natgillin/translations-raw huggingface dataset:
• There have been reports of kidney failure in some patients when taking pregabalin.
• Pri nekaterih bolnikih, ki so jemali pregabalin, so opisani primeri odpovedi ledvic.
Talk to your doctor or pharmacist before taking Pregabalin Zentiva k.s.
Pred začetkom jemanja zdravila Pregabalin Zentiva k.s.
NAME OF THE MEDICINAL PRODUCT Pregabalin Zentiva k.s.
Shranjevanje zdravila Pregabalin Zentiva k.s.
Date of first authorisation: 23 February 2012 Date of latest renewal: 14 November 2016
Datum prve odobritve: 23. februar 2012 Datum zadnjega podaljšanja: 14. november 2016
WHAT YOU NEED TO KNOW BEFORE USE?
KAJ MORATE VEDETI PRED UPORABO?
Median change at week 13
Mediana spremembe v 13. tednu
WHAT TO DO BEFORE DURING AND AFTER YOUR TREATMENT?
KAJ STORITI PRED, MED IN PO ZDRAVLJENJU?
b Patients with missing values were exluded from the analysis.
b Bolnice z manjkajočimi vrednostmi so bile izključene iz analize.
See also section 2 Warnings and precautions.
Glejte tudi poglavje 2 Opozorila in previdnostni ukrepi.
Repeated intermittent use:
Ponavljajoča se intermitentna uporaba:
Tablets should be swallowed with water.
Tablete je treba pogoltniti z vodo.
Frequency Not known
Pogostnost neznana
The educational material shall contain the following key elements:
Izobraževalno gradivo mora vsebovati naslednje ključne elemente:
Do not drive or use machines if you experience these symptoms.
Ne upravljajte vozil ali strojev, če imate te simptome.
ATC code: G03XB02.
Oznaka ATC: G03XB02.
Patients with controlled bleeding b,c, d
Bolnice z nadzorovano krvavitvijo b,c,d
The safety for a human embryo is unknown.
Varnost za zarodek pri človeku ni znana.
P values: 1 = <0.001, 2 = 0.037, 3= <0.002, 4 = <0.006.
Vrednosti p: 1 = <0,001, 2 = 0,037, 3= <0,002, 4 = <0,006.
You should discuss this with your doctor.
O tem se posvetujte z zdravnikom.
Frequencies are defined as very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data).
Pogostnost je opredeljena kot zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Tablets may be taken with or without food.
Tablete se lahko jemljejo s hrano ali brez nje.
Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Hungary
Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Madžarska
During each course of treatment, do not stop taking your tablets without the advice of your doctor even if you feel better, as symptoms may re-occur later.
V času vsakega cikla zdravljenja ne prenehajte jemati tablet, če vam tako ne naroči zdravnik, tudi če se počutite bolje, saj se simptomi lahko pozneje pojavijo znova.
The main route of elimination is through faeces and less than 10% is excreted in the urine.
Glavna pot izločanja je z blatom, manj kot 10 % pa se izloči z urinom.
Have regular blood tests
Redno opravljanje krvnih preiskav
The educational material shall consist of the following:
Izobraževalno gradivo mora vsebovati naslednje:
The most frequent adverse reaction was hot flush.
Najpogostejši neželeni učinek je bil vročinski obliv.
The safety and efficacy of ulipristal acetate was only established in women of 18 years and older.
Varnost in učinkovitost ulipristalacetata so ugotovili samo pri ženskah, starih 18 let ali več.
Adverse reactions listed below are classified according to frequency and system organ class.
Spodaj navedeni neželeni učinki so razvrščeni glede na pogostnost in organske sisteme.
• pain in the upper right stomach
• bolečina v zgornjem desnem delu trebuha
These tests need to happen every month, including a few weeks after you finish a course of treatment (see schedule below).
Te preiskave je treba izvesti vsak mesec, vključno s preiskavo nekaj tednov po zaključku zdravljenja (glejte razpored spodaj).
Pack of 28, 30 and 84 tablets.
Pakiranje z 28, 30 in 84 tabletami.
Hot flushes were reported by 8.1% of patients but the rates varied across trials.
O vročinskih oblivih so poročali pri 8,1 % bolnic, vendar pa je bil ta delež med preskušanji različen.
Alu/PVC/PE/PVDC or Alu/PVC/PVDC blister.
Pretisni omot iz Al/PVC/PE/PVDC ali Al/PVC/PVDC.
• the indications.
• indikacije,
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
• fatigue, severe tiredness
• utrujenost, huda utrujenost
Headache Mild or moderate severity headache was reported in 5.8% of patients.
Glavobol O blagem ali zmernem glavobolu so poročali pri 5,8 % bolnic.
* see section "Description of selected adverse reactions" ** The verbatim term “mild hair loss” was coded to the term “alopecia”
* glejte poglavje »Opis izbranih neželenih učinkov« ** Dobesedni izraz blaga izguba las se je razvrstil kot izraz »alopecija«.
Esmya should not be taken by children under 18 years of age since safety and efficacy of ulipristal acetate has not been established in this age group.
Otroci, mlajši od 18 let, zdravila Esmya ne smejo jemati, saj varnost in učinkovitost ulipristalacetata v tej starostni skupini nista dokazani.
Pregnancy should be precluded prior to treatment.
Pred zdravljenjem je treba izključiti nosečnost.
These are possible symptoms of angioedema (frequency not known).
To so možni simptomi angioedema (pogostnost ni znana).
Contraception in females
Kontracepcija pri ženskah
At doses which were low enough to maintain gestation in the animal species, no teratogenic potential was observed.
Pri odmerkih, ki so bili dovolj majhni za vzdrževanje brejosti pri živalskih vrstah, niso opazili nobenega teratogenega potenciala.
Esmya passes into the breast milk.
Zdravilo Esmya prehaja v materino mleko.
THE TABLE BELOW HELPS YOU TO TRACK YOUR BLOOD TESTS:
SPODNJA PREGLEDNICA SLUŽI KOT POMOČ PRI SPREMLJANJU KRVNIH PREISKAV:
Do not take Esmya if you are pregnant.
Ne jemljite zdravila Esmya, če ste noseči.
Educational material for pathologists
Izobraževalno gardivo za patologe
It is available in Alu/PVC/PE/PVDC blisters in cartons containing 28, 30 and 84 tablets or Alu/PVC/PVDC blisters in cartons containing 28 and 84 tablets.
Na voljo je v pretisnih omotih iz Al/PVC/PE/PVDC, v škatlah, ki vsebujejo 28, 30 in 84 tablet ali omotih iz Al/PVC/PVDC, v škatlah, ki vsebujejo 28 in 84 tablet.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
The observed frequency is in line with control groups and prevalence reported in literature for symptomatic premenopausal women of this age group (mean of 40 years).
Opažena pogostost je bila skladna s kontrolnimi skupinami in prevalenco, o kateri poročajo v literaturi, pri simptomatskih ženskah pred menopavzo v tej starostni skupini (povprečno 40 let).
Treatment whilst pregnant might affect your pregnancy (it is not known if Esmya might harm your baby or whether can cause miscarriage).
Zdravljenje med nosečnostjo lahko vpliva na nosečnost (ni znano, ali zdravilo Esmya lahko škoduje vašemu otroku ali morda lahko pride do spontanega splava).
If you miss a dose by less than 12 hours, take it as soon as you remember.
Če za manj kot 12 ur pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
Do not throw away via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Table 1: Results of primary and selected secondary efficacy assessments in Phase III studies
Preglednica 1: Rezultati ocenjevanja primarne in izbrane sekundarne učinkovitosti v študijah III. faze
• absence of safety data on the endometrium for continuous treatment longer than 3 months.
• odsotnost podatkov o varnosti za endometrij pri neprekinjenem zdravljenju, ki traja dlje kot 3 mesece,
The doctor should check your liver immediately and decide if you can continue the treatment.
Zdravnik mora takoj opraviti preiskavo delovanja jeter in se odločiti, ali lahko z zdravljenjem nadaljujete.
• yellow skin/eyes
• porumenelost kože/oči
This medicine acts by modifying the activity of progesterone, a naturally occuring hormone in the body.
To zdravilo deluje tako, da spremeni aktivnost progesterona, naravnega hormona v telesu.
The vast majority of adverse reactions were mild and moderate (95.0%), did not lead to discontinuation of the medicinal product (98.0%) and resolved spontaneously.
Neželeni učinki so bili večinoma blagi do zmerni (95,0 %), niso povzročili prekinitve jemanja zdravila (98,0 %) in so izginili spontano.
In case of repeated intermittent treatment, periodic monitoring of the endometrium is recommended.
V primeru ponavljajočega se intermitentnega zdravljenja se priporoča redno spremljanje stanja endometrija.
Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Pred prihodom zdravila na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom ¸s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega gradiva.
EU/1/12/750/001 28 tablets EU/1/12/750/002 84 tablets EU/1/12/750/003 30 tablets EU/1/12/750/004 28 tablets EU/1/12/750/005 84 tablets
EU/1/12/750/001 28 tablet EU/1/12/750/002 84 tablet EU/1/12/750/003 30 tablet EU/1/12/750/004 28 tablet EU/1/12/750/005 84 tablet
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
1st TEST (before treatment start) Start of treatment
PREISKAVA (pred začetkom zdravljenja) Začetek zdravljenja
The effect on newborn/infants has not been studied.
Tveganje za novorojenčke/dojenčke ni bilo raziskano.
Most patients treated with ulipristal acetate stopped bleeding within the first week of treatment (amenorrhea).
Večina bolnic, ki so jih zdravili z ulipristalacetatom, je prenehala krvaveti v prvem tednu zdravljenja (amenoreja).
28 tablets 30 tablets 84 tablets
28 tablet 30 tablet 84 tablet
Patients in amenorrhea b,c
Bolnice z amenorejo b,c
In Study 2, change in the volume of the three largest myomas was measured by ultrasound.
V drugi študiji so spremembo prostornine treh največjih miomov merili z ultrazvokom.
Manufacturer Cenexi
Izdelovalec Cenexi
What Esmya is and what it is used for
Kaj je zdravilo Esmya in za kaj ga uporabljamo
Such a pattern has been observed in approximately 60% of patients treated with ulipristal acetate for 3 months.
Tak vzorec so opazili pri približno 60 % bolnic, ki so 3 mesece prejemale ulipristalacetat.
About 5% of patients of reproductive age experiencing heavy menstrual bleeding have an endometrial thickness of greater than 16 mm.
Pri približno 5 % bolnic v rodni dobi, ki imajo močno menstruacijsko krvavitev, je debelina endometrija večja od 16 mm.
17, Rue de Pontoise FR-95520 Osny France
17, Rue de Pontoise FR-95520 Osny Francija
If you do become pregnant during Esmya treatment, you should stop taking Esmya immediately and contact your doctor or pharmacist.
Če med zdravljenjem z zdravilom Esmya zanosite, morate takoj prenehati jemati zdravilo Esmya in obvestiti svojega zdravnika ali farmacevta.
In case of atypical hyperplasia, investigation and management as per usual clinical practice should be performed.
V primeru atipične hiperplazije je treba uvesti preiskave in zdravljenje kot pri običajni klinični praksi.
These symptoms may be signs of liver injury (frequency not known).
Ti simptomi so lahko znaki okvare jeter (pogostnost ni znana).
If pregnancy is suspected prior to initiation of a new treatment course, a pregnancy test should be performed.
Če pred začetkom novega cikla zdravljenja obstaja sum na nosečnost, je treba opraviti test za ugotavljanje nosečnosti.
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.
17 rue de Pontoise F-95520 Osny France
17 rue de Pontoise F-95520 Osny Francija
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).