qanastek/EMEA-V3 huggingface dataset:
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg• kg-1• day-1.
Mycophenolate mofetil ma kellu l- ebda effett fuq il- fertilità ta ’ firien maskili f’ dożi mill- ħalq sa 20 mg• kg- 1• jum- 1.
The systemic exposure at this dose represents 2 – 3 times the clinical exposure at the recommended clinical 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.
L- esponiment sistemiku f’ din id- doża jirrappreżenta 2 – 3 darbiet ogħla mill - esponiment kliniku fid- doża rakkomandata klinikament ta ’ 2 g/ jum f’ pazjenti bi trapjant renali u 1. 3 – 2 darbiet ogħla mill- esponiment kliniku ta ’ 3 g/ jum f’ pazjenti bi trapjant tal- qalb.
In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg• kg-1• day-1 caused malformations (including anophthalmia, agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
Fi studju dwar il- fertilità u r- riproduzzjoni femminili li sar fuq il- firien, dożi li ttieħdu mill- ħalq ta ’ 4. 5 mg• kg- 1• jum- 1 wasslu għal malformazzjonijiet (inklużi anoftalmja, agnatja, u idroċefalu) fl- ewwel ġenerazzjoni ta ’ frieħ fin- nuqqas ta ’ tossiċità għall- omm.
The systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended clinical dose of 2 g/ day for renal transplant patients and approximately 0.3 times the clinical exposure at the recommended clinical dose of 3 g/ day for cardiac transplant patients.
L- esponiment sistemiku b’ din id- doża kienet ta ’ madwar 0. 5 darbiet ogħla mill - esponiment kliniku fid- doża rakkomandata ta ’ 2 g/ jum f’ pazjenti bi trapjant renali u madwar 0. 3 darbiet ogħla mill- esponiment kliniku ta ’ 3 g/ jum f’ pazjenti bi trapjant tal- qalb.
No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.
Ma kienu evidenti l- ebda effetti fuq il- fertilità jew parametri reproduttivi fl- ommijiet jew fil- ġenerazzjoni ta ’ wara.
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg• kg-1• day-1 (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg• kg1• day-1 (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
Fi studji dwar it- teratoġeniċità fil- firien u fil- fniek, resorbiment tal- fetu u malformazzjonijiet seħħew fil - firien f’ dożi ta ’ 6 mg• kg- 1• jum- 1 (inklużi anoftalmja, agnatja, u idroċefalu) u fil- fniek f’ dożi ta ’ 90 mg• kg - 1 • jum- 1 (inklużi anomaliji kardjovaskulari u renali bħal per eżempju ectopia cordis u kliewi ektopiċi, u ftuq umbilikali u fid- dijaframma), fin- nuqqas ta ’ tossiċità materna.
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 for renal transplant patients and approximately 0.3 times the clinical exposure at the recommended clinical dose of 3 g/ day for cardiac transplant patients.
L- esponimenti sistematiku f’ dawn il - livelli huwa kważi ekwivalenti għal jew inqas minn 0. 5 darbiet ogħla mill- esponiment kliniku bid- doża rakkomandata klinikament ta ’ 2 g/ jum f’ pazjenti bi trapjant renali u madwar 0. 3 darbiet ogħla mill - esponiment kliniku bid- doża rakkomandata klinikament ta ’ 3 g/ jum f’ pazjenti bi trapjant tal- qalb.
Refer to section 4.6.
Irreferi għal sezzjoni 4. 6.
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
Is- sistemi ematopoetiċi u tal- limfojdi kienu l- organi ewlenin affettwati fi studji tat- tossikoloġija li twettqu b’ mycophenolate mofetil fil- far, ġurdien, kelb u xadina.
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 for renal transplant recipients.
Dawn l- effetti seħħew f’ livelli ta ’ esponiment sistemiku ekwivalenti għal jew inqas mill- esponiment kliniku fid- dożi rakkomandati ta ’ 2 g/ jum għal riċevituri ta ’ trapjant renali.
Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose.
Effetti gastro- intestinali kienu osservati fil- kelb f’ livelli ta ’ esponiment sistemiku ekwivalenti għal jew inqas mill- esponiment kliniku fid- doża rakkomandata.
Gastrointestinal and renal effects consistent with dehydration were also observed in the monkey at the highest dose (systemic exposure levels equivalent to or greater than clinical exposure).
Kienu osservati ukoll effetti gastro- intestinali u renali konsisteni ma ’ deidrazzjoni fix- xadina fl- ogħla doża (livelli ta ’ esponiment sistemiku ekwivalenti għal jew ogħla mill- esponiment kliniku).
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).
Il- profil ta ’ tossiċità mhux kliniku ta ’ mycophenolate mofetil jidher li huwa konsistenti ma ’ l- avvenimenti avversi osservati fi provi kliniċi umani li issa jipprovdu tagħrif ta 'sigurtà ta' relevanza akbar għall- popolazzjoni ta ’ pazjenti (ara s - sezzjoni 4. 8).
CellCept capsules: pregelatinised maize starch croscarmellose sodium polyvidone (K-90) magnesium stearate
Kapsuli CellCept: pregelatinised maize starch croscarmellose sodium polyvidone (K- 90) magnesium stearate.
11 Capsule shells: gelatin indigo carmine (E132) yellow iron oxide (E172) red iron oxide (E172) titanium dioxide (E171) black iron oxide (E172) potassium hydroxide shellac.
Il- qoxra tal- kapsula: gelatin indigo carmine (E132) iron oxide isfar (E172) iron oxide aħmar (E172) titanium dioxide (E171) iron oxide iswed (E172) potassium hydroxide shellac.
6.3 Shelf-life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Do not store above 30°C.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali, sabiex tilqa ’ mill- umdità.
6.5 Nature and contents of container
6. 5 In- naturatal- kontenitur u ta ’ dak li hemm ġo fiħ
CellCept 250 mg capsules:
CellCept 250 mg kapsuli:
1 carton contains 100 capsules (in blister packs of 10) 1 carton contains 300 capsules (in blister packs of 10)
kartuna 1 fiha 100 kapsula (f’ paketti tal- folja ta ’ 10) kartuna 1 fiha 300 kapsula (f’ paketti tal- folja ta ’ 10)
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept capsules should not be opened or crushed.
Minħabba li mycophenolate mofetil wera effetti teratoġeniċi fil- firien u fil- fniek, kapsuli ta ’ CellCept ma għandhomx jinfettħu jew jitfarrku.
Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CellCept capsules.
Evita li t- trab li jinstab fil- kapsuli CellCept jittieħed man- nifs jew jiġi f’ kuntatt dirett mal- ġilda jew membrani mukużi.
If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Jekk iseħħ kuntatt, aħsel sewwa bl- ilma u s- sapun; laħlaħ l- għajnejn b’ ilma naturali.
(100 capsules) (300 capsules)
(100 kapsula) (300 kapsula)
14 February 1996 Date of latest renewal:
14 ta ’ Frar 1996 Data ta 'l- aktar tiġdid reċenti:
14 February 2006
14 ta 'Frar 2006
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
CellCept 500 mg powder for concentrate for solution for infusion.
CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni.
Each vial contains the equivalent of 500 mg mycophenolate mofetil (as hydrochloride salt).
Kull kunjett fih l- ekwivalenti ta '500 mg mycophenolate mofetil (bħala melħ tal- hydrochloride).
Powder for concentrate for solution for infusion.
Trab għall- konċentrat għal soluzzjoni għall- infużjoni.
CellCept 500 mg powder for concentrate for solution for infusion must be reconstituted and further diluted with glucose intravenous infusion 5% prior to administration to the patient (see section 6.6).
CellCept 500 mg trab għal konċentrat għal soluzzjoni għall- infużjoni irid jiġi rikostitwit u dilwit aktar ma 'infusjoni ta ’ 5% glukosju għal ġol- vini qabel ma jingħata lill- pazjent (ara sezzjoni 6. 6).
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.
CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni huwa ndikat f’ taħlita ma 'ciclosporin u kortikosterojdi għall- profilassi ta ’ tiċħid akut tat- trapjant f' pazjenti li rċevew trapjant alloġeniku renali jew epatiku.
CAUTION:
ATTENZJONI:
CELLCEPT I. V.
CELLCEPT SOLUZZJONI I. V.
SOLUTION SHOULD NEVER BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.
M’ GĦANDHA QATT TINGĦATA PERMEZZ TA 'INJEZZJONI MINN ĠOL- VINI BOLUS JEW MGĦAĠĠLA.
CellCept 500 mg powder for concentrate for solution for infusion is an alternative dosage form to CellCept oral forms (capsules, tablets and powder for oral suspension) that may be administered for up to 14 days.
Trab CellCept 500 mg għall- konċentrat għal soluzzjoni għall- infużjoni huwa forma alternattiva ta ’ dożaġġ għall- forom orali ta ’ CellCept, (kapsuli, pilloli jew trab għal suspensjoni orali), li jista ’ jingħata sa 14- il ġurnata.
The initial dose of CellCept 500 mg powder for concentrate for solution for infusion should be given within 24 hours following transplantation.
Id- doża tal- bidu ta 'CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni għandha tingħata fi żmien 24 siegħa wara t- trapjant.
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).
Wara r- rikostituzzjoni għall- konċentrazzjoni ta '6 mg/ ml, CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni għandu jingħata permezz ta' infużjoni fil- vini bil- mod fuq perjodu ta ’ sagħtejn minn vina ċentrali jew periferali (ara sezzjoni 6. 6).
Use in renal transplant: the recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Użu fi trapjanti renali: id- doża rakkomandata f’ pazjenti bi trapjant renali hija ta '1 g darbtejn kuljum (doża ta ’ 2 g kuljum).
Use in hepatic transplant: the recommended dose of CellCept for infusion in hepatic transplant patients is 1 g administered twice daily (2 g daily dose).
Użu fi trapjanti epatiku: id- doża rakkomandata għall- infużjoni ta ’ CellCept f’ pazjenti bi trapjant epatiku hija ta '1 g mogħtija darbtejn kuljum (doża ta ’ 2 g kuljum).
IV CellCept should continue for the first 4 days following hepatic transplant, with oral CellCept initiated as soon after this as it can be tolerated.
CellCept IV għandu jitkompla għall- ewwel erbat ijiem wara t- trapjant, u wara CellCept orali għandu jinbeda malajr kemm jista ’ jkun, hekk kif jiġi ttollerat.
The recommended dose of oral CellCept in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Id- doża rakkomandata ta ’ CellCept orali f' pazjent bi trapjant tal- fwied hija ta '1. 5 g mogħtija darbtejn kuljum (doża ta ’ 3 g kuljum).
Use in children: safety and efficacy of CellCept for infusion in paediatric patients have not been established.
Użu fit- tfal: is- sigurtà u l- effikaċja ta ’ CellCept għall- infużjoni għadhom ma ġewx stabbiliti f’ pazjenti pedjatriċi.
No pharmacokinetic data with CellCept for infusion are available for paediatric renal
Mhux disponibbli tagħrif farmakokinetiku b’ CellCept għall- infużjoni għall- pazjenti pedjatriċi bi trapjant renali.
No pharmacokinetic data are available for paediatric patients following hepatic transplants.
Mhux disponibbli tagħrif farmakokinetiku għall- pazjenti pedjatriċi wara trapjant renali.
Use in elderly (≥ 65 years): the recommended dose of 1 g administered twice a day for renal or hepatic transplant patients is appropriate for the elderly.
14 Użu fl- anzjani (≥ 65 sena): id- doża rakkomandata hija ta '1 g mogħtija darbtejn kuljum għall- pazjenti bi trapjant renali jew tal- fwied hija xierqa għall- anzjani.
No data are available for hepatic transplant patients with severe chronic renal impairment.
M’ hemmx tagħrif disponibbli dwar pazjenti bi trapjant epatiku b’ indeboliment kroniku sever tal- kliewi.
Use in severe hepatic impairment: no dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Użu f' pazjenti b’ indeboliment sever tal- fwied: m' hemmx bżonn ta ’ aġġustament fid- doża f' pazjenti bi trapjant renali b’ mard parenkimali sever tal- fwied.
CellCept 500 mg powder for concentrate for solution for infusion is contraindicated in patients who are allergic to polysorbate 80.
CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni huwa kontra- indikat f’ pazjenti li huma allerġiċi għal polisorbat 80.
For information on use in pregnancy and contraceptive requirements, see section 4.6.
Għal tagħrif dwar l- użu fit- tqala u l- ħtiġijiet ta ’ kontraċezzjoni ara sezzjoni 4. 6.
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Dawn l- infezzjonijiet ħafna drabi huma relatati ma ’ esponiment immunosoppressiv totali għoli u jistgħu jwasslu għall- kundizzjonijiet serji jew fatali li t- tobba għandhom jikkunsidraw fid- dijanjosi differenzjali f’ pazjenti immunosoppressi b’ funzjoni tal- fwied li qed tiddeterjora jew b’ sintomi newroloġiċi.
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.
Pazjenti li qed jirċievu CellCept għandhom jiġu sorveljati għal newtropenja, li tista tkun relatata ma ’ CellCept innifsu, mediċini fl- istess waqt, infezzjonijiet virali jew xi taħlita ta ’ dawn il- kawżi.
Patients taking CellCept should have complete blood counts weekly during the first month, twice monthly for the
Pazjenti li qed jieħdu CellCept għandhom jagħmlu test ta ’ l- għadd komplet taċ- ċelluli tad- demm kull ġimgħa waqt l - ewwel xahar, darbtejn fix- xahar fit- tieni u t- tielet xahar u wara darba fix- xahar matul l- ewwel sena ta ’ kura.
If neutropenia develops (absolute neutrophil count < 1.3 x 103/ µl) it may be appropriate to interrupt or discontinue CellCept.
Jekk tiżvilluppa newtropenja, (għadd assolut ta ’ newtrofili < 1. 3 x 10³/ µl), jista ’ jkun xieraq li CellCept titwaqqaf għal xi żmien, jew għall- kollox.
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).
15 Il- pazjenti għandhom jiġu avżati li waqt il- kura b' CellCept, it- tilqim jista ’ jkun anqas effettiv u l- użu ta ’ tilqim b organiżmu ħaj għandu jiġi evitat (ara sezzjoni 4. 5).
On theoretical grounds, therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Għalhekk fuq bażi teoretika, għandu jiġi evitat f’ pazjenti b’ nuqqas ereditarju, rari ta 'l- enżima hypoxanthine- guanine phosphoribosyl- transferase (HGPRT) bħas- sindromu Lesch- Nyhan u Kelley- Seegmiller.
Some degree of enterohepatic recirculation is anticipated following intravenous administration of CellCept.
Huwa antiċipat xi grad ta ’ riċirkolazzjoni entero- epatika wara amministrazzjoni minn ġol- vini ta ’ CellCept.
Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e. g. valaciclovir, to compete for tubular secretion, and further increases in concentrations of both substances may occur.
Peress li fil- preżenza ta ’ indeboliment renali l - konċentrazzjonijiet fil- plażma ta 'MPAG u ta ’ aciclovir jiżdiedu, hemm il- potenzjal li mycophenolate mofetil u aciclovir, jew il- prodrugs tiegħu e. ż. valaciclovir jikkompetu għat- tneħħija mit- tubi tal- kliewi u dan iwassal għal aktar żieda fil- konċentrazzjoni taż- żewġ sustanzi.
(see section 4.4, and section 5.2).
Cholestyramine: wara l- għotja orali ta ’ doża waħda ta '1. 5 g ta' mycophenolate mofetil lil individwi b' saħħithom li kienu kkuratati minn qabel b’ 4 g tliet darbiet kuljum ta ’ cholestyramine għal erbat ijiem, kien hemm tnaqqis ta ’ 40% fl- AUC ta ’ l- MPA (ara sezzjoni 4. 4 u sezzjoni 5. 2).
Medicinal products that interfere with enterohepatic circulation: caution should be used with medicinal products that interfere with enterohepatic circulation because of their potential to reduce the efficacy of CellCept.
Prodotti mediċinali li jinterferixxu maċ- ċirkolazzjoni entero- epatika: għandu jkun hemm kawtela b’ mediċini li jinterferixxu maċ- ċirkolazzjoni entero- epatika minħabba l- potenzjal tagħhom li jnaqqsu l - effikaċja ta ’ CellCept.
Ciclosporin A: ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Ciclosporin A: il- farmakokinetika ta 'ciclosporin A (CsA) mhix affetwata minn mycophenolate mofetil.
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.
Ganciclovir: ibbażat fuq riżultati ta ’ studju b’ għotja ta ’ doża waħda ta ’ dożi rakkomandata ta ’ mycophenolate orali u ganciclovir IV u l- effetti magħrufa ta ’ indeboliment renali fuq il- farmakokinetika ta ’ CellCept (ara sezzjoni 4. 2) u ganciclovir, huwa mbassar li l- għotja flimkien ta ’ dawn is- sustanzi (li jikkompetu għall- mekkaniżmi ta ’ sekrezzjoni tubulari mill- kliewi) tirriżultaw f’ żieda fil -
No substantial alteration of MPA pharmacokinetics is anticipated and 16 CellCept dose adjustment is not required.
Mhux mistennija bidla sostanzjali fil- farmakokinetika ta 'MPA u mhux meħtieġa bidla fid- doża ta' CellCept.
In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of CellCept (1.5 g BID) were administered to patients taking tacrolimus.
Tacrolimus: f’ pazjenti li rċevew trapjant tal- fwied li nbdew fuq CellCept u tacrolimus, l- AUC u Cmax ta ’ MPA, l- metabolit attiv ta ’ CellCept, ma kienux affettwati b’ mod sinifikanti mill- għotja fl- istess waqt ta ’ tacrolimus. B’ kuntrast, kien hemm żjieda ta ’ madwar 20% fl- AUC ta ’ tacrolimus meta dożi multipli ta 'CellCept (1. 5 g BID) ingħataw lil pazjenti li kienu qed jieħdu tacrolimus.
Live vaccines: live vaccines should not be given to patients with an impaired immune response.
Vaċċini b' mikrobi ħajjin: vaċċini b’ mikrobi ħajjin m’ għandhomx jingħataw lil pazjenti b' indeboliment fir - rispons immunitarju.
CellCept should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus.
CellCept għandu jintuża f’ nisa tqal biss jekk il- benefiċċju potenzjali
17 to CellCept in combination with other immunosuppressants during pregnancy.
Hemm tagħrif limitat dwar l- użu ta ’ CellCept f’ nisa tqal.
No studies on the effects on the ability to drive and use machines have been performed.
Ma saru l- ebda studji fuq l- effetti fuq il- ħila biex issuq u tħaddem magni.
The pharmacodynamic profile and the reported adverse reactions indicate that an effect is unlikely.
Il- profil farmakodinamiku u r - rapporti ta ’ reazzjonijiet avversi, jindikaw effett mhux probabbli.
The adverse reaction profile associated with the administration of CellCept 500 mg powder for concentrate for solution for infusion has been shown to be similar to that observed after oral administration.
Il- profil ta ’ reazzjonijiet avversi assoċjat ma ’ l- għotja ta ’ CellCept 500 trab għall- konċentrat għal soluzzjoni għall- infużjoni intwera li huwa simili għal dak osservat wara amministrazzjoni orali.
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.
L- iktar infezzjonijiet opportunistiċi komuni f' pazjenti fuq CellCept (2 g jew 3 g kuljum) flimkien ma 'immunosoppressanti oħra fi provi kliniċi kkontrollati f’ pazjenti bi trapjant tal- kliewi (tagħrif ta ’ 2 g), tal- qalb u tal- fwied li ġew osservati għal mill - inqas sena kienu candida mukokutanja, viremija/ sindromu b’ CMV u Herpes simplex.
The proportion of patients with CMV viraemia/ syndrome was 13.5%.
Il- proporzjon ta 'pazjenti viremija/ sindromu b’ CMV kien ta 13. 5%.
The following data refer to the safety experience of oral CellCept in renal transplant patients.
It- tagħrif li ġej jirreferi għall- esperjenza ta ’ sigurtà b’ CellCept orali f’ pazjenti bi trapjant renali.
Data in hepatic transplant patients are based on i. v. dosing of CellCept for up to 14 days followed by oral dosing.
Tagħrif f’ pazjenti bi trapjant epatiku huwa bbażat fuq dożaġġ ta ’ CellCept minn ġol- vini sa 14- il ġurnata segwit b’ dożaġġ orali.
Adverse reactions, probably or possibly related to CellCept, reported in ≥ 1/ 10 and in ≥ 1/ 100 to < 1/ 10 of patients treated with CellCept in the controlled clinical trials of renal (2 g data) and hepatic transplant patients are listed in the following table.
18 1/ 10 u f ’ ≥1/ 100 sa < 1/ 10 tal- pazjenti kkurati b’ CellCept fil- provi kliniċi kkontrollati f’ pazjenti bi trapjant renali (tagħrif ta ’ 2 g), tal - qalb u tal- fwied huma mniżżla fit- tabella taħt:
18 Adverse Reactions, Probably or Possibly Related to CellCept, Reported in Patients Treated with CellCept in Renal and Hepatic Clinical Trials when Used in Combination with Ciclosporin and Corticosteroids
Reazzjonijiet avversi, Possibilment jew Probabilment Relatati ma 'CellCept, irrapportati F’ pazjenti Kkurati B’ CellCept Fi provi Kliniċi Tal- Kliewi, Tal- Qalb u Tal- Fwied Meta Użat Flimkien Ma ’ Ciclosporin U Kortikosterojdi:
Leucopenia, thrombocytopenia, anaemia Pancytopenia, leucocytosis - Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, anorexia
Lewkopenja, tromboċitopenja, anemija Panċitopenja, lewkoċitożi - Aċidożi, iperkalimja, ipokalimja, ipergliċemija, ipomagnesimja, ipokalċimja, iperkoleserolimja, iperlipidimja, ipofosfatimja, anoressija
- Depression, thinking abnormal, insomnia
- Depressjoni, ħsibijiet mhux normali, nuqqas ta ’ rqad
- Convulsion, hypertonia, tremor, somnolence, headache, paraesthesia
- Konvulżjoni, ipertonija, rogħda, ħedla ta ’ ngħas, uġigħ ta ’ ras, parasteżija
- Tachycardia
- Takikardja
- Hypotension, hypertension
- Ipotensjoni, ipertensjoni
Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders
Disturbi respiratorji, toraċiċi u medjastinali Disturbi gastro- intestinali
- Pleural effusion, dyspnoea, cough Vomiting, abdominal pain, diarrhoea, nausea Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence
- Effużjoni fil- plewra, qtugħ ta ’ nifs, sogħla Rimettar, uġigħ fl- addome, dijarea, tqalligħ Fsada gastro- intestinali, peritonite, ileus, kolite, ulċera gastrika, ulċera fid- duwodenu, gastrite, osofaġite, stomatite, stitikezza, dispepsja, gass
Hepatobiliary disorders
Disturbi fil- fwied u fil- marrara
Very common Common
Komuni ħafna
- Hepatitis
-
Renal impairment
Epatite
General disorders and administration site conditions
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Disturbi muskolu- skeletrali u tat- tessut konnettiv Disturbi fil- kliewi u fis- sistema urinarja Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Investigazzjonijiet
- Oedema, pyrexia, chills, pain, malaise, asthenia,
Komuni ħafna Komuni Komuni ħafna Common Komuni ħafna Komuni Komuni ħafna Komuni Komuni ħafna - Komuni
- Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased, weight decreased
- Raxx, akne, alopeċja - Artralġja - Indeboliment renali - Edima, deni, tertir, uġigħ, tħossok ma tiflaħx, astenja Żieda ta ’ l- enżima epatika, żieda fil- krejatinina fid- demm, żieda tal- lactate dehydrogenase fid - demm, żieda tal- alkaline phosphatase fid - demm, tnaqqis fil- piż
501 (2 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.
501 (2 g ta 'CellCept kuljum) u 277 (2 g IV / 3 g mill- ħalq ta' CellCept kuljum) pazjent kienu kkurati fl- istudji tat- III fażi għall- prevenzjoni ta ’ tiċħid ta 'trapjant tal- kliewi jew tal- fwied rispettivament.
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.
Reazzjonijiet avversi kkawżati minn infużjoni fil- vini periferali kienu flebite u trombożi, li t- tnejn kienu osservati f’ 4% tal- pazjenti kkurati b’ CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall - infużjoni.
Adverse reactions reported during post-marketing with CellCept are similar to those seen in the controlled renal and hepatic transplant studies.
L- effetti mhux mixtieqa li ġejjin ikopru reazzjonijiet avversi minn esperjenza wara t- tqegħid fis- suq: reazzjonijiet avversi rrappurtati b’ CellCept wara t- tqegħid fis- suq, kienu simili għal dawk li dehru, fl - istudji kontrollati bi trapjant tal- kliewi u tal- fwied.
Additional adverse reactions reported during post- marketing experience with CellCept are described below with the frequencies reported within brackets if known.
Reazzjonijiet avversi oħrajn irrappurtati b’ CellCept waqt l- esperjenza ta ’ wara t- tqegħid fis- suq huma deskritti hawn taħt bil- frekwenzi rrappurtati fil- parentesi, jekk magħrufa.
Gastrointestinal: colitis including cytomegalovirus colitis, (≥ 1/ 100 to < 1/ 10), pancreatitis (≥ 1/ 100 to < 1/ 10) and intestinal villous atrophy.
Kolite (inkluż kolite b’ cytomegalovirus), (≥1/ 100 sa < 1/ 10), pankrejatite, (≥1/ 100 sa < 1/ 10) u atrofija tal- villi fl- imsaren.
Disorders related to immunosuppression: serious life-threatening infections including meningitis, endocarditis tuberculosis and atypical mycobacterial infection.
Disturbi relatati ma ’ immunosoppressjoni: infezzjonijiet serji li jipperikolaw il- ħajja inkluż meninġite, endokardite, tuberkulożi, u infezzjonijiet atipiċi mycobacteria.
Agranulocytosis (≥ 1/ 1000 to < 1/ 100) and neutropenia have been reported; therefore regular monitoring of patients taking CellCept is advised (see section 4.4).
Kienu rrapportati agranuloċitożi (≥1/ 1000 sa < 1/ 100) u newtropenja; għalhekk hija rakkomandata osservazzjoni regolari ta ’ pazjenti li qed jirċievu CellCept (ara sezzjoni 4. 4).
In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the medicinal product.
F’ dawk il - każijiet ta ’ doża eċċessiva fejn kienu rrappurtati avveniment avversi, l- avveniment jaqgħu fi ħdan il- profil tas- sigurtà magħruf tal- prodott mediċinali.
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 4.4).
20 Huwa mistenni li doża eċċessiva ta ’ mycophenolate mofetil tista ’ possibilment twassal għal soppressjoni żejda tas- sistema mmuni u żieda fis- suxxettibilità għall- infezzjonijiet u soppressjoni tal- mudullun (ara sezzjoni 4. 4).
20 Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG.
L- emodijalisi mhuwiex mistenni li jneħħi ammonti klinikament sinifikanti ta ’ MPA jew ta ’ MPAG.
Bile acid sequestrants, such as cholestyramine, can remove MPA by decreasing the enterohepatic re- circulation of the drug (see section 5.2).
Sekwestranti ta ’ l- aċidi tal- bili, bħal cholestyramine, jistgħu jneħħu MPA billi jnaqqsu iċ- ċirkulazzjoni enteroepatika mill- ġdid tal- mediċina (ara sezzjoni 5. 2).
Following intravenous administration, mycophenolate mofetil undergoes rapid and complete metabolism to the active metabolite, MPA.
Wara għotja minn ġol- vini, mycophenolate mofetil jgħaddi minn metaboliżmu rapidu u komplet għall - metabolu attiv, MPA.
MPA at clinically relevant concentrations is 97% bound to plasma albumin.
F’ konċentrazzjonijiet li huma klinikament relevanti MPA huwa 97% maqgħud mal - albumina tal- plażma.
The parent substance mycophenolate mofetil can be measured systemically during intravenous infusion; however, after oral administration it is below the limit of quantitation (0.4 μ g/ ml).
Is- sustanza oriġinali mycophenolate mofetil tista ’ titkejjel sistematikament waqt infużjoni fil- vini; iżda, wara amminstrazzjoni orali hija taħt il- limitu ta 'kwantifikazzjoni (0. 4 μg/ ml).
MPA is metabolised principally by glucuronyl transferase to form the phenolic glucuronide of MPA (MPAG), which is not pharmacologically active.
MPA huwa metabolizzat l- aktar minn glucuronyl transferase biex jifforma il - glucuronide fenoliku ta ’ l - MPA (MPAG), li mhuwiex attiv farmakoloġikament.
Orally administered 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 faeces.
Mycophenolate mofetil radjutikketjat mogħti mill- ħalq jiġi rkuprat kompletament, b’ 93% tad- doża amministrata rkuprata fl - awrina u 6% tad- doża rkuprata fl- ippurgar.
At clinically encountered concentrations, MPA and MPAG are not removed by haemodialysis.
F’ konċentrazzjonijiet li jintużaw klinikament, MPA u MPAG ma jitneħħewx bl- emodijalisi.
MPA AUC values obtained following administration of 1 g BID intravenous CellCept to renal transplant patients in the early post- transplant phase are comparable to those observed following 1 g BID oral CellCept.
Il- valuri ta ’ l- AUC ta ’ MPA miksuba wara l- amministrazzjoni ta ’ 1 g BID ta ’ CellCept minn ġol- vini lil pazjenti bi trapjant renali fil- fażi bikrija ta ’ wara t- trapjant huma simili għal dawk osservati wara 1 g BID ta ’ CellCept mill - ħalq.
In hepatic transplant patients, administration of 1 g BID intravenous CellCept followed by 1.5 g BID oral CellCept resulted in MPA AUC values similar to those found in renal transplant patients administered 1 g CellCept BID.
F’ pazjenti bi trapjant epatiku, l- amministrazzjoni ta ’ 1 g BID ta ’ CellCept minn ġol- vini segwit minn 1. 5 g BID CellCept mill- ħalq wassal għal valuri ta ’ l- AUC ta ’ MPA simili għal dawk li nstabu f’ pazjenti bi trapjant renali li ġew amministrati 1 g CellCept BID.
Renal impairment:
21 Indeboliment renali:
However, the mean single dose MPAG AUC was 3 – 6 fold higher in subjects with severe 21 renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Iżda il- medja tal- AUC ta ’ doża waħda ta ’ MPAG kienet 3 – 6 darbiet ogħla f’ individwi b’ indeboliment renali sever milli f’ persuni b’ indeboliment renali ħafif jew f’ persuni normali b’ saħħithom, kosistenti ma ’ l- eliminazzjoni renali magħrufa ta ’ MPAG.
No data are available for hepatic transplant patients with severe chronic renal impairment.
Ma hemm l - ebda tagħrif disponibbli għal pazjenti bi trapjant epatiku b’ indeboliment renali kroniku sever.
In patients with delayed renal graft function post-transplant, mean MPA AUC (0– 12h) was comparable to that seen in post-transplant patients without delayed graft function.
F’ pazjenti li l- kliewi tagħhom idumu biex jibdew jaħdmu wara li jsir it- trapjant, l- AUC medja ta ’ MPA (0 - 12- il siegħa) kienet simili għal dik osservata f’ pazjenti wara t- trapjant mingħajr dewmien sal- funzjoni tat - trapjant.
There may be a transient increase in the free fraction and concentration of plasma MPA in patients with delayed renal graft function.
Jista ’ jkun hemm żieda għal ftit żmien fil- frazzjoni ħielsa u l- konċentrazzjoni ta ’ MPA fil- plażma f’ pazjenti b’ dewmien sal- funzjoni tat - trapjant.
A study of the coadministration of CellCept (1 g bid) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other immunosupressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of CellCept on the ovulation suppressing action of the oral contraceptives.
Studju ta ’ l- għotja ta ’ CellCept (1 g bid) flimkien ma ’ kontraċettivi orali kombinati li fihom ethinylestradiol (0. 02 mg sa 0. 04 mg) u levonorgestrel (0. 05 mg sa 0. 15 mg), desogestrel (0. 15 mg) jew gestodene (0. 05 mg sa 0. 10 mg) li sar fuq 18- il mara mingħajr trapjant (u li ma kienux qed jieħdu immunosoppressanti oħrajn) fuq medda ta ’ tliet ċikli menstruwali ma wrew l- ebda influwenza klinikament relevanti ta ’ CellCept fuq l- azzjoni ta ’ soppressjoni ta ’ l- ovulazzjoni tal- kontraċettivi orali.
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.
L- ogħla doża eżaminata fl - istudji dwar il- karċinoġeniċità fuq l- annimali wasslu għal esponimenti madwar 2 – 3 darbiet ogħla mill - esponimenti sistemiċi (AUC jew Cmax) li kienu osservati f’ pazjenti bi trapjant renali fid- doża rakkomandata klinikament ta ’ 2 g/ jum.
The systemic exposure at this dose represents 2 – 3 times the clinical exposure at the recommended clinical dose of 2 g/ day.
L- esponiment sistemiku f’ din id- doża jirrappreżenta 2 – 3 darbiet ogħla mill - esponiment kliniku fid- doża rakkomandata klinikament ta ’ 2 g/ jum.
In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg• kg-1• day-1 caused malformations (including anophthalmia, agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
Fi studju dwar il- fertilità u r - riproduzzjoni femminili li sar fuq il- firien, dożi li ttieħdu mill- ħalq ta ’ 4. 5 mg• kg- 1• jum- 1 wasslu għal malformazzjonijiet (inklużi anoftalmja, agnatja, u idroċefalu) fl- ewwel ġenerazzjoni ta ’ frieħ fin- nuqqas ta ’ tossiċità għall- omm.
The systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended clinical dose of 2 g/ day.
22 esponiment kliniku fid- doża rakkomandata ta ’ 2 g/ jum.
The systemic
Fi studji dwar it- teratoġeniċità fil- firien u fil- fniek, resorbiment tal- fetu u malformazzjonijiet seħħew fil - firien f’ dożi ta ’ 6 mg• kg- 1• jum- 1 (inklużi anoftalmja, agnatja, u idroċefalu) u fil- fniek f’ dożi ta ’ 90 mg• kg - 1 • jum- 1 (inklużi anomaliji kardjovaskulari u renali bħal per eżempju ectopia cordis u kliewi ektopiċi, u ftuq umbilikali u fid- dijaframma), fin- nuqqas ta ’ tossiċità materna.
22 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.
L- esponimenti sistematiku f’ dawn il - livelli huwa kważi ekwivalenti għal jew inqas minn 0. 5 darbiet ogħla mill- esponiment kliniku bid- doża rakkomandata klinikament ta ’ 2 g/ jum.
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.
Dawn l- effetti seħħew f’ livelli ta ’ esponiment sistemiku ekwivalenti għal jew inqas mill- esponiment kliniku fid- dożi rakkomandati ta ’ 2 g/ jum.
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).
Il- profil ta ’ tossiċità mhux kliniku ta ’ mycophenolate mofetil jidher li huwa konsistenti ma ’ l- avvenimenti avversi osservati fi provi kliniċi umani li issa jipprovdu tagħrif ta 'sigurtà ta' relevanza akbar għall- popolazzjoni ta ’ pazjenti (ara s- sezzjoni 4. 8).
PHARMACEUTICAL PARTICULARS
6 TAGĦRIF FARMAĊEWTIKU
6.1 List of excipients
6. 1 Lista ta 'sustanzi mhux attivi
CellCept 500 mg powder for concentrate for solution for infusion: polysorbate 80 citric acid hydrochloric acid sodium chloride.
Polysorbate 80 citric acid hydrochloric acid sodium chloride.
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.
CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni m’ għandux jitħallat jew jingħata fl - istess ħin mill- istess catheter, ma 'prodotti mediċinali oħra li jingħataw minn ġol- vini jew taħlitiet oħra għall- infużjoni.
Powder for concentrate for solution for infusion:
Trab għall- konċentrat għal soluzzjoni għall- infużjoni:
Reconstituted solution and infusion solution:
Is- soluzzjoni rikostitwita u s- soluzzjoni għall- infużjoni:
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.
Jekk is- soluzzjoni għall- infużjoni ma tkunx ippreparata eżatt qabel ma tingħata, il- bidu ta ’ l- għotja tas- soluzzjoni għall- infużjoni għandu jkun sa tlett sigħat wara r- rikostituzzjoni u d- dilwitazzjoni tal- prodott mediċinali.
Do not store above 30 °C.
Taħżinx f' temperatura 'l fuq minn 30°C
Store at 15 – 30°C.
Aħżen f' temperatura ta '15 - 30°C
6.5 Nature and contents of container
23 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fiħ
20 ml type I clear glass vials with grey butyl rubber stopper and aluminium seals with plastic flip-off caps.
Kunjetti ta ’ ħġieġ trasparenti tat- tip I ta '20 ml b' tapp griż tal- lasktu butyl u b’ siġilli ta ’ l- aluminju b’ għotjien flip- off tal- plastik.
CellCept 500 mg powder for concentrate for solution for infusion is available in packs containing 4 vials.
CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni huwa disponibbli f' pakketti ta '4 kunjetti.
23 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Preparation of Infusion Solution (6 mg/ ml)
Preparazzjoni tas- soluzzjoni għall- infużjoni (6 mg/ ml)
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.
CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni ma fihx preservattiv kontra l - mikrobi; għalhekk ir- rikostituzzjoni u d- dilwazzjoni trid issir f’ kundizzjonijiet assettiċi.
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%.
CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni għandu jiġi ppreparat f’ żewġ stadji: l- ewwel stadju huwa r- rikostituzzjoni ma ’ infużjoni għal ġol- vini ta ’ 5% glukosju u t- tieni stadju huwa d - dilwazzjoni ma ’ infużjoni għal ġol- vini ta ’ 5% glukosju.
A detailed description of the preparation is given below:
Deskrizzjoni dettaljata tal- preparrazzjoni qed tingħata taħt:
Step 1 a.
L- ewwel Stadju a.
Two vials of CellCept 500 mg powder for concentrate for solution for infusion are used for preparing each 1 g dose.
Jintużaw żewġ kunjetti ta 'CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni għall- preparazzjoni ta ’ kull doża 1 g.
Reconstitute the content of each vial by injecting 14 ml of glucose intravenous infusion 5%.
Irrikostitwixxi l- kontenut ta ’ kull kunjett billi tinjetta 14 ml ta ’ infużjoni għal ġol- vini ta ’ 5% glukosju.
Gently shake the vial to dissolve the medicinal product yielding a slightly yellow solution.
Ħawwad il- kunjett bil- mod biex il- prodott mediċinali jinħall u jagħti soluzzjoni kemmxejn safranija.
Inspect the resulting solution for particulate matter and discoloration prior to further dilution.
Spezzjona s- soluzzjoni li tirriżulta għal xi frak u telf fil- kulur qabel ma tkompli bid- dilwazzjoni.
Discard the vial if particulate matter or discoloration is observed.
Armi l- kunjett jekk tinnota xi frak jew bidla fil- kulur.
Step 2 a.
It- Tieni Stadju a.
2 x 15 ml) into 140 ml of glucose intravenous infusion 5%.
Iddilwa aktar il- kontenut taż- żewġ kunjetti rikostitwiti (madwar 2 x 15 ml) f’ 140 ml ta ’ infużjoni għal ġol- vini ta ’ 5% glukosju.
The final concentration of the solution is 6 mg/ ml mycophenolate mofetil.
Il- konċentrazzjoni finali tas- soluzzjoni hija 6 mg / ml mycophenolate mofetil.
Inspect the infusion solution for particulate matter or discoloration.
Spezzjona s- soluzzjoni għall- infużjoni għal xi frak u telf fil- kulur..
Discard the infusion solution if particulate matter or discoloration is observed.
Armi s- soluzzjoni għall - infużjoni jekk tinnota xi frak jew bidla fil- kulur.
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.
Jekk is- soluzzjoni għall- infużjoni ma tiġix ippreparata eżatt qabel ma tingħata, l- bidu ta ’ l - amministrazzjoni tas- soluzzjoni għall- infużjoni għandu jkun sa 3 sigħat mir- rikostituzzjoni u dilwitazzjoni tal- prodott mediċinali.
Keep solutions at 15 – 30° C.
Żomm is- soluzzjonijiet f' temperatura ta '15 - 30°C.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid direct contact of prepared solutions of CellCept 500 mg powder for concentrate for solution for infusion with skin or mucous membranes.
Minħabba li mycophenolate mofetil wera effetti teratoġeniċi fil- firien u l- fniek, evita kuntatt dirett mas - soluzzjonijiet ippreparati ta ’ CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni mal - ġilda jew membrani mukużi.
If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Jekk iseħħ kuntatt, aħsel sewwa bis- sapun u l- ilma; laħlaħ l- għajnejn bl- ilma naturali.
(4 vials)
(4 kunjetti)
CellCept 1 g/ 5 ml powder for oral suspension.
CellCept 1 g/ 5 ml trab għal suspensjoni orali.
Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Kull flixkun fih 35 g mycophenolate mofetil f' 110 g trab għal suspensjoni orali.
5 ml of the reconstituted suspension contains 1 g of mycophenolate mofetil.
5 ml tas- suspensjoni rikostitwita fiha 1 g ta 'mycophenolate mofetil.
Powder for oral suspension.
Trab għal suspensjoni orali.
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.
CellCept 1 g/ 5 ml trab għal suspensjoni orali huwa ndikat f’ taħlita ma 'ciclosporin u kortikosterojdi għall - profilassi ta ’ tiċħid akut tat- trapjant f' pazjenti li rċevew trapjant alloġeniku renali, tal- qalb, jew tal- fwied.
Use in renal transplant:
Użu fi trapjanti renali:
Adults: oral CellCept 1 g/ 5 ml powder for oral suspension should be initiated within 72 hours following transplantation.
CellCept 1 g/ 5 ml trab għal suspensjoni orali għandu jinbeda 72 siegħa wara li jkun sar it- trapjant.
The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose), i. e.
Id- doża rakkomandata f' pazjenti bi trapjant tal- kliewi hija ta '1g mogħtija darbtejn kuljum (doża ta ’ 2 g kuljum), i. e.
5 ml oral suspension twice daily.
5 ml ta ’ suspensjoni orali darbtejn kuljum.
Children and adolescents (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).
Tfal u adoloxxenti (b’ età minn 2 sa 18- il sena): id- doża rakkomandata ta 'CellCept 1 g/ 5 ml trab għal suspensjoni orali hija ta' 600 mg/ m2 mogħtija darbtejn kuljum (sa massimu ta ’ 2 g/ 10 ml ta ’ suspensjoni orali kuljum).
As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
Peress li xi reazzjonijiet avversi jseħħu b’ iktar frekwenza f’ pazjenti ta 'din l- età (ara sezzjoni 4. 8) meta mqabbla ma ’ adulti, jista ’ jkun hemm bżonn li jew titwaqqaf il- mediċina għal ftit żmien jew titnaqqas id- doża; dawn ikollhom bżonn jieħdu f’ kunsiderazzjoni fatturi kliniċi relevanti inkluż s - severità tar- reazzjoni.
Children (< 2 years): there are limited safety and efficacy data in children below the age of 2 years.
Tfal (< sentejn (2): hemm tagħrif ta ’ sigurtà u effikaċja limitat fi tfal taħt l- età ta ’ sentejn.
These are insufficient to make dosage recommendations, and therefore use in this age group is not recommended.
Dawn m’ humiex suffiċjenti biex isiru rakkomandazzjonijiet tad- doża u għalhekk użu f’ dan il- grupp ta ’ età m’ huwiex rakkomandat.
26 Use in hepatic transplant:
Użu fi trapjanti tal- fwied:
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.
CellCept IV għandu jiġi mogħti għall- ewwel erbat ijiem wara t- trapjant tal- fwied, u wara CellCept
No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively.
M' hemmx bżonn ta ’ aġġustament fid- doża f' pazjenti, li l- kliewi tagħhom idumu biex jibdew jaħdmu wara l- operazzjoni (ara sezzjoni 5. 2).
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).
Nota Jekk meħtieġ CellCept 1 g/ 5 ml trab għal suspensjoni orali jista ’ jingħata permezz ta ’ tubu nasogastriku b’ daqs minimu ta ’ 8 French (dijametru interjuri ta ’ mill- anqas 1. 7 mm).
For information on use in pregnancy and contraceptive requirements, see section 4.6.
Għal tagħrif dwar l- użu fit- tqala u l- ħtiġijiet ta ’ kontraċezzjoni, ara sezzjoni 4. 6.
Among the opportunistic infections are BK virus associated nephropathy and JC virus associated progressive
Fost l- infezzjonijiet opportunistiċi hemm nefropatija assoċjata mal- virus BK u lewkoenċefalopatija multifokali progressiva assoċjata mal- virus JC (PML).
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
27 għandhom jikkunsidraw fid- dijanjosi differenzjali f’ pazjenti immunosoppressi b’ funzjoni tal- fwied li qed tiddeterjora jew b’ sintomi newroloġiċi.
If neutropenia develops (absolute neutrophil count < 1.3 x 103/ µl), it may be appropriate to interrupt or discontinue CellCept.
Jekk tiżvilluppa newtropenja, (għadd assolut ta ’ newtrofili < 1. 3 x 10³/ µl), jista ’ jkun xieraq li CellCept titwaqqaf għal xi żmien, jew għall- kollox.