FrancophonIA/ELRC3.0 huggingface dataset:
English: Also try not to get it on your skin, inside your mouth or nose.
Danish: Undgå også at få pulveret på huden og ind i mund eller næse.
English: Pull the plunger out slowly.
Danish: Træk stemplet langsomt tilbage.
English: This needs mixing with purified water before using.
Danish: Pulveret skal blandes med renset vand før anvendelse.
English: Patients in all study arms also received cyclosporine and corticosteroids.
Danish: Alle patienter i alle behandlingsarmene fik også ciclosporin og kortikosteroider.
English: Treatment with CellCept should be initiated and maintained by appropriately qualified transplant specialists.
Danish: Behandling med CellCept bør påbegyndes og fortsættes af specialister med særligt kendskab til transplantationer.
English: Keep solutions at 15 - 30° C.
Danish: Opløsninger opbevares ved 15 - 30 °C.
English: You need to use the dispenser and bottle adapter supplied with the medicine to measure the dose.
Danish: Indtagelse af medicinen Du skal bruge en dispenser og flaskeadaptor, som følger med medicinen, til at udmåle dosis.
English: PVC/aluminium foil blister strips
Danish: PVC/aluminium blisterfolie
English: A bottle adapter and 2 oral dispensers are also provided.
Danish: Endvidere medfølger en flaskeadaptor og 2 orale dispensere.
English: Write the date of expiration of the reconstituted suspension on the bottle label.
Danish: Skriv udløbsdatoen for den rekonstituerede suspension på flaskens etiket.
English: These changes may suggest a ‘left shift' in the maturity of neutrophils in haematological investigations, which may be mistakenly interpreted as a sign of infection in immunosuppressed patients such as those that receive CellCept.
Danish: Hæmatologiske analyser antyder, at disse ændringer er et ”venstre skift” i modenhed af neutrofilerne, som fejlagtigt kan blive tolket som et tegn på infektion hos immunsupprimerede patienter, som dem der behandles med CellCept.
English: • telmisartan - used to treat high blood pressure
Danish: • telmisartan - bruges til behandling af forhøjet blodtryk
English: • antibiotics - used to treat bacterial infections
Danish: • antibiotika - bruges til behandling af bakterielle infektioner
English: LIST OF EXCIPIENTS Also contains aspartame (E951) and methyl parahydroxybenzoate (E218).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også aspartam (E951) og methylparahydroxybenzoat (E218).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Roche Registration GmbH
English: Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
Danish: Ældre patienter (≥ 65 år) har i almindelighed større risiko for bivirkninger pga. immunsuppression.
English: This belongs to a group of medicines called “immunosuppressants”.
Danish: • Det tilhører en gruppe af medicin kaldet ”immunsuppressiva”.
English: * contains phenylalanine equivalent to 2.78 mg/5 mL of suspension.
Danish: * indeholder phenylalanin svarende til 2,78 mg/5 ml suspension.
English: The Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme and a follow-up pregnancy questionnaire, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Markedsføringsindehaver og de nationale myndigheder skal være enige om indholdet og formen af uddannelsesprogrammet og et opfølgende spørgeskema ved graviditet, herunder også kommunikationsplaner, distributionsmetoder og alle andre aspekter af programmet.
English: CellCept contains sorbitol (a type of sugar).
Danish: • CellCept indeholder sorbitol (en sukkerart).
English: Pseudolymphoma
Danish: Pseudolymfom
English: Take the dispenser and push the plunger completely down toward the tip of the dispenser.
Danish: Tag dispenseren og tryk stemplet helt ned mod dispenserens spids.
English: However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.
Danish: Derimod skal der ske en tæt klinisk monitorering under behandlingskombinationen samt kort tid efter den antibiotiske behandling.
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 sjælden arvelig mangel på hypoxantin-guanin-fosforibosyltransferase (HGPRT) såsom Lesch-Nyhan og Kelley-Seegmiller syndrom.
English: If you feel drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines until you feel better.
Danish: Hvis du oplever døsighed, følelsesløshed eller forvirring, bør du tale med din læge eller sygeplejerske, og vente med at køre bil eller bruge værktøj eller maskiner til du har fået det bedre.
English: PRCA may resolve with dose reduction or cessation of CellCept therapy.
Danish: PRCA kan forsvinde ved reduktion af dosis eller ved ophør af CellCeptbehandling.
English: These are insufficient to make dosage recommendations, and therefore use in this age group is not recommended.
Danish: De er ikke tilstrækkelige til at komme med dosisrekommendationer, og det anbefales derfor ikke at anvende CellCept til denne aldersgruppe.
English: Mycophenolate has been shown to be genotoxic in animal studies at concentrations exceeding the human therapeutic exposures only by small margins such that the risk of genotoxic effects on sperm cells cannot completely be excluded.
Danish: Mycophenolat har vist sig at være genotoksisk i dyrestudier ved koncentrationer, der kun overstiger de menneskelige terapeutiske eksponeringer med små marginer, således at risikoen for genotoksiske virkninger på sædceller ikke helt kan udelukkes.
English: METHOD OF ADMINISTRATION For intravenous infusion only Read the package leaflet before use
Danish: ADMINISTRATIONSMETODE Kun til intravenøs infusion Læs indlægssedlen inden brug
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: Before starting CellCept treatment, women of childbearing potential should have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL in order to exclude unintended exposure of the embryo to mycophenolate.
Danish: Før CellCept-behandlingen initieres, skal fertile kvinder have to negative graviditetstests (serum eller urin) med en sensitivitet på mindst 25 mIE/ml for at udelukke en uønsket mycophenolat-eksponering til fosteret.
English: The shelf-life of the powder for oral suspension is 2 years.
Danish: Holdbarheden af pulveret til oral suspension er 2 år.
English: Film coated tablets (tablets).
Danish: Filmovertrukne tabletter (tabletter).
English: The educational programme is aimed at ensuring that the health professionals and patients are aware of the teratogenicity and mutagenicity, the need for pregnancy tests before starting therapy with Cellcept, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Cellcept.
Danish: Uddannelsesprogrammets formål er at sikre, at sundhedspersoner og patienter er bevidste om teratogeniciteten og mutageniciteten, nødvendigheden af graviditetstests, før behandlingen initieres, kravene til prævention for både mandlige og kvindelig patienter, og hvilke tiltag der skal initieres, hvis der opstår graviditet under behandling med CellCept.
English: Changes to CellCept therapy should only be undertaken under appropriate supervision in transplant recipients in order to minimise the risk of graft rejection (see section 4.8).
Danish: Ændringer i behandlingen med Cellcept må kun foretages under tilstrækkelig overvågning af den transplanterede patient, så risikoen for afstødning af transplantatet minimeres (se pkt 4.8).
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: Therapeutic drug monitoring of MPA may be appropriate when switching combination therapy (e.g. from ciclosporin to tacrolimus or vice versa) or to ensure adequate immunosuppression in patients with high immunological risk (e.g. risk of rejection, treatment with antibiotics, addition or removal of an interacting medication).
Danish: Terapeutisk lægemiddelovervågning af MPA kan være hensigtsmæssigt ved skift i kombinationsbehandling (f.eks fra ciclosporin til tacrolimus eller omvendt) eller for at sikre tilstrækkelig immunosuppression hos patienter med høj immunologisk risiko (f.eks risiko for afstødning, behandling med antibiotika, tilføjelse eller seponering af interagerende lægemidler).
English: The mechanism for mycophenolate mofetil induced PRCA is unknown.
Danish: Mekanismen for mycophenolatmofetilinduceret PRCA er ukendt.
English: The patient information pack should contain: · The Package Leaflet · Guide for patients
Danish: Informationsmaterialet for patienter skal indeholde: · Indlægsseddel · En vejledning for patienter
English: Do not take any capsules that have broken open or split.
Danish: • Indtag ikke kapsler, der er åbnede eller gået itu.
English: As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Danish: For at minimere risikoen for hudkræft må det generelt tilrådes, at udsættelse for sollys og UV-lys begrænses ved at bære beskyttende beklædning, og anvende en solblokker med en høj beskyttelsesfaktor.
English: A kidney, heart or liver.
Danish: • Nyre, hjerte eller lever.
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, ikkekompetitiv og reversibel inhibitor af inosin-monophosfat-dehydrogenase og hæmmer derfor de novovejen for en guanosin-nucleotid-syntese uden inkorporering i DNA.
English: Preparation of suspension
Danish: Fremstilling af oral suspension
English: If neutropenia develops (absolute neutrophil count < 1.3 x 103/µl), it may be appropriate to interrupt or discontinue CellCept.
Danish: Hvis der optræder neutropeni (det absolutte neutrofilocyttal < 1,3 x 103/µl), skal behandlingen med CellCept måske afbrydes eller stoppes.
English: It will be explained that the correct course of action, based on an assessment of the individual benefit-risk, will be determined on a case by case basis through a discussion between the treating physician and the patient.
Danish: Det skal forklares, at den bedste fremgangsmåde, vil blive fastlagt fra tilfælde til tilfælde, gennem en diskussion mellem den behandlende læge og patienten og baseret på fordele versus risici for den enkelte patient.
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: There are no data on CellCept with phosphate binders other than sevelamer.
Danish: Der er ingen data for administrationen af CellCept med andre phosphatbindere end sevelamer.
English: • Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
Danish: • Dine æggeledere og begge æggestokke er blevet fjernet ved operation (bilateral salpingoooforektomi)
English: Metabolism and nutrition disorders Acidosis
Danish: Metabolisme og ernæring Acidose
English: A further dilution with glucose intravenous infusion 5% is required to a final concentration of 6 mg/mL.
Danish: Yderligere fortynding med 5 % glucoseinfusionsvæske er nødvendig for at få en slutkoncentration på 6 mg/ml.
English: The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes mycophenolate.
Danish: Tilgængelige data indikerer ikke øget risiko for misdannelser eller abort, hvis faderen tager mycophenolat.
English: • fluid on the lungs or inside the chest,
Danish: • vand i lungerne eller inde i brysthulen
English: The most serious gastrointestinal disorders were ulceration and hemorrhage which are known risks associated with mycophenolate mofetil.
Danish: De mest alvorlige bivirkninger i fordøjelsessystemet var ulceration og blødninger, som er velkendte risici associeret med mycophenolatmofetil.
English: Do not use solvent-containing wipes for cleaning.
Danish: Brug ikke vådservietter indeholdende opløsningsmiddel til rengøring.
English: CellCept 500 mg powder for concentrate for solution for infusion is an alternative dosage form to CellCept oral forms (capsules, tablets and powder for oral suspension) that may be administered for up to 14 days.
Danish: CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, er en alternativ doseringsform til CellCept orale formuleringer (kapsler, tabletter og pulver til oral suspension), som kan gives i op til 14 dage.
English: • CellCept tablets are lavender coloured and caplet shaped.
Danish: • CellCept tabletter er lavendelfarvede og kappeformede.
English: Date of latest renewal: 13 March 2006
Danish: Dato for første tilladelse: 14. februar 1996 Dato for seneste fornyelse af tilladelsen: 13. marts 2006
English: CellCept should be administered with caution in patients with active serious digestive system disease.
Danish: CellCept bør administreres med forsigtighed til patienter med aktiv alvorlig sygdom i fordøjelsessystemet.
English: Risk management plan (RMP)
Danish: • Risikostyringsplan (RMP) Ikke relevant.
English: Protozoal infections
Danish: Protozoale infektioner
English: These include diarrhoea, infections, fewer white cells and fewer red cells in the blood.
Danish: Disse inkluderer diarré, infektioner, færre hvide og røde blodlegemer i blodet.
English: Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with CellCept.
Danish: Der er observeret nedsat eksponering af MPA, når antacida, såsom magnesium- og aluminiumhydroxider, og protonpumpehæmmere, inklusive lansoprazol og pantoprazol, bliver administeret sammen med CellCept.
English: When reconstituted, the volume of the suspension is 175 mL, providing a usable volume of 160 - 165 mL.
Danish: Efter rekonstitution er volumenet af suspensionen 175 ml, hvilket giver et brugbart volumen på 160-165 ml.
English: Treatment will continue for as long as you need to prevent you from rejecting your transplant organ.
Danish: Behandlingen skal fortsætte så længe, at du har behov for at forhindre, at du afstøder det transplanterede organ.
English: As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of CellCept is correlated with MPA concentration.
Danish: Som vist ved suppression af akut afstødning efter nyretransplantation er den immunsuppressive virkning af CellCept korreleret til MPA-koncentrationen.
English: Patients receiving CellCept should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow failure.
Danish: Patienter, som får CellCept, skal informeres om straks at indberette alle tegn på infektion, uventede blodudtrædninger, blødning eller andre manifestationer på knoglemarvssvigt.
English: The need to avoid foetal exposure: Contraceptive requirements for patients of reproductive potential prior to, during and after treatment with mycophenolate mofetil.
Danish: • Nødvendigheden af at undgå føtal eksponering: Kravene til prævention for fertile patienter før, under og efter behandling med mycophenolatmofetil.
English: If any of the above apply to you (or you are not sure), talk to your doctor straight away before starting treatment with CellCept.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), skal du tale med din læge med det samme, før behandling med CellCept igangsættes.
English: In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 - 6 months post-transplant).
Danish: I den tidlige posttransplantationsperiode (< 40 dage efter transplantationen) var den gennemsnitlige MPA-AUC hos nyre-, hjerte- og levertransplanterede patienter ca. 30 % lavere og Cmax ca. 40 % lavere sammenlignet med den sene posttransplantationsperiode (3 - 6 måneder efter transplantationen).
English: A study of the co-administration of CellCept (1 g bid) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of CellCept on the ovulation suppressing action of the oral contraceptives.
Danish: Et studie om samtidig administration af CellCept (1 g 2 gange daglig) og orale kontraceptiva af kombinationstypen indeholdende ethinylestradiol (0,02-0,04 mg) og levonorgestrel (0,05-0,15 mg), desogestrel (0,15 mg) eller gestoden (0,05-0,10 mg) hos 18 ikke-transplanterede kvinder (som ikke fik andre immunsuppressiva) i 3 konsekutive menstruationscykler viste ingen klinisk relevant påvirkning af CellCept på den ovulationshæmmende virkning af de orale kontraceptiva.
English: CellCept has a moderate influence on your ability to drive or use any tools or machines.
Danish: CellCept påvirker i moderat grad din evne til at køre bil eller bruge værktøj eller maskiner.
English: • pneumonia, bronchitis,
Danish: • lungebetændelse, bronkitis
English: • If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
Danish: • hvis du ikke anvender effektiv prævention (se ”Graviditet, prævention og amning”)
English: • They are available as a carton of 100 or 300 capsules (both in blister packs of 10).
Danish: • De findes i pakninger med 100 eller 300 kapsler (begge i blisterkort med 10 stk.).
English: The MAH shall ensure that in each MS where Cellcept is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Cellcept are provided with the following educational package: · Physician educational material · Patient information pack
Danish: Markedsføringsindehaver skal sikre, at alle sundhedspersoner og patienter, som forventes at udskrive, håndtere eller anvende CellCept, i alle medlemslande, hvor CellCept markedsføres, har fået følgende uddannelsespakker: · Uddannelsesmateriale for sundhedspersoner · Informationsmateriale for patienter
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start CellCept:
Danish: Fortæl især lægen eller apotekspersonalet, hvis du tager noget af nedenstående medicin, før du begynder at tage CellCept:
English: Therefore, the following precautionary measures are recommended: sexually active male patients or their female partners are recommended to use reliable contraception during treatment of the male patient and for at least 90 days after cessation of mycophenolate mofetil.
Danish: Derfor anbefales det som sikkerhedsforanstaltning, at seksuelt aktive mandlige patienter eller deres kvindelige partnere anvender pålidelig antikonception under behandling af den mandlige patient og i mindst 90 dage efter ophør af mycophenolatmofetil.
English: CellCept is an IMPDH (inosine monophosphate dehydrogenase) inhibitor.
Danish: CellCept er en IMPDH-hæmmer (inosinmonofosfatdehydrogenase-hæmmer).
English: Concomitant administration of telmisartan and CellCept resulted in an approximately 30% decrease of MPA concentrations.
Danish: Samtidig administration af telmisartan og CellCept resulterede i et fald i MPA-koncentrationerne på ca. 30 %.
English: If you need to have a vaccine (a live vaccine) while taking CellCept, talk to your doctor or pharmacist first.
Danish: Hvis du skal vaccineres (med en levende vaccine), mens du tager CellCept, skal du tale med lægen eller apoteketspersonalet først.
English: • Immediately after use - take the dispenser to pieces and rinse it under running tap water.
Danish: • Skil dispenseren ad umiddelbart efter brug og rens den under rindende vand.
English: CellCept 500 mg film-coated tablets: 1 carton contains 50 tablets (in blister packs of 10)
Danish: CellCept 500 mg filmovertrukne tabletter: 1 pakning indeholder 50 tabletter (blisterkort med 10 tabletter).
English: • phosphate binders - used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood.
Danish: • fosfatbindere - bruges til mennesker med kronisk nyresvigt for at reducere absorptionen af fosfat til blodet.
English: It is recommended that the suspension be reconstituted by the pharmacist prior to dispensing to the patient
Danish: Det anbefales, at suspensionen rekonstitueres på apoteket før udlevering til patienten Læs indlægssedlen inden brug
English: If neutropenia develops, dosing with CellCept should be interrupted or the dose reduced (see section 4.4).
Danish: Hvis der udvikles neutropeni, skal administrationen af CellCept afbrydes eller dosis nedsættes (se pkt.
English: CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures by 30-50% in renal transplant patients treated with CellCept and CsA compared with patients receiving sirolimus or belatacept and similar doses of CellCept (see also section 4.4).
Danish: CsA interfererer med det enterohepatiske kredsløb af MPA, resulterende i en reduceret eksponering af MPA på 30-50 % hos nyretransplanterede patienter behandlet med CellCept og CsA, sammenlignet med patienter behandlet med sirolimus eller belatacept og sammenlignelige doser CellCept (se også pkt.
English: However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of CellCept.
Danish: Kombinationen af norfloxacin og metronidazol reducerede imidlertid MPA-eksponeringen med ca. 30 % efter én CellCept-dosis.
English: In patients not also taking ciclosporin, concomitant administration of CellCept and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Danish: Hos patienter, som ikke fik ciclosporin, sås ved samtidig administration af CellCept og rifampicin et fald på 18-70 % i MPA-eksponeringen (AUC0-12 timer).
English: The most serious infections were sepsis, peritonitis, meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Danish: De mest alvorlige infektioner var sepsis, peritonitis, meningitis, endocarditis, tuberkulose og atypisk mycobakteriel infektion.
English: In healthy volunteers, no significant interaction was observed when CellCept was concomitantly administered with norfloxacin or metronidazole separately.
Danish: Der blev ikke observeret nogen signifikant interaktion hos raske frivillige, når CellCept blev administreret samtidigt med norfloxacin eller metronidazol hver for sig.
English: Agranulocytosis and neutropenia have been reported; therefore, regular monitoring of patients taking CellCept is advised (see section 4.4).
Danish: Agranulocytose og neutropeni er rapporteret; derfor tilrådes regelmæssig monitorering af patienter i behandling med CellCept (se pkt.
English: Do not break or crush them.
Danish: • De må ikke brækkes over eller knuses.