FrancophonIA/ELRC3.0 huggingface dataset:
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 mal-għotja ta' mycophenolate mofetil flimkien ma' ciclosporin u kortikosterojdi jinkludu dijarea, lewkopenija, sepsis u rimettar u hemm evidenza ta' frekwenza aktar għolja ta' ċertu tipi ta' infezzjonijiet (ara sezzjoni 4.4).
English: Other unwanted effects may include:
Maltese: Effetti oħra mhux mixtieqa jistgħu jinkludu:
English: Influenza vaccination may be of value.
Maltese: Tilqim kontra l-influwenza jista' jkun utli.
English: By interfering with enterohepatic circulation of the medicinal product, bile acid sequestrants such as cholestyramine, reduce MPA AUC (see section 4.9).
Maltese: Billi jfixxklu r-riċiklaġġ enterepatiku tal-mediċina, sekwestranti tal-aċidi tal-bili bħal cholestyramine, inaqqsu l-AUC ta' MPA (ara sezzjoni 4.9).
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: There have also been reports of bronchiectasis in children and adults (frequency not known).
Maltese: Kien hemm ukoll rapporti ta' bronkjektasi fi tfal u adulti (frekwenza mhux magħrufa).
English: • Take 6 capsules in the morning then 6 capsules in the evening.
Maltese: • Ħu 6 kapsuli filgħodu u wara 6 kapsuli filgħaxija.
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-esponimenti 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 tal-qalb (ara sezzjoni 4.6).
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: F'każijiet ta' ipogammaglobulinimja sostnuta ta' rilevanza klinika, għandha tiġi kkunsidrata azzjoni klinika xierqa b'konsiderazzjoni tal-effetti ċitostatiċi potenti li mycophenolic acid għandu fuq limfoċiti T u B.
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leucoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including mycophenolate mofetil. Agranulocytosis (≥ 1/1000 to < 1/100) and neutropenia have been reported; therefore, regular monitoring of patients taking Myclausen is advised (see section 4.4).
Maltese: Każijiet ta' newropatija assoċjata mal-virus BK, kif ukoll każijiet ta' lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leucoencephalopathy) assoċjata mal-virus JC, kienu rrappurtati f'pazjenti kkurati b'immunosoppressanti, inkluż 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/m mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g mycophenolate mofetil twice daily.
Maltese: Fi studju kliniku fuq 92 pazjent pedjatriku b'età minn sentejn sa 18-il sena li ngħataw mycophenolate mofetil 600 mg/m 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' mycophenolate mofetil darbtejn kuljum.
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-nucleotida f'ċelluli sensittivi.
English: NAME OF THE MEDICINAL PRODUCT Myclausen 250 mg hard capsules
Maltese: TAL-PRODOTT MEDIĊINALI Myclausen 250 mg kapsuli ibsin.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for mycophenolate mofetil, mycophenolic acid, the scientific conclusions of CHMP are as follows: Following a review of all available information regarding pregnancies following paternal exposure to mycophenolate mofetil or mycophenolic acid, including a review of all nonclinical data and information on transmission of mycophenolic acid via the semen, the PRAC concluded that the data does not highlight any patterns or an increase in congenital malformations or spontaneous abortions.
Maltese: Wara analiżi tal-informazzjoni kollha disponibbli dwar it-tqala wara esponiment tal-missier għal mycophenolate mofetil jew mycophenolic acid, inkluż analiżi tad-data mhux klinika u l-informazzjoni kollha dwar it-trażmissjoni ta' mycophenolic acid permezz tas-semen, il-PRAC ikkonkluda li d-data ma tenfasizza l-ebda disinn jew żieda fil-malformazzjonijiet konġenitali jew aborti spontanji.
English: The antibody response to other vaccines may be diminished (see also section 4.4).
Maltese: Irrispons tal-antikorpi għal tilqim ieħor jista' jkun imnaqqas (ara wkoll sezzjoni 4.4).
English: Common Hypotension, hypertension, vasodilatation
Maltese: Epatite, suffejra, iperbilirubinimja
English: Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, Myclausen should be administered with caution in patients with active serious digestive system disease.
Maltese: Mycophenolic mofetil kien assoċjat ma' inċidenza ogħla ta' effetti avversi fuq is-sistema diġestiva, inklużi każijiet mhux frekwenti ta' ulċerazzjoni fl-apparat gastro-intestinali, emorraġija u perforazzjoni.
English: Myclausen 500 mg film-coated tablets are available in PVC-aluminium blisters containing 10 tablets.
Maltese: Il-pilloli miksija b'rita ta' Myclausen 500 mg jiġu f'folji tal-PVC-aluminju b'10 pilloli.
English: Myclausen 500 mg film-coated tablets Mycophenolate mofetil
Maltese: Myclausen 500 mg pilloli miksijin b'rita Mycophenolate mofetil
English: The pharmacokinetics of oral contraceptives were unaffected by coadministration of mycophenolate mofetil (see also section 4.5).
Maltese: Il-farmakokinetika ta' kontraċettivi orali ma ġewx affettwati bl-għotja flimkien ta' mycophenolate mofetil (ara ukoll sezzjoni 4.5).
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 ta' l-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: • Myclausen should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Maltese: • Myclausen m'għandux jingħata lil nisa li jistgħu joħorġu tqal li ma jkunux qed jużaw kontraċezzjoni effettiva ħafna (ara sezzjoni 4.6).
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: Dawn l-infezzjonijiet jinkludu riattivazzjoni virali moħbija, bħal riattivazzjoni u infezzjonijiet talepatite B jew tal-epatite Ċ ikkawżati minn poliomavirusis (nefropatija assoċjata mal-virus BK u lewkoenċefalopatija multifokali progressiva assoċjata mal-virus JC PML).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/002
Maltese: FIS-SUQ EU/1/10/647/002
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 (salpingooophorectomy bilaterali)
English: NAME OF THE MEDICINAL PRODUCT Myclausen 250 mg hard capsules Mycophenolate mofetil
Maltese: TAL-PRODOTT MEDIĊINALI Myclausen 250 mg kapsuli ibsin Mycophenolate mofetil
English: • Myclausen should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6)
Maltese: • Myclausen m'għandux jintuża waqt it-tqala ħlief jekk ma jkunx disponibbli trattament alternattiv xieraq biex jiġi evitat rifjut tat-trapjant (ara sezzjoni 4.6).
English: Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to Myclausen in combination with other immunosuppressants during pregnancy.
Maltese: Malformazzjonijiet konġenitali, inkluż rapporti ta' malformazzjonijiet multipli, kienu osservati wara ttqegħid fis-suq fi tfal ta' pazjenti esposti għal Myclausen flimkien ma' immunosoppressanti oħra waqt it-tqala.
English: • Myclausen should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed in section 6.1.
Maltese: • Myclausen m'għandux jingħata lil pazjenti b'sensittività eċċessiva għal mycophenolate mofetil, mycophenolic acid jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
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' possibilment twassal għal soppressjoni żejda tas-sistema mmuni u żieda fis-suxxettibilità għall-infezzjonijiet u soppressjoni talmudullun (ara sezzjoni 4.4).
English: In experimental models, mycophenolate mofetil was not tumourigenic.
Maltese: F'mudelli esperimentali, mycophenolate mofetil ma kienx tumuroġeniku.
English: Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Maltese: Kienu rappurtati reazzjonijiet ta' sensittività eċċessiva inkluż edima anġjonewrotika u reazzjoni anafilattika.
English: Most (about 87 %) of the administered dose is excreted in the urine as MPAG.
Maltese: Il-maġġoranza (madwar 87 %) tad-doża amministrata hija mneħħija fl-awrina bħala MPAG.
English: Common Arthralgia
Maltese: Komuni ħafnaCommon Artralġja
English: The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94 % relative to IV 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: B'kuntrast, kien hemm żieda ta' madwar 20 % fl-AUC ta' tacrolimus meta dożi multipli ta' mycophenolate mofetil (1.5 g BID) ingħataw lil pazjenti bi trapjant tal-fwied li kienu qed jieħdu tacrolimus.
English: Common Agitation, confusional state, depression,
Maltese: Aġitazzjoni, stat konfuż, depressjoni, ansjetà, ħsibijiet mhux normali, nuqqas ta' rqad
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/001
Maltese: FIS-SUQ EU/1/10/647/001
English: • Swallow your tablets whole with a glass of water.
Maltese: • Ibla' l-pilloli tiegħek sħaħ ma' tazza ilma.
English: Tablet coating
Maltese: Tumuri malinni
English: B. PACKAGE LEAFLET
Maltese: Problemi tas-soltu
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: 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: There are limited safety and efficacy data in children below the age of 2 years.
Maltese: Hemm tagħrif ta' sigurtà u effikaċja limitat fi tfal taħt l-età ta' sentejn.
English: (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with Myclausen.
Maltese: (eż. metodi ta' kontraċezzjoni, ittestjar għat-tqala) qabel, matul u wara terapijab'Myclausen.
English: PHARMACEUTICAL FORM AND CONTENTS 150 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 150 pillola miksija b'rita
English: Lung problems such as:
Maltese: Problemi oħra bħal:
English: There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate mofetil, some of which have been fatal.
Maltese: Kien hemm rapporti ta' anemija aplastika u depressjoni tal-mudullun f'pazjenti kkurati b'mycophenolate mofetil, li wħud minnhom kienu fatali.
English: 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 Myclausen.
Maltese: Prodotti mediċinali li jinterferixxu maċ-ċirkolazzjoni enter-epatika Għandu jkun hemm kawtela b'mediċini li jinterferixxu maċ-ċirkolazzjoni enter-epatika minħabba lpotenzjal tagħhom li jnaqqsu l-effikaċja ta' Myclausen.
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)).Your baby may be affected by one or more of these.
Maltese: Difetti tat-twelid li kienu rrappurtati jinkludu anomaliji talwidnejn, 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 (per eżempju spina bifida (fejn lgħadam tas-sinsla tad-dahar ma jkunux żviluppati sew)).
English: The patient information pack should contain:
Maltese: Il-Pakkett ta' informazzjoni għall-pazjent: ·
English: Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.
Maltese: Mycophenolate mofetil ma kellu l-ebda effett fuq il-fertilità ta' firien maskili f'dożi mill-ħalq sa 20 mg/kg/jum.
English: 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.
Maltese: Peress li fil-preżenza ta' indeboliment renali lkonċentrazzjonijiet fil-plażma ta' MPAG u ta' aciclovir jiżdiedu, hemm il-potenzjal li mycophenolate mofetil u aciclovir, jew il-prodrugs tiegħu eż.
English: Before starting Myclausen treatment, women of child bearing 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'Myclausen, nisa li jistgħu joħorġu tqal għandu jkollhom żewġ testijiet tat-tqala tas-serum jew tal-awrina negattivi b'sensittività ta' mill-inqas 25 mIU/mL sabiex jiġi eskluż esponiment mhux intenzjonat tal-embriju għal mycophenolate.
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (see section 4.4).
Maltese: F'pazjenti kkurati b'mycophenolate mofetil kienu irrappurtati każijiet ta' aplasija pura taċ-ċelluli ħomor (PRCA) (ara sezzjoni 4.4).
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 talglomerulus < 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: • If you are pregnant or planning to become pregnant or think you may be pregnant 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: NAME OF THE MEDICINAL PRODUCT Myclausen 500 mg film-coated tablets Mycophenolate mofetil
Maltese: TAL-PRODOTT MEDIĊINALI Myclausen 500 mg pilloli miksijin b'rita Mycophenolate mofetil
English: In addition there have been isolated reports of the following malformations:
Maltese: Barra minn hekk kien hemm rapporti iżolati tal-malformazzjonijiet li ġejjin:
English: 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.
Maltese: L-esponiment sistemiku b'din id-doża kienet madwar 0.5 darbiet ogħla mill-esponiment kliniku fid-doża rakkomandata klinikament ta' 2 g/jum f'pazjenti bi trapjant renali u madwar 0.3 darbiet l-esponiment kliniku fid-doża rakkomandata klinikament ta' 3 g/jum f'pazjenti bi trapjant tal-qalb.
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 lmutaġeniċità ta' mycophenolate mofetil.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Passauer Pharma GmbH
Maltese: FIS-SUQ Passauer Pharma GmbH
English: Two complementary forms of contraception simultaneously are preferred to minimise the potential for contraceptive failure and unintended pregnancy.
Maltese: Żewġ forom komplimentari ta' kontraċezzjoni fl-istess waqt huma ppreferuti biex jiġi minimizzat il-potenzjal ta' falliment tal-kontraċettiv u tqala mhux intenzjonata.
English: Ciprofloxacin and amoxicillin plus clavulanic acid Reductions in pre-dose (trough) MPA concentrations of about 50 % have been reported in renal transplant recipients in the days immediately following commencement of oral ciprofloxacin or amoxicillin plus clavulanic acid.
Maltese: Ciprofloxacin u amoxicillin flimkien ma' clavulanic acid Tnaqqis fil-konċentrazzjonijiet ta' MPA ta' qabel id-doża (konċentrazzjonijiet l-aktar baxxi) ta' madwar 50 % kienu irrappurtati f'pazjenti li rċevew trapjant tal-kliewi fil-ġranet eżatt wara l-bidu ta' ciprofloxacin jew amoxicillin flimkien ma' clavulanic acid orali.
English: Elderly patients receiving mycophenolate mofetil as part of a combination immunosuppressive regimen, may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger individuals.
Maltese: Pazjenti anzjani li qed jirċievu mycophenolate mofetil bħala parti minn kors immunosoppressiv kombinat, jistgħu jkunu f'riskju akbar ta' ċertu infezzjonijiet (inkluż mard b'cytomegalovirus invasiv fit-tessut) u possibilment emorraġija gastro-intestinali u edima filpulmun meta mqabbla ma' individwi iżgħar.
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.
English: • Renal abnormalities.
Maltese: • Tkissirhomx u tfarrakomx.
English: PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 50 pillola miksija b'rita
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 250 mg mycophenolate mofetil.
Maltese: U KWANTITATTIVAKull kapsula iebsa fiha 250 mg mycophenolate mofetil.
English: There have also been isolated reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal (see section 4.8).
Maltese: Kien hemm ukoll rapporti iżolati ta' mard tal-interstizju tal-pulmun u fibrożi pulmonari, li wħud minnhom kienu fatali (ara sezzjoni 4.8).
English: BATCH NUMBER Batch
Maltese: NUMRU TAL-LOTT Lott
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) f'kull doża, jiġifieri essenzjalment huwa ‘ħieles mis-sodju'.
English: Very common
Maltese: Komuni ħafnaKomuni
English: The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
Maltese: Żewġ forom ta' kontraċezzjoni huma preferibbli għax dan inaqqas ir-riskju ta' tqala mhux intenzjonata.
English: All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4).
Maltese: Il-pazjenti li jirċievu trapjant kollha huma f'riskju akbar ta' infezzjonijiet opportunistiċi; ir-riskju jiżdied bl-għotja totali tal-immunosoppressiv (ara sezzjoni 4.4).
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 ll-esponiment kliniku fid-doża rakkomandata klinikament ta' 2 g/jum f'pazjenti bi trapjant renali u 1.
English: The active substance is mycophenolate mofetil. Each tablet contains 500 mg mycophenolate mofetil
Maltese: U KWANTITATTIVAKull pillola miksija b'rita fiha 500 mg mycophenolate mofetil.
English: Contraception in men taking Myclausen
Maltese: Kontraċezzjoni f'irġiel li jieħdu Myclausen
English: • Myclausen treatment should not be initiated in women of child bearing potential without providing a pregnancy test result to rule out unintended use in pregnancy (see section 4.6).
Maltese: • Trattament b'Myclausen m'għandux jinbeda f'nisa li jistgħu joħorġu tqal mingħajr ma jiġi pprovdut riżultat ta' test tat-tqala biex jiġi żgurat li ma jintużax b'mod mhux intenzjonat waqt ittqala (ara sezzjoni 4.6).
English: • Take 2 tablets in the morning then 2 tablets in the evening.
Maltese: • Ħu 2 pilloli filgħodu u wara 2 pilloli filgħaxija.
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 tal-limfojdi kienu l-organi ewlenin affettwati fi studji tat-tossikoloġija li twettqu b'mycophenolate mofetil fil-far, ġurdien, kelb u xadina.
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 kkurati b'mycophenolate mofetil kienu osservati każijiet iżolati ta' morfoloġija mhux normali ta' newtrofili, inkluż l-anomalija miksuba ta' Pelger-Huet.
English: Other in vitro tests for detection of gene mutation did not demonstrate genotoxic activity.
Maltese: Testijiet oħrajn in vitro għas-sejba ta' mutazzjoni tal-ġeni ma wrewx attività ġenotossika.