natgillin/translations-raw huggingface dataset:
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73°m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided. 
Bolnikom s hudo kronično ledvično okvaro (glomerulna filtracija < 25 ml/min/1,73 m2) izven obdobja neposredno po presaditvi ne dajemo odmerkov, večjih od 1 g dvakrat na dan.
As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction. 
V tej starostni skupini se v primerjavi z odraslimi bolniki nekateri neželeni učinki pojavljajo pogosteje (glejte poglavje 4.8), zato bo morda treba zmanjšati odmerek ali prekiniti zdravljenje.
Treatment should not be initiated without providing a negative pregnancy test result to rule out unintended use in pregnancy. 
Zdravljenja ne smemo uvesti brez predložitve negativnega izvida testa nosečnosti.
Before starting Myfenax treatment, women of childbearing potential must have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL in order to exclude unintended exposure of the embryo to mycophenolate. 
Da izključimo nenamerno izpostavljenost zarodka mofetilmikofenolatu, morajo bolnice v rodni dobi pred začetkom zdravljenja z zdravilom Myfenax opraviti dva serumska ali urinska testa nosečnosti z občutljivostjo najmanj 25 mi.e./ml, ki morata biti negativna.
• bacterial infections usually resulting in a serious lung disorder (tuberculosis, atypical mycobacterial infection) 
• bakterijske okužbe, ki običajno povzročijo resno pljučno bolezen (tuberkuloza, atipična mikobakterijska okužba) • resna bolezen ledvic (nefropatija, povezana z virusom BK)
Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide. 
Črnilo vsebuje: šelak, črni železov oksid (E172), propilenglikol in kalijev hidroksid.
A negligible amount of substance is excreted as MPA (<°1% of dose) in the urine. 
Zanemarljiva količina učinkovine (manj kot 1 % odmerka) se kot mikofenolna kislina izloča v urin.
Heart Transplant 
Presaditev srca
Swallow your capsules whole with a glass of water. 
Pogoltnite cele kapsule z zadostno količino tekočine!
• Guide for patients 
• Svetovanje bolnikom
Myfenax should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6). 
Zdravila Myfenax ne smemo uporabljati med nosečnostjo, razen če ni na voljo primernega alternativnega zdravljenja za preprečitev zavrnitve presadka (glejte poglavje 4.6).
The first dose will be given within 5 days following the transplant operation. 
Prvi odmerek boste prejeli v 5 dneh po presaditvenem posegu.
Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). 
Mofetilmikofenolat je 2-morfolinoetilni ester mikofenolne kisline.
Oral Myfenax should be initiated within 72°hours following transplantation. 
Zdravilo Myfenax damo uvodoma peroralno v 72 urah po presaditvi.
As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are usually observed at approximately 6-12 hours post-dose. 
Zaradi enterohepatičnega ponovnega obtoka se plazemske koncentracije mikofenolne kisline 6 do 12 ur po odmerku ponovno zvečajo.
There have been published reports of bronchiectasis in adults and children who received mycophenolate mofetil in combination with other immunosuppressants. 
Objavljeni so bili primeri bronhiektazije pri odraslih in otrocih, ki so prejeli mofetilmikofenolat v kombinaciji z drugimi imunosupresivi.
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. 
Tako druge učinkovine, za katere je znano, da so podvržene renalni tubularni sekreciji, lahko tekmujejo z mikofenolglukuronidom in tako zvišajo koncentracije mikofenolglukuronida v plazmi ali drugih učinkovin, podvrženih renalni tubularni sekreciji.
• 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, 
• vnetje debelega črevesa, ki povzroča bolečine v trebuhu ali drisko (včasih posledica citomegalovirusa), razjede v želodcu in/ali dvanajsterniku, vnetje želodca, požiralnika in/ali ust in ustnic
Paediatric population No data are available for paediatric cardiac transplant patients. 
Pediatrična populacija Za otroke s srčnim presadkom podatki niso znani.
• decrease in the number of white blood cells, platelets or red blood cells, which can result in increased risk of infections, bruising, bleeding, breathlessness and weakness 
• herpes, pasasti izpuščaj • zmanjšanje števila belih krvnih celic, trombocitov ali rdečih krvnih celic, ki lahko povzroči povečano tveganje za okužbe, modrice, krvavitve, zasoplost in šibkost
The active substance in this medicine is called mycophenolate mofetil. 
Zdravilna učinkovina, ki jo vsebuje zdravilo, se imenuje mofetilmikofenolat.
If you forget to take Myfenax 
Če ste pozabili vzeti zdravilo Myfenax
Myfenax is used to prevent your body rejecting a transplanted kidney, heart or liver. 
Z zdravilom Myfenax vašemu telesu preprečimo zavrnitev ledvičnega, srčnega ali jetrnega presadka.
This means taking 2°tablets in the morning then 2°tablets in the evening. 
2 tableti vzemite zjutraj, 2 pa zvečer.
No pharmacokinetic data are available during hepatic transplant rejection. 
Farmakokinetični podatki med zavrnitvijo jetrnega presadka niso znani.
• accumulation of fluid in the lung, shortness of breath, cough 
• kopičenje tekočine v pljučih, kratka sapa, kašelj
Myfenax contains sodium 
Zdravilo Myfenax vsebuje natrij
100 capsules 300 capsules 100 x 1 capsules 
100 x 1 kapsula
Congenital malformations have been observed post-marketing in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants, see section 4.6. 
Kongenitalne okvare Po prihodu zdravila na trg so pri otrocih bolnikov, ki so bili izpostavljeni zdravilu Myfenax v kombinaciji z drugimi imunosupresivi, poročali o kongenitalnih malformacijah; glejte poglavje 4.6.
• serious diseases of the bone marrow 
• resne bolezni kostnega mozga
Patients on mycophenolate mofetil who develop recurrent infections should have their serum immunoglobulins measured. 
Bolnikom, ki jemljejo mofetilmikofenolat in se jim okužbe ponavljajo, je treba določiti raven imunoglobulinov v serumu.
In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, agnathia and hydrocephaly) in the first generation offspring in the absence of maternal toxicity. 
V študijah fertilnosti in reproduktivnosti so peroralni odmerki po 4,5 mg/kg/dan pri podganjih samicah povzročili malformacije (vključno z anoftalmijo, agnatijo in hidrocefalijo) pri prvi generaciji potomcev, pri materah pa škodljivih učinkov ni bilo.
If you are a woman who could become pregnant you must use an effective method of contraception with Myfenax. 
Če ste bolnica, ki bi lahko zanosila, morate med zdravljenjem z zdravilom Myfenax uporabljati učinkovito kontracepcijsko zaščito, in sicer: - preden začnete jemati zdravilo Myfenax;
AcMPAG is pharmacologically active and is suspected to be responsible for some of MMF´s side effects (diarrhoea, leucopenia). 
Ta je farmakološko aktiven in verjetno odgovoren za nekaj neželenih učinkov mofetilmikofenolata (diareja, levkopenija).
The capsule cap is light blue opaque printed ‘M' axially in black ink. 
Glava kapsule je svetlo modra s črnim napisom “M” v smeri osi kapsule.
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. 
Neželeni učinki, ki so verjetno ali možno povezani z mofetilmikofenolatom in so se pojavili pri ≥1/10 in pri ≥1/100 do <1/10 bolnikov, zdravljenih z mofetilmikofenolatom v nadziranih kliničnih preskušanjih bolnikov z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, so našteti v spodnji preglednici.
Do not take Myfenax, 
Ne jemljite zdravila Myfenax:
Hypersensitivity reactions to Myfenax have been observed (see section 4.8). 
Opazili so preobčutljivostne reakcije na mofetilmikofenolat (glejte poglavje 4.8).
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. 
Zdravilo Myfenax 500 mg filmsko obložene tablete je na voljo v PVC/PVdC aluminijastem pretisnem omotu, v pakiranjih po 50 ali 150 ali 50 x 1 tableta v škatli.
Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased 
Preiskave zelo pogosti pogosti zvišani jetrni encimi, zvišan kreatinin v krvi, zvišana laktat dehidrogenaza v krvi, zvišana sečnina v krvi, zvišana alkalna fosfataza v krvi, zmanjšana telesna masa
Spontaneous abortion (rate of 45% to 49%) and congenital malformations (estimated rate of 23% to 27%) have been reported following MMF exposure during pregnancy. 
Po izpostavljenosti mofetilmikofenolatu med nosečnostjo so poročali o spontanem splavu (ocenjeni delež 45 % do 49 %) in kongenitalnih malformacijah (ocenjeni delež 23 % do 27 %).
Swallow your tablets whole with a glass of water. 
Pogoltnite cele tablete z zadostno količino tekočine.
Lymphoproliferative disease or lymphoma developed in 0.6% of patients receiving mycophenolate mofetil (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. 
Limfoproliferativne bolezni ali limfomi so se pojavili pri 0,6 % bolnikov, ki so dobivali mofetilmikofenolat (2 g ali 3 g dnevno) skupaj z drugimi imunosupresivi v nadzorovanih kliničnih preskušanjih pri bolnikih z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, ki so trajala vsaj eno leto.
If you stop taking Myfenax 
Če ste prenehali jemati zdravilo Myfenax
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. 
Najpogostejše oportunistične okužbe pri bolnikih z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, ki so v nadzorovanih kliničnih preskušanjih prejemali mofetilmikofenolat (2 g ali 3 g na dan) z drugimi imunosupresivi vsaj eno leto, so bile okužbe z glivicami (Candida mucocutaneus), sindrom CMV/viremija in okužbe z virusom herpesa simpleksa.
Do not break or crush them and do not take any capsules that have broken open or split. 
Ne zaužijte kapsul, ki so odprte ali poškodovane.
Oral administration of radiolabelled mycophenolate mofetil results in complete recovery of the administered dose; with 93% of the administered dose recovered in the urine and 6% recovered in the faeces. 
Peroralno zaužit in radioaktivno označen mofetilmikofenolat se je skoraj popolnoma izločil, od tega 93 % s sečem in 6 % z blatom.
Each tablet contains 500 mg mycophenolate mofetil. 
Ena tableta vsebuje 500 mg mofetilmikofenolata.
• decrease in the amount of antibodies in the blood 
• zmanjšanje števila protiteles v telesu
• muscle weakness of the limbs, drooping or falling of the upper eyelid (myasthenic syndrome) 
• mišična šibkost okončin, povešene ali upadle zgornje veke (miastenični sindrom) • moten občutek za okus
If you answer yes to any of the following questions talk to your doctor before you start to take Myfenax: 
Če na katero od spodaj naštetih vprašanj odgovorite pritrdilno, se pred jemanjem zdravila Myfenax posvetujte s svojim zdravnikom.
Myfenax should not be given to women who are breastfeeding (see section 4.6). 
Zdravila Myfenax ne smemo uporabljati pri bolnicah, ki dojijo (glejte poglavje 4.6).
Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)).Your baby may be affected by one or more of these. 
(razcep ustnice ali neba), razvoja prstov, srca, požiralnika (cevi, ki povezuje žrelo z želodcem), ledvic in živčnega sistema (na primer spino bifido (kjer kosti hrbtenice niso pravilno razvite)).
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). 
Ciklosporin A vpliva na enterohepatični obtok mikofenolne kisline in s tem zmanjša izpostavljenost mikofenolni kislini za 30 - 50 % pri bolnikih z ledvičnim presadkom, ki so bili zdravljeni z mofetilmikofenolatom in ciklosporinom A, v primerjavi z bolniki, ki so prejemali sirolimus ali belatacept in podobne odmerke mofetilmikofenolata (glejte tudi poglavje 4.4).
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. 
Opomba: V III. fazi študij preprečevanja zavrnitve ledvičnega, srčnega in jetrnega presadka so vključili 501 (2 g mofetilmikofenolata na dan), 289 (3 g mofetilmikofenolata na dan) in 277 (2 g i.v./3 g peroralne oblike mofetilmikofenolata na dan) bolnikov.
System organ class Frequency Adverse drug reactions 
Organski sistem Pogostnost
How to take Myfenax 
Kako jemati zdravilo Myfenax
Each capsule contains 250 mg mycophenolate mofetil. 
Ena kapsula vsebuje 250 mg mofetilmikofenolata.
• kidney problems 
• težave z ledvicami
Myfenax is a medicine that is used to suppress immune activity. 
Zdravilo Myfenax spada v skupino zdravil, znano kot zdravila za zaviranje imunske odzivnosti.
Organic anion-transporting polypeptides (OATPs) and multidrug resistance-associated protein 2 (MRP2) are involved in MPA's disposition; OATP 
Na razporeditev mikofenolne kisline vplivajo organski anionski prenašalni polipeptidi (OATP - Organic anion-transporting polypeptides) in protein za multiplo odpornost na zdravila 2 (MRP2 - Multidrug resistance-associated protein 2).
• inflammation of the liver, yellowing of the skin and whites of the eyes 
• vnetje jeter, porumenelost kože in beločnic
• Tracheo-Oesophageal malformations (e.g. oesophageal atresia); 
• malformacije sapnika in požiralnika (npr. ezofagijska atrezija),
Concomitant administration of telmisartan and mycophenolate mofetil resulted in an approximately 30% decrease of MPA concentrations. 
Ob sočasnem jemanju telmisartana in mofetilmikofenolata se je koncentracija mikofenolne kisline zmanjšala za približno 30 %.
Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myfenax capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Myfenax capsules. 
Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, kapsul zdravila Myfenax ne smemo odpreti ali drobiti, da se izognemo vdihavanju ali neposrednemu stiku praška v kapsulah zdravila Myfenax s kožo ali sluznico.
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). 
V zgodnjem obdobju po presaditvi (do 40. dneva po presaditvi) je srednja AUC mikofenolne kisline pri bolnikih z ledvičnim, srčnim ali jetrnim presadkom za približno 30 % manjša, Cmax pa za približno 40 %
The capsule body is caramel opaque, printed with ‘250' axially in black ink. 
trda kapsula (kapsula) Telo kapsule je karamelne barve s črnim napisom “250”v smeri osi kapsule.
Gingival hyperplasia (≥1/100 to <1/10), colitis including cytomegalovirus colitis (≥1/100 to <1/10), 
Gingivalna hiperplazija (≥ 1/100 do < 1/10), kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus
The following undesirable effects cover adverse reactions from post-marketing experience The types of adverse reactions reported during post-marketing with mycophenolate mofetil are similar to those seen in the controlled renal, cardiac and hepatic transplant studies. 
Neželeni učinki, opaženi v postmarketinških raziskavah Neželeni učinki, ki so se pojavili v postmarketinških raziskavah zdravljenja z mofetilmikofenolatom, so podobni neželenim učinkom v nadzorovanih raziskavah bolnikov z ledvičnim, srčnim in jetrnim presadkom.
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). 
Zdravila, ki vplivajo na enterohepatični obtok mikofenolne kisline (npr. holestiramin, antibiotiki), je treba uporabljati previdno, saj lahko zmanjšajo plazemske koncentracije in učinkovitost mofetilmikofenolata (glejte tudi poglavje 4.5).
• fever, feeling of coldness, pain, feeling unwell, feeling weak and feeble 
• zvišana telesna temperatura, občutek mraza, bolečina, slabo počutje, šibkost in slabotnost
In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively unaffected by hepatic parenchymal disease. 
Jetrna okvara Pri prostovoljcih z alkoholno jetrno cirozo procesi glukuronidacije mikofenolne kisline v jetrih niso bili pomembno spremenjeni zaradi bolezni jetrnega parenhima.
There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving mycophenolate mofetil in combination with other immunosuppressants. 
Poročali so o primerih hipogamaglobulinemije v povezavi s ponavljajočimi se okužbami pri bolnikih, ki so prejemali mofetilmikofenolat v kombinaciji z drugimi imunosupresivi.
Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in patients treated with mycophenolate mofetil in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids 
Neželeni učinki, verjetno ali možno povezani z mofetilmikofenolatom, ki so se pojavili pri bolnikih zdravljenih z mofetilmikofenolatom v kombinaciji s ciklosporinom in kortikosteroidi pri kliničnih preskušanjih bolnikov z ledvičnim, srčnim ali jetrnim presadkom.
The recommended dose of 1°g administered twice a day for renal transplant patients and 1.5°g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly. 
Priporočeni odmerek za starejše bolnike je 1 g dvakrat na dan za bolnike z ledvičnim presadkom in 1,5 g dvakrat na dan za starejše bolnike s srčnim ali jetrnim presadkom.
The educational programme is aimed at ensuring that the health professionals and patients are aware of the teratogenicity and mutagenicity, the need for pregnancy tests before starting therapy with Myfenax, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Myfenax. 
Namen izobraževalnega programa je zagotoviti, da bi se zdravstveni delavci in bolniki zavedali teratogenosti in mutagenosti, potrebe po testih nosečnosti pred začetkom zdravljenja z zdravilom
Oral Myfenax should be initiated within 5 days following transplantation. 
V začetku damo zdravilo Myfenax peroralno v 5 dneh po presaditvi.
Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed 
Bolnikom s telesno površino nad 1,5 m2
• Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist). 
• vaši jajčniki ne delujejo več (prezgodnja okvara jajčnikov, ki jo je potrdil specialist ginekolog); • ste se rodili z eno od naslednjih redkih stanj, zaradi katerih nosečnost ni mogoča: genotip XY,
• fit, increased tension of the muscles, shaking, sleepiness, feeling dizzy, headache, tingling, pricking or numbness 
• krči, povečana napetost mišic, tresenje, zaspanost, vrtoglavica, glavobol, mravljinčenje, zbadanje ali odrevenelost
Myfenax should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6). 
Zdravila Myfenax ne smemo uporabljati pri bolnicah v rodni dobi, ki ne uporabljajo zelo učinkovitih kontracepcijskih metod (glejte poglavje 4.6).
Caution is therefore recommended when administering these drugs concomitantly with mycophenolate mofetil. 
Zato je pri sočasni uporabi teh zdravil z mofetilmikofenolatom potrebna previdnost.
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. 
Zato morajo bolnice v rodni dobi pred začetkom zdravljenja, med zdravljenjem in šest tednov po končanem zdravljenju z zdravilom Myfenax uporabljati vsaj eno zanesljivo obliko kontracepcije (glejte poglavje 4.3), razen če niso izbrale metode vzdržnosti.
• Abnormalities of the eye (e.g. coloboma); 
• očesne nenormalnosti (npr. kolobom),
• high level of uric acid in the blood, gout 
• visoka raven sečne kisline v krvi, protin
Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate. 
Nasvet, naj bolniki in bolnice ne darujejo krvi med zdravljenjem in še najmanj 6 tednov po zaključku zdravljenja z mofetilmikofenolatom.
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. 
Zdravilo Myfenax 250 mg trde kapsule je na voljo v prozornem PVC/PVdC aluminijastem pretisnem omotu, v pakiranjih po 100 ali 300 ali 100 x 1 kapsula v škatli.
• feeling restless, abnormalities of thought, perception and levels of awareness, depression, feeling anxious, abnormal thinking, difficulty in sleeping 
• občutek nemirnosti, nenormalne misli, zaznave in ravni zavedanja, depresija, občutek tesnobe,
Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells. 
Mikofenolna kislina ima večji citostatični učinek na limfocite kot na druge celice, ker je razmnoževanje limfocitov T in B odločilno odvisno od de novo sinteze purinov, medtem ko lahko drugi tipi celic uporabljajo rešilne sintezne poti.
Dose adjustment of Myfenax does not appear to be necessary. 
Prilagajanje odmerkov zdravila Myfenax ni potrebno.