FrancophonIA/ELRC3.0 huggingface dataset:
English: Geriatrics 2006; 61: 31-33 5 Nitche J et al Subtrochanteric femoral stress fractures in patients on chronic bisphosphonate therapy: a case series.
Danish: 5 Nitche J et al Subtrochanteric femoral stress fractures in patients on chronic bisphosphonate therapy: a case series.
English: In addition, given the lack of evidence regarding the optimal duration of bisphosphonate treatment for osteoporosis, and considering that duration of treatment is a risk factor for atypical femoral fractures, the CHMP also recommended that information should be added to section 4.2. of the product information for bisphosphonates authorised for osteoporosis, about the need to periodically evaluate the need for continuing bisphosphonate treatment, particularly after 5 years of treatment, on an individual patient basis.
Danish: På grund af den manglende dokumentation vedrørende den optimale varighed af behandling med bisfosfonater, og i betragtning af at behandlingens varighed er en risikofaktor for atypiske femurfrakturer, anbefalede CHMP desuden at tilføje information i punkt 4.2. i produktresuméer for http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=05caf316-b73e-47b8-a011-bf0766b062c0.
English: You can take them with or without food.
Danish: Du kan tage dem med eller uden mad.
English: • You plan to become pregnant.
Danish: • Du planlægger at blive gravid.
English: Because of this, there is an increased risk of skin cancer.
Danish: Af denne grund er der en øget risiko for hudkræft.
English: • changes in different laboratory parameters
Danish: • ændringer i forskellige laboratorieparametre
English: Information concerning the following antibiotics is available:
Danish: Oplysninger om følgende antibiotika er tilgængelige:
English: The educational materials should be implemented within four months after completion of this procedure and shall contain the following key elements:
Danish: Uddannelsesmaterialet skal implementeres inden for 4 måneder efter afslutning af denne procedure og skal indeholde følgende hovedemner:
English: Talk to your doctor about the most suitable contraception for you.
Danish: Kontakt lægen om den bedst egnede prævention for dig.
English: • Do you need to receive vaccines (live vaccines)?
Danish: • Skal du vaccineres (levende vaccine)?
English: This dose achieved MPA AUC
Danish: Med denne dosis opnåedes MPA AUC
English: It is important not to take too many capsules.
Danish: Det er vigtigt ikke at indtage for mange kapsler.
English: Talk to a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Kontakt straks lægen, hvis du bemærker nogle af de følgende alvorlige bivirkninger - du kan have behov for akut medicinsk behandling:
English: Your treatment is started and monitored by a doctor who is specialised in transplants.
Danish: Din behandling startes af og overvåges af en læge, som er specialiseret i transplantationer.
English: Date of first authorisation: 21 February 2008 Date of first renewal: 19 November 2012
Danish: Dato for første markedsføringstilladelse: 21. februar, 2008 Dato for seneste fornyelse: 19. november 2012
English: • serious infection which may affect the whole body
Danish: • alvorlig infektion, som kan påvirke hele kroppen
English: Your doctor will decide the most appropriate dose based on body surface area (height and weight).
Danish: Din læge afgør den mest passende dosis baseret på legemsoverfladens areal (højde og vægt).
English: In many of these cases, no adverse events were reported.
Danish: I adskillige af disse tilfælde blev der ikke rapporteret bivirkninger.
English: These may be signs of bleeding in the stomach or intestines.
Danish: Det kan være tegn på blødning i mave eller tarm.
English: If you forget to take your medicine at any time, take it as soon as you remember, then continue to take it at the usual times.
Danish: Hvis du på noget tidspunkt har glemt at tage medicinen, skal du tage den, så snart du kommer i tanke om det. Fortsæt derefter med at tage den til de sædvanlige tider.
English: Povidone K-30
Danish: Povidon K-30
English: • You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have treatment for cancer, then there is still a chance you could become pregnant).
Danish: • Du har passeret overgangsalderen, dvs. er mindst 50 år, og din sidste menstruation var for mere end et år siden (hvis din menstruation er stoppet, fordi du er blevet behandlet for kræft, er der stadigvæk mulighed for, at du kan blive gravid).
English: Children and adolescents (aged 2 to 18)
Danish: Børn og unge (2-18 år)
English: Hepatic transplant patients were followed for at least 1°year, but less than 3°years.
Danish: Levertransplanterede patienter fulgtes i mindst 1 år, men i mindre end 3 år.
English: The dose given will vary depending on the size of the child.
Danish: Dosis afhænger af barnets størrelse.
English: These changes are not associated with impaired neutrophil function.
Danish: Ændringerne er ikke associerede med en svækket neutrophilfunktion.
English: • insufficient production of red blood cells
Danish: • utilstrækkelig produktion af røde blodceller
English: It is important not to take too many tablets.
Danish: Det er vigtigt ikke at indtage for mange tabletter.
English: The pharmacodynamic profile and the reported adverse reactions indicate that an effect is unlikely.
Danish: Den farmakodynamiske profil og de rapporterede bivirkninger peger på, at en påvirkning er usandsynlig.
English: See also further information in this section under “Warnings and precautions” and “Pregnancy, contraception and breast-feeding”.
Danish: Se også yderligere information i dette afsnit under ”Advarsler og forsigtighedsregler” og ”Graviditet, prævention og amning”.
English: There are limited safety and efficacy data in children below the age of 2°years.
Danish: For børn under 2 år er der begrænsede data om sikkerhed og virkning.
English: It is not known whether this substance is excreted in human milk.
Danish: Det er ukendt, om dette lægemiddel udskilles i human mælk.
English: Avoid contact with any powder that spills out from damaged capsules.
Danish: Undgå kontakt med pulver fra itugåede kapsler.
English: • too much acid in the body
Danish: • for megen syre i kroppen
English: • if you have or ever have had any problems with your digestive system, e.g. stomach ulcers.
Danish: - Hvis du har eller nogensinde har haft problemer med dit fordøjelsessystem, f.eks. mavesår.
English: Most (about 87%) of the administered dose is excreted in the urine as MPAG.
Danish: Det meste (ca. 87 %) af den administrerede dosis udskilles i urinen som MPAG.
English: Separate guides for healthcare professionals and patients should be provided.
Danish: Der skal udleveres vejledninger til henholdsvis sundhedspersonale og patienter.
English: 50 tablets 150 tablets 50 x 1 tablets
Danish: 50 tabletter 150 tabletter 50x1 tabletter
English: Swallow your tablets whole with a glass of water.
Danish: Synk tabletterne hele med et glas vand.
English: MPA AUC values across age groups were similar in the early and late post-transplant period.
Danish: MPA AUC værdier mellem aldersgrupper var sammenlignelige i den tidlige og sene posttransplantationsperiode.
English: Myfenax reduces your body's defence mechanism.
Danish: Myfenax nedsætter din organismes forsvarsmekanismer.
English: • high level of sugar in the blood
Danish: • højt niveau af sukker i blodet
English: Do not break or crush them.
Danish: De må ikke brækkes over eller knuses.
English: It is important to take the medicine for as long as the doctor has told you to.
Danish: Det er vigtigt at indtage medicinen så lang tid, som din læge har fortalt dig.
English: However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.
Danish: Derimod skal der foretages en nøje klinisk monitorering under behandlingskombinationen samt kort tid efter den antibiotiske behandling.
English: 100 capsules 300 capsules 100 x 1 capsules
Danish: 100 kapsler 300 kapsler 100x1 kapsler
English: • You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner`s syndrome or uterine agenesis.
Danish: • Du blev født med en af følgende sjældne tilstande, som gør graviditet umulig: XY-genotype, Turners syndrom eller manglende livmoder.
English: A negligible amount of substance is excreted as MPA (<°1% of dose) in the urine.
Danish: Ubetydelige mængder af stoffet udskilles som MPA (< 1 % af dosis) i urinen.
English: However, MPA Cmax was decreased by 40% in the presence of food.
Danish: MPA C max var dog nedsat med 40 % i nærvær af føde.
English: • you have black or bloody stool or if you vomit blood or dark particles that look like coffee grounds.
Danish: • din afføring er sort eller blodig, eller du kaster blod op eller mørke partikler, der ligner kaffegrums.
English: Swallow your capsules whole with a glass of water.
Danish: Synk kapslerne hele med et glas vand.
English: • you have any unexpected bruising or bleeding.
Danish: • du har uventede blå mærker eller blødninger.
English: 2031 GA Haarlem The Netherlands
Danish: 2031 GA Haarlem Nederlandene
English: EU/1/07/438/003 (50 tablets) EU/1/07/438/004 (150 tablets) EU/1/07/438/005 (50 x 1 tablets)
Danish: EU/1/07/438/003 (50 tabletter) EU/1/07/438/004 (150 tabletter) EU/1/07/438/005 (50x1 tabletter)
English: • Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist).
Danish: • Dine æggestokke er ophørt med at fungere (for tidligt ovariesvigt, som er blevet bekræftet af en speciallæge i gynækologi).
English: The health professional educational material should contain:
Danish: Uddannelsesmaterialet for sundhedspersonale skal indeholde:
English: Do not stop taking your medicine unless you have discussed this with your doctor first.
Danish: Stop ikke med at tage din medicin, med mindre du først har talt med din læge.
English: Potential interaction
Danish: Potentielle interaktioner
English: • Septum pellucidum agenesis;
Danish: • septum pellucidum agenesi;
English: If you answer yes to any of the following questions talk to your doctor before you start to take Myfenax:
Danish: Hvis du kan svare ja til nogen af de følgende spørgsmål, skal du tale med din læge, før du begynder at tage Myfenax:
English: • you have a sign of infection such as a fever or sore throat.
Danish: • du har tegn på infektion, såsom feber eller ondt i halsen.
English: MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.
Danish: MPA er en potent, selektiv, ikke-kompetitiv og reversibel inhibitor af inosin-monophosfat-dehydrogenase og hæmmer derfor de novo vejen for en guanosin-nucleotid- syntese uden inkorporering i DNA.
English: The change in predose level may not accurately represent changes in overall MPA exposure.
Danish: Ændringen i præ-dosisniveauet viser ikke nødvendigvis et præcist billede af ændringerne i den samlede MPA-eksponering.
English: Therefore you should limit your exposure to sunlight and ultraviolet (UV) light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
Danish: Derfor skal du begrænse din udsættelse for sollys og ultraviolet (UV) lys ved hjælp af beskyttende beklædning og solblokker med høj beskyttelsesfaktor.
English: In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the medicinal product.
Danish: I de tilfælde af overdosering, hvor der var bivirkninger, fandtes disse at være inden for den kendte sikkerhedsprofil for lægemidlet.
English: Treatment will continue for you as long as you need immunosuppression to prevent your body from rejecting your transplanted organ.
Danish: Behandlingen skal fortsætte så længe, du har behov for at få nedsat immunforsvaret, for at hindre at din krop afstøder det transplanterede organ.
English: Medicinal products that interfere with enterohepatic circulation (e.g. cholestyramine, ciclosporin A, antibiotics)
Danish: Lægemidler som interfererer med den enterohepatiske cirkulation (f.eks. colestyramin, ciclosporin A, antibiotika)
English: It is recommended, however, to administer Myfenax at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Danish: Myfenax bør imidlertid administreres mindst én time før eller tre timer efter indtagelsen af sevelamer for at minimere dets indvirkning på MPA-absorptionen.
English: • Counselling of patients: This section will emphasise the importance of a thorough, informative and ongoing dialogue between patient and healthcare professional about the pregnancy risks associated with mycophenolate mofetil and the relevant minimisation strategies including alternative treatment choices, if applicable.
Danish: • Vejledning til patienter: Dette afsnit skal understrege vigtigheden af en grundig, informativ og løbende dialog mellem patient og sundhedspersonale omkring de graviditetsrisici, der er forbundet med mycophenolatmofetil, og de relevante minimeringsstrategier, herunder alternative behandlingsmuligheder, hvis det er relevant.
English: Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Danish: Det bør derfor undgås til patienter med sjældne arvelig mangel på hypoxantin-guanin-fosforibosyltransferase (HGPRT) såsom LeschNyhan og Kelley-Seegmiller syndrom.
English: Talk to your doctor if you develop a persistent cough or breathlessness.
Danish: Kontakt lægen, hvis du udvikler vedvarende hoste eller kortåndethed.
English: Non-melanoma skin carcinomas occurred in 3.6% of patients; other types of malignancy occurred in 1.1% of patients.
Danish: Nonmelanom hudcancer indtraf hos 3,6 % af patienterne og andre maligniteter hos 1,1 %.
English: • severe reduction in the number of certain white blood cells (possible symptoms are fever, sore throat, frequent infections) (agranulocytosis)
Danish: • betydelig reduktion af antallet af visse hvide blodceller (mulige symptomer er feber, ondt i halsen, hyppige infektioner) (agranulocytose).
English: Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 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).Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver systemorganklasse er bivirkninger opstillet efter frekvens under anvendelse af følgende kategorier: 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 estimeres ud fra forhåndenværende data).
English: Serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH) and progesterone were not significantly affected.
Danish: Serumnivauet af luteiniserende hormon (LH), follikelstimulerende hormon (FSH) og progesteron blev ikke signifikant påvirket.
English: However, the following treatment-related adverse events were more frequent in the paediatric population, particularly in children under 6°years of age, when compared to adults: diarrhoea, sepsis, leucopenia, anaemia and infection.
Danish: Imidlertid var følgende behandlingsrelaterede bivirkninger hyppigere i den pædiatriske population, især hos børn under 6 år, sammenlignet med voksne: diarré, sepsis, leukopeni, anæmi og infektion.
English: Contraceptive requirements for sexually active male patients (including vasectomised men) and female patients of childbearing potential will be explained.
Danish: Kravene til prævention for seksuelt aktive mandlige patienter (herunder vasektomerede mænd) og for kvindelige patienter i den fertile alder skal forklares.
English: • high level of potassium in the blood, low level of potassium, magnesium, calcium and/or phosphate in the blood
Danish: • højt niveau af kalium i blodet, lavt niveau af kalium, magnesium, calcium og/eller fosfat i blodet
English: It will explain that although this guide is very important it does not provide full information on mycophenolate mofetil and that the SmPC (healthcare professionals) and package leaflet (patients) supplied with the medicine must also be read carefully.
Danish: Vejledningen skal forklare, at selv om denne vejledning er meget vigtig, så indeholder den ikke al information om mycophenolatmofetil, og at produktresuméet (sundhedspersonale) og indlægssedlen (patienter), som findes i pakningen med lægemiddel, skal også læses grundigt.
English: Gastrointestinal
Danish: Gastrointestinale
English: • you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).
Danish: • du har et udslæt, hævelse af ansigt, læber, tunge eller halsen, med vejrtrækningsbesvær - du kan have en alvorlig allergisk reaktion på lægemidlet (såsom anafylaksi, angioødem).
English: EU/1/07/438/001 (100 capsules) EU/1/07/438/002 (300 capsules) EU/1/07/438/006 (100 x 1 capsules)
Danish: EU/1/07/438/001 (100 kapsler) EU/1/07/438/002 (300 kapsler) EU/1/07/438/006 (100x1 kapsler)
English: Additional adverse reactions reported during post-marketing are described below with the frequencies reported within brackets if known.
Danish: Andre bivirkninger, som er indberettet efter markedsføringen, beskrives nedenfor med frekvenserne angivet i parentes, hvis de er kendt.
English: The antibody response to other vaccines may be diminished (see also section 4.4).
Danish: Antistofresponset overfor andre vacciner kan nedsættes (se også pkt.
English: Patients taking Myfenax should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment then monthly through the first year.
Danish: Patienter på Myfenax bør have foretaget fuldstændig blodtælling hver uge den første måned, to gange om måneden den anden og tredie behandlingsmåned og derefter en gang om måneden igennem det første år.
English: • decrease in the number of certain white blood cells (neutropenia)
Danish: • fald i antallet af visse hvide blodceller (neutropeni)
English: Oral administration of radiolabelled mycophenolate mofetil results in complete recovery of the administered dose; with 93% of the administered dose recovered in the urine and 6% recovered in the faeces.
Danish: Oral administration af radioaktivt mærket mycophenolatmofetil resulterede i fuldstændig genfinding af den administrerede dosis: 93 % af den administrerede dosis genfundet i urinen og 6 % genfundet i fæces.
English: • bacterial infections usually resulting in a serious lung disorder (tuberculosis, atypical mycobacterial infection)
Danish: • bakterieinfektioner, der sædvanligvis resulterer i en alvorlig lungesygdom (tuberkulose, atypisk mycobakteriel infektion)
English: If any powder gets into your eyes or mouth, rinse thoroughly with plenty of plain, fresh water.
Danish: Hvis du får pulver fra en itugået kapsel i øjnene eller i munden, skal du skylle grundigt med rigeligt, frisk vand.
English: The information provided in this section will facilitate a correct understanding of the risk and explain the rationale for the following pregnancy prevention measures.
Danish: Informationen i dette afsnit skal sikre en korrekt forståelse for risikoen og forklare formålet med forholdsreglerne for at undgå graviditet.
English: • decrease in the number of white blood cells, platelets or red blood cells, which can result in increased risk of infections, bruising, bleeding, breathlessness and weakness
Danish: • fald i antallet af hvide blodceller, blodplader eller røde blodceller, hvilket kan resultere i en øget risiko for infektioner, blå mærker, blødninger, kortåndethed og svaghed
English: Myfenax should not be used at all in children under 2 years old.
Danish: Myfenax bør under ingen omstændigheder anvendes til børn under 2 år.
English: • Your womb (uterus) has been removed by surgery (hysterectomy).
Danish: • Din livmoder (uterus) er blevet fjernet ved operation (hysterektomi).
English: Serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Danish: Alvorlige, livstruende infektioner inklusive meningitis, endocarditis, tuberkulose og atypisk mycobakteriel infektion.
English: Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23-27%) in the unborn baby.
Danish: Mycophenolat forårsager en meget høj frekvens af aborter (50 %) og svære misdannelser (23-27 %) hos det ufødte barn.
English: Conversely, changes of MPA exposure should be expected when switching patients from CsA to one of the immunosuppressants which does not interfere with MPA´s enterohepatic cycle.
Danish: Ligeledes bør der forventes ændringer i eksponeringen af MPA hos patienter, som skifter fra CsA til et af de immunsuppressiva, som ikke interfererer med MPAs enterohepatiske kredsløb.
English: • inflammation of the tissue that lines the inner wall of the abdomen and covers most of the abdominal organs
Danish: • betændelse i det væv, der dækker den indre væg af bughulen (abdomen) og dækker de fleste organer i bughulen
English: Myfenax should be administered with caution in patients with active serious digestive system disease.
Danish: Myfenax bør administreres med forsigtighed til patienter med aktiv alvorlig sygdom i fordøjelsessystemet.
English: However, at high MPAG plasma concentrations (>°100 µg/mL), small amounts of MPAG are removed.
Danish: Ved høje MPAGplasmakoncentrationer (> 100 µg/ml) fjernes dog mindre mængder MPAG.
English: • An introduction in each guide will inform the reader that the purpose of the guide is to tell them that a foetal exposure must be avoided and how to minimize the risk of birth defects and miscarriage associated with mycophenolate mofetil.
Danish: • Introduktionen til vejledningerne skal informere læseren om, at formålet med vejledningen er at informere om, at føtal eksponering skal undgås, og hvorledes risikoen for medfødte misdannelser og aborter, som er forbundet med mycophenolatmofetil, minimeres.
English: Ciprofloxacin or amoxicillin plus clavulanic acid
Danish: Ciprofloxacin eller amoxicillin plus clavulansyre
English: • decrease in the number of all blood cells, increase in the number of white blood cells
Danish: • fald i antallet af alle blodceller, stigning i antallet af hvide blodceller
English: Pregnancy tests should be repeated as clinically required (e.g. after any gap in contraception is reported).
Danish: En ny graviditetstest skal udføres som klinisk indiceret (f.eks. efter rapportering af manglende kontraception).
English: Telmisartan changes MPA's elimination by enhancing PPAR gamma (peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced UGT1A9 expression and activity.
Danish: Telmisartan ændrer eliminationen af MPA ved at øge ekspressionen af PPAR-gamma (peroxisom-proliferator-aktiveret receptor gamma), hvilket resulterer i en øget UGT1A9-ekspression og -aktivitet.
English: It is recommended that mycophenolate mofetil should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
Danish: Mycophenolatmofetil bør ikke administreres sammen med azathioprin, da en sådan samtidig administration ikke er blevet undersøgt.
English: Microcrystalline cellulose Povidone K-30
Danish: Mikrokrystallinsk cellulose Povidon K-30
English: Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.
Danish: Kontakt lægen så hurtigt som muligt, hvis du tror at din prævention har svigtet, eller hvis du har glemt at tage de svangerskabsforebyggende tabletter (f.eks. p-piller).