FrancophonIA/ELRC3.0 huggingface dataset:
English: Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and congenital malformations in case of exposure during pregnancy;
Maltese: Mycophenolate huwa teratoġen qawwi fil-bnedmin, b'żieda fir-riskju ta' aborti spontanji u malformazzjonijiet konġenitali f'każ ta' esponiment waqt it-tqala;
English: Note: 501 (2 g mycophenolate mofetil daily), 289 (3 g mycophenolate mofetil daily) and 277 (2 g intravenous / 3 g oral mycophenolate mofetil daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
Maltese: Nota: 501 (2 g ta' mycophenolate mofetil kuljum), 289 (3 g ta' mycophenolate mofetil kuljum) u 277 (2 g ġol-vina / 3 g mill-ħalq ta' mycophenolate mofetil kuljum) pazjent kienu kkurati fl-istudji ta' fażi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/003 (100 hard capsules)
Maltese: FIS-SUQ EU/1/10/647/003 (100 kapsula iebsa)
English: • gut problems including bleeding, liver problems
Maltese: • problemi intestinali inkluż fsada, problemi tal-fwied,
English: PHARMACEUTICAL FORM Capsule, hard.
Maltese: GĦAMLA FARMAĊEWTIKA Kapsula, iebsa. kapsuli oblungi u bojod
English: • This belongs to a group of medicines called “immunosuppressants”.
Maltese: • Dan jagħmel parti minn grupp ta' mediċini msejħa “immunosoppressanti”.
English: Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 years) given 600 mg/m mycophenolate mofetil orally twice daily.
Maltese: Parametri farmakokinetiċi kienu evalwati f'49 pazjent pedjatriku bi trapjant renali (età ta' 2 sa 18-il sena) li ngħataw 600 mg/m ta' mycophenolate mofetil mill-ħalq darbtejn kuljum.
English: Congenital disorders
Maltese: Disturbi konġenitali
English: Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Fis-sistema tal-klassifika tal-organi, effetti mhux mixtieqa huma mniżżla taħt it-titli ta' frekwenza, blużu tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma jistax jiġi stmat mit-tagħrif disponibbli).
English: Each carton contains either 50 or 150 tablets.
Maltese: Kull kartuna fiha jew 50 jew 150 pillola.
English: However, the following treatment-related adverse events were more frequent in the paediatric population, particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leucopenia, anaemia and infection.
Maltese: Madankollu r-reazzjonijiet avversi relatati mal-kura li ġejjin kienu aktar komuni fil-popolazzjoni pedjatrika, speċjalment tfal taħt l-età ta' sitt snin, meta mqabbla ma' adulti: dijarea, sepsis, lewkopenija, anemija u infezzjoni.
English: Decrease in MPA Cmax and AUC (0-12h) by 30 % and 25 %, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
Maltese: Tnaqqis f'Cmax u fl-AUC (0-12h) ta' MPA bi 30 % u 25 %, rispettivament, kien osservat meta mycophenolate mofetil ingħata flimkien ma' sevelamer mingħajr l-ebda konsegwenzi kliniċi (i.e tiċħid tat-trapjant).
English: Myclausen contains mycophenolate mofetil.
Maltese: Myclausen fih mycophenolate mofetil.
English: Patients treated with immunosuppressants, including Myclausen, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Maltese: Pazjenti kkurati b'immunosoppressanti, inkluż Myclausen, huma f'riskju akbar għall-infezzjonijiet opportunistiċi (mill-batterja, moffa, virus u protożoa), infezzjonijiet fatali u sepsis (ara sezzjoni 4.8).
English: AcMPAG is pharmacologically active and is suspected to be responsible for some of mycophenolate mofetil´s side effects (diarrhoea, leucopenia).
Maltese: AcMPAG huwa farmakoloġikament attiv u hemm suspett li huwa responsabbli għal xi wħud milleffetti sekondarji ta' mycophenolate mofetil (dijarea, lewkopenija).
English: Myclausen capsules should only be prescribed to patients with a body surface area of at least 1.25 m 2.
Maltese: Il-kapsuli Myclausen għandhom jiġu preskritti biss lill-pazjenti li ġisimhom huwa ta' erja ta' mill-inqas 1.25 m 2.
English: 4.1 Therapeutic indications
Maltese: 4.1 Indikażzjonijiet terapewtici
English: Blood and immune system
Maltese: Demm u sistema immuni
English: Tablet coat: Polyvinyl alcohol (partially hydrolysed), titanium dioxide (E 171) macrogol 3000,talc
Maltese: Polyvinyl alcohol (partially hydrolysed), titanium dioxide (E 171), macrogol 3000, talc Kif jidher Myclausen u l-kontenuti tal-pakkett:
English: Capsule content Pregelatinised starch (maize) Croscarmellose sodium Povidone (K-30) Magnesium stearate
Maltese: Kontenut tal-kapsula Pre-gelatinised starch (maize) Croscarmellose sodium Povidone (K-30) Magnesium stearate
English: Pharmacokinetic behaviour of mycophenolate mofetil in the elderly ( 65 years) has not been formally evaluated.
Maltese: Anzjani Il-farmakokinetika ta' mycophenolate mofetil fl-anzjani ( 65 sena) ma kienitx evalwata formalment.
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 2 dożi separati.
English: • Microphthalmia;
Maltese: • Mikroftalmija;
English: It will provide details about the nature and magnitude of the risk, in line with the information provided in the SmPC.
Maltese: Se tipprovdi dettalji dwar in-natura u d-daqs tar-riskju, f'konformità mal-informazzjoni pprovduta fl-SmPC.
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 kkurati b'immunosoppressanti minbarra mycophenolate mofetil).
English: Spontaneous abortion (rate of 45% to 49%) and congenital malformations (estimated rate of 23% to 27%) have been reported following MMF exposure during pregnancy.
Maltese: Wara esponiment għal MMF waqt it-tqala kienu rrappurtati abort spontanju (rata ta' 45 - 49%) u malformazzjonijiet konġenitali (rata stmata ta' 2327%).
English: Leucopenia, thrombocytopenia, anaemia Common Pancytopenia, leukocytosis
Maltese: Komuni ħafna Lewkopenija, tromboċitopenija, anemija Komuni
English: Capsule content: pre-gelatinised starch (maize), croscarmellose sodium, povidone (K-30), magnesium stearate
Maltese: Pre-gelatinised starch (maize), croscarmellose sodium, povidone (K 30), magnesium stearate
English: Very common Common Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased Note: 501 (2 g mycophenolate mofetil daily), 289 (3 g mycophenolate mofetil daily) and 277 (2 g intravenous / 3 g oral mycophenolate mofetil daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
Maltese: Żieda tal-enżima epatika, żieda fil-kreatinina fid-demm, żieda tal-lactate dehydrogenase fiddemm, żieda fil-urea fid-demm, żieda talalkaline phosphatase fid-demm, tnaqqis fil-piż Nota: 501 (2 g ta' mycophenolate mofetil kuljum), 289 (3 g ta' mycophenolate mofetil kuljum) u 277 (2 g ġol-vina / 3 g mill-ħalq ta' mycophenolate mofetil kuljum) pazjent kienu kkurati fl-istudji ta' fażi
English: Myclausen 250 mg capsules is available PVC-aluminium blister containing 10 capsules.
Maltese: Il-kapsuli ta' Myclausen 250 mg jiġu f'folji tal-PVC-aluminju b'10 kapsuli.
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 studju ta' doża waħda (6 individwi/grupp), il-medja tal-AUC fil-plażma ta' MPA osservata f'persuni b'indeboliment kroniku renali sever (rata ta' filtrazzjoni glomerulari < 25 mL/min/1.73 m kienu 28-75 % ogħla meta mqabbla ma' medja osservati f'individwi normali f'saħħithom jew individwi b'indeboliment renali ta' gradi inqas gravi.
English: Microcrystalline cellulose Povidone (K-30) Croscarmellose sodium Magnesium stearate
Maltese: Qalba tal-pilloli Microcrystalline cellulose Povidone (K-30) Croscarmellose sodium Magnesium stearate
English: Myclausen is for oral use.
Maltese: Myclausen inaqqas id-difiżi tal-ġisem tiegħek.
English: Very common Common Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
Maltese: Aċidożi, iperkalimja, ipokalimja, ipergliċemija, ipomagnesimja, ipokalċimja, iperkoleserolimja, iperlipidimja, ipofosfatimja, iperurikimja, gotta, anoressija
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: • tremor, muscle spasms, convulsions
Maltese: • tregħid, spażmi tal-muskoli, konvulżjonijiet,
English: In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
Maltese: Fi studji dwar it-teratoġeniċità fil-firien u fil-fniek, resorbiment tal-fetu u malformazzjonijiet seħħew fil-firien f'dożi ta' 6 mg/kg/jum (inklużi anoftalmja, agnatja, u idroċefalu) u fil-fniek f'dożi ta' 90 mg/kg/jum (inklużi anomaliji kardjovaskulari u renali bħal per eżempju ectopia cordis u kliewi ektopiċi, u ftuq umbilikali u fid-dijaframma), fin-nuqqas ta' tossiċità materna.
English: Read the information carefully and follow the instructions.
Maltese: Aqra l-informazzjoni b'attenzjoni u segwi l-istruzzjonijiet.
English: Each carton contains either 100 or 300 capsules.
Maltese: Kull kartuna fiha jew 100 jew 300 kapsula.
English: Delayed renal graft function
Maltese: Funzjoni ttardjata ta' trapjant renali
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-mikronukleju talmudullun tal-ġurdien in vivo) urew li mycophenolate mofetil għandu potenzjal li jikkawża aberrazzjonijiet fil-kromosomi.
English: Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (2327%) in the unborn baby.
Maltese: Mycophenolate jikkawża frekwenza għolja ħafna ta' korriment (50%) u ta' difetti severi tat-twelid (23-27%) fit-tarbija mhux imwielda.
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 sinifikanti ta' riċiklaġġ enterepatiku.
English: • cholestyramine (used to treat high cholesterol)
Maltese: • cholestyramine (użat biex jikkura kolesterol għoli)
English: Non-melanoma skin carcinomas occurred in 3.6 % of patients; other types of malignancy occurred in 1.1 % of patients.
Maltese: Carċinoma mhux melanoma tal-ġilda seħħet f'3.6 % tal-pazjenti: tipi oħra ta' tumuri malinni seħħew f'1.1 % tal-pazjenti.
English: Myclausen 250 mg hard capsules Mycophenolate mofetil
Maltese: Myclausen 250 mg kapsuli ibsin Mycophenolate mofetil
English: Other medicines and Myclausen
Maltese: Mediċini oħra u Myclausen
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 filfarmakokinetika ta' MPAG (il-phenolic glucuronide ta' MPA) kien minimu (MPAG żdied bi 8 %) u m'huwiex ikkunsidrat bħala klinikament rilevanti.
English: The most common opportunistic infections in patients receiving mycophenolate mofetil (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex.
Maltese: L-iktar infezzjonijiet opportunistiċi komuni f'pazjenti fuq mycophenolate mofetil (2 g jew 3 g kuljum) flimkien ma' immunosoppressanti oħra fi provi kliniċi kkontrollati f'pazjenti bi trapjant tal-kliewi (tagħrif ta' 2 g), tal-qalb u tal-fwied li ġew osservati għal mill-inqas sena kienu candida mukokutanja, viremija/ sindrome b'CMV u Herpes simplex.
English: Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in ≥ 1/10 and in ≥ 1/100 to < 1/10 of patients treated with mycophenolate mofetil in the controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients are listed in the following table.
Maltese: Reazzjonijiet avversi, possibilment jew probabilment relatati ma' mycophenolate mofetil, irrappurtati f'≥ 1/10 u f'≥ 1/100 sa < 1/10 tal-pazjenti kkurati b'mycophenolate mofetil fil-provi kliniċi kkontrollati f'pazjenti bi trapjant renali (tagħrif ta' 2 g), tal- qalb u tal-fwied huma mniżżla fit-tabella taħt:
English: Hypersensitivity reactions to mycophenolate mofetil have been observed (see section 4.8).
Maltese: Kienu osservati reazzjonijiet ta' sensittività eċċessiva għal Myclausen (ara sezzjoni 4.8).
English: Myclausen capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Maltese: 1.5 m jistgħu jingħataw riċetta għal kapsuli Myclausen f'doża ta' 750 mg darbtejn kuljum (doża ta' kuljum ta' 1.5 g).
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 test 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 taddisponibilità 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: • Myclausen should not be given to women who are breast-feeding (see section 4.6).
Maltese: • Myclausen m'għandux jingħata lil nisa li jkunu qed ireddgħu (ara sezzjoni 4.6).
English: Because of robust clinical evidence showing a high risk of abortion and congenital malformations when mycophenolate mofetil is used in pregnancy every effort to avoid pregnancy during treatment should be taken.
Maltese: Minħabba evidenza klinika robusta li turi riskju għoli ta' abort u malformazzjonijiet konġenitali meta mycophenolate mofetil jintuża waqt it-tqala, għandu jittieħed kull sforz biex tiġi evitata t-tqala waqt ittrattament.
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 kienux affetwati bl-għotja flimkien ta' mycophenolate mofetil (ara wkoll sezzjoni 5.2).
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 2 dożi separati.
English: MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.
Maltese: MPA huwa impeditur qawwi, selettiv, mhux kompetittiv u riversibli ta' inosine monophosphate dehydrogenase, u għalhekk jimpedixxi r-rotta de novo tas-sintesi ta' guanosine nucleotide mingħajr inkorporazzjoni fid-DNA.
English: Paediatric population aged 2 to 18 years The recommended dose of mycophenolate mofetil is 600 mg/m administered orally twice daily (up to a maximum of 2 g daily).
Maltese: Id-doża rakkomandata ta' mycophenolate mofetil hija ta' 600 mg/m mogħtija mill-ħalq darbtejn kuljum (sa massimu ta' 2 g kuljum).
English: Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Maltese: Il-farmakokinetika ta' ciclosporin A (CsA) mhix affetwata minn mycophenolate mofetil.
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 gastro-intestinali u edima pulmonari, meta mqabbla ma' individwi iżgħar (ara sezzjoni 4.8).
English: Limited clinical evidence does not indicate an increased risk of malformations or miscarriage following paternal exposure to mycophenolate mofetil.
Maltese: Evidenza klinika limitata ma tindikax riskju akbar ta' malformazzjonijiet jew ta' korriment wara esponiment tal-missier għal mycophenolate mofetil.
English: Nervous system problems such as:
Maltese: Problemi fis-sistema urinarja bħal:
English: Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
Maltese: Ġeneralment, pazjenti anzjani (≥ 65 sena) jistgħu jkunu f'riskju akbar ta' reazzjonijiet avversi minħabba immunosoppressjoni.
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 (see section 4.4 and section 5.2).
Maltese: Wara l-għotja ta' doża waħda ta' 1.5 g ta' mycophenolate mofetil lil individwi normali f'saħħithom li kienu kkuratati minn qabel b'4 g tliet darbiet kuljum ta' cholestyramine għal erbat ijiem, kien hemm tnaqqis ta' 40 % fl-AUC ta' MPA (ara sezzjoni 4.4 u sezzjoni 5.2).
English: White oblong capsules.
Maltese: Kapsuli oblongi u bojod.
English: The nonclinical toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in human clinical trials which now provide safety data of more relevance to the patient population (see section 4.8).
Maltese: Il-profil ta' tossiċità mhux klinika ta' mycophenolate mofetil jidher li huwa konsistenti mal-avvenimenti avversi osservati fi provi kliniċi umani li issa jipprovdu tagħrif ta' sigurtà ta' rilevanza akbar għallpopolazzjoni ta' pazjenti (ara s-sezzjoni 4.8).
English: • You have sex without using an effective method of contraception.
Maltese: • Jekk tagħmel sess mingħajr l-użu ta' metodu effettiv ta' kontraċezzjoni.
English: Men must not donate semen during treatment with Myclausen and for at least 90 days after stopping treatment.
Maltese: Irġiel m'għandhomx jagħtu semen waqt it-trattament b'Myclausen u għal millinqas 90 jum wara li jitwaqqaf it-trattament.
English: See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Maltese: Ara wkoll aktar informazzjoni f'din it-taqsima taħt “Twissijiet u prekawzjonijiet” u “Tqala u treddigħ”.
English: • Take 4 capsules in the morning then 4 capsules in the evening.
Maltese: • Ħu 4 kapsuli filgħodu u wara 4 kapsuli filgħaxija.
English: Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA.
Maltese: Wara għotja mill-ħalq, mycophenolate mofetil jgħaddi minn assorbiment rapidu u estensiv u metaboliżmu pre-sistemiku komplut għall-metabolit attiv, MPA.
English: Mycophenolate is a powerful human teratogen.
Maltese: Mycophenolate huwa teratoġen qawwi fil-bnedmin.
English: Tablet core: Microcrystalline cellulose, povidone (K-30), croscarmellose sodium, magnesium stearate
Maltese: Microcrystalline cellulose, povidone (K-30), croscarmellose sodium, magnesium stearate Kisja tal-pilloli:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/001-002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/647/001-002
English: • Congenital heart disease such as atrial and ventricular septal defects;
Maltese: • Mard konġenitali tal-qalb bħal difetti fis-septum tal-atriju u tal-ventriklu;
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 ukoll effetti gastro-intestinali u renali konsisteni ma' deidrazzjoni fix-xadina fl-ogħla doża (livelli ta' esponiment sistemiku ekwivalenti għal jew ogħla mill-esponiment kliniku).
English: PVC-aluminium blisters containing 10 hard capsules.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fiħ Folji tal-PVC-aluminju, li fihom 10 kapsula iebsa.
English: Neoplasms
Maltese: Pożoloġija
English: Myclausen is contraindicated during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
Maltese: Myclausen huwa kontraindikat waqt it-tqala ħlief jekk ma jkunx hemm trattament alternattiv xieraq biex jiġi evitat rifjut tat-trapjant.
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 mycophenolate mofetil (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'għotja ta' doża waħda ta' dożi rakkomandata ta' mycophenolate orali u ganciclovir IV u l-effetti magħrufa ta' indeboliment renali fuq il-farmakokinetika ta' mycophenolate mofetil (ara sezzjoni 4.2) u ganciclovir, huwa mbassar li l-għotja flimkien ta' dawn is-sustanzi (li jikkompetu għall-mekkaniżmi ta' sekrezzjoni tubulari mill-kliewi) tirriżulta f'żieda filkonċentrazzjonijiet ta' MPAG u ganciclovir.
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 irrappurtati f'pazjenti esposti għal mycophenolate mofetil, il-biċċa lkbira fl-ewwel trimester, ara sezzjoni 4.6.