natgillin/translations-raw huggingface dataset:
I et enkeltdosisstudie (6 personer per gruppe) blev middelværdi for plasma MPA-AUC hos personer med svær, kronisk nedsat nyrefunktion (glomerulær filtrationsrate < 25 ml/min/1,73 m2) observeret til 28-75 % højere i forhold til middelværdierne hos normale, sunde personer eller personer med let nedsat nyrefunktion.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2) were 28 - 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Patienter, der får CellCept, bør monitoreres for neutropeni, som kan være relateres til CellCept, samtidig medicin, virale infektioner eller en eller anden kombination af disse årsager.
Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept itself, concomitant medications, viral infections, or some combination of these causes.
Andre lidelser såsom: • vægttab, urinsyregigt, forhøjet blodsukker, blødning, blå mærker.
Other problems such as: weight loss, gout, high blood sugar, bleeding, bruising.
Følgende hyppighedskategorier er anvendt: meget almindelig
The corresponding frequency category for each adverse drug reaction is based on the following convention: very common
Lidelser i hjerte og blodkar såsom: • ændringer i blodtrykket, øget hjerterytme, udvidelse af blodkar
Heart and blood vessel problems such as: change in blood pressure, accelerated heartbeat, widening of blood vessels.
Meget almindelig Meget almindelig Benigne, maligne og uspecificerede neoplasmer (inkl.
Very Common Very Common Very Common Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign neoplasm of skin
INFORMATION I BRAILLESKRIFT cellcept 250 mg
INFORMATION IN BRAILLE cellcept 250 mg
Note: 991 (2 g / 3 g CellCept daglig), 289 (3 g CellCept daglig) og 277 (2 g intravenøs / 3 g oral CellCept daglig) patienter i fase III- studier blev behandlet med henblik på forebyggelse af afstødelse efter henholdsvis nyre-, hjerte- og levertransplantation.
Note: 991 (2 g / 3 g CellCept daily), 289 (3 g CellCept daily) and 277 (2 g IV / 3 g oral CellCept daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
Bivirkninger fra de kliniske studier og efter markedsføring er angivet i tabel 1 efter MedDRAs systemorganklasse og hyppighed.
The adverse drug reactions (ADRs) from clinical trials and post marketing experience are listed in Table 1, by MedDRA system organ class (SOC) along with their frequencies.
Kontakt lægen, hvis du udvikler vedvarende hoste eller kortåndethed
Talk to your doctor if you develop a persistent cough or breathlessness
CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, skal fremstilles over to trin; første trin er rekonstitution med 5 % glucose intravenøs infusionsvæske og andet trin er fortynding med 5 % glucose intravenøs infusionsvæske.
CellCept 500 mg powder for concentrate for solution for infusion must be prepared in two steps: the first step is a reconstitution step with glucose intravenous infusion 5% and the second step is a dilution step with glucose intravenous infusion 5%.
Undgå at den opblandede medicin kommer i kontakt med dine øjne.
Take care not to let the made-up medicine get into your eyes.
Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Da mycophenolatmofetil har udvist teratogen virkning hos rotter og kaniner, skal det undgås, at hud og slimhinder kommer i direkte kontakt med tørt pulver og opløsninger af CellCept 500 mg pulver til koncentrat til infusionsvæske undgås.
Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid direct contact of the dry powder or prepared solutions of CellCept 500 mg powder for concentrate for solution for infusion with skin or mucous membranes.
Multipakning indeholder 150 (3 pakker af 50) tabletter.
Multipacks containing 150 (3 packs of 50) tablets
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE DELPAKNING TIL BLISTER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON FOR BLISTER
• diarré, forstoppelse, kvalme, fordøjelsesbesvær, appetitløshed, luft i maven.
diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
Disse data supporterer ekstrapolering af dette fund til alle antacida, fordi reduktionen i eksponering er betydelig mindre, når Cellcept gives samtidig med magnesium- og aluminumhydroxider, end når Cellcept gives samtidig med protonpumpehæmmere.
This data support extrapolation of this finding to all antacids because the reduction in exposure when CellCept was coadministered with magnesium and aluminium hydroxides is considerably less than when CellCept was co-administered with PPIs.
Denne indlægsseddel blev senest godkendt den {MM/ÅÅÅÅ} Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
This leaflet was last revised on {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
• Der er ingen information om brug af CellCept til levertransplanterede børn.
• There is no information for the use of CellCept in children with a liver transplant.
Smerter i led og muskler som myalgi, nakke- og rygsmerter blev også indberettet som meget almindelige bivirkninger.
Musculoskeletal pain such as myalgia, and neck and back pain were also very commonly reported.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 100 kapsler
PHARMACEUTICAL FORM AND CONTENTS 100 Capsules
I alt 1.557 (estimeret antal) patienter blev i fem kliniske studier behandlet med CellCept med henblik på forebyggelse af akut transplantatafstødelse.
An estimated total of 1557 patients received CellCept during five clinical trials in the prevention of acute organ rejection.
Disse effekter forekom ved systemiske eksponeringsniveauer som er lig med eller mindre end de kliniske niveauer ved den anbefalede dosis på 2 g daglig.
These effects occurred at systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended dose of 2 g/day.
Note: 991 (2 g / 3 g CellCept daglig) og 277 (2 g intravenøs / 3 g oral CellCept daglig) patienter i fase III- studier blev behandlet med henblik på forebyggelse af afstødelse efter henholdsvis nyre- og levertransplantation.
Note: 991 (2 g / 3 g CellCept daily) and 277 (2 g IV / 3 g oral CellCept daily) patients were treated in Phase III studies for the prevention of rejection in renal and hepatic transplantation, respectively
OPLØSNING MÅ IKKE GIVES SOM EN HURTIG INJEKTION ELLER SOM EN BOLUSINJEKTION.
SOLUTION MUST NOT BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.
Hud hypertrofi
Skin hypertrophy
CellCept indeholder:
What CellCept contains
Hud og subkutane væv Alopeci
Skin and subcutaneous tissues disorders Acne
EU/1/96/005/003 CellCept (300 kapsler)
EU/1/96/005/003 CellCept
Afmål 94 ml renset vand i et målebæger.
Measure 94 mL of purified water in a measuring cylinder.
CellCept tabletter mikrokrystallinsk cellulose polyvidon (K-90) croscarmellosenatrium magnesiumstearat
CellCept tablets microcrystalline cellulose polyvidone (K-90) croscarmellose sodium magnesium stearate
Tag altid lægemidlet nøjagtigt efter lægens anvisning.
Always take CellCept exactly as your doctor has told you.
CellCept 1 g/5 ml pulver til oral suspension er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre-, hjerte- eller levertransplantater.
CellCept 1 g/5 ml powder for oral suspension is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Der er publicerede tilfælde af bronkiektasi hos voksne og børn, der har fået Cellcept i kombination med andre immunsuppressiva.
There have been published reports of bronchiectasis in adults and children who received CellCept in combination with other immunosuppressants.
Ialt 1.268 (estimeret antal) patienter blev i fire kliniske studier behandlet med CellCept med henblik på forebyggelse af akut transplantatafstødelse.
An estimated total of 1268 patients received CellCept during four clinical trials in the prevention of acute organ rejection.
• Pulver til oral suspension: Må ikke opbevares ved temperaturer over 30 °C.
• Powder for oral suspension: do not store above 30°C.
Fremstiller, ansvarlig for batchfrigivelse: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Tyskland.
Manufacturing Authorisation holder responsible for batch release: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Germany.
• Øvrige indholdsstoffer: Polysorbat 80, citronsyre, saltsyre, natriumchlorid.
The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 50 filmovertrukne tabletter.
PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets.
Infusionsopløsningen bortkastes, hvis der ses partikler eller misfarvning.
Discard the infusion solution if particulate matter or discoloration is observed.
Når CellCept blev administreret samtidig med sevelamer, faldt MPA-Cmax og AUC0-12 timer med henholdsvis 30 % og 25 %, dog uden at dette havde kliniske konsekvenser (f.eks. i form af transplantatafstødning).
Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when CellCept was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver flaske indeholder 35 g mycophenolatmofetil i 110 g pulver til oral suspension.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
• Den første dosis CellCept til indtagelse gennem munden gives til dig tidligst 4 dage efter transplantationen, og når du er i stand til at indtage medicin gennem munden.
• The first dose of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
• CellCept må ikke anvendes hos fertile kvinder, som ikke anvender højeffektiv prævention (se pkt.
• CellCept should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
CellCept kapsler pregelatineret majsstivelse croscarmellosenatrium polyvidon (K-90) magnesiumstearat
CellCept capsules pregelatinised maize starch croscarmellose sodium polyvidone (K-90) magnesium stearate
• hvis du er gravid eller planlægger at blive gravid eller tror, at du kan være gravid
• If you are pregnant or planning to become pregnant or think you may be pregnant
Nyrer og urinveje Forhøjet serumcreatinin
Renal and urinary disorders Blood creatinine increased
Trin 2. a) Derefter fortyndes indholdet af de 2 rekonstiuerede hætteglas (ca. 2 x 15 ml) med 140 ml 5 % glucose intravenøs infusionsvæske.
Further dilute the content of the two reconstituted vials (approx. 2 x 15 mL) into 140 mL of glucose intravenous infusion 5%.
Farmakokinetikken af orale kontraceptiva påvirkedes ikke af samtidig administration af CellCept (se også pkt.
The pharmacokinetics of oral contraceptives were unaffected by co-administration of CellCept (see also section 4.5).
• CellCept må ikke anvendes til ammende kvinder (se pkt.
• CellCept should not be given to women who are breastfeeding (see section 4.6).
• Ryst derefter den lukkede flaske godt i yderligere 1 minut.
Then shake the closed bottle well for about another minute.
• Opbevares i den originale yderpakning for at beskytte mod fugt.
• Store in the original package in order to protect from moisture.
Hyperglykæmi
Hyperglycemia
Fjern det børnesikrede låg og tryk flaskeadaptoren ned i flaskehalsen.
Take off the child safety bottle cap and push the bottle adapter into the neck of the bottle.
• Den første dosis gives inden for 3 dage efter transplantationen.
• The first dose is given within 3 days of the transplant operation.
• Rekonstitueret opløsning og fortyndet opløsning: Opbevares ved temperaturer mellem 15 °C og
Reconstituted solution and the diluted solution: store between 15°C and 30°C.
Den anbefalede dosis til nyretransplanterede patienter er 1 g administreret to gange daglig (døgndosis, 2 g), dvs. 5 ml oral suspension to gange daglig.
The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose), i.e. 5 mL oral suspension twice daily.
• iklæde dig beskyttende beklædning, som også dækker hoved, hals, arme og ben
Do this by: wearing protective clothing which also covers your head, neck, arms and legs using a sunscreen with a high protection factor.
Medicinens fulde navn er CellCept 1 g/5 ml pulver til oral suspension.
The full name of your medicine is CellCept 1 g/5 ml powder for oral suspension.
CellCept tabletter må kun ordineres til patienter med en legemsoverflade på mindst 1,5 m2, i en dosis på 1 g to gange daglig (daglig dosis: 2 g).
CellCept tablets should only be prescribed to patients with a body surface area greater than 1.5 m2, at a dose of 1 g twice daily (2 g daily dose).
Infusionshastigheden skal indstilles til ca. 2 timer.
The infusion flow rate should be controlled to equate to a 2-hour period of administration.
Hos patienter med forsinket renal transplantatfunktion post-transplantativt var middelværdi for MPAAUC0-12 timer sammenlignelig med, hvad man så hos posttransplanterede patienter uden forsinket transplantatfunktion.
In patients with delayed renal graft function post-transplant, mean MPA AUC0-12h was comparable to that seen in post-transplant patients without delayed graft function.
• CellCept-behandling må ikke initieres hos fertile kvinder uden at en negativ graviditetstest foreligger, for at udelukke en uønsket anvendelse under graviditet (se pkt.
• CellCept treatment should not be initiated in women of childbearing potential without providing a pregnancy test result to rule out unintended use in pregnancy (see section 4.6).
1 pakning indeholder 100 kapsler (blisterkort med 10 kapsler).
1 carton contains 100 capsules (in blister packs of 10) 1 carton contains 300 capsules (in blister packs of 10)
Medicinens fulde navn er CellCept 250 mg kapsler.
The full name of your medicine is CellCept 250 mg capsules.
Tablet-overtrækket hydroxypropylmethylcellulose hydroxypropylcellulose titandioxid (E171) polyethylenglycol 400 indigotin aluminiumlak (E132) rød jernoxid (E172)
Tablet coating hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide (E171) polyethylene glycol 400 indigo carmine aluminium lake (E132) red iron oxide (E172)
Efter markedsføring er der observeret medfødte misdannelser, herunder rapporter om multiple misdannelser hos børn af patienter, som under graviditeten var blevet behandlet med CellCept i kombination med andre immunsuppressiva.
Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to CellCept during pregnancy in combination with other immunosuppressants.
• CellCept må ikke anvendes under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet (se pkt.
• CellCept should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om CellCept findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Den systemiske eksponering af denne dosis repræsenterer 2 - 3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 2 g daglig.
The systemic exposure at this dose represents 2 - 3 times the clinical exposure at the recommended clinical dose of 2 g/day.
Hyperkolesterolæmi
Hypercholesterolemia
Med denne dosis opnåedes MPA AUC-værdier svarende til hos voksne, nyretransplanterede patienter, som fik 1 g CellCept to gange daglig i den tidlige og sene posttransplantationsperiode.
values similar to those seen in adult renal transplant patients receiving CellCept at a dose of 1 g bid in the early and late post-transplant period.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer
Any unused product or waste material should be disposed of in accordance with local requirements
Luftveje, thorax og mediastinum Bronkiektasi
Respiratory, thoracic and mediastinal disorders Bronchiectasis
Konvulsion
Convulsion
Den systemiske eksponering på disse niveauer er omtrent lig med eller mindre end 0,5 gange den kliniske eksponering ved den anbefalede dosis på 2 g daglig (se pkt.
The systemic exposure at these levels is approximately equivalent to or less than 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day (see section 4.6).
• Tag 4 kapsler om morgenen og 4 kapsler om aftenen.
• Take 4 capsules in the morning and then 4 capsules in the evening.
• Den første dosis gives inden for 24 timer efter transplantationen.
The first dose is given within 24 hours of the transplant operation.
CellCept er blevet sat i forbindelse med en øget incidens af bivirkninger i fordøjelsessystemet, inklusive sjældne tilfælde af ulceration, blødning og perforation.
CellCept has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.
Brug af anden medicin sammen med CellCept
Other medicines and CellCept
infusionsvæske må aldrig gives som en hurtig injektion eller som en bolusinjektion.
CellCept IV solution should never be administered by rapid or bolus intravenous injection.
Almene symptomer og reaktioner på administrationsstedet Ødemer, inklusiv perifere, ansigts- og skrotalødemer, blev indberettet som meget almindelige bivirkninger i de pivotale kliniske studier.
General disorders and administration site conditions Edema, including peripheral, face and scrotal edema, was reported very commonly during the pivotal trials.
Afstødning af nyretransplantat medfører ingen ændringer af MPAs farmakokinetik; dosisreduktion eller afbrydelse af CellCept er ikke nødvendig.
Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of CellCept is not required.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 5 ml suspension indeholder 1 g mycophenolatmofetil efter rekonstitution.
STATEMENT OF ACTIVE SUBSTANCE(S) 5 ml suspension contains 1 g mycophenolate mofetil when reconstituted.
Pædiatrisk population Der er ingen data vedrørende hjertetransplantationer hos pædiatriske patienter.
Paediatric population No data are available for paediatric cardiac transplant patients.
1 flaske indeholder 35 g mycophenolatmofentil i 110 g pulver til oral suspension.
1 bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Svært nedsat leverfunktion
Weight decreased
Undgå at den opblandede medicin kommer i kontakt med din hud.
Take care not to let the made-up medicine get onto your skin.
CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre- eller levertransplantater.
CellCept 500 mg powder for concentrate for solution for infusion is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal or hepatic transplants.
600 mg/m2 to gange daglig.
The recommended dose is 600 mg/ m² taken twice a day.
Almene symptomer og reaktioner på administrations-stedet Asteni
General disorders and administration site conditions Asthenia
• Brug ikke CellCept efter den udløbsdato, der står på pakningen og flaskeetiketten efter EXP.
• Do not use after the expiry date stated on the carton and bottle label (EXP).
Medicinens fulde navn er CellCept 500 mg filmovertrukne tabletter.
The full name of your medicine is CellCept 500 mg film-coated tablets.
• Lad være med at blande medicinen med anden væske, når du synker den.
• Do not mix the medicine with any other liquid when you swallow it. Close the bottle with the child safety bottle cap after each use.
• Nyre eller lever.
A kidney or liver.
• Vejledning om, at patienter ikke må være bloddonorer under behandlingen og i mindst 6 uger efter, at mycophenolat er seponeret .
Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Efter rekonstitution er suspensionens volumen 175 ml svarende til et nyttevolumen på 160-165 ml.
The usable volume of the reconstituted suspension is 160-165 ml.
CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, skal gives som intravenøs infusion.
CellCept 500 mg powder for concentrate for solution for infusion must be given as an intravenous (IV) infusion.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse
METHOD AND ROUTE(S) OF ADMINISTRATION For oral administration
Det skal du vide, før du begynder at tage CellCept
What you need to know before you take CellCept
DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om CellCept findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
• De findes i pakninger med 50 (blisterpakninger a 10 stk.) eller multipakninger indeholdende
• They are available as packs of 50 (in blister packs of 10) or Multipacks containing 150 (3 packs of 50) tablets.
Efter enkeltdosis-administration af 1,5 g mycophenolatmofetil til normale, sunde personer forbehandlet med 4 g colestyramin tre gange daglig i 4 dage var der en 40 % reduktion af MPA-AUC (se pkt.
Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4 and section 5.2).
4.6 (f.eks. prævention, graviditetstests) før, under og efter behandling med CellCept.
Female patients of childbearing potential should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with CellCept.
• CellCept tabletter: Mikrokrystallinsk cellulose, polyvidon (K-90), croscarmellosenatrium, magnesiumstearat
• CellCept tablets: microcrystalline cellulose, polyvidone (K-90), croscarmellose sodium,
Immunsystemet Hypersensitivitet
Immune system disorders Hypersenstivity
Venetrombose
Venous thrombosis
I nogle af disse tilfælde sås forbedringer i de respiratoriske symptomer, når Cellcept blev erstattet af alternative immunsuppressiva.
In some of these cases switching CellCept to another immunosuppressant resulted in improvement in respiratory symptoms.
LÆGEMIDLETS NAVN CellCept 250 mg kapsler.
NAME OF THE MEDICINAL PRODUCT CellCept 250 mg capsules.
Efter enkeltdosis oral administration af 1,5 g mycophenolatmofetil til normale, sunde personer forbehandlet med 4 g colestyramin tre gange daglig i 4 dage var der en 40 % reduktion af MPA-AUC (se pkt.
Following single dose, oral administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4, and section 5.2).
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 500 mg mycophenolatmofetil (som hydrochlorid).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains the equivalent of 500 mg mycophenolate mofetil (as hydrochloride salt).