FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregnancy, puerperium and perinatal conditions Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil, mainly in the first trimester, see section 4.6.
Maltese: Kondizzjonijiet ta' waqt it-tqala, il-ħlas u wara l-ħlas Każijiet ta' abort spontanju kienu rrappurtati f'pazjenti esposti għal mycophenolate mofetil, il-biċċa lkbira fl-ewwel trimestru, ara sezzjoni 4.6.
English: Hepatic transplant
Maltese: Trapjanti epatiku
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including CellCept.
Maltese: Każijiet ta' nefropatija assoċjata mal-virus BK, kif ukoll każijiet ta' lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy) assoċjata mal-virus JC, kienu rrappurtati f'pazjenti ttrattati b'immunosoppressanti, inkluż CellCept.
English: This section will provide important background information concerning the teratogenicity and mutagenicity of mycophenolate mofetil.
Maltese: Din is-sezzjoni se tipprovdi informazzjoni importanti fl-isfond dwar it-teratoġeniċità u l mutaġeniċità ta' mycophenolate mofetil.
English: • Capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), red iron oxide (E172),
Maltese: Il-qoxra tal-kapsula: gelatin, indigo carmine (E132), iron oxide isfar (E172), iron oxide aħmar
English: CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures by 30-50% in renal transplant patients treated with CellCept and CsA compared with patients receiving sirolimus or belatacept and similar doses of CellCept (see also section 4.4).
Maltese: CsA jinterferixxi mar-riċiklaġġ enteroepatiku ta' MPA, u jwassal għal tnaqqis ta' 30-50% fl-esponimenti għal MPA f'pazjenti bi trapjant renali ttrattati b'CellCept u CsA meta mqabbla ma' pazjenti li jkunu qed jirċievu sirolimus jew belatacept u dożi simili ta' CellCept (ara wkoll sezzjoni 4.4).
English: NAME OF THE MEDICINAL PRODUCT CellCept 1 g/5 ml powder for oral suspension mycophenolate mofetil
Maltese: CellCept 1 g/5 ml trab għal suspensjoni orali mycophenolate mofetil
English: Men must not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.
Maltese: L-irġiel m'għandhomx jagħtu semen waqt it-trattament b'CellCept u għal mill-inqas 90 jum wara li jitwaqqaf it-trattament.
English: Two genotoxicity assays (in vitro mouse lymphoma assay and in vivo mouse bone marrow micronucleus test) showed a potential of mycophenolate mofetil to cause chromosomal aberrations.
Maltese: Żewġ analiżi tal-ġenotossiċità (analiżi ta' limfoma tal-ġurdien in vitro u t-test tal-mikronukleu talmudullun tal-ġurdien in vivo) urew li mycophenolate mofetil għandu potenzjal li jikkawża aberrazzjonijiet fil-kromosomi.
English: • CellCept should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Maltese: · CellCept m'għandux jingħata lil nisa li jistgħu joħorġu tqal li ma jkunux qed jużaw kontraċezzjoni effettiva ħafna (ara sezzjoni 4.6).
English: NAME OF THE MEDICINAL PRODUCT CellCept 250 mg capsules mycophenolate mofetil
Maltese: CellCept 250 mg kapsuli mycophenolate mofetil
English: Blood lactate dehydrogenase increased
Maltese: Żieda ta' lactate dehydrogenase fid-demm
English: Uncommon Very Common
Maltese: Ħsibijiet mhux normali
English: Abnormalities of the eye (e.g. coloboma);
Maltese: Anormalitajiet tal-għajnejn (eż. koloboma); ·
English: • Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
Maltese: · Abbażi ta' rapporti mil-letteratura, malformazzjonijiet seħħew fi 23 sa 27% ta' twelid ħaj f'nisa esposti għal mycophenolate mofetil waqt it-tqala (imqabbla ma' 2 sa 3% ta' twelid ħaj filpopolazzjoni ġenerali u madwar 4 sa 5% ta' twelid ħaj f'riċevituri ta' trapjant ta' organi solidi ttrattati b'immunosoppressanti minbarra mycophenolate mofetil).
English: Therefore, care should be taken if CellCept 1 g/5 ml powder for oral suspension is administered to patients with phenylketonuria (see section 6.1)
Maltese: Għalhekk għandu jkun hemm attenzjoni jekk CellCept 1 g/5 ml trab għal suspensjoni orali jingħata lil pazjenti b'phenylketonuria (ara sezzjoni 6.1)
English: Paediatric population aged 2 to 18 years The recommended dose of mycophenolate mofetil is 600 mg/m2 administered orally twice daily (up to a maximum of 2 g daily).
Maltese: Popolazzjoni pedjatrika b'età minn 2 sa 18-il sena Id-doża rakkomandata ta' mycophenolate mofetil hija ta' 600 mg/m2 mogħtija mill-ħalq darbtejn kuljum (sa massimu ta' 2 g kuljum).
English: Gastrointestinal hemorrhage
Maltese: Emorraġija gastrointestinali
English: Take 6 capsules in the morning and then 6 capsules in the evening.
Maltese: Ħu 6 kapsuli filgħodu u wara 6 kapsuli filgħaxija.
English: • Cellcept is provided in a 20 mL type I clear glass vial with a grey butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Maltese: · Cellcept huwa pprovdut f'kunjett ta' 20 mL magħmul minn ħġieġ ċar tat-tip I b'tapp ġriż ta' lasktu butyl u siġill tal-aluminju b'għatu flip-off tal-plastik.
English: The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not considered clinically significant.
Maltese: It-tibdil fil farmakokinetika ta' MPAG (il-phenolic glucuronide ta' MPA) kien minimu (MPAG żdied bi 8%) u mhuwiex ikkunsidrat bħala klinikament rilevanti.
English: • They are available as a carton of 100 or 300 capsules (both in blister packs of 10).
Maltese: Huma disponibbli bħala kartuna ta' 100 jew 300 kapsula (it-tnejn f'pakketti tal-folja ta' 10).
English: 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.
Maltese: Ibbażat fuq riżultati ta' studju b'għoti ta' doża waħda ta' dożi rakkomandati 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-għoti flimkien ta' dawn is-sustanzi (li jikkompetu għall mekkaniżmi ta' sekrezzjoni tubulari mill-kliewi) jirriżulta f'żieda fil-konċentrazzjonijiet ta' MPAG u ganciclovir.
English: 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.
Maltese: Fi studju kliniku fuq 92 pazjent pedjatriku b'età minn sentejn sa 18-il sena li ngħataw mycophenolate mofetil 600 mg/m2 mill-ħalq darbtejn kuljum, instab li t-tip u l-frekwenza tar-reazzjonijiet avversi ġeneralment kienu simili għal dawk osservati f'pazjenti adulti li ngħataw 1 g ta' CellCept darbtejn kuljum.
English: Uncommon Uncommon Common
Maltese: Komuni Ħafna Komuni
English: A further dilution with glucose intravenous infusion 5% is required to a final concentration of 6 mg/mL.
Maltese: Hija meħtieġa dilwizzjoni oħra ma' infużjoni għal ġol-vini ta' 5% glucose għall-konċentrazzjoni finali ta' 6 mg/mL.
English: A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating that there is a significant amount of enterohepatic recirculation.
Maltese: Tnaqqis fl-AUC ta' MPA ta' madwar 40% huwa assoċjat ma' għoti flimkien ma' cholestyramine (4 g TID), li jindika li hemm ammont sinifikanti ta' ċirkolazzjoni enteroepatika mill-ġdid.
English: An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of isavuconazole.
Maltese: Ġiet osservata żieda ta' 35% fl-AUC0-∞ ta' MPA bl-għoti flimkien ma' isavuconazole.
English: 5 mL of the reconstituted suspension contains 1 g of mycophenolate mofetil.
Maltese: Meta rikostitwita 5 ml tas-suspensjoni fiha 1 g ta' mycophenolate mofetil.
English: It is recommended that the second test should be performed 8 - 10 days after the first test. For transplants from deceased donors, if it is not possible to perform two tests 8-10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8-10 days later.
Maltese: Għal trapjanti minn donaturi mejtin, jekk ma jkunx possibbli li jsiru żewġ testijiet 8-10 ijiem bogħod minn xulxin qabel ma jibda t-trattament (minħabba ż-żmien tad disponibilità tal-organu li se jiġi trapjantat), għandu jsir test tat-tqala eżatt qabel ma jinbeda t trattament u test ieħor għandu jsir 8-10 ijiem wara.
English: NAME OF THE MEDICINAL PRODUCT CellCept 1 g/5 ml powder for oral suspension.
Maltese: IL-PRODOTT MEDIĊINALI CellCept 1 g/5 ml trab għal suspensjoni orali.
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Maltese: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Il-Ġermanja.
English: This belongs to a group of medicines called “immunosuppressants”.
Maltese: Dan jagħmel parti minn grupp ta' mediċini msejħa “immunosoppressanti”.
English: Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Maltese: Kull flixkun fih 35 g mycophenolate mofetil f'110 g ta' trab għal suspensjoni orali.
English: 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.
Maltese: CellCept 500 mg trab għal 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.
English: • They are available as packs of 50 (in blister packs of 10) or Multipacks containing 150 (3 packs of 50) tablets.
Maltese: Huma disponibbli bħala pakketti ta' 50 (f'pakketti tal-folja ta' 10) jew Pakketti multipli li fihom 150 (3 pakketti ta' 50) pillola.
English: Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
Maltese: Abbażi ta' rapporti mil-letteratura, malformazzjonijiet seħħew fi 23 sa 27% ta' twelid ħaj f'nisa esposti għal mycophenolate mofetil waqt it-tqala (imqabbla ma' 2 sa 3% ta' twelid ħaj fil popolazzjoni ġenerali u madwar 4 sa 5% ta' twelid ħaj f'riċevituri ta' trapjant ta' organi solidi ttrattati b'immunosoppressanti minbarra mycophenolate mofetil).
English: Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA.
Maltese: Wara għoti mill-ħalq, mycophenolate mofetil jgħaddi minn assorbiment rapidu u estensiv u metaboliżmu presistemiku komplut għall-metabolit attiv, MPA.
English: The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal, cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex.
Maltese: L-aktar 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 u tal-fwied li ġew osservati għal mill inqas sena kienu candida mukokutanja, viremija/sindrome b'CMV u Herpes simplex.
English: Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Maltese: Ciclosporin A Il-farmakokinetika ta' ciclosporin A (CsA) mhix affettwata minn mycophenolate mofetil.
English: By interfering with enterohepatic recirculation of the drug, bile acid sequestrants such as cholestyramine, reduce MPA AUC (see section 4.9).
Maltese: Billi jinterferixxu maċ-ċirkolazzjoni enteroepatika mill-ġdid tal-mediċina, sekwestranti talaċidi biljari bħal cholestyramine, inaqqsu l-AUC ta' MPA (ara sezzjoni 4.9).
English: 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.
Maltese: Reazzjonijiet avversi li jistgħu jiġu attribwiti lil infużjoni fil-vini periferali kienu flebite u trombożi, li t-tnejn kienu osservati f'4% tal-pazjenti ttrattati b'CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Take 5 mL suspension in the morning and then 5 mL suspension in the evening.
Maltese: Ħu 5 mL ta' suspensjoni filgħodu u wara 5 mL ta' suspensjoni filgħaxija.
English: The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride.
Maltese: Is-sustanzi mhux attivi l-oħra huma: polysorbate 80, citric acid, hydrochloric acid, sodium chloride.
English: Eructation
Maltese: Ansjetà
English: The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by coadministration of CellCept (see also section 5.2).
Maltese: Il-farmakokinetika u l-farmakodinamika ta' kontraċettivi orali ma kinux affettwati bl-għoti flimkien ta' CellCept (ara wkoll sezzjoni 5.2).
English: Edema
Maltese: Edima
English: • CellCept capsules are oblong shaped with one end blue and the other end brown.
Maltese: Kapsuli CellCept huma ta' forma oblung, b'tarf blu u t-tarf l-ieħor kannella.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign neoplasm of skin
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Neoplażma beninna tal-ġilda
English: Ciprofloxacin or amoxicillin plus clavulanic acid
Maltese: Ciprofloxacin jew amoxicillin flimkien ma' clavulanic acid
English: In addition, there have been isolated reports of the following malformations: Microphthalmia; congenital choroid plexus cyst; septum pellucidum agenesis; olfactory nerve agenesis.
Maltese: Mikroftalmija; · ċesta konġenitali fil-choroid plexus; · aġenesi tas-septum pellucidum; · aġenesi tan-nerv tax-xamm.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/006 CellCept (1 bottle 110g)
Maltese: EU/1/96/005/006 CellCept (flixkun ta' 110 g)
English: The risk/benefit ratio of mycophenolate mofetil in combination with sirolimus has not been established (see also section 4.5).
Maltese: Il-proporzjon tar-riskju u l-benefiċju ta' mycophenolate mofetil f'kombinazzjoni ma' sirolimus ma ġiex stabbilit (ara wkoll sezzjoni 4.5).
English: In cases of sustained, clinically relevant hypogammaglobulinaemia, appropriate clinical action should be considered taking into account the potent cytostatic effects that mycophenolic acid has on T- and B-lymphocytes.
Maltese: rilevanza klinika, għandha tiġi kkunsidrata azzjoni klinika xierqa b'konsiderazzjoni tal-effetti ċitostatiċi potenti li mycophenolic acid għandu fuq limfoċiti T u B.
English: Blood and lymphatic system disorders Anemia
Maltese: Disturbi tad-demm u tas-sistema limfatika Anemija
English: In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 - 6 months post-transplant).
Maltese: Fil-perijodu bikri ta' wara t-trapjant (< 40 ġurnata wara t-trapjant), pazjenti bi trapjant renali, tal-qalb u epatiku kellhom medja tal-AUC ta' MPA madwar 30% aktar baxxa u Cmax madwar 40% aktar baxxa meta mqabbel mal-perijodu tard ta' wara t-trapjant (3 - 6 xhur wara t-trapjant).
English: 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.
Maltese: CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni ma fihx preservattiv kontra l mikrobi; għalhekk ir-rikostituzzjoni u d-dilwizzjoni tal-prodott iridu jsiru f'kondizzjonijiet assettiċi.
English: The risk increases with total immunosuppressive load (see section 4.4).
Maltese: Ir-riskju jiżdied bl-ammont totali talimmunosoppressiv (ara sezzjoni 4.4).
English: Cellcept is usually given by a doctor or nurse in hospital.
Maltese: CellCept normalment jingħata minn tabib jew infermier fi sptar.
English: In healthy volunteers, no significant interaction was observed when CellCept was concomitantly administered with norfloxacin or metronidazole separately.
Maltese: F'voluntiera f'saħħithom, ma kienet osservata l-ebda interazzjoni sinifikanti meta CellCept ingħata flimkien ma' norfloxacin jew metronidazole separatament.
English: Multipacks containing 150 (3 packs of 50) tablets
Maltese: Pakkett multiplu: 150 (3 pakketti ta' 50) pillola miksija b'rita
English: Elderly patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared with younger individuals (see section 4.8).
Maltese: Pazjenti anzjani jista' jkollhom riskju akbar ta' avvenimenti avversi bħal ċertu infezzjonijiet (inkluż marda ta' invażjoni ta' cytomegalovirus fit-tessut) u possibbilment emorraġija gastrointestinali u edima pulmonari, meta mqabbla ma' individwi iżgħar (ara sezzjoni 4.8).
English: • CellCept should not be given to women who are breastfeeding (see section 4.6).
Maltese: · CellCept m'għandux jingħata lil nisa li jkunu qed ireddgħu (ara sezzjoni 4.6).
English: Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA enterohepatic recirculation thus leading to reduced systemic MPA exposure.
Maltese: Antibijotiċi li jeliminaw batterji li jipproduċu β-glucuronidase fl-intestini (eż. klassijiet ta' antibijotiċi ta' aminoglycoside, cephalosporin, fluoroquinolone, u penicillin) jistgħu jinterferixxu maċċirkolazzjoni enteroepatika mill-ġdid ta' MPAG/MPA u b'hekk iwasslu għal esponiment sistemiku għal MPA imnaqqas.
English: 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).
Maltese: CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni jrid jiġi rikostitwit u dilwit aktar ma' infusjoni ta' 5% glucose għal ġol-vini qabel ma jingħata lill-pazjent (ara sezzjoni 6.6).
English: 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.
Maltese: L-esponiment sistemiku f'din id-doża jirrappreżenta 2 - 3 darbiet l-esponiment kliniku fid-doża rakkomandata klinikament ta' 2 g/jum f'pazjenti bi trapjant renali u 1.3 - 2 darbiet lesponiment kliniku fid-doża rakkomandata klinikament ta' 3 g/jum f'pazjenti bi trapjant tal-qalb.
English: 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.
Maltese: CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni huwa indikat f'kombinazzjoni ma' ciclosporin u kortikosterojdi għall-profilassi ta' tiċħid akut tat-trapjant f'pazjenti li rċevew trapjant alloġeniku renali jew epatiku.
English: 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.
Maltese: L-ogħla doża eżaminata flistudji dwar il-karċinoġeniċità fuq l-annimali wasslet 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 u 1.3 - 2 darbiet l-eponimenti sistemiċi (AUC jew Cmax) osservati f'pazjenti bi trapjant tal-qalb fid-doża rakkomandata klinikament ta' 3 g/jum.
English: Pain
Maltese: FEJN
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg tablets mycophenolate mofetil
Maltese: CellCept 500 mg pilloli mycophenolate mofetil
English: Hypokalemia
Maltese: Ipomanjeżimja
English: The recommended dose is 600 mg/ m² taken twice a day.
Maltese: Id-doża rakkomandata hija 600 mg/m² li tittieħed darbtejn kuljum.
English: Esophagitis
Maltese: Esofaġite
English: 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.
Maltese: CellCept 1 g/5 ml trab għal suspensjoni orali huwa indikat f'kombinazzjoni ma' ciclosporin u kortikosterojdi għall-profilassi ta' tiċħid akut tat-trapjant f'pazjenti li rċevew trapjant alloġeniku renali,
English: 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.
Maltese: Ir-reazzjonijiet avversi tal-mediċina (ADRs - adverse drug reactions) mill-provi kliniċi u millesperjenza wara t-tqegħid fis-suq huma elenkati fit-Tabella 1, skont il-klassifika tas-sistemi u talorgani (SOC - system organ class) MedDRA flimkien mal-frekwenzi tagħhom.
English: It is expected that an overdose of mycophenolate mofetil could possibly result in over suppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 4.4).
Maltese: Huwa mistenni li doża eċċessiva ta' mycophenolate mofetil tista' possibbilment twassal għal soppressjoni żejda tas-sistema immuni u żieda fis-suxxettibilità għall-infezzjonijiet u soppressjoni talmudullun (ara sezzjoni 4.4).
English: Cytopenias, including leucopenia, anemia, thrombocytopenia and pancytopenia, are known risks associated with mycophenolate mofetil and may lead or contribute to the occurrence of infections and hemorrhages (see section 4.4).
Maltese: Ċitopeniji, inklużi lewkopenija, anemija, tromboċitopenija u panċitopenija, huma riskji magħrufa assoċjati ma' mycophenolate mofetil u jistgħu jwasslu jew jikkontribwixxu għall-okkorrenza ta' infezzjonijiet u emorraġiji (ara sezzjoni 4.4).
English: olfactory nerve agenesis.
Maltese: immunosoppressanti oħra.
English: In some of these cases switching CellCept to an alternative immunosuppressant resulted in serum IgG levels returning to normal.
Maltese: F'xi wħud minn dawn il-każijiet bidla minn CellCept għal immunosoppressant alternattiv irriżultat li l-livelli ta' IgG fis-serum reġgħu lura għan-normal.
English: 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.
Maltese: Nota: 991 (2 g / 3 g ta' CellCept kuljum), 289 (3 g ta' CellCept kuljum) u 277 (2 g IV / 3 g mill-ħalq ta' CellCept kuljum) pazjent kienu ttrattati fl-istudji ta' Fażi