FrancophonIA/ELRC3.0 huggingface dataset:
English: Endoscopic investigation of patients with CellCept-related diarrhea have revealed isolated cases of intestinal villous atrophy (see section 4.4).
Maltese: pazjenti b'dijarea relatata ma' CellCept żvelat każijiet iżolati ta' atrofija tal-villi tal-imsaren (ara sezzjoni 4.4).
English: In patients not also taking ciclosporin, concomitant administration of CellCept and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Maltese: F'pazjenti li mhux qed jieħdu wkoll ciclosporin, l-għoti ta' CellCept flimkien ma' rifampicin wassal għal tnaqqis ta' 18% sa 70% fl-esponiment għal MPA (AUC0-12-il siegħa).
English: The parent substance mycophenolate mofetil can be measured systemically during intravenous infusion.
Maltese: Is-sustanza oriġinali mycophenolate mofetil tista' titkejjel sistematikament waqt infużjoni fil-vini.
English: CellCept 500 mg powder for concentrate for solution for infusion polysorbate 80 citric acid hydrochloric acid sodium chloride
Maltese: polysorbate 80 citric acid hydrochloric acid sodium chloride
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains the equivalent of 500 mg mycophenolate mofetil (as hydrochloride salt).
Maltese: Kull kunjett fih l-ekwivalenti ta' 500 mg mycophenolate mofetil (bħala melħ tal-hydrochloride).
English: 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).
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 tal mudullun (ara sezzjoni 4.4).
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose m'għandhomx jieħdu din il-mediċina.
English: CellCept 500 mg powder for concentrate for solution for infusion is available in packs containing 4 vials.
Maltese: CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni huwa disponibbli f'pakketti ta' 4 kunjetti.
English: Following intravenous administration, mycophenolate mofetil undergoes rapid and complete metabolism to the active metabolite, MPA.
Maltese: Wara għoti fil-vini, mycophenolate mofetil jgħaddi minn metaboliżmu rapidu u komplut għallmetabolit attiv, MPA.
English: Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
Maltese: Anzjani Ġeneralment, pazjenti anzjani (³ 65 sena) jistgħu jkunu f'riskju akbar ta' reazzjonijiet avversi minħabba immunosoppressjoni.
English: General disorders and administration site conditions Edema, including peripheral, face and scrotal edema, was reported very commonly during the pivotal trials.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Edima, inkluża edima periferali, tal-wiċċ u tal-iskrotu, kienet irrappurtata b'mod komuni ħafna matul il-provi pivitali.
English: The daily dose is 10 mL suspension (2 g of the medicine) taken as 2 separate doses.
Maltese: Id-doża ta' kuljum hija ta' 10 mL ta' suspensjoni (2 g ta' mediċina) li tittieħed bħala żewġ dożi separati. ·
English: The recommended dose of CellCept for infusion in hepatic transplant patients is 1 g administered twice daily (2 g daily dose).
Maltese: CellCept f'doża ta' 1 g darbtejn kuljum (doża ta' 2 g kuljum).
English: Table 1 Summary of adverse drug reactions occurring in patients treated with CellCept reported from clinical trials and post marketing experience
Maltese: Tabella 1 Sommarju tar-reazzjonijiet avversi tal-mediċina li seħħew f'pazjenti ttrattati b'CellCept irrappurtati mill-provi kliniċi u mill-esperjenza wara t-tqegħid fis-suq
English: The contents of CellCept 500 mg powder for concentrate for solution for infusion vials must be reconstituted with 14 mL of glucose intravenous infusion 5% each.
Maltese: Il-kontenut tal-kunjetti ta' CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni għandu jiġi rikostitwit b'14 mL ta' infużjoni għal ġol-vini ta' 5% glucose kull wieħed.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Do not use the suspension past this expiry date.
Maltese: Tużax is-suspensjoni wara din id-data ta' meta tiskadi.
English: Therapeutic drug monitoring of MPA may be appropriate when switching combination therapy (e.g. from ciclosporin to tacrolimus or vice versa) or to ensure adequate immunosuppression in patients with high immunological risk (e.g. risk of rejection, treatment with antibiotics, addition or removal of an interacting medication).
Maltese: Jista' jkun xieraq monitoraġġ terapewtiku tal-mediċina ta' MPA meta tinbidel it-terapija kombinata (eż. minn ciclosporin għal tacrolimus jew viċe versa) jew biex tiġi żgurata immunosoppressjoni adegwata f'pazjenti b'riskju immunoloġiku għoli (eż. riskju ta' tiċħid, trattament b'antibijotiċi, żieda jew tneħħija ta' medikazzjoni li tikkawża interazzjoni).
English: Patients taking oral contraceptives
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: It is available in packs of 4 vials.
Maltese: Huwa disponibbli f'pakketti ta' 4 kunjetti.
English: No pharmacokinetic data with CellCept for infusion are available for paediatric renal transplant patients.
Maltese: M'hemm l-ebda data farmakokinetika disponibbli għall-pazjenti pedjatriċi wara trapjant renali.
English: The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses.
Maltese: Id-doża ta' kuljum hija ta' 4 pilloli (2 g ta' mediċina) li tittieħed bħala żewġ dożi separati.
English: The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered in the elderly patients (≥ 65 years) when compared to younger patients.
Maltese: Il-farmakokinetika ta' mycophenolate mofetil u l-metaboliti tiegħu ma nstabitx li tinbidel f'pazjenti anzjani (≥ 65 sena) meta mqabbla ma' pazjenti iżgħar.
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see section 4.4).
Maltese: pure red cell aplasia) (ara sezzjoni 4.4).
English: Diarrhoea, leucopenia, sepsis and vomiting were among the most common and/or serious adverse drugs reactions associated with the administration of CellCept in combination with ciclosporin and corticosteroids.
Maltese: Dijarea, lewkopenija, sepsis u rimettar kienu fost ir-reazzjonijiet avversi tal-mediċina l-aktar komuni u/jew serji assoċjati mal-għoti ta' CellCept flimkien ma' ciclosporin u kortikosterojdi.
English: Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, CellCept is contraindicated in nursing mothers (see section 4.3).
Maltese: reazzjonijiet avversi serji għal mycophenolate mofetil fi trabi li jkunu qed jingħataw il-ħalib tas-sider, CellCept huwa kontraindikat f'nisa li qed ireddgħu (ara sezzjoni 4.3).
English: PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 50 pillola miksija b'rita.
English: 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).
Maltese: Kienu osservati wkoll effetti gastrointestinali u renali konsistenti ma' deidratazzjoni fix-xadina fl-ogħla doża (livelli ta' esponiment sistemiku ekwivalenti għal jew ogħla mill-esponiment kliniku).
English: MPA AUC values across age groups were similar in the early and late post-transplant period.
Maltese: Il-valuri tal-AUC ta' MPA fil-gruppi ta' età differenti kienu simili fil-perijodu bikri u tard wara t-trapjant.
English: Neoplasm
Maltese: Pożoloġija
English: Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Maltese: Kienu rrappurtati reazzjonijiet ta' sensittività eċċessiva inkluż edima anġjonewrotika u reazzjoni anafilattika.
English: The daily dose is 15 mL suspension (3 g of the medicine) taken as 2 separate doses.
Maltese: Id-doża ta' kuljum hija 15 mL ta' suspensjoni (3 g ta' mediċina) li tittieħed bħala żewġ dożi separati.
English: Sevelamer
Maltese: Planġer
English: These effects can be related to the pharmacodynamic mode of action, i.e. inhibition of nucleotide synthesis in sensitive cells.
Maltese: Dawn l-effetti jistgħu jkunu relatati mal-mod ta' azzjoni farmakodinamika, i.e. impediment tas-sintesi tan-nucleotide f'ċelluli sensittivi.
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg powder for concentrate for solution for infusion.
Maltese: IL-PRODOTT MEDIĊINALI CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Caution should be used with medicinal products that interfere with enterohepatic recirculation because of their potential to reduce the efficacy of CellCept.
Maltese: Għandu jkun hemm kawtela bi prodotti mediċinali li jinterferixxu maċ-ċirkolazzjoni enteroepatika mill-ġdid minħabba l-potenzjal tagħhom li jnaqqsu l-effikaċja ta' CellCept.
English: Oral CellCept 1 g/5 ml powder for oral suspension should be initiated within 72 hours following transplantation.
Maltese: CellCept 1 g/5 ml trab għal suspensjoni orali għandu jinbeda 72 siegħa wara li jkun sar it-trapjant.
English: The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose), i.e. 5 mL oral suspension twice daily.
Maltese: Iddoża rakkomandata f'pazjenti bi trapjant tal-kliewi hija ta' 1 g mogħtija darbtejn kuljum (doża ta' 2 g kuljum), i.e. 5 mL ta' suspensjoni orali darbtejn kuljum.
English: Before starting CellCept treatment, women of childbearing potential should have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL in order to exclude unintended exposure of the embryo to mycophenolate.
Maltese: Qabel ma jinbeda trattament b'CellCept, nisa li jistgħu joħorġu tqal għandu jkollhom żewġ testijiet tattqala tas-serum jew tal-awrina b'sensittività ta' mill-inqas 25 mIU/mL negattivi sabiex jiġi eskluż esponiment mhux intenzjonat tal-embriju għal mycophenolate.
English: 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 (see section 4.6).
Maltese: L-esponiment sistematiku f'dawn il-livelli huwa kważi ekwivalenti għal jew inqas minn 0.5 darbiet l-esponiment kliniku bid-doża rakkomandata klinikament ta' 2 g/jum f'pazjenti bi trapjant renali u madwar 0.3 darbiet l-esponiment kliniku bid-doża rakkomandata klinikament ta' 3 g/jum f'pazjenti bi trapjant talqalb (ara sezzjoni 4.6).
English: Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to CellCept during pregnancy in combination with other immunosuppressants.
Maltese: Malformazzjonijiet konġenitali, inkluż rapporti ta' malformazzjonijiet multipli, kienu osservati wara ttqegħid fis-suq fi tfal ta' pazjenti esposti għal CellCept flimkien ma' immunosoppressanti oħra waqt it-tqala.
English: Capsule shells gelatin indigo carmine (E132) yellow iron oxide (E172) red iron oxide (E172) titanium dioxide (E171) black iron oxide (E172) potassium hydroxide shellac.
Maltese: titanium dioxide (E171) iron oxide iswed (E172) potassium hydroxide shellac.
English: Gout
Maltese: Lott
English: • The daily dose is 8 capsules (2 g of the medicine) taken as 2 separate doses.
Maltese: Id-doża ta' kuljum hija ta' 8 kapsuli (2 g ta' mediċina) li tittieħed bħala żewġ dożi separati. ·
English: Very Common Very Common Very Common Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign neoplasm of skin
Maltese: Komuni Ħafna Komuni Ħafna Komuni Ħafna Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Neoplażma beninna tal-ġilda
English: The systemic exposure at this dose represents 2 - 3 times the clinical exposure at the recommended clinical dose of 2 g/day.
Maltese: L-esponiment sistemiku f'din id-doża jirrappreżenta 2 - 3 darbiet l-esponiment kliniku fid-doża rakkomandata klinikament ta' 2 g/jum.
English: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Maltese: F'pazjenti bi trapjant tal-kliewi b'indeboliment kroniku sever renali (rata ta' filtrazzjoni tal-glomeruli < 25 mL/min/1.73 m2), wara l-perijodu immedjat ta' wara t-trapjant, dożi aktar minn 1 g mogħtija darbtejn kuljum għandhom jiġu evitati.
English: Antibiotics eliminating -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 â-glucuronidase fl-intestini (eż. klassijiet ta' antibijotiċi ta' aminoglycoside, cephalosporin, fluoroquinolone, u penicillin) jistgħu jinterferixxu maċ ċirkolazzjoni enteroepatika mill-ġdid ta' MPAG/MPA u b'hekk iwasslu għal esponiment sistemiku għal MPA imnaqqas.
English: The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered in the elderly patients (≥ 65 years) when compared to younger transplant patients.
Maltese: Anzjani Il-farmakokinetika ta' mycophenolate mofetil u l-metaboliti tiegħu ma nstabitx li tinbidel f'pazjenti anzjani (≥ 65 sena) meta mqabbla ma' pazjenti iżgħar li jkunu rċevew trapjant.
English: If this happens, rinse with plenty of plain water.
Maltese: Akkumulazzjoni ta' fluwidu limfatiku
English: Hyperlipidemia
Maltese: Artralġja
English: The recommended dose of mycophenolate mofetil is 600 mg/m2 administered orally twice daily (up to a maximum of 2 g daily).
Maltese: Id-doża rakkomandata ta' mycophenolate mofetil hija ta' 600 mg/m2 mogħtija mill-ħalq darbtejn kuljum (sa massimu ta' 2 g kuljum).
English: Hematuria
Maltese: Rimettar
English: 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).
Maltese: Wara r-rikostituzzjoni għal konċentrazzjoni ta' 6 mg/mL, CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni għandu jingħata permezz ta' infużjoni bil-mod fil-vini fuq perijodu ta' sagħtejn minn vina periferali jew ċentrali (ara sezzjoni 6.6).
English: CellCept has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.
Maltese: CellCept kien assoċjat ma' inċidenza għola ta' avvenimenti avversi fuq is-sistema diġestiva, inklużi każijiet mhux frekwenti ta' ulċerazzjoni, emorraġija u perforazzjoni fl-apparat gastrointestinali. CellCept għandu jingħata b'kawtela f'pazjenti b'mard attiv serju tas-sistema diġestiva.
English: • Microphthalmia;
Maltese: (AcMPAG) minuri.
English: • Take 4 capsules in the morning and then 4 capsules in the evening.
Maltese: Ħu 4 kapsuli filgħodu u wara 4 kapsuli filgħaxija.
English: • cholestyramine - used to treat high cholesterol
Maltese: · cholestyramine - użat biex jittratta kolesterol għoli
English: Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid direct contact of the dry powder or prepared solutions of CellCept 500 mg powder for concentrate for solution for infusion with skin or mucous membranes.
Maltese: Peress li mycophenolate mofetil wera effetti teratoġeniċi fil-firien u l-fniek, evita kuntatt dirett mattrab niexef jew mas-soluzzjonijiet ippreparati ta' CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni mal-ġilda jew ma' membrani mukużi.
English: Oral administration.
Maltese: Kompetenti Nazzjonali.
English: If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
Maltese: Jekk mhux qed tuża kontraċezzjoni effettiva (ara Tqala, kontraċezzjoni u treddigħ).
English: Film coated tablets (tablets).
Maltese: Pilloli miksija b'rita (pilloli).
English: Malaise
Maltese: Konvulżjoni
English: Safety and efficacy of CellCept for infusion in paediatric patients have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' CellCept għall-infużjoni ma ġewx determinati f'pazjenti pedjatriċi.
English: What in this leaflet:
Maltese: • Għoti ta' pariri lill-pazjenti:
English: 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%.
Maltese: CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni għandu jiġi ppreparat f'żewġ stadji: l-ewwel stadju huwa r-rikostituzzjoni ma' infużjoni għal ġol-vini ta' 5% glucose u t-tieni stadju huwa d-dilwizzjoni ma' infużjoni għal ġol-vini ta' 5% glucose.
English: Hyperkalemia
Maltese: Ipokalċemija
English: How to take CellCept
Maltese: X'fih CellCept
English: Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed).
Maltese: Difetti tat-twelid li kienu rrappurtati jinkludu anomaliji tal widnejn, tal-għajnejn, tal-wiċċ (xoffa/palat mixquq), tal-iżvilupp tas-swaba', tal-qalb, tal-esofagu (tubu li jgħaqqad il-gerżuma mal-istonku), tal-kliewi u tas-sistema nervuża (pereżempju spina bifida
English: The mean single dose MPAG AUC was 3 - 6 fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Maltese: Iżda l-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 f'saħħithom, kosistenti mal-eliminazzjoni renali magħrufa ta' MPAG.
English: CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Maltese: CellCept huwa indikat f'kombinazzjoni ma' ciclosporin u kortikosterojdi għall-profilassi ta' tiċħid akut tat-trapjant f'pazjenti li rċevew trapjant alloġeniku tal-kliewi, tal-qalb, jew tal-fwied.
English: 20 mL type I clear glass vials with grey butyl rubber stopper and aluminium seals with plastic flip-off caps.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjetti ta' ħġieġ trasparenti tat-tip I ta' 20 mL b'tapp griż tal-lasktu butyl u b'siġilli tal-aluminju b'għotjien flip-off tal-plastik.
English: Digestive system and mouth problems such as: swelling of the gums and mouth ulcers, inflammation of the pancreas, colon or stomach, gastrointestinal disorders including bleeding, liver disorders, diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
Maltese: · infjammazzjoni tal-frixa, kolon jew stonku, · disturbi gastrointestinali inkluż fsada, · disturbi fil-fwied, · dijarea, stitikezza, tħossok imdardar (tqalligħ), indiġestjoni, nuqqas ta' aptit, gass.
English: Lung problems such as:
Maltese: Problemi fil-ġilda bħal:
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: Komuni Ħafna 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)
English: The systemic exposure at these levels is approximately equivalent to or less than 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day (see section 4.6).
Maltese: L-esponiment sistematiku f'dawn il-livelli huwa kważi ekwivalenti għal jew inqas minn 0.5 darbiet l-esponiment kliniku bid-doża rakkomandata klinikament ta' 2 g/jum (ara sezzjoni 4.6).
English: Gastro-intestinal
Maltese: Gastrointestinali
English: CellCept is contraindicated during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
Maltese: CellCept huwa kontraindikat waqt it-tqala ħlief jekk ma jkunx hemm trattament alternattiv xieraq biex jiġi evitat tiċħid tat-trapjant.
English: Hypocalcemia
Maltese: Ipokalimja
English: Lymphocele
Maltese: Bronkjektasi
English: In the kidney MPA and its metabolites potently interact with renal organic anion transporters.
Maltese: Fil-kliewi MPA u l metaboliti tiegħu jinteraġixxu b'mod qawwi ma' trasportaturi ta' anjoni organiċi fil-kliewi.
English: For 6 weeks after you stop taking CellCept.
Maltese: jum wara li tieqaf tieħu CellCept.
English: 4.6 Pregnancy and lactation
Maltese: 4.6 Tqala u treddigħ
English: Take 2 tablets in the morning and then 2 tablets in the evening.
Maltese: · Ħu 2 pilloli filgħodu u 2 pilloli filgħaxija.
English: 1 bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Maltese: Kull flixkun ta' 110 g ta' trab għal suspensjoni orali fih 35 g ta' mycophenolate mofetil.
English: Hyperbilirubinaemia
Maltese: Uġigħ fl-addome
English: Renal transplant The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Maltese: Id-doża rakkomandata f'pazjenti bi trapjant renali hija ta' 1 g darbtejn kuljum (doża ta' 2 g kuljum).
English: PHARMACEUTICAL FORM AND CONTENTS 300 Capsules
Maltese: 300 Kapsula
English: Female patients of childbearing potential should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with CellCept.
Maltese: Pazjenti nisa li jistgħu joħorġu tqal għandhom jingħataw parir dwar ir-riskji u għandhom isegwu r-rakkomandazzjonijiet ipprovduti fis sezzjoni 4.6 (eż. metodi ta' kontraċezzjoni, ittestjar għat-tqala) qabel, matul u wara terapija b'CellCept.
English: Your treatment will then continue at the normal times.
Maltese: Wara t-trattament tiegħek se jkompli fil-ħinijiet normali.
English: Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA.
Maltese: Wara l-għoti ta' doża waħda ta' 1.5 g ta' mycophenolate mofetil lil individwi normali f'saħħithom li kienu ttrattati minn qabel b'4 g TID ta' cholestyramine għal 4 ijiem, kien hemm tnaqqis ta' 40% fl
English: Paresthesia
Maltese: Paresteżija
English: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CellCept capsules.
Maltese: Peress li mycophenolate mofetil wera effetti teratoġeniċi fil-firien u l-fniek, kapsuli CellCept m'għandhomx jinfetħu jew jitfarrku biex jiġi evitat teħid man-nifs jew kuntatt dirett mal-ġilda jew ma' membrani mukużi tat-trab li jinsab fil-kapsuli CellCept.
English: Tracheo-Oesophageal malformations (e.g. oesophageal atresia);
Maltese: Prodotti mediċinali li jaffettwaw il-glukuronidazzjoni (eż. isavuconazole, telmisartan)
English: The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
Maltese: Id-doża ta' kuljum hija 12-il kapsula (3 g ta' mediċina) li jittieħdu bħala żewġ dożi separati.