FrancophonIA/ELRC3.0 huggingface dataset:
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 pri razpoložljivosti organov za presaditev), je treba test nosečnosti opraviti neposredno pred začetkom zdravljenja, naslednji test pa 8-10 dni po prvem.
English: • Your doctor will decide the most appropriate dose based on your child's height and weight (body surface area - measured as square metres or “m2”).
Slovenian: • Zdravnik bo določil najbolj ustrezen odmerek glede na višino in telesno maso otroka (telesna površina, izmerjena v kvadratnih metrih oziroma »m2«).
English: Patients taking CellCept should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year.
Slovenian: Med zdravljenjem z zdravilom CellCept moramo napraviti preiskave celotne krvne slike enkrat na teden prvi mesec, dvakrat mesečno v drugem in tretjem mesecu in nato enkrat mesečno v prvem letu.
English: Keep pulling it out until the desired amount of medicine is in the dispenser.
Slovenian: • Vlecite, dokler v razdelilnik ne zajamete želene količine zdravila.
English: This is because CellCept can affect the way some other medicines work.
Slovenian: Zdravilo CellCept namreč lahko vpliva na delovanje nekaterih drugih zdravil.
English: In some of these cases switching CellCept to another immunosuppressant resulted in improvement in respiratory symptoms.
Slovenian: V nekaj od teh primerov je zamenjava zdravila CellCept za drugi imunosupresiv povzročila izboljšanje respiratornih simptomov.
English: Important information about some of the ingredients of CellCept
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila CellCept
English: CellCept should be used together with other medicines: Ciclosporin and corticosteroids.
Slovenian: Zdravilo CellCept je treba uporabljati skupaj z drugimi zdravili, kot so: • ciklosporin in kortikosteroidi.
English: Shake the closed bottle well for about 5 seconds before each use.
Slovenian: Pred vsako uporabo zaprto steklenico dobro stresajte približno 5 sekund.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
Slovenian: Skupine pogostnosti neželenih učinkov so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: A. PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: CellCept reduces your body's defences.
Slovenian: Zdravilo CellCept zmanjša obrambno sposobnost vašega organizma.
English: PHARMACEUTICAL FORM Powder for oral suspension.
Slovenian: FARMACEVTSKA OBLIKA prašek za peroralno suspenzijo
English: Physicians should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult their physician if there is a possibility of pregnancy.
Slovenian: Zdravniki morajo zagotoviti, da bolnice, ki jemljejo mofetilmikofenolat, razumejo tveganje za škodo otroku, nujnost uporabe učinkovite kontracepcije in nujnost, da se nemudoma posvetujejo z zdravnikom, če obstaja možnost, da je prišlo do zanositve.
English: Skin problems such as:
Slovenian: Težave s kožo, kot so:
English: Do not take CellCept:
Slovenian: Ne jemljite zdravila CellCept:
English: Treatment with CellCept should be initiated and maintained by appropriately qualified transplant specialists.
Slovenian: Zdravljenje z zdravilom CellCept mora vpeljati in voditi ustrezen specialist za presaditve.
English: Tap the closed bottle several times to loosen the powder.
Slovenian: Zaprto steklenico večkrat rahlo pretresite, da se prašek razrahlja.
English: • azathioprine or other medicines which suppress your immune system - given after a transplant operation
Slovenian: • azatioprin ali druga zdravila, ki zavirajo imunski sistem - uporabljajo se po presaditveni operaciji,
English: Do not use cloths or wipes for drying.
Slovenian: Za sušenje ne uporabljajte krp ali robčkov.
English: (150 (3x50) tablets multipack)
Slovenian: (150 (3×50) tablet v skupnem pakiranju)
English: 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 Cellcept, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Cellcept.
Slovenian: 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 CellCept, zahteve po kontracepciji za bolnike in bolnice ter da bi vedeli, kaj storiti v primeru zanositve med zdravljenjem z zdravilom CellCept.
English: It is recommended to monitor MPA exposure levels and to adjust CellCept doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Slovenian: Priporočljivo je spremljanje ravni izpostavljenosti mikofenolni kislini in prilagoditev odmerkov zdravila CellCept za ohranitev klinične učinkovitosti, kadar sočasno dajemo rifampicin.
English: • If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
Slovenian: • če ne uporabljate učinkovite kontracepcije (glejte Nosečnost, kontracepcija in dojenje),
English: If a dose of CellCept is missed, this will be given to you as soon as possible.
Slovenian: Če je bil odmerek zdravila CellCept izpuščen, vam ga bodo dali čimprej, ko bo to mogoče.
English: You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
Slovenian: • vam je ali menite, da bi vam lahko izostala menstruacija, imate neobičajno menstrualno krvavitev ali sumite, da ste noseči;
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 CellCept.
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 CellCept, napačno razlaga kot znak okužbe.
English: • cholestyramine - used to treat high cholesterol
Slovenian: • holestiramin - uporablja se za zdravljenje visokega holesterola,
English: Do not take any capsules that have broken open or split.
Slovenian: • Ne zaužijte kapsul, ki so odprte ali poškodovane.
English: If you stop your treatment you may increase the chance of rejection of your transplant organ.
Slovenian: Če prenehate z zdravljenjem, lahko povečate možnost zavrnitve vašega presadka.
English: The recommended dose is 600 mg/ m2
Slovenian: Priporočeni odmerek je 600 mg/m2
English: Try not to inhale the dry powder.
Slovenian: Izogibajte se vdihavanju suhega praška.
English: (100 capsules)
Slovenian: (100 kapsul)
English: Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06
Slovenian: Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, oznaka ATC: L04AA06
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, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
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 z načinom obveščanja, načinom distribucije in vsemi drugimi vidiki programa.
English: Do not use solvent-containing wipes for cleaning.
Slovenian: Za čiščenje ne uporabljajte robčkov, ki vsebujejo topila.
English: An introduction in each guide will inform the reader that the purpose of the guide is to tell them that a foetal exposure must be avoided and how to minimize the risk of birth defects and miscarriage associated with mycophenolate mofetil.
Slovenian: • uvod v obeh vodnikih bo informiral bralca, da je namen vodnika pojasniti, da se je treba izogibati izpostavljenosti ploda in kako kar najbolj zmanjšati tveganje za prirojene okvare in spontani splav, povezane z uporabo mofetilmikofenolata.
English: In patients not also taking ciclosporin, concomitant administration of CellCept and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Slovenian: Pri bolnikih, ki ne jemljejo tudi ciklosporina, je sočasno dajanje zdravila CellCept in rifampicina povzročilo zmanjšanje izpostavljenosti mikofenolni kislini (AUC0-12h) za 18 do 70 %.
English: • Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
Slovenian: • so vam z operacijo odstranili jajcevoda in oba jajčnika (bilateralna salpingo-ooforektomija);
English: Sodium less than 1 mmol (23 mg) per dose
Slovenian: Natrij: manj kot 1 mmol (23 mg) na odmerek
English: CellCept capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Slovenian: Kapsule CellCept lahko predpišemo samo bolnikom, katerih telesna površina je najmanj 1,25 m2.
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 (fenolnega glukuronida mikofenolne kisline) (ki ga je bilo za 8 % več) so bile minimalne in jih ne smatramo za klinično pomembne.
English: Your pharmacist will normally make up the medicine for you.
Slovenian: Zdravilo vam običajno pripravi farmacevt.
English: These include diarrhoea, infections, fewer white cells and fewer red cells in the blood.
Slovenian: Ti vključujejo drisko, okužbe ter zmanjšano število belih in rdečih krvnih celic.
English: Note: If required, CellCept 1 g/5 ml powder for oral suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
Slovenian: Opomba: Če je treba, lahko zdravilo CellCept 1 g/5 ml prašek za peroralno suspenzijo bolniku damo z nazogastrično sondo z velikostjo najmanj 8 French (najmanj 1,7 mm notranjega premera).
English: If neutropenia develops, dosing with CellCept should be interrupted or the dose reduced (see section 4.4).
Slovenian: Če se pojavi nevtropenija, je treba odmerjanje zdravila CellCept prekiniti ali odmerek zmanjšati (glejte poglavje 4.4).
English: CellCept contains aspartame.
Slovenian: • Zdravilo CellCept vsebuje aspartam.
English: For 6 weeks after you stop taking CellCept.
Slovenian: • 6 tednov po prenehanju jemanja zdravila CellCept.
English: The medicine comes as a powder.
Slovenian: Zdravilo je v obliki praška.
English: The risk increases with total immunosuppressive load (see section 4.4).
Slovenian: Nevarnost narašča z zvečano stopnjo imunosupresije (glejte poglavje 4.4).
English: • antacids or proton pump inhibitors - used for acid problems in your stomach such as indigestion
Slovenian: • antacidi ali zaviralci protonske črpalke - uporabljajo se pri težavah s kislino v želodcu, kot je dispepsija,
English: (300 capsules)
Slovenian: (300 kapsul)
English: Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept itself, concomitant medications, viral infections, or some combination of these causes.
Slovenian: Bolnike, ki prejemajo zdravilo CellCept, je treba skrbno nadzorovati zaradi nevtropenije, ki je lahko posledica jemanja zdravila CellCept, sočasno uporabljenih zdravil, virusnih okužb ali nekaterih kombinacij teh vzrokov.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Slovenian: Povejte zdravniku ali farmacevtu, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
English: Advice on action if a pregnancy occurs or is suspected during or shortly after being treated with mycophenolate mofetil.
Slovenian: • Nasvet o postopku, če se nosečnost pojavi (ali sumi nanjo) med ali kmalu po zdravljenju z mofetilmikofenolatom.
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 CellCept.
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 zdravilom CellCept.
English: However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of CellCept.
Slovenian: Kombinacija norfloksacina in metronidazola pa je zmanjšala izpostavljenost mikofenolni kislini za približno 30 % po enkratnem odmerku zdravila
English: This section will provide important background information concerning the teratogenicity and mutagenicity of mycophenolate mofetil.
Slovenian: To poglavje bo vsebovalo pomembne informacije o teratogenosti in mutagenosti mofetilmikofenolata.
English: • olfactory nerve agenesis.
Slovenian: • agenezija olfaktornega živca.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate ali ne morete prebavljati nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte z zdravnikom.
English: Take 5 mL suspension in the morning and then 5 mL suspension in the evening.
Slovenian: • Vzemite 5 ml suspenzije zjutraj in 5 ml suspenzije zvečer.
English: • phosphate binders - used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood.
Slovenian: • fosfatni vezalci - jemljejo jih ljudje s kronično ledvično odpovedjo, da zmanjšajo količino fosfatov, ki se absorbirajo v kri,
English: • They are available as a carton of 100 or 300 capsules (both in blister packs of 10).
Slovenian: • Na voljo so v škatli s 100 in 300 kapsulami (oboje v pretisnem omotu z 10 kapsulami).
English: Patients receiving CellCept should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow failure.
Slovenian: Bolnikom, ki prejemajo zdravilo CellCept, je treba naročiti, da morajo takoj poročati o kakršnem koli znaku okužbe, nepričakovani modrici, krvavitvi ali drugih znakih odpovedi kostnega mozga.
English: Please tell your doctor or nurse if you are taking or have recently taken any other medicines.
Slovenian: Povejte zdravniku ali medicinski sestri, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
English: If you are pregnant or planning to become pregnant or think you may be pregnant If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
Slovenian: • če ste noseči, načrtujete nosečnost ali menite, da bi lahko bili noseči, • če ne uporabljate učinkovite kontracepcije (glejte Nosečnost, kontracepcija in dojenje),
English: • congenital choroid plexus cyst;
Slovenian: • kongenitalne ciste horoidnega pleksusa,
English: PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 50 filmsko obloženih tablet.
English: Other problems such as: weight loss, gout, high blood sugar, bleeding, bruising.
Slovenian: Druge težave, kot so: • izguba telesne mase, protin, visok krvni sladkor, krvavitve, modrice.
English: Tél: +33 (0)1 47 61 40 00
Slovenian: Roche Tél: +33 (0) 1 47 61 40 00
English: The most serious gastrointestinal disorders were ulceration and hemorrhage which are known risks associated with mycophenolate mofetil.
Slovenian: Najresnejše bolezni prebavil so bile razjede in krvavitve, ki so znana tveganja, povezana z mofetilmikofenolatom.
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 CellCept zato ne dajemo bolnikom z redkim dednim pomanjkanjem hipoksantin-gvanin-fosforibozil-transferaze (HGPRT), kot sta Lesch-Nyhlanov in Kelley-Seegmillerjev sindrom.
English: As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of CellCept is correlated with MPA concentration.
Slovenian: Kot je razvidno iz supresije akutne zavrnitvene reakcije po transplantaciji ledvice, je imunosupresivno delovanje zdravila CellCept povezano s koncentracijo mikofenolne kisline.
English: The MAH shall ensure that in each MS where Cellcept is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Cellcept are provided with the following educational package: · Physician educational material · Patient information pack
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da v vseh državah članicah, kjer je zdravilo CellCept na tržišču, vsi zdravstveni delavci in bolniki, za katere se pričakuje, da bodo predpisovali, izdajali ali uporabljali zdravilo CellCept, prejeli naslednja izobraževalna gradiva:
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 CellCept.
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: The most serious infections were sepsis, peritonitis, meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Slovenian: Najbolj resne okužbe so bile sepsa, peritonitis, meningitis, endokarditis, tuberkuloza in atipična mikobakterijska okužba.
English: PHARMACEUTICAL FORM AND CONTENTS 100 Capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 100 kapsul
English: CellCept contains sorbitol (a type of sugar).
Slovenian: • Zdravilo CellCept vsebuje sorbitol (vrsta sladkorja).
English: PHARMACEUTICAL FORM AND CONTENTS Multipack:150 (3 packs of 50) film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Skupno pakiranje: 150 (3 škatle po 50) filmsko obloženih tablet
English: • You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner's syndrome or uterine agenesis
Slovenian: • ste se rodili z eno od naslednjih redkih stanj, zaradi katerih nosečnost ni mogoča: genotip XY,
English: Because of robust clinical evidence showing a high risk of abortion and congenital malformations when mycophenolate mofetil is used in pregnancy every effort to avoid pregnancy during treatment should be taken.
Slovenian: Zaradi zanesljivih kliničnih dokazov, ki kažejo na visoko tveganje za splav in kongenitalne malformacije, če se mofetilmikofenolat uporablja v nosečnosti, je treba poskrbeti za ukrepe, ki preprečijo nosečnost med zdravljenjem.
English: CellCept is an IMPDH (inosine monophosphate dehydrogenase) inhibitor.
Slovenian: Zdravilo CellCept je zaviralec inozin-monofosfat-dehidrogenaze (IMPDH).
English: 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).
Slovenian: 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 % manjša v primerjavi s poznejšim obdobjem po presaditvi (3 do 6 mesecev po presaditvi).
English: (The shelf-life of the reconstituted suspension is two months.)
Slovenian: (Rok uporabnosti pripravljene suspenzije je dva meseca.)
English: 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).
Slovenian: Okvare ob rojstvu, o katerih so poročali, vključujejo nepravilnosti ušes, oči, obraza (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)).
English: There is evidence of a higher frequency of certain types of infections (see section 4.4).
Slovenian: Zabeležili so tudi višjo incidenco določenih vrst okužb (glejte poglavje 4.4).
English: What CellCept is and what it is used for
Slovenian: Kaj je zdravilo CellCept in za kaj ga uporabljamo 2.
English: Following reconstitution to a concentration of 6 mg/mL, CellCept 500 mg powder for concentrate for solution for infusion must be administered by slow intravenous infusion over a period of 2 hours by either a peripheral or a central vein (see section 6.6).
Slovenian: Po pripravi raztopine v koncentraciji 6 mg/ml CellCept 500 mg praška za koncentrat za raztopino za infundiranje jo je treba dajati s počasno intravensko infuzijo vsaj 2 uri bodisi v periferno ali centralno veno (glejte poglavje 6.6).
English: This leaflet was last revised on {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Slovenian: Navodilo je bilo nazadnje revidirano {MM/LLLL} Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: Add about half of the total amount of purified water to the bottle.
Slovenian: Polovico prečiščene vode dajte v steklenico.
English: • isavuconazole - used to treat fungal infections
Slovenian: • izavukonazol - uporablja se za zdravljenje glivičnih okužb,
English: CellCept 500 mg powder for concentrate for solution for infusion is an alternative dosage form to CellCept oral forms (capsules, tablets and powder for oral suspension) that may be administered for up to 14 days.
Slovenian: Zdravilo CellCept 500 mg prašek za koncentrat za raztopino za infundiranje je alternativna odmerna oblika peroralnim oblikam zdravila CellCept (kapsule, tablete in prašek za peroralno suspenzijo), ki jo lahko bolnik prejema do 14 dni.
English: Mycophenolate has been shown to be genotoxic in animal studies at concentrations exceeding the human therapeutic exposures only by small margins such that the risk of genotoxic effects on sperm cells cannot completely be excluded.
Slovenian: Mofetilmikofenolat je bil v študijah na živalih pri koncentracijah, ki le v majhni meri presegajo terapevtske izpostavljenosti pri človeku, genotoksičen in tako tveganja za genotoksične učinke na spermije ne moremo popolnoma izključiti.
English: • Nervous system malformations such as spina bifida;
Slovenian: • malformacije živčnega sistema, kot je spina bifida
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 v perinatalnem obdobju Poročali so o primerih spontanih splavov pri bolnicah, izpostavljenih mofetilmikofenolatu, pretežno v prvem trimesečju, glejte poglavje 4.6.