natgillin/translations-raw huggingface dataset:
In a study in which leflunomide was given concomitantly with a triphasic oral contraceptive pill containing 30 µg ethinyloestradiol to healthy female volunteers, there was no reduction in contraceptive activity of the pill, and A771726 pharmacokinetics were within predicted ranges.
V študiji, v kateri so zdravim prostovoljkam dajali leflunomid sočasno s trifaznimi kontracepcijskimi tabletami, ki so vsebovale 30 µg etinilestradiola, se kontracepcijsko delovanje tablet ni zmanjšalo, farmakokinetika A771726 pa je bila v predvidenem območju.
No incremental overall benefit was observed in the studied population with the use of a loading dose regimen.
V raziskovani populaciji z uporabo sheme z začetnim odmerkom v celoti niso ugotovili dodatne koristi.
Do not take Leflunomide Zentiva if you are, or think you may be pregnant.
Ne jemljite zdravila Leflunomid Zentiva, če ste ali mislite, da ste noseči.
If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Leflunomide Zentiva rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Če test potrdi, da ste noseči, vam bo zdravnik morda predlagal zdravljenje z določenimi zdravili, ki lahko hitro in učinkovito odstranijo zdravilo Leflunomid Zentiva iz vašega telesa, ker to lahko zmanjša tveganje za otroka.
Therefore, when warfarin or another coumarin anticoagulant is co-administered, close international normalised ratio (INR) follow-up and monitoring is recommended.
Zato so med sočasno uporabo varfarina ali drugih kumarinskih antikoagulantov priporočljivi skrbno spremljanje in kontrole internacionalnega normaliziranega razmerja (INR).
The usual starting dose of Leflunomide Zentiva is one 100 mg tablet once daily for the first three days.
Običajni začetni odmerek zdravila Leflunomid Zentiva je ena 100-mg tableta enkrat na dan prve tri dni.
There were no adverse events reported in the majority of case reports of overdose.
V večini poročil o primerih prevelikega odmerjanja niso poročali o neželenih učinkih.
In a carcinogenicity study in mice an increased incidence of malignant lymphoma occurred in males of the highest dose group, considered to be due to the immunosuppressive activity of leflunomide.
V študiji kancerogenosti pri miših se je v skupini, ki je dobivala največji odmerek, pri samcih zvečala pogostnost malignih limfomov; to je domnevno posledica imunosupresivnega delovanja leflunomida.
What Leflunomide Zentiva is and what it is used for
Kaj je zdravilo Leflunomid Zentiva in za kaj ga uporabljamo
interstitial lung disease (including interstitial pneumonitis), which may be fatal.
intersticijska bolezen pljuč (vključno z intersticijsko pljučnico), ki je lahko usodna.
A more rapid elimination of A771726 was observed in haemodialysis subjects which was not due to extraction of medicinal product in the dialysate.
Hitrejša eliminacija A771726 je bila opažena pri osebah na hemodializi, kar pa ni bila posledica izločanja zdravila v dializat.
It is recommended that monitoring of liver enzymes be maintained after discontinuation of leflunomide treatment, until liver enzyme levels have normalised.
Nadziranje jetrnih encimov je priporočljivo nadaljevati tudi po prekinitvi zdravljenja z leflunomidom, vse dokler se njihove vrednosti ne normalizirajo.
The efficacy of Leflunomide Zentiva in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Učinkovitost zdravila Leflunomid Zentiva so pri zdravljenju revmatoidnega artritisa dokazali v 4 kontroliranih preskušanjih (1 v II.
Similar studies showed that ibuprofen and diclofenac did not displace A771726, whereas the unbound fraction of A771726 is increased 2- to 3-fold in the presence of tolbutamide.
Podobne študije so pokazale, da ibuprofen in diklofenak ne izpodrineta A771726, v prisotnosti tolbutamida pa se nevezana frakcija A771726 zveča za 2- do 3-krat.
Similarly, recent treatment with hepatotoxic or haematotoxic medicinal products (e.g. methotrexate) may result in increased side effects; therefore, the initiation of leflunomide treatment has to carefully be considered regarding these benefit/risk aspects and closer monitoring is recommended in the initial phase after switching.
Podobno lahko nedavno zdravljenje s hepatotoksičnimi ali hematotoksičnimi zdravili (npr. z metotreksatom) zveča tveganje za pojav neželenih učinkov; zato je treba uvedbo zdravljenja z leflunomidom skrbno pretehtati upoštevaje koristi in tveganja; v začetnem obdobju po zamenjavi je priporočljivo natančnejše nadziranje.
Repeated doses of A771726 had no effect on the pharmacokinetics of S-warfarin, indicating that A771726 is not an inhibitor or an inducer of CYP2C9.
Ponavljajoči se odmerki A771726 niso vplivali na farmakokinetiko S-varfarina; to kaže, da A771726 ni ne zaviralec ne induktor CYP2C9.
The time to peak plasma concentrations of A771726 is very variable; peak plasma levels can occur between 1 hour and 24 hours after single administration.
Čas do najvišje plazemske koncentracije A771726 je zelo različen; najvišja koncentracija v plazmi se lahko pojavi med 1 in 24 urami po enkratnem odmerku.
Leflunomide was studied in a single multicenter, randomized, double-blind, active-controlled trial in 94 patients (47 per arm) with polyarticular course juvenile rheumatoid arthritis.
Leflunomid so raziskali v enem multicentričnem, randomiziranem, dvojno slepem preskušanju z aktivno kontrolo pri 94 bolnikih (47 na krak), ki so imeli juvenilni revmatoidni artritis s poliartikularnim potekom.
• active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD),
• aktivnim revmatoidnim artritisom kot imunomodulirajoče protirevmatično zdravilo ("disease modifying antirheumatic drug" (DMARD)),
severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis
hude anafilaktične/anafilaktoidne reakcije, vaskulitis, vključno s kožnim nekrotizirajočim vaskulitisom
Alternatively, 50 g of activated powdered charcoal is administered 4 times daily.
Druga možnost je uporaba 50 g aktivnega oglja v prahu, 4krat na dan.
The relevance of the findings in mice relative to the clinical use of leflunomide is uncertain.
Pomen teh izsledkov pri miših za klinično uporabo leflunomida ni gotov.
Leflunomide is metabolised to one primary (A771726) and many minor metabolites including TFMA (4-trifluoromethylaniline).
Leflunomid se presnovi v en glavni (A771726) in več stranskih presnovkov, med katerimi je tudi TFMA (4-trifluorometilanilin).
Following concomitant administration of a single dose of leflunomide to subjects receiving multiple doses of rifampicin (non-specific cytochrome P450 inducer) A771726 peak levels were increased by approximately 40%, whereas the AUC was not significantly changed.
Po sočasni aplikaciji enega samega odmerka leflunomida osebam, ki so prejemale ponavljajoče se odmerke rifampicina (nespecifičnega induktorja citokroma P450), so se najvišje koncentracije A771726 zvišale za približno 40 %, AUC pa se ni pomembno spremenila.
Store in the original package.
Shranjujte v originalni ovojnini.
Due to a potential for additive hepatotoxic effects, it is recommended that alcohol consumption be avoided during treatment with leflunomide.
Zaradi možnosti aditivnih hepatotoksičnih učinkov naj bolniki med zdravljenjem z leflunomidom ne pijejo alkohola.
In a small (n=30) study with co-administration of leflunomide (10 to 20 mg per day) with methotrexate (10 to 25 mg per week) a 2- to 3-fold elevation in liver enzymes was seen on 5 of 30 patients.
V majhni (n = 30) študiji sočasne uporabe leflunomida (10 do 20 mg na dan) in metotreksata (10 do 25 mg na teden) se je pri 5 od 30 bolnikov pojavilo 2- do 3-kratno zvišanje jetrnih encimov.
As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide Zentiva and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately.
Čim se na koži in/ali sluznici pojavijo reakcije, ki zbujajo sum na takšne hude reakcije, je treba prekiniti uporabo zdravila Leflunomid Zentiva in drugih zdravil, ki bi jih lahko povzročila, in takoj začeti postopek izpiranja.
Certain vaccinations should not be given while taking Leflunomide Zentiva, and for a certain amount of time after stopping treatment.
Določenih cepiv se med uporabo zdravila Leflunomid Zentiva in določen čas po koncu tega zdravljenja ne sme uporabljati.
Symptoms of rheumatoid arthritis include inflammation of joints, swelling, difficulty moving and pain.
Simptomi revmatoidnega artritisa vključujejo vnetje sklepov, zatekanje, težko premikanje in bolečine.
Switching to other treatments
Prehod na druga zdravila
Packs of 30, 50 and 100 tablets are available.
Na voljo so pakiranja s 30, 50 in 100 tabletami.
A pack of 3 tablets is available
Na voljo je pakiranje s 3 tabletami.
It may take about 4 weeks or longer until you start to feel an improvement in your condition.
Do opaznega izboljšanja stanja lahko minejo približno 4 tedni ali še dlje.
At a dose level of 20 mg/day, average plasma concentration of A771726 at steady state is approximately 35 µg/ml.
Pri odmerku 20 mg/dan je bila povprečna plazemska koncentracija A771726 v stanju dinamičnega ravnotežja približno 35 µg/ml.
No clinical data are available on the efficacy and safety of vaccinations under leflunomide treatment.
O učinkovitosti in varnosti cepljenj med zdravljenjem z leflunomidom ni kliničnih podatkov.
Symptoms of active psoriatic arthritis include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions).
Simptomi aktivnega psoriatičnega artritisa vključujejo vnetje sklepov, zatekanje, težko premikanje, bolečine in rdeče, luskaste površine na koži (lezije kože).
• The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate).
• O ugotovljenem tveganju za sinergistično hepato ali hemato toksičnost v povezavi s kombinirano terapijo z drugimi imunomodulirajočimi protirevmatičnimi zdravili (disease modifying antirheumatic drug (DMARD) zdravili (na primer metotreksat).
pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes <2 G/L), eosinophilia
pancitopenija (verjetno zaradi antiproliferacijskega mehanizma), levkopenija (levkociti < 2 x 109/l), eozinofilija
The risk of their occurrence can be increased in patients with a history of interstitial lung disease.
Tveganje za njun pojav je lahko povečano pri bolnikih z anamnezo intersticijske bolezni pljuč.
• Breast-feeding women (see section 4.6).
• Doječe ženske (glejte poglavje 4.6).
leucopenia (leucocytes >2 G/L)
levkopenija (levkociti > 2 x 109/l)
Pregnancy must be excluded before start of treatment with leflunomide.
Pred začetkom zdravljenja z leflunomidom je treba izključiti nosečnost.
The results of a population pharmacokinetic analysis of these trials have demonstrated that paediatric patients with body weights ≤40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section
Rezultati populacijske farmakokinetične analize teh preskušanj so pokazali, da je pri pediatričnih bolnikih s telesno maso  40 kg sistemska izpostavljenost A771726 (merjena s Css) manjša kot pri odraslih bolnikih z revmatoidnim artritisom (glejte poglavje 4.2).
Since such therapy can lead to additive or even synergistic toxicity (e.g. hepato- or haematotoxicity), combination with another DMARD (e.g. methotrexate) is not advisable.
Ker lahko takšno zdravljenje povzroči aditivne ali celo sinergistične (npr. hepato- ali hemato-) toksične učinke, kombiniranje z drugimi imunomodulirajočimi protirevmatičnimi zdravili (npr. z metotreksatom) ni priporočljivo.
severe increase in blood pressure Respiratory, thoracic and mediastinal disorders Rare:
izrazito zvišanje krvnega tlaka Bolezni dihal, prsnega koša in mediastinalnega prostora Redki:
Effect of other medicinal products on leflunomide:
Vpliv drugih zdravil na leflunomid:
• Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide or to any of the excipients listed in section 6.1.
• Preobčutljivost (posebno s predhodnim Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo, multiformnim eritemom) na zdravilno učinkovino, osnovni aktivni presnovek teriflunomid ali katero koli pomožno snov, navedeno v poglavju 6.1.
DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Sindrom DRESS se v začetku pojavi v obliki gripi podobnih simptomov in izpuščaja na obrazu, nato v obliki razširjenega izpuščaja z visoko telesno temperaturo, zvišanih vrednosti jetrnih encimov, opaženih v preiskavah krvi, in povečanega števila določenega tipa belih krvnih celic (eozinofilija) ter povečanih bezgavk.
A771726 was still detectable in urine and faeces 36 days after a single administration.
A771726 je bil v urinu in blatu prisoten še 36 dni po enkratnem odmerku.
Imprint on one side: ZBO.
Na eni strani imajo napis: ZBO.
Interaction studies with cimetidine (non-specific cytochrome P450 inhibitor) and rifampicin (non-specific cytochrome P450 inducer), indicate that in vivo CYP enzymes are involved in the metabolism of leflunomide only to a small extent.
Študije interakcij s cimetidinom (nespecifičnim zaviralcem citokroma P450) in rifampicinom (nespecifičnim induktorjem citokroma P450) kažejo, da so encimi CYP in vivo v presnovo leflunomida vpleteni le v majhni meri.
Due to the very long half-life of A771726 (approximately 2 weeks), a loading dose of 100 mg for 3 days was used in clinical studies to facilitate the rapid attainment of steady-state levels of A771726.
Zaradi zelo dolgega razpolovnega časa A771726 (približno 2 tedna) so v kliničnih študijah 3 dni uporabljali udarni odmerek 100 mg, da so pospešili hitro doseganje koncentracij A771726 v stanju dinamičnega ravnotežja.
Drinking alcohol while taking Leflunomide Zentiva may increase the chance of liver damage.
Pitje alkohola med jemanjem zdravila Leflunomid Zentiva lahko poveča možnost poškodbe jeter.
Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties.
Leflunomid je imunomodulirajoče protirevmatično zdravilo z antiproliferacijskimi lastnostmi.
Therefore, when co-administered with substrates of OAT3, such as cefaclor, benzylpenicillin, ciprofloxacin, indomethacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is recommended.
Zato je med sočasno uporabo s substrati OAT3, kakršni so cefaklor, benzilpenicilin, ciprofloksacin, indometacin, ketoprofen, furosemid, cimetidin, metotreksat ali zidovudin, priporočljiva previdnost.
Effect on warfarin (CYP2C9 substrate)
Vpliv na varfarin (substrat CYP2C9)
You will normally take Leflunomide Zentiva over long periods of time.
Običajno boste zdravilo Leflunomid Zentiva jemali dolgo časa.
• Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/L (see section 4.6).
• Nosečnice in ženske v rodni dobi, ki med zdravljenjem z leflunomidom ne uporabljajo zanesljive kontracepcije; to velja tudi po zdravljenju, vse dokler je plazemska koncentracija aktivnega presnovka nad 0,02 mg/l (glejte poglavje 4.6).
Imprint on one side: ZBN.
Na eni strani imajo napis: ZBN.
If you suspect that you are pregnant while taking Leflunomide Zentiva or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Če med jemanjem zdravila Leflunomid Zentiva ali v dveh letih po koncu zdravljenja posumite, da ste zanosili, morate o tem nemudoma obvestiti svojega zdravnika in opraviti nosečnostni test.
Adverse events consistent with the safety profile for leflunomide were: abdominal pain, nausea, diarrhoea, elevated liver enzymes, anaemia, leucopenia, pruritus and rash.
Neželeni učinki, skladni z varnostnim profilom leflunomida, so bili: bolečine v trebuhu, navzeja, driska, zvišani jetrni encimi, anemija, levkopenija, srbenje in izpuščaj.
Leflunomide 20 mg/day was significantly superior to placebo in reducing the symptoms of arthritis in patients with psoriatic arthritis: the PsARC (Psoriatic Arthritis treatment Response Criteria) responders were 59% in the leflunomide group and 29.7% in the placebo group by 6 months (p<0.0001).
Leflunomid v odmerku 20 mg/dan je simptome artritisa pri bolnikih s psoriatičnim artritisom zmanjšal značilno bolj kot placebo: bolnikov, ki so se odzvali po merilih PsARC (Psoriatic Arthritis treatment Response Criteria; merila odziva na zdravljenje psoriatičnega artritisa), je bilo do 6. meseca med prejemniki leflunomida 59 % in med prejemniki placeba 29,7 % (p < 0,0001).
Administration of activated charcoal (powder made into a suspension) orally or via nasogastric tube (50 g every 6 hours for 24 hours) has been shown to reduce plasma concentrations of the active metabolite A771726 by 37% in 24 hours and by 48% in 48 hours.
Dokazano je, da uporaba aktivnega oglja (prašek, pripravljen v suspenziji) peroralno ali po nazogastrični sondi (50 g na 6 ur v 24 urah) zniža plazemsko koncentracijo aktivnega presnovka A771726 za 37 % v 24 urah in za 48 % v 48 urah.
The metabolic biotransformation of leflunomide to A771726 and subsequent metabolism of A771726 is not controlled by a single enzyme and has been shown to occur in microsomal and cytosolic cellular fractions.
Presnovne biotransformacije leflunomida v A771726 in nadaljnje presnove A771726 ne uravnava en sam encim in dokazano je, da se pojavi v mikrosomski in citosolski celični frakciji.
All of these also resolved, 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
Tudi pri teh je izginilo, pri 2 ob nadaljevanju uporabe obeh zdravil in pri 3 po opustitvi leflunomida.
Animal pharmacology
Farmakologija pri živalih
An in vivo interaction study with leflunomide and cimetidine (non-specific weak cytochrome P450 (CYP) inhibitor) has demonstrated a lack of a significant impact on A771726 exposure.
Študija interakcij z leflunomidom in cimetidinom (nespecifičnim šibkim zaviralcem citokroma P450) in vivo ni pokazala pomembnega vpliva na izpostavljenost A771726.
If a patient taking Leflunomide Zentiva develops a peripheral neuropathy, consider discontinuing Leflunomide Zentiva therapy and performing the drug elimination procedure (see section 4.4).
Če bolnik med jemanjem zdravila Leflunomid Zentiva razvije periferno nevropatijo, je potrebno razmisliti o ukinitvi terapije z zdravilom Leflunomid Zentiva in o izvajanju postopka za eliminacijo zdravila (glejte poglavje 4.4).
cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
kožni eritematozni lupus, postulozna psoriaza ali njeno poslabšanje, neželena reakcija z eozinofilijo in sistemskimi simptomi (sindrom DRESS)
Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable.
Študije s hemodializo in kontinuirano ambulantno peritonealno dializo (CAPD) kažejo, da A771726, primarnega presnovka leflunomida, ni mogoče odstraniti z dializo.
If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, these may be continued after starting leflunomide.
Če bolnik že prejema nesteroidna protivnetna zdravila (NSAIDs - nonsteroidal anti-inflammatory drugs), kortikosteroide ali oboje, jih lahko po začetku jemanja leflunomida uporablja še naprej.
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Leflunomide Zentiva are provided with a physician educational pack containing the following:
Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo Leflunomid Zentiva dobili izobraževalno gradivo, ki vsebuje:
Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.
Sočasna uporaba hepatotoksičnih ali hematotoksičnih imunomodulirajočih protirevmatičnih zdravil (npr. metotreksata) ni priporočljiva.
Reliable contraception during treatment with leflunomide should also be guaranteed.
Zato je tudi med njihovim zdravljenjem z leflunomidom potrebna zanesljiva kontracepcija.
Male patients should be aware of the possible male-mediated foetal toxicity.
Moški bolniki se morajo zavedati možnih toksičnih učinkov za plod, ki jih lahko posreduje moški.
Therefore, when warfarin is co-administered, close INR follow-up and monitoring is recommended.
Zato so med sočasno uporabo varfarina priporočljivi skrbno spremljanje in kontrole INR.
The extent of leflunomide absorption is not affected if it is taken with food.
Zaužitje leflunomida s hrano ne vpliva na obseg njegove absorpcije.
The principal faecal component was A771726.
Glavna sestavina blata je A771726.
Aluminium / Aluminium blister.
Pretisni omot: Aluminij/aluminij pretisni omot.
Therefore, closer monitoring of liver enzymes and haematological parameters is recommended in the initial phase after switching.
V začetnem obdobju po zamenjavi je zato priporočljivo natančnejše spremljanje jetrnih encimov in hematoloških parametrov.
This includes any possible side effects not listed in this leaflet.
Posvetujte se tudi, če opazite katerekoli neželene učinke, ki niso navedeni v tem navodilu.
A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n=121) with early RA, who received either 20 mg or 100 mg of leflunomide in two parallel groups during the initial three day double blind period.
Randomizirana študija je ocenila delež odzivnosti pri bolnikih (n = 121), ki še niso bili zdravljeni z imunomodulirajočimi protirevmatičnimi zdravili, so imeli zgoden RA in so med uvodnim tridnevnim dvojno slepim obdobjem prejemali bodisi 20 mg bodisi 100 mg leflunomida v dveh vzporednih skupinah.
Leflunomide Zentiva is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Zdravilo Leflunomid Zentiva je kontraindicirano pri bolnikih s hudo hipoproteinemijo ali okvarjenim delovanjem jeter (glejte poglavje 4.3).
Pack sizes: 30 and 100 film-coated tablets.
Velikosti pakiranj: 30 in 100 filmsko obloženih tablet.
Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide Zentiva, as you need to ensure that all traces of Leflunomide Zentiva have left your body before trying to become pregnant.
Povejte svojemu zdravniku, če nameravate po prenehanju zdravljenja z zdravilom Leflunomid Zentiva zanositi, saj se morate, preden poskušate zanositi prepričati, da v telesu ni več ostankov zdravila Leflunomid Zentiva.
Thereafter, the A771726 plasma concentration must be determined again after an interval of at least 14 days.
Potem je treba koncentracijo A771726 v plazmi znova izmeriti po intervalu vsaj 14 dni.
The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy.
Aktivni presnovek leflunomida, A771726, domnevno povzroča resne okvare ploda, če ga jemljejo nosečnice.
Leflunomide Zentiva is contraindicated in pregnancy(see section 4.3).
Zdravilo Leflunomid Zentiva je kontraindicirano med nosečnostjo (glejte poglavje 4.3).