natgillin/translations-raw huggingface dataset:
Most findings in general toxicity studies were related to its action on progesterone receptors (and at higher concentrations on glucocorticoid receptors), with antiprogesterone activity observed at exposures similar to therapeutic levels. 
Večina ugotovitev študij splošne toksičnosti je bila povezana z delovanjem na progesteronske receptorje (in v večjih koncentracijah na glukokortikoidne receptorje), pri čemer so delovanje proti progesteronu opazili pri izpostavljenosti, podobni terapevtskim ravnem.
The size of the three largest myomas was assessed by ultrasound at the end of treatment (Week 13) and for another 25 weeks without treatment in patients who did not have hysterectomy or myomectomy performed. 
Velikost treh največjih miomov so z ultrazvokom ocenjevali na koncu zdravljenja (13. teden) in še 25 tednov po koncu zdravljenja pri bolnicah, pri katerih niso izvedli histerektomije ali miomektomije.
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However, if you continue to experience excessive bleeding tell your doctor. 
Če pa čezmerne krvavitve ne prenehajo, povejte svojemu zdravniku.
In all Phase III studies including repeated intermittent treatment studies, a total of 7 cases of hyperplasia were observed out of 789 patients with adequate biopsies (0.89%). 
V vseh študijah III. faze, vključno s študijami ponavljajočega se intermitentnega zdravljenja, so med 789 bolnicami, pri katerih so opravili ustrezno biopsijo (0,89 %), opazili skupno 7 primerov hiperplazije.
When ulipristal acetate treatment is stopped, menstrual cycles generally resume within 4 weeks. 
Ko se zdravljenje z ulipristalacetatom konča, se menstruacijski cikel navadno ponovno začne v 4 tednih.
Due to its mechanism of action, ulipristal acetate has an embryolethal effect in rats, rabbits (at repeated doses above 1 mg/kg), guinea pigs and in monkeys. 
Zaradi načina delovanja ima ulipristalacetat smrtne učinke na zarodke podgan, kuncev (pri ponavljajočih se odmerkih nad 1 mg/kg), morskih prašičkov in opic.
Esmya is used in adult women (over 18 years of age) before they reach the menopause. 
Zdravilo Esmya se uporablja pri odraslih ženskah (starejših od 18 let), ki še niso v menopavzi.
These blood tests will inform the doctor of the functioning of your liver and are vital when monitoring your treatment. 
Te krvne preiskave odražajo delovanje vaših jeter in so za zdravnika bistvene pri spremljanju vašega zdravljenja.
Ulipristal acetate should only be prescribed after careful diagnosis. 
Ulipristalacetat se sme predpisati samo po skrbni diagnozi.
In the placebo-controlled study, the rate of hot flushes was 1.0% for ulipristal acetate and 0% for placebo. 
V s placebom nadzorovani študiji je bil delež vročinskih oblivov v skupini z ulipristalacetatom 1,0 %, v skupini s placebom pa 0 %.
The European Medicines Agency has waived the obligation to submit the results of studies with Esmya in all subsets of the paediatric population in leiomyoma of uterus (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Esmya za vse skupine pediatrične populacije pri zdravljenju materničnih leiomiomov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The tablet should be swallowed with water and may be taken with or without food. 
Tableto pogoltnite z vodo, lahko pa jo vzamete s hrano ali brez nje.
The treatment courses should each not exceed 3 months as the risk of adverse impact on the endometrium is unknown if treatment is continued without interruption. 
Cikli zdravljenja ne smejo trajati več kot 3 mesece, saj je tveganje za neželeni vpliv na endometrij pri nadaljevanju zdravljenja brez prekinitev neznano.
There have been no reports of serious harmful effects from taking several doses of this medicine at once. 
Ni poročil o tem, da bi zaužitje več odmerkov tega zdravila naenkrat povzročilo resne neželene učinke.
In a 39-week study in cynomolgus monkeys, histological changes resembling PAEC were noted at low doses. 
V 39-tedenski študiji pri opicah iz rodu Cynomolgus so pri majhnih odmerkih opazili histološke spremembe, podobne spremembam PAEC.
• inform the patients about the symptoms and signs of possible liver injury so that they are aware of situations in which they should stop treatment and contact a physician in a timely manner. 
• bolnice obvestite o simptomih in znakih morebitne okvare jeter, tako da se zavedajo primerov, v katerih morajo prenehati z zdravljenjem in pravočasno obvestiti zdravnika.
The most common finding in clinical trials was amenorrhea (79.2%), which is considered as a desirable outcome for the patients (see section 4.4). 
Najpogostejša ugotovitev v kliničnih preskušanjih je bila amenoreja (79,2 %), ki so jo obravnavali kot želeni rezultat pri bolnicah (glejte poglavje 4.4).
If you miss a dose by more than 12 hours, skip the missed tablet and take only a single tablet as usual. 
Če odmerek zamudite za več kot 12 ur, izpustite pozabljeno tableto in vzemite samo eno tableto, kot običajno.
Ulipristal acetate does not affect serum levels of TSH, ACTH or prolactin. 
Ulipristalacetat ne vpliva na ravni TSH, ACTH ali prolaktina v serumu.
These changes should not be confused with endometrial hyperplasia. 
Teh sprememb se ne sme zamenjati s hiperplazijo endometrija.
• treatment must be stopped if the patient develops ALT or AST > 3 x ULN. 
• zdravljenje je treba prekiniti, če se pri bolnici pojavijo vrednosti ALT ali AST > 3 x ZMN.
These histological changes are denoted as “Progesterone Receptor Modulator Associated Endometrial Changes” (PAEC) and should not be mistaken for endometrial hyperplasia (see sections 4.8 and 5.1). 
Te histološke spremembe se imenujejo »spremembe endometrija, povezane z modulatorji progesteronskih receptorjev« (PAEC - Progesterone Receptor Modulator Associated Endometrial Changes) in jih ne smemo zamenjati za hiperplazijo endometrija (glejte poglavji 4.8 in 5.1).
This card provides information on blood tests you will need throughout treatment and on what you should do if liver side effects occur. 
Ta kartica vsebuje informacije o krvnih preiskavah, ki jih boste opravili tekom zdravljenja, in o tem, kaj morate storiti, če se pojavijo neželeni učinki povezani z delovanjem jeter.
Menstrual periods generally return within 4 weeks after the end of each treatment course. 
Menstruacije se praviloma ponovno pojavijo v 4 tednih po koncu vsakega cikla zdravljenja.
Patients who develop transaminase levels (ALT or AST) > 3 times the upper limit of normal during treatment should stop treatment and be closely monitored. 
Bolnice, pri katerih se med zdravljenjem pojavijo koncetracije transaminaz (ALT ali AST) > 3-krat višje od zgornje meje normalnih vrednosti, morajo prenehati z zdravljenjem in jih je treba pozorno spremljati.
Study 4 was a randomized, double-blind clinical study assessing ulipristal acetate 5 or 10 mg. 
Študija 4 je bila randomizirana, dvojno slepa klinična študija za oceno ulipristalacetata v odmerku 5 ali 10 mg.
In vitro data indicate that ulipristal acetate and its active metabolite are not P-gp (ABCB1) substrates. 
Podatki in vitro kažejo, da ulipristalacetat in njegov aktivni presnovek nista substrata P-gp (ABCB1)
Simultaneous administration of ulipristal acetate and a P-gp substrate has not been studied and an interaction cannot be excluded. 
Sočasne uporabe ulipristalacetata in substrata P-gp niso raziskali, tako da interakcije ni mogoče izključiti.
Table 2: Results of primary and selected secondary efficacy assessments in long term Phase III studies Parameter 
Preglednica 2: Rezultati ocenjevanja primarne in izbrane sekundarne učinkovitosti v dolgotrajnih študijah III. faze
Medicinal products containing progestagen should not be taken within 12 days after cessation of ulipristal acetate treatment. 
Zdravil, ki vsebujejo progestagen, bolnice ne smejo jemati 12 dni po prenehanju zdravljenja z ulipristalacetatom.
In addition, reversible changes to the endometrium are denoted PAEC and are different from endometrial hyperplasia. 
Poleg tega so reverzibilne spremembe endometrija razvrščene kot spremembe PAEC in se razlikujejo od hiperplazije endometrija.
• Educational material for pathologists which contains o Pathologist's guide o USB stick or CD ROM with images of digital specimens (digital library with high resolution images) o SmPC 
• Izobraževalno gradivo za patologe, ki vsebuje: o vodnik za patologe, o pogon USB ali CD ROM z digitalnimi slikami vzorcev (digitalna knjižnica s slikami v visoki ločljivosti), o povzetek glavnih značilnosti zdravila,
Other medicines and Esmya 
Druga zdravila in zdravilo Esmya
• the differential diagnosis between PAEC, unopposed oestrogen and endometrial hyperplasia. 
• diferencialna diagnoza med PAEC, neoviranim estrogenom in hiperplazijo endometrija.
In study 1, a statistically significant difference was observed in reduction in menstrual blood loss in favour of the patients treated with ulipristal acetate compared to placebo (see Table 1 below), resulting in faster and more efficient correction of anaemia than iron alone. 
V prvi študiji so opazili statistično pomembno razliko v zmanjšanju izgube menstruacijske krvi v korist bolnic, ki so jih zdravili z ulipristalacetatom, v primerjavi s placebom (glejte spodnjo preglednico 1), kar je povzročilo hitrejšo in učinkovitejšo korekcijo anemije kot monoterapija z železom.
• inform the patients about the need for monitoring of liver function before starting each treatment course, monthly during treatment and within a few weeks after the treatment has stopped. 
• bolnice obvestite, da je treba opraviti preiskave delovanja jeter pred začetkom vsakega cikla zdravljenja, mesečno med zdravljenjem in v nekaj tednih po prenehanju zdravljenja.
A few cases have been reported during ulipristal acetate treatment or within 2-3 months after ulipristal acetate treatment was stopped. 
O nekaj primerih so poročali med zdravljenjem z ulipristalacetatom ali 2-3 mesece po koncu zdravljenja z ulipristalacetatom.
In case of hyperplasia (without atypia), monitoring as per usual clinical practice (e.g. a follow-up control 3 months later) would be recommended. 
V primeru hiperplazije endometrija (brez atipičnosti) se priporoča spremljanje skladno z običajno klinično prakso (npr. kontrolni pregled čez 3 mesece).
When comparing repeated treatment courses, overall adverse reactions rate was less frequent in subsequent treatment courses than during the first one and each adverse reaction was less frequent or remained in the same frequency category (except for dyspepsia which was classified as uncommon in treatment course 3 based on one patient occurence). 
Pri primerjavi ponavljajočih se ciklov zdravljenja so bili neželeni učinki na splošno manj pogosti pri nadaljnjih ciklih zdravljenja kot med prvim in vsak neželeni učinek je bil manj pogost ali je ostal v isti skupini pogostnosti (razen dispepsije, ki je bila na podlagi pojavnosti pri eni bolnici opredeljena kot občasna v 3. ciklu zdravljenja).
Patients in this study were required to be anaemic at Study entry (Hb < 10.2 g/dl) and all patients were to receive oral iron 80 mg Fe++ in addition to study medicinal product. 
Bolnice, vključene v to študijo, so morale biti ob vključevanju v študijo anemične (Hb < 10,2 g/dl), vse bolnice pa so morale poleg preiskovanega zdravila peroralno prejemati tudi železo, 80 mg Fe++.
Available toxicological data in animals have shown excretion of ulipristal acetate in milk (for details see section 5.3). 
Toksikološki podatki, ki so na voljo, so pokazali, da se ulipristalacetat izloča v mleko (podrobnosti so v poglavju 5.3).
• recommendation of a periodic monitoring of the endometrium in case of repeated intermittent treatment. 
• priporočilo rednega spremljanja stanja endometrija pri ponavljajočem se intermitentnem zdravljenju.
• key effects of Esmya on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen. 
• ključni učinki zdravila Esmya na spremembe endometrija, povezane z modulatorji progesteronskih receptorjev (PAEC- Progesterone Receptor Modulator Associated Endometrial Changes) in kako se ti učinki razlikujejo od učinkov neoviranega estrogena,
- The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium, talc and magnesium stearate. 
- Druge sestavine zdravila so mikrokristalna celuloza, manitol, premreženi natrijev karmelozat, smukec in magnezijev stearat.
In vitro data indicate that ulipristal acetate and its active metabolite do not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, or induce CYP1A2 at clinically relevant concentrations. 
Podatki in vitro kažejo, da ulipristalacetat in njegovi aktivni presnovki pri klinično pomembnih koncentracijah ne zavirajo encimov CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 in 3A4 ali inducirajo CYP1A2.
In vivo results show that ulipristal acetate (administered as a single 10 mg tablet) 1.5 hour before administration of the P-gP substrate fexofenadine (60 mg) has no clinically relevant effects on the pharmacokinetic of fexofenadine. 
In vivo rezultati kažejo, da ulipristalacetat (uporaba v obliki ene 10 mg tablete) 1,5 ure pred uporabo substrata P-gp feksofenadina (60 mg) nima klinično pomembnih učinkov na farmakokinetiko feksofenadina.
Esmya is likely to make some hormonal contraceptives less effective (see “Other medicines and Esmya”). 
Zdravilo Esmya lahko zmanjša učinkovitost nekaterih hormonskih kontracepcijskih sredstev (glejte poglavje »Druga zdravila in zdravilo Esmya«).
Renal impairment is not expected to significantly alter the elimination of ulipristal acetate. 
Ni pričakovati, da bi ledvična okvara bistveno spremenila izločanje ulipristalacetata.
Patients with heavy menstrual bleeding due to uterine fibroids are at risk of excessive bleeding, which may require surgical intervention. 
Bolnice z močnimi menstruacijami zaradi materničnih leiomiomov so izpostavljene tveganju čezmerne krvavitve, pri kateri je lahko potrebna kirurška intervencija.
Should the excessive bleeding persist, patients should notify their physician. 
Če čezmerne krvavitve ne prenehajo, morajo bolnice obvestiti svojega zdravnika.
In vitro data indicate that this is predominantly mediated by the cytochrome P450 3A4 isoform (CYP3A4). 
Podatki in vitro kažejo, da to večinoma poteka prek izoforme 3A4 citokroma P450 (CYP3A4).
Repeated intermittent treatment has been studied up to 4 intermittent treatment courses. 
Pri ponavljajočem se intermitentnem zdravljenju so preučili do 4 intermitentne cikle zdravljenja.
Based on pooled data from four phase III studies in patients with uterine fibroids treated for 3 months, the following adverse reactions have been reported. 
Na podlagi združenih podatkov štirih študij III. faze pri bolnicah z materničnimi leiomiomi, ki so jih zdravili 3 mesece, so poročali o naslednjih neželenih učinkih.
Although no teratogenic potential was observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3). 
Čeprav niso opazili nobenega teratogenega potenciala, študije na živalih niso zadostne za oceno vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
Study 2 contained the active comparator, leuprorelin 3.75 mg given once per month by intramuscular injection. 
Druga študija je vključevala primerjalno zdravilno učinkovino, levprorelin, 3,75 mg enkrat na mesec v obliki intramuskularnega injiciranja.
Patients starting treatment course 2 or 4 
Bolnice, ki so začele 2. ali 4. cikel zdravljenja
• detailed recommendations for management of endometrial thickening. 
• podrobna priporočila za obravnavanje odebelitve endometrija,
Reproduction studies performed in rats at doses giving exposure in the same range as the human dose have revealed no evidence of impaired fertility due to ulipristal acetate in treated animals or the offspring of treated females. 
Študije razmnoževanja in plodnosti, ki so jih opravili na podganah pri odmerkih, pri katerih je bila izpostavljenost v enakem razponu kot odmerjanje pri človeku, niso pokazale nobenih dokazov zmanjšane plodnosti zaradi ulipristalacetata pri zdravljenih živalih in potomcih zdravljenih samic.
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progesterone receptor modulators. 
Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, modulatorji progesteronskih receptorjev.
Adverse reactions during treatment course 1 Very common Common 
Neželeni učinki v 1. ciklu zdravljenja Zelo pogosti
If hysterectomy or endometrial biopsy specimens are sent for histology, then the pathologist should be informed that the patient has taken ulipristal acetate (see sections 4.4 and 5.1). 
Če se vzorci histerektomije ali biopsije endometrija pošljejo na histološke preiskave, je treba patologa obvestiti, da bolnica jemlje ulipristalacetat (glejte poglavji 4.4 in 5.1).
Ulipristal acetate may have minor influence on the ability to drive or use machines as mild dizziness has been observed after ulipristal acetate intake. 
Ulipristalacetat ima lahko manjši vpliv na sposobnost vožnje ali upravljanja strojev, saj so pri zaužitju ulipristalacetata opazili blago omotico.
Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Esmya treatment. 
Zato uporaba hormonskih kontracepcijskih sredstev ni priporočljiva in morate med zdravljenjem z zdravilom Esmya uporabiti drugo zanesljivo pregradno kontracepcijsko metodo, kot je kondom.
Studies 3 and 4 showed efficacy in controlling uterine fibroid symptoms (e.g. uterine bleeding) and reducing fibroid size after 2 and 4 courses. 
Študiji 3 in 4 sta dokazali učinkovitost pri nadzoru simptomov leiomiomov (npr. krvavitve iz maternice) ter zmanjšanju velikosti leiomiomov po 2 in 4 ciklih zdravljenja.
• inform the patients about potential adverse reactions related to liver that could be caused by the use of Esmya. 
• bolnice obvestite o možnih neželenih učinkih, povezanih z jetri, ki jih lahko povzroči jemanje zdravila Esmya.
You should always start taking Esmya within the first week of your menstrual period. 
Zdravilo Esmya vedno začnite jemati v prvem tednu menstruacije.
In both studies menstrual blood loss was assessed using the Pictorial Bleeding Assessment Chart (PBAC). 
V obeh študijah se je izguba krvi med menstruacijo ocenjevala s Slikovno lestvico za ocenjevanje krvavitve (Pictorial Bleeding Assessment
Ulipristal acetate and its active mono-N-demethylated metabolite are excreted in breast milk with a mean AUCt milk/plasma ratio of 0.74 ± 0.32 for ulipristal acetate. 
Ulipristalacetat in njegov aktivni mono-N-demetilirani presnovek se izločata v materinem mleku s povprečnim razmerjem AUCt mleko/plazma, ki znaša 0,74 ±0,32 za ulipristalacetat.
Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported. 
Omejenemu številu preskušancev so dajali enkratne odmerke do 200 mg in dnevne odmerke 50 mg v 10 zaporednih dneh, vendar niso poročali o nobenih hudih ali resnih neželenih učinkih.
Likewise, patients treated with ulipristal acetate had a greater reduction in myoma size, as assessed by MRI. 
Bolnice, ki so prejemale ulipristalacetat, so imele prav tako večje zmanjšanje miomov, ki so ga ocenili z MRI.
Thus administration of ulipristal acetate is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes. 
Zato ni verjetno, da bo uporaba ulipristalacetata spremenila očistek zdravil, ki jih presnavljajo ti encimi.
Potential for other medicinal products to affect ulipristal acetate: 
Možnost vpliva drugih zdravil na ulipristalacetat:
Esmya with food and drink You should avoid drinking grapefruit juice while on treatment with Esmya. 
Zdravilo Esmya skupaj s hrano in pijačo Med jemanjem zdravila Esmya se izogibajte uživanju soka grenivke.
This includes annual ultrasound to be performed after resumption of menstruation during off-treatment period. 
To vključuje letni pregled z ultrazvokom po ponovnem pojavu menstruacije v obdobju brez zdravljenja.
What you need to know before you take Esmya 
Kaj morate vedeti, preden boste vzeli zdravilo Esmya
Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment. 
Bolnice je treba obvestiti, da ulipristalacetat v prvih 10 dneh zdravljenja ponavadi povzroči bistveno zmanjšanje menstrualnih krvavitev ali amenorejo.
Due to the CYP-mediated metabolism, hepatic impairment is expected to alter the elimination of ulipristal acetate, resulting in increased exposure. 
Zaradi presnavljanja prek CYP pričakujejo, da bo jetrna okvara spremenila izločanje ulipristalacetata, kar bo povzročilo povečano izpostavljenost.
Depending on the result of these tests, the doctor will decide if treatment with Esmya is suitable for you. 
Glede na rezultate teh preiskav bo zdravnik odločil, ali je zdravljenje z zdravilom Esmya za vas primerno.
Anxiety Emotional disorder 
Psihiatrične motnje tesnoba čustvene motnje
Esmya is likely to make some hormonal contraceptives less effective. 
Zdravilo Esmya lahko zmanjša učinkovitost nekaterih hormonskih kontracepcijskih sredstev.
Marketing Authorisation Holder Gedeon Richter Plc. 
Imetnik dovoljenja za promet Gedeon Richter Plc.
You should nonetheless ask your doctor or pharmacist for advice if you take more Esmya than you should. 
Kljub temu pa se posvetujte s svojim zdravnikom ali farmacevtom, če ste vzeli večji odmerek zdravila Esmya, kot bi smeli.
Asthma patients 
Bolnice z astmo
For further treatment courses, your liver will be checked once before each new treatment course and if you experience any of the symptoms described below. 
Za nadaljnje cikle zdravljenja pa se bodo preiskave delovanja vaših jeter opravljale pred vsakim novim ciklom zdravljenja in če se bo pri vas pojavil kateri od simptomov, opisanih spodaj.
Pregnancy and breastfeeding. 
Nosečnost in dojenje.
Functional ovarian cysts were observed during and after treatment in 1.0% of patients and in most of the cases spontaneously disappeared within a few weeks. 
Med zdravljenjem in po njem so pri 1,0 % bolnic opazili funkcionalne ciste jajčnikov, od katerih jih je večina izginila v nekaj tednih.
Study 1 was double-blind placebo controlled. 
Prva študija je bila dvojno slepa in nadzorovana s placebom.
One possible side effect is serious damage to your liver. 
Eden izmed možnih neželenih učinkov je resna okvara jeter.
Typically, the histological appearance is an inactive and weakly proliferating epithelium associated with asymmetry of stromal and epithelial growth resulting in prominent cystically dilated glands with admixed oestrogen (mitotic) and progestin (secretory) epithelial effects. 
Pri histološkem pregledu se običajno kaže neaktivni epitelij, ki se slabo razmnožuje in je povezan z asimetrijo med stromalno in epitelijsko rastjo, kar povzroča močno cistično razširjene žleze in dodatne estrogenske (mitotske) in progestinske (sekrecijske) epitelijske učinke.
In the active comparator controlled study the rates were 24% (10.5% moderate or severe) for ulipristal acetate and 60.4% (39.6% moderate or severe) for leuprorelin-treated patients. 
V nadzorovani študiji s primerjalno zdravilno učinkovino je bil delež v skupini z ulipristalacetatom 24 % (10,5 %zmernih ali hudih), v skupini bolnic, ki so jih zdravili z levprorelinom pa 60,4 % (39,6 % zmernih ali hudih).
This kinetic effect of food is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets. 
Ni pričakovati, da bi bil kinetični učinek hrane klinično pomemben za dnevno uporabo tablet ulipristalacetata.
What Esmya is and what it is used for What you need to know before you take Esmya How to take Esmya 
Kaj je zdravilo Esmya in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Esmya Kako jemati zdravilo Esmya Možni neželeni učinki
Endometrial changes 
Spremembe na endometriju
These tests will be repeated monthly for the first 2 treatment courses. 
Te preiskave se bodo v prvih dveh ciklih zdravljenja izvajale enkrat mesečno.