FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Lymphoseek, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Lymphoseek, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: A special camera that detects radiation is then used to see where the lymph nodes are and therefore where the cancer is likely to spread.
Danish: Derefter bruges et specielt kamera, som registrerer strålingen og gør det muligt at se hvor lymfeknuderne er, og dermed hvor kræften forventes at brede sig til.
English: In a third study in patients with cancer of the head and neck including mouth cancer, Lymphoseek was used to detect sentinel lymph nodes before patients had their lymph nodes removed surgically.
Danish: I en tredje undersøgelse hos patienter med hoved-hals-kræft, herunder mundhulekræft, blev Lymphoseek brugt til at påvise skildvagtlymfeknuder, før patienterne fik fjernet lymfeknuderne ved operation.
English: Lymphoseek is used in patients with breast cancer, melanoma (a skin cancer) and a type of cancer of the mouth known as squamous cell carcinoma.
Danish: Lymphoseek bruges hos patienter med brystkræft, hudkræft af typen melanom og mundhulekræft af typen pladecellekarcinom.
English: The blue dye is used during surgery to stain the lymph nodes so they can be seen and then checked for cancerous tissue.
Danish: Den blå farve bruges under operationen til at farve lymfeknuderne, så de kan ses og derefter kontrolleres for kræftvæv.
English: If the sentinel nodes are found to have no cancer then more extensive lymph nodal surgery can be avoided.
Danish: Hvis skildvagtlymfeknuderne viser sig at være fri for kræft, kan man undgå mere omfattende operation på lymfeknuderne.
English: Because it attaches to these proteins, the radiolabelled medicine builds up in the lymph nodes surrounding the cancer, making them visible with the special camera.
Danish: Når det radioaktivt mærkede lægemiddel bindes til disse proteiner, ophobes det i lymfeknuderne omkring kræften, så lymfeknuderne kan ses med specialkameraet.
English: Lymphoseek is a diagnostic medicine used in patients with cancer to identify sentinel lymph nodes.
Danish: Lymphoseek er et diagnostisk lægemiddel, der bruges hos kræftpatienter til at finde skildvagtlymfeknuder.
English: Lymphoseek is a solution that is injected either around or inside the cancerous tissue and and is expected to attach to and build up in the nearby lymph nodes.
Danish: Lymphoseek er en opløsning, der indsprøjtes enten omkring eller i kræftvævet og forventes at bindes til de omkringliggende lymfeknuder, så det ophobes der.
English: How is Lymphoseek used?
Danish: Hvordan anvendes Lymphoseek?
English: What benefits of Lymphoseek have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Lymphoseek?
English: When sentinel lymph nodes are found they are removed surgically and checked for cancer cells.
Danish: Når skildvagtlymfeknuderne er fundet, fjernes de ved operation og kontrolleres for kræftceller.
English: Before being injected into the patient, Lymphoseek is ‘radiolabelled', which means that it is tagged with a small amount of radiation.
Danish: Før lægemidlet indsprøjtes i patienten, mærkes det med radioaktivitet.
English: How does Lymphoseek work?
Danish: Hvordan virker Lymphoseek?
English: Given the importance of locating lymph nodes in the treatment of cancers and the manageable side effects seen with Lymphoseek, the Committee concluded that its benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Udvalget fandt derfor, at fordelene ved Lymphoseek overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse i EU.
English: • You are a woman trying to become pregnant.
Danish: • De er kvinde og forsøger at blive gravid.
English: • The other ingredients are:
Danish: • De øvrige indholdsstoffer er:
English: • if you are under 16 years of age
Danish: • hvis De er under 16 år
English: Your doctor will want to discuss your treatment from time to time.
Danish: Lægen vil drøfte Deres behandling med Dem af og til.
English: This increase is not generally important for most patients.
Danish: Denne øgning er generelt uvæsentlig for de fleste patienter.
English: • You are elderly (i.e., over 65 years of age).
Danish: • De er ældre (dvs. over 65 år).
English: This medicinal product is authorized in the Member States of the EEA under the following names: Austria
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Belgien
English: National competent authorities (NCA) shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Danish: De nationale kompetente myndigheder skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelsen:
English: • You are being treated for an infection.
Danish: • De er i behandling for en infektion.
English: Consult your doctor if you are unsure or need more advice.
Danish: Spørg Deres læge til råds, hvis De er usikker eller har brug for mere vejledning.
English: - The Committee considered the referral made under Article 6(12) of Commission Regulation EC No 1084/2003, for Arcoxia and associated names.
Danish: - Udvalget behandlede sagen, der var indbragt i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003, for Arcoxia og tilknyttede navne.
English: Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied.
Danish: Doser, der er højere end de anbefalede for hver indikation, har enten ikke vist yderligere effekt eller er ikke undersøgt.
English: Relative Risk (95% CI)
Danish: Relativ Risiko (95 % KI)
English: The potential for human risk in pregnancy is unknown.
Danish: Den potentielle risiko for mennesker er ukendt.
English: Between Treatment Comparison
Danish: Sammenligning mellem behandling
English: However, most hepatic adverse experiences in the MEDAL Program were non-serious.
Danish: De fleste hepatiske bivirkninger i MEDAL-programmet var dog ikke-alvorlige.
English: Do not take a double dose to make up for the forgotten tablet.
Danish: De må ikke tage en dobbeltdosis som erstatning for en glemt tablet.
English: These can increase your risk of heart disease.
Danish: Disse tilstande kan øge risikoen for hjertesygdom.
English: [Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000), not known (cannot be estimated from the available data)]
Danish: [Meget almindelig (≥1/10), Almindelig (> 1/100 til < 1/10), Ikke-almindelig (> 1/1000 til < 1/100), Sjælden (> 1/10.000 til < 1/1000), Meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data)]
English: Therefore, France sent a notification that was received by the EMEA on 19 September 2007 and a referral under Article 6 (12) of Commission Regulation EC No 1084/2003 was started on 20 September 2007.
Danish: Frankrig indgav derfor en meddelelse, som blev modtaget af EMEA den 19. september 2007, og den 20. september 2007 blev der indledt en indbringelsesprocedure i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr.
English: • if you have high blood pressure that has not been controlled by treatment (check with your doctor or nurse if you are not sure whether your blood pressure is adequately controlled)
Danish: • hvis De har forhøjet blodtryk, som ikke er velbehandlet (kontakt Deres læge eller sygeplejerske, hvis De ikke er sikker på, om Deres blodtryk er tilstrækkeligt behandlet).
English: Children and adolescents under 16 years of age.
Danish: Børn og unge under 16 år.
English: Do not use <ARCOXIA> after the expiry date which is stated on the pack.
Danish: Brug ikke ARCOXIA efter den udløbsdato, der står på pakningen.
English: Overall Safety:
Danish: Sikkerhed totalt:
English: The safety data and details from this program are presented in section 5.1.
Danish: Sikkerhedsdata og detaljer fra dette program ses i pkt.
English: 1123 Budapest
Danish: 1123 Budapest Hungary
English: It is important that you use the lowest dose that controls your pain and you should not take <ARCOXIA> for longer than necessary.
Danish: Det er vigtigt, at De tager den mindste dosis, der kan lindre Deres smerter, og De bør ikke tage ARCOXIA i længere tid end nødvendigt.
English: • if you are or could be pregnant or are breast-feeding (see ‘Pregnancy and breast feeding')
Danish: • hvis De er eller kan være gravid, eller hvis De ammer (se "Graviditet og amning")
English: Do not take more than the recommended dose for your condition.
Danish: Tag ikke mere end den anbefalede dosis til behandling af Deres tilstand.
English: Use of gastroprotective agents and low dose aspirin were permitted in the studies.
Danish: Brug af gastroprotektive lægemidler og lavdosis aspirin var tilladt i undersøgelserne.
English: This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.
Danish: Dette skyldes, at risikoen for hjerteanfald og slagtilfælde kan stige efter længere tids behandling, især ved høje doser.
English: These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Disse tilhører en gruppe lægemidler, der kaldes nonsteroide antiinflammatoriske lægemidler (NSAID).
English: Blood pressure should be monitored within two weeks after initiation of treatment and periodically thereafter.
Danish: Blodtrykket bør monitoreres inden for to uger efter initiering af behandling og herefter regelmæssigt.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs hele denne indlægsseddel grundigt, inden De begynder at tage medicinen.
English: • rifampicin (an antibiotic)
Danish: • Rifampicin (et antibiotikum).
English: If you are elderly (i.e., over 65 years of age), your doctor will want to appropriately keep a check on you.
Danish: Hvis De er ældre (dvs. over 65 år), vil lægen undersøge Dem regelmæssigt.
English: Take <ARCOXIA> Tablets by mouth once a day.
Danish: Tag ARCOXIA-tabletten én gang dagligt gennem munden.
English: The following side effects can occur during treatment with <ARCOXIA>:
Danish: Følgende bivirkninger kan forekomme under behandling med ARCOXIA:
English: • You have diabetes, high cholesterol, or are a smoker.
Danish: • De har diabetes, forhøjet kolesterol eller er ryger.
English: Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion.
Danish: Renale prostaglandiner kan spille en kompensatorisk rolle i opretholdelse af renal perfusion.
English: Patients enrolled in the Program had a wide range of cardiovascular and gastrointestinal risk factors at baseline.
Danish: De patienter, der blev inkluderet i programmet, havde en lang række kardiovaskulære og gastrointestinale risikofaktorer ved baseline.
English: In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
Danish: Såfremt der ikke ses en øget terapeutisk effekt, bør andre terapeutiske muligheder overvejes.
English: Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled.
Danish: Patienter med hypertension, hvor blodtrykket er vedvarende forhøjet over 140/90mmHg og ikke er tilfredsstillende kontrolleret.
English: If you miss a dose, just resume your usual schedule the following day.
Danish: Hvis De glemmer en dosis, skal De blot genoptage behandlingen næste dag.
English: METHOD OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE Oral anvendelse.
English: <ARCOXIA> works equally well in older and younger adult patients.
Danish: ARCOXIA virker lige godt hos ældre og yngre voksne patienter.
English: What is ankylosing spondylitis?
Danish: Hvad er ankyloserende spondylitis?
English: Events per 100 Patient-Years; CI=confidence interval N=total number of patients included in Per-protocol population
Danish: Intent-to-treat †Hændelser pr. 100 patientår; KI=Konfidensinterval N=samlet antal patienter inkluderet i per-protocol-populationen
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Intent-to-treat: all confirmed events up to the end of the trial (included patients potentially exposed to non-study interventions following discontinuation of study medication).
Danish: Intent-to-treat: Alle bekræftede hændelser op til slutningen af undersøgelsen (inklusive patienter, der potentielt blev eksponeret for indgreb, der ikke hørte til undersøgelsen, efter ophør med studiemedicinen).
English: These beneficial effects were maintained over the 12-week treatment periods.
Danish: Den gavnlige effekt blev opretholdt over behandlingsperioden på 12 uger.
English: It is important to take <ARCOXIA> as your doctor has prescribed.
Danish: Det er vigtigt, at De tager ARCOXIA, som lægen har foreskrevet.
English: Do not use any tools or machines if you experience dizziness or sleepiness.
Danish: Brug ikke værktøj eller maskiner, hvis De oplever svimmelhed eller søvnighed.
English: If you do take too many <ARCOXIA> tablets, you should seek medical attention immediately.
Danish: Hvis De tager for mange ARCOXIA-tabletter, skal De straks søge lægebehandling.
English: • The active substance is etoricoxib.
Danish: • Det aktive stof er etoricoxib.
English: The 30 mg dose has not been studied in osteoarthritis of hands.
Danish: 30 mg er ikke blevet undersøgt til osteoarthrose i hænderne.
English: The onset of the effect of the medicinal product may be faster when <ARCOXIA> is administered without food.
Danish: Virkningen af lægemidlet kan indtræde hurtigere når ARCOXIA administreres uden mad.
English: The cardiorenal results for EDGE and EDGE II were consistent with those described for the MEDAL Study.
Danish: De kardiorenale resultater for EDGE og EDGE II var i overensstemmelse med de resultater, der er beskrevet for MEDAL-undersøgelsen.
English: Renal Function Study in the Elderly
Danish: Nyrefunktionsundersøgelse hos ældre
English: Healthcare professionals were to be reminded of these measures through a communication letter (DHCP).
Danish: Lægefaglige personer skulle mindes om disse tiltag gennem et informationsbrev.
English: Very rare: hypertensive crisis.
Danish: Meget sjælden: Hypertensiv krise.
English: LIST OF EXCIPIENTS Lactose (see leaflet for more information).
Danish: LISTE OVER HJÆLPESTOFFER Lactose (se indlægssedlen for yderligere information).
English: • yellowing of the skin and eyes (jaundice) - these are signs of liver problems
Danish: • gulfarvning af hud og øjne (gulsot) - dette er tegn på leversygdom
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Hvis De har yderligere spørgsmål om brugen af denne medicin, skal De spørge lægen eller på apoteket.
English: Box 581
Danish: P.O Box 581
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN FREMLAGT AF EMEA
English: Per-protocol: all events on study therapy or within 14 days of discontinuation (excluded: patients who took < 75% of their study medication or took non-study NSAIDs >10% of the time).
Danish: Per-protocol: Alle hændelser under behandling i undersøgelsen eller inden for 14 dage efter seponering (ekskluderede: Patienter, som tog <75 % af studiemedicinen eller tog NSAID, der ikke hørte til undersøgelsen >10 % af tiden).
English: Approximately 50% of patients enrolled in the MEDAL study had a history of hypertension at baseline.
Danish: Ca. 50 % af de patienter, der var inkluderet i MEDAL-undersøgelsen, havde ved baseline hypertension i anamnesen.
English: <ARCOXIA> can be taken with or without food.
Danish: ARCOXIA kan tages med eller uden mad.
English: Etoricoxib may slightly increase your risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke
Danish: Etoricoxib kan medføre let øget risiko for hjerte- og slagtilfælde, og derfor bør det ikke anvendes af dem, som tidligere har haft hjerteproblemer eller slagtilfælde
English: • an allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the face,
Danish: • allergisk reaktion - som kan medføre hudproblemer såsom sår eller blærer, eller hævelse af ansigt,
English: lips, tongue, or throat which may cause difficulty in breathing
Danish: læber, tunge eller svælg, som kan medføre besvær med at trække vejret.
English: Very rare: peptic ulcers including gastrointestinal perforation and bleeding (mainly in the elderly).
Danish: Meget sjælden: Peptisk ulcera inklusive gastrointestinal perforation og blødning (hovedsageligt hos ældre).
English: If you become pregnant, stop taking the tablets and consult your doctor.
Danish: Hvis De bliver gravid, skal De stoppe med at tage tabletterne og kontakte Deres læge.
English: Take special care with <ARCOXIA> <ARCOXIA> may not be suitable for you, or you may need to be monitored regularly while taking it if any of the following apply to you:
Danish: Vær ekstra forsigtig med at tage ARCOXIA ARCOXIA er måske ikke egnet for Dem, eller måske er det nødvendigt, at lægen følger Dem regelmæssigt, mens De tager medicinen, hvis noget af det følgende passer på Dem:
English: As with other drugs, caution should be exercised in elderly patients (see section 4.4).
Danish: Som med andre lægemidler bør der udvises forsigtighed hos ældre patienter (se pkt.
English: No studies on the effect of etoricoxib on the ability to drive or use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen af etoricoxib på evnen til at føre motorkøretøj eller betjene maskiner.
English: Important information about some of the ingredients of <ARCOXIA> <ARCOXIA> contains lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i ARCOXIA ARCOXIA indeholder lactose.
English: Etoricoxib was included in previous CHMP referrals on the safety of COX-2 selective inhibitors in which concluded in 2004 and 2005.
Danish: Etoricoxib var omfattet af tidligere indbringelser for CHMP om sikkerheden af selektive COX-2hæmmere, som blev afsluttet i 2004 og 2005.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Patienterne bør hydreres tilfredsstillende, og det bør overvejes at monitorere nyrefunktionen efter initiering af kombinationsbehandling samt regelmæssigt herefter.
English: What is gout?
Danish: Hvad er slidgigt?
English: The CHMP therefore recommends the strengthening of the contraindication in hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially within 2 weeks of treatment initiation.
Danish: CHMP anbefaler derfor, at kontraindkationen for patienter med hypertension skærpes, og at de ordinerende læger skal advares om, at patientens blodtryk skal overvåges, især i de første to uger efter behandlingsstart.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC Code: M01 AH05
Danish: Farmakoterapeutisk gruppe: Antiinflammatoriske og antirheumatiske lægemidler, non-steriod, coxiber, ATC-kode: M01 AH05
English: The clinical significance of these increases is unknown, and higher doses of PREMARIN were not studied in combination with etoricoxib.
Danish: Den kliniske signifikans af disse stigninger er ukendt, og højere doser af Premarin, givet i kombination med etoricoxib, er ikke undersøgt.
English: Like all medicines, <ARCOXIA> can cause side effects, although not everybody gets them.
Danish: ARCOXIA kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) Program The MEDAL Program was a prospectively designed Cardiovascular (CV) Safety Outcomes Program of pooled data from three randomized, double-blind active comparator controlled trials, the MEDAL study, EDGE II and EDGE.
Danish: Multinationalt Etoricoxib og Diclofenac Arthritis Long-term (MEDAL) Program: MEDAL-programmet var et prospektivt designet kardiovaskulært Safety Outcomes Program med poolede data fra tre randomiserede, dobbeltblindede aktive komparatorkontrollerede undersøgelser, MEDAL, EDGE II og EDGE.
English: • <ARCOXIA> is one of a group of medicines called selective COX-2 inhibitors.
Danish: • ARCOXIA tilhører en gruppe af lægemidler, der kaldes selektive COX-2-hæmmere.
English: The CHMP reviewed the data submitted by the marketing authorisation holders from clinical trials, drug utilisation studies and spontaneous reporting of adverse drug reactions.
Danish: CHMP gennemgik de af indehaverne af markedsføringstilladelsen indsendte data fra kliniske undersøgelser, undersøgelser af lægemiddelbrug og spontane rapporteringer af bivirkninger.
English: Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
Danish: Svær leverdysfunktion (serumalbumin <25 g/l eller Child Pugh score ≥ 10).
English: <ARCOXIA> can mask or hide a fever, which is a sign of infection.
Danish: ARCOXIA kan sløre eller skjule feber, som er tegn på infektion.
English: The CHMP therefore recommends that dose finding studies are explored to conclude if treatment with 60mg once daily would also be adequate for some patients.
Danish: CHMP anbefaler derfor, at data fra dosisundersøgelserne undersøges nærmere, før man kan konkludere, om behandling med 60 mg én gang daglig også kan være tilstrækkeligt for nogle patienter.
English: Following concerns of a possible increased cardiovascular (CV) risk related to the use of the 90mg dose of etoricoxib, France considered that a review of the benefit/risk profile of Arcoxia was needed.
Danish: Efter at der var udtrykt betænkeligheder ved en mulig øget kardiovaskulær (CV) risiko i forbindelse med brug af dosen på 90 mg etoricoxib, anså Frankrig, at der var behov for en revurdering af benefit/risk-forholdet for Arcoxia.
English: <ARCOXIA> Tablets are available in four strengths:
Danish: ARCOXIA-tabletter fås i fire styrker:
English: <ARCOXIA> is administered orally and may be taken with or without food.
Danish: ARCOXIA administreres oralt og kan tages med eller uden mad.
English: No dosage adjustment is necessary for elderly patients.
Danish: Justering af dosis er ikke nødvendig hos ældre.
English: This increase in EE concentration should be considered when selecting an oral contraceptive for use with etoricoxib.
Danish: Denne øgning af EØ-koncentrationen bør overvejes, når der vælges oral antikonception til anvendelse sammen med etoricoxib.
English: Etoricoxib is an inhibitor of human sulfotransferase activity, particularly SULT1E1, and has been shown to increase the serum concentrations of ethinyl estradiol.
Danish: Etoricoxib har en hæmmende effekt på den humane sulfotransferase aktivitet, specielt SULT1E1, og er påvist at øge serumkoncentrationen af ethinylestradiol.
English: Cyclosporin and tacrolimus: Although this interaction has not been studied with etoricoxib, coadministration of cyclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of cyclosporin or tacrolimus.
Danish: Ciclosporin og tacrolimus: Selvom denne interaktion ikke er undersøgt med etoricoxib, kan samtidig administration af ciclosporin eller tacrolimus og et hvilket som helst NSAID øge den nefrotoksiske effekt af ciclosporin eller tacrolimus.
English: Drug utilisation data showed that some patients with high blood pressure are being initiated on etoricoxib.
Danish: Dataene for lægemiddelbrug viste, at nogle patienter med højt blodtryk sættes i behandling med etoricoxib.