natgillin/translations-raw huggingface dataset:
Skin cancer, benign neoplasm of skin
vrlo često često karcinom kože, dobroćudna neoplazma kože
Myfenax 500 mg film-coated tablets are available in PVC/PVdC-aluminium blisters in pack sizes of 50 or 150 or 50 x 1 tablets per carton.
Myfenax 500 mg filmom obložene tablete dostupne su u PVC/PVdC -aluminij blisterima u pakiranju od 50 ili 150 ili 50 x 1 tableta, u kutiji.
Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.
Primjena mofetilmikofenolata povezuje se s povećanom incidencijom nuspojava vezanih uz probavni sustav, uključujući manje česte pojave ulkusa gastrointestinalnog trakta, krvarenja i perforacije.
MPA AUC values across age groups were similar in the early and late post-transplant period.
Vrijednosti AUC-a MPA u ranom su i kasnom razdoblju nakon presađivanja bile slične u svim dobnim skupinama.
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Myfenax, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
Bolesnici koji primaju imunosupresivnu terapiju koja obuhvaća kombinaciju lijekova, uključujući Myfenax, izloženi su povećanom riziku od nastajanja limfoma i drugih zloćudnih bolesti, osobito kože (vidjeti dio 4.8).
Myfenax film-coated tablets should be handled with care.
Myfenax filmom obloženim tabletama rukujte oprezno.
No substantial alteration of MPA pharmacokinetics is anticipated and Myfenax dose adjustment is not required.
Ne očekuje se znatna promjena farmakokinetike MPA pa nije potrebna prilagodba doze Myfenaxa.
Note: 501 (2°g mycophenolate mofetil daily), 289 (3°g mycophenolate mofetil daily) and 277 (2°g intravenous/3°g oral mycophenolate mofetil daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
Napomena: u fazi III ispitivanja sprječavanja odbacivanja bubrežnog, srčanog odnosno jetrenog presatka liječeno je 501 (2 g mofetilmikofenolata dnevno), 289 (3 g mofetilmikofenolata dnevno) odnosno 277 (2 g intravenskog / 3 g oralnog mofetilmikofenolata dnevno) bolesnika.
Myfenax 250 mg hard capsules are available in PVC/PVdC-aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Myfenax 250 mg tvrde kapsule dostupne su u PVC/PVdC -aluminij blisterima u pakiranju od 100 ili 300 ili 100 x 1 kapsula, u kutiji.
When comparing rates of transplant rejection or rates of graft loss between mycophenolate mofetil patients taking PPIs vs. mycophenolate mofetil patients not taking PPIs, no significant differences were seen.
Uspoređujući stope odbacivanja transplantata ili stope gubitka presatka između bolesnika koji su uzimali mofetilmikofenolat i IPP naspram bolesnika koji s mofetilmikofenolatom nisu uzimali IPP, nisu primijećene značajne razlike.
Myfenax treatment should not be initiated in women of child bearing potential without providing a pregnancy test result to rule out unintended use in pregnancy (see section 4.6).
Liječenje lijekom Myfenax ne smije se započeti kod žena reproduktivne dobi bez predočenja nalaza testa na trudnoću kako bi se isključila mogućnost nehotične primjene u trudnoći (vidjeti dio 4.6).
In patients with delayed renal graft function post-transplant, mean MPA AUC (0-12°h) was comparable to that seen in post-transplant patients without delayed graft function.
Kod bolesnika kod kojih nakon presađivanja dolazi do odgođene funkcije presađenog bubrega srednji AUC (0-12 h) MPA mogao se usporediti s AUC-om MPA bolesnika kod kojih nakon presađivanja nije došlo do odgođene funkcije presađenog bubrega.
The patient information pack should contain:
Paket s informacijama za bolesnike mora sadržavati: • Uputu o lijeku
Pregnancy, puerperium and perinatal conditions Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil, mainly in the first trimester, see section 4.6.
U bolesnica izloženih mofetilmikofenolatu prijavljeni su slučajevi spontanog pobačaja, prvenstveno u prvom tromjesečju trudnoće, vidjeti dio 4.6.
• inflammation of the colon which causes abdominal pain or diarrhoea (sometimes caused by cytomegalovirus), ulcer of the stomach and/or duodenum, inflammation of the stomach,
• upala debelog crijeva koja uzrokuje bol u trbuhu ili proljev (ponekad je uzrokuje citomegalovirus),
Congenital malformations have been observed post-marketing in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants, see section 4.6.
Nakon stavljanja lijeka u promet primijećene su kongenitalne malformacije u djece bolesnica izloženih mofetilmikofenolatu u kombinaciji s drugim imunosupresivima (vidjeti dio 4.6).
Read the package leaflet before use.
Prije uporabe pročitajte uputu o lijeku
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Nositelj odobrenja za stavljanje lijeka u promet i proizvođači Nositelj odobrenja za stavljanje lijeka u promet
Package leaflet: Information for the user Myfenax 500mg film-coated tablets
Uputa o lijeku: Informacije za korisnika Myfenax 500 mg filmom obložene tablete mofetilmikofenolat
Liver Transplant
Presađivanje jetre
Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to mycophenolate in combination with other immunosuppressants during pregnancy.
Nakon stavljanja lijeka u promet prijavljene su kongenitalne malformacije, uključujući višestruke malformacije, kod djece bolesnica koje su bile izložene mikofenolatu u kombinaciji s drugim imunosupresivima tijekom trudnoće.
Transparent PVC/PVdC - aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Prozirni PVC/PVdC - aluminij blisteri sa 100 ili 300 ili 100 x 1 kapsula, u kutiji.
Each capsule contains 250 mg mycophenolate mofetil.
Jedna kapsula sadrži 250 mg mofetilmikofenolata.
Myfenax should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Myfenax ne smije se davati ženama reproduktivne dobi koje ne koriste visoko učinkovite metode kontracepcije (vidjeti dio 4.6).
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).
Myfenax tablete propisuju se samo bolesnicima tjelesne površine veće od 1,5 m2 u dozi od 1 g dvaput dnevno (dnevna doza od 2 g).
• During your entire treatment with Myfenax
• čitavo razdoblje liječenja lijekom Myfenax
• fit, increased tension of the muscles, shaking, sleepiness, feeling dizzy, headache, tingling, pricking or numbness
• napadaj, povećana mišićna napetost, drhtanje, pospanost, omaglica, glavobolja, trnci, bockanje ili utrnulost
In patients with renal impairment in whom 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.
Kod bolesnika s oštećenjem bubrega kod kojih se istodobno primjenjuju mofetilmikofenolat i ganciklovir ili njegovi predlijekovi, npr. valganciklovir, treba razmotriti primjenu preporučene doze ganciklovira i pažljivo nadzirati bolesnika.
In some of these cases switching mycophenolate mofetil to an alternative immunosuppressant resulted in serum IgG levels returning to normal.
U nekima od tih slučajeva zamjena mofetilmikofenolata drugim imunosupresivom rezultirala je vraćanjem razine serumskog
Myfenax is contraindicated during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
Myfenax je kontraindiciran tijekom trudnoće, osim ako ne postoji prikladno alternativno liječenje kojim bi se spriječilo odbacivanje presatka.
• low/high blood pressure, widening of blood vessels
• ubrzani otkucaji srca • nizak/visoki krvni tlak, proširenje krvnih žila
Therefore Myfenax is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection.
Stoga je Myfenax kontraindiciran tijekom trudnoće, osim ako ne postoje prikladni alternativni načini liječenja kojima bi se spriječilo odbacivanje presatka.
CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures by 30-50% in renal transplant patients treated with mycophenolate mofetil and CsA compared with patients receiving sirolimus or belatacept and similar doses of mycophenolate mofetil (see also section 4.4).
A smanjuje izloženost MPA-u za 30-50% u usporedbi s bolesnicima koji primaju sirolimus ili belatacept i slične doze mofetilmikofenolata (vidjeti i dio 4.4).
The following undesirable effects cover adverse reactions from clinical trials The principal adverse reactions associated with the administration of mycophenolate mofetil in combination with ciclosporin and corticosteroids include diarrhoea, leucopenia, sepsis and vomiting and there is evidence of a higher frequency of certain types of infections (see section 4.4).
Glavne nuspojave, vezane uz primjenu mofetilmikofenolata u kombinaciji s ciklosporinom i kortikosteroidima, su proljev, leukopenija, sepsa i povraćanje, a dokazana je veća učestalost određenih vrsta infekcija (vidjeti dio 4.4).
Myfenax should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
Myfenax ne smije se koristiti u trudnoći, osim ako ne postoji prikladno alternativno liječenje kojim bi se spriječilo odbacivanje presatka (vidjeti dio 4.6).
Mean plasma MPAG AUC (0-12°h) was 2-3-fold higher than in post-transplant patients without delayed graft function.
Srednja vrijednostAUC (0-12 h) MPAG-a u plazmi bio je 2-3 puta veća nego kod bolesnika kod kojih nakon presađivanja nije došlo do odgođene funkcije presatka.
Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide.
Crna boja koja sadrži: šelak, crni željezov oksid (E172), propilenglikol i kalijev hidroksid.
Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Savjet o tome da bolesnici ne smiju darivati krv tijekom liječenja ili najmanje 6 tjedana nakon prekida primjene mikofenolata.
Men must not donate semen during treatment with Myfenax and for at least 90°days after stopping treatment.
Muškarci ne smiju donirati spermu tijekom liječenja lijekom Myfenax i najmanje 90 dana nakon prestanka liječenja.
You are a woman who is not capable of becoming pregnant if any of the following applies to you:
U slučaju da se bilo koji od sljedećih navoda odnosi na Vas, Vi ste žena koja ne može ostati trudna:
Each tablet contains 500 mg mycophenolate mofetil.
Jedna tableta sadrži 500 mg mofetilmikofenolata.
• vomiting, stomach pain, diarrhoea, feeling sick
• povraćanje, bol u trbuhu, proljev, mučnina
Oral Myfenax should be initiated within 72°hours following transplantation.
Myfenax tablete treba uzeti u roku od 72 sata nakon presađivanja.
Capsule content Pregelatinised starch (maize) Povidone K-30
Sadržaj kapsule prethodno gelirani kukuruzni škrob povidon K-30 umrežena karmelozanatrij magnezijev stearat
• Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory canal atresia (middle ear);
• abnormalnosti uha (npr. abnormalan oblik ili izostanak vanjskog), atrezija vanjskog zvukovoda
Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML).
ili hepatitisa C i infekcije uzrokovane polioma virusima (nefropatija povezana s BK virusom i progresivna multifokalna leukoencefalopatija (PML) povezana s JC virusom).
This means taking 4 capsules in the morning then 4 capsules in the evening.
To znači da se 4 kapsule uzimaju ujutro, a
Myfenax 250 mg hard capsules
Myfenax 250 mg tvrde kapsule
Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia Psychiatric disorders Very commonCommon
Poremećaji metabolizma i prehrane vrlo često često acidoza, hiperkalijemija, hipokalijemija, hiperglikemija, hipomagnezijemija, hipokalcijemija, hiperkolesterolemija, hiperlipidemija, hipofosfatemija, hiperuricemija, giht, anoreksija
Film-coated tablets
Filmom obložene tablete:
The systemic exposure at these levels is approximately equivalent to or less than 0.5°times the clinical exposure at the recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3°times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients (see section 4.6).
Sistemska izloženost na tim razinama otprilike je ekvivalentna ili manja od 0,5 puta od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan za bolesnike s presađenim bubregom i otprilike 0,3 puta od kliničke izloženosti pri preporučenoj kliničkoj dozi od 3 g/dan kod bolesnika s presađenim srcem (vidjeti dio 4.6).
• if you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
• ako ste žena koja bi mogla zatrudnjeti, a niste predočili negativan nalaz testa na trudnoću prije nego što
• constipation, indigestion, wind (flatulence), belching
• zatvor, loša probava, vjetrovi (nadutost), podrigivanje
Therefore women of childbearing potential must use at least one form of reliable contraception (see section 4.3) before starting Myfenax therapy, during therapy, and for six weeks after stopping the therapy, unless abstinence is the chosen method of contraception.
Stoga žene reproduktivne dobi moraju prije započinjanja liječenja, tijekom liječenja i još šest tjedana nakon prekida liječenja lijekom Myfenax koristiti najmanje jedan pouzdan oblik kontracepcije (vidjeti dio 4.3), osim ako je kao metoda kontracepcije odabrana apstinencija.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Nema podataka o primjeni u bolesnika s presađenim srcem ili jetrom i s teškim kroničnim oštećenjem bubrega.
Do not take Myfenax if you are breast-feeding.
Nemojte uzimati Myfenax ako dojite.
Oral Myfenax should be initiated within 5 days following transplantation.
Myfenax tablete treba primijeniti u roku od 5 dana nakon presađivanja.
The recommended daily dose is 6°tablets (3°g of the active ingredient) taken as 2°separate doses.
Preporučena dnevna doza je 6 tableta (3 g djelatne tvari) koje se uzimaju u 2 odvojene doze.
• fever, feeling of coldness, pain, feeling unwell, feeling weak and feeble
• zadržavanje tekućine u tijelu • vrućica, osjećaj hladnoće, bol, loše osjećanje, osjećaj slabosti i iznemoglosti
• inflammation of the liver, yellowing of the skin and whites of the eyes
• upala jetre, žuta boja kože i bjeloočnica
Transparent PVC/PVdC-aluminium blisters in pack sizes of 50 or 150 or 50 x 1 tablets per carton.
Prozirni PVC/PVdC-aluminij blisteri sa 50 ili 150 ili 50 x 1 tableta, u kutiji.
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.
Kod bolesnika liječenih imunosupresivima, uključujući i Myfenax, prijavljeni su slučajevi nefropatije povezane s BK virusom, kao i slučajevi progresivne multifokalne leukoencefalopatije (PML) povezane s JC virusom.
Medicinal product subject to medical prescription.
Lijek se izdaje na recept
• Malformations of the fingers (e.g. polydactyly, syndactyly);
• malformacije prstiju (npr. polidaktilija, sindaktilija); • malformacije dušnika i jednjaka (npr. atrezija jednjaka);
Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone.
Veće koncentracije aciklovira u plazmi primijećene su prilikom primjene mofetilmikofenolata s aciklovirom, u odnosu na zasebnu primjenu svakog lijeka.
This means taking 6°capsules in the morning then 6°capsules in the evening.
To znači da se 6 kapsula uzima ujutro, a
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.
Starije osobe koje primaju Myfenax kao dio kombiniranog imunosupresivnog liječenja mogu u odnosu na mlađe pojedince biti izložene povećanom riziku od određenih infekcija (uključujući invazivnu citomegalovirusnu bolest), a vjerojatno i gastrointestinalnih krvarenja te plućnog edema.
• serious disease of the kidney (BK virus associated nephropathy)
• ozbiljna bolest bubrega (nefropatija povezana s BK virusom)
Microcrystalline cellulose Povidone K-30
Jezgra tablete celuloza, mikrokristalična povidon K-30 magnezijev stearat karmelozanatrij, umrežena
values similar to those seen in adult renal transplant patients receiving mycophenolate mofetil at a dose of 1°g BID in the early and late post-transplant period.
Uz tu su dozu postignute vrijednosti AUC-a MPA slične vrijednostima opaženima u odraslih bolesnika s presađenim bubregom koji su primali 1 g mofetilmikofenolata dvaput dnevno u ranom i kasnom razdoblju nakon presađivanja.
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Prilagodbe terapijske doze nisu potrebne kod bolesnika s presađenim bubregom i teškim oštećenjem jetrenog parenhima.
Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
Infekcije i infestacije vrlo često sepsa, gastrointestinalna kandidijaza, infekcija mokraćnog sustava, herpes simpleks, herpes zoster često upala pluća, gripa, respiratorne infekcije, respiratorna monilijaza, gastrointestinalna infekcija, kandidijaza, gastroenteritis, infekcija, bronhitis, faringitis, sinusitis,
Drugs which interfere with MPA's enterohepatic cycle (e.g. cholestyramine, antibiotics) should be used with caution due to their potential to reduce the plasma levels and efficacy of mycophenolate mofetil (see also section 4.5).
kolestiramin, antibiotici) treba primjenjivati uz oprez jer mogu sniziti plazmatske razine i djelotvornost mofetilmikofenolata (vidjeti također dio 4.5).
There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated with mycophenolate mofetil in combination with other immunosuppressants, some of which have been fatal.
Poremećaji dišnog sustava, prsišta i sredoprsja Zabilježeni su izolirani slučajevi intestinalne plućne bolesti i pulmonarne fibroze kod bolesnika liječnih mofetilmikofenolatom u kombinaciji s drugim imunosupresivima, od kojih su neki bili sa smrtnim ishodom.
There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving mycophenolate mofetil in combination with other immunosuppressants.
Prijavljeni su slučajevi hipogamaglobulinemije povezani s rekurentnim infekcijama kod bolesnika koji su primali mofetilmikofenolat u kombinaciji s drugim imunosupresivima.
The most common opportunistic infections in patients receiving mycophenolate mofetil (2°g or 3°g daily) with other immunosuppressants in controlled clinical trials in renal (2°g data), cardiac and hepatic transplant patients followed for at least 1°year were candida mucocutaneous, cytomegalovirus (CMV) viraemia/syndrome and Herpes simplex.
Najčešće oportunističke infekcije koje se pojavljuju kod bolesnika koji primaju mofetilmikofenolat (2 g ili 3 g dnevno) uz druge imunosupresive u kontroliranim kliničkim ispitivanjima u bolesnika s presađenim bubregom (podaci o dozi od 2 g), srcem i jetrom, tijekom praćenja od barem godinu dana, bile su mukokutana kandidijaza,
Convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia
Poremećaji živčanog sustava vrlo često često konvulzije, hipertonija, tremor, somnolencija, mijastenični sindrom, omaglica, glavobolja, parestezija, disgeuzija
• The active substance is mycophenolate mofetil.
• Djelatna tvar je mofetilmikofenolat.
In hepatic transplant patients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by coadministration with tacrolimus.
Kod primatelja s presađenom jetrom kod kojih je započeto liječenje mofetilmikofenolatom i takrolimusom, razine takrolimusa nisu značajnije utjecale na AUC i Cmax MPA, aktivnog metabolita mofetilmikofenolata.
Myfenax 500 mg film-coated tablets
Myfenax 500 mg filmom obložene tablete
This means taking 2°tablets in the morning then 2°tablets in the evening.
To znači da se 2 tablete uzimaju ujutro, a
Hypersensitivity reactions to Myfenax have been observed (see section 4.8).
Myfenax (vidjeti dio 4.8).
Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in ≥1/10 and in ≥1/100 to <1/10 of patients treated with mycophenolate mofetil in the controlled clinical trials of renal (2°g data), cardiac and hepatic transplant patients are listed in the following table.
Nuspojave, vjerojatno ili moguće povezane sa mofetilmikofenolatom, prijavljene u kontroliranim kliničkim ispitivanjima bolesnika s presađenim bubregom (podaci za dozu od 2 g), srcem ili jetrom kod ≥1/10 i ≥1/100 do <1/10 bolesnika liječenih mofetilmikofenolatom, navedene su u sljedećoj tablici.
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18°years who were given 600°mg/m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1°g mycophenolate mofetil twice daily.
do 18 godina, koji su peroralno primali 600 mg/m2 mofetilmikofenolata dvaput dnevno, bila je uglavnom slična onima uočenima kod odraslih bolesnika koji su uzimali 1 g mofetilmikofenolata dvaput dnevno.
Isavuconazole An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of isavuconazole.
Kod istodobne primjene izavukonazola primijećen je porast AUC0-∞ MPA-a za 35%.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (see section 4.4).
Poremećaji krvi i limfnog sustava Prijavljeni su slučajevi izolirane aplazije eritrocita (PRCA) kod bolesnika liječenih mofetilmikofenolatom (vidjeti dio 4.4).
The systemic exposure at this dose was approximately 0.5°times the clinical exposure at the recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3°times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients.
Sistemska izloženost pri ovoj dozi iznosila je otprilike 0,5 puta od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan za bolesnike s presađenim bubregom i otprilike 0,3 puta od kliničke izloženosti pri preporučenoj kliničkoj dozi od 3 g/dan kod bolesnika s presađenim srcem.
The pharmacokinetics of oral contraceptives were unaffected by co-administration of mycophenolate mofetil (see also section 4.5).
Istodobna primjena mofetilmikofenolata nije utjecala na farmakokinetiku oralnih kontraceptiva (vidjeti i dio 4.5).
Myfenax should not be given to women who are breastfeeding (see section 4.6).
Myfenax ne smije se davati dojiljama (vidjeti dio 4.6).
Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myfenax tablets should not be crushed.
Budući da je mofetilmikofenolat pokazao teratogene učinke kod štakora i kunića, Myfenax tablete ne smiju se drobiti.
Keep this medicine out of the sight and reach of children.
Kako čuvati Myfenax Lijek čuvajte izvan pogleda i dohvata djece.
Sími: +354 5222900
Alvogen ehf. Sími: +358 5222900