FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, the discordance between the PK and PD data for Flutiform suggests that the PK data do not accurately reflect comparative pulmonary deposition and are not a valid surrogate for clinical effect.
Estonian: Lisaks viitab Flutiformi farmakokineetiliste ja farmakodünaamiliste andmete lahknevus sellele, et farmakokineetilised andmed ei peegelda täpselt ravimi ladestumist kopsus ega ole seega kliinilise toime sobiv asendusnäitaja.
English: Of the five pivotal studies submitted with this Marketing Authorisation Application three studies were designed such that they facilitate a rigorous, internally validated examination as to whether the long-acting β2 agonist formoterol fumarate “masks” deficient corticosteroid effects of Flutiform upon pre-dose FEV1.
Estonian: Kortikosteroidi mis tahes väiksema kliinilise toime varjamine pikatoimelise ß2-agonisti poolt Müügiloa taotlusega esitatud viiest katseuuringust olid kolm kavandatud selleks, et lihtsustada ranget sisehindamist, mille eesmärk on kindlaks teha, kas pikatoimeline β2-agonist formoteroolfumaraat varjab
English: The CHMP was of the view that clinical data generated over 6 to 12 months to further elucidate the level of asthma control and to further assess exacerbation rates seen with Flutiform compared with fluticasone propionate administered concomitantly with formoterol fumarate or administered alone, are not required.
Estonian: Inimravimite komitee oli seisukohal, et 6-12-kuuline kliiniline uuring astma kontrolli taseme ja ägenemismäära hindamiseks, et võrrelda Flutiformi flutikasoonpropionaadiga (eraldi või koos formoteroolfumaraadiga manustatuna), ei ole vajalik.
English: Approximately 20 subjects in each arm of this parallel group study were administered Flutiform 500/20 (fluticasone propionate 500µg and formoterol fumarate 20µg) or GSK fluticasone propionate 500µg pMDI + Novartis formoterol fumarate 24µg pMDI.
Estonian: Umbes 20 isikule paralleelrühmadega uuringu igas rühmas manustati Flutiformi 500/20 (500 µg flutikasoonpropionaati ja 20 µg formoteroolfumaraati) või GSK 500 µg flutikasoonpropionaati ühe toimeainega dosaatorinhalaatoriga ja lisaks Novartise 24 µg formoteroolfumaraati ühe toimeainega dosaatorinhalaatoriga.
English: The clinical findings suggest that fluticasone propionate in Flutiform is non-inferior in respect of clinical effects to GSK fluticasone propionate.
Estonian: Kliinilised tulemused näitavad, et Flutiformis sisalduva flutikasoonpropionaadi kliiniline toime ei ole nõrgem kui GSK ühe toimeainega dosaatorinhalaatori flutikasoonpropionaadi kliiniline toime.
English: Data submitted by the Applicant demonstrated that asthma control with Flutiform is superior to that with fluticasone propionate pMDI alone and that asthma control with Flutiform is similar to that with fluticasone propionate pMDI + formoterol fumarate pMDI.
Estonian: Taotleja esitatud andmed näitasid, et astma on Flutiformiga paremini kontrollitud kui ühte toimeainet flutikasoonpropionaati sisaldava dosaatorinhalaatoriga ja et astma kontroll Flutiformiga on sarnane kumbagi toimeainet sisaldava dosaatorinhalaatoriga (flutikasoonpropionaat või formoteroolfumaraat koos manustatuna) tehtava raviga.
English: The pre-dose FEV1 data in this study which were again a demonstrably inhaled corticosteroid-mediated effect provided no evidence of a lesser inhaled corticosteroid effect with Flutiform than seen with fluticasone propionate + formoterol fumarate.
Estonian: Selles uuringus ei osutanud ka manustamiseelse FEV1 andmed, mis olid taas inhaleeritava kortikosteroidi vahendatud, et Flutiformi inhaleeritava kortikosteroidi toime oleks nõrgem kui flutikasoonpropionaadi ja formoteroolfumaraadi kombinatsiooni toime.
English: Effects with the low dose of Flutiform (100µg/10µg) upon pre-dose FEV1 were similar to those with the high dose of GSK fluticasone propionate 500µg (alone or in combination with formoterol fumarate 24µg).
Estonian: Flutiformi väiksema annuse (100 µg/10 µg) toime manustamiseelsele FEV1-le olid sarnane GSK suure 500 µg flutikasoonpropionaadi annuse toimega (eraldi või koos 24 µg formoteroolfumaraadiga manustatuna).
English: This comparison showed that despite a lower relative fluticasone propionate bioavailability, the effect upon pre-dose FEV1 (which was demonstrably mediated by fluticasone propionate alone in Study FLT3503) was numerically greater with Flutiform 500µg/20µg than with GSK fluticasone propionate 500µg (either alone or in conjunction with Novartis formoterol fumarate 24µg).
Estonian: Võrdlus näitas, et hoolimata flutikasoonpropionaadi väiksemast suhtelisest biosaadavusest on manustamiseelne FEV1-toime (mida uuringus FLT3503 vahendas selgelt ainult flutikasoonpropionaat) arvuliselt suurem 500 µg/20 µg Flutiformi puhul kui 500 µg GSK flutikasoonpropionaadi puhul (kas eraldi või koos 24 µg Novartise formoteroolfumaraadiga manustatuna).
English: However, an analysis of annualised exacerbation rates in this study was able to differentiate the effects of high dose ICS-LABA (inhaled corticosteroid - long-acting β2 agonist) treatments (Flutiform 500µg/20µg and fluticasone propionate 500µg + formoterol fumarate 24µg) from low dose ICS-LABA treatment (fluticasone propionate 100µg/10µg) and fluticasone propionate 500µg monotherapy.
Estonian: Siiski näitas aastaste ägenemiste analüüs erinevust inhaleeritava kortikosteroidi - pikatoimelise β2-agonisti (ICS-LABA) suure annuse (Flutiform 500 µg/20µg ja flutikasoonpropionaat 500 µg + formoteroolfumaraat 24 µg) ning inhaleeritava kortikosteroidi - pikatoimelise β2-agonisti väikese annuse (flutikasoonpropionaat 100 µg/10 µg) ja 500 µg flutikasoonpropionaadi monoteraapia ravitoimes.
English: In addition, the comparison of these PK data with PD data, Study FLT3503, shows that despite the lower relative bioavailability of fluticasone propionate in this new fixed-dose combination product the effect upon predose FEV1 (which was demonstrably mediated by fluticasone propionate alone in Study FLT3503) was numerically greater with Flutiform 500µg/20µg than with GSK fluticasone propionate 500µg (either administered alone or administered together with Novartis formoterol fumarate 24µg).
Estonian: Lisaks näitas farmakokineetiliste ja farmakodünaamiliste andmete võrdlus (uuring FLT3503), et hoolimata flutikasoonpropionaadi väiksemast suhtelisest biosaadavusest uues fikseeritud annustega kombinatsioonravimis on manustamiseelne FEV1-toime (mida uuringus FLT3503 selgelt vahendas flutikasoonpropionaat) arvuliselt suurem 500 µg/20 µg Flutiformi kui 500 µg GSK flutikasoonpropionaadi puhul (kas eraldi või koos 24 µg Novartise formoteroolfumaraadiga manustatuna).
English: Study FLT 3503 also included a comparison with a lower dose of Flutiform and effects seen with this lower dose of Flutiform (100µg/10µg) upon pre-dose FEV1 were similar to those seen with the high dose of GSK fluticasone propionate 500µg (administered both alone or in combination with formoterol fumarate 24µg).
Estonian: Uuring FLT3503 sisaldas ka võrdlust Flutiformi väiksema annusega: Flutiformi väikese annusega (100 µg/10 µg) täheldatud toime manustamiseelsele FEV1-le oli sarnane GSK suure 500 µg annuse flutikasoonpropionaadi toimega (eraldi või koos 24 µg formoteroolfumaraadiga manustatuna).
English: With regard to the “Switch” indication, the proportion of patients experiencing exacerbations in the pivotal “Switch” study (Study FLT3503) was similar in Flutiform and fluticasone propionate + formoterol fumarate treated patients (36.4% and 35.3%, respectively) although this analysis lacked discriminative capacity as the proportion of fluticasone propionate monotherapy-treated patients experiencing exacerbations was similar (37.4%).
Estonian: Ülemineku katseuuringus (FLT3503) oli ägenemistega patsientide osakaal Flutiformiga ning flutikasoonpropionaadi ja formoteroolfumaraadiga ravitud patsientidel sarnane (vastavalt 36,4% ja 35,3%).
English: These PK and PD studies both included the same strengths/doses of Flutiform, GSK fluticasone propionate pMDI and Novartis formoterol fumarate pMDI, and all products in both studies were administered via the same spacing device, so allowing a valid comparison of PK and PD data.
Estonian: Nii farmakokineetika kui ka farmakodünaamika uuringutes manustati sama tugevusega / samades annustes Flutiformi, GSK flutikasoonpropionaati ühe toimeainega dosaatorinhalaatoriga ja Novartise formoteroolfumaraati ühe toimeainega dosaatorinhalaatoriga.
English: The effect should gradually disappear within a few days in most cases.
Estonian: Enamikul juhtudel peaks toime mõne päeva jooksul järk-järgult kaduma.
English: propranolol, amlodipine).
Estonian: (nt propranolool, amlodipiin).
English: See also section 2 under ‘Warnings and precautions'.
Estonian: Vt ka lõik 2 „Hoiatused ja ettevaatusabinõud“.
English: Mirvaso may also cause the following other side effects:
Estonian: Mirvaso võib põhjustada ka teisi järgmisi kõrvaltoimeid:
English: In some cases, symptoms may extend beyond the treatment area.
Estonian: Mõnel juhul võivad sümptomid laieneda üle ravipiirkonna.
English: Then pull the cap off.
Estonian: Seejärel tõmmake kork ära.
English: Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy has not been established for this age group.
Estonian: Ärge andke seda ravimit kuni 18 aasta vanustele lastele ja noorukitele, sest ohutus ja efektiivsus ei ole selles vanuserühmas tõestatud.
English: Manufacturer Laboratoires Galderma Z.I.
Estonian: Laboratoires Galderma Z.I.
English: This is particularly important in children under the age of 2 years (see ‘Do not use Mirvaso').
Estonian: See on eriti tähtis kuni 2 aasta vanuste laste puhul (vt „ÄRGE kasutage Mirvasot”).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2014
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 21. veebruar 2014
English: Most of the cases were observed within the first 2 weeks of starting the treatment (see section 4.8).
Estonian: Enamik juhtudest täheldati kahe esimese nädala jooksul alates ravi alustamise päevast (vt lõik 4.8).
English: Children aged less than 2 years.
Estonian: Kuni 2 aasta vanused lapsed.
English: 92927 La Défense Cedex France
Estonian: 92927 La Défense Cedex Prantsusmaa
English: Both children were reported to have made a full recovery within 24 hours.
Estonian: Mõlemad lapsed paranesid 24 tunni jooksul täielikult.
English: Take the medicine pack with you, so the doctor knows what was swallowed.
Estonian: Võtke ravimi pakend kaasa, et arst teaks, mida on alla neelatud.
English: Date of latest renewal: 22 November 2018
Estonian: Viimase müügiloa uuendamise kuupäev: 24. novembri 2018
English: If anyone, especially a child, accidentally swallows Mirvaso, they may have serious side effects and need to be treated in a hospital.
Estonian: Kui keegi, eriti laps, neelab Mirvasot kogemata alla, võivad tal tekkida tõsised kõrvaltoimed ja ta võib vajada haiglaravi.
English: Mirvaso works on a daily basis, starting with the first day of treatment.
Estonian: Mirvaso toimib iga päev alates esimesest ravipäevast.
English: Study 1 + Study 2
Estonian: 1. uuring + 2. uuring
English: Pharmacotherapeutic group: Other dermatological preparations, Other dermatologicals, ATC code: D11AX21.
Estonian: Farmakoterapeutiline rühm: teised dermatoloogilised preparaadid, ATC-kood: D11AX21
English: * Adverse reactions reported from post-marketing data.
Estonian: * Kõrvaltoimed, millest on teatatud turuletulekujärgsete andmete põhjal
English: A potential consequence of stopping the treatment before finishing the course of treatment is the disease to come back to its initial state.
Estonian: Ravimi kasutamise katkestamise võimalik tagajärg enne ravikuuri lõppemist on haiguse esialgse seisundi taastekkimine.
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequently updates published on the European medicines web-portal.
Estonian: Nõuded asjaomase ravimi perioodiliste ohutusaruannete esitamiseks on sätestatud direktiivi 2001/83/EÜ artikli 107c punkti 7 kohaselt liidu kontrollpäevade loetelus (EURD loetelu) ja iga hilisem uuendus avaldatakse Euroopa ravimite veebiportaalis.
English: The pump is child-resistant again.
Estonian: Pump on taas lastekindel.
English: Of these, 539 completed 29 days of treatment and had data available to be included in the efficacy analysis at Day 29, with the majority being Caucasians between 18 and 65 years of age.
Estonian: Neist 539 lõpetas 29-päevase ravi ja nende kohta olid saadaval andmed, mida kasutati 29. päeva seisuga toimunud efektiivsuse analüüsis ja enamik neist olid valge nahavärviga ja vanuses 18 kuni 65 aastat.
English: The experience of use of Mirvaso in patients aged above 65 years is limited (see also section 4.8).
Estonian: Mirvaso kasutamise kogemus üle 65-aastastel patsientidel on piiratud (vt ka lõik 4.8).
English: How to use Mirvaso Mirvaso is recommended to be applied to the face once a day only.
Estonian: Kuidas Mirvasot kasutada Mirvasot on soovitatud kanda näole ainult üks kord päevas.
English: The results from a long term open label study in 449 patients, with continuous treatment for up to one year, confirmed that chronic use of Mirvaso is safe and effective.
Estonian: Pikaajalise avatud uuringu tulemused aasta jooksul pidevalt ravi saanud 449 patsiendiga kinnitasid, et Mirvaso pikaajaline kasutus on ohutu ja efektiivne.
English: You should wash your hands immediately after applying this medicine.
Estonian: Peske oma käed kohe pärast selle ravimi pealekandmist.
English: Other medicines and Mirvaso
Estonian: Muud ravimid ja Mirvaso
English: Across all clinical studies, 16% of patients receiving Mirvaso experienced an event of symptom exacerbation.
Estonian: Kõikides kliinilistes uuringutes koges 16% Mirvasot saavatest patsientidest sümptomide ägenemist.
English: You must avoid the eyes, eyelids, lips, mouth, and the inside of the nose.
Estonian: Peate vältima silmi, lauge, huuli, suud ja nina sisepinda.
English: They are typically mild to moderate in severity, and usually do not require discontinuation of treatment.
Estonian: Need on tüüpiliselt kerge või mõõduka raskusastmega ja tavaliselt ei tingi ravi katkestamist.
English: This is because its effects on your unborn baby are unknown.
Estonian: Selle toime sündimata lapsele on teadmata.
English: Mirvaso is contraindicated in children aged less than 2 years because of serious systemic safety risk (see section 4.3).
Estonian: Mirvaso on vastunäidustatud lastel vanuses kuni 2 aastat tõsise süsteemse ohutusriski tõttu (vt lõik 4.3).
English: Mirvaso should not be applied close to the eyes.
Estonian: Mirvasot ei tohi kanda silmade lähedale.
English: If you miss a daily dose, your redness will not be reduced for that day.
Estonian: Kui päevaannuse vahele jätate, ei vähene teil sel päeval punetus.
English: The studies were conducted in 553 randomised subjects aged 18 years and older who were treated once daily for 4 weeks with either Mirvaso or vehicle.
Estonian: Uuringutes osales 553 juhuslikult valitud isikut, kes olid 18-aastased või vanemad ja keda raviti 4 nädala vältel üks kord päevas Mirvaso või vehiikliga.
English: Fertility Brimonidine did not present any special reproductive or developmental hazard in animal species.
Estonian: Fertiilsus Brimonidiini kasutamisel ei olnud erilisi riske loomaliikide reproduktsioonile või arengule.
English: Should any gel get onto these areas, wash them immediately with plenty of water.
Estonian: Geeli sinna sattudes peske neid piirkondi kohe rohke veega.
English: To close the pump, place the cap back on the pump.
Estonian: Pumba sulgemiseks asetage kork pumbale tagasi.
English: If your symptoms remain the same or improve only slightly, you may then gradually increase the amount of gel.
Estonian: Kui sümptomid ei muutu või paranevad vaid väga vähe, võite geeli kogust järk-järgult suurendada.
English: No adverse reactions had an increase in frequency over time, and there was no evidence that long-term use of Mirvaso conveyed an increased risk of occurrence of any specific type of adverse reaction.
Estonian: Ükski kõrvaltoime ei sagenenud aja jooksul ja ei leitud ühtegi tõendit, et Mirvaso pikaajaline kasutus põhjustaks mistahes kõrvaltoime suurenenud tekkeriski.
English: No meaningful differences in the safety profiles were observed between the elderly subject population and subjects 18 to 65 years of age.
Estonian: Märkimisväärseid erinevusi eakate ja 18 kuni 65-aastatste isikute ohutusprofiilis ei täheldatud.
English: The most commonly reported adverse reactions are erythema, pruritus, flushing and skin burning sensation, all occurring in 1.2 to 3.3% of patients in clinical studies.
Estonian: Kõige sagedamini esinenud kõrvaltoimed on erüteem, kihelus, õhetus ja naha kõrvetustunne, mida kõiki esines kliinilistes uuringutes 1,2 kuni 3,3 % patsientidest.
English: You should not use this medicine during breast-feeding, as it is unknown whether this medicine passes into the breast milk.
Estonian: Ärge kasutage seda ravimit rinnaga toitmise ajal, kuna ei ole teada, kas see ravim eritub rinnapiima.
English: Please contact your doctor before stopping your treatment, so that he could advice a replacement treatment as appropriate.
Estonian: Pidage enne ravi lõpetamist nõu oma arstiga, et arst annaks nõu sobivaks asendusraviks.
English: Success day 29
Estonian: Tulemus 29. päeval
English: Treatment should be initiated with a smaller amount of gel (less than the maximum) for at least one week.
Estonian: Ravi tuleb alustada väiksema geeli kogusega (vähem kui maksimaalne kogus) vähemalt ühe nädala jooksul.
English: Galderma Laboratorium GmbH Toulouser Allee 19a-23a D-40211 Düsseldorf Germany
Estonian: Galderma Laboratorium GmbH Toulouser Allee 19a-23a D-40211 Düsseldorf Saksamaa
English: Such worsening of redness usually develops within the first 2 weeks of treatment with Mirvaso.
Estonian: Tavaliselt tekib punetuse süvenemine kahe esimese nädala jooksul pärast Mirvasoga ravi alustamist.
English: Brimonidine is a highly selective alpha2-adrenergic receptor agonist that is 1000-fold more selective for the alpha2-adrenergic receptor than the alpha1-adrenergic receptor.
Estonian: Brimonidiin on väga selektiivne alfa-2-adrenergilise retseptori agonist, mis on 1000 korda selektiivsem alfa-2-adrenergilise retseptori kui alfa-1-adrenergilise retseptori suhtes.
English: Do not apply any other skin medicines or cosmetics immediately before the daily application of Mirvaso.
Estonian: Ärge kandke nahale muid naharavimeid ega kosmeetikavahendeid vahetult enne Mirvaso igapäevast pealekandmist.
English: Bradycardia and hypotension
Estonian: Bradükardia ja hüpotensioon
English: Generally, it resolves spontaneously after treatment is stopped.
Estonian: Üldjuhul kaob see iseenesest pärast ravi katkestamist.
English: Montdésir 74540 Alby-sur-Chéran France or
Estonian: Montdésir 74540 Alby-sur-Chéran Prantsusmaa ja
English: Before the first use, prime the pump by pressing down several times until the medicine is idispensed onto your fingertip.
Estonian: Enne esmast kasutamist vajutage pumpa mitu korda, kuni teie sõrmeotsal on ravimit.
English: Brimonidine may cause clinically insignificant decreases in blood pressure in some patients.
Estonian: Brimonidiin võib põhjustada mõnel patsiendil vererõhu kliiniliselt ebaolulist langust.
English: Do not use this medicine on other parts of your body, especially moist body surfaces, e.g. your eyes, mouth, nose or vagina.
Estonian: Ärge kasutage seda ravimit muudel kehaosadel, eriti niisketel kehapindadel, nagu silmad, suu, nina või tupp.
English: Do not use this medicine after the expiry date which is stated on the carton, tube and pump after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil, tuubil ja pumbal pärast Kõlblik kuni/EXP.
English: Repeated doses within the same 24 hour period could result in side effects, such as low blood pressure, drowsiness or sleepiness.
Estonian: Korduvate annuste manustamine 24-tunnise perioodi jooksul võib põhjustada kõrvaltoimeid, näiteks madalat vererõhku või unisust.
English: The amount of gel can then be increased gradually based on tolerability and patient response.
Estonian: Geeli kogust võib seejärel järk-järgult suurendada, lähtudes taluvusest ja patsiendi ravivastusest.
English: Spread it smoothly and evenly as a very thin layer as directed by your doctor or nurse.
Estonian: Hõõruge see sujuvalt ja ühtlaselt laiali väga õhukese kihina, järgides arsti või meditsiiniõe juhiseid.
English: Distribution The protein binding of brimonidine has not been studied.
Estonian: Jaotumine Brimonidiini seondumist valkudega ei ole uuritud.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because these medicines could affect your treatment with Mirvaso or Mirvaso could affect your treatment with these medicines.
Estonian: Öelge oma arstile või apteekrile, kui te kasutate, olete hiljuti kasutanud või võite kasutada ükskõik millist muud ravimit, sest need ravimid võivad mõjutada Mirvaso-ravi või Mirvaso võib mõjutada teie ravi nende ravimitega.
English: Some cases involved application of Mirvaso following laser procedures (see section 4.4).
Estonian: Mõnel juhul oli Mirvasot kasutatud pärast laserprotseduuri (vt lõik 4.4).
English: Pack sizes: 1 tube of 2 g,10 g or 30 g; 1 pump of 30 g. Not all pack sizes may be marketed.
Estonian: Pakendi suurused: 1 tuub 2 g, 10 g või 30 g; 1 pumbaga konteiner 30 g. Kõik pakendi suurused ei pruugi olla müügil.
English: Any increase in the daily amount applied above 5 pea sized amounts and/or increase in frequency of daily application of the medicinal product should be avoided, since the safety of higher daily doses or repeated daily application has not been assessed.
Estonian: Päevas pealekantava koguse suurendamist üle 5 herneterasuuruse koguse ja/või pealekandmissageduse suurendamist tuleb vältida, sest suuremate päevaannuste või mitu korda päevas pealekandmise ohutust ei ole hinnatud.
English: In case of severe irritation or contact allergy, the treatment with the medicinal product should be discontinued.
Estonian: Raske ärrituse või kontaktallergia korral tuleb ravi katkestada.
English: These products should not be applied immediately before the daily application of Mirvaso; they may be used only after the applied Mirvaso has dried.
Estonian: Neid tooteid ei tohi kanda nahale vahetult enne Mirvaso igapäevast pealekandmist; neid võib kasutada ainult pärast pealekantud Mirvaso kuivamist.
English: What Mirvaso contains - The active substance is brimonidine.
Estonian: Mida Mirvaso sisaldab - Toimeaine on brimonidiin.
English: If this occurs, you should discard the excess gel so as not to apply more than the recommended dose.
Estonian: Kui see juhtub, visake üleliigne geel ära, et mitte kanda peale soovituslikust suuremat annust.
English: Biotransformation Brimonidine is extensively metabolised by the liver.
Estonian: Biotransformatsioon Brimonidiin metaboliseerub ulatuslikult maksas.
English: As a precautionary measure, it is preferable to avoid the use of Mirvaso during pregnancy.
Estonian: Ettevaatusena on parem vältida Mirvaso kasutamist raseduse ajal.
English: Important: Mirvaso is intended for adults and only for use on the skin of the face.
Estonian: Tähtis: Mirvaso on ette nähtud kasutamiseks täiskasvanutel ja ainult näonahal.
English: Before you restart the treatment with Mirvaso, test it on a small area of the face on a day when you can stay at home.
Estonian: Enne Mirvaso-ravi taasalustamist, katsetage seda näol väikesel nahapinnal päeval, kui te kodust ei välju.
English: Use of Mirvaso when taking these medicines may result in a fall in blood pressure.
Estonian: Mirvaso kasutamine nende ravimite manustamise ajal võib põhjustada vererõhu alanemist.
English: What you need to know before you use Mirvaso
Estonian: Mida on vaja teada enne Mirvaso kasutamist