natgillin/translations-raw huggingface dataset:
Based on experience with the use of other medicinal products that affect the renin-angiotensin- aldosterone system, concomitant use of Ipreziv with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (e.g. heparin) may lead to increases in serum potassium in hypertensive patients (see section 4.5).
Na osnovi izkušenj pri uporabi drugih zdravil, ki vplivajo na sistem renin-angiotenzin-aldosteron, lahko pri bolnikih s povišanim krvnim tlakom sočasno dajanje zdravila Ipreziv z diuretiki, ki zadržujejo kalij, z dodatki kalija, z nadomestki soli, ki vsebujejo kalij, ali z drugimi učinkovinami, ki lahko povečujejo koncentracijo kalija (npr. heparin), vodi k povečani serumski koncentraciji kalija (glejte poglavje 4.5).
Based on exposure, relative potency, and pharmacokinetic properties, both hydroxy- and desmethyl-dabrafenib are likely to contribute to the clinical activity of dabrafenib. while the activity of carboxy-dabrafenib is not likely to be significant.
Na podlagi izpostavljenosti, relativne jakosti in farmakokinetičnih lastnosti verjetno h kliničnemu delovanju prispevata tako hidroksi- kot dezmetildabrafenib, medtem ko za delovanje karboksidabrafeniba ni verjetno, da bi bilo pomembno.
Based on extrapolation from a pharmacokinetic study with ketoconazole in 7 patients, consider a 50% docetaxel dose reduction if patients require co- administration of a strong CYP3A4 inhibitor such as azole antifungals, ritonavir and some macrolides (clarithromycin, telithromycin).
Na podlagi ekstrapolacije iz farmakokinetične študije s ketokonazolom pri 7 bolnikih pride v poštev 50 % zmanjšanje odmerka docetaksela, če bolnik sočasno potrebuje zdravljenje s kakšnim močnim zaviralcem CYP3A4, npr. kakšnim azolskim antimikotikom, ritonavirjem ali nekaterimi makrolidi (klaritromicin, telitromicin).
Based on extrapolation from a pharmacokinetic study with ketoconazole in 7 patients, consider a 50% docetaxel dose reduction if patients require co- administrtion of a stron CYP3A4 inhibitor such as azole antifungals, ritonavir and some macrolides (clarithromycin, telithromycin).
Na podlagi ekstrapolacije iz farmakokinetične študije s ketokonazolom pri 7 bolnikih pride v poštev 50 % zmanjšanje odmerka docetaksela, če bolnik sočasno potrebuje zdravljenje s kakšnim močnim zaviralcem CYP3A4, npr. kakšnim azolskim antimikotikom, ritonavirjem ali nekaterimi makrolidi (klaritromicin, telitromicin).
Based on findings in animals, IMBRUVICA may cause foetal harm when administered to pregnant women.
Glede na ugotovitve pri živalih bi zdravilo IMBRUVICA pri uporabi med nosečnostjo lahko imelo škodljiv učinek na plod.
Based on FXIII activity as measured by the Berichrom assay for 471 monthly doses of rFXIII, a half- life of rFXIII of 11.8 days was estimated in patients with congenital FXIII deficiency.
Na podlagi aktivnosti FXIII, izmerjene s preizkusom Berichrom pri 471 mesečnih odmerkih rFXIII, je bil ocenjeni razpolovni čas rFXIII pri bolnikih s prirojenim pomanjkanjem FXIII 11,8 dneva.
Based on how patients treated with TYSABRI are currently monitored at national level, the Marketing Authorisation Holder (MAH) shall discuss and agree with the National Competent Authorities measures to enhance further this monitoring (e.g. registries, post-marketing surveillance studies) as appropriate.
Glede na trenutno spremljanje bolnikov na nacionalni ravni, ki se zdravijo z zdravilom TYSABRI, se imetnik dovoljenja za promet z zdravilom dogovari in uskladi z nacionalnimi pristojnimi organi glede ukrepov za nadaljnje povečanje tega spremljanja (npr. registri in študije v obdobju po začetku trženja), kot je primerno.
Based on how you respond to the medicine, your doctor may prescribe you a higher dose; one 8 mg tablet a day.
Glede na to, kako se odzivate na zdravilo, vam lahko zdravnik predpiše večji odmerek, eno 8 mg tableto na dan.
Based on in vitro and in vivo studies, raltegravir is eliminated mainly by metabolism via a UGT1A1- mediated glucuronidation pathway.
Na osnovi in vitro ter in vivo študij se raltegravir v glavnem izloča s presnavljanjem z glukuronidacijo z UGT1A1.
Based on in vitro and in vivo studies, raltegravir is eliminated mainly by metabolism via a UGT1A1-mediated glucuronidation pathway.
Na osnovi študij in vitro in in vivo se raltegravir izloča v glavnem s presnavljanjem z glukuronidacijo z UGT1A1.
Based on in vitro bazedoxifene plasma protein-binding characteristics, interactions with warfarin, digoxin or diazepam are unlikely.
Na podlagi in vitro značilnosti vezave bazedoksifena na plazemske beljakovine je medsebojno delovanje z varfarinom, digoksinom in diazepamom malo verjetno.
Based on in vitro data, inhibition of BCRP and MRP2 (in the intestine), as well as organic anion transporter 3 (OAT3) and organic cation transporter 1 (OCT1) (systemically) cannot be excluded.
Na podlagi podatkov in vitro ni mogoče izključiti inhibicije BCRP in MRP2 (v črevesju), kot tudi prenašalca organskih anionov 3 (OAT3 - organic anion transporter 3) in prenašalca organskih kationov 1 (OCT1 - organic cation transporter 1) (sistemski).
Based on in vitro data, pomalidomide is not an inhibitor or inducer of cytochrome P-450 isoenzymes,and does not inhibit any drug transporters that were studied.
Na podlagi podatkov in vitro pomalidomid ni zaviralec ali spodbujevalec izoencimov citokroma P-450 in ne zavira nobenega od prenašalcev zdravil, ki so jih proučevali.
Based on in vitro data, sonidegib is not a substrate of P-gp, BCRP or multi-resistance protein 2 (MRP2).
Po in vitro podatkih sonidegib ni substrat P-glikoproteina (P-gp), proteina rezistence pri raku dojke (angl. breast cancer resistance protein, BCRP) ali proteina, ki je povezan z rezistenco na več zdravil (angl. multi-resistance protein 2, MRP2).
Based on in vitro investigations florbetaben (18F) is metabolized predominantly by CYP2J2 and CYP4F2.
Na podlagi preiskav in vitro se [18F]florbetaben presnavlja predvsem s CYP2J2 in CYP4F2.
Based on in vitro investigations rivaroxaban is a substrate of the transporter proteins P-gp (P-glycoprotein) and Bcrp (breast cancer resistance protein).
Študije in vitro kažejo, da je rivaroksaban substrat transportnih beljakovin P-gp (P- glikoprotein) in Bcrp (Breast cancer resistance protein).
Based on in vitro results, there is a risk for enzyme induction by tedizolid phosphate.
Glede na rezultate in vitro obstaja tveganje za indukcijo encimov s tedizolid fosfatom.
Based on in vitro studies, ataluren is a substrate of UGT1A9 and breast cancer resistant protein (BCRP).
Študije in vitro so pokazale, da je ataluren substrat UGT1A9 in proteina odpornosti za raka dojke (breast cancer resistant protein – BCRP).
Based on in vitro studies, ataluren is an inhibitor of UGT1A9, organic anion transporter 1 (OAT1), organic anion transporter 3 (OAT3) and organic anion transporting polypeptide 1B3 (OATP1B3).
Študije in vitro so pokazale, da je ataluren zaviralec UGT1A9, prenašalca organskih anionov 1 (OAT1), prenašalca organskih anionov 3 (OAT3) in polipeptidnega prenašalca organskih anionov 1B3 (OATP1B3).
Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4.
Na podlagi raziskav in vitro so za dehidrogenacijo in hidroksilacijo aripiprazola odgovorni encimi CYP3A4 in CYP2D6, N- dealkilacijo pa katalizira CYP3A4.
Based on in vitro studies, daratumumab may utilize multiple effector functions, resulting in immune mediated tumour cell death.
Po podatkih študij in vitro daratumumab lahko povzroči imunsko posredovano smrt tumorskih celic preko več mehanizmov.
Based on in vitro studies, nitisinone is not expected to inhibit CYP 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4-mediated metabolism.
Študije in vitro so pokazale, da nitizonon ne bi smel zavirati presnove, ki deluje preko encimov CYP 1A2, 2C9, 2C19, 2D6, 2E1 ali 3A4.
Based on in vitro studies, osimertinib is a competitive inhibitor of BCRP transporters.
Na podlagi študij in vitro je osimertinib kompetitivni zaviralec prenašalcev BCRP.
Based on in vitro studies, osimertinib is a substrate of P-glycoprotein and breast cancer resistant protein (BCRP), but is unlikely to result in clinically relevant drug interactions with active substances by osimertinib at the clinical doses.
Na podlagi študij in vitro je osimertinib substrat P-glikoproteina in BCRP (breast cancer resistant protein), vendar ni verjetno, da bi to ob kliničnih odmerkih osimertiniba povzročilo klinično pomembna medsebojna delovanja osimertiniba z drugimi zdravilnimi učinkovinami.
Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Glede na in vitro raziskave palonosetron v klinično pomembnih koncentracijah ne inhibira ali inducira izoencima citokrom P450.
Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A).
Na podlagi večje izpostavljenosti se lahko poveča tudi tveganje za neželene dogodke pri bolnikih z blago jetrno okvaro (Child Pugh A).
Based on individual efficacy and tolerability, the dose may be increased to a maximum dose of 200 mg or decreased to 50 mg.
Glede na učinkovitost in prenašanje zdravila pri posamezniku se lahko odmerek poveča na največ 200 mg ali zmanjša na 50 mg.
Based on individual patient response and tolerability, the dose may be increased to 300 mg (15 ml) per day after 1 week.
Glede na bolnikov odziv in prenašanje se lahko odmerek po enem tednu poveča na 300 mg (15 ml) na dan.
Based on individual patient response and tolerability, the dose may be increased to 300 mg (15 ml) per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg (30 ml) per day after an additional 7-day interval.
Glede na bolnikov odziv in prenašanje je mogoče čez 3 do 7 dni odmerek zvečati na 300 mg (15 ml) na dan in – če je potrebno – čez nadaljnjih 7 dni na največji odmerek 600 mg (30 ml) na dan.
Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week.
Glede na bolnikov odziv in prenašanje se lahko odmerek po enem tednu poveča na 300 mg na dan.
Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
Glede na bolnikov odziv in prenašanje je mogoče čez 3 do 7 dni odmerek zvečati na 300 mg na dan in – če je potrebno – čez nadaljnjih 7 dni na največji odmerek 600 mg na dan.
Based on individual response, the dose may be increased to 1,200 mg once daily (see section 5.1).
Glede na odziv posameznika se odmerek lahko zveča do 1.200 mg enkrat na dan (glejte poglavje 5.1).
Based on information available from published literature and the existing product labels for the individual constituents, systemic exposure is significantly higher for bupropion and its metabolites (two- to three-fold), and naltrexone and its metabolites in subjects with moderate-to-severe renal impairment.
Na podlagi podatkov, razpoložljivih v objavljeni literaturi, in na podlagi obstoječih etiket izdelkov za posamezne sestavine je sistemska izpostavljenost pomembneje večja pri preiskovancih z zmerno do hudo ledvično okvaro, tako za bupropion in njegove presnovke (dva- do trikrat) kot za naltrekson in njegove presnovke.
Based on information available from published literature and the existing product labels for the individual constituents, systemic exposure is significantly higher for bupropion and metabolites (two- to three-fold), and naltrexone and metabolites (up to 10-fold higher) in subjects with cirrhosis exhibiting moderate-to-severe hepatic impairment.
Na podlagi podatkov, razpoložljivih v objavljeni literaturi, in na podlagi obstoječih informacij o zdravilih za posamezni učinkovini je sistemska izpostavljenost pomembneje večja pri preiskovancih s cirozo, ki imajo zmerno do hudo jetrno okvaro, tako za bupropion in presnovke (dva- do trikrat) kot za naltrekson in presnovke (do 10-krat večja).
Based on information from an open-label randomised study, conversion from the calcineurin inhibitor tacrolimus to Rapamune in maintenance renal transplant patients was associated with an unfavourable safety profile without efficacy benefit and can therefore not be recommended (see section 5.1).
Na podlagi podatkov iz odprte randomizirane študije je bil pri bolnikih na vzdrževalnem zdravljenju po presaditvi ledvice prehod z zaviralca kalcinevrina takrolimusa na zdravilo Rapamune povezan z neugodnim varnostnim profilom brez dodatne učinkovitosti in zato ni priporočljiv (glejte poglavje 5.1).
Based on information from subsequent clinical studies, the use of Rapamune, mycophenolate mofetil, and corticosteroids, in combination with IL-2 receptor antibody (IL2R Ab) induction, is not recommended in the de novo renal transplant setting (see section 5.1).
Na podlagi podatkov iz poznejših kliničnih študij se ne priporoča uporaba zdravila Rapamune, mofetilijevega mikofenolata in kortikosteroidov v kombinaciji z indukcijo protiteles proti receptorjem IL-2 (IL2R Ab) pri ledvičnem presadku de novo (glejte poglavje 5.1).
Based on its half-life, 6-beta-naltrexol is estimated to reach steady state concentrations in approximately 3 days.
Na podlagi razpolovnega časa se ocenjuje, da 6-beta- naltrekson doseže koncentracije v stanju dinamičnega ravnovesja v približno 3 dneh.
Based on its mechanism of action (PARP inhibition), olaparib could cause foetal harm when administered to a pregnant woman.
Glede na mehanizem delovanja (zavrtje PARP) olaparib lahko škoduje plodu, če se uporablja pri nosečnici.
Based on its mechanism of action and animal models where EGFR expression is disrupted, necitumumab may cause foetal harm or developmental anomalies.
Na podlagi mehanizma delovanja necitumumaba in živalskih modelov z moteno izraženostjo EGFR lahko necitumumab povzroča poškodbe ploda ali razvojne nepravilnosti.
Based on its pharmacodynamic properties, CoAprovel is unlikely to affect this ability.
Na osnovi farmakodinamičnih lastnosti je malo verjetno, da bi zdravilo CoAprovel vplivalo na te sposobnosti.
Based on its pharmacodynamic properties, Ifirmacombi is unlikely to affect this ability.
Na osnovi farmakodinamičnih lastnosti je malo verjetno, da bi zdravilo Ifirmasta HCT vplivalo na te sposobnosti.
Based on its pharmacodynamic properties, Irbesartan Hydrochlorothiazide Zentiva is unlikely to affect this ability.
Na osnovi farmakodinamičnih lastnosti je malo verjetno, da bi zdravilo Irbesartan Hydrochlorothiazide Zentiva vplivalo na te sposobnosti.
Based on its pharmacodynamic properties, Irbesartan/Hydrochlorothiazide Teva is unlikely to affect this ability.
Na osnovi farmakodinamičnih lastnosti je malo verjetno, da bi zdravilo Irbesartan/hidroklorotiazid Teva vplivalo na te sposobnosti.
Based on its pharmacodynamic properties, Karvezide is unlikely to affect this ability.
Na osnovi farmakodinamičnih lastnosti je malo verjetno, da bi zdravilo Karvezide vplivalo na te sposobnosti.
Based on its pharmacological properties any risk to the breast-fed newborns/infants cannot be excluded.
Zaradi farmakoloških lastnosti zdravila tveganja za dojenega novorojenca/otroka ne moremo izključiti.
Based on its review of the quality, safety and effectiveness of the medicine, the Committee decided that Ziagen’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Na podlagi pregleda kakovosti, varnosti in učinkovitosti zdravila je zaključil, da so koristi zdravila Ziagen večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Based on Kaplan-Meier estimates, the proportions of patients who were maintaining response for 72 months among patients who achieved CCyR were 99.1% (95% CI: 97.9-100%) in the nilotinib
Po oceni z metodo po Kaplan-Meierju so med tistimi, ki so dosegli popolni citogenetični odziv, deleži bolnikov, ki so odziv ohranili 72 mesecev, naslednji: 99,1 % (95-odstotni IZ: 97,9-100 %) v skupini z nilotinibom 300 mg dvakrat dnevno, 98,7 % (95-odstotni IZ: 97,1-100 %) v skupini z nilotinibom
Based on Kaplan-Meier product limit estimates.
Ocena po metodi Kaplan-Meier.
Based on laboratory animal data, gamithromycin has not produced any evidence of selective developmental or reproductive effects.
S študijami na laboratorijskih živalih niso bili ugotovljeni nobeni selektivni učinki gamitromicina na razvoj ali reprodukcijo.
Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of Aclasta-treated patients in a large clinical trial compared to 21% of Aclasta-treated patients in the Paget’s disease trials.
Na podlagi laboratorijskih preiskav so ugotovili, da je do prehodnega asimptomatskega znižanja koncentracij kalcija pod okvir normalnih referenčnih vrednosti (pod 2,10 mmol/l) prišlo pri 2,3 % bolnikov, ki so prejemali zdravilo Aclasta v obsežnem kliničnem preskušanju, v primerjavi z 21 % pri bolnikih, ki so prejemali zdravilo Aclasta v preskušanjih zdravljenja Pagetove bolezni.
Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-treated patients in the Paget’s disease trials.
Na podlagi laboratorijskih preiskav so ugotovili, da je do prehodnega asimptomatskega znižanja koncentracij kalcija pod okvir normalnih referenčnih vrednosti (pod 2,10 mmol/l) prišlo pri 2,3 % bolnikov, ki so prejemali zoledronsko kislino v obsežnem kliničnem preskušanju, v primerjavi z 21 % pri bolnikih, ki so prejemali zoledronsko kislino v preskušanjih zdravljenja Pagetove bolezni.
Based on laboratory assessments.
Na podlagi laboratorijskih ocen.
Based on laboratory values (percentages done on patients with laboratory assessments)
Na podlagi laboratorijskih vrednosti (odstotki se nanašajo na bolnike, ki so imeli laboratorijske preiskave).
Based on limited available data in adolescents (12 to less than 18 years of age and weighing at least 40 kg), there were no additional types of adverse reactions beyond those observed in the adult population.
Na podlagi omejenih razpoložljivih podatkov pri mladostnikih (starih od 12 do manj kot 18 let, s telesno maso vsaj 40 kg) ni bilo nobenih dodatnih neželenih učinkov poleg tistih, ki so jih zabeležili pri odraslih.
Based on limited data available, no dose adjustment is required during pregnancy and postpartum (see section 5.2).
Na voljo so omejeni podatki, ki kažejo, da prilagajanje odmerkov med nosečnostjo in po porodu ni potrebno (glejte poglavje 5.2).
Based on limited data from REGARD patients with HER2-positive gastric or GEJ adenocarcinoma and patients previously treated with trastuzumab (in RAINBOW), it is considered unlikely that Cyramza has a detrimental effect or that it has no effect in patients with HER2-positive gastric cancer.
Na podlagi omejenih podatkov o bolnikih iz študije REGARD z želodčnim rakom, pozitivnim na gen HER2 ali z adenokarcinomom gastro-ezofagealnega prehoda ter bolnikov, ki so bili predhodno zdravljeni s trastuzumabom (v študiji RAINBOW), se šteje za malo verjetno, da bi zdravilo Cyramza imelo škodljiv učinek ali da ne bi imelo nobenega učinka pri bolnikih z rakom želodca, pozitivnim na gen HER2.
Based on limited data in patients with liver metastases, it is recommended that the initial dose of Myocet is reduced in accordance with the following table
Glede na omejene podatke pri bolnicah z metastazo jeter se priporoča, da se začetni odmerek zdravila Myocet zmanjša v skladu s spodnjo preglednico
Based on limited data this percentage has been found to be lower (7%) in the male paediatric population.
Na podlagi navedenih podatkov je ta odstotek manjši (7 %) pri moških pediatričnih bolnikih.
Based on limited data, pharmacokinetics parameters (AUC, Cmax and half-life) of ketoconazole for doses of 5 to 10 mg/kg/days, corresponding approximately to daily doses of 200-800 mg, are similar in paediatric and adult population.
Na podlagi omejenih podatkov so farmakokinetični parametri (AUC, Cmax in razpolovni čas) ketokonazola za odmerke od 5 do 10 mg/kg/dan, kar ustreza približnim dnevnim odmerkom 200–800 kg, podobni pri pediatrični in odrasli populaciji.
Based on limited data, the recommended dose in infants is as follows: age less than 6 months: 6,700 U/m² BSA, age 6 – 12 months: 7,500 U/m² BSA.
Na podlagi malo podatkov je priporočeni intravenski odmerek pri dojenčkih: mlajših od 6 mesecev: 6.700 E/m² telesne površine, starih 6-12 mesecev: 7.500 E/m² telesne površine.
Based on literature cases, para-aminosalicylic acid may be associated with an increased risk of hypothyroidism in HIV co-infected patients.
Na podlagi primerov iz literature lahko para-aminosalicilno kislino povezujemo s povečanim tveganjem za hipotiroidizem pri bolnikih, ki so sočasno okuženi z virusom HIV.
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).
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).
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).
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).
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).
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 bolnica s presajenim solidnim organom, zdravljenih z drugimi imunosupresivi razen mofetilmikofenolata).
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).
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).