FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Maltese: F'pazjenti li mhux qed jieħdu wkoll ciclosporin, it-teħid konkomitanti ta' mycophenolate mofetil u rifamicin irriżulta fi tnaqqis fl-espożizzjoni għal MPA (AUC0-12h) ta' 18% sa 70%.
English: However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of mycophenolate mofetil.
Maltese: Madanakollu, norfloxacin u metronidazole flimkien naqqsu l-esponiment għal MPA b'madwar 30% wara doża waħda ta' mycophenolate mofetil .
English: Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Maltese: ulċera gastrika, ulċera fid-duwodenu, gastrite, osofaġite, stomatite, stitikezza, dispepsja, gass, tifwiq
English: Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
Maltese: Sevelamer Tnaqqis f'Cmax u AUC0-12h ta' MPA bi 30 % u 25 % rispettivament kienu osservati meta mycophenolate mofetil kien mogħti flimkien ma' sevelamer mingħajr konsegwenzi kliniċi (i.e. riġettazzjoni tat-trapjant).
English: Blood and immune system
Maltese: Demm u s-sistema immuni
English: • severe reduction in the number of certain white blood cells (possible symptoms are fever, sore throat, frequent infections) (agranulocytosis)
Maltese: • tnaqqis sever fin-numru ta' ċerti ċelluli bojod tad-demm (sintomi possibbli huma deni, uġigħ filgriżmejn, infezzjonijiet frekwenti) (agranuloċitosi)
English: Myfenax 250mg hard capsules Mycophenolate mofetil
Maltese: Myfenax 250 mg kapsuli iebsin Mycophenolate mofetil
English: This section will provide important background information concerning the teratogenicity and mutagenicity of mycophenolate mofetil.
Maltese: Din is-sezzjoni se jipprovdi informazzjoni importanti fl-isfond dwar it-teratoġeniċità u l mutaġeniċità ta' mycophenolate mofetil.
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' tirriżulta possibilment fi trażżin żejjed tas-sistema immuni u suxxettibilità akbar għal infezzjonijiet u suppressjoni tal-mudullun (ara sezzjoni 4.4).
English: • serious disease of the kidney (BK virus associated nephropathy)
Maltese: • marda serja tal-kliewi (nefropatija assoċjata mal-virus BK)
English: • kidney problems
Maltese: • problemi fil-kliewi
English: Mean plasma MPAG AUC (0-12°h) was 2-3-fold higher than in post-transplant patients without delayed graft function.
Maltese: L-MPAG AUC (0-12-il siegħa) medju tal-plażma kien 2-3 darbiet ogħla f'pazjenti wara t-trapjant li ma kellhomx dewmien fil-funzjoni tal-graft.
English: Tablet coat
Maltese: Kisi tal-pilloli
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-tibdiliet fil-farmakokinetiċi MPAG (phenolic glucuronide ta' MPA) (MPAG tiżdied bi 8%) huma minimi u mhumiex ikkunsiderati klinikament sinifikattivi.
English: Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
Maltese: infezzjoni, bronkite, farinġite, sinusite, infezzjoni fungali tal-ġilda, kandida tal-ġilda, kandidjasi vaġinali, rinite
English: • constipation, indigestion, wind (flatulence), belching
Maltese: • stitikezza, indiġestjoni, gass (uġigħ ikkawżat minn gass), tifwiq
English: The following undesirable effects cover adverse reactions from clinical trials The principal adverse reactions associated with the administration of mycophenolate mofetil in combination with ciclosporin and corticosteroids include diarrhoea, leucopenia, sepsis and vomiting and there is evidence of a higher frequency of certain types of infections (see section 4.4).
Maltese: Ir-reazzjonijiet avversi prinċipali assoċjati ma'l-amministrazzjoni ta' mycophenolate mofetil flimkien ma' ciclosporin u corticosteroids jinkludu dijarrea, lewkopenija, sepsis u remettar u hemm evidenza ta' frekwenza ogħla ta' ċertu tipi ta' infezzjonijiet (ara sezzjoni 4.4).
English: Capsule content
Maltese: Il-Kontenut tal-kapsula
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' amministrazzjoni flimkien ma' cholestyramine (4 g TID), li jindika li hemm ammont sinifikattiv ta' riċiklaġġ enterepatiku.
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 jiġu relatati mal-mod ta' azzjoni farmakodinamika, i.e. impediment ta' sintesi tan-nukleotidi f'ċelloli sensittivi.
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 assays fuq ġenotossicità (assaġġ in vitro f'limfoma tal-ġrieden u in vivo mikronuklejus test fil-mudullun tal-ġrieden) urew potenzjal ta' mycophenolate mofetil li jikkawża aberrazzjonijiet.
English: This means taking 4 capsules in the morning then 4 capsules in the evening.
Maltese: Dan ifisser li għandhom jittieħdu 4 kapsuli filgħodu u 4 filgħaxija.
English: Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia
Maltese: Aġitazzjoni, stat konfuż, depressjoni, ansjetà, ħsibijiet mhux normali, nuqqas ta' rqad
English: • fungal infection of the digestive tract
Maltese: • infezzjoni fungali tal-apparat diġestiv
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: Id-doża rakkomandata ta' mycophenolate mofetil hija ta' 600 mg/m2 li tingħata mill-ħalq darbtejn kuljum (sa' massimu ta' 2 g kuljum).
English: The active substance in this medicine is called mycophenolate mofetil.
Maltese: Is-sustanza attiva ta' din il- mediċina jisimha mycophenolate mofetil.
English: Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Maltese: Ciclosporin A Il-farmakokinetika ta' ciclosporin A (CsA) mhumiex affettwati b'mycophenolate mofetil.
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 mycophenolate mofetil twice daily.
Maltese: It-tip u l-frekwenza ta' reazzjonijiet avversi fi studju kliniku, fejn ġew ingaġġati 92 pazjent pedjatriku bejn l-etajiet ta' 2-18-il sena li ngħataw 600mg/m2 mycophenolate mofetil oralment darbtejn kuljum,
English: Each tablet contains 500 mg mycophenolate mofetil.
Maltese: Kull pillola fiha 500 mg mycophenolate mofetil.
English: CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures by 30-50% in renal transplant patients treated with mycophenolate mofetil and CsA compared with patients receiving sirolimus or belatacept and similar doses of mycophenolate mofetil (see also section 4.4).
Maltese: CsA ifixkel ir-riċiklaġġ enterepatiku ta' MPA, u jwassal għal tnaqqis ta' 30-50% fl-esponiment għal MPA f'pazjenti bi trapjant tal-kliewi kkurati b'mycophenolate mofetil u CsA meta mqabbel ma' pazjenti li kienu qed jirċievu sirolimus jew belatacept u dożi simili ta' mycophenolate mofetil (ara wkoll sezzjoni 4.4).
English: The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by coadministration of mycophenolate mofetil (see also section 5.2).
Maltese: Il-farmakokinetika u l-farmakodinamika ta' kontraċettivi orali ma kinux effettwati mill-għoti konkomitanti ta' mycophenolate mofetil (ara wkoll sezzjoni 5.2).
English: • Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory canal atresia (middle ear);
Maltese: • Anormalitajiet tal-widnejn (eż. widna ta' barra ffurmata b'mod mhux normali jew nieqsa), atreżja tal-kanal estern tas-smigħ (widna tan-nofs);
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML).
Maltese: Infezzjonijiet bħal dawn jinkludu attivazzjoni mill-ġdid ta' virusijiet mhux attivi, bħal attivazzjoni mill-ġdid tal-epatite B jew tal-epatite Ċ u infezzjonijiet ikkawżati minn poliomavirusijiet (nefropatija assoċjata mal-virus BK, lewkoenċefalopatija multifokali progressiva PML assoċjata mal-virus JC).
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 ttrattament u test ieħor għandu jsir 8-10 ijiem wara.
English: Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in patients treated with mycophenolate mofetil in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids
Maltese: Reazzjonijiet avversi, possibbilment jew probabbilment relatati ma' mycophenolate mofetil, irrappurtati f'pazjenti kkurati b'mycophenolate mofetil fi provi kliniċi tal-kliewi, tal-qalb u tal fwied meta użat flimkien ma' ciclosporin u kortikosterojdi
English: Capsule shells
Maltese: Il-qoxra tal-kapsuli
English: The pharmacokinetics of oral contraceptives were unaffected by co-administration of mycophenolate mofetil (see also section 4.5).
Maltese: Il-farmakokinetika ta' kontraċettivi orali ma ġietx affettwata bl-għoti flimkien ta' mycophenolate mofetil (ara wkoll sezzjoni 4.5).
English: The recommended daily dose is 12°capsules (3°g of the active ingredient) taken as 2°separate doses.
Maltese: Id-doża rakkomandata ta' kuljum hi ta' 12-il kapsula (3 g tas-sustanza attiva) li tittieħed f'żewġ dożi separati.
English: Non-melanoma skin carcinomas occurred in 3.6% of patients; other types of malignancy occurred in 1.1% of patients.
Maltese: tal-ġilda seħħew fi 3.6% tal-pazjenti; tipi oħra ta' mard malinn seħħew f'1.1%.
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: Effetti gastrointestinali u renali konsistenti ma' deidrazzjoni kienu ukoll osservati fix-xadini fl-għola doża (livelli sistemiċi ta' espozizzjoni ekwivalenti għal jew akbar minn l-espożizzjoni klinika).
English: Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and congenital malformations in case of exposure during pregnancy;
Maltese: Myfenax huwa teratoġen qawwi fil-bnedmin, b'żieda fir-riskju ta' aborti spontanji u malformazzjonijiet konġenitali f'każ ta' esponiment waqt it-tqala:
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: Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to mycophenolate in combination with other immunosuppressants during pregnancy.
Maltese: Malformazzjonijiet konġenitali, inkluż rapporti ta' malformazzjonijiet multipli, kienu osservati wara t tqegħid fis-suq fi tfal ta' pazjenti esposti għal mycophenolate flimkien ma' immunosoppressanti oħra waqt it-tqala.
English: Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc
Maltese: Titanium dioxide (E171) Macrogol
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 jum wara t-trapjant), pazjenti bi trapjanti tal-kliewi, tal-qalb u tal-fwied kellhom MPA AUCs medji bejn wieħed u ieħor 30% aktar baxxi u Cmax bejn wieħed u ieħor 40% aktar baxxa kkomparat mal-perijodu aktar tard wara t-trapjant (3-6 xhur wara t-trapjant).
English: • The other ingredients are:
Maltese: • Għoti ta' pariri lill-pazjenti:
English: Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) Concomitant administration of drugs inhibiting glucuronidation of MPA may increase MPA exposure.
Maltese: Prodotti mediċinali li jaffettwaw il-glucuronidation (eż. isavuconazole, telmisartan) L-għoti fl-istess waqt ta' mediċini li jimpedixxu l-glucuronidation ta' MPA jista' jżid l-esponiment għal MPA.
English: • Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingooophorectomy).
Maltese: • It-tubi fallopjani tiegħek u ż-żewġ ovarji tneħħew permezz ta' operazzjoni (salpingo oophorectomy bilaterali)
English: How to take Myfenax
Maltese: Myfenax.
English: Myfenax should not be used in children and adolescents (aged 2 to 18) for heart or liver transplantation.
Maltese: Myfenax m'għandux jintuża fi tfal u adoloxxenti (b'età minn 2 sa 18-il sena) għal trapjanti tal-qalb jew fwied.
English: By interfering with enterohepatic circulation of the drug, bile acid sequestrants such as cholestyramine, reduce MPA AUC (see section 4.9).
Maltese: Billi jfixklu r-riċiklaġġ enterepatiku tal-mediċina, sekwestranti talaċidi tal-bili bħal cholestyramine, inaqqsu l-AUC ta' MPA (ara sezzjoni 4.9).
English: • Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.
Maltese: rata rappurtata ta' bejn 12 u 33% f'pazjenti bi trapjant ta' organi solidi ttrattati b'immunosoppressanti oħra minbarra mycophenolate mofetil.
English: Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia Psychiatric disorders Very commonCommon
Maltese: Aċidożi, iperkalimja, ipokalimja, ipergliċemija, ipomagnesimja, ipokalċimja, iperkoleserolimja,
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 trapjanti tal-kliewi b'indeboliment kroniku sever tal-kliewi (rata ta' filtrazzjoni glomerulari < 25 mL/min/1.73 m2), barra milli fil-perijodu immedjat ta' wara t-trapjant, dożi akbar minn 1 g mogħtijin darbtejn kuljum għandhom jiġu evitati.
English: Pleural effusion, dyspnoea, cough
Maltese: Effużjoni fil-plewra, qtugħ ta' nifs, sogħla
English: • For 6°weeks after you stop taking Myfenax.
Maltese: • Għal 6 ġimgħat wara li tieqaf tieħu Myfenax.
English: In the kidney MPA and its metabolites potently interact with renal organic anion transporters.
Maltese: Filkliewi MPA u l-metaboliti tiegħu jinteraġixxu b'mod qawwi ma' trasportaturi organiċi ta' anjoni renali.
English: Agranulocytosis (≥1/1000 to <1/100) and neutropenia have been reported; therefore regular monitoring of patients taking Myfenax is advised (see section 4.4).
Maltese: Agranuloċitosi (≥1/1,000 to <1/100) u newtropenija ġew irrapportati: għalhekk moniteraġġ tal-pazjenti li qegħdin jieħdu Myfenax huwa rakkomandat (ara sezzjoni 4.4).
English: Hepatitis, jaundice, hyperbilirubinaemia
Maltese: Epatite, suffejra, iperbilirubinimja
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).
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' rifjut, trattament b'antibijotiċi).
English: Patients with a body surface area greater than 1.5 m2 may be prescribed Myfenax capsules at a dose of 1 g twice daily (2 g daily dose).
Maltese: Pazjenti b' erja superfiċjali korporali akbar minn 1.5 m2 għandhom jiġu ppreskritti l kapsuli Myfenax f'doża ta' 1 g darbtejn kuljum (doża ta' 2 g kuljum).
English: • The active substance is mycophenolate mofetil. Each tablet contains 500mg of mycophenolate mofetil.
Maltese: • Is-sustanza attiva hi 500 mg mycophenolate mofetil.
English: The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94% relative to intravenous mycophenolate mofetil. Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5°g BID to renal transplant patients.
Maltese: Il-bijodisponabilità medja ta' mycophenolate mofetil meħud oralment, ibbażata fuq MPA AUC, hija 94% relattiva ma' mycophenolate mofetil intravenuż.
English: This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kapsula iebsa, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, agnathia and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
Maltese: Fi stħarriġ fuq il fertilità u r-riproduzzjoni magħmul fuq firien nisa, dożi orali ta' 4.5 mg/kg/day ikkaġunaw malformazzjonijiet (inklużi anoftalmja, agnatija u idrokefali) f'wild tal-ewwel ġenerazzjoni fl-assenza ta' tossiċità materna.
English: The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
Maltese: Is-sistemi ematopoetiċi u limfojdi kienu l-organi prinċipali effettwati fi stħarrig tossikoloġiku magħmul b'mycophenolate mofetil fuq il-firien, il-ġrieden, il-klieb u x-xadini.
English: Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Maltese: Sensittività eċċessiva Ġew irraportati reazzjonijiet ta' sensittività eċċessiva, li jinkludu edema angionewtrotika u reazzjoni anafilattika.
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 ttestjata fi stħarriġ fuq il-karċinogenetiċità fl-annimali rriżultat f'bejn wieħed u ieħor 2-3 darbiet l-esponiment sistemiku (AUC jew Cmax) osservat f'pazjenti bi trapjanti tal-kliewi f'doża klinika rakkomandata ta' 2 g/kuljum u 1.3 - 2 darbiet l-esponimet sistemiku (AUC jew Cmax) osservat f'pazjenti bi trapjanti talqalb f'doża klinika rakkomandata ta' 3 g/kuljum.
English: Myfenax 500mg film-coated tablets Mycophenolate mofetil
Maltese: Myfenax 500mg pilloli miksijin b'rita Mycophenolate mofetil
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-espożizzjoni sistemika f'din id-doża tirrappreżenta 2-3 darbiet l-espożizzjoni klinika fid-doża klinika rakkomandata ta' 2 g/kuljum f'pazjenti bi trapjanti tal-kliewi u 1.3 - 2 darbiet l-espożizzjoni klinika fid-doża klinika rakkomandata ta' 3 g/kuljum f'pazjenti bi trapjanti tal-qalb.
English: See also further information in this section under “Warnings and precautions” and “Pregnancy, contraception and breast-feeding”.
Maltese: Ara wkoll aktar informazzjoni f'din it-taqsima taħt “Twissijiet u prekawzjonijiet” u “Tqala u treddigħ”.
English: In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2) were 28-75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Maltese: Fi stħarriġ fuq doża ewlenija (6 suġġetti/grupp), l-MPA AUC medju fil-plażma osservat f'suġġetti b'indeboliment kroniku tal-kliewi sever (rata tal-filtrazzjoni mill-glomeruli < 25 mL/min/1.73 m2)
English: Very commonCommon
Maltese: Komuni ħafna
English: Myfenax 500 mg film-coated tablets are available in PVC/PVdC-aluminium blisters in pack sizes of 50 or 150 or 50 x 1 tablets per carton.
Maltese: Il-pilloli miksija b'rita ta' Myfenax 500 mg jiġu f'pakketti tal-folji ta' PVC/PVdC - aluminju li d daqsijiet tagħhom huma ta' 50, 150 jew 50x1 pillola f'kull kartuna Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
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: ipogammaglobulinemija sostnuta, klinikament rilevanti, għandha tiġi kkunsidrata azzjoni klinika xierqa billi jitqiesu l-effetti ċitostatiċi potenti li mycophenolic acid għandu fuq il-limfoċiti T- u B-.
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux maghrufa (il-frekwenza ma tistax tiġi stabbilita mid-dejta disponibbli)
English: Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with mycophenolate mofetil.
Maltese: F'pazjenti ttrattati b'mycophenolate mofetil kienu osservati każijiet iżolati ta' morfoloġija mhux normali ta' newtrofili, inkluż l-anomalija miksuba ta' Pelger-Huet.
English: Convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia
Maltese: Konvulżjoni, ipertonija, rogħda, ħedla ta' ngħas, sindrome mijasteniku, sturdament, uġigħ ta' ras, parasteżija, disġewsja