qanastek/EMEA-V3 huggingface dataset:
It is recommended to monitor MPA exposure levels and to adjust Mycophenolate mofetil Teva doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Huwa rakkomandat li l- livelli ta ’ espożizzjoni ta ’ MPA jiġu monitorati u sabiex id- dożi ta ’ Mycophenolate mofetil Teva jiġu aġġustati skond dan sabiex tibqa ’ tiġi mantenuta l- effikaċja klinika meta rifampicin tiġi mogħtija ma ’ dan.
Sirolimus: in renal transplant patients, concomitant administration of mycophenolate mofetil and CsA resulted in reduced MPA exposures by 30-50% compared with patients receiving the combination of sirolimus and similar doses of mycophenolate mofetil (see also section 4.4).
18 Sirolimus: f’ pazjenti li għandhom trapjant renali, it- teħid konkomitanti ta ’ mycophenolate mofetil u CsA irriżulta fi tnaqqis għal espożizzjonijiet għal MPA bi 30- 50% meta mqabbel ma ’ pazjenti li qed jirċievu kombinazzjoni ta ’ sirolimus u dożi simili ta ’ mycophenolate mofetil (ara wkoll sezzjoni 4. 4).
Sevelamer: decrease in MPA C max and AUC 0-12 by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection).
Sevelamer: tnaqqis f’ Cmax u AUC0- 12 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).
It is recommended, however, to administer Mycophenolate mofetil Teva at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Madankollu, huwa rakkomandat li Mycophenolate mofetil Teva jiġi mogħti ta ’ lanqas siegħa qabel jew tliet sigħat wara it- teħid ta ’ sevelamer biex jitnaqqas kemm jista ’ l- impatt ta ’ l- assorbiment ta ’ MPA.
Tacrolimus: in liver transplant recipients initiated on mycophenolate mofetil and tacrolimus, the AUC and C max of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by trough tacrolimus level.
Tacrolimus: f’ pazjenti bi trapjanti tal- fwied mibdija fuq mycophenolate mofetil u tacrolimus, l- AUC u Cmax ta ’ MPA, il- metabolit attiv ta ’ mycophenolate mofetil ma kienx affettwat b’ mod sinifikanti bil - livell lanqas baxx ta ’ tacrolimus.
In renal transplant patients, the tacrolimus concentration did not appear to be
F’ pazjenti bi trapjant renali, il- konċentrazzjoni ta ’ tacrolimus ma dehritx li kienet mibdula b’ mycophenolate mofetil.
However, in hepatic transplant patients, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5 g taken twice a day, morning and evening [BID]) were administered to patients taking tacrolimus (see also section 4.4).
Madankollu, f’ pazjenti bi trapjant tal- fwied kien hemm żieda ta ’ madwar 20% fl- AUC ta ’ tacrolimus meta dożi multipli ta ’ mycophenolate mofetil (1. 5 g li għandhom jittieħdu darbtejn kuljum [BID] filgħodu u filgħaxija) ġew amministrati lil pazjenti li ħadu tacrolimus (ara wkoll sezzjoni 4. 4).
Other interactions: co administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of MPAG by 3-fold.
Interazzjonijiet oħrajn: l- għoti konkomitanti ta ’ probenicid ma ’ mycophenolate mofetil fix- xadini jgħolli l- plażma AUC ta ’ MPAG bi 3 darbiet.
Thus, other substances known to undergo renal tubular secretion may compete with MPAG and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
Għalhekk, sustanzi oħra li jnixxu mit- tubuli tal- kliewi jistgħu jikkompetu ma ’ MPAG u b’ hekk jgħollu l- konċentrazzjonijiet fil- plażma ta ’ MPAG jew ta ’ sustanza li tkun qed tnixxi mit- tubuli.
Effective contraception must be used before beginning Mycophenolate mofetil Teva therapy, during therapy, and for six weeks following discontinuation of therapy (see section 4.5).
Kontraċezzjoni effettiva għandha tiġi wżata qabel tinbeda terapija b’ Mycophenolate mofetil Teva, waqt it- terapija, u għal sitt ġimgħat wara li tintemm it- terapija (ara sezzjoni 4. 5).
Patients should be instructed to consult their physician immediately should pregnancy occur.
Pazjenti għandhom jingħataw parir biex jikkonsultaw mat- tabib tagħhom hekk kif jinqabdu tqal.
However, congenital malformations including ear malformations, i. e. abnormally formed or absent external/ middle ear have been reported in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants during pregnancy.
Madankollu, malformazzjonijiet konġenitali li jinkludu malformazzjonijiet tal- widna i. e żvilupp abnormali jew in - nuqqas ta ’ widna tan- nofs jew il- widna esterna ġew rapportati fi tfal ta ’ pazjenti esposti għal mycophenolate mofetil ma ’ immunosuppressanti oħra waqt it- tqala.
Lymphoproliferative disease or lymphoma developed in 0.6% of patients receiving mycophenolate (2 g or 3 g daily) in combination with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year.
Mard limfoproliferattiv jew limfoma żviluppaw f’ 0. 6% ta ’ pazjenti li jkunu qegħdin jingħataw mycophenolate (2 g jew 3 g kuljum) f’ kumbinazzjoni ma ’ mediċini immunosoppressivi oħrajn fi provi kliniċi kkontrollati fuq pazjenti bi trapjanti tal- kliewi (2 g kuljum), tal- qalb u tal- fwied, li kienu seġwiti għal ta ’ l- anqas sena.
Three-year safety data in renal and cardiac transplant patients did not 19 reveal any unexpected changes in incidence of malignancy compared to the 1-year data.
Tagħrif ta ’ siġurta fuq tliet snin f’ pazjenti bi trapjanti tal- kliewi u tal- qalb ma wrew l- ebda bidla mhux mistennija fl- inċidenza ta ’ mard malinn meta mqabbel ma ’ dejta ta ’ sena.
The proportion of patients with CMV viraemia/ syndrome was 13.5%.
Il- proporzjon ta ’ pazjenti b’ viremja/ sindromu CMV kien ta’ 13. 5%.
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who where given 600 mg/ m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g mycophenolate twice daily.
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, kienu ġeneralment simili għal dawk osservati f’ pazjenti adulti li ngħataw 1 g mycophenolate darbtejn kuljum.
Elderly patients receiving Mycophenolate mofetil Teva 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.
Pazjenti anzjani li qegħdin jingħataw Mycophenolate mofetil Teva bħala parti minn reġimen immunosoppressiv kkombinat, jistgħu jkunu f’ riskju akbar ta ’ ċertu nfezzjonijiet (li jinkludu mard ta ’ invażjoni tat- tessuti minn cytomegalovirus) u possibilment t’ emorraġija gastrointestinali u edema pulmonarja, meta mqabblin ma ’ individwi aktar żgħar.
Adverse reactions, probably or possibly related to mycophenolate, reported in  1/ 10 and in ≥ 1/ 100 to < 1/ 10 of patients treated with mycophenolate in the controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients are listed in the following table.
Reazzjonijiet avversi, li probabilment jew possibilment huma relatati ma ’ mycophenolate, irraportati f’ ≥ 1/ 10 u f’ ≥1/ 100 sa1/ 10 ta ’ pazjenti trattati b’ mycophenolate fil- provi kliniċi kkontrollati ta ’ pazjenti bi trapjanti renali (dejta ta ’ 2 g), kardijaċi u epatiċi huma elenkati fit- tabella li ġejja.
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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
Fi ħdan kull grupp ta ’ frekwenzi, l - effetti mhux mixtieqa huma ppreżentati f’ ordni fejn is- severità tagħhom tonqos
20 Adverse reactions, probably or possibly related to mycophenolate, reported in patients treated with mycophenolate in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids
Reazzjonijiet avversi, li b’ mod probabbli jew possibbli huma relatati ma ’ mycophenolate, irraportati f’ pazjenti trattati b’ mycophenolate fi provi renali, kardijaċi u epatiċi meta użati flimkien ma ’ ciclosporin u corticosteroids
System organ class
Sistema tal -
Adverse drug reactions
klassifikazzjoni tal- organi
- Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased
- Żieda fil- livell ta ’ enżima epatika, żieda fil- kreatinin tad- demm, żieda ta ’ lactate dehydrogenase fid - demm, żieda ta ’ urea fid- demm, żieda ta ’ alkaline phosphatase fid- demm, tnaqqis fil- piż
Cardiac disorders
Disturbi kardijaċi
- Convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia
- Aċċessjoni, ipertonija, tregħid, ħedla, sindromu mijasteniku, sturdamenti, uġigħ ta ’ ras, parestesija, disgewsja
- Pleural effusion, dyspnoea, cough
- Effużjoni plewrali, dispnea, sogħla
Vomiting, abdominal pain, diarrhoea, nausea Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Remettar, uġigħ addominali, dijarrea, dardir Emorraġija gastro- intestinali, peritonite, ileus, kolite, ulċeri fl- istonku, ulċeri duwodenali, gastrite, esofagite, stomatite, stitikezza, dispepsja, gass, tifwiq
Renal and urinary disorders Skin and subcutaneous tissue disorders
Disturbi renali u tas- sistema urinarja Disturbi tal- ġilda u t- tessuti subkutanji Disturbi muskolu - skeletali u tat - tessut konnettiv
Very common Common Very common Common
Komuni ħafna Komuni Komuni ħafna Komuni Komuni ħafna Komuni
- Renal impairment - Skin hypertrophy, rash, acne, alopecia
- Indeboliment renali - Ipertrofija tal- ġilda, raxx, akne, alopeċja - Artralġja
Musculoskeletal and connective tissue disorders
Disturbi marbuti mal- metaboliżmu u n- nutrizzjon
- Arthralgia
Komuni ħafna
- Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
Pnewmonja, influwenza, infezzjoni tal- passaġġ respiratorju, moniljasi respiratorja, infezzjoni gastrointestinali, kandidjasi, gastroenterite, infezzjoni, bronkite, farinġite, sinusite, infezzjoni fungali tal- ġilda, kandida tal- ġilda, kandidjasi vaġinali, rinite
Infections and infestations
Neoplażmi beninn, malinn u mhux speċifiċi (li jinkludu ċisti u polipi)
Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
- Kanser tal- ġilda, neoplażmu beninn tal- ġilda
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disturbi vaskulari
- Skin cancer, benign neoplasm of skin
- Ipotensjoni, ipertensjoni, vażodilazzjoni
Vascular disorders General disorders and administration site conditions
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jittieħed
Very common Common Very common Common
Komuni ħafna Komuni
- Hypotension, hypertension, vasodilatation - Oedema, pyrexia, chills, pain, malaise, asthenia
- Edema, deni, tertir, uġigħ, telqa, astenja
Hepatobiliary disorders Psychiatric disorders
Disturbi epato - biljari Disturbi psikjattriċi
- Hepatitis, jaundice, hyperbilirubinaemia - Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia
- Epatite, suffejra, iperbilirubinemija Aġitazzjoni, stat ta ’ konfużjoni, depressjoni, ansjetà, ħsibijiet mhux normali, nuqqas ta ’ rqad
The following undesirable effects cover adverse reactions from post-marketing experience: the types of adverse reactions reported during post-marketing with mycophenolate are similar to those seen in the controlled renal, cardiac and hepatic transplant studies.
L- effetti mhux mixtieqa li ġejjin ikopru reazzjonijiet avversi skont esperjenzi ta ’ wara t- tqegħid fis - suq: it- tipi ta ’ reazzjonijet avversi rapportati wara t- tqegħid fis- suq b’ mycophenolate huma simili għal dawk li jidhru fi stħarriġ ikkontrollat li jinvolvi trapjanti tal- kliewi, tal- qalb u tal- fwied.
Gastrointestinal: colitis including cytomegalovirus colitis, (common), pancreatitis, (common) and intestinal villous atrophy.
Gastrointestinali: kolite li tinkludi kolite minn ċitomegalovajrus, (kolite) (komuni), pankreatite, (komuni) u atrofija tal- villi intestinali.
Disorders related to immunosuppression: serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Disturbi relatati ma ’ l- immunosoppressjoni: infezzjonijiet serji li jipperikolaw il- ħajja jinkludu meninġite, endkardite, tuberkulożi u infezzjonijiet b’ mikobatterja atipika.
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 Teva.
Każijiet ta ’ ta ’ newropatija assoċjata mal- virus BK, kif ukoll każijiet ta ’ lewkoenċefalopatija multifokali progressiva (PML) assoċjata mal- virus JC, kienu rrapportati f’ pazjenti kkurati b’ immunosoppressanti, inkluż Mycophenolate mofetil Teva.
Agranulocytosis (uncommon) and neutropenia have been reported; therefore regular monitoring of patients taking Mycophenolate mofetil Teva is advised (see section 4.4).
Agranuloċitosi (mhux komuni) u newtropenija ġew irrapportati: għalhekk moniteraġġ tal- pazjenti li qegħdin jieħdu Mycophenolate mofetil Teva huwa rakkomandat (ara sezzjoni 4. 4).
There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate, some of which have been fatal.
Kien hemm rapporti ta ’ anemija aplastika u depressjoni tal- mudullun f ’ pazjenti ttrattati b’ mycophenolate, li xi ftit minnhom kienu fatali.
22 Hypersensitivity: hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Sensittività eċċessiva: ġew irraportati reazzjonijiet ta ’ sensittività eċċessiva, li jinkludu edema angionewtrotika u reazzjoni anafilattika.
Congenital disorders: see further details in section 4.6.
Disturbi konġenitali: ara aktar dettalji f’ sezzjoni 4. 6
Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience.
22 Waslu rapporti ta ’ dożi eċċessivi b’ mycophenolate mofetil minn provi kliniċi u mill- esperjenza ta ’ wara t- tqegħid fis- suq.
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).
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).
If neutropenia develops, dosing with Mycophenolate mofetil Teva should be interrupted or the dose reduced (see section 4.4).
Jekk tiżviluppa n- newtropenja, Myfenax għandu jiġi mwaqqaf jew id- doża mnaqqsa (ara sezzjoni 4. 4).
Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA).
Mycophenolate mofetil huwa l- 2- morpholinoethyl ester ta ’ mycophenolic esther (MPA).
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.
MPA huwa impeditur potenti, silettiv, mhux kompettitiv u impeditur reversibbli ta ’ inosine monophosphate dehydrogenase, u għalhekk jimpedixxi l- passaġġ de novo tas- sintesi ta ’ guanosine nucleotide mingħajr ma jinkorporah fid- DNA.
However, MPA C max was decreased by 40% in the presence of food.
Madankollu, MPA Cmax kinet imnaqqsa b’ 40% fil- preżenza ta ’ l- ikel.
As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are usually observed at approximately 6 – 12 hours post-dose.
Bħala riżultat ta ’ ċirkulazzjoni enteroepatika mill- ġdid, żjidiet sekondarji fil- konċentrazzjoni ta ’ MPA fil- plażma huma ġeneralment osservati bejn wieħed u ieħor minn 6- 12- il siegħa wara d- doża.
A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating that these is a significant amount of enterohepatic recirculation.
Tnaqqis fl- AUC ta ’ MPA ta ’ bejn wieħed u ieħor 40% huwa assoċjat ma ’ l- għoti konkomitanti ta ’ cholestyramine (4 g TID), li tindika li hemm ammont sinifikattiv ta ’ ċirkulazzjoni enteroepatika mill - ġdid.
23 A negligible amount of substance is excreted as MPA (< 1% of dose) in the urine.
Ammont negliġibbli ta ’ sustanza hija merħija bħala MPA (< 1% tad- doża) fl- awrina.
At clinically encountered concentrations, MPA and MPAG are not removed by haemodialysis.
23 F’ konċentrazzjonijiet li niltaqgħu magħhom klinikament, MPA u MPAG mhumiex imneħħijin bl - emodialiżi.
However, at high MPAG plasma concentrations (> 100  g/ ml), small amounts of PAG are removed.
Madankollu, f’ konċentrazzjonijiet ta ’ MPAG fil- plażma għoljin (> 100µg/ ml), ammonti żgħar ta ’ MPAG huma mneħħijin.
In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplants patients had mean MPA AUCs approximately 30% lower and C max approximately 40% lower compared to the late post-transplant period (3 – 6 months post-transplant).
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).
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 1.73 m-2) were 28-75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
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 mlmin- 11. 73 m- 2) kienet 28 - 75% aktar għolja relattivament mal- medji osservati f’ suġġetti normali u f’ saħħithom jew suġġetti bi gradi anqas ta ’ indeboliment tal- kliewi.
However, 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.
Madankollu, il- MPAG AUC medju ta ’ doża ewlenija kien minn 3- 6 darbiet ogħla f’ suġġetti b’ indeboliment kroniku tal- kliewi sever milli f’ suġġetti b’ indeboliment tal- kliewi ħafif jew suġġetti normali u f’ saħħithom, konsistenti mat- tneħħija mill - kliewi ta ’ MPAG kif magħrufa.
Mean plasma MPAG AUC (0- 12h) was 2 – 3-fold higher than in post-transplant patients without delayed graft function.
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.
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients given 600 mg/ m2 mycophenolate mofetil orally twice daily.
Parametri farmakokinetiċi kienu evalwati f’ 49 pazjenti pedjatriċi bi trapjant tal- kliewi li ngħataw 600 mg/ m2 mycophenalate mofetil oralment darbtejn kuljum.
This dose achieved MPA AUC values similar to those seen in adult renal transplant patients receiving mycophenolate at a dose of 1 g BID in the early and late post-transplant period.
Din id- doża kisbet valuri ta ’ MPA AUC simili għal dawk li dehru f’ pazjenti adulti bi trapjanti tal- kliewi li kienu qegħdin jingħataw mycophenolate f’ doża ta ’ 1 g BID fil- perijodi bikrin u dawk aktar tard ta ’ wara t- trapjant.
A study of the co administration of mycophenolate (1 g BID) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of mycophenolate on the ovulation suppressing action of the oral contraceptives.
Il- farmakokinetiċi ta ’ kontraċettivi orali ma kinux effettwati mill- għoti konkomitanti ta ’ mycophenolate (ara wkoll sezzjoni 4. 5) Studju dwar l- għoti konġunt ta ’ mycophenolate (1 g BID) u kontraċettivi orali kkombinati li jkun fihom ethinylestradiol (0. 02 mg sa 0. 04 mg) u levonorgestrel (0. 05 mg sa 0. 15 mg), desogestrel (0. 15 mg) jew gestodene (0. 05 mg to 0. 10 mg) magħmul fi 18- il mara li ma kellhomx trapjant (mhux qegħdin jieħdu immunosoppressanti oħrajn) fuq 3 ċiċkli menstruwali konsekuttivi ma wrew l- ebda influwenza klinikament relevanti ta ’ mycophenolate fuq l - azzjoni ta ’ trażżin ta ’ l- ovulazzjoni tal- kontraċettivi orali.
Serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH) and progesterone were not significantly affected.
Livelli fis- sirum ta ’ l- ormon Lewtanizzanti (LH), ormon li jistimula l- follikuli (FSH) u progesterone ma kinux sinifikattivament effettwati.
5.3 Preclinical safety data 24 In experimental models, mycophenolate mofetil was not tumourigenic.
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina 24 F’ mudelli sperimentali, mycophenolate mofetil ma kienx tumuriġeniku.
The highest dose tested in the animal carcinogenicity studies resulted in approximately 2 – 3 times the systemic exposure (AUC or C max) observed in renal transplant patients as the recommended clinical dose of 2 g/ day and 1.3 – 2 times the systemic exposure (AUC or C max) observed in cardiac transplant patients at the recommended clinical dose of 3 g/ day.
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 tal - qalb f’ doża klinika rakkomandata ta ’ 3 g/ kuljum.
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.
Żewġ assays dwar 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.
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg kg-1 day-1.
Mycophenolate mofetil ma kellu l- ebda effett fuq il- fertilità ta ’ firien irġiel f’ dożi orali sa 20mg kg- 1 day- 1.
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.
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.
In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg kg-1 day-1 caused malformations (including anophthalmia, agnathia and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
Fi stħarriġ fuq il - fertilità u r- riproduzzjoni magħmul fuq firien nisa, dożi orali ta ’ 4. 5 mg kg- 1jum- 1 ikkaġunaw malformazzjonijiet (inklużi anoftalmja, agnatija u idrokefali) f’ wild ta ’ l- ewwel ġenerazzjoni fl - assenza ta ’ tossiċità materna.
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg kg-1  day-1 (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg kg-1 day-1 (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
Fl- istudji teratoloġiċi fil- firien u fil- fniek, risorbiment tal- fetu u malformazzjonijiet seħħew fil- firien f’ 6mg kg- 1 day- 1 (li jinkludu anoftalmja, agnatija u idrokefali) u fil- fniek f’ 90mg kg- 1 day- 1 (li jinkludu anomaliji kardjovaskularu u tal- kliewi, bħal ma huma ektopia kordis u kliewi ektopiċi, u ftuq dijafragmatiku u umbilikali), fl- assenza ta ’ tossicità materna.
These effects occurred at systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended dose of 2 g/ day for renal transplant recipients.
Dawn l- effetti seħħew f’ livelli ta ’ espożizzjoni sistemiċi li huma ekwivalenti għal jew għal anqas minn l- espożizzjoni klinika f’ doża rakkomandata ta ’ 2 g/ kuljum għar- reċipjenti tat- trapjanti tal- kliewi.
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).
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).
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).
Il- profil tat- tossiċità mhux kliniku ta ’ mycophenolate mofetil jidher li huwa konsistenti ma ’ każijiet avversi osservati fi provi kliniċi fuq il - bniedem li issa jipprovdu tagħrif ta ’ sigurtà li hija aktar ta ’ rilevanza għall- populazzjoni tal- pazjenti (ara sezzjoni 4. 8).
Microcrystalline cellulose Povidone K-30 Magnesium stearate Croscarmellose sodium 25 Tablet coat:
25 Microcrystalline cellulose Povidone K- 30 Magnesium stearate Croscarmellose sodium
Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol Talc Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux kundizzjonijiet ta ’ ħażna speċjali
6.5 Nature and contents of container
6. 5 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Transparent PVC/ PVdC-aluminium blisters in pack sizes of 50 or 150 tablets per carton.
Pakketti tal- folji trasparenti ta ’ PVC/ PVdC ta ’ folji ta ’ 50 jew 150 pillola f’ kull kartuna.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbit, Mycophenolate mofetil Teva film-coated tablets should not be crushed.
Peress li mycophenolate mofetil wera effetti teratogeniċi fil- firien u l- fniek, il- pilloli miksija b’ rita Mycophenolate mofetil Teva m’ għandhomx jinfetħu jew jiġu mitħunin.
Computerweg 10 3542 DR Utrecht The Netherlands
Computerweg 10, 3542 DR Utrecht, L- Olanda
EU/ 1/ 07/ 439/ 003 (50 tablets) EU/ 1/ 07/ 439/ 004 (150 tablets)
NUMRU( I) TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 07/ 439/ 003 (50 pillola) EU/ 1/ 07/ 439/ 004 (150 pillola)
21 February 2008
21 ta ’ Frar 2008 26 10.
26 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifatturi tas- sustanza( i) bijoloġika( ċi) attiva( i)
Debrecen H-4042 Hungary
TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, Debrecen H- 4142 L- Ungerija
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő Táncsics Mihály út 82 Hungary
TEVA Pharmaceutical Works Private Limited Company H- 2100 Gödöllő, Táncsics Mihály út 82 L- Ungerija
TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom
TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG Ir- Renju Unit
Swensweg 5 2031 GA Haarlem The Netherlands
Swensweg 5 2031 GA Haarlem l- Olanda
TEVA Santé SA Rue Bellocier 89107 Sens France
TEVA Santé SA Rue Bellocier 89107 Sens Franza
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0, dated September 2006 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 2. 0, iddatata Settembru 2006 ippreżentata f’ Moduli 1. 8. 1 ta ’
29 Risk Management Plan No description of Risk Management Plan has been provided by the applicant.
29 l- Applikazzjoni dwar l- Awtorizzazjoni għat- Tqegħid fis- Suq, tinsab f’ postha u qed tiffunzjona qabel u waqt li l- prodott ikun fis- suq.
Since the application concerns a generic with a reference medicinal product for which no safety concern requiring additional risk minimisation activities has been identified this approach is considered acceptable.
Peress li l- applikazzjoni tikkonċerna mediċina ġenerika b’ riferiment għal prodott mediċinali ta ’ referenza li għaliha m’ hemmx tħassib dwar sigurtà identifikata li teħtieġ attivitajiet addizzjonali minimi dwar ir - riskju dan il- proċess hu konsidrat aċċettabbli.
PSURs The PSUR submission schedule for both strengths should follow the PSUR schedule for the reference products.
PSUR Is- sottomissjoni ta ’ l- iskeda tal- PSUR għaż- żewġ qawwiet għandha ssegwi l- iskeda tal- PSUR għall- prodotti ta ’ riferiment
31 A. LABELLING
TIKKETTA
Mycophenolate mofetil Teva 250mg hard capsules Mycophenolate mofetil
Mycophenolate mofetil Teva 250mg kapsuli iebsin Mycophenolate mofetil.
Each capsule contains 250 mg mycophenolate mofetil
Kull kapsula fiha 250 mg mycophenolate mofetil
100 capsules 300 capsules
100 kapsula 300 kapsula
Read the package leaflet before use
Jittieħed mill- ħalq Aqra l- fuljett ta ’ tagħrif qabel l- użu
Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin.
Il- kapsuli Mycophenolate mofetil Teva għandhom jiġu mmaniġġjati b’ attenzjoni M’ għandekx tiftaħ jew tfarrak il- kapsuli u tibla ’ t- trab man- nifs ġewwa l- kapsuli jew tippermetti li t - trab imiss mal- ġilda tiegħek
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TAL- AWTORIZZAZZJONI GĦALL- KUMMERĊ
Mycophenolate mofetil Teva 250 mg Capsules
ISEM TAL- PRODOTT MEDIĊINALI
34 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
BLISTER FOIL
Strixxa
Mycophenolate mofetil Teva 250mg hard capsules Mycophenolate mofetil
Mycophenolate mofetil Teva 250mg kapsuli iebsin Mycophenlate mofetil
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
OUTER CARTON
Kartuna ta ’ barra
Mycophenolate mofetil Teva 500mg film-coated tablets Mycophenolate mofetil
Mycophenolate mofetil Teva 500mg pilloli miksija b’ rita Mycophenolate mofetil
Each tablet contains 500 mg mycophenolate mofetil
Kull pillola fiha 500 mg mycophenolate mofetil
50 tablets 150 tablets
50 pillola 150 pillola
Read the package leaflet before use.
Jittieħed mill- ħalq Aqra l- fuljett ta ’ tagħrif qabel l- użu
Do not crush the tablets.
Il- pilloli miksija b’ rita ta ’ Mycophenolate mofetil Teva għandhom jiġu mmaniġġjati b’ attenzjoni Tfarrakx il- pilloli
EU/ 1/ 07/ 439/ 003 (50 tablets) EU/ 1/ 07/ 439/ 004 (150 tablets)
EU/ 1/ 07/ 439/ 003 (50 pillola) EU/ 1/ 07/ 439/ 004 (150 pillola)
Mycophenolate mofetil Teva 500 mg Film-coated Tablets
ISEM TAL- PRODOTT MEDIĊINALI
37 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Mycophenolate mofetil Teva 500 mg film-coated tablets Mycophenolate mofetil
Mycophenolate mofetil Teva 500 mg Pilloli miksija b’ rita Mycophenlate mofetil
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TA ’ SID L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
38 B. PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER
43 FULJETT TA ’ TAGĦRIF:
Mycophenolate mofetil Teva 250 mg hard capsules Mycophenolate mofetil
Mycophenolate mofetil Teva 250 mg kapsuli iebsin Mycophenolate mofetil
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek..
What Mycophenolate mofetil Teva is and what it is used for 2.
X’ inhu Mycophenolate mofetil Teva u għalxiex jintuża 2.
Before you take Mycophenolate mofetil Teva 3.
Qabel ma tieħu Mycophenolate mofetil Teva 3.
How to take Mycophenolate mofetil Teva 4.
Kif għandek tieħu Mycophenolate mofetil Teva 4.
How to store Mycophenolate mofetil Teva 6.
Kif taħżen Mycophenolate mofetil Teva 6.
WHAT MYCOPHENOLATE MOFETIL TEVA IS AND WHAT IT IS USED FOR
X’ INHU MYCOPHENOLATE MOFETIL TEVA U GĦALXIEX JINTUŻA
Mycophenolate mofetil Teva is a medicine that is used to suppress immune activity.
Mycophenolate mofetil Teva huwa mediċina li jintuża biex irażżan l- attività immunoloġika.
Mycophenolate mofetil Teva is used to prevent your body rejecting a transplanted kidney, heart or liver.
Mycophenolate mofetil Teva jintuża biex jimpedixxi ’ l ġisemek milli jirriġetta kliewi, qalb jew fwied trapjantat.
It is used in combination with other medicines with a similar function (i. e. ciclosporin and corticosteroids).
Huwa jintuża flimkien ma ’ mediċini oħra li għandhom l- istess funzjoni (i. e ciclosporin u corticosteroids)
BEFORE YOU TAKE MYCOPHENOLATE MOFETIL TEVA
QABEL MA TIEĦU MYCOPHENOLATE MOFETIL TEVA
Do not take Mycophenolate mofetil Teva
Tieħux Mycophenolate mofetil Teva
- if you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal mycophenolate mofetil,
other ingredients of Mycophenolate mofetil Teva.
mycophenolic acid jew sustanza oħra ta ’ Mycophenolate mofetil Teva.
- if you are breast-feeding.
- jekk qegħda tredda ’.
Take special care with Mycophenolate mofetil Teva You should inform your doctor immediately:
Oqgħod attent ħafna b’ Mycophenolate mofetil Teva Għandek tgħarraf lit- tabib tiegħek minnufih:
- if you experience any evidence of infection (e. g. fever, sore throat), unexpected bruising and/ or
- jekk ikollok xi evidenza ta ’ infezzjoni (e. g. deni, griżmejk juġawk), tbenġil mhux mistenni u/ jew
bleeding
fsada
- if you have or ever have had any problems with your digestive system, e. g. stomach ulcers
- jekk għandek jew qatt kellek xi problem ibis- sistema diġestiva tiegħek eż. brixx fl- istonku
Mycophenolate mofetil Teva reduces your body’ s defence mechanism.
Mycophenolate mofetil Teva inaqqas il- mekkaniżmu tad- difiża tal- ġisem.
Because of this, there is an increased risk of skin cancer.
Minħabba f’ hekk hemm riskju akbar ta ’ kanċer tal- ġilda.
Therefore you should limit your exposure to sunlight and ultra violet (UV) light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
Għalhekk għandek tillimita l- espożizzjoni tiegħek għax- xemx u għad- dawl ultra vjola (UV) billi tilbes ilbies protettiv u billi tuża sunscreen b’ fattur ta ’ protezzjoni għoli.
Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If you answer yes to any of the following questions talk to your doctor before you start to take Mycophenolate mofetil Teva:
Jekk it- tweġiba hija iva għal xi waħda mill- mistoqsijiet li ġejjin kellem lit- tabib tiegħek qabel ma tibda ’ tieħu Mycophenolate mofetil Teva
- Are you taking any medicines containing: azathioprine or other immunosuppressive agents (which
- Qed tieħu xi mediċini li fihom: azathioprine jew mediċini immunosuppressivi (li xi kultant
are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic renal kidney failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
jingħataw lil pazjenti wara operazzjoni ta ’ trapjant), cholestyramine (użat biex jittratta pazjenti li għandhom livell għoli ta ’ kolesterol fid- demm), rifampicin (antibijotiku), antacidi, phosphate binders (użati f’ pazjenti li għandhom indeboliment renali kroniku li jnaqqas l- assorbiment ta ’ fosfat) jew xi mediċini oħra (inkluż dawk li tista ’ tixtri mingħajr riċetta) li t- tabib tiegħek ma jafx dwarhom?
- Do you need to receive vaccines (live vaccines)?
- Għandek bżonn tieħu xi vaċċini (vaċċini ħajjin)?
Your doctor will have to advise you what is
It- tabib tiegħek ser jirrakomandalek x’ inhu
indicated for you
indikat għalik.
Taking Mycophenolate mofetil Teva with food and drink Taking food and drink has no influence on your treatment with Mycophenolate mofetil Teva.
Meta tieħu Mycophenolate mofetil Teva ma ’ l- ikel u max- xorb It- teħid ta ’ l- ikel u x- xorb ma jaffettwax it- trattament tiegħek b’ Mycophenolate mofetil Teva.
Pregnancy and breast-feeding Do not take Mycophenolate mofetil Teva if you are breast-feeding.
Tqala u treddigħ M’ għandekx tieħu Mycophenolate mofetil Teva jekk qed tredda ’.
Your doctor should advise you about using contraception before taking Mycophenolate mofetil Teva, whilst taking Mycophenolate mofetil Teva, and for 6 weeks after you have stopped taking Mycophenolate mofetil Teva.
It- tabib tiegħek għandu jirrakomandalek dwar l- użu ta ’ kontraċezzjoni qabel ma ’ tieħu Mycophenolate mofetil Teva, waqt li qed tieħu Mycophenolate mofetil Teva, u għal sitt ġimgħat wara li tkun waqqaft tieħu Mycophenolate mofetil Teva.
Mycophenolate mofetil Teva may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Dan għaliex Mycophenolate mofetil Teva jista ’ jikkaġuna abort spontanju jew ħsara, li jinkludu problemi fl- iżvilupp tal- widnejn lit- tarbija tiegħek li għadha ma twellditx.
Tell your doctor straight away if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.
Għarraf lit- tabib tiegħek minnufih jekk inti tqila, tinqabad tqila jew qed tippjana li tibda familja fil - futur qrib.
Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel ma tieħu xi mediċina.
Driving and using machines Mycophenolate mofetil Teva has not been shown to impair your ability to drive or operate machines.
Sewqan u tħaddim ta ’ magni Mycophenolate mofetil Teva ma ntweriex li jimpedixxi l- ħila tiegħek biex issuq jew tħaddem l- inġenji.
HOW TO TAKE MYCOPHENOLATE MOFETIL TEVA
KIF GĦANDEK TIEĦU MYCOPHENOLATE MOFETIL TEVA
Always take Mycophenolate mofetil Teva exactly as your doctor has told you.
Dejjem għandek tieħu Mycophenolate mofetil Teva eżatt skont il- parir tat- tabib.
The usual way to take Mycophenolate mofetil Teva is as follows:
Id- doża li ssoltu tingħata hija kif ġej:
Kidney Transplant
Trapjant tal- Kliewi
The first dose will be given within 72 hours after the transplant operation.
L- ewwel doża għandha tingħata fi żmien 72 siegħa minna wara l- operazzjoni tat- trapjant.
The recommended daily dose is 8 capsules (2 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hi ta ’ 8 kapsuli (2 g tas- sustanza attiva) meħuda f’ żewġ dożi separati.
This means taking 4 capsules in the morning then 4 capsules in the evening.
Dan ifisser li għandhom jittieħdu 4 kapsuli filgħodu u 4 filgħaxija.
The dose given will vary depending on the size of the child.
Tfal u adoloxxenti Id- doża li tingħata għandha tvarja skond id- daqs tat- tifel/ tifla.
Your doctor will decide the most appropriate dose based on body surface area (height and weight).
It- tabib tiegħek ser jiddeċiedi l- aktar doża xierqa ibbażżata fuq l- erja superfiċjali tal- ġisem (tul u piż).
The recommended dose is 600 mg/ m2 taken twice a day.
Id- doża rakkomandata hija ta ’ 600mg/ m2 li tingħata mill- ħalq darbtejn kuljum.
Heart Transplant
Trapjanti tal- Qalb
The first dose will be given within 5 days following the transplant operation.
L- ewwel doża għandha tingħata fi żmien 5 ijiem wara l- operazzjoni tat- trapjant.
The recommended daily dose is 12 capsules (3 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hi ta ’ 12- il kapsula (3 g tas- sustanza attiva) li tittieħed f’ żewġ dożi separati.
This means taking 6 capsules in the morning then 6 capsules in the evening.
Dan ifisser li għandhom jittieħdu 6 kapsuli filgħodu u mbagħad 6 kapsuli filgħaxija.
No data are available to recommend the use of Mycophenolate mofetil Teva in children and adolescents who have received a heart transplant.
Tfal u adoloxxenti L- ebda tagħrif ma hu disponibbli sabiex Mycophenolate mofetil Teva jiġi rakkomandat fi tfal u adoloxxenti li rċevew trapjant tal- qalb.
Adults:
45 Adulti:
41 The first dose of oral Mycophenolate mofetil Teva will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
L- ewwel doża ta ’ Mycophenolate mofetil Teva li tittieħed mill- ħalq għandha tingħatalek ta ’ lanqas 4 ijiem wara l- operazzjoni ta ’ trapjant u meta tkun kapaci tibla ’ l- mediċini mill- ħalq.
This means taking 6 capsules in the morning then 6 capsules in the evening.
Dan ifisser li għandhom jittieħdu 6 kapsuli filgħodu imbagħad 6 kapsuli filgħaxija.
No data are available to recommend the use of Mycophenolate mofetil Teva in children and adolescents who have received a liver transplant.
L- ebda tagħrif ma hu disponibbli sabiex Mycophenolate mofetil Teva jiġi rakkomandat fi tfal u adoloxxenti li rċevew trapjant tal- fwied.
Method and route of administration Swallow your capsules whole with a glass of water.
Mod ta ’ kif u mnejn jingħata Ibla ’ l- kapsuli tiegħek b’ mod sħiħ b’ tazza ilma.
Do not break or crush them and do not take any capsules that have broken open or split.
La għandek tkisser u lanqas titħannhom u lanqas m’ għandek tieħu kapsuli li jkunu nfetħu jew inqassmu.
Avoid contact with any powder that spills out from damaged capsules.
Evita kull kuntatt ma ’ trab li jkun ħareġ minn kapsuli mħassra.
If a capsule breaks open accidentally, wash any powder from your skin with soap and water.
Jekk kapsula tkun infetħet b’ mod aċċidentali, laħlaħ it- trab minn mal- ġilda bis- sapun u l- ilma.
If any powder gets into your eyes or mouth, rinse thoroughly with plenty of plain, fresh water.
Jekk xi trab jidħol f’ għajnejk laħlaħ sew b’ ħafna ilma nadif u frisk għajnejk u ħalqek,
Treatment will continue for you as long as you need immunosuppression to prevent your body from rejecting your transplanted organ.
It- trattament ser jissokta għalik sakemm ikollok bżonn l- immunosoppressjoni sabiex jimpedixxi lil ġismek milli jirriġetta l- organu ttrapjantat.
If you take more Mycophenolate mofetil Teva than you should It is important not to take too many capsules.
Jekk tieħu aktar Mycophenolate mofetil Teva milli suppost Huwa importanti li ma tieħux aktar kapsuli milli suppost.
Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed more capsules than you have been told to take or if you think a child has swallowed any.
Ikkuntattja l- eqreb dipartiment ta ’ l - Aċċidenti u l- Emerġenza fi sptar jew tabib għal parir jekk blajt aktar kapsuli milli qalulek biex tieħu jew jekk it - tifel/ tifla tiegħek belgħet minnhom.
If you forget to take Mycophenolate mofetil Teva If you forget to take your medicine at any time, take it as soon as you remember, then continue to take it at the usual times.
Jekk tinsa tieħu Mycophenolate mofetil Teva Jekk fi kwalunkwe ħin insejt tieħu l- mediċina tiegħek, ħudha meta tiftakar, imbagħad kompli ħudha fil- ħinijiet tas- soltu.
Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal xi doża li nsejt tieħu.
If you stop taking Mycophenolate mofetil Teva Do not stop taking Mycophenolate mofetil Teva because you feel better.
Jekk tieqaf tieħu Mycophenolate mofetil Teva M’ għandekx tieqaf tieħu Mycophenolate mofetil Teva għax tħossok aħjar.
It is important to take the medicine for as long as the doctor has told you to.
Hu importanti li ddum tieħu l- mediċina skond kif qallek it- tabib.
Stopping your treatment with Mycophenolate mofetil Teva may increase the chance of rejection of your transplanted organ.
Jekk twaqqaf it- trattament tiegħek b’ Mycophenolate mofetil Teva jista ’ jiżdied iċ- ċans għal riġezzjoni ta ’ l- organu trapjantat.
Do not stop taking your medicine unless your doctor tells you to.
Tieqafx tieħu l- mediċina tiegħek kemm- il darba t- tabib tiegħek ma jgħidlekx biex tagħmel hekk.
Like all medicines, Mycophenolate mofetil Teva can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Mycophenolate mofetil Teva jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects likely to affect more than 1 in 10 people:  Diarrhoea, vomiting, feeling sick  Decrease in normal amounts of different blood cells, which can result in increased risk of infections, bruising, bleeding, breathlessness and weakness  Bacterial, fungal and viral infections of the digestive and urinary tract, cold sores and shingles
Effetti sekondarji komuni ħafna li x’ aktarx jaffettwaw aktar minn persuna 1 f’ 10: • Dijarea, remettar, tħossok ma tiflaħx • Tnaqqis fl- ammonti normali ta ’ ċelluli differenti tad- demm, li jistgħu jirriżultaw f’ riskju ogħla ta ’ infezzjonijiet, tbenġil, emorraġiji, qtugħ ta ’ nifs u debbulezza • Infezzjonijiet batteriċi, fungali u virali tal- passaġġ diġestiv u urinarju, nfafet fuq ix- xufftejn u ħruq ta ’ Sant Antnin