natgillin/translations-raw huggingface dataset:
• Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring. 
• preobčutljivost, oteklost obraza, srbenje, koprivnica, izcedek iz nosu, krvavitve iz nosu, kašelj,
If you stop taking Pregabalin Zentiva k.s. 
Če ste prenehali jemati zdravilo Pregabalin Zentiva k.s.
The 25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg capsules also contain polyethylene glycol. 
25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg kapsule vsebujejo tudi makrogol.
Excipient with known effect: Each hard capsule also contains 47.57 mg lactose monohydrate. 
Pomožne snovi z znanim učinkom: Ena trda kapsula vsebuje tudi 47,57 mg laktoze monohidrata.
• Difficulty breathing, dry nose, nasal congestion. 
• pteženo dihanje, suhost nosu, zamašen nos
Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness 
Dispneja, epistaksa, kašelj, zamašenost nosu, rinitis, smrčanje, suhost nosu
These include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flulike symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness. 
Med temi so: težave s spanjem, glavobol, slabost s siljenjem na bruhanje, tesnoba, driska, gripi podobni simptomi, krči, živčnost, depresija, bolečina, potenje in omotica.
If while taking Pregabalin Zentiva k.s. 
Če med jemanjem zdravila Pregabalin Zentiva k.s.
300 mg hard capsules Capsule cap 
300 mg trde kapsule Pokrovček kapsule
225 mg hard capsules Capsule cap 
225 mg trde kapsule Pokrovček kapsule
75 mg hard capsules Capsule cap 
75 mg trde kapsule Pokrovček kapsule
Excipient with known effect: Each hard capsule also contains 22.5 mg lactose monohydrate. 
Pomožne snovi z znanim učinkom: Ena trda kapsula vsebuje tudi 22,5 mg laktoze monohidrata.
• There have been reports of reduction in brain function (encephalopathy) in some patients taking pregabalin when they have other conditions. 
• Pri nekaterih bolnikih, ki jemljejo pregabalin in imajo tudi druge težave z zdravjem, so poročali o zmanjšanju možganske funkcije (encefalopatiji).
225 mg hard capsules Pregabalin 
225 mg trde kapsule pregabalin
150 mg hard capsules Capsule cap and body 
150 mg trde kapsule Pokrovček in telo kapsule
Reduction of pregabalin dose may be required in patients who have age related compromised renal function (see section 4.2 table 1). 
Pri bolnikih, ki imajo starostno oslabelo delovanje ledvic, utegne biti potrebno zmanjšanje odmerka pregabalina (glejte poglavje 4.2, preglednico 1).
Ascites, pancreatitis, swollen tongue, dysphagia 
Ascites, pankreatitis, oteklost jezika, disfagija
225 mg hard capsules: EU/1/16/1166/023 
225 mg trde kapsule: EU/1/16/1166/023
Do not take Pregabalin Zentiva k.s. 
Ne jemljite zdravila Pregabalin Zentiva k.s.
Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm 
Krči mišic, artralgija, bolečine v hrbtu, bolečine v udih, spazem v vratu
150 mg hard capsules 
150 mg trde kapsule
200 mg hard capsules Capsule cap and body 
200 mg trde kapsule Pokrovček in telo kapsule
How to take Pregabalin Zentiva k.s. 
Kako jemati zdravilo Pregabalin Zentiva k.s.
Red cap and light grey body; approx. 21,7 mm in length, hard gelatin capsule with imprinting “300”, containing almost white powder. 
Rdeč pokrovček in svetlo sivo telo; dolžine približno 21,7 mm, trda želatinasta kapsula z odtisom "300", ki vsebuje skoraj bel prašek.
200 mg hard capsules Pregabalin Zentiva k.s. 
200 mg trde kapsule Pregabalin Zentiva k.s.
• Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell. 
• spremembe vida, nenavadni gibi oči, spremembe vida (vključno z izgubo obrobnega vida), bliski svetlobe, trzanje, zmanjšanje refleksov, čezmerna dejavnost, omotica ob vstajanju,
150 mg hard capsules: EU/1/16/1166/017 
150 mg trde kapsule: EU/1/16/1166/017
Black iron oxide (E172) Titanium dioxide (E171) Gelatin 
− titanov dioksid (E171)
Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness 
Otekanje sklepov, mialgija, trzanje mišic, bolečine v vratu, togost mišic
100 mg hard capsules Pregabalin Zentiva k.s. 
100 mg trde kapsule Pregabalin Zentiva k.s.
75 mg hard capsules: EU/1/16/1166/011 
75 mg trde kapsule: EU/1/16/1166/011
Excipient with known effect: Each hard capsule also contains 7.5 mg lactose monohydrate. 
Pomožne snovi z znanim učinkom: Ena trda kapsula vsebuje tudi 7,5 mg laktoze monohidrata.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 75 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 75 mg pregabalina.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 225 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 225 mg pregabalina.
200 mg hard capsules: EU/1/16/1166/020 
200 mg trde kapsule: EU/1/16/1166/020
100 mg hard capsules Pregabalin 
100 mg trde kapsule pregabalin
300 mg hard capsules: EU/1/16/1166/026 
300 mg trde kapsule: EU/1/16/1166/026
50 mg hard capsules: EU/1/16/1166/006 
50 mg trde kapsule: EU/1/16/1166/006
100 mg hard capsules: EU/1/16/1166/014 
100 mg trde kapsule: EU/1/16/1166/014
25 mg hard capsules: EU/1/16/1166/001 
25 mg trde kapsule: EU/1/16/1166/001
100 mg hard capsules Capsule cap and body 
100 mg trde kapsule Pokrovček in telo kapsule
225 mg hard capsules Pregabalin Zentiva k.s. 
225 mg trde kapsule Pregabalin Zentiva k.s.
Excipient with known effect: Each hard capsule also contains 20 mg lactose monohydrate. 
Pomožne snovi z znanim učinkom: Ena trda kapsula vsebuje tudi 20 mg laktoze monohidrata.
Red cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “75”, containing almost white powder. 
Rdeč pokrovček in svetlo sivo telo; dolžine približno 14,3 mm, trda želatinasta kapsula z odtisom "75", ki vsebuje skoraj bel prašek.
150 mg hard capsules Pregabalin 
150 mg trde kapsule pregabalin
75 mg hard capsules Pregabalin 
75 mg trde kapsule pregabalin
75 mg hard capsules Pregabalin Zentiva k.s. 
75 mg trde kapsule Pregabalin Zentiva k.s.
Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles. 
Bolečino, ki se pojavi, bolniki opisujejo različno, npr. kot žgočo, pekočo, kljuvajočo, sunkovito, zbadajočo, ostro, krčevito, trgajočo, ali mravljinčenje, otrplost ali ščemenje.
Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “25”, containing almost white powder. 
Svetlo siv pokrovček in svetlo sivo telo; dolžine približno 15,9 mm, trda želatinasta kapsula z odtisom "25", ki vsebuje skoraj bel prašek.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 150 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 150 mg pregabalina.
150 mg hard capsules Pregabalin Zentiva k.s. 
150 mg trde kapsule Pregabalin Zentiva k.s.
25 mg hard capsules Pregabalin 
25 mg trde kapsule pregabalin
Excipient with known effect: Each hard capsule also contains 30 mg lactose monohydrate. 
Pomožne snovi z znanim učinkom: Ena trda kapsula vsebuje tudi 30 mg laktoze monohidrata.
Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, containing almost white powder. 
Rdeč pokrovček in rdečo telo; dolžine približno 15,9 mm, trda želatinasta kapsula z odtisom "100", ki vsebuje skoraj bel prašek.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 200 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 200 mg pregabalina.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 100 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 100 mg pregabalina.
If you take more Pregabalin Zentiva k.s. 
Če jemljete zdravilo Pregabalin Zentiva k.s.
225 mg hard capsules 
225 mg trde kapsule
Light grey cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “50”, containing almost white powder. 
Svetlo siv pokrovček in svetlo sivo telo; dolžine približno 14,3 mm, trda želatinasta kapsula z odtisom "50", ki vsebuje skoraj bel prašek.
Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting “150”, containing almost white powder. 
Svetlo siv pokrovček in svetlo sivo telo; dolžine približno 18,0 mm, trda želatinasta kapsula z odtisom "150", ki vsebuje skoraj bel prašek.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 300 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 300 mg pregabalina.
Table 2: Pregabalin Adverse Drug Reactions 
Preglednica 2: Neželeni učinki pregabalina
300 mg hard capsules Pregabalin 
300 mg trde kapsule pregabalin
100 mg hard capsules 
100 mg trde kapsule
Black iron oxide (E172) Propylene glycol 
− črni železov oksid (E172)
300 mg hard capsules 
300 mg trde kapsule
Excipient with known effect: Each hard capsule also contains 10 mg lactose monohydrate. 
Pomožne snovi z znanim učinkom: Ena trda kapsula vsebuje tudi 10 mg laktoze monohidrata.
Excipient with known effect: Each hard capsule also contains 5 mg lactose monohydrate. 
Pomožne snovi z znanim učinkom: Ena trda kapsula vsebuje tudi 5 mg laktoze monohidrata.
200 mg hard capsules 
200 mg trde kapsule
50 mg hard capsules Pregabalin 
50 mg trde kapsule pregabalin
200 mg hard capsules Pregabalin 
200 mg trde kapsule pregabalin
Flesh opaque cap and light grey body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “225”, containing almost white powder. 
Neprosojen rožnat pokrovček in svetlo sivo telo; dolžine približno 19,4 mm, trda želatinasta kapsula z odtisom "225", ki vsebuje skoraj bel prašek.
Excipient with known effect: Each hard capsule also contains 15 mg lactose monohydrate. 
Pomožne snovi z znanim učinkom: Ena trda kapsula vsebuje tudi 15 mg laktoze monohidrata.
The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence. 
anksioznost, diareja, gripozni sindrom, živčnost, depresija, bolečine, krči, hiperhidroza in omotica; leti kažejo na fizično odvisnost.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 50 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 50 mg pregabalina.
75 mg hard capsules 
75 mg trde kapsule
25 mg hard capsules Pregabalin Zentiva k.s. 
25 mg trde kapsule Pregabalin Zentiva k.s.
50 mg hard capsules Pregabalin Zentiva k.s. 
50 mg trde kapsule Pregabalin Zentiva k.s.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 25 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 25 mg pregabalina.
50 mg hard capsules 
50 mg trde kapsule
Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness 
Izguba vida, keratitis, oscilopsija, spremenjeno vidno zaznavanje globine, midriaza, strabizem, občutek svetlosti pri gledanju Ušesne bolezni, vključno z motnjami labirinta Pogosti
25 mg hard capsules 
25 mg trde kapsule
Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “200”, containing almost white powder. 
Neprosojen rožnat pokrovček in neprosojno rožnato telo; dolžine približno 19,4 mm, trda želatinasta kapsula z odtisom "200", ki vsebuje skoraj bel prašek.
• 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.