natgillin/translations-raw huggingface dataset:
9 Hypersensitivity: hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Preobčutljivost: poročali so o preobčutljivostnih reakcijah, vključno z angionevrotičnim edemom in anafilaktično reakcijo.
In many of these cases, no adverse events were reported.
Pri veliko the primerov o neželenih dogodkih niso poročali.
It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 4.4). If neutropenia develops, dosing with Mycophenolate mofetil Teva should be interrupted or the dose reduced (see section 4.4).
Če se pojavi nevtropenija, je treba odmerjanje zdravila Mofetilmikofenolat Teva prekiniti ali odmerek zmanjšati (glejte poglavje 4. 4).
Pharmacotherapeutic group: immunosuppressive agents ATC code:
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, oznaka ATC:
Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.
Mikofenolna kislina je močan, selektivni, nekompetitivni in reverzibilni zaviralec inozin- monofosfat- dehidrogenaze in tako zavira de novo sintezo gvanozinskih nukleotidov, brez vključevanja v DNA.
As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of mycophenolate is correlated with MPA concentration.
Kot je razvidno iz supresije akutne zavrnitvene reakcije po transplantaciji ledvice, je imunosupresivno delovanje mofetilmikofenolata povezano s koncentracijo mikofenolne kisline.
The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94% relative to intravenous mycophenolate mofetil.
Srednja biološka uporabnost peroralne oblike mofetilmikofenolata, temelječa na AUC mikofenolne kisline, znaša 94% glede na intravenske oblike mofetilmikofenolata.
Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5 g BID to renal transplant patients.
Hrana na obseg absorpcije mofetilmikofenolata
However, MPA C max was decreased by 40% in the presence of food.
10 (AUC mikofenolne kisline), če ga dajemo v odmerkih 1, 5 g dvakrat na dan bolnikom s presajeno ledvico, ne vpliva, zmanjša pa največjo plazemsko koncentracijo (Cmax) mikofenolne kisline za približno 40%.
10 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.
Orally administered 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.
However, at high MPAG plasma concentrations (> 100 g/ ml), small amounts of MPAG are removed.
Pri visokih koncentracijah mikofenolglukuronida v plazmi (> 100 µg/ ml) se majhne količine mikofenolglukuronida vendarle odstranijo.
In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and C max 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% manjša v primerjavi s poznejšim obdobjem po presaditvi (3 do 6 mesecev po presaditvi).
In a single dose study (6 subjects/ group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 ml min-1 1.73 m-2) were 28-75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
V študiji enkratnega odmerjanja (6 oseb/ skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija < 25 ml• mim- 1• 1, 73 m- 2) srednji AUC mikofenolne kisline v plazmi za 28 do 75% večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
However, the mean single dose MPAG AUC was 3 -6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
To se je ujemalo z znanim izločanjem mikofenolglukuronida skozi ledvice.
In patients with delayed renal graft function post-transplant, mean MPA AUC (0-12h) was comparable to that seen in post-transplant patients without delayed graft function.
Pri bolnikih z zapoznelim delovanjem ledvičnega presadka je bila srednja AUC (0- 12 ur) mikofenolne kisline primerljiva s tisto pri bolnikih brez zapoznelega delovanja ledvičnega presadka.
Mean plasma MPAG AUC (0- 12h) was 2-3-fold higher than in post-transplant patients without delayed graft function.
Srednja AUC (0- 12 ur) mikofenolglukuronida pa je bila 2 - do 3- krat večja kot pri bolnikih brez zapoznelega delovanja ledvičnega presadka.
This dose achieved MPA AUC values similar to those seen in adult renal transplant patients receiving mycophenolate at a dose of 1 g BID in the early and late post-transplant period.
Ti odmerki so dali podobne vrednosti AUC mikofenolne kisline kot pri odraslih bolnikih z ledvičnim presadkom, ki so prejemali mofetilmikofenolat v
Pharmacokinetic behaviour of mycophenolate in the elderly has not been formally evaluated.
Farmakokinetičnih parametrov mofetilmikofenolata pri starejših bolnikih niso proučevali.
The pharmacokinetics of oral contraceptives were unaffected by co-administration of mycophenolate (see also section 4.5). A study of the co-administration of mycophenolate (1 g BID) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of mycophenolate on the ovulation suppressing action of the oral contraceptives.
V treh zaporednih menstruacijskih ciklih niso opazili klinično pomembnih vplivov mofetilmikofenolata na supresijo ovulacije peroralnih kontraceptivov.
5.3 Preclinical safety data 11 In experimental models, mycophenolate mofetil was not tumourigenic.
Mofetilmikofenolat v eksperimentalnih modelih ni bil kancerogen.
The highest dose tested in the animal carcinogenicity studies resulted in approximately 2-3 times the systemic exposure (AUC or C max) observed in renal transplant patients as the recommended clinical dose of 2 g/ day and 1.3-2 times the systemic exposure (AUC or C max) observed in cardiac transplant patients at the recommended clinical dose of 3 g/ day.
Najvišji preizkušani odmerek v živalskih študijah karcinogenosti je povzročil približno 2 - do 3- krat večjo sistemsko izpostavljenost (AUC ali Cmax) kot pri bolnikih z ledvičnim presadkom, ki so prejemali priporočeni klinični odmerek 2 g na dan, in 1, 3 - do 2- krat večjo sistemsko izpostavljenost (AUC ali Cmax) kot pri bolnikih s srčnim presadkom, ki so prejemali priporočeni klinični odmerek 3 g na dan.
These effects can be related to the pharmacodynamics mode of action, i. e. inhibition of nucleotide synthesis in sensitive cells.
Te učinke lahko povežemo s farmakodinamičnim načinom delovanja, to je zaviranje sinteze nukleotidov v občutljivih celicah.
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg kg-1 day-1. The systemic exposure at this dose represents 2-3 times the clinical exposure at the recommended clinical dose of 2 g/ day in renal transplant patients and 1.3-2 times the clinical exposure at the recommended clinical dose of 3 g/ day in cardiac transplant patients.
Sistemska izpostavljenost pri tem odmerku predstavlja 2 - do 3- kratno klinično izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan pri bolnikih z ledvičnim presadkom, in 1, 3 - do 2- kratno klinično izpostavljenost pri priporočenem kliničnem odmerku 3 g na dan pri bolnikih s srčnim presadkom.
In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg kg-1 day-1 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- 1• dan- 1 pri podganjih samicah povzročili malformacije (vključno z anoftalmijo, agnatijo in hidrocefalijo) pri prvi generaciji potomcev, pri materah pa škodljivih učinkov ni bilo.
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg kg-1 day-1 (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg kg-1 day-1 (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
V študijah teratogenosti pri podganah in kuncih so se pojavile malformacije in resorpcija zarodka pri odmerkih 6 mg• kg- 1• dan- 1 pri podganah (vključno z anoftalmijo, agnatijo in hidrocefalijo) ter pri odmerkih 90 mg• kg- 1• dan- 1 pri kuncih (vključno s kardiovaskularnimi motnjami in motnjami delovanja ledvic, kot so ektopija srca in ledvic ter preponska in popkovna kila), pri materah pa škodljivih učinkov ni bilo.
The systemic exposure at these levels are approximately equivalent to or less than 0.5 times the clinical exposure at the recommended clinical dose of 2 g/ day for renal transplant patients and approximately 0.3 times the clinical exposure at the recommended clinical dose of 3 g/ day for cardiac transplant patients.
Sistemska izpostavljenost pri tem odmerku je bila približno enaka ali manj kot 0, 5- krat večja kot klinična izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan pri bolnikih z ledvičnim presadkom in približno 0, 3- krat večja kot klinična izpostavljenost pri priporočenem kliničnem odmerku 3 g na dan pri bolnikih s srčnim presadkom.
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
Učinki so se pojavili pri
These effects occurred at systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended dose of 2 g/ day for renal transplant recipients.
12 sistemski izpostavljenosti, ki je bila enaka ali manjša kot klinična izpostavljenost pri priporočenem odmerjanju 2 g na dan pri bolnikih z ledvičnim presadkom.
Gastrointestinal and renal effects consistent with dehydration were also observed in the monkey at the highest dose (systemic exposure levels equivalent to or greater than clinical exposure). 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).
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 (glej poglavje 4. 8).
Pregelatinised starch (maize) Povidone K-30 Croscarmellose sodium Magnesium stearate
Kapsula vsebuje: predgeliran koruzni škrob povidon K- 30 premrežen natrijev karmelozat magnezijev stearat
12 Capsule shell:
Ovojnica kapsule:
Red iron oxide (E172) Yellow iron oxide (E! 72) Titanium dioxide (E171) Gelatin Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide.
Pokrovček: indigotin (E132) titanov dioksid (E171) želatina Telo: rdeči železov oksid (E172) rumeni železov oksid (E172). titanov dioksid (E171) želatina Črnilo vsebuje: šelak, črni železov oksid (E172), propilenglikol in kalijev hidroksid.
Transparent PVC/ PVdC – aluminium blisters in pack sizes of 100 or 300 capsules per carton.
Prozorna PVC/ PVdC – aluminijasti pretisni omoti v pakiranjih po 100 in 300 kapsul v škatli.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbit, Mycophenolate mofetil Teva capsules should not be opened or crushed.
Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, kapsul zdravila Mofetilmikofenolat Teva ne smemo odpreti ali drobiti.
Inhalation or direct contact with skin or mucous membranes of the powder contained in the capsules should be avoided.
Če pride do stika s
If such contact occurs, soap and water should be used to wash thoroughly and the eyes should be rinsed with plain water.
13 praškom, je potrebno temeljito izpiranje z vodo in milom, oči pa izpiramo le z vodo.
EU/ 1/ 07/ 439/ 001 (100 capsules) EU/ 1/ 07/ 439/ 002 (300 capsules)
EU/ 1/ 07/ 439/ 001 (100 kapsul) EU/ 1/ 07/ 439/ 002 (300 kapsul)
13 Date of first authorisation:
Datum pridobitve dovoljenja za promet:
Each tablet contains 500 mg mycophenolate mofetil For a full list of excipients, see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Film-coated tablet (tablet) Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other side.
Temno vijoličaste barve, filmsko obložene tablete ovalne oblike, z vgraviranim napisom “ M500 ” na eni strani in brez napisa na drugi.
Children and adolescents: the recommended dose of mycophenolate mofetil is 600 mg/ m2 administered orally twice daily (up to a maximum of 2 g daily).
Otroci in mladostniki: priporočeni odmerek mofetilmikofenolata je 600 mg/ m2, vzetih peroralno dvakrat na dan (do največ 2 g na dan).
Mycophenolate mofetil Teva tablets should only be prescribed to patients with a body surface area greater than 1.5 m2, at a dose of 1 g twice daily (2 g daily dose).
Tablete zdravila Mofetilmikofenolat Teva lahko predpišemo samo bolnikom, katerih telesna površina je večja od 1, 5 m2, v odmerku 1 g dvakrat na dan (dnevni odmerek 2 g).
As some adverse reactions occur with greater frequency in this age group (see section 48) 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.
Pri tem je treba upoštevati ustrezne klinične dejavnike vključno z resnostjo neželenega učinka.
Adults: oral Mycophenolate mofetil Teva should be initiated within 5 days following transplantation.
Odrasli: v začetku damo zdravilo Mofetilmikofenolat Teva peroralno v 5 dneh po presaditvi.
15 Children and adolescents: no data are available for paediatric cardiac transplant patients, therefore use in this patients group is not recommended until further data to support this is available.
15 Uporaba pri presaditvi jeter:
Adults: intravenous mycophenolate should be administered for the first 4 days following hepatic transplant, with oral Mycophenolate mofetil Teva initiated as soon after this as it can be tolerated.
Odrasli: prve 4 dni po presaditvi jeter je treba dajati mofetilmikofenolat intravensko, takoj ko je bolnik sposoben požirati, pa nadaljujemo s peroralno obliko mofetilmikofenolata.
Children and adolescents: no data are available for paediatric hepatic transplant patients, therefore use in this patient group is not recommended until further data to support this is available.
Otroci in mladostniki: za otroke in mladostnike z jetrnim presadkom podatki niso znani, zato uporaba zdravila Mofetilmikofenolat Teva v tej starostni skupini ni priporočljiva, dokler ne bodo na voljo zadostni podatki.
Use in elderly ( 65 years)
Uporaba pri starejših bolnikih (stari 65 let ali več):
Use in renal impairment
Uporaba pri bolnikih z ledvično okvaro:
Use in severe hepatic impairment
Uporaba pri bolnikih z jetrno okvaro:
Treatment during rejection episodes
Zdravljenje med zavrnitveno reakcijo:
Hypersensitivity reactions to the active substance, to mycophenolic acid or any of the excipients
Preobčutljivost za zdravilno učinkovino, mikofenolno kislino ali katerokoli pomožno snov.
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Mycophenolate mofetil Teva, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
Bolniki, ki prejemajo kombinacije imunosupresivnih zdravil, vključno z zdravilom Mofetilmikofenolat Teva, so izpostavljeni povečanem tveganju nastanka limfomov in drugih malignih sprememb, zlasti kožnih (glejte poglavje 4. 8).
As general advice to minimise the risk for skin cancer, exposure to sunlight and ultra-violet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
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.
16 Patients receiving Mycophenolate mofetil Teva should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Bolnikom, ki prejemajo zdravilo Mofetilmikofenolat Teva, naročimo, da morajo takoj poročati o kakršnemkoli znaku okužbe, nepričakovani modrici, krvavitvi ali drugih znakih depresije kostnega mozga.
Patients treated with immunosuppressants, including Mycophenolate mofetil Teva, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
16 Bolniki, ki se zdravijo z imunosupresivi, vključno z zdravilom Mofetilmikofenolat Teva, imajo povečano tveganje za oportunistične okužbe (bakterijske, glivične, virusne in protozojske), smrtne okužbe in sepso (glejte poglavje 4. 8).
In view of the significant reduction in the area under the curve (AUC) of MPA by cholestyramine, caution should be used in the concomitant administration of Mycophenolate mofetil Teva with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Mycophenolate mofetil Teva.
Ker holestiramin značilno zmanjša AUC (površino pod krivuljo) mikofenolne kisline, dajemo zdravilo Mofetilmikofenolat Teva previdno bolnikom, ki sočasno jemljejo druga zdravila, ki vplivajo na enterohepatični obtok zaradi možnosti zmanjšanja učinkovitosti zdravila Mofetilmikofenolat Teva.
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.
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.
17 Antacids with magnesium and aluminium hydroxides: absorption of mycophenolate mofetil was decreased when administered with antacids.
Antacidi z magnezijevimi in aluminijevimi hidroksidi: absorpcija mofetilmikofenolata se ob hkratnem dajanju antacidov zmanjša.
Cholestyramine: following single dose administration 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g three times a day (TID) of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4 and section 5.2).
17 Holestiramin: če dajemo holestiramin 4 dni v odmerku 4 g trikrat na dan, ta zmanjša AUC mikofenolne kisline po enkratnem peroralnem vnosu 1, 5 g mofetilmikofenolata za približno 40% (glejte poglavje 4. 4 in poglavje 5. 2).
Ganciclovir: based on the results of a single dose administration study of recommended doses of oral mycophenolate and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate (see section 4.2) and ganciclovir, it is anticipated that co- administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Ganciklovir: 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.
In patients with renal impairment in which mycophenolate mofetil and ganciclovir or its prodrugs, e. g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
Bolnike z ledvično okvaro, ki sočasno dobivajo zdravilo mofetilmikofenolat in ganciklovir oziroma njegova predzdravila, npr. valganciklovir, je treba skrbno nadzorovati in proučiti odmerjanje ganciklovirja.
Rifampicin: in patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC 0-12h) of 18% to 70%.
Rifampicin: pri bolnikih, ki ne jemljejo tudi ciklosporina, je sočasno mofetilmikofenolata in rifampicina povzročilo zmanjšanje izpostavljenosti mikofenolni kislini (AUC0- 12h) za 18 d0 70%.
Sevelamer: decrease in MPA C max and AUC 0-12 by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection).
Sevelamer: pri sočasnem dajanju mofetilmikofenolata in sevelamerja so opazili zmanjšanje cmax mikofenolne kisline za 30% in AUC0- 12h mikofenolne kisline za 25%, kliničnih posledic (zavrnitve presadka) pa ni bilo.
Tacrolimus: in liver transplant recipients initiated on mycophenolate mofetil and tacrolimus, the AUC and C max of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by trough tacrolimus level.
Takrolimus: pri bolnikih z jetrnim presadkom, pri katerih so uvedli mofetilmikofenolat in takrolimus, sprememba AUC in cmax mikofenolne kisline, aktivnega presnovka mofetilmikofenolata, zaradi sočasnega dajanja takrolimusa ni bila pomembna.
In renal transplant patients, the tacrolimus concentration did not appear to be
(glejte tudi poglavje 4. 4).
However, in hepatic transplant patients, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5 g taken twice a day, morning and evening [BID]) were administered to patients taking tacrolimus (see also section 4.4).
18 Druge interakcije: sočasno jemanje probenecida in mofetilmikofenolata je pri opicah povzročilo zvišanje AUC mikofenolglukuronida v plazmi za trikrat.
Effective contraception must be used before beginning Mycophenolate mofetil Teva therapy, during therapy, and for six weeks following discontinuation of therapy (see section 4.5).
Pred in med zdravljenjem ter najmanj šest tednov po končani terapiji z zdravilom Mofetilmikofenolat Teva, morajo bolnice uporabljati učinkovito kontracepcijo (glejte poglavje 4. 5).
There is limited data from the use of mycophenolate mofetil in pregnant women.
Ustreznih podatkov o uporabi mofetilmikofenolata pri nosečnicah ni.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije pri živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3