af den høje overfladespænding af Symbioflor E. coli kan man ikke helt undgå problemer med at frigøre og stoppe dråberne af opløsningen.
English: Although there are no known harmful effects of Symbioflor E. coli on the unborn child, the drops should be used during pregnancy and when breast-feeding only after a careful benefit-risk assessment by the doctor.
Danish: Selv om der ikke kendes skadelige virkninger af Symbioflor E. coli på det ufødte barn, bør dråberne under graviditet og ved amning kun tages, efter at lægen nøje har vurderet risikoen.
English: Shake Symbioflor E. coli well before use.
Danish: Omryst Symbioflor E. coli godt før brugen.
English: In the group of children aged 12 - 18 years with the IBS subtype “pain + alternating diarrhoea and constipation” the physician's and patient/parent's assessment of efficacy was lowest (55 % or 66 %, respectively).
Danish: I gruppen af børn i alderen 12-18 år med irritabel tyktarm af undertypen "smerter + alternerende diarré og konstipation" var virkningen lavest i henhold til lægens og patientens/forældrenes vurdering (henholdsvis 55 % og 66 %).
English: Severe organic diseases of the gastrointestinal tract such as acute cholecystitis, acute pancreatitis, ileus, as well as cachexia and marasmus.
Danish: Alvorlige organsygdomme i mave-tarmkanalen såsom akut cholecystitis, akut pancreatitis og ileus samt kakeksi og marasmus.
English: Section 2 What you need to know before you take Symbioflor E. coli The text below should be inserted by replacing the existing text of this section:
Danish: Afsnit 2 Det skal du vide, før du begynder at tage Symbioflor E. coli Nedenstående tekst indsættes som erstatning for den eksisterende tekst i dette afsnit:
English: A clinical trial including 298 patients with irritable bowel syndrome recruited in primary care centres showed a good or very good treatment success on Symbioflor E. coli in 62.9 % of the patients and in 39.4 % of the patients treated with placebo based on the investigator's global assessment of efficacy on a 4-point rating scale
Danish: En klinisk undersøgelse, hvor 298 patienter med irritabel tyktarm blev rekrutteret på centre i den primære sundhedssektor, viste vellykket eller meget vellykket behandling med Symbioflor E. coli hos 62,9 % af patienterne og med placebo hos 39,4 %, baseret på undersøgerens samlede vurdering af virkning på en 4-punkts bedømmelsesskala
English: Efficacy was confirmed when using two post-hoc defined patient assessed endpoints, i.e. patient's assessment of symptoms and abdominal discomfort/pain comprising each of 8 or respectively 5 IBS relevant symptoms.
Danish: Virkningen blev bekræftet ved anvendelse af to post-hoc-definerede patientvurderede endepunkter, som var patientens vurdering af symptomer og ubehag/smerter i abdomen og hver omfattede 8 henholdsvis 5 symptomer, der er relevante i forbindelse med irritabel tyktarm.
English: Escherichia coli, the active substance in Symbioflor E. coli, is a living bacterium that is present in the healthy intestinal flora of humans.
Danish: Escherichia coli, det aktive stof i Symbioflor E. coli, er en levende bakterie, der findes i den normale humane tarmflora.
English: The number of patients free of all the assessed IBS relevant symptoms after the treatment period of 8 weeks was significantly higher for Symbioflor E. coli treatment compared to placebo
Danish: Antallet af patienter, der var fri for alle de vurderede symptomer med relevans for irritabel tyktarm efter 8 ugers behandling, var signifikant højere for behandling med Symbioflor E. coli end med placebo
English: If symptoms worsen during treatment or persist after 8 weeks of treatment, the patient should seek medical advice.
Danish: Hvis symptomerne forværres under behandlingen eller persisterer efter 8 ugers behandling, bør patienten søge rådgivning hos lægen.
English: Symbioflor E. coli contains no preservatives and is therefore susceptible to contamination in the event of improper use.
Danish: Symbioflor E. coli indeholder ingen konserveringsmidler og er derfor modtageligt for urenheder i tilfælde af ukorrekt brug.
English: In this model enough bacteria of the E. coli strain survived the acid stomach passage so that their number increased again when they reached the small intestine conditions.
Danish: I denne model overlevede tilstrækkeligt mange bakterier af denne stamme af E. coli passagen gennem mavesyren til, at antallet af dem igen steg, når de nåede frem til betingelserne i tyndtarmen.
English: An in-vitro study carried out using polymerase chain reaction (PCR) to investigate the effects of Symbioflor E. coli on epithelial cells (SW 480) from the human intestinal mucosa showed an upregulation of the cytokines IL-1β, TNF-α, GM-CSF and the chemokine IL-8.
Danish: En in vitro-undersøgelse udført ved anvendelse af polymerasekædereaktion (PCR) af virkningerne af Symbioflor E. coli på epitelceller (SW 480) fra human tarmmucosa har vist opregulering af cytokinerne IL-1β, TNF-α, GM-CSF og kemokinet IL-8.
English: In a non-interventional study with 203 children aged 4 - 18 years, that were diagnosed for having IBS based on the ROM III criteria for children, the overall assessment of efficacy for all 4 IBS subtypes was very good to good in more than 80 % of the children for both, the physician's and the patient/parent's assessment.
Danish: I en ikke-interventionsundersøgelse med 203 børn i alderen 4-18 år, der blev diagnosticeret med irritabel tyktarm på grundlag af ROM III-kriterierne, var den samlede vurdering af virkningen for alle 4 undertyper af irritabel tyktarm meget god hos over 80 % af børnene efter både lægens og patientens/forældrenes vurdering.
English: When the same volume was tested in the SHIME model (Simulation of the Human Intestinal Microbial Ecosystem) under conditions simulating food intake fewer bacteria were killed in the stomach while their numbers were relatively stable in the conditions simulating the upper gastrointestinal tract.
Danish: Når samme volumen blev testet i SHIME-modellen (Simulation of the Human Intestinal Microbial Ecosystem) (simulering af det humane økosystem i tyndtarmen) under betingelser, der simulerede fødeindtagelse, blev færre bakterier dræbt i ventriklen, mens deres antal var relativt stabilt under de betingelser, der simulerede den øvre del af mave-tarmkanalen.
English: The existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below] Summary of product characteristics
Danish: Den eksisterende produktinformation rettes (med indsættelse, erstatning eller i givet fald sletning af tekst) i overensstemmelse med den vedtagne ordlyd, som fremgår af nedenstående.
English: The overall assessment of tolerability was good to very good in more than 98 % of the children for both, the physician's and the patient/parent's assessment (see also section 4.8).
Danish: Den samlede vurdering af tolerabiliteten var god til meget god hos over 98 % af børnene efter både lægens og patientens/forældrenes vurdering (se også pkt.
English: Symbioflor E. coli has no or negligible influence on the ability to drive or use machines.
Danish: Symbioflor E. coli påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Talk to your doctor or pharmacist before taking Symbioflor E. coli.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Symbioflor E. coli.
English: If symptoms worsen during treatment or persist after 8 weeks of treatment, seek medical advice.
Danish: Hvis symptomerne bliver værre under behandlingen eller vedbliver efter 8 ugers behandling, skal du søge lægelig rådgivning.
English: Symbioflor E. coli with food and drink Take the drops during meals (see section 3 How to take Symbioflor E. coli)
Danish: Brug af Symbioflor E. coli sammen med mad og drikke Tag dråberne sammen med måltiderne (se afsnit 3 Sådan skal du tage Symbioflor E. coli)
English: In an in-vitro gastric exposure model mimicking the human stomach and ileus under fasting conditions 1 ml (less than a single dose) of Symbioflor E. coli was tested for the survivability of the E. coli production strain.
Danish: I en in vitro-model for gastrisk eksponering, der simulerede den humane ventrikel og ileus under fastende betingelser, blev 1 ml Symbioflor E. coli (mindre end en enkelt dosis) testet med hensyn til E. coli-produktionsstammens overlevelsesevne.
English: The qualitative effect on the gene expression in the mucosal epithelial cells, the key control elements of immune function in the human intestine, is similar to that exerted by the natural, physiological intestinal flora.
Danish: Den kvalitative virkning på genekspressionen i epitelceller fra mucosa, der er de vigtigste regulerende elementer af immunfunktionen i den humane tyndtarm, svarer til den, der udøves af den fysiologiske naturlige tarmflora.
English: Symbioflor E. coli should not be taken during a treatment with antibiotics or within 5 days after the end of such a treatment (see also section 4.5).
Danish: Symbioflor E. coli bør ikke bruges under behandling med antibiotika eller inden for 5 dage efter afslutningen af en sådan behandling (se også afsnit 4.5).
English: Do not take a double dose to make up for a forgotten dose, but continue taking the dosage prescribed.
Danish: Hvis du har glemt at tage Symbioflor E. coli Tag ikke en dobbeltdosis som erstatning for den glemte dosis, men fortsæt med den foreskrevne dosis.
English: The text below should be inserted by replacing the existing text of this section: Summary of safety profile
Danish: Nedenstående tekst indsættes som erstatning for den eksisterende tekst i dette afsnit: Oversigt over sikkerhedsprofilen
English: At the beginning of the treatment: 10 drops three-times daily.
Danish: Ved initiering af behandlingen: 10 dråber tre gange dagligt.
English: Pharmacotherapeutic group: Other immunostimulants, Antidiarrheal microorganisms ATC code: L03AX, A07FA
Danish: Nedenstående tekst indsættes som erstatning for den eksisterende tekst i dette afsnit: Farmakoterapeutisk gruppe: Andre immunstimulanter, tarmfloraregulerende mikroorganismer, ATC-kode: L03AX, A07FA