natgillin/translations-raw huggingface dataset:
Derfor kan andre stoffer, der vides at udskilles ved renal tubulær sekretion, konkurrere med MPAG og derved forhøje plasmakoncentrationerne af MPAG eller det andet stof, der udskilles ved tubulær sekretion.
Thus, other substances known to undergo renal tubular secretion may compete with MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
Disse inkluderer alvorlige allergiske reaktioner (såsom anafylaksi, angioødem), feber, træthedsfornemmelse, søvnbesvær, smerter (såsom smerter i maven, brystkassen, led eller muskler), hovedpine, influenzasymptomer og opsvulmen.
These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle), headache, flu symptoms and swelling.
Blod og lymfesystem Anæmi
Blood and lymphatic system disorders Anemia
Samtidig administration af probenecid og mycophenolatmofetil forhøjer MPAGs plasma-AUC 3 gange hos aber.
Co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of MPAG by 3-fold.
CellCept 1 g/5 ml pulver til oral suspension indeholder aspartam.
CellCept 1 g/5 ml powder for oral suspension contains aspartame.
20 ml type I klare hætteglas med grå butylgummiprop og aluminiumhætte med plastikafrivningshætte.
20 mL type I clear glass vials with grey butyl rubber stopper and aluminium seals with plastic flip-off caps.
Efter intravenøs administration metaboliseres mycophenolatmofetil hurtigt og fuldstændigt til den aktive metabolit, MPA.
Following intravenous administration, mycophenolate mofetil undergoes rapid and complete metabolism to the active metabolite, MPA.
Hos nyretransplanterede patienter blev tacrolimuskoncentrationen imidlertid tilsyneladende ikke påvirket af CellCept (se også pkt.
However, in renal transplant patients, tacrolimus concentration did not appear to be altered by CellCept (see also section 4.4).
”CellCept 500” er præget på den ene side og ”Roche” er præget på den anden.
They have “CellCept 500” engraved on one side and “ROCHE” on the other.
Pulver til oral suspension og rekonstitueret oral suspension: Må ikke opbevares ved temperaturer over 30 °C.
Powder for oral suspension and reconstituted suspension: Do not store above 30 °C.
En reduktion af MPAAUC på ca. 40 % er associeret til den samtidige administration af colestyramin (4 g tre gange daglig), hvilket indikerer, at der er en betragtelig enterohepatisk recirkulation.
A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating that there is a significant amount of enterohepatic recirculation.
Alle patienter, som bliver behandlet med immunsuppressiva, har forhøjet risiko for bakterielle, virale og svampeinfektioner (hvoraf nogle kan forårsage dødelige tilstande), inklusiv dem, der skyldes opportunistiske mikroorganismer og latent viral reaktivering.
All patients treated with immunosuppressants are at increased risk of bacterial, viral and fungal infections (some of which may lead to a fatal outcome), including those caused by opportunistic agents and latent viral reactivation.
• colestyramin - bruges til behandling af forhøjet kolesterol
• cholestyramine - used to treat high cholesterol
CellCept påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
CellCept has a moderate influence on the ability to drive and use machines.
Der skal derfor udvises forsigtighed hvis CellCept 1 g/5 ml pulver til oral suspension gives til patienter med phenylketonuri (se pkt.
Therefore, care should be taken if CellCept 1 g/5 ml powder for oral suspension is administered to patients with phenylketonuria (see section 6.1)
Kvalificeret sundhedspersonale bør gøre mandlige patienter med reproduktivt potentiale opmærksomme på og tale med dem om de potentielle risici ved at blive far til et barn.
Male patients of reproductive potential should be made aware of and discuss with a qualified health-care professional the potential risks of fathering a child.
Bank let nogle gange på bunden af den lukkede flaske for at løsne pulveret.
Tap the bottom of the closed bottle several times to loosen the powder.
Prævention hos kvinder, som tager CellCept
Contraception in women taking CellCept
• CellCept findes i et 20 ml klart hætteglas (type I glas) med grå butylgummiprop og aluminiumssegl med aftageligt plastiklåg.
• Cellcept is provided in a 20 mL type I clear glass vial with a grey butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Pulveret skal blandes med glucoseinfusionsvæske før anvendelse.
This needs mixing with glucose before using.
• Rekonstitueret suspension: Må ikke opbevares ved temperaturer over 30 °C.
• Reconstituted suspension: do not store above 30°C.
• Baggrundsinformation om mycophenolatmofetils teratogenicitet og mutagenicitet hos mennesker.
Background information on mycophenolate mofetil teratogenicity and mutagenicity in humans.
Hvis du er kvinde og kan blive gravid, skal du bruge en effektiv præventionsmetode, mens du tager CellCept, herunder:
If you are a woman who could become pregnant you must use an effective method of contraception with CellCept.
LISTE OVER HJÆLPESTOFFER Indeholder også polysorbat 80, citronsyre, saltsyre og natriumchlorid.
LIST OF EXCIPIENTS Also contains polysorbate 80, citric acid, hydrochloric acid and sodium chloride.
Sådanne infektioner inkluderer latent viral reaktivering, såsom hepatitis B- eller hepatitis Creaktivering og infektioner forårsaget af polyomavira (BK-virus associeret med nefropati, JC-virus associeret med progressiv multifokal leukoencefalopati PML).
Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML) .
A.
c.
Tilfælde af BK-virus associeret med nefropati såvel som tilfælde af JC-virus associeret med progressiv multifokal leukoencefalopati (PML) er blevet rapporteret hos patienter, der behandles med immunsuppressiva herunder CellCept.
Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including CellCept.
CellCept indeholder mycophenolatmofetil.
CellCept contains mycophenolate mofetil.
Da der er observeret store forskelle i hyppigheden af nogle bivirkninger på tværs af de forskellige transplantat-indikationer, er hyppighederne angivet separat for nyre- og levertransplanterede patienter.
Due to the large differences observed in the frequency of certain ADRs across the different transplant indications, the frequency is presented separately for renal and hepatic transplant patients.
Pakningsstørrelser og yderligere oplysninger Opblanding af medicinen
Contents of the pack and other information Making-up the medicine
b) Ryst hætteglasset forsigtigt for at opløse lægemidlet til en let gul opløsning.
Gently shake the vial to dissolve the medicinal product yielding a slightly yellow solution.
Dette gælder også medicin, som ikke er købt på recept f.eks. naturlægemidler og vitaminer og mineraler.
This includes medicines obtained without a prescription, such as herbal medicines.
• Dette sikrer, at flaskeadaptoren og låget sidder i den rigtige position.
This will make sure that the bottle adapter and child safety bottle cap are in the right position.
Du må ikke give blod under behandling med CellCept og i mindst 6 uger efter behandlingens ophør.
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment.
Pædiatrisk population 2-18 år Den anbefalede dosis af CellCept 1 g/5 ml pulver til oral suspension er 600 mg/m2 administreret to gange daglig (højst 2 g/10 ml oral suspension daglig).
Paediatric population aged 2 to 18 years The recommended dose of CellCept 1 g/5 ml powder for oral suspension is 600 mg/m2 administered twice daily (up to a maximum of 2 g/10 mL oral suspension daily).
Levertransplantat (n = 277)
Hepatic transplant (n = 277)
Opbevar blisterkortene i den ydre karton for at beskytte mod lys.
Keep the blister in the outer carton in order to protect from light.
Der forudses ingen væsentlig ændring af MPAs farmakokinetik og dosisjustering af CellCept er ikke nødvendig.
No substantial alteration of MPA pharmacokinetics is anticipated and CellCept dose adjustment is not required.
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse - CellCept 250 mg kapsler - CellCept 500 mg filmovertrukne tabletter Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Tyskland.
Name and address of the manufacturer(s) responsible for batch release CellCept 250 mg capsules CellCept 500 mg film-coated tablets Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany.
• CellCept må ikke anvendes til patienter med overfølsomhed over for mycophenolatmofetil, mycophenolsyre eller et eller flere af hjælpestofferne anført i pkt.
• CellCept should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed in section 6.1.
Ved modtagelse af transplantater fra afdøde donorer, kan det på grund af tidspunktet for tilgængeligheden af transplantationsorganet, ikke altid være muligt at udføre to tests 8-10 dage efter hinanden, inden behandlingen initieres.
It is recommended that the second test should be performed 8 - 10 days after the first test. For transplants from deceased donors, if it is not possible to perform two tests 8-10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8-10 days later.
Mænd må ikke være sæddonorer under behandling med CellCept og i mindst 90 dage efter behandlingens ophør.
Men must not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.
Da T- og B-lymfocytter i deres proliferation, i modsætning til andre celletyper, der kan anvende alternative veje, er helt afhængige af en de novo-syntese af puriner, har MPA en mere potent cytostatisk virkning på lymfocytter end på andre celler.
Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells.
Diarré, leukopeni, sepsis og opkastning var blandt de mest almindelige og/eller alvorlige bivirkninger i forbindelse med administration af CellCept i kombination med ciclosporin og kortikosteroider.
Diarrhoea, leucopenia, sepsis and vomiting were among the most common and/or serious adverse drugs reactions associated with the administration of CellCept in combination with ciclosporin and corticosteroids.
For at opretholde den kliniske effekt bør MPAeksponeringen overvåges, og CellCept-doserne justeres i forhold til dette, når rifampicin administreres samtidigt.
It is recommended to monitor MPA exposure levels and to adjust CellCept doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Derfor er CellCept kontraindiceret under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet.
Therefore, CellCept is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection.
Hæld ca. halvdelen af det rensede vand i flasken, og ryst den lukkede flaske i ca. 1 min.
Add approximately half of the total amount of purified water to the bottle and shake the closed bottle well for about 1 minute.
Ecchymose
Ecchymosis
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEK SAMT AFFALD HERAF
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Hvis du har glemt at tage CellCept
If you forget to take CellCept
Ciclosporins (CsA) farmakokinetik påvirkes ikke af mycophenolatmofetil.
Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Medfødte misdannelser, som har været rapporteret, inkluderer abnormiteter i ører, øjne og ansigt (læbe-gane spalte) eller i fingrenes udvikling, samt i hjerte, spiserør, nyrer og nervesystem (f.eks. manglende sammenvoksning af ryggraden (spina bifida)).
Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed).
• Baseret på litteraturrapporter forekom misdannelser hos 23 til 27% af levendefødte børn, hvor moderen var eksponeret for mycophenolatmofetil under graviditet (sammenlignet med 2 til 3% hos levendefødte børn i hele populationen og ca. 4 til 5% hos patienter, der havde gennemgået en transplantation af solide organer, og som blev behandlet med andre immunsuppressiva end mycophenolatmofetil).
• Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
Hos patienter med nedsat nyrefunktion, som får CellCept og ganciclovir, eller dets prodrugs, f.eks. valganciclovir, samtidig, bør dosisanbefalingerne for ganciclovir følges og patienterne bør monitoreres omhyggeligt.
In patients with renal impairment in whom CellCept and ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered, the dose recommendations for ganciclovir should be observed and patients should be monitored carefully.
6.1 Der er observeret overfølsomhedsreaktioner over for CellCept (se pkt.
Hypersensitivity reactions to CellCept have been observed (see section 4.8).
Hvis du holder op med at tage CellCept
If you stop taking CellCept
Farmakokinetiske parametre evalueredes hos 49 nyretransplanterede børn (2-18 år), som fik 600 mg/m2 mycophenolatmofetil oralt to gange daglig.
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 years) given 600 mg/m2 mycophenolate mofetil orally twice daily.
CellCept 1 g/5 ml pulver til oral suspension sorbitol silica, kolloid, vandfri natriumcitrat sojabønnelecithin blandet frugtsmag xanthangummi aspartam* (E951) methylparahydroxybenzoat (E218) citronsyre, vandfri
CellCept 1 g/5 ml powder for oral suspension sorbitol silica, colloidal anhydrous sodium citrate soybean lecithin mixed fruit flavour xanthan gum aspartame* (E951) methyl parahydroxybenzoate (E218) citric acid anhydrous
Sår i munden, spiserøret, mavesækken, duodenum og tarmene, ofte forværret af blødninger, såvel som hæmatemese, melæna og hæmoragisk gastritis og colitis blev indberettet som almindelige bivirkninger i de pivotale kliniske studier.
Mouth, esophageal, gastric, duodenal, and intestinal ulcers often complicated by hemorrhage, as well as hematemesis, melena, and hemorrhagic forms of gastritis and colitis were commonly reported during the pivotal clinical trials.
Derimod må en stigning i MPAs AUC på ca. 30 % forventes, hvis samtidig CsA-behandling seponeres.
In contrast, if concomitant CsA treatment is stopped, an increase in MPA AUC of around 30% should be expected.
• hvis du ammer.
• If you are breast-feeding.
Det kan være skadeligt for andre, selv om de har de samme symptomer, som du har.
even if their symptoms are the same as yours
Da der er observeret store forskelle i hyppigheden af nogle bivirkninger på tværs af de forskellige transplantat-indikationer, er hyppighederne angivet separat for nyre-, lever- og hjertetransplanterede patienter.
Due to the large differences observed in the frequency of certain ADRs across the different transplant indications, the frequency is presented separately for renal, hepatic and cardiac transplant patients.
ADMINISTRATIONSMETODE Oral anvendelse
METHOD OF ADMINISTRATION Oral use
Psykiske forstyrrelser Konfusion
Psychiatric disorders Confusional state
Det betyder, at for at fremstille en dosis på 1 g mycophenolatmofetil skal indholdet af to rekonstituerede hætteglas (ca. 2 x 15 ml) fortyndes yderligere med 140 ml 5 % glucoseinfusionsvæske.
This means that to prepare a 1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx. 2 x 15 mL) must be further diluted into 140 mL glucose intravenous infusion 5% solution.
• Før du starter med at tage CellCept
Before you start taking CellCept
CellCept 250 mg kapsler:
CellCept 250 mg capsules:
Tilfælde af pure red cell aplasia (PRCA) er rapporteret hos patienter, behandlet med CellCept (se pkt
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see section
Det anbefales at rekonstituere CellCept 1 g/5 ml pulver til oral suspension på apoteket før den udleveres til patienten.
It is recommended that CellCept 1 g/5 ml powder for oral suspension be reconstituted by the pharmacist prior to dispensing to the patient.
De mest almindelige bivirkninger i fordøjelsessystemet var diarré, kvalme og opkastning.
The most common gastrointestinal disorders, however, were diarrhea, nausea and vomiting.
Prævention hos mænd, som tager Cellcept
Contraception in men taking CellCept
Middelværdien af MPAG-AUC efter en enkelt dosis var 3-6 gange højere hos personer med svært nedsat nyrefunktion end hos personer med let nedsat nyrefunktion eller normale, sunde personer svarende til den kendte renale udskillelse af MPAG.
The mean single dose MPAG AUC was 3 - 6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Den endelige koncentration af opløsningen er 6 mg mycophenolatmofetil per ml.
The final concentration of the solution is 6 mg/mL mycophenolate mofetil.
Hvis du tager mere CellCept, end du har fået besked på, skal du straks tale med en læge eller tage på sygehuset.
If you take more CellCept than you should, talk to a doctor or go to a hospital straight away.
Tilfælde af pure red cell aplasia (PRCA) er blevet rapporteret hos patienter i behandling med CellCept i kombination med andre immunsuppressiva.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressants.
Der er ingen data vedrørende behandling af førstegangs- eller recidiverende afstødning hos pædiatriske transplanterede patienter.
No data are available for treatment of first or refractory rejection in paediatric transplant patients.
CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, indeholder ikke konserveringsmiddel; derfor skal rekonstitution og fortynding af produktet foretages under aseptiske forhold.
CellCept 500 mg powder for concentrate for solution for infusion does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
• syreneutraliserende midler eller protonpumpehæmmere - bruges mod for meget mavesyre, f.eks. ved fordøjelsesbesvær
• antacids or proton pump inhibitors - used for acid problems in your stomach such as indigestion
Hæld resten af vandet i og ryst den aflukkede flaske i ca. 1 min.
Add the remainder of water and shake the closed bottle well for about 1 minute.
• Vejledning i, hvilke tiltag der skal igangsættes, hvis graviditet indtræder, eller hvis der er en mistanke om, at graviditet er indtrådt under behandling med mycophenolatmofetil eller kort tid efter behandlingen.
Advice on action if a pregnancy occurs or is suspected during or shortly after being treated with mycophenolate mofetil.
Undgå pulver fra itugåede kapsler kommer i kontakt med dine øjne eller mund.
Take care not to let any powder from inside a broken capsule get into your eyes or mouth.
INFORMATION I BRAILLESKRIFT cellcept 500 mg
INFORMATION IN BRAILLE cellcept 500 mg
Der har været indberetninger om aplastisk anæmi og knoglemarvssvigt hos patienter behandlet med CellCept, hvor nogle har været dødelige.
There have been reports of aplastic anaemia and bone marrow failure in patients treated with CellCept, some of which have been fatal.
Farmakokinetikken og farmakodynamikken af orale antikonceptionsmidler påvirkedes ikke af samtidig administration af CellCept (se også pkt.
The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by coadministration of CellCept (see also section 5.2).
Mave-tarmkanalen Abdominal distension
Gastrointestinal disorders Abdominal distension
• Ryst derefter den lukkede flaske godt i ca. 1 minut.
Then shake the closed bottle well for about 1 minute.
Vaskulære sygdomme Hypertension
Vascular disorders Hypertension
CellCept skal gives intravenøst i de 4 første dage efter en levertransplantation og herefter skal oral administration påbegyndes så snart det tåles.
IV CellCept should be administered for the first 4 days following hepatic transplant, with oral CellCept initiated as soon after this as it can be tolerated.
Oralt CellCept bør gives inden for 5 døgn efter transplantationen.
Oral CellCept should be initiated within 5 days following transplantation.
Hjertetransplantat (n = 289)
Cardiac transplant n = 289
Diarré
Diarrhea
Virale infektioner
Viral infections
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Undgå at infusionsopløsningen kommer i kontakt med huden
OTHER SPECIAL WARNING(S), IF NECESSARY Avoid skin contact with infusion solution
CellCept er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre-, hjerte- eller levertransplantater.
CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 50 tabletter
PHARMACEUTICAL FORM AND CONTENTS 50 Tablets
• Øvrige indholdsstoffer: Sorbitol, silica, kolloid, vandfri, natriumcitrat, sojabønne lecitin, blandet frugtsmag, xanthangummi, aspartam* (E951), methylparahydroxybenzoat (E218), citronsyre, vandfri.
• The other ingredients are sorbitol, colloidal anhydrous silica, sodium citrate, soybean lecithin, mixed fruit flavour, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218), citric acid anhydrous.
Isavuconazol Ved samtidig administration af isavuconazol blev der observeret en stigning i MPA AUC0-∞ med 35%.
An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of isavuconazole.
Luk derefter flasken tæt med det børnesikrede låg.
Then, tightly close the bottle with child safety bottle cap.
Endoskopi af patienter med CellCept-relatered diarré har identificeret isolerede tilfælde af intestinal villøs atrofi (se pkt 4.4).
Endoscopic investigation of patients with CellCept-related diarrhea have revealed isolated cases of intestinal villous atrophy (see section 4.4).
Hos nyretransplanterede patienter med svær kronisk nedsat nyrefunktion (glomerulær filtrationsrate < 25 ml/min/1,73 m2), bortset fra perioden umiddelbart efter transplantationen, skal doser på mere end 1 g administreret to gange daglig undgås.
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 300 kapsler
PHARMACEUTICAL FORM AND CONTENTS 300 Capsules
CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, infusionsopløsning må ikke blandes eller gives samtidigt gennem det samme kateter med andre intravøse lægemidler eller infusionsblandinger.
CellCept 500 mg powder for concentrate for solution for infusion solution should not be mixed or administered concurrently via the same catheter with other intravenous medicinal products or infusion admixtures.