qanastek/EMEA-V3 huggingface dataset:
Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
Pazjenti anzjani (> 65 sena) jistgħu ġeneralment ikunu f’ riskju akbar għal reazzjonijiet avversi minħabba immunosoppressjoni.
Elderly patients receiving Myfenax 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 Myfenax bħala parti minn reġimen immunosoppressiv kkombinat, jistgħu jkunu f’ riskju akbar ta ’ ċertu infezzjonijiet (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 sa < 1/ 10 ta ’ pazjenti trattati b’ mycophenolate fil- provi kliniċi kkontrollati ta ’ pazjenti bi trapjanti renali (dejta ta ’ 2 g), kardijaċi e 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.
- 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
Renal and urinary disorders
Disturbi renali u tas- sistema urinarja Disturbi tal- ġilda u t- tessuti subkutanji Disturbi muskolu - skeletali u tat- tessut konnettiv
Very common Common
Komuni ħafna Komuni Komuni ħafna Komuni Komuni ħafna Komuni
- Renal impairment
- Indeboliment renali - Ipertrofija tal- ġilda, raxx, akne, alopeċja - Artralġja
Skin and
Disturbi marbuti
subcutaneous
mal- metaboliżmu u n- nutrizzjon
Skin hypertrophy, rash, acne, alopecia
Aċidosi, iperkalemija, ipokalemija, ipergliċemija, ipomagnesemija, ipokalċemija, iperkolesterolemija, iperlipidemija, ipofosfatemija, iperurikemija, gotta, anoreksja
tissue disorders Musculoskeletal and connective tissue disorders
Infezzjonijiet u
- Arthralgia
Sepsis, kandidjasi gastrointestinali, infezzjoni
Metabolism and nutrition disorders
infestazzjonijiet
- Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
tal- passaġġ urinarju, herpes simplex, herpes zoster 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
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.
Każijiet ta ’ Lewkoenċefalopatija Multifokali Progressiva (PML), xi drabi fatali, ġew irrapportati f’ pazjenti kkurati b ’ mycophenolate mofetil.
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 Myfenax.
Il- każijiet irrapportati ġeneralment kellhom fatturi ta ’ riskju għal PML, li jinkludu terapija immunosoppressanti u indeboliment tal- funzjoni immuniKażijiet 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 Myfenax.
Agranulocytosis (uncommon) and neutropenia have been reported; therefore regular monitoring of
Kien hemm rapporti ta ’ anemija
There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate, some of which have been fatal.
9 aplastika u depressjoni tal- mudullun f ’ pazjenti ttrattati b’ mycophenolate, li xi ftit minnhom kienu fatali.
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.
4.9 Overdose Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience.
Waslu rapporti ta ’ dożi eċċessivi b’ mycophenolate mofetil minn provi kliniċi u mill- esperjenza ta ’ wara t- tqegħid fis- suq.
If neutropenia develops, dosing with Myfenax 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 acid (MPA).
However, MPA Cmax was decreased by 40% in the presence of food.
Madankollu, MPA Cmax kienet imnaqqsa b’ 40% fil- preżenza ta ’ l- ikel.
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.
10 cholestyramine (4 g TID), li tindika li hemm ammont sinifikattiv ta ’ ċirkulazzjoni enteroepatika mill - ġdid.
However, at high MPAG plasma concentrations (> 100μ g/ ml), small amounts of MPAG 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 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).
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 ml• min- 1• 1. 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.
Dose adjustment of Myfenax does not appear to be necessary.
Aġġustament fid- doża ta ’ Myfenax ma jidhirx li huwa meħtieġ.
Oral contraceptives:
11 Kontraċettivi orali:
The pharmacokinetics of oral contraceptives were unaffected by co administration of mycophenolate (see also section 4.5).
Il- farmakokinetiċi ta ’ kontraċettivi orali ma kinux effettwati mill- għoti konkomitanti ta ’ mycophenolate (ara wkoll sezzjoni 4. 5).
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.
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.
In experimental models, mycophenolate mofetil was not tumourigenic.
F’ mudelli esperimentali, 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 Cmax) observed in renal transplant patients as 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.
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 fuq ġenotossicità (assaġġ in vitro f’ limfoma tal- ġrieden u in vivo mikronuklejus test fil- mudullun tal- ġrieden) urew potenzjal ta ’ mycophenolate mofetil li jikkawża aberrazzjonijiet.
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 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’ 6 mg 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.
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 12 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).
Pregelatinised starch (maize) Povidone K-30 Croscarmellose sodium Magnesium stearate 12 Capsule shell:
Pregelatinised maize starch Povidone K- 30 Croscarmellose sodium Magnesium stearate
Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide.
Red iron oxide (E127) Yellow iron oxide (E110) Titanium dioxide (E171) Ġelatin Il- linka sewda tikkonsisti minn: shellac, black iron oxide (E172), propylene glycol u potassium hydroxide
This medicinal product does not require any special storage conditions
Dan il- prodott mediċinali m’ għandux kundizzjonijiet ta ’ ħażna speċjali..
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbit, Myfenax capsules should not be opened or crushed.
Peress li mycophenolate mofetil wera effetti teratogeniċi fil- firien u l- fniek, il- kapsuli Myfenax m’ għandhomx jinfetħu jew jiġu mitħunin.
If such contact occurs, soap and water should be used to wash thoroughly and the eyes should be rinsed with plain water.
Jekk ikun hemm kuntatt bħal dan, laħlaħ sew bis- sapun u l - ilma; baħbaħ l- għajnejn bl- ilma biss.
EU/ 1/ 07/ 438/ 001 (100 capsules) EU/ 1/ 07/ 438/ 002 (300 capsules)
EU/ 1/ 07/ 438/ 001 (100 kapsula) EU/ 1/ 07/ 438/ 002 (300 kapsula)
21 February 2008 13 10.
21 ta ’ Frar 2008
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
Myfenax 500 mg film-coated tablets
Myfenax 500 mg pilloli miksija b’ rita
Myfenax tablets should only be prescribed to patients with a body surface area greater than 1.5 m2, at a dose of 1 g twice daily (2 g daily dose).
Il- pilloli Myfenax għandhom jiġu preskritti biss lil pazjenti b’ erja superfiċjali korporali ta ’ aktar minn 1. 5m2, f’ doża ta ’ 1 g darbtejn kuljum (doża ta ’ 2 g kuljum).
Use in hepatic transplant:
15 Użu f’ indeboliment tal- fwied:
15 Adults: intravenous mycophenolate should be administered for the first 4 days following hepatic transplant, with oral Myfenax initiated as soon after this as it can be tolerated.
Adulti: mycophenolate intravenuż għandu jiġi mogħti għall- ewwel 4 ijiem wara t- trapjant tal- fwied, b’ doża orali ta ’ Myfenax li tkun ittollerata li tinbeda kemm jista ’ jkun malajr wara dan.
Use in elderly (≥ 65 years)
Użu fl- anzjani (≥ 65 sena):
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 ml min-1 1.73 m-2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
F’ pazjenti bi trapjanti tal- kliewi b’ indeboliment kroniku sever tal- kliewi (rata ta ’ filtrazzjoni glomerulari < 25 ml min- 1 1. 73 m- 2), barra milli fil- perijodu immedjat ta ’ wara t- trapjant, dożi akbar minn 1 g mogħtijin darbtejn kuljum għandhom jiġu evitati.
Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dose reduction or interruption of Myfenax is not required.
Tiċħid tat- trapjant tal - kliewi ma jwassalx għal tibdil fil- farmakokinetiċi ta ’ MPA; tnaqqis fid- doża jew twaqqif ta ’ Myfenax mhux meħtieġ.
Hypersensitivity reactions to the active substance, to mycophenolic acid or any of the excipients
Sensittività eċċessiva għas- sustanza attiva, għal mycophenolic acid jew għal xi sustanzi mhux attivi.
As general advice to minimise the risk for skin cancer, exposure to sunlight and ultra-violet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Bħala rakkomandazzjoni ġenerali biex jitnaqqas ir- riskju għal kanċer tal- ġilda, espożizzjoni għad- dawl tax- xemx u d- dawl ultra vjola (UV) għandu jkun ristrett billi jintlibsu ħwejjeġ protettivi u billi jintuża sunskrin b’ fattur ta ’ protezzjoni għoli.
Patients receiving Myfenax should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
16 Pazjenti li jirċievu Myfenax għandhom jiġu mogħtija istruzzjonijiet biex jirraportaw minnufih kull evidenza ta ’ infezzjoni, tbenġil mhux mistenni, fsada jew xi manifestazzjoni oħra ta ’ dipressjoni tal - mudullun.
Patients treated with immunosuppressants, including Myfenax, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Pazjenti trattati b’ immunosoppressanti, inkluż Myfenax, huma f’ riskju akbar għall- infezzjonijiet opportunistiċi (mill- batterja, moffa, virus u protożoa), infezzjonijiet fatali u sepsis (ara sezzjoni 4. 8).
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider 16 in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Dawn l- infezzjonijiet ħafna drabi huma relatati ma ’ esponiment immunosoppressiv totali għoli u jistgħu jwasslu għall- kundizzjonijiet serji jew fatali li t- tobba għandhom jikkunsidraw fid- dijanjosi differenzjali f’ pazjenti immunosoppressi b’ funzjoni tal - fwied li qed tiddeterjora jew b’ sintomi newroloġiċi.
Patients receiving Myfenax should be monitored for neutropenia, which may be related to Myfenax itself, concomitant medicinal products, viral infections, or some combination of these causes.
Pazjenti li jirċievu Myfenax għandhom jiġu sorveljati għan- newtropenija, li tista ’ tkun relatata ma ’ Myfenax innifsu, prodotti mediċinali konkomitanti, infezzjonijiet minn vajrusis, jew xi kumbinazzjoni ta ’ dawn il- kawżi.
If neutropenia develops (absolute neutrophil count < 1.3 x 103/μ l) it may be appropriate to interrupt or discontinue Myfenax.
Jekk tiżviluppa n- newtropenija (għadd ta ’ newtrofils assolut < 1. 3 x 103/ µl) jkun aħjar li Myfenax jiġi interrot jew imwaqqaf.
In view of the significant reduction in the area under the curve (AUC) of MPA by cholestyramine, caution should be used in the concomitant administration of Myfenax with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Myfenax.
In vista tat- tnaqqis sinifikattiv fl- erja taħt il- kurva (AUC) jew MPA minn cholestyramine, għandha tiġi użata l- kawtela fl- użu konkomitanti ta ’ Myfenax ma ’ prodotti mediċinali li jiddisturbaw iċ - ċirkulazzjoni mill- ġdid enteroepatika minħabba l- potenzjal li jnaqqas l- effikaċja ta ’ Myfenax.
Interaction studies have only been performed in adults.
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott 17 Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott fl - adulti.
Cholestyramine: following single dose administration 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g three times a day (TID) of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4, and section 5.2).
Cholestyramine: wara l- għoti ta ’ doża waħdanija ta ’ 1. 5 g ta ’ mycophenolate mofetil lil soġġetti normali f’ saħħithom li jkunu diġa ġew trattati b’ 4 g tliet darbiet kuljum (TID) ta ’ cholestyramine għal 4 ijiem, kien hemm tnaqqis ta ’ 40% fl- AUC ta ’ MPA (ara sezzjoni 4. 4 u sezzjoni 5. 2).
Caution should be used during concomitant administration because of the potential to reduce efficacy of Myfenax.
Għandha tintuża l- kawtela waqt l- għoti konkomitanti minħabba l- potenzjal li titnaqqas l- effikaċja ta ’ Myfenax.
17 In contrast, if concomitant ciclosporin treatment is stopped, an increase in MPA AUC of around 30% should be expected.
Mill- banda l- oħra, jekk it trattatment konkomitanti b’ ciclosporin jiġi mwaqqaf, huwa mistenni li jkun hemm żieda ta ’ madwar 30% fl- AUC ta ’ MPA.
No substantial alteration of MPA pharmacokinetics is anticipated and Myfenax dose adjustment is not required.
L- ebda tibdil sostanzjali ma huwa antiċipat u aġġustament tad- doża ta ’ Myfenax mhux meħtieġ.
In patients with renal impairment in which mycophenolate mofetil and ganciclovir or its prodrugs, e. g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
F’ pazjenti b’ indeboliment tal - kliewi fejn mycophenolate mofetil u ganciclovir jew il- prodrugs tagħha, eż. valganciclovir, huma mgħotijin konkomitantement ir- rakkomandazzjonijiet tad- doża għal ganciclovir għandhom jiġu osservati u l- pażjenti moniterjati bir- reqqa.
Oral contraceptives: the pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co administration of mycophenolate (see also section 5.2).
Kontraċettivi orali: il- farmakokinetiċi u l- farmakodinamiċi ta ’ kontraċettivi orali ma kinux effettwati mill- għoti konkomitanti ta ’ mycophenolate (ara wkoll sezzjoni 5. 2).
Rifampicin: in patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Rifampicin: f’ pazjenti li mhux qed jieħdu wkoll ciclosporin, it- teħid konkomitanti ta ’ mycophenolate mofetil u rifamicin irriżulta fi tnaqqis fl- espożizzjoni għal MPA (AUC 1- 12h) ta ’ 18% sa 70%.
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).
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 Cmax and AUC0-12 by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection).
18 riġettazzjoni tat- trapjant).
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).
18 It is recommended that Myfenax therapy should not be initiated until a negative pregnancy test has been obtained.
Huwa rakkomandat li t- terapija b’ Myfenax m’ għandiex tinbeda sakemm jinkiseb test tat- tqala neġattiv.
The following undesirable effects cover adverse reactions from clinical trials:
19 L- effetti mhux mixtieqa li ġejjin ikopru reazzjonijiet avversi tal- mediċina minn provi kliniċi:
Non-melanoma skin carcinomas occurred in 3.6% of patients; other types of malignancy occurred in 1.1% of patients.
Karsinomi (mhux melanoma) tal- ġilda seħħew fi 3. 6% tal- pazjenti; tipi oħra ta ’ mard malinn seħħew f’ 1. 1%.
Hepatic transplant patients were followed for at least 1 year, but less than 3 years.
Pazjenti bi trapjanti tal- fwied kienu segwiti għal ta ’ l- anqas sena, iżda għal anqas minn 3 snin.
However, the following treatment-related adverse events were more frequent in the paediatric population, 19 particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leucopenia, anaemia and infection.
Madankollu, l- avvenimenti avversi relatati mat- trattament segwenti kienu aktar spissi fil - populazzjoni pedjatrika, partikolarment fi tfal taħt l- età ta ’ 6 snin, meta mqabbla ma ’ l- adulti: dijarea, sepsis, lewkopenja, anemija u infezzjoni.
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
20 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
Adverse drug reactions
klassifikazzjoni ta ’ l- organi
Metabolism and nutrition disorders
malinn u mhux speċifiċi (li jinkludu ċisti u polipi)
- Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
Kanser tal- ġilda, neoplażmu beninn tal- ġilda
Infections and infestations
Sistema
Very common Common
Frekwenza
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
Reazzjonijiet avversi għal mediċina
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tal- klassifikazzjoni ta ’ l- organi Disturbi vaskulari
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 Myfenax.
Każijiet 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 Myfenax.
Agranulocytosis (uncommon) and neutropenia have been reported; therefore regular monitoring of patients taking Myfenax is advised (see section 4.4). There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate, some of which have been fatal.
Il- każijiet irrapportati ġeneralment kellhom fatturi ta ’ riskju għal PML, li jinkludu terapija immunosoppressanti u indeboliment tal- funzjoni immuni.
22 Congenital disorders: see further details in section 4.6.
Disturbi konġenitali: ara aktar dettalji f’ sezzjoni 4. 6
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). If neutropenia develops, dosing with Myfenax 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).
However, MPA Cmax was decreased by 40% in the presence of food.
Madankollu, MPA Cmax kinet imnaqqsa b’ 40% fil- preżenza ta ’ l- ikel.
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.
Orally administered radiolabelled mycophenolate mofetil results in complete recovery of the administered dose; with 93%
Mycophenolate mofetil radjutikkettat mogħti oralment jirriżulta fi ġbir mill- ġdid komplut tad- doża li tkun ingħatat; b’ 93% tad- doża mgħotija miġbura mill- ġdid fl- awrina u 6% miġbura mill- ġdid mill- ippurgar.
However, at high MPAG plasma concentrations (> 100μ 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 Cmax approximately 40% lower compared to the late post-transplant period (3 – 6 months post-transplant).
23 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.
24 In experimental models, mycophenolate mofetil was not tumourigenic.
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 Cmax) observed in renal transplant patients as 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.
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 24 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.
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 kg1 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.
Microcrystalline cellulose Povidone K-30 Magnesium stearate Croscarmellose sodium
Microcrystalline cellulose Povidone K- 30 Magnesium stearate Croscarmellose sodium 25 Kisi tal- pilloli:
25 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)
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbit, Myfenax film- coated tablets should not be crushed.
Peress li mycophenolate mofetil wera effetti teratogeniċi fil- firien u l- fniek, il- pilloli miksija b’ rita Myfenax m’ għandhomx jinfetħu jew jiġu mitħunin.
Computerweg 10, 3542 DR Utrecht The Netherlands
Computerweg 10, 3542 DR Utrecht, L- Olanda
EU/ 1/ 07/ 438/ 003 (50 tablets) EU/ 1/ 07/ 438/ 004 (150 tablets)
EU/ 1/ 07/ 439/ 003 (50 pillola) EU/ 1/ 07/ 439/ 004 (150 pillola)
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu 26 ANNEX II
DATA TA ’ META ĠIET RIVEDUTA L- KITBA 26 Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
27 A.
27 ANNESS II
Name and address of the manufacturer responsible for batch release
KUNDIZZJONIJIET TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
29 ANNEX III
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.
LABELLING AND PACKAGE LEAFLET
PSUR Is- sottomissjoni ta ’ l- iskeda tal- PSUR għaż- żewġ qawwiet għandha ssegwi l- iskeda tal- PSUR għall- prodotti ta ’ riferiment
30 A. LABELLING
30 ANNESS III
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
Myfenax 250mg hard capsules Mycophenolate mofetil
Myfenax 250mg kapsuli iebsin Mycophenolate mofetil.
Myfenax capsules should be handled with care.
Il- kapsuli Myfenax għandhom jiġu mmaniġġjati b’ attenzjoni.
Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin.
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.
Myfenax 250 mg Capsules
ISEM TAL- PRODOTT MEDIĊINALI
33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Myfenax 250mg hard capsules Mycophenolate mofetil
Myfenax 250mg kapsuli iebsin Mycophenlate mofetil
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
37 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Myfenax 500mg film-coated tablets Mycophenolate mofetil
Myfenax 500mg pilloli miksija b’ rita Mycophenolate mofetil
Do not crush the tablets.
Il- pilloli miksija b’ rita ta ’ Myfenax għandhom jiġu mmaniġġjati b’ attenzjoni Tfarrakx il- pilloli
Myfenax 500 mg Film-coated Tablets
ISEM TAL- PRODOTT MEDIĊINALI
36 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Myfenax 500 mg film-coated tablets Mycophenolate mofetil
Myfenax 500 mg Pilloli miksija b’ rita Mycophenlate mofetil
37 B. PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF
38 PACKAGE LEAFLET:
43 FULJETT TA ’ TAGĦRIF:
Myfenax 250 mg hard capsules Mycophenolate mofetil
Myfenax 250 mg kapsuli iebsin Mycophenolate mofetil
What Myfenax is and what it is used for 2.
X’ inhu Myfenax u għalxiex jintuża 2.
Before you take Myfenax 3.
Qabel ma tieħu Myfenax 3.
How to take Myfenax 4.
Kif għandek tieħu Myfenax 4.
How to store Myfenax 6.
Kif taħżen Myfenax 6.
WHAT MYFENAX IS AND WHAT IT IS USED FOR
X’ INHU MYFENAX U GĦALXIEX JINTUŻA
Myfenax is a medicine that is used to suppress immune activity.
Myfenax huwa mediċina li jintuża biex irażżan l- attività immunoloġika.
Myfenax is used to prevent your body rejecting a transplanted kidney, heart or liver.
Myfenax jintuża biex jimpedixxi ’ l ġisemek milli jirriġetta kliewi, qalb jew fwied trapjantat.
BEFORE YOU TAKE MYFENAX
QABEL MA TIEĦU MYFENAX
Do not take Myfenax
Tieħux Myfenax
other ingredients of Myfenax.
mycophenolic acid jew sustanza oħra ta ’ Myfenax.
Take special care with Myfenax You should inform your doctor immediately:
Oqgħod attent ħafna b’ Myfenax Għandek tgħarraf lit- tabib tiegħek minnufih:
Myfenax reduces your body’ s defence mechanism.
Myfenax inaqqas il- mekkaniżmu tad- difiża tal- ġisem.
If you answer yes to any of the following questions talk to your doctor before you start to take Myfenax:
Jekk it- tweġiba hija iva għal xi waħda mill- mistoqsijiet li ġejjin kellem lit- tabib tiegħek qabel ma tibda ’ tieħu Myfenax
are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients 39 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?
44 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?
Taking Myfenax with food and drink Taking food and drink has no influence on your treatment with Myfenax.
Meta tieħu Myfenax ma ’ l- ikel u max- xorb It- teħid ta ’ l- ikel u x- xorb ma jaffettwax it- trattament tiegħek b’ Myfenax.
Pregnancy and breast-feeding Do not take Myfenax if you are breast feeding.
Tqala u treddigħ M’ għandekx tieħu Myfenax jekk qed tredda ’.
Your doctor should advise you about using contraception before taking Myfenax, whilst taking Myfenax, and for 6 weeks after you have stopped taking Myfenax.
It- tabib tiegħek għandu jirrakomandalek dwar l- użu ta ’ kontraċezzjoni qabel ma ’ tieħu Myfenax, waqt li qed tieħu Myfenax, u għal sitt ġimgħat wara li tkun waqaft tieħu Myfenax.
Myfenax may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Dan għaliex Myfenax jista ’ jikkaġuna abort spontanju jew ħsara li jinkludu problemi fl- iżvilupp tal- widnejn tat- tarbija tiegħek li għadha ma twelditx.
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.
Driving and using machines Myfenax has not been shown to impair your ability to drive or operate machines.
Sewqan u tħaddim ta ’ magni Myfenax ma ntweriex li jimpedixxi l- ħila tiegħek biex issuq jew tħaddem l- inġenji.
HOW TO TAKE MYFENAX
KIF GĦANDEK TIEĦU MYFENAX
Always take Myfenax exactly as your doctor has told you.
Dejjem għandek tieħu Myfenax eżatt skont il- parir tat- tabib.
The usual way to take Myfenax is as follows:
Id- doża li ssoltu tingħata hija kif ġej:
No data are available to recommend the use of Myfenax in children and adolescents who have received a heart transplant.
Tfal u adoloxxenti L- ebda tagħrif ma hu disponibbli sabiex Myfenax jiġi rakkomandat fi tfal u adoloxxenti li rċevew trapjant tal- qalb.
The first dose of oral Myfenax will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
45 L- ewwel doża ta ’ Myfenax li tittieħed mill- ħalq għandha tingħatalek ta ’ lanqas 4 ijiem wara l - operazzjoni ta ’ trapjant u meta tkun kapaci tibla ’ l- mediċini mill- ħalq.
The recommended daily dose is 12 capsules (3 g of the
Id- doża rakkomandata ta ’ kuljum hi ta ’ 12- il kapsula (3 g tas- sustanza attiva) li tittieħed f’ żewġ dożi separati.
No data are available to recommend the use of Myfenax in children and adolescents who have received a liver transplant.
L- ebda tagħrif ma hu disponibbli sabiex Myfenax jiġi rakkomandat fi tfal u adoloxxenti li rċevew trapjant tal- fwied.
If you take more Myfenax than you should It is important not to take too many capsules.
Jekk tieħu aktar Myfenax milli suppost Huwa importanti li ma tieħux aktar kapsuli milli suppost.
If you forget to take Myfenax 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 Myfenax Jekk fi kwalunkwe ħin insejt tieħu l- mediċina tiegħek, ħudha meta tiftakar, imbagħad kompli ħudha fil- ħinijiet tas- soltu.
If you stop taking Myfenax Do not stop taking Myfenax because you feel better.
Jekk tieqaf tieħu Myfenax M’ għandekx tieqaf tieħu Myfenax għax tħossok aħjar.
Stopping your treatment with Myfenax may increase the chance of rejection of your transplanted organ.
Jekk twaqqaf it- trattament tiegħek b’ Myfenax jista ’ jiżdied iċ- ċans għal riġezzjoni ta ’ l- organu trapjantat.
Like all medicines, Myfenax can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Myfenax jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects likely to affect less than 1 in 10, but more than 1 in 100 people: • Changes in different laboratory parameters, including increase in liver enzymes, renal parameters such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid • Kidney problems with increased levels of urea • Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding • Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain • Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss • Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose
Effetti sekondarji komuni li x’ aktax jaffettwaw anqas minn persuna 1 f’ kull 10 imma aktar minn 1 f’ kull 100 persuna. • Bidliet fil- parametri tal- laboratorju, li jinkludi żieda fl- enżimi tal- fwied, parametri tal- kliewi bħal kreatinin u urea, potassjum, iz- zokkor fid- demm, lipidi fid- demm, kolesterol, phosphates, manjesju, kalċju, u aċidu uriku • Disturbi tal- kliewi b’ żieda fil- livelli ta ’ l- urea
41 • Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina • Changes in blood pressure, faster heart beat, dilation of blood vessels • Fluid retention in the body, fever, discomfort, lethargy and weakness • Inflammation of the liver, yellowing of the skin and whites of the eyes
46 • Disturbi fis- sistema diġestiva bħal stitikezza, indiġestjoni, gass fl- istonku, tifwieq, infjammazzjoni tal- ħalq, l- esofagu, l- istonku, l- imsaren, il- fwied jew il- frixa u emorraġija gastrointestinali. • Aċċessjonijiet, żieda fit- tensjoni tal- muskoli, rogħda u debolezza muskolari, uġigħ fil- ġogi • Nuqqas ta ’ rqad, stordamenti u uġigħ ta ’ ras, tnemin jew tirżiħ, bidla fis- sensazzjoni ta ’ togħma, nuqqas t’ aptit, nuqqas fil- piż • Infjammazzjoni u infezzjonijiet fl- apparat respiratorju u gastrointestinali, uġigħ fil- griżmejn, infjammazzjoni tas- sinus, imnieħer iqattar jew bil- ħakk • Kanċer tal- ġilda jew żvilupp mhux kanċeroġeniku u infezzjonijiet fungali tal- ġilda u l- vaġina • Bidliet fil- pressjoni tad- demm, il- qalb tħabbat aktar malajr, jitwessgħu l- vażi tad- demm • Żamma ta ’ fluwidu fil- ġisem, deni, skonfort, letarġija u debbolezza • Infjammazzjoni tal- fwied, ġilda u l- abjad tal- għajnejn li jisfaru
Do not stop taking your medicine unless you have discussed this with your doctor first.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, waqt li qed tieħu Myfenax għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE MYFENAX
KIF TAĦŻEN MYFENAX
Do not use Myfenax after the expiry date as stated on the blister and carton.
Tużax Myfenax wara d- data ta ’ skadenza li tidher fuq il- kartuna wara JIS.
What Myfenax contains:
X’ fih Myfenax:
Each capsule contains 250 mg mycophenolate
Kull kapsula fiha 250 mg mycophenolate mofetil.
Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) 42 Gelatin Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide
Red iron oxide (E127) Yellow iron oxide (E110) Titanium dioxide (E171) Gelatin Il- linka sewda tikkonsisti minn: shellac, black iron oxide (E172), propylene glycol u potassium hydroxide
What Myfenax looks like and contents of the pack
Id- dehra ta ’ Myfenax u d- daqs tal- pakkett
Cap: light blue opaque printed ‘ M ’ axially in black ink.
Il- korp; lewn il- karamelli opak, li fuqu hemm stampat ‘ 250 ’ b’ mod assjali b’ linka sewda Ir- ras: kaħlanija ċara opaka li fuqha hemm stampat “ M ” b’ mod assjali b’ linka sewda.
Myfenax 250 mg hard capsules are available in PVC/ PVdC – aluminium blisters in pack sizes of 100 or 300 capsules per carton.
Myfenax 250 mg kapsuli iebsin jiġu f’ pakketti tal- folji tal- PVC/ PVdC- aluminju f’ daqsijiet ta ’ 100 jew 300 kapsula f’ kull kartuna
Manufacturers Teva Pharmaceutical Works Private Limited Company Pallagi út 13.
Teva Pharmaceutical Works Private Limited Company Pallagi út 13.
Debrecen H-4042 Hungary
Debrecen H- 4042, l- Ungerija
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő Táncsics Mihály út 82 Hungary
TEVA Pharmaceuticals Works Pribate Limited Company H- 2100 Gödöllő, Táncsics Mihály út 82 L- Ungerija
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) hhtp: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
43 PACKAGE LEAFLET:
50 FULJETT TA ’ TAGĦRIF:
Myfenax 500mg film-coated tablets Mycophenolate mofetil
Myfenax 500mg pilloli miksijin b’ rita Mycophenolate mofetil
Myfenax is used to prevent your body rejecting a transplanted kidney, heart or liver.
Myfenax jintuża biex jimpedixxi ‘ l ġisemek milli jirriġetta kliewi, qalb jew fwied trapjantati.
other ingredients of Myfenax. if you are breast-feeding.
mycophenolic acid jew sustanza oħra ta ’ Myfenax.
- if you experience any evidence of infection (e. g. fever, sore throat), unexpected bruising
- jekk ikollok xi evidenza ta ’ infezzjoni (e. g. deni, griżmejk juġawk), tbenġil mhux mistenni u/ jew
and/ or bleeding
fsada