natgillin/translations-raw huggingface dataset:
Baseret på resultaterne fra en undersøgelse med enkelt dosis indgift af anbefalede doser af oral mycophenolatmofetil og i. v. ganciclovir og de kendte virkninger af nedsat nyrefunktion på CellCept’ s og ganciclovirs farmakokinetik (se pkt. 4. 2), forudses det at samtidig administration af disse lægemidler (som konkurrerer om den renale tubulære ekskretionsmekanisme) vil medføre forhøjelser af MPAG - og ganciclovir- koncentrationerne.
40 Ganciclovir: based on the results of a single dose administration study of recommended doses of oral mycophenolate and IV ganciclovir and the known effects of renal impairment on the pharmacokinetics of CellCept (see section 4.2) and ganciclovir, it is anticipated that co-administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
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 which 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.
Samtidig administration af probenecid og mycophenolatmofetil forhøjer MPAG' s plasma AUC 3 gange hos aber.
Other interactions: co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of MPAG by 3-fold.
4. 4).
The antibody response to other vaccines may be diminished (see also 4.4).
41 Anvendelse af CellCept anbefales ikke under graviditet og bør begrænses til tilfælde, hvor der ikke findes andre mere passende behandlinger.
41 The use of CellCept is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available.
I kontrollerede kliniske studier hos nyre - (2 g data), hjerte - og levertransplanterede patienter, som blev fulgt i mindst 1 år, var de almindeligste opportunistiske infektioner hos patienter, som fik CellCept (2 g eller 3 g daglig) sammen med andre immunsupprimerende stoffer, mukokutane candidainfektioner, CMV- viræmi/ syndrom og herpes simplex- infektioner.
All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4) The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/ syndrome and Herpes simplex.
I et klinisk studie, som rekrutterede 92 børn i alderen 2- 18 år, og som fik 600 mg/ m2 mycophenolatmofetil oralt to gange daglig, var arten og hyppigheden af uønskede hændelser generelt den samme som dem, der observeredes hos voksne patienter, som fik 1 g CellCept to gange daglig.
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who were given 600 mg/ m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g CellCept twice daily.
42 Ældre patienter (≥ 65 år):
Elderly patients (≥ 65 years):
Ældre patienter som får CellCept som led i et kombinations immunsuppressivt regi, kan have større risiko for visse infektioner (inklusive vævsinvasiv sygdom forårsaget af cytomegalovirus) og muligvis gastrointestinal blødning og lungeødem, sammenlignet med yngre individer.
42 regimen, may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger individuals.
Benigne, maligne
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meget
Very common Common
og uspecificerede
- Skin cancer, benign neoplasm of skin
tumorer (inkl. cyster og polypper)
Blood and lymphatic system disorders Metabolism and nutrition disorders
Almindelig
Very common Common Very common Common
Hudkræft, benignt neoplasme af huden
Leucopenia, thrombocytopenia, anaemia Pancytopenia, leucocytosis - Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
Blod og lymfesystem
Psychiatric disorders
Leukopeni, trombocytopeni, anæmi Pancytopeni, leukocytose
- Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia
- Acidose, hyperkaliæmi, hypokaliæmi, hyperglykæmi, hypomagnesæmi, hypocalcæmi, hyperkolesterolæmi, hyperlipæmi, hypophosphatæmi, hyperuricæmi, ægte gigt, anoreksi
- Convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia
Nervesystemet
- Tachycardia
Meget almindelig
Vascular disorders
Kramper, hypertoni, tremor, somnolens, muskelsvaghed, svimmelhed, hovedpine, paræstesier, smagsforstyrrelser
- Hypotension, hypertension, vasodilatation
Hjerte
Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders
Meget almindelig
Very common Common Very common
-
- Pleural effusion, dyspnoea, cough Vomiting, abdominal pain, diarrhoea, nausea
almindelig Almindelig
Adverse drug reactions
Mave- tarmkanalen: colitis inklusive cytomegalovirus colitis, (≥ 1/ 100 til < 1/ 10, pancreatitis, (≥ 1/ 100 til < 1/ 10) og intestinal villøs atrofi.
Gastrointestinal: colitis including cytomegalovirus colitis, (≥ 1/ 100 to < 1/ 10), pancreatitis (≥ 1/ 100 to < 1/ 10) and intestinal villous atrophy.
44 Hypersensitivitet:
Hypersensitivity:
4. 4).
It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 44 4.4).
MPA er ved klinisk relevante koncentrationer for 97% 's vedkommende bundet til plasma- albumin.
MPA at clinically relevant concentrations, is 97% bound to plasma albumin.
MPA metaboliseres hovedsageligt af glucuronyltransferase til et phenolglucuronid af MPA, som ikke er farmakologisk aktiv.
MPA is metabolised principally by glucuronyl transferase to form the phenolic glucuronide of MPA (MPAG), which is not pharmacologically active.
I en enkelt- dosis undersøgelse (6 personer per gruppe) blev middel plasma MPA- AUC hos personer med svær, kronisk nyreinsufficiens (glomerulær filtrationsrate < 25 ml• min- 1• 1, 73 m- 2) observeret til 28- 75% højere i forhold til middelværdierne hos normale, sunde personer eller personer med mindre grad af nyreinsufficiens.
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• 1.73 m-2) were 28 – 75% higher 45 relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Der er ingen tilgængelige data for hjerte - eller levertransplanterede patienter med svær, kronisk nyreinsufficiens.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Middel plasma MPAG AUC0- 12 timer var 2- 3 gange højere end hos post - transplantationspatienter uden forsinket transplantatfunktion.
Mean plasma MPAG AUC (0-12h) was 2 – 3-fold higher than in post-transplant patients without delayed graft function.
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 postransplantationsperiode.
This dose achieved MPA AUC 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.
46 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
2 - 3 gange den systemiske eksponering (AUC eller Cmax) der er observeret hos nyretransplanterede patienter der fik den anbefalede kliniske dosis på 2 g daglig og 1, 3 - 2 gange den systemiske eksponering (AUC eller Cmax) observeret hos hjertetransplanterede patienter der fik den anbefalede kliniske dosis på 3 g daglig.
The highest dose tested in the animal carcinogenicity studies resulted in approximately 2 – 3 times the systemic exposure (AUC or Cmax) observed in renal transplant patients at the recommended clinical dose of 2 g/ day and 1.3 – 2 times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the recommended clinical dose of 3 g/ day.
Den systemiske eksponering af denne dosis repræsenterer 2 til 3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 2 g daglig til nyretransplanterede patienter og 1, 3 - 2 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig til hjertetransplanterede patienter.
The systemic exposure at this dose represents 2 – 3 times the clinical exposure at the recommended clinical 46 dose of 2 g/ day in renal transplant patients and 1.3 – 2 times the clinical exposure at the recommended clinical dose of 3 g/ day in cardiac transplant patients.
CellCept tabletter: mikrokrystallinsk cellulose polyvidon (K- 90) croscarmellosenatrium magnesiumstearat
CellCept tablets: microcrystalline cellulose polyvidone (K-90) croscarmellose sodium magnesium stearate
47 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)
6. 4 Særlige opbevaringsforhold
47 6.4 Special precautions for storage
6. 5 Emballagetype og pakningsstørrelser CellCept 500 mg tabletter:
CellCept 500 mg tablets:
1 pakning indeholder 150 tabletter (blisterkort med 10 tabletter).
1 carton contains 50 tablets (in blister packs of 10) 1 carton contains 150 tablets (in blister packs of 10)
Da mycophenolatmofetil har demonstreret fosterbeskadigende virkning på rotter og kaniner, må CellCept tabletter ikke knuses.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept tablets should not be crushed.
EU/ 1/ 96/ 005/ 002 CellCept (50 tabletter) EU/ 1/ 96/ 005/ 004 CellCept (150 tabletter)
EU/ 1/ 96/ 005/ 002 CellCept EU/ 1/ 96/ 005/ 004 CellCept
14, februar, 1996 Dato for sidste fornyelse af tilladelsen:
14 February 1996 Date of latest renewal:
DATO FOR ÆNDRING AF TEKSTEN
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
CONDITIONS OF THE MARKETING AUTHORISATION
49 BILAG II
49 A.
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Navn og adresse på fremstillerne ansvarlig for batchfrigivelse
Name and address of the manufacture(s) responsible for batch release
- CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning
- CellCept 500 mg powder for concentrate for solution for infusion
- CellCept 1 g/ 5 ml pulver til oral suspension:
- CellCept 1 g/ 5 ml powder for oral suspension:
1, 79639 Grenzach- Wyhlen, Tyskland.
1, 79639 Grenzach-Wyhlen, Germany.
- CellCept 250 mg kapsler
- CellCept 250 mg capsules
- CellCept 500 mg tabletter:
- CellCept 500 mg tablets:
51 BILAG III
51 A.
ETIKETTERING
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CellCept 250 mg kapsler Mycophenolatmofetil
CellCept 250 mg capsules Mycophenolate mofetil
100 kapsler
100 Capsules
Oral anvendelse Læs indlægssedlen inden brug
For oral administration Read the package leaflet before use
CellCept kapsler skal håndteres forsigtigt Kapslerne må ikke åbnes eller knuses, og pulveret i kapslerne må ikke indåndes eller komme i berøring med huden
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
Må ikke opbevares ved temperaturer over 30 °C Opbevares i den originale emballage for at beskytte mod fugt
Do not store above 30 °C Store in the original package in order to protect from moisture
55 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
300 kapsler
300 Capsules
57 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
56 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
58 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning Mycophenolatmofetil
CellCept 500 mg powder for concentrate for solution for infusion Mycophenolate mofetil
4 hætteglas
4 Vials
60 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
59 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LÆGEMIDLETS NAVN, STYRKE OG/ ELLER ADMINISTRATIONSVEJ( E)
NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
CellCept 500 mg ulver til koncentrat til infusionsvæske, opløsning Mycophenolatmofetil
CellCept 500 mg powder for concentrate for solution for infusion Mycophenolate mofetil
Kun til intravenøs infusion Læs indlægssedlen inden brug
For intravenous infusion only Read the package leaflet before use
61 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
CellCept 1 g/ 5 ml pulver til oral suspension Mycophenolatmofetil
CellCept 1 g/ 5 ml powder for oral suspension Mycophenolate mofetil
5 ml suspension indeholder 1 g mycophenolatmofetil efter rekonstituering.
5 ml suspension contains 1 g mycophenolate mofetil when reconstituted.
1 flaske indeholder 110 g pulver til oral suspension Det brugbare volumen af den rekonstituerede suspension er 160- 165 ml Der medfølger en flaskeadaptor og 2 orale dispensere
1 bottle with 110 g powder for oral suspension The usable volume of the reconstituted suspension is 160-165 ml 1 bottle adapter and 2 oral dispensers are provided
Til oral anvendelse efter rekonstituering
For oral administration after constitution
Det anbefales at suspensionen rekonstitueres på apoteket før udlevering til patienten
It is recommended that the suspension be reconstituted by the pharmacist prior to dispensing to the patient
Pulveret må ikke indåndes før rekonstituering eller komme i berøring med huden Undgå at den rekonstituerede suspension kommer i berøring med huden
Do not breathe the powder before constitution or allow it to touch your skin Avoid skin contact with the reconstituted suspension
62 8.
61 8.
Må ikke opbevares ved temperaturer over 30 °C Den rekonstituerede suspension er holdbar i 2 måneder
Do not store above 30°C The shelf-life of the reconstituted suspension is 2 months
63 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
5 ml suspension indeholder 1 g mycophenolatmofetil efter rekonstituering
5 ml suspension contain 1 g mycophenolate mofetil when reconstituted.
Må ikke opbevares ved temperaturer over 30 °C Den rekonstituerede suspension er holdbar i 2 måneder Anv. senest:
Do not store above 30°C The shelf-life of the reconstituted suspension is 2 months Use before
65 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CellCept 500 mg tabletter Mycophenolatmofetil
CellCept 500 mg tablets Mycophenolate mofetil
50 tabletter
50 Tablets
CellCept tabletter skal håndteres forsigtigt Tabletterne må ikke knuses
CellCept tablets should be handled with care Do not crush the tablets
Må ikke opbevares ved temperaturer over 30 °C Opbevar blisterkortene i den ydre karton for at beskytte mod lys
Do not store above 30 °C Keep the blister in outer carton in order to protect from light
67 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
150 tabletter
150 Tablets
69 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
68 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
INDLÆGSSEDDEL
70 PACKAGE LEAFLET:
CellCept 250 mg kapsler mycophenolatmofetil
CellCept 250 mg capsules mycophenolate mofetil
- Lægen har ordineret CellCept til dig personligt.
- This medicine has been prescribed for you.
Det kan være skadeligt for andre, selv om de har de samme symptomer, som du har.
if their symptoms are the same as yours.
Virkning og anvendelse 2.
What CellCept is and what it is used for 2.
Det skal du vide, før du begynder at tage CellCept 3.
Before you take CellCept 3.
Sådan skal du tage CellCept 4.
How to take CellCept 4.
Opbevaring 6.
How to store CellCept 6.
VIRKNING OG ANVENDELSE
WHAT CELLCEPT IS AND WHAT IT IS USED FOR
Immunsuppressiva.
Immunosuppressants.
CellCept kapsler anvendes til at forhindre kroppen i at afstøde en transplanteret nyre, hjerte eller lever.
CellCept capsules are used to prevent your body rejecting a transplanted kidney, heart or liver.
CellCept bruges sædvanligvis sammen med andre lægemidler inklusive ciclosporin og binyrebarkhormon.
CellCept is used together with other medicines known as ciclosporin and corticosteroids.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE CELLCEPT
BEFORE YOU TAKE CELLCEPT
- Hvis du er overfølsom (allergisk) over for mycophenolatmofetil, mycophenolsyre eller et af de
- If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the
øvrige indholdsstoffer i CellCept.
other ingredients of CellCept.
- Hvis du ammer.
- If you are breastfeeding.
Vær ekstra forsigtig med at tage CellCept:
Take special care with CellCept:
Du bør straks informere din læge:
You should inform your doctor immediately:
- Hvis du oplever nogen form for tegn på infektion (f. eks. feber, ondt i halsen), uventede blå
- If you experience any evidence of infection (e. g. fever, sore throat), unexpected bruising and/ or
mærker og/ eller blødning.
bleeding.
- Hvis du har eller nogensinde har haft problemer med dit fordøjelsessystem, f. eks. mavesår
- If you have or ever have had any problems with your digestive system, e. g., stomach ulcers.
CellCept nedsætter din organismes forsvarsmekanismer.
CellCept reduces your body’ s defence mechanism.
Derfor skal du begrænse din udsættelse for sollys og UV- lys ved at iklæde dig passende beskyttende beklædning og anvende en solblokker med høj beskyttelsesfaktor.
Therefore you should limit your exposure to sunlight and UV light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
Dette gælder også medicin, som ikke er købt på recept.
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed.
72 Hvis du kan svare ja til nogen af de følgende spørgsmål skal du tale med din læge før du begynder at tage CellCept:
71 If you answer yes to any of the following questions talk to your doctor before you start to take CellCept:
- Tager du nogen form for medicin som indeholder: azathioprin eller andre immunosuppressive
- Are you taking any medicines containing: azathioprine or other immunosuppressive agents
stoffer (som undertiden gives til patienter efter en transplantationsoperation), colestyramin (som bruges til behandling af patienter med for højt kolesteroltal), rifampicin (antibiotika), mavesårsmedicin, phosphatbindere (bruges til patienter med kronisk nyresvigt for at reducere absorptionen af phosphat) eller andre lægemidler (inklusive håndkøbsmedicin), som din læge ikke er bekendt med?
(which are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic renal failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
- Skal du vaccineres (levende vaccine)?
- Do you need to receive vaccines (live vaccines)?
Din læge vil rådgive dig om, hvilke vacciner du må
Your doctor will have to advise you what is
bruge.
indicated for you.
Brug af CellCept sammen med mad og drikke:
Taking CellCept with food and drink:
Indtagelse af mad og drikkevarer har ingen indflydelse på din behandling med CellCept.
Taking food and drink has no influence on your treatment with CellCept.
Tag ikke CellCept, hvis du ammer.
Do not take CellCept if you are breastfeeding.
Din læge bør rådgive dig om at anvende antikonception, før du begynder at indtage CellCept, mens du indtager CellCept og i 6 uger efter du er ophørt med at tage CellCept.
You must not use CellCept during pregnancy unless clearly indicated by your doctor. Your doctor should advise you about using contraception before taking CellCept, whilst taking CellCept, and for 6 weeks after you have stopped taking CellCept.
Dette er fordi CellCept måske kan forårsage spontane aborter eller skade dit ufødte barn, herunder give problemer med udvikling af ørerne.
This is because CellCept may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Du skal straks fortælle din læge, hvis du er blevet gravid, ammer, eller hvis du bliver eller påtænker at blive gravid i den nærmeste fremtid.
Tell your doctor straight away if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.
Trafik - og arbejdssikkerhed:
Driving and using machines:
Det er ikke påvist, at Cellcept påvirker evnen til at føre bil eller betjene maskiner
CellCept has not been shown to impair your ability to drive or operate machinery.
SÅDAN SKAL DU TAGE CELLCEPT
HOW TO TAKE CELLCEPT
Tag altid CellCept nøjagtigt efter lægens anvisning.
Always take CellCept exactly as your doctor has told you.
Den sædvanlige dosis er:
The usual way to take CellCept is as follows:
Den første dosis gives inden for 72 timer efter transplantationen.
The first dose will be given within 72 hours after the transplant operation.
Den anbefalede daglige dosis er 8 kapsler (2 g af den aktive bestanddel) indtaget som to separate doser.
The recommended daily dose is 8 capsules (2 g of the active ingredient) taken as 2 separate doses.
Børn (2- 18 år):
Children (aged 2 to 18 years):
Den anbefalede dosis er 600 mg/ m2 to gange daglig.
The recommended dose is 600 mg/ m2 taken twice a day.
Den anbefalede daglige dosis er 12 kapsler (3 g af den aktive bestanddel) indtaget som to separate doser.
The recommended daily dose is 12 capsules (3 g of the active ingredient) taken as 2 separate doses.
Børn:
72 Children:
Anvendelse af CellCept til hjertetransplanterede børn anbefales ikke, da der ikke findes data.
No data are available to recommend the use of CellCept in children who have received a heart transplant.
73 Levertransplantation
Liver Transplant
Den første dosis CellCept til indtagelse gennem munden gives 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 medications.
Den anbefalede daglige dosis er 12 kapsler (3 g aktivt stof) indtaget som to separate doser.
The recommended daily dose is 12 capsules (3 g of the active ingredient) taken as 2 separate doses.
Anvendelse af CellCept til levertransplanterede børn anbefales ikke, da der ikke findes data.
No data are available to recommend the use of CellCept in children who have received a liver transplant.
Indtag ikke kapsler der er åbnede eller gået itu.
Do not break or crush them and do not take any capsules that have broken open or split.
Behandlingen skal fortsætte så længe, du har behov for immunsuppression for at hindre, at du afstøder det transplanterede organ.
Treatment will continue for as long as you need immunosuppression to prevent you rejecting your transplanted organ.
Hvis du har taget for mange CellCept- kapsler:
If you take more CellCept than you should: