natgillin/translations-raw huggingface dataset:
Det anbefales, at suspensionen rekonstitueres på apoteket før udlevering til patienten Læs indlægssedlen inden brug
It is recommended that the suspension be reconstituted by the pharmacist prior to dispensing to the patient
Hvis der udvikles neutropeni, skal administrationen af CellCept afbrydes eller dosis nedsættes (se pkt.
If neutropenia develops, dosing with CellCept should be interrupted or the dose reduced (see section 4.4).
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.
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).
Kombinationen af norfloxacin og metronidazol reducerede imidlertid MPA-eksponeringen med ca. 30 % efter én CellCept-dosis.
However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of CellCept.
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).
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%.
De mest alvorlige infektioner var sepsis, peritonitis, meningitis, endocarditis, tuberkulose og atypisk mycobakteriel infektion.
The most serious infections were sepsis, peritonitis, meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Der blev ikke observeret nogen signifikant interaktion hos raske frivillige, når CellCept blev administreret samtidigt med norfloxacin eller metronidazol hver for sig.
In healthy volunteers, no significant interaction was observed when CellCept was concomitantly administered with norfloxacin or metronidazole separately.
Agranulocytose og neutropeni er rapporteret; derfor tilrådes regelmæssig monitorering af patienter i behandling med CellCept (se pkt.
Agranulocytosis and neutropenia have been reported; therefore, regular monitoring of patients taking CellCept is advised (see section 4.4).
• De må ikke brækkes over eller knuses.
Do not break or crush them.
Om nødvendigt kan CellCept 1 g/5 ml pulver til oral suspension gives via en næsesonde af minimum størrelse på 8 French (den indre diameter skal være mindst 1,7 mm).
Note: If required, CellCept 1 g/5 ml powder for oral suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
Antistofresponset overfor andre vacciner kan nedsættes (se også pkt.
The antibody response to other vaccines may be diminished (see also 4.4).
Isolerede tilfælde af abnorm neutrofil morfologi, inklusive den erhvervede Pelger-Huet anomali, er observeret hos patienter, som er behandlet med CellCept.
Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with CellCept.
• Under hele behandlingen med CellCept
During your entire treatment with CellCept
Som det kan forekomme hos patienter, der tager denne type medicin (immunsuppressiva), har et meget lille antal CellCept-patienter udviklet kræft i lymfevæv og hud.
As can happen in patients taking this type of medicine (immune-suppressants), a very small number of CellCept patients have developed cancer of the lymphoid tissues and skin.
Der skal udvises forsigtighed med lægemidler, som interfererer med den enterohepatiske recirkulation pga. risikoen for nedsat effekt af CellCept.
Caution should be used with medicinal products that interfere with enterohepatic recirculation because of their potential to reduce the efficacy of CellCept.
Patienter i behandling med CellCept, der får tilbagevendende infektioner, skal have målt serumimmunoglobuliner.
Patients on CellCept who develop recurrent infections should have their serum immunoglobulins measured.
Knips flere gange på den aflukkede flaske for at løsne pulveret.
Tap the closed bottle several times to loosen the powder.
På grund af risikoen for alvorlige bivirkninger af mycophenolatmofetil hos ammende spædbørn, er CellCept kontraindiceret hos ammende mødre (se pkt.
Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, CellCept is contraindicated in nursing mothers (see section 4.3).
Moderstoffet mycophenolatmofetil kan måles systemisk under intravenøs infusion.
The parent substance mycophenolate mofetil can be measured systemically during intravenous infusion.
Brug af CellCept sammen med mad og drikke Indtagelse af mad og drikke har ingen virkning på din behandling med CellCept.
Taking food and drink has no effect on your treatment with CellCept.
Meget almindelig Meget almindelig Almene symptomer og reaktioner på administrations-stedet Asteni
Very Common Very Common General disorders and administration site conditions Asthenia
Graviditet, puerperium og den perinatale periode Der er rapporteret tilfælde af spontane aborter hos patienter, som har været eksponeret for mycophenolatmofetil, hovedsagelig i første trimester (se pkt.
Pregnancy, puerperium and perinatal conditions Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil, mainly in the first trimester, see section 4.6.
Spontane aborter (frekvens på 45% til 49%) og medfødte misdannelser (estimeret frekvens på 23% til 27%) er blevet rapporteret efter mycophenolatmofetil eksponering under graviditet.
Spontaneous abortion (rate of 45% to 49%) and congenital malformations (estimated rate of 23% to 27%) have been reported following MMF exposure during pregnancy.
• Den første dosis gives så hurtigt som muligt efter transplantationen.
The first dose is given to you as soon as possible after the transplant operation.
Brug ikke klude eller vådservietter til tørring.
Do not use cloths or wipes for drying.
• isavuconazol - bruges til behandling af svampeinfektioner
• isavuconazole - used to treat fungal infections
Patienter, som får CellCept, skal have foretaget fuldstændig blodtælling ugentligt i den første måned, to gange månedligt i anden og tredje behandlingsmåned og derefter månedligt i det første år.
Patients taking CellCept 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.
Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Der skal udvises forsigtighed ved samtidig administration pga. risikoen for nedsat effekt af CellCept.
Caution should be used during concomitant administration because of the potential to reduce efficacy of CellCept.
• hvis du er allergisk over for mycophenolatmofetil, mycophenolsyre eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt 6)
• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in Section 6)
Som en sikkerhedsforanstaltning anbefales det at du eller din kvindelige partner bruger pålidelig prævention under behandlingen og i 90 dage efter, at du er stoppet med at tage CellCept.
As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking CellCept.
Hos levertransplanterede patienter, der indledningsvis blev behandlet med CellCept og tacrolimus samtidigt, blev MPAs Cmax og AUC - CellCepts aktive metabolit - ikke signifikant påvirket af den samtidige administration af tacrolimus.
In hepatic transplant patients initiated on CellCept and tacrolimus, the AUC and Cmax of MPA, the active metabolite of CellCept, were not significantly affected by co-administration with tacrolimus.
• Det findes i pakninger med 4 hætteglas
It is available in packs of 4 vials.
Efter rekonstitution til en koncentration på 6 mg/ml skal CellCept 500 mg pulver til infusionsvæske gives som langsom intravenøs infusion over en periode på 2 timer via en perifer eller central vene (se pkt.
Following reconstitution to a concentration of 6 mg/mL, CellCept 500 mg powder for concentrate for solution for infusion must be administered by slow intravenous infusion over a period of 2 hours by either a peripheral or a central vein (see section 6.6).
Flasken skal rystes godt før brugen
Shake bottle well before use
Uddannelsesmaterialet vil fremhæve advarsler vedrørende mycophenolats teratogenicitet, give vejledning om antikonception inden behandling initieres og vejledning omkring nødvendigheden af graviditetstests.
The educational materials will reinforce the warnings about the teratogenicity of mycophenolate, provide advice on contraception before therapy is started and guidance on the need for pregnancy testing.
Spørgeskemaet skal indeholde fyldestgørende oplysninger om eksponering under graviditet, herunder tidsangivelse og dosis; behandlingsvarighed før og under graviditet; lægemidler, som har været anvendt samtidig; kendte teratogene risici og fyldestgørende oplysninger om medfødte misdannelser.
In addition, a pregnancy follow-up questionnaire including details of exposure during pregnancy, including timing and dose; duration of therapy, before and during pregnancy; concomitant drugs; known teratogenic risks and full details of congenital malformations should be agreed to with the national competent authorities.
• Tag 5 ml suspension om morgenen og 5 ml suspension om aftenen.
Take 5 mL suspension in the morning and then 5 mL suspension in the evening.
Der skal udvises forsigtighed ved skift fra kombinationsbehandling indeholdende immunsupressiva som interfererer med MPAs enterohepatiske kredsløb, f.eks. ciclosporin, til andre som ikke interfererer, f.eks tacrolimus, sirolimus, belatacept, eller omvendt, da dette kan ændre eksponeringen af MPA.
Caution should be exercised when switching combination therapy from regimens containing immunosuppressants, which interfere with MPA enterohepatic recirculation, e.g. ciclosporin, to others devoid of this effect, e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in changes of MPA exposure.
Patienterne skal underrettes om, at under behandling med CellCept kan vaccinationer være mindre effektive, og levende svækkede vacciner bør undgås (se pkt.
Patients should be advised that during treatment with CellCept, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Den ikke-kliniske toksikologiske profil af mycophenolatmofetil forekommer i overenstemmelse med bivirkninger observerede i de humane kliniske studier som nu fremviser bivirkningsdata, der er mere relevante for en patientpopulation (se 4.8).
The nonclinical toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in human clinical trials which now provide safety data of more relevance to the patient population (see section 4.8).
Lungelidelser såsom:
Lung problems such as:
SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 °C
SPECIAL STORAGE CONDITIONS Do not store above 30 °C
c) Inspicer opløsningen for partikler og misfarvning før yderligere fortynding.
Inspect the resulting solution for particulate matter and discoloration prior to further dilution.
Hvis du tror, at du har fået for meget medicin, skal du tale med lægen eller sundhedspersonalet med det samme.
If you think that you have had too much medicine, talk to your doctor or nurse straight away.
Justering af CellCept-dosis er ikke nødvendig.
Dose adjustment of CellCept does not appear to be necessary.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER CellCept filmovertrukne tabletter skal håndteres forsigtigt Tabletterne må ikke knuses
OTHER SPECIAL WARNING(S), IF NECESSARY CellCept film-coated tablets should be handled with care Do not crush the tablets
To genotoksicitetstests (in vitro muselymfom test og in vivo museknoglemarvs-mikronucleus-test) viste, at mycophenolatmofetil potentielt kan forårsage kromosomaberrationer.
Two genotoxicity assays (in vitro mouse lymphoma assay and in vivo mouse bone marrow micronucleus test) showed a potential of mycophenolate mofetil to cause chromosomal aberrations.
En ny graviditetstest skal udføres som klinisk indiceret (f.eks. efter rapportering af manglende antikonception).
Pregnancy tests should be repeated as clinically required (e.g. after any gap in contraception is reported).
(Holdbarheden af den rekonstituerede suspension er 2 måneder).
(The shelf-life of the reconstituted suspension is two months.)
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til oral anvendelse efter rekonstitution
METHOD AND ROUTE(S) OF ADMINISTRATION For oral administration after constitution
• Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
Ask your pharmacist how to dispose of medicines no longer required.
I modsætning hertil blev AUC for tacrolimus øget med ca. 20 %, når flere CellCept-doser (1,5 g to gange daglig) blev givet til levertransplanterede patienter, som fik tacrolimus.
In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of CellCept (1.5 g BID) were administered to hepatic transplant patients taking tacrolimus.
Af disse deltog 991 i tre nyrestudier og 277 deltog i et leverstudie.
Of these, 991 were included in the three renal studies and 277 were included in one hepatic study.
Azathioprin var komparator i leverstudiet og i to af nyrestudierne, hvorimod det sidste nyrestudie var placebokontrolleret.
Azathioprine was the comparator used in the hepatic study and in two of the renal studies whilst the other renal study was placebo-controlled.
Cytopenier, inklusiv leukopeni, anæmi, trombocytopeni og pancytopeni er velkendte risici associeret med mycophenolatmofetil og kan forårsage eller medvirke til infektioner og blødninger (se pkt.
Cytopenias, including leucopenia, anemia, thrombocytopenia and pancytopenia, are known risks associated with mycophenolate mofetil and may lead or contribute to the occurrence of infections and hemorrhages (see section 4.4).
”CellCept 250” er printet i sort på kapselhovedet, og ”Roche” er printet i sort på kapselkroppen.
They have “CellCept 250” printed in black on the capsule cap and “Roche” printed in black on the capsule body.
Af disse deltog 991 i tre nyrestudier, 277 deltog i et leverstudie og 289 deltog i et hjertestudie.
Of these, 991 were included in the three renal studies, 277 were included in one hepatic study, and 289 were included in one cardiac study.
• Hvis dette sker, skal du skylle øjnene med vand.
If this happens, rinse your eyes with plain water.
• Tag 7,5 ml suspension om morgenen og 7,5 ml suspension om aftenen.
• Take 7.5 mL suspension in the morning and then 7.5 mL suspension in the evening.
Bivirkninger som kunne tilskrives den perifere intravenøse infusion var flebitis og tromboser som begge blev observeret hos 4 % af de patienter, som blev behandlet med CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning.
Adverse reactions attributable to peripheral venous infusion were phlebitis and thrombosis, both observed at 4% in patients treated with CellCept 500 mg powder for concentrate for solution for infusion.
Typen af bivirkninger rapporteret efter markedsføring er sammenlignelig med de der ses i de kontrollerede nyre-, hjerte- og levertransplantantionsstudier.
The types of adverse reactions reported during post-marketing with CellCept are similar to those seen in the controlled renal, cardiac and hepatic transplant studies.
Stop ikke med at tage CellCept, medmindre lægen har bedt dig om det.
Do not stop taking CellCept unless your doctor tells you to.
Risikoen øges med stigende immunsuppressiv belastning (se pkt.
The risk increases with total immunosuppressive load (see section 4.4).
Gastrointestinal blødning
Gastrointestinal hemorrhage
Oral administration af radioaktivt mærket mycophenolatmofetil resulterede i fuldstændig genfinding af den administrerede dosis med 93 % af den administrerede dosis genfundet i urinen og 6 % genfundet i fæces.
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.
Farmakokinetikken af mycophenolatmofetil og dets metabolitter er ikke observeret at være anderledes hos ældre patienter (≥ 65 år) sammenlignet med yngre patienter.
The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered in the elderly patients (≥ 65 years) when compared to younger patients.
Oral dosis af CellCept 1 g/5 ml pulver til oral suspension bør gives inden for 72 timer efter transplantationen.
Oral CellCept 1 g/5 ml powder for oral suspension should be initiated within 72 hours following transplantation.
• hvis du har et sjældent problem med din metabolisme kaldet ”phenylketonuri”, som løber i familien
If you have ever had a problem with your digestive system such as a stomach ulcer If you have a rare problem with your metabolism called “phenylketonuria” which runs in families
• Hvis dette sker, skal du skylle med rigeligt vand.
If this happens, rinse with plenty of plain water.
CellCept tabletter: lille kappeformet, lavendelfarvet tablet, med "CellCept 500" præget på den ene side og "Roche" på den anden.
CellCept tablets: lavender coloured caplet-shaped tablet, engraved with "CellCept 500" on one side and "ROCHE" name on the other.
Derved sikres at adapteren sidder rigtigt i flasken og bevarer lågets børnesikring.
This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.
Pure red cell aplasia (PRCA)
Aplasia pure red cell
Nyretransplantat (n = 991)
Renal transplant (n = 991)
Antibiotika, der eliminerer β-glukuronidaseproducerende bakterier i tarmen (f.eks. aminoglycosid, cephalosporin, fluorquinolon og penicillinklasser af antibiotika) kan interferere med MPAG/MPA enterohepatisk recirkulation, hvilket fører til reduceret systemisk MPA-eksponering.
Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA enterohepatic recirculation thus leading to reduced systemic MPA exposure.
• Spontante aborter er rapporteret hos 45 til 49 % af de gravide kvinder, som var eksponeret for mycophenolatmofetil, sammenlignet med en hyppighed på 12 til 33 % hos patienter, der havde gennemgået en transplantation af solide organer, og som blev behandlet med andre immunsuppressiva end mycophenolatmofetil.
• Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.
• Tag 3 tabletter om morgenen og derefter 3 tabletter om aftenen.
Take 3 tablets in the morning and then 3 tablets in the evening.
(mellemøret);
(MedDRA)
Tabel 1: Skema over indberettede bivirkninger hos patienter behandlet med CellCept i kliniske studier og efter markedsføring
Table 1 Summary of adverse drug reactions occurring in patients treated with CellCept reported from clinical trials and post marketing experience
• CellCept kapsler er aflange og blå i den ene ende og brun i den anden.
• CellCept capsules are oblong shaped with one end blue and the other end brown.
• Tag 2 tabletter om morgenen og 2 tabletter om aftenen.
Take 2 tablets in the morning and then 2 tablets in the evening.
CellCept kapsler: aflang, blå/brun, mærket med "CellCept 250" i sort på kapslens "hoved" og "Roche" på kapslens "krop".
CellCept capsules: oblong, blue/brown, branded with black "CellCept 250" on the capsule cap and "Roche" name on the capsule body.
Farmakokinetikken af mycophenolatmofetil og dets metabolitter er ikke observeret at være anderledes hos ældre patienter (≥ 65 år) sammenlignet med yngre transplanterede patienter.
The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered in the elderly patients (≥ 65 years) when compared to younger transplant patients.
Rystes godt før brug Læs indlægssedlen inden brug
Shake well before use Read the package leaflet before use
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Pulveret må ikke indåndes før rekonstitution eller komme i berøring med huden Undgå at den rekonstituerede suspension kommer i berøring med huden
OTHER SPECIAL WARNING(S), IF NECESSARY Do not breathe the powder before constitution or allow it to touch your skin Avoid skin contact with the reconstituted suspension
Stop ikke med at bruge CellCept, medmindre lægen har bedt dig om det.
Do not stop having CellCept unless your doctor tells you to.
Patienter, som bliver behandlet med immunsuppressiva herunder CellCept, har en øget risiko for opportunistiske infektioner (bakteriel, svampe, viral og protozoel), dødelige infektioner og sepsis (se pkt.
Patients treated with immunosuppressants, including CellCept, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Tag ikke CellCept, hvis du ammer.
Do not take CellCept if you are breast-feeding.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 150 (3 pakker af 50) filmovertrukne tabletter
PHARMACEUTICAL FORM AND CONTENTS Multipack:150 (3 packs of 50) film-coated tablets
Der er ikke grundlag for justering af CellCept dosis efter afstødning af hjertetransplantat.
There is no basis for CellCept dose adjustment following cardiac transplant rejection.
Derfor er det normalt ikke nødvendigt at ændre dosis af CellCept, hvis der ikke er klinisk evidens for dysfunktion af transplantatet.
Therefore, a change in the dose of CellCept should not normally be necessary in the absence of clinical evidence of graft dysfunction.
CellCept kan forårsage somnolens, konfusion, svimmelhed, tremor og hypotension, og patienterne bør derfor tilrådes forsigtighed ved bilkørsel og maskinbetjening.
Cellcept may cause somnolence, confusion, dizziness, tremor or hypotension, and therefore patients are advised to use caution when driving or using machines.
Azathioprin var komparator i lever- og hjertestudierne og i to af nyrestudierne, hvorimod det sidste nyrestudie var placebokontrolleret.
Azathioprine was the comparator used in the hepatic and cardiac studies and in two of the renal studies whilst the other renal study was placebocontrolled.
Oralt CellCept bør gives inden for 72 timer efter transplantationen.
Oral CellCept should be initiated within 72 hours following transplantation.
• hvis du er kvinde og kan blive gravid, og der ikke foreligger en negativ graviditetstest, før du har fået den første recept, eftersom mycophenolat forårsager medfødte misdannelser og abort.
• If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription as mycophenolate causes birth defects and miscarriage.
Sæt derefter dispenserens spids fast i flaskeadaptorens åbning.
Then put the tip of the dispenser firmly into the opening of the bottle adapter.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER CellCept kapsler skal håndteres forsigtigt Kapslerne må ikke åbnes eller knuses, og pulveret i kapslerne må ikke indåndes eller komme i berøring med huden
OTHER SPECIAL WARNING(S), IF NECESSARY CellCept capsules should be handled with care Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin
Hvis infusionsopløsningen ikke er fremstillet umiddelbart før administrationen, skal infusion af infusionsopløsningen påbegyndes senest 3 timer efter rekonstitution og fortynding af lægemidlet.
If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product.