FrancophonIA/ELRC3.0 huggingface dataset:
English: In rats, there were adverse effects of lusutrombopag on foetal intrauterine growth and skeletal morphology as follows: a suppression of foetal intrauterine growth (low foetal body weight and a decrease in the number of ossified sternebrae) at 80 mg/kg/day, and an high incidence of short cervical supernumerary ribs at 40 mg/kg/day or more, and an high incidence of short thoracolumbar supernumerary rib at 4 mg/kg/day or more.
Estonian: Rottidel avaldas lusutrombopaag järgmisi kõrvaltoimeid loote emakasisesele kasvule ja luustiku morfoloogiale: annuses 80 mg/kg ööpäevas loote emakasisese kasvu supressioon (loote kehakaalu ja luustunud rinnakulülide arvu vähenemine) ning annuse 40 mg/kg ööpäevas või suurema annuse kasutamisel suurenes lühikeste liigsete kaelalülide esinemissagedus ning annuse 4 mg/kg ööpäevas või suurema annuse kasutamisel suurenes lühikese torakolumbaalse liigse lüli esinemissagedus.
English: Carcinogenesis
Estonian: Kantserogenees
English: The pharmacokinetics of lusutrombopag was similar in both healthy subjects and the chronic liver disease population.
Estonian: Lusutrombopaagi farmakokineetika tervetel uuringus osalejatel ja kroonilise maksahaigusega populatsioonil oli sarnane.
English: Lusutrombopag is a substrate of P-gp and BCRP, but not a substrate of OATP1B1, OATP1B3, and OCT1.
Estonian: Lusutrombopaag on P-gp ja BCRP substraat, kuid mitte OATP1B1, OATP1B3 ja OCT1 substraat.
English: Each box contains 7 film-coated tablets.
Estonian: Karbis on 7 õhukese polümeerikattega tabletti.
English: A population pharmacokinetic analysis using plasma lusutrombopag concentrations from clinical studies with lusutrombopag did not identify a clinically meaningful effect of age, gender or race on the pharmacokinetics of lusutrombopag.
Estonian: Lusutrombopaagi kliiniliste uuringute populatsiooni farmakokineetika analüüsis vanuse, soo ega rassi kliiniliselt olulist mõju lusutrombopaagi farmakokineetikale ei täheldatud.
English: The duration of the increase in platelet count to ≥ 50,000/µL in Studies M0631 and M0634 and the pooled (Studies M0631 and M0634) lusutrombopag group was significantly greater than compared with placebo (Table 5).
Estonian: Trombotsüütide arvu suurenemine ≥ 50 000/µl kestis uuringutes M0631 ja M0634 ja lusutrombopaagi koondrühmas (uuringutes M0631 ja M0634) oluliselt kauem võrreldes platseeboga (tabel 5).
English: Lusutrombopag has no known influence on the ability to drive and use machines.
Estonian: Lusutrombopaag ei mõjuta autojuhtimise ja masinate käsitsemise võimet.
English: Each film-coated tablet contains 3 mg lusutrombopag.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 3 mg lusutrombopaagi.
English: • Blood clot in the liver (portal vein thrombosis)
Estonian: • verehüüve maksas (portaalveeni tromboos);
English: No dosage adjustment is necessary for patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment.
Estonian: Kerge (Child-Pugh' klass A) kuni mõõduka (Child-Pugh' klass B) maksakahjustusega patsientidel ei ole annuse kohandamine vajalik.
English: → If you are already breast-feeding, talk to your doctor immediately.
Estonian: → Kui te juba imetate last, öelge seda kohe arstile.
English: Platelet count should be measured prior to the procedure.
Estonian: Enne protseduuri alustamist tuleb määrata trombotsüütide arv.
English: There is limited information on the use of lusutrombopag in patients previously exposed to lusutrombopag.
Estonian: Lusutrombopaagi kasutamise kohta varem lusutrombopaagiga ravitud patsientidel on vähe andmeid.
English: This medicinal product may pose a risk to the environment (see section 5.3).
Estonian: 6.6 Erihoiatused ravimpreparaadi hävitamiseks See ravimpreparaat võib olla ohtlik keskkonnale (vt lõik 5.3).
English: Phase 3 Study M0634
Estonian: III faasi uuring M0634
English: Lusutrombopag did not affect male and female fertility and early embryo development in rats at doses up to 100 mg/kg/day (176 and 252 times respectively, the human clinical exposures in adults based on AUC).
Estonian: Lusutrombopaag ei mõjutanud rottidel isas- ja emasloomade fertiilsust ja varast embrüo arengut annustel kuni 100 mg/kg ööpäevas (mis ületavad inimestel AUC põhjal vastavalt 176 ja 252 korda täiskasvanutel esinevaid kliinilisi kontsentratsioone).
English: There is limited information on the use of lusutrombopag in patients with body weight <45 Kg. Platelet count should be measured at least once approximately 5 days after the first dose and as necessary thereafter.
Estonian: Trombotsüütide arvu tuleb mõõta vähemalt ühel korral ligikaudu 5 päeva pärast esimest annust ja seejärel vajaduse korral.
English: No effects on foetal viability embryo-foetal development were noted in rabbits at doses up to 1000 mg/kg/day (161 times the human clinical exposures in adults based on AUC).
Estonian: Küülikutel toimeid loote elujõulisusele ega embrüo-loote arengule annustel kuni 1000 mg/kg ööpäevas (mis ületavad inimestel AUC põhjal 161 korda täiskasvanutel esinevaid kliinilisi kontsentratsioone) ei täheldatud.
English: • pain in the abdomen (tummy), swollen abdomen, blood in your stools.
Estonian: • kõhuvalu, kõhu turse, vere sisaldumine väljaheites.
English: Figure 1 Time course profiles of platelet count in the Phase 3 studies in thrombocytopenic patients with chronic liver disease (lusutrombopag-treated subjects without platelet transfusion and placebo-treated subjects with platelet transfusion) Phase 3 Study M0631
Estonian: Joonis 1 Trombotsüütide arvu ajaprofiilid III faasi uuringutes kroonilise maksahaigusega trombotsütopeeniaga patsientidel (lusutrombopaagiga ravitud uuringus osalejatel ilma trombotsüütide ülekanneteta ja platseeboga ravitud patsientidel trombotsüütide ülekannetega)
English: A suppression of foetal intrauterine growth as well as cervical ribs occurred at doses (40 mg/kg/day or more), showing maternal toxicity.
Estonian: Annuse 40 mg/kg ööpäevas või suurema annuse kasutamisel tekkisid lootel emakasisese kasvu supressioon ja kaelalülid, mis näitas emasloomal avalduvat toksilisust.
English: The key secondary endpoints in Studies M0631 and M0634 were
Estonian: Uuringute M0631 ja M0634 tähtsamad teisesed tulemusnäitajad olid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 3 mg lusutrombopag
Estonian: TOIMEAINE(TE) SISALDUS Üks õhukese polümeerikattega tablett sisaldab 3 mg lusutrombopaagi
English: Subjects were randomised to either of 3 mg of lusutrombopag or placebo in a 1:1 ratio.
Estonian: Uuringus osalejad randomiseeriti suhtega 1:1 rühmadesse, kellele manustati kas 3 mg lusutrombopaagi või platseebot.
English: NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets lusutrombopag
Estonian: RAVIMPREPARAADI NIMETUS Mulpleo 3 mg õhukese polümeerikattega tabletid Lusutrombopaag
English: Platelet count should be carefully monitored in patients with a history of splenectomy treated with lusutrombopag.
Estonian: Lusutrombopaagiga ravitavatel patsientidel, kellele on tehtud splenektoomia, tuleb hoolikalt jälgida trombotsüütide arvu.
English: NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Mulpleo 3 mg õhukese polümeerikattega tabletid
English: Table 3 Proportion of Subjects who required no platelet transfusion during the study (Day 1 through Day 35)
Estonian: Tabel 3 Uuringu jooksul (1. kuni 35. päeval) trombotsüütide ülekannet mittevajanud uuringus osalejate osakaal
English: A double dose should not be taken to make up for a missed dose.
Estonian: Ei tohi võtta kahekordset annust, kui annus jäi eelmisel korral võtmata.
English: if the platelet count reaches ≥50,000/µL as a result of a 20,000/µL increase from baseline.
Estonian: ≥ 50 000/μl koos tõusuga ≥ 20 000/μl ravieelselt tasemelt.
English: ➤ Check with your doctor if this applies to you before you take Mulpleo
Estonian: ➤ Küsige oma arstilt enne Mulpleo võtmist, kas see puudutab teid.
English: Adverse reaction - Common
Estonian: Kõrvaltoime - sage
English: Proportion of subjects who required no platelet transfusion during the study (Day 1 through Day 35) The proportion of subjects who required no platelet transfusion during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 3).
Estonian: Uuringu jooksul trombotsüütide ülekannet mittevajanud uuringus osalejate osakaal oli konkreetsete uuringute lusutrombopaagi rühmas ja lusutrombopaagi koondrühmades (uuringutes M0631 ja M0634) statistiliselt oluliselt suurem võrreldes platseeborühmaga (tabel 3).
English: Duration of the increase in platelet count to ≥ 50,000/μL
Estonian: Trombotsüütide arvu suurenemise ≥ 50 000/μl kestus
English: ≥ 50,000/μL with an increase of ≥ 20,000/μL from baseline) during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 4).
Estonian: Ravivastusega uuringus osalejate osakaal Uuringus osalejate osakaal, kes vastasid uuringu jooksul ravivastuse kriteeriumile (määratletud tromotsüütide arvu suurenemisena ≥ 50 000/μl koos tõusuga ≥ 20 000/μl ravieelselt tasemelt), oli konkreetsete uuringute lusutrombopaagi rühmas ja lusutrombopaagi koondrühmades (uuringutes M0631 ja M0634) oluliselt suurem võrreldes platseeborühmaga (tabel 4).
English: Mulpleo contains sodium
Estonian: Mulpleo sisaldab naatriumi
English: The time course of platelet counts in lusutrombopag-treated subjects without platelet transfusion and placebo-treated subjects with platelet transfusion in Studies M0631 and M0634 is presented in Figure 1.
Estonian: Trombotsüütide arvu muutumine ajas uuringutes M0631 ja M0634 lusutrombopaagiga ravitud uuringus osalejatel, kes trombotsüütide ülekandeid ei saanud, ja platseeboga ravitud uuringus osalejatel, kes said trombotsüütide ülekandeid, on esitatud joonisel 1.
English: Severe hepatic impairment
Estonian: Seedetrakti häired iiveldus
English: MARKETING AUTHORISATION NUMBER(S)
Estonian: RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV(AD) TOOTJA(D)
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Estonian: B. HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD Retseptiravim.
English: Film-coating
Estonian: • nahalööve.
English: The patients were treated for 4 weeks.
Estonian: Patsiente raviti neli nädalat.
English: If symptoms persist after 2 weeks, the patient should see a doctor.
Estonian: Kui sümptomid püsivad pärast kahte nädalat, peab patsient pöörduma arsti poole.
English: The Committee concluded that patients could safely treat themselves with the medicine for up to 2 weeks.
Estonian: Komitee järeldas, et patsiendid võivad ravimit ohutult võtta kuni kaks nädalat.
English: The recommended dose is one tablet per day for up to 2 weeks until the symptoms are relieved.
Estonian: Soovitatav annus on üks tablett ööpäevas kuni kahe nädala vältel, kuni sümptomid on leevendunud.
English: The full EPAR for Nexium Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Nexium Controli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nexium Control on 26 August 2013.
Estonian: Euroopa Komisjon andis Nexium Controli müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 26. augustil 2013.
English: The CHMP concluded that the medicine's effects were already well established, as esomeprazole-containing medicines have been authorised in EU countries since 2000, and that its short-term benefits had been demonstrated in studies where most patients' symptoms cleared up in 2 weeks.
Estonian: Inimravimite komitee oli seisukohal, et ravimi toime on juba hästi tõendatud, sest esomeprasooli sisaldavatel ravimitel on müügiluba Euroopa Liidu riikides alates 2000. aastast, ning selle lühiajalist kasulikkust on tõendatud uuringutes, kus enamiku patsientide sümptomid taandusid kahe nädala jooksul.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nexium Control's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Nexium Controli kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: By blocking the pumps, esomeprazole reduces acid production, thereby relieving the symptoms of acid reflux.
Estonian: Prootonipumpade blokeerimisega vähendab Esomeprasool happe teket ning leevendab seeläbi happe tagasivoolu sümptomeid.
English: A risk management plan has been developed to ensure that Nexium Control is used as safely as possible.
Estonian: Töötati välja riskijuhtimisstrateegia, et tagada Nexium Controli võimalikult ohutu kasutamine.
English: It is available as tablets (20 mg) which are gastro-resistant (the contents pass through the stomach without being broken down until they reach the intestine).
Estonian: Seda turustatakse tablettidena (20 mg), mis on gastroresistentsed (tablett läbib mao ja selle sisu ei lagune enne, kui tablett jõuab soolestikku).
English: What measures are being taken to ensure the safe and effective use of Nexium Control?
Estonian: Mis meetmed võetakse, et tagada Nexium Controli ohutu ja efektiivne kasutamine?
English: Other information about Nexium Control
Estonian: Muu teave Nexium Controli kohta
English: The main measure of effectiveness in both studies was the percentage of patients whose heartburn symptoms had completely cleared up at the end of the study.
Estonian: Mõlemas uuringus oli efektiivsuse põhinäitaja nende patsientide osakaal, kelle kõrvetised olid uuringu lõpuks täielikult taandunud.
English: In both studies, most patients whose symptoms completely cleared up had already achieved this in the first 2 weeks, while patients whose symptoms did not completely clear up in 2 weeks showed little further improvement from continued treatment.
Estonian: Enamikul patsientidest, kelle sümptomid taandusid täielikult, saavutati see efektiivsusnäitaja mõlemas uuringus juba esimese kahe nädala jooksul, ning neist patsientidest, kelle sümptomid ei taandunud kahe nädala jooksul täielikult, täheldati ravi jätkamisel mõningast täiendavat seisundi paranemist.
English: The reference medicine is only available with a prescription, but Nexium Control is intended for short term use without a prescription.
Estonian: Võrdlusravimit turustatakse üksnes retseptiravimina, kuid Nexium Control on ette nähtud lühiajaliseks kasutamiseks käsimüügiravimina.
English: Nexium Control must not be used together with another medicine called nelfinavir (used to treat HIV infection).
Estonian: Nexium Controli ei tohi kasutada koos ravimiga nelfinaviir (kasutatakse HIV-nakkuse ravis).
English: Nexium Control has been compared with placebo (a dummy treatment) in two main studies involving 718 adult patients with reflux symptoms including heartburn.
Estonian: Nexium Controli võrreldi platseeboga (näiva ravimiga) kahes põhiuuringus, kuhu oli kaasatud reflekshaiguse sümptomitega (sealhulgas kõrvetistega) 718 täiskasvanud patsienti.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nexium Control, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Strateegiast lähtudes lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Nexium Controli ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavate ettevaatusmeetmete teave.
English: This is a summary of the European public assessment report (EPAR) for Nexium Control.
Estonian: See on ravimi Nexium Control Euroopa avaliku hindamisaruande kokkuvõte.
English: Nexium Control esomeprazole
Estonian: Nexium Control esomeprasool
English: It is used in adults for the short-term treatment of reflux symptoms (sometimes called acid reflux), such as heartburn and acid regurgitation.
Estonian: Seda kasutatakse reflukshaiguse (mõnikord nimetatakse ka happe tagasivooluks), näiteks kõrvetiste ja maohappe tagasivoolu sümptomite lühiajaliseks raviks täiskasvanutel.
English: For practical information about using Nexium Control, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Nexium Controli kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Why is Nexium Control approved?
Estonian: Miks Nexium Control heaks kiideti?
English: It is not intended to provide practical advice on how to use Nexium Control.
Estonian: Hindamisaruandes ei anta Nexium Controli kasutamise praktilisi nõuandeid.
English: Nexium Control is a medicine that contains the active substance esomeprazole.
Estonian: Nexium Control on ravim, mis sisaldab toimeainena esomeprasooli.
English: In the second study, around 42% of patients taking Nexium Control (47 out of 113) had no more heartburn symptoms, compared with around 12% of patients taking placebo (14 out of 118).
Estonian: Teises uuringus taandusid kõrvetised ligikaudu 42 protsendil Nexium Controli võtnud patsientidest (47 patsienti 113st), võrreldes platseebot saanud ligikaudu 12 protsendiga patsientidest (14 patsienti 118st).
English: In the first study, around 34% of patients taking a 20 mg dose of Nexium Control (41 out of 121) had no more heartburn symptoms, compared with around 14% of patients taking placebo (17 out of 124).
Estonian: Esimeses uuringus taandusid kõrvetised ligikaudu 34 protsendil patsientidest (41 patsiendil 121st), kes võtsid Nexium Controli annuses 20 mg, võrreldes platseebot saanud ligikaudu 14 protsendiga patsientidest (17 patsienti 124st).
English: The active substance in Nexium Control, esomeprazole, is a proton pump inhibitor.
Estonian: Nexium Controli toimeaine esomeprasool on prootonpumba inhibiitor.
English: For the full list of all side effects reported with Nexium Control, see the package leaflet.
Estonian: Nexium Controli kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What is Nexium Control and what is it used for?
Estonian: Mis on Nexium Control ja milleks seda kasutatakse
English: For more information about treatment with Nexium Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Nexium Controliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Nexium Control is similar to a ‘reference medicine' already authorized in the European Union (EU) containing the same active substance, called Nexium.
Estonian: Nexium Control on sarnane sama toimeainet sisaldava võrdlusravimiga Nexium, millel juba on Euroopa Liidus müügiluba.
English: What are the risks associated with Nexium Control?
Estonian: Mis riskid Nexium Controliga kaasnevad?
English: How is Nexium Control used?
Estonian: Kuidas Nexium Controli kasutatakse?
English: How does Nexium Control work?
Estonian: Kuidas Nexium Control toimib?
English: What benefits of Nexium Control have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Nexium Controli kasulikkus?
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining, which pump acid into the stomach.
Estonian: Ravimi toimemehhanismiks on prootonipumpade (makku hapet „pumpavate” mao parietaalrakkudes leiduvate rakkude valkude)
English: Headache, abdominal pain, diarrhoea and nausea are among the most common side effects with Nexium Control (which may affect up to 1 in 10 patients).
Estonian: Nexium Controli kõige sagedamad kõrvalnähud (võivad esineda 1 patsiendil 10st) on peavalu, kõhuvalu, kõhulahtisus ja iiveldus.
English: B-1080 Brussels
Estonian: B-1080 Brüssel
English: This combination is, therefore, not recommended.
Estonian: Seetõttu ei soovitata seda kombinatsiooni kasutada.
English: These changes are specific to small rodents and have not been observed in other animal species.
Estonian: Need muutused on spetsiifilised väikenärilistele ja neid ei ole täheldatud teistel loomaliikidel.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 April 2011
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Esmase müügiloa väljastamise kuupäev: 14 Aprill 2011
English: No specific antidote is known.
Estonian: Spetsiifilist antidooti ei ole.
English: The following two side effects are important and will require immediate action.
Estonian: Järgmised kõrvaltoimed on olulised ja vajavad kohest sekkumist.
English: Practically all the drug is eliminated within 6 days.
Estonian: Peaaegu kogu ravim eritub 6 ööpäeva jooksul.
English: What should I know about cholesterol and triglycerides?
Estonian: Mida ma peaksin kolesterooli ja triglütseriidide kohta teadma?
English: The volume of distribution is about 0.5 l/kg.
Estonian: Jaotusruumala on ligikaudu 0,5 l/kg.
English: Package leaflet: Information for the user
Estonian: PAKENDI INFOLEHT: INFORMATSIOON KASUTAJALE
English: (see section 4.4).
Estonian: (vt lõik 4.4).
English: - Tell your doctor about all your medical conditions including allergies.
Estonian: - Rääkige arstile kõigist tervisehäiretest, sealhulgas allergiatest.
English: Always take Pravafenix exactly as your doctor has told you.
Estonian: Võtke Pravafenixit alati täpselt nii, nagu arst on teile rääkinud.
English: The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown.
Estonian: Selle koostoime mehhanism (kas see on farmakodünaamiline või farmakokineetiline või mõlemat) ei ole praegusel hetkel teada.
English: This is a very rare reaction which can be serious if it occurs.
Estonian: See reaktsioon esineb väga harva, aga võib olla raske.
English: Fenofibrate Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Estonian: Fenofibraat Fenofibriinhape on tugevasti seotud plasma albumiiniga (üle 99%).
English: In most people, there are no signs of cholesterol problems at first.
Estonian: Enamikul inimestest ei esine alguses kolesteroolihäirete tunnuseid.
English: ∞, AUCt, and Cmax is of 111.88%, 114.06%, and 115.28% respectively.
Estonian: t, ja Cmax suurenesid vastavalt 111,88%, 114,06% ja 115,28%.
English: If confirmed, the treatment should definitively not be initiated (see section 4.3).
Estonian: Kui tulemus kinnitatakse, ei tohi ravi mingil juhul alustada (vt lõik 4.3).
English: Polyamide-Aluminium-PVC/aluminium blister 2 years.
Estonian: Polüamiid-alumiinium-PVC/alumiiniumblistrid 2 aastat.
English: If you are not sure about this, please follow your doctor's advice.
Estonian: Kui te ei ole milleski kindel, järgige palun arsti nõuandeid.
English: Swallow the capsule with water.
Estonian: Kapsel tuleb alla neelata koos veega.
English: Before treatment initiation
Estonian: Enne ravi alustamist
English: Children and adolescents Do not take Pravafenix if you are under 18 years old
Estonian: Lapsed Ärge võtke Pravafenixit, kui te olete alla 18 aasta vana.
English: Pruritus, urticaria
Estonian: Kihelus, urtikaaria
English: Also see section 4.4
Estonian: Vt ka lõik 4.4
English: If you plan to become pregnant or become pregnant, inform your doctor immediately.
Estonian: Kui te soovite rasestuda või rasestute, teatage sellest kohe oma arstile.
English: This clogging can slow or block blood flow to vital organs such as the heart and brain.
Estonian: Selline ummistus võib vähendada või takistada verevoolu tähtsatesse elunditesse, nagu südamesse ja ajju.
English: Do not take Pravafenix if any of the above applies to you.
Estonian: Ärge võtke Pravafenixit, kui mõni eelnev väide kehtib teie kohta.