FrancophonIA/ELRC3.0 huggingface dataset:
English: • Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3% of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
Slovenian: • V literaturnih poročilih so se malformacije pojavljale pri 23 do 27 % živorojenih otrok bolnic, ki so bile med nosečnostjo izpostavljene mofetilmikofenolatu, (v primerjavi z 2 do 3 % pri živorojenih otrocih v celokupni populaciji ter približno 4 do 5 % pri živorojenih otrocih bolnic s presajenim solidnim organom, zdravljenih z drugimi imunosupresivi razen mofetilmikofenolata).
English: • Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingooophorectomy).
Slovenian: • so vam z operacijo odstranili jajcevoda in oba jajčnika (bilateralna salpingo-ooforektomija);
English: • Congenital choroid plexus cyst;
Slovenian: • kongenitalne ciste horoidnega pleksusa,
English: Myfenax should not be used at all in children under 2 years old.
Slovenian: Zdravila Myfenax se ne sme uporabljati pri otrocih, starih manj kot 2 leti.
English: • if you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na mofetilmikofenolat, mikofenolno kislino ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: • serious inflammation of the membrane that covers the brain and spinal cord
Slovenian: • resno vnetje membrane, ki pokriva možgane in hrbtenjačo
English: The recommended dose is 600°mg/m2 taken twice a day.
Slovenian: Priporočeni odmerek je 600 mg/m2 dvakrat na dan.
English: As general advice to minimise the risk for skin cancer, exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Slovenian: Splošen nasvet za zmanjšanje tveganja nastanka kožnega raka je, da se bolniki ne izpostavljajo soncu in UV-svetlobi brez uporabe zaščitne obleke in sončne kreme z visokim zaščitnim faktorjem.
English: It is recommended that the second test should be performed 8-10 days after the first test. For transplants from deceased donors, if it is not possible to perform two tests 8-10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8-10 days later.
Slovenian: Če pri presaditvah od umrlih darovalcev pred začetkom zdravljenja ni mogoče opraviti dveh testov v razmiku 8-10 dni (zaradi časovnih omejitev organov za presaditev), je treba test nosečnosti opraviti neposredno pred začetkom zdravljenja, naslednji test pa 8-10 dni po prvem.
English: Female patients of childbearing potential should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with mycophenolate.
Slovenian: Bolnice v rodni dobi se morajo zavedati tveganj in upoštevati priporočila iz poglavja 4.6 (npr. glede kontracepcijskih metod, preverjanja nosečnosti) pred, med in po zdravljenju z mofetilmikofenolatom.
English: It is used in combination with other medicines with a similar function (i.e. ciclosporin and corticosteroids).
Slovenian: Zdravilo Myfenax uporabljamo skupaj z drugimi zdravili s podobnim delovanjem (to so ciklosporin in kortikosteroidi).
English: If neutropenia develops, dosing with Myfenax should be interrupted or the dose reduced (see section 4.4).
Slovenian: Če se pojavi nevtropenija, je treba odmerjanje zdravila Myfenax prekiniti ali odmerek zmanjšati (glejte poglavje 4.4).
English: Do not stop taking Myfenax because you feel better.
Slovenian: Zdravljenja z zdravilom Myfenax ne prekinjajte, ker se počutite bolje.
English: Contents of the pack and other information What Myfenax contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Myfenax
English: Male patients of reproductive potential should be made aware of and discuss the potential risks of fathering a child with a qualified health-care professional.
Slovenian: Bolniki, ki lahko spočnejo otroka, se morajo zavedati možnih tveganj spočetja med zdravljenjem in se o njih pogovoriti z usposobljenim zdravstvenim delavcem.
English: The Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme and a follow-up pregnancy questionnaire, including communication media,
Slovenian: Imetnik dovoljenja za promet se mora z nacionalnim organom, pristojnim za zdravila, dogovoriti o vsebini in obliki izobraževalnega programa in vprašalnika o spremljanju nosečnosti, vključno s komunikacijskim medijem, načinom distribucije in vsemi drugimi vidiki programa.
English: • The other ingredients are:
Slovenian: - Druge sestavine zdravila so:
English: • decrease in the number of certain white blood cells (neutropenia)
Slovenian: • zmanjšanje števila nekaterih belih krvnih celic (nevtropenija)
English: Pregnancy, contraception and breast-feeding Contraception in women taking Myfenax
Slovenian: Nosečnost, kontracepcija in dojenje Kontracepcija pri bolnicah, ki jemljejo zdravilo Myfenax
English: • if you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
Slovenian: - če opazite znake okužbe (npr. zvišana telesna temperatura, vneto grlo), nepričakovane podplutbe in/ali krvavitve.
English: 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).
Slovenian: Take okužbe vključujejo latentno virusno reaktivacijo, kot je reaktivacija virusa hepatitisa B ali hepatitisa C in okužbe, povzročene s poliomavirusi (nefropatijo, povezano z virusom BK, progresivno multifokalno levkoencefalopatijo (PML), povezano z virusom JC).
English: Patients should be advised that during treatment with Myfenax, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Slovenian: Bolnike, ki prejemajo zdravilo Myfenax, moramo opozoriti, da so lahko cepiva manj učinkovita, uporabi živih cepiv pa se morajo izogibati (glejte poglavje 4.5).
English: Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.
Slovenian: Mofetilmikofenolat ni vplival na fertilnost podganjih samcev pri peroralnih odmerkih do 20 mg/kg/dan.
English: • shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung).
Slovenian: • kratka sapa, kašelj, ki sta lahko posledici bronhiektazije (stanja, pri katerem so dihalne poti v pljučih nenormalno razširjene) ali pljučne fibroze (brazgotinjenje pljuč).
English: • Nervous system malformations such as spina bifida;
Slovenian: • malformacije živčnega sistema, kot je spina bifida, • ledvične nenormalnosti.
English: • you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).
Slovenian: • imate nepričakovane podplutbe ali krvavitve, • imate izpuščaje, otekel obraz, ustnice, jezik ali vrat ter težave z dihanjem - lahko imate resno alergijsko reakcijo na zdravilo (kot je anafilaksa, angioedem).
English: Stopping your treatment with Myfenax may increase the chance of rejection of your transplanted organ.
Slovenian: zdravljenja z zdravilom Myfenax lahko poveča možnost zavrnitve vašega presadka.
English: However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of mycophenolate mofetil.
Slovenian: Kombinacija norfloksacina in metronidazola pa je zmanjšala izpostavljenost mikofenolni kislini za približno 30 % po enkratnem odmerku mofetilmikofenolata.
English: Serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH) and progesterone were not significantly affected.
Slovenian: Koncentracije luteinizirajočega hormona (LH), folikle stimulirajočega hormona (FSH) in progesterona v serumu niso bile pomembno spremenjene.
English: The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not considered clinically significant.
Slovenian: Spremembe v farmakokinetiki mikofenolglukuronida (ki ga je za 8 % več) so bile minimalne in niso klinično pomembne.
English: Pregnancy, puerperium and perinatal conditions Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil, mainly in the first trimester, see section 4.6.
Slovenian: Motnje v času nosečnosti, puerperija in perinatalnem obdobju Poročali so o primerih spontanih splavov pri bolnicah izpostavljenih mofetilmikofenolatu, pretežno v prvem trimesečju, glejte poglavje 4.6.
English: Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Slovenian: Zdravila Myfenax zato ne dajemo bolnikom z redkim dednim pomanjkanjem hipoksantin-gvanin-fosforiboziltransferaze (HGPRT), kot sta Lesch-Nyhlanov in Kelley-Seegmillerjev sindrom.
English: • skin cancer, non-cancerous growth of the skin
Slovenian: • rak kože nerakasta rast kože
English: Myfenax capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Slovenian: Kapsule zdravila Myfenax lahko predpišemo samo bolnikom, katerih telesna površina je večja od 1,25 m2.
English: What Myfenax is and what it is used for What you need to know before you take Myfenax How to take Myfenax
Slovenian: 1 Kaj je zdravilo Myfenax in za kaj ga uporabljamo 2 Kaj morate vedeti, preden boste vzeli zdravilo Myfenax 3 Kako jemati zdravilo Myfenax
English: Other medicines and Myfenax
Slovenian: Druga zdravila in zdravilo Myfenax
English: Myfenax has not been shown to impair your ability to drive or operate machines.
Slovenian: Za zdravilo Myfenax ni bilo pokazano, da vpliva na sposobnost za upravljanje vozil ali strojev.
English: Agranulocytosis (≥1/1000 to <1/100) and neutropenia have been reported; therefore regular monitoring of patients taking Myfenax is advised (see section 4.4).
Slovenian: Poročali so tudi o agranulocitozi (≥ 1/1.000 do < 1/100) in nevtropeniji, zato je priporočljivo bolnike, ki jemljejo zdravilo Myfenax, redno spremljati (glejte poglavje 4.4).
English: Ask your pharmacist how to throw away medicines no longer required.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: What you need to know before you take Myfenax
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Myfenax
English: • if you have or ever have had any problems with your digestive system, e.g. stomach ulcers.
Slovenian: - če imate ali ste kdaj imeli težave s prebavili, npr. rano na želodcu.
English: • Septum pellucidum agenesis;
Slovenian: • agenezija septuma pelluciduma,
English: Ciprofloxacin or amoxicillin plus clavulanic acid
Slovenian: Ciprofloksacin ali amoksicilin s klavulansko kislino
English: The first dose will be given within 72°hours after the transplant operation.
Slovenian: Prvi odmerek boste prejeli v 72 urah po presaditvenem posegu.
English: 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.
Slovenian: Odrasli Prvi peroralni odmerek zdravila Myfenax boste prejeli vsaj 4 dni po presaditvenem posegu in takoj, ko boste lahko jemali zdravila peroralno.
English: These changes may suggest a ‘left shift' in the maturity of neutrophils in haematological investigations, which may be mistakenly interpreted as a sign of infection in immunosuppressed patients such as those that receive Myfenax.
Slovenian: Te spremembe lahko pri preiskavah krvi predstavljajo ‘premik v levo' pri zorenju nevtrofilcev, kar se lahko pri imunosupresiranih bolnikih, kot so ti, ki prejemajo zdravilo Myfenax, napačno tolmači kot znak okužbe.
English: Most (about 87%) of the administered dose is excreted in the urine as MPAG.
Slovenian: Večina (87 %) zaužitega odmerka se je izločila v urin v obliki mikofenolglukuronida.
English: • You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have treatment for cancer, then there is still a chance you could become pregnant).
Slovenian: Med ženske, ki ne morejo zanositi, sodite, če kar koli izmed naslednjega velja za vas: • ste v postmenopavzi, torej stari vsaj 50 let in ste imeli zadnjo menstruacijo pred več kot 1 letom (če menstruacije niste imeli, ker ste se zdravili zaradi raka, še vedno obstaja možnost, da zanosite);
English: The risk/benefit ratio of mycophenolate mofetil in combination with sirolimus has not been established (see also section 4.5).
Slovenian: Razmerja med tveganjem in koristnostjo mofetilmikofenolata v kombinaciji s sirolimusom še niso raziskali (glejte tudi poglavje 4.5).
English: • Malformations of the fingers (e.g. polydactyly, syndactyly);
Slovenian: • malformacije prstov (npr. polidaktilija, sindaktilija),
English: EU/1/07/438/001 (100 capsules) EU/1/07/438/002 (300 capsules) EU/1/07/438/006 (100 x 1 capsules)
Slovenian: EU/1/07/438/001 (100 kapsul) EU/1/07/438/002 (300 kapsul) EU/1/07/438/006 (100 x 1 kapsula)
English: • fungal infections (e.g. of the respiratory tract, skin and vagina)
Slovenian: • glivične okužbe (npr. dihal, kože in nožnice)
English: Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other side.
Slovenian: Temno vijoličaste barve, filmsko obložene tablete ovalne oblike, z vgraviranim napisom “M500” na eni strani in brez napisa na drugi.
English: The nonclinical toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in human clinical trials which now provide safety data of more relevance to the patient population (see section 4.8).
Slovenian: Neklinični profil toksičnosti mofetilmikofenolata je v skladu z neželenimi učinki, ki so jih opazili pri kliničnih študijah pri ljudeh, ki so z varnostnega vidika pomembnejši (glejte poglavje 4.8).
English: Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA enterohepatic recirculation thus leading to reduced systemic MPA exposure.
Slovenian: Antibiotiki, ki uničujejo bakterije v črevesu, ki proizvajajo β-glukuronidazo (npr. aminoglikozidi, cefalosporini, fluorokinoloni in razredi penicilinskih antibiotikov), lahko motijo enterohepatični ponovni obtok mikofenolglukuronida/mikofenolne kisline, kar vodi do zmanjšane sistemske izpostavljenosti mikofenolni kislini.
English: Elderly patients (≥°65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
Slovenian: V splošnem je lahko pri starejših bolnikih (starih 65 let ali več) zaradi imunosupresije nevarnost za neželene učinke povečana.
English: Based on the results of a single dose administration study of recommended doses of oral mycophenolate mofetil and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate mofetil (see section 4.2) and ganciclovir, it is anticipated that coadministration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Slovenian: Na podlagi rezultatov študije enkratnega odmerjanja priporočenih odmerkov peroralne oblike mofetilmikofenolata in intravenske oblike ganciklovirja in znanih učinkov ledvične okvare na farmakokinetiko mofetilmikofenolata (glejte poglavje 4.2) in ganciklovirja, je pričakovati, da bo sočasno dajanje obeh učinkovin, ki tekmujeta v mehanizmih renalne tubularne sekrecije, povzročilo zvišanje koncentracij mikofenolglukuronida in ganciklovirja.
English: Myfenax is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted kidney.
Slovenian: Zdravilo Myfenax se uporablja pri otrocih in mladostnikih (starih od 2 do 18 let) za preprečevanje zavrnitve presajene ledvice.
English: PRCA may resolve with dose reduction or cessation of Myfenax therapy.
Slovenian: PRCA je lahko reverzibilna z zmanjšanjem odmerka ali s prekinitvijo zdravljenja z zdravilom Myfenax.
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom
Slovenian: TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG Velika Britanija
English: Myfenax should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed in section 6.1.
Slovenian: Zdravila Myfenax ne smemo uporabljati pri bolnikih s preobčutljivostjo za mofetilmikofenolat, mikofenolno kislino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Myfenax capsules should be handled with care.
Slovenian: Zdravilo Myfenax kapsule je treba uporabljati previdno.
English: Myfenax should not be used in children and adolescents (aged 2 to 18) for heart or liver transplantation.
Slovenian: Zdravila Myfenax se ne sme uporabljati pri otrocih in mladostnikih (starih od 2 do 18 let) za preprečevanje zavrnitve presajenega srca ali jeter.
English: Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion and further increases in concentrations of both substances may occur.
Slovenian: Ker so pri ledvični okvari koncentracije mikofenolglukuronida in aciklovirja v plazmi povečane, obstaja možnost, da med mofetilmikofenolatom in aciklovirjem ali njegovim predzdravilom, npr. valaciklovirjem, prihaja do kompeticije pri tubularni sekreciji in do možnih nadaljnjih povečanj koncentracij obeh učinkovin.
English: Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended doses.
Slovenian: Pri psih so se pojavili gastrointestinalni neželeni učinki pri sistemski izpostavljenosti, ki je bila enaka ali manjša od klinične izpostavljenosti pri priporočenem odmerjanju.
English: Pharmacokinetic behaviour of mycophenolate mofetil in the elderly (≥°65 years) has not been formally evaluated.
Slovenian: Farmakokinetičnih parametrov mofetilmikofenolata pri starejših bolnikih (starih 65 let ali več) niso proučevali.
English: Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Slovenian: Zdravilo Myfenax je indicirano skupaj s ciklosporinom in kortikosteroidi za preprečevanje akutnih zavrnitvenih reakcij pri bolnikih z alogenim ledvičnim, srčnim ali jetrnim presadkom.
English: 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).
Slovenian: Bolniki, ki se zdravijo z imunosupresivi, vključno z zdravilom Myfenax, imajo povečano tveganje za oportunistične okužbe (bakterijske, glivične, virusne in protozojske), smrtne okužbe in sepso (glejte poglavje 4.8).
English: isoforms, MRP2 and breast cancer resistance protein (BCRP) are transporters associated with the glucuronides' biliary excretion.
Slovenian: Izoencimi OATP, MRP2 in protein odpornosti pri raku dojk (BCRP - breast cancer resistance protein) so prenašalci, povezani z izločanjem glukuronidov z žolčem.
English: Contraception in men taking Myfenax
Slovenian: Kontracepcija pri moških, ki jemljejo zdravilo Myfenax
English: The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes mycophenolate.
Slovenian: Razpoložljivi podatki ne kažejo na povečano tveganje za okvare ali splav, če mofetilmikofenolat uporablja oče.
English: Skin cancer, benign neoplasm of skin
Slovenian: zelo pogosti pogosti kožni rak, benigna neoplazma kože
English: No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.
Slovenian: Pri samicah in nadaljnjih generacijah potomcev niso opazili učinkov na reproduktivnost ali fertilnost.
English: • 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.
Slovenian: • če ste bolnica, ki bi lahko bila noseča, in pred prvim predpisanim receptom nimate potrjenega negativenega testa nosečnosti, saj lahko mofetilmikofenolat povzroči prirojene okvare in spontani splav,
English: If neutropenia develops (absolute neutrophil count <°1.3°x 103/°µl) it may be appropriate to interrupt or discontinue Myfenax.
Slovenian: Če se pojavi nevtropenija (absolutno število nevtrofilcev < 1,3 x 103/µl), moramo odmerke zdravila Myfenax zmanjšati ali zdravljenje prekiniti.
English: As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90°days after you stop taking Myfenax.
Slovenian: Kot previdnostni ukrep je za vas ali vašo partnerko priporočljivo, da med zdravljenjem in 90 dni po končanem zdravljenju uporabljate/uporablja zanesljivo obliko kontracepcije.
English: When comparing rates of transplant rejection, rates of graft loss or adverse event profiles between mycophenolate mofetil patients with and without concomitant telmisartan medication, no clinical consequences of the pharmacokinetic drug-drug interaction were seen.
Slovenian: Ko so primerjali deleže zavrnitve presadka, deleže izgube presadka ali profile neželenih učinkov med bolniki, zdravljenimi z mofetilmikofenolatom v kombinaciji s telmisartanom ali brez njega, niso opazili nobenih kliničnih posledic farmakokinetičnega medsebojnega delovanja med zdraviloma.
English: 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.
Slovenian: Krvni in imunski sistem Bolnike, ki prejemajo zdravilo Myfenax, je treba skrbno nadzorovati zaradi nevtropenije, ki je lahko posledica jemanja zdravila Myfenax, sočasno uporabljenih zdravil, virusnih okužb ali nekaterih kombinacij teh vzrokov.
English: 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).
Slovenian: Sledeče neželene učinke so opazili pri kliničnih preskušanjih Glavni neželeni učinki povezani z jemanjem mofetilmikofenolata v kombinaciji s ciklosporinom in kortikosteroidi vključujejo drisko, levkopenijo, sepso in bruhanje, opisali pa so tudi višjo incidenco določenih tipov okužb (glejte poglavje 4.4).
English: • Your womb (uterus) has been removed by surgery (hysterectomy).
Slovenian: • so vam z operacijo odstranili maternico (uterus) - histerektomija;
English: • infection of the lung, flu, infection of the respiratory tract
Slovenian: • okužba pljuč, gripa, okužba dihal
English: This means taking 4 capsules in the morning then 4 capsules in the evening.
Slovenian: 4 kapsule vzemite zjutraj, 4 pa zvečer.
English: 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.
Slovenian: 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.