FrancophonIA/ELRC3.0 huggingface dataset:
English: Luxembourg/Luxemburg Zentiva, k.s.
Estonian: Luxembourg/Luxemburg
English: Generalised oedema, face oedema, chest tightness, pain, pyrexia, thirst, chills, asthenia
Estonian: Generaliseerunud turse, näoturse, pigistustunne rindkeres, valu, püreksia, janu, külmavärinad, asteenia
English: Peripheral and central neuropathic pain, epilepsy or generalised anxiety disorder Take the number of hard capsules as instructed by your doctor.
Estonian: Perifeerne ja tsentraalne neuropaatiline valu, epilepsia või generaliseerunud ärevushäire
English: • Dilated pupils, cross eyes.
Estonian: • Pupillide laienemine, kõõrdsilmsus.
English: Strong ammonia solution Potassium hydroxide
Estonian: − Ammooniumhüdroksiidi lahus
English: 225 mg hard capsules: EU/1/16/1166/023
Estonian: 225 mg kõvakapslid: EU/1/16/1166/023
English: 100 mg hard capsules Capsule cap and body
Estonian: 100 mg kõvakapslid Kapsli kaas ja keha
English: • Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
Estonian: • Ülitundlikkus, näoturse, nahasügelus, nõgeslööve, nohu, ninaverejooks, köha, norskamine.
English: 150 mg hard capsules: EU/1/16/1166/017
Estonian: 150 mg kõvakapslid: EU/1/16/1166/017
English: • Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
Estonian: • Lihastõmblused, liigeste turse, lihasjäikus, valu, k.a lihasvalu, kaelavalu.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED BLISTER
English: Excipient with known effect: Each hard capsule also contains 20 mg lactose monohydrate.
Estonian: Teadaolevat toimet omav abiaine: iga kõvakapsel sisaldab 20 mg laktoosmonohüdraati.
English: Reduction of pregabalin dose may be required in patients who have age related compromised renal function (see section 4.2 table 1).
Estonian: Patsientidel, kellel esineb vanusest tingitud neerufunktsiooni halvenemine, võib olla vajalik vähendada pregabaliini annust (vt lõik 4.2, tabel 1).
English: 150 mg hard capsules
Estonian: 150 mg kapslid
English: Pregabalin did not achieve non-inferiority to lamotrigine based on the 6-month seizure freedom endpoint.
Estonian: 6-kuulise krambihoogudeta perioodi tulemusnäitaja osas ei saavutanud pregabaliin samaväärsust lamotrigiiniga.
English: Red cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “75”, containing almost white powder.
Estonian: Punase kaane ja helehalli kehaga kõva želatiinkapsel pikkusega ligikaudu 14,3 mm ja sissepressitud märgistusega „75“, sisaldab peaaegu valget pulbrit.
English: Rhabdomyolysis
Estonian: Annustamisskeem
English: 100 mg hard capsules Pregabalin Zentiva k.s.
Estonian: 100 mg kõvakapslid Pregabalin Zentiva k.s.
English: Take your box of Pregabalin Zentiva k.s.
Estonian: Võtke karp Pregabalin Zentiva k.s-i kõvakapslitega endaga kaasa.
English: 75 mg hard capsules: EU/1/16/1166/011
Estonian: 75 mg kõvakapslid: EU/1/16/1166/011
English: Flesh opaque cap and light grey body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “225”, containing almost white powder.
Estonian: Ihuvärvi läbipaistmatu kaane ja helehalli kehaga kõva želatiinkapsel pikkusega ligikaudu 19,4 mm ja sissepressitud märgistusega „225“, sisaldab peaaegu valget pulbrit.
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Estonian: sisaldab laktoosmonohüdraati.
English: Excipient with known effect: Each hard capsule also contains 30 mg lactose monohydrate.
Estonian: Teadaolevat toimet omav abiaine: iga kõvakapsel sisaldab 30 mg laktoosmonohüdraati.
English: 200 mg hard capsules: EU/1/16/1166/020
Estonian: 200 mg kõvakapslid: EU/1/16/1166/020
English: 50 mg hard capsules: EU/1/16/1166/006
Estonian: 50 mg kõvakapslid: EU/1/16/1166/006
English: Uncommon: may affect up to 1 in 100 people
Estonian: Aeg-ajalt: võivad tekkida kuni 1 inimesel 100-st
English: Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, containing almost white powder.
Estonian: Punase kaane ja punase kehaga kõva želatiinkapsel pikkusega ligikaudu 15,9 mm ja sissepressitud märgistusega „100“, sisaldab peaaegu valget pulbrit.
English: 225 mg hard capsules Pregabalin Zentiva k.s.
Estonian: 225 mg kõvakapslid Pregabalin Zentiva k.s.
English: 300 mg hard capsules: EU/1/16/1166/026
Estonian: 300 mg kõvakapslid: EU/1/16/1166/026
English: Vision blurred, diplopia
Estonian: Nägemise ähmastumine, diploopia
English: Contents of the pack and other information
Estonian: Kuidas Pregabalin Zentiva k.s-i säilitada Pakendi sisu ja muu teave
English: 75 mg hard capsules Pregabalin Zentiva k.s.
Estonian: 75 mg kõvakapslid Pregabalin Zentiva k.s.
English: 100 mg hard capsules: EU/1/16/1166/014
Estonian: 100 mg kõvakapslid: EU/1/16/1166/014
English: 150 mg hard capsules Pregabalin Zentiva k.s.
Estonian: 150 mg kõvakapslid Pregabalin Zentiva k.s.
English: Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth
Estonian: Oksendamine, iiveldus, kõhukinnisus, kõhulahtisus, kõhupuhitus, kõhuvenitus, suukuivus
English: • Allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis)
Estonian: • Allergilised reaktsioonid, nt hingamisraskused, silma sarvkesta põletik (keratiit) ja raske nahareaktsioon, mida iseloomustavad lööve, villid, naha irdumine (koorumine) ja valu.
English: Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting “150”, containing almost white powder.
Estonian: Helehalli kaane ja helehalli kehaga kõva želatiinkapsel pikkusega ligikaudu 18,0 mm ja sissepressitud märgistusega „150“, sisaldab peaaegu valget pulbrit.
English: Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Estonian: − Titaandioksiid (E171)
English: Talk to your doctor or pharmacist before taking Pregabalin Zentiva k.s.
Estonian: Enne Pregabalin Zentiva k.s-i võtmist pidage nõu oma arsti või apteekriga.
English: How to take Pregabalin Zentiva k.s.
Estonian: Kuidas Pregabalin Zentiva k.s-i võtta
English: Light grey cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “50”, containing almost white powder.
Estonian: Helehalli kaane ja helehalli kehaga kõva želatiinkapsel pikkusega ligikaudu 14,3 mm ja sissepressitud märgistusega „50“, sisaldab peaaegu valget pulbrit.
English: Your doctor will prescribe Pregabalin Zentiva k.s.
Estonian: Mis ravim on Pregabalin Zentiva k.s.
English: Excipient with known effect: Each hard capsule also contains 15 mg lactose monohydrate.
Estonian: Teadaolevat toimet omav abiaine: iga kõvakapsel sisaldab 15 mg laktoosmonohüdraati.
English: 200 mg hard capsules
Estonian: 200 mg kapslid
English: Excipient with known effect: Each hard capsule also contains 10 mg lactose monohydrate.
Estonian: Teadaolevat toimet omav abiaine: iga kõvakapsel sisaldab 10 mg laktoosmonohüdraati.
English: Excipient with known effect: Each hard capsule also contains 5 mg lactose monohydrate.
Estonian: Teadaolevat toimet omav abiaine: iga kõvakapsel sisaldab 5 mg laktoosmonohüdraati.
English: Rare: may affect up to 1 in 1,000 people
Estonian: Harv: võivad tekkida kuni 1 inimesel 1000-st
English: 25 mg hard capsules: EU/1/16/1166/001
Estonian: 25 mg kõvakapslid: EU/1/16/1166/001
English: Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness
Estonian: Düspnoe, ninaverejooksud, köha, ninakinnisus, riniit, norskamine, ninakuivus
English: 100 mg hard capsules
Estonian: 100 mg kapslid
English: In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing.
Estonian: Kontrollitud kliinilistes uuringutes oli nägemise ähmastumisest teatanud patsientide osakaal pregabaliiniga ravitud patsientide seas suurem kui platseebot saanud patsientide seas.
English: How to store Pregabalin Zentiva k.s.
Estonian: Kuidas Pregabalin Zentiva k.s-i säilitada
English: Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “25”, containing almost white powder.
Estonian: Helehalli kaane ja helehalli kehaga kõva želatiinkapsel pikkusega ligikaudu 15,9 mm ja sissepressitud märgistusega „25“, sisaldab peaaegu valget pulbrit.
English: • Difficulty breathing, dry nose, nasal congestion.
Estonian: • Suurenenud süljeeritus, kõrvetised, suuümbruse tuimus.
English: 50 mg hard capsules Pregabalin Zentiva k.s.
Estonian: 50 mg kõvakapslid Pregabalin Zentiva k.s.
English: 25 mg hard capsules Pregabalin Zentiva k.s.
Estonian: 25 mg kõvakapslid Pregabalin Zentiva k.s.
English: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm
Estonian: Lihaskrambid, artralgia, seljavalu, jäsemevalu, kaela spasm
English: Immune system disorders Uncommon
Estonian: Immuunsüsteemi häired
English: 25 mg hard capsules
Estonian: 25 mg kapslid
English: 200 mg hard capsules Pregabalin
Estonian: 200 mg kõvakapslid Pregabalinum
English: Amenorrhoea, breast discharge, breast enlargement, gynaecomastia General disorders and administration site conditions Common
Estonian: Amenorröa, eritis rinnanäärmetest, rinnanäärmete suurenemine, günekomastia
English: PV-Hungary@zentiva.com
Estonian: PV-Greece@zentiva.com
English: If you take more Pregabalin Zentiva k.s.
Estonian: Kui te võtate Pregabalin Zentiva k.s-i rohkem kui ette nähtud
English: • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
Estonian: • Tähelepanuhäired, kohmakus, mälu halvenemine, mälukaotus, värisemine, kõnehäired,
English: 300 mg hard capsules Pregabalin
Estonian: 300 mg kõvakapslid Pregabalinum
English: Anorexia, hypoglycaemia
Estonian: Isutus, hüpoglükeemia
English: 100 mg hard capsules Pregabalin
Estonian: 100 mg kõvakapslid Pregabalinum
English: may be taken with oral contraceptives.
Estonian: Pregabalin Zentiva k.s-i võib võtta koos suukaudsete rasestumisvastaste ainetega.
English: EU/1/16/1166/017 EU/1/16/1166/018 EU/1/16/1166/033 EU/1/16/1166/019
Estonian: EU/1/16/1166/033 EU/1/16/1166/019
English: Dose regimen
Estonian: Dolni Měcholupy
English: Pulmonary oedema, throat tightness
Estonian: Zentiva Pharma GmbH
English: 150 mg hard capsules Pregabalin
Estonian: 150 mg kõvakapslid Pregabalinum
English: EU/1/16/1166/026 EU/1/16/1166/027 EU/1/16/1166/036 EU/1/16/1166/028
Estonian: EU/1/16/1166/026 EU/1/16/1166/027 EU/1/15/1021/036
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Estonian: B. HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD
English: Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin.
Estonian: Pregabaliini kasutamise ajal või kohe pregabaliini kasutamise lõpetamise järel võivad tekkida krambid, sealhulgas ka epileptilised ja generaliseerunud toonilis-kloonilised (grand mal) hood.
English: Eye disorders Common
Estonian: Silma kahjustused
English: 50 mg hard capsules Pregabalin
Estonian: 50 mg kõvakapslid Pregabalinum
English: Printing ink Shellac
Estonian: Trükitint − Šellak
English: PHARMACOLOGICAL PROPERTIES
Estonian: Eelželatiniseeritud maisitärklis
English: Slovenská republika Zentiva, a.s.
Estonian: Zentiva, a.s.
English: Common
Estonian: Talk
English: Date of first authorisation: 23 February 2012 Date of latest renewal: 14 November 2016
Estonian: Müügiloa esmase väljastamise kuupäev: 23 veebruar 2012 Müügiloa viimase uuendamise kuupäev: 14. november 2016
English: Frequency Not known
Estonian: Sagedus teadmata
English: You should discuss this with your doctor.
Estonian: Peaksite seda arutama oma arstiga.
English: The safety for a human embryo is unknown.
Estonian: Ohutus inimese embrüole on teadmata.
English: ATC code: G03XB02.
Estonian: ATC-kood: G03XB02.
English: Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Hungary
Estonian: Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Ungari
English: Alu/PVC/PE/PVDC or Alu/PVC/PVDC blister.
Estonian: Al/PVC/PE/PVDC või Al/PVC/PVDC blister.
English: b Patients with missing values were exluded from the analysis.
Estonian: b Puuduvate väärtustega patsiente selles analüüsis ei arvestatud.
English: Repeated intermittent use:
Estonian: Korduv vahelduv kasutamine:
English: Do not take Esmya if you are pregnant.
Estonian: Ärge võtke Esmya't, kui olete rase.
English: P values: 1 = <0.001, 2 = 0.037, 3= <0.002, 4 = <0.006.
Estonian: P väärtused: 1 = < 0,001, 2 = 0,037, 3= < 0,002, 4 = < 0,006.
English: Asthma patients
Estonian: Astmaga patsiendid
English: The doctor should check your liver immediately and decide if you can continue the treatment.
Estonian: Arst peab kohe teie maksa kontrollima, et otsustada, kas te võite ravi jätkata.
English: WHAT TO DO BEFORE DURING AND AFTER YOUR TREATMENT?
Estonian: MIDA TULEB TEHA ENNE RAVI, RAVI AJAL JA PÄRAST RAVI?
English: Tablets should be swallowed with water.
Estonian: Tablette tuleb neelata koos veega.
English: • the indications.
Estonian: • Näidustused.
English: Have regular blood tests
Estonian: Laske regulaarselt vereanalüüse teha
English: 28 tablets 30 tablets 84 tablets
Estonian: 28 tabletti 30 tabletti 84 tabletti
English: Other medicines and Esmya
Estonian: Muud ravimid ja Esmya
English: 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.
Estonian: Esmya't ei tohi võtta alla 18-aastased lapsed, kuna ulipristaalatsetaadi ohutus ja efektiivsus selles vanuserühmas ei ole tõestatud.
English: Tablets may be taken with or without food.
Estonian: Tablette võib võtta koos toiduga või ilma.
English: The safety and efficacy of ulipristal acetate was only established in women of 18 years and older.
Estonian: Ulipristaalatsetaadi ohutus ja efektiivsus on tõestatud vaid 18-aastastel ja vanematel naistel.
English: 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.
Estonian: Ärge lõpetage ühegi ravikuuri jooksul tablettide võtmist ilma oma arsti soovituseta isegi siis, kui tunnete end paremini, kuna sümptomid võivad hiljem korduda.
English: Adverse reactions listed below are classified according to frequency and system organ class.
Estonian: Alljärgnevalt loetletud kõrvaltoimed on klassifitseeritud esinemissageduse ja organsüsteemi klasside kaupa.
English: Biotransformation/Elimination
Estonian: Biotransformatsioon/Eritumine
English: It is used either before an operation of your fibroids or for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count.
Estonian: Seda kasutatakse kas enne fibroidide opereerimist või fibroidide pikaajaliseks raviks, et vähendada nende suurust, peatada või vähendada veritsust ning suurendada teie punaste vereliblede arvu.
English: • Educational material for patients which contains o Patient card
Estonian: • Infomaterjal patsientidele, milles sisaldub o patsiendikaart
English: A PBAC >100 within the first 8 days of menses is considered to represent excessive menstrual blood loss.
Estonian: PBAC > 100 menstruatsiooni esimese 8 päeva jooksul peetakse ülemääraseks menstruaalvere kaoks.
English: • 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.
Estonian: • kui muudetakse riskijuhtimissüsteemi, eriti kui saadakse uut teavet, mis võib oluliselt mõjutada riski/kasu suhet, või kui saavutatakse oluline (ravimiohutuse või riski minimeerimise) eesmärk.
English: Treatment whilst pregnant might affect your pregnancy (it is not known if Esmya might harm your baby or whether can cause miscarriage).
Estonian: Ravi raseduse ajal võib teie rasedust mõjutada (ei ole teada, kas Esmya võib kahjustada last või viia nurisünnituseni).
English: Patients in amenorrhea b,c
Estonian: Amenorröaga patsiendid b,c
English: If you miss a dose by less than 12 hours, take it as soon as you remember.
Estonian: Kui te unustate annuse võtta ja möödunud on alla 12 tunni, võtke see niipea, kui see teile meenub.
English: Do not throw away via wastewater or household waste.
Estonian: Ärge visake ravimeid kanalisatsiooni ega olmejäätmete hulka.
English: These changes should not be confused with endometrial hyperplasia.
Estonian: Neid muutusi ei tohi segi ajada endomeetriumi hüperplaasiaga.
English: 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).
Estonian: Sagedused on jaotatud kui väga sage ( 1/10), sage ( 1/100 kuni < 1/10), aeg-ajalt ( 1/1000 kuni < 1/100), harv ( 1/10 000 kuni < 1/1000), väga harv (< 1/10 000) ja teadmata (ei saa hinnata olemasolevate andmete alusel).
English: Esmya is used in adult women (over 18 years of age) before they reach the menopause.
Estonian: Esmya't kasutatakse täiskasvanud (vähemalt 18-aastastel) naistel, kes ei ole veel jõudnud menopausini.
English: The effect on newborn/infants has not been studied.
Estonian: Toimet vastsündinutele/imikutele ei ole uuritud.
English: You should know that most women have no menstrual bleeding (period) during the treatment and for a few weeks afterwards.
Estonian: Peaksite teadma, et enamikul naistest ei esine ravi ajal ja mõni nädal pärast ravi menstruaalverejooksu (päevasid).
English: These are possible symptoms of angioedema (frequency not known).
Estonian: Need on angioödeemi (sagedus teadmata) võimalikud sümptomid.
English: 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
Estonian: Ravimi trükitud pakendi infolehel peab olema vastava ravimipartii kasutamiseks vabastamise eest vastutava tootja nimi ja aadress.
English: These tests need to happen every month, including a few weeks after you finish a course of treatment (see schedule below).
Estonian: Neid analüüse tuleb teha iga kuu ja ka mõni nädal pärast ravikuuri lõppu (vt ajakava allpool).
English: Simultaneous administration of ulipristal acetate and a P-gp substrate has not been studied and an interaction cannot be excluded.
Estonian: Ulipristaalatsetaadi ja P-gp substraadi samaaegset manustamist ei ole uuritud ja koostoimeid ei saa välistada.
English: The treating physician should explain to the patient the requirement for treatment free intervals.
Estonian: Raviarst peab patsiendile selgitama ravivabade intervallide vajadust.
English: 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.
Estonian: Funktsionaalseid munasarjatsüste täheldati ravi ajal ja pärast ravi 1,0% patsientidel ja enamikul juhtudel kadusid need iseenesest mõne nädala jooksul.
English: WHAT YOU NEED TO KNOW BEFORE USE?
Estonian: MIDA ON VAJA TEADA ENNE RAVIMI KASUTAMIST?
English: Such a pattern has been observed in approximately 60% of patients treated with ulipristal acetate for 3 months.
Estonian: Sellist mustrit on täheldatud ligikaudu 60% ulipristaalatsetaadiga kolm kuud ravitud patsientidel.
English: Headache*
Estonian: Peavalu*
English: * see section "Description of selected adverse reactions" ** The verbatim term “mild hair loss” was coded to the term “alopecia”
Estonian: * vt lõik „Valitud kõrvaltoimete kirjeldus” **sõnasõnalise termini „juuksekao kerge vormi“ puhul kasutatakse terminit „alopeetsia”
English: The educational material shall contain the following key elements:
Estonian: Infomaterjal peab sisaldama järgmiseid peamiseid elemente.
English: Hot flushes were reported by 8.1% of patients but the rates varied across trials.
Estonian: Kuumahoogudest teatas 8,1% patsientidest, kuid esinemissagedused olid uuringuti erinevad.
English: What Esmya is and what it is used for What you need to know before you take Esmya How to take Esmya
Estonian: Mis ravim on Esmya ja milleks seda kasutatakse Mida on vaja teada enne Esmya võtmist Kuidas Esmya't võtta
English: 17 rue de Pontoise F-95520 Osny France
Estonian: 17 rue de Pontoise F-95520 Osny Prantsusmaa
English: 17, Rue de Pontoise FR-95520 Osny France
Estonian: 17, Rue de Pontoise FR-95520 Osny Prantsusmaa
English: Tell your doctor or pharmacist if you are taking any of the medicines listed below, as these medicines can affect Esmya or be affected by Esmya: - Certain medicines which are used to treat the heart (e.g. digoxin).
Estonian: Informeerige oma arsti või apteekrit, kui võtate ükskõik millist allpool nimetatud ravimitest, sest need ravimid võivad mõjutada Esmya toimet ja Esmya võib mõjutada nende toimet: - Teatud ravimid, mida kasutatakse südame ravis (nt digoksiin).
English: Medicinal products containing progestagen should not be taken within 12 days after cessation of ulipristal acetate treatment.
Estonian: Progestageeni sisaldavaid ravimeid ei tohi manustada 12 päeva jooksul pärast ulipristaalatsetaat-ravi lõpetamist.
English: In both studies menstrual blood loss was assessed using the Pictorial Bleeding Assessment Chart (PBAC).
Estonian: Mõlemas uuringus hinnati menstruaalvere kadu illustreeritud veritsuse hindamisegraafiku (Pictorial Bleeding Assessment Chart - PBAC) abil.
English: 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.
Estonian: Oma toimemehhanismi tõttu on ulipristaalatsetaadil embrüoletaalne toime rottidel, küülikutel (korduvates annustes üle 1 mg/kg), merisigadel ja ahvidel.
English: In vitro data indicate that ulipristal acetate and its active metabolite are not P-gp (ABCB1) substrates.
Estonian: In vitro andmed viitavad, et ulipristaalatsetaat ja selle aktiivne metaboliit pole P-gp (ABCB1) substraadid.
English: 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
Estonian: EU/1/12/750/001 28 tabletti EU/1/12/750/002 84 tabletti EU/1/12/750/003 30 tabletti EU/1/12/750/004 28 tabletti EU/1/12/750/005 84 tabletti
English: In vitro data indicate that this is predominantly mediated by the cytochrome P450 3A4 isoform (CYP3A4).
Estonian: In vitro andmed osutavad sellele, et see toimub peamiselt tsütokroom P450 3A4 isovormi (CYP3A4) kaudu.
English: Table 1: Results of primary and selected secondary efficacy assessments in Phase III studies
Estonian: Tabel 1: Esmased ja valitud teisesed tulemusnäitajad III faasi uuringutes
English: 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.
Estonian: Suur osa kõrvaltoimetest olid kerged ja mõõdukad (95,0%), ei viinud ravimi manustamise lõpetamiseni (98,0%) ja möödusid iseenesest.
English: Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, high density lipoprotein and low density lipoprotein.
Estonian: Ulipristaalatsetaat on suures ulatuses (> 98%) seotud plasmavalkudega, sealhulgas albumiini, alfa-lhappe glükoproteiini, kõrge tihedusega lipoproteiini ja madala tihedusega lipoproteiiniga.
English: • absence of safety data on the endometrium for continuous treatment longer than 3 months.
Estonian: • Ohutusandmete puudumine endomeetriumi osas üle 3 kuu kestval pideval ravil.
English: 1st TEST (before treatment start) Start of treatment
Estonian: ANALÜÜS (enne ravi algust) Ravi algus
English: The tablet should be swallowed with water and may be taken with or without food.
Estonian: Tablett tuleb alla neelata koos veega ja neid võib võtta koos toiduga või ilma.
English: Esmya with food and drink You should avoid drinking grapefruit juice while on treatment with Esmya.
Estonian: Esmya koos toidu ja joogiga Ravi ajal Esmya´ga peaksite vältima greipfruudimahla joomist.