FrancophonIA/ELRC3.0 huggingface dataset:
Bulgarian: б p≤0,001 сравнено с плацебо.
Estonian: b p≤0,001 võrreldes platseeboga c Märkimisväärset reieluukaela murdude juhtude vähenemist ei ole näidatud.
Bulgarian: Phadisco Ltd Τηλ: + 357 22 715000
Estonian: Τηλ: + 357 22 715000
Bulgarian: Специални противопоказания и предупреждения за употреба
Estonian: 4.4 Erihoiatused ja ettevaatusabinõud kasutamisel
Bulgarian: 3 писалки 2,4 ml разтвор всяка.
Estonian: 3 ampullsüstalt, igaühes 2,4 ml lahust.
Bulgarian: Ефектите, които може да се очакват в случай на предозиране, включват гадене, повръщане, замаяност и главоболие.
Estonian: Võimalikeks üleannuse toimeteks on iiveldus, oksendamine, pearinglus ja peavalu.
Bulgarian: Необходимо е повишено внимание при пациенти с умерено бъбречно нарушение.
Estonian: Neerupuudulikkus Mõõduka neerupuudulikkusega patsientidega tuleb olla ettevaatlik.
Bulgarian: Махнете капачката на иглата и я изхвърлете както Ви е инструктирал Вашият лекар или фармацевт.
Estonian: Tõmmake nõela kate ära ning visake see minema, nii nagu arst või apteeker teid õpetas.
Bulgarian: Махнете иглата и я изхвърлете както Ви е инструктирал Вашият лекар или фармацевт.
Estonian: Tõmmake nõel ära ja visake minema, nagu arst või apteeker teid on õpetanud.
Bulgarian: Съхранявайте FORSTEO с поставена бяла капачка.
Estonian: • Hoidke FORSTEO'd valge otsikuga kaetult
Bulgarian: Съществуваща преди хиперкалциемия
Estonian: • Eelnev hüperkaltseemia.
Bulgarian: Отвъртете иглата напълно като изпълните 3 до 5 пълни оборота на капачката на иглата.
Estonian: Keerake nõel täiesti lahti, milleks on vaja teha nõela kattega 3…5 täispööret.
Bulgarian: Хиперхолестеролемия
Estonian: Sage: Hüperkolesteroleemia
Bulgarian: FORSTEO трябва да се прилага веднъж дневно чрез подкожно инжектиране в областта на бедрото или корема.
Estonian: Manustamisviis FORSTEO'd manustatakse üks kord päevas nahaaluse süstena reie või kõhunaha alla.
Bulgarian: Какво представлява FORSTEO и за какво се използва
Estonian: 1 Mis ravim on FORSTEO ja milleks seda kasutatakse
Bulgarian: FORSTEO може да се прилага със или без храна.
Estonian: FORSTEO'd võib manustada söögi ajal või ka muul ajal.
Bulgarian: Множествени вертебрални фрактури (2)
Estonian: Mitmed lülisamba murrud (≥2) a
Bulgarian: докато здраво се закрепи.
Estonian: Keerake peale nõel, kuni see jääb kõvasti kinni.
Bulgarian: Прочетете и следвайте указанията в Листовката с информация за пациента как да съхранявате
Estonian: Lugege ja järgige õpetusi, mis on antud Pakendi infolehes ampullsüstla säilitamise kohta.
Bulgarian: Проучванията при животни показват, че силно намаленият чернодробен кръвоток понижава експозицията на PTH върху основната делителна система
Estonian: Loomkatsetest on selgunud, et oluliselt vähenenud maksaverevarustus vähendab parathormooni (PTH) allumist peamisele lõhustamissüsteemile (Kupfferi rakkudele) ning seega ka PTH(1-84) kliirensit.
Bulgarian: Ако не сте сигурни, попитайте Вашия лекар.
Estonian: Kui te ei tea seda täpselt, siis konsulteerige arstiga.
Bulgarian: Глюкокортикоид-индуцирана остеопороза
Estonian: Glükokortikoididest põhjustatud osteoporoos
Bulgarian: Подгответе мястото за инжектиране, както Ви е инструктирал Вашият лекар или фармацевт.
Estonian: Valmistage süstekoht ette, nagu arst või apteeker teile õpetas.
Bulgarian: Годен до:
Estonian: Pärast süstimist:
Bulgarian: Средната (медианата на) кумулативна доза на глюкокортикоид е 474,3 (66,2) mg в рамото, получаващо терипаратид и 898,0 (100,0) mg в рамото, получаващо ризедронат.
Estonian: Glükokortikoidi keskmine (mediaan) kumulatiivne annus teriparatiidi rühmas oli 474,3 (66,2) mg ja risedronaadi rühmas 898,0 (100,0) mg. Keskmine (mediaan) D-vitamiini annus teriparatiidi rühmas oli 1433 RÜ/ööpäevas (1400 RÜ/ööpäevas) ja risedronaadi rühmas 1191 RÜ/ööpäevas (900 mg/ööpäevas).
Bulgarian: Пациенти с чернодробно нарушение
Estonian: Neerupuudulikkusega patsiendid
Bulgarian: Моля, позовавайте се на ръководството за употреба за инструкции как да използвате писалката.
Estonian: Palun lugege ampullsüstla kasutusjuhendit.
Bulgarian: Средното повишение на КМП от 18-я до 24-я месец е 1,4%, 1,2% и 1,6% съответно в лумбалната област на гръбначния стълб, тазобедрената област и бедрената шийка.
Estonian: Võrreldes 18 kuu tasemega suurenes keskmine luu mineraalne tihedus 24 kuu järel lumbaallülides, kogu puusas ja reieluukaelas vastavalt 1,4 %, 1,2 %, ja 1,6 %.
Bulgarian: Бъбречно нарушение
Estonian: • vererõhu langus
Bulgarian: Писалката трябва да се върне в хладилника незабавно след употреба.
Estonian: Kohe pärast kasutamist tuleb ampullsüstal tagasi külmkappi panna.
Bulgarian: необичаен сърдечен шум
Estonian: • ebaregulaarne südamerütm
Bulgarian: Серумен калций и калций в урината
Estonian: Seerumi ja uriini kaltsiumisisaldus
Bulgarian: Всяка доза от 80 микролитра съдържа 20 микрограма терипаратид*.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga 80 mikroliitrine annus sisaldab 20 mikrogrammi teriparatiidi.
Bulgarian: ако страдате от камъни в бъбреците или имате анамнеза за бъбречни камъни.
Estonian: kui Teil on neerukivid või kui Teil on kunagi neerukivid olnud.
Bulgarian: Сериозни случаи на крампи или болка в гърба са съобщавани в рамките на минути от инжектирането.
Estonian: Aeg-ajalt: kehakaalu tõus, südamekahin, alkaalse fosfataasi tõus * Minutite jooksul pärast süsti on täheldatud raskeid seljakrampide või -valu juhtumeid.
Bulgarian: Forsteo can be used for up to two years.
Estonian: Forsteot võib kasutada kuni kaks aastat.
Bulgarian: This summary was last updated in 05-2016.
Estonian: Kokkuvõtte viimane uuendus: 05-2016.
Bulgarian: What measures are being taken to ensure the safe and effective use of Forsteo?
Estonian: Mis meetmed võetakse, et tagada Forsteo ohutu ja efektiivne kasutamine?
Bulgarian: Forsteo teriparatide
Estonian: Forsteo teriparatiid
Bulgarian: Patients may inject themselves once they have been trained.
Estonian: Patsiendid võivad end ise süstida, kui nad on saanud asjakohase väljaõppe.
Bulgarian: Forsteo must not be used in children or in young adults whose bones are not yet fully mature, or during pregnancy or breastfeeding.
Estonian: Forsteot ei tohi kasutada lapsed ja noorukid, kelle luud alles kasvavad, ega raseduse või imetamise ajal.
Bulgarian: Other information about Forsteo
Estonian: Muu teave Forsteo kohta
Bulgarian: It is available as a solution for injection in prefilled pens (one 2.4 ml prefilled pen contains 600 micrograms of teriparatide).
Estonian: Seda turustatakse süstelahusena eeltäidetud pensüstaldes (üks 2,4 ml eeltäidetud pensüstal sisaldab 600 µg teriparatiidi).
Bulgarian: The most common side effect with Forsteo (seen in more than 1 patient in 10) is pain in the arms or legs.
Estonian: Forsteo kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) oli valu kätes või jalgades.
Bulgarian: The CHMP concluded that Forsteo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee järeldas, et Forsteo kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
Bulgarian: Forsteo must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Estonian: Seda ei tohi kasutada patsiendid, kellel on mõni muu luuhaigus, nt Pageti tõbi, luuvähk või luumetastaasid (luudesse levinud vähisiirded), kes on saanud luustiku kiiritusravi, või patsiendid, kellel on hüperkaltseemia (kaltsiumi liigne sisaldus veres), alkaalfosfataasi (teatud ensüümi) seletamatult suur sisaldus või raske neeruhaigus.
Bulgarian: The studies also showed that the benefits of Forsteo treatment continued to increase for up to two years, with further increases in bone density.
Estonian: Uuringud näitasid ka, et Forsteo ravi kasulikkus kasvas kuni kaks aastat, sest luutihedus suurenes veelgi.
Bulgarian: What is Forsteo?
Estonian: Mis on Forsteo?
Bulgarian: It also increases the absorption of calcium from food and prevents too much calcium being lost in the urine.
Estonian: Ravim suurendab ka kaltsiumi imendumist toidust ning takistab kaltsiumi liigset eritumist uriiniga.
Bulgarian: Why has Forsteo been approved?
Estonian: Miks Forsteo heaks kiideti?
Bulgarian: For the full list of restrictions, see the package leaflet.
Estonian: Piirangute täielik loetelu on pakendi infolehel.
Bulgarian: Forsteo is a medicine that contains the active substance teriparatide.
Estonian: Forsteo on ravim, mis sisaldab toimeainena teriparatiidi.
Bulgarian: Patients should receive calcium and vitamin D supplements if they do not get enough from their diet.
Estonian: Kui patsient ei saa toidust piisavalt kaltsiumi ja D-vitamiini, tuleb neid täiendavalt võtta.
Bulgarian: men who are at an increased risk of fractures;
Estonian: • suurenenud luumurruohuga mehed;
Bulgarian: In these patients, Forsteo has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of
Estonian: Neil patsientidel on tõendatud, et Forsteo vähendab märkimisväärselt lülisamba- ja muid luumurde, kuid mitte puusamurde;
Bulgarian: What is the risk associated with Forsteo?
Estonian: Mis riskid Forsteoga kaasnevad?
Bulgarian: Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment.
Estonian: Osteoporoos võib esineda glükokortikoidravi kõrvalnähuna mõlemal sugupoolel.
Bulgarian: the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Forsteo.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
Bulgarian: The active substance in Forsteo, teriparatide, is identical to part of the human parathyroid hormone.
Estonian: Forsteo toimeaine teriparatiid on inimese kõrvalkilpnäärme hormooni osaga identne.
Bulgarian: Forsteo is used for the treatment of osteoporosis (a disease that makes bones fragile) in the following groups:
Estonian: Forsteot kasutatakse osteoporoosi (luu-urbnemuse) raviks järgmistes patsiendirühmades:
Bulgarian: increased bone density in the spine by about 6% after an average of almost 12 months.
Estonian: Meespatsientide uuringus suurendas Forsteo lülisamba luutihedust keskmiselt 12 kuud kestnud ravi järel ligikaudu 6%.
Bulgarian: The recommended dose is 20 micrograms of Forsteo given once a day as an injection under the skin of the thigh or abdomen (tummy).
Estonian: Soovituslik annus on 20 µg Forsteot manustatuna üks kord ööpäevas nahaaluse süstina reie- või kõhupiirkonda.
Bulgarian: the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Forsteo, read the package leaflet (also part of
Estonian: Euroopa avaliku hindamisaruande täistekst Forsteo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Bulgarian: the European Union for Forsteo on 10 June 2003.
Estonian: Euroopa Komisjon andis Forsteo müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 10. juunil
Bulgarian: to long-term treatment with glucocorticoids (a type of steroid).
Estonian: (glükokortikoidid on teatud tüüpi steroidid).
Bulgarian: It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells).
Estonian: Toimeaine toimib samal viisil kui see hormoon, mõjutades osteoblaste (luukude moodustavaid rakke) ning stimuleerides nii luukoe teket.
Bulgarian: What is Forsteo used for?
Estonian: Milleks Forsteot kasutatakse?
Bulgarian: men and women who are at an increased risk of fractures due
Estonian: • mehed ja naised, kellel on suurem luumurruoht pikaajalise glükokortikoidravi tõttu
Bulgarian: An additional study looked at the effects of Forsteo on bone density over two years in 234 women who had been through the menopause.
Estonian: Lisauuringus uuriti kahe aasta kestel Forsteo toimet luutihedusele 234 menopausijärgses eas naisel.
Bulgarian: the European public assessment report (EPAR) for Forsteo.
Estonian: See on ravimi Forsteo Euroopa avaliku hindamisaruande kokkuvõte.
Bulgarian: How does Forsteo work?
Estonian: Kuidas Forsteo toimib?
Bulgarian: than alendronate: after 18 months, patients receiving Forsteo had a 7% increase in bone density in the spine, compared with 3% in those receiving alendronate.
Estonian: Glükokortikoide manustavatel patsientidel oli Forsteo efektiivsem kui alendronaat: 18 kuu pärast suurenes Forsteot saanud patsientidel lülisamba luutihedus 7%, alendronaati saanud patsientidel aga
Bulgarian: It also reduced the risk of non-vertebral fractures by 62%, but did not reduce the risk of hip fractures.
Estonian: Forsteo vähendas ka muude luumurdude (v.a puusamurdude) riski 62%.
Bulgarian: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Forsteo have been
Estonian: Forsteo omaduste kokkuvõttesse ja pakendi infolehele lisati ravimi ohutu ja tõhusa kasutamise teave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
Bulgarian: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break.
Estonian: Osteoporoos tekib, kui looduslikult laguneva luukoe asemele ei teki piisavalt uut kude.
Bulgarian: studied in three main studies. The first study involved 1,637 women with osteoporosis who had been through the menopause (average age: 69.5 years), in which Forsteo was compared with placebo (a dummy treatment) for an average of 19 months. The main measure of effectiveness was the number of new vertebral fractures at the end of the study, although the study also looked at non-vertebral fractures. The patients were treated for up to 23 months. The second study looked at the use of Forsteo in 437 men with osteoporosis, comparing its effect on the density of bones in the spine with that of placebo.
Estonian: Esimeses uuringus osales 1637 osteoporoosiga menopausijärgses eas naist (keskmine vanus 69,5 aastat), kellel võrreldi keskmiselt 19 kuu vältel Forsteot platseeboga (näiva ravimiga).
Bulgarian: shown during the studies?
Estonian: Forsteot uuriti kolmes põhiuuringus.
Bulgarian: How has Forsteo been studied?
Estonian: Kuidas Forsteot uuriti?
Bulgarian: The third study compared the effects of Forsteo and alendronate (another medicine used to treat osteoporosis) on spine bone density over three years. The study included 429 women and men who had osteoporosis and had been
Estonian: Kolmandas uuringus võrreldi enam kui kolme aasta kestel Forsteo ja alendronaadi (samuti osteoporoosiravim) toimet lülisamba luutihedusele.
Bulgarian: than placebo in reducing vertebral fractures: 5% of the women who received Forsteo had a new fracture during the study, compared with 14% in the group who received placebo.
Estonian: Forsteo oli lülisambamurdude arvu vähendamisel efektiivsem kui platseebo: Forsteot saanud naistest esines uuringu kestel uusi murde 5%-l ja platseebot saanutest 14%-l. Forsteo vähendas 19-kuulise uuringu kestel uue lülisambamurru riski platseeboga võrreldes 65%.
Bulgarian: the female hormone oestrogen fall.
Estonian: Naistel on osteoporoos sagedam pärast menopausi, kui naissuguhormooni östrogeeni sisaldus väheneb.
Bulgarian: women who have been through the menopause.
Estonian: • menopausijärgses eas naised.
Bulgarian: Съдържание (концентрация)
Estonian: Pakendid sisu (kontsentratsio on)
Bulgarian: Лекарствена форма
Estonian: Ravimvorm Manustamisviis Sisepakendi iseloomustus
Bulgarian: Партньорите попълват въпросника PEP в третия месец.
Estonian: Partnerid täitsid PEP küsimustiku kolmandal kuul.
Bulgarian: Възможно е тези ефекти да са животозастрашаващи.
Estonian: Need toimed võivad olla eluohtlikud.
Bulgarian: Не давайте това лекарство на деца или юноши на възраст под 18 години.
Estonian: Ärge andke seda ravimit alla 18-aastastele lastele või noorukitele.
Bulgarian: Това позволява да се продължи наблюдението на съотношението полза/риск за лекарствения продукт.
Estonian: See võimaldab jätkuvalt hinnata ravimi kasu/riski suhet.
Bulgarian: Металният контейнер е под налягане.
Estonian: Metallmahuti on rõhu all.
Bulgarian: Поради това двамата партньори могат да усетят леко изтръпване за кратък период и трябва да внимават да не се наранят, особено при половия акт.
Estonian: Seetõttu võivad mõlemad partnerid tunda lühiajaliselt kerget tuimust ja peavad olema ettevaatlikud, et end mitte vigastada, eriti seksuaalse tegevuse ajal.
Bulgarian: Данните за ефикасността и безопасността на Fortacin при пациенти на 65 и повече години са ограничени.
Estonian: Andmed Fortacin efektiivsuse ja ohutuse kohta 65-aastastel ning vanematel patsientidel on piiratud.
Bulgarian: Честотата на нежеланите реакции се определя като: много чести (≥1/10), чести (≥1/100 до <1/10), нечести (≥1/1 000 до <1/100), редки (≥1/10 000 до <1/1,000), много редки (<1/10 000), с неизвестна честота (от наличните данни не може да бъде направена оценка).
Estonian: Kõrvaltoimete sagedus on määratletud järgmiselt: väga sage (≥ 1/10), sage (≥ 1/100 kuni < 1/10), aegajalt (≥ 1/1000 kuni < 1/100), harv (≥ 1/10 000 kuni < 1/1000), väga harv (< 1/10 000), teadmata (ei saa hinnata olemasolevate andmete alusel).
Bulgarian: неспособност да се постигне или задържи ерекция
Estonian: • võimetus saavutada või säilitada erektsiooni;
Bulgarian: Фармакотерапевтична група: Анестетици, амиди, ATC код: N01BB20
Estonian: Farmakoterapeutiline rühm: anesteetikumid, amiidid, ATC-kood: N01BB20
Bulgarian: Има по-голяма вероятност то да възникне, когато се приемат едновременно и други лекарства.
Estonian: See on tõenäolisem, kui samal ajal võetakse teatud ravimeid.
Bulgarian: Pharmaserve (North West) Ltd 9 Arkwright Road Astmoor Industrial Estate Runcorn WA7 1NU
Estonian: Pharmaserve (North West) Ltd 9 Arkwright Road Astmoor Industrial Estate Runcorn WA7 1NU Ühendkuningriik
Bulgarian: Ако приложите прекалено голямо количество, избършете го.
Estonian: Kui te kannate ravimit peale liiga palju, pühkige see maha.
Bulgarian: Липсват обаче данни за системната експозиция за сравнение с клиничната експозиция.
Estonian: Puuduvad süsteemse ekspositsiooni andmed võrdlemiseks kliinilise ekspositsiooniga.
Bulgarian: Насочете контейнера встрани от лицето, за да избегнете контакт с очите, носа, устата и ушите.
Estonian: Suunake mahuti näost eemale, et vältida kokkupuudet silmade, nina, suu ja kõrvadega.
Bulgarian: Recordati Ireland Ltd. Raheens East Ringaskiddy Co. Cork
Estonian: Recordati Ireland Ltd. Raheens East Ringaskiddy Co. Cork Iirimaa
Bulgarian: Участниците трябва да бъдат посъветвани да използват алтернативни методи за контрацепция.
Estonian: Patsiente tuleb nõustada kasutama alternatiivseid rasestumisvastaseid vahendeid.
Bulgarian: по искане на Европейската агенция по лекарствата; винаги, когато се изменя системата за управление на риска, особено в резултат на получаване на нова информация, която може да доведе до значими промени в съотношението полза/риск, или след достигане на важен етап (във връзка с проследяване на лекарствената безопасност или свеждане на риска до минимум).
Estonian: Euroopa Ravimiameti nõudel; kui muudetakse riskijuhtimissüsteemi, eriti kui saadakse uut teavet, mis võib oluliselt mõjutada riski/kasu suhet, või kui saavutatakse oluline (ravimiohutuse või riski minimeerimise) eesmärk.
Bulgarian: Други лекарства и Fortacin
Estonian: Muud ravimid ja Fortacin
Bulgarian: Ако използвате Fortacin с презервативи, има по-голяма вероятност да не успеете да постигнете или задържите ерекция.
Estonian: Kui te kasutate Fortacin koos kondoomiga, võib olla tõenäolisem, et te ei suuda erektsiooni saavutada või säilitada.
Bulgarian: Тази хипоестезия може да замаскира обичайните усещания за болка и следователно да увеличи опасностите от локализирано нараняване.
Estonian: See hüpoesteesia võib maskeerida normaalseid valuaistinguid ja seetõttu suurendada lokaliseeritud vigastuse ohtu.
Bulgarian: Ако това се случи, кожата става сиво-синкава поради липсата на кислород.
Estonian: Sel juhul muutub nahk hapnikupuuduse tõttu sinakashallikaks.
Bulgarian: Демонстрирана е устойчива ефективност на лекарствения продукт при многократно прилагане в течение на времето.
Estonian: On näidatud, et ravimi efektiivsus korduva kasutamise aja jooksul püsib.
Bulgarian: Освен това съществува по-голяма вероятност за намалено усещане във и около пениса.
Estonian: Samuti on teil suurem tõenäosus tundlikkuse vähenemiseks peenises ja selle ümbruses.
Bulgarian: Не трябва да се пробива, чупи или изгаря, дори когато е видимо празен.
Estonian: Seda ei tohi läbi torgata, lõhkuda ega põletada isegi siis, kui see tundub olevat tühi.
Bulgarian: При всяко активиране трябва да се покрие една трета от главичката на пениса.
Estonian: Iga pihustamisega tuleb katta üks kolmandik sugutipeast.
Bulgarian: При сериозни случаи на предозиране симптомите могат да включват припадъци, ниско кръвно налягане, забавено дишане, спиране на дишането или промяна на сърдечния ритъм.
Estonian: Rasketel üleannustamise juhtudel võivad sümptomite hulka kuuluda krambid, madal vererõhk, hingamise aeglustumine, hingamisseiskus ja südametöö muutused.
Bulgarian: Това е особено важно, ако използвате следните лекарства, които може да взаимодействат с Fortacin:
Estonian: See on eriti tähtis, kui te kasutate ravimeid, millel võib olla koostoime Fortacin, näiteks:
Bulgarian: Вагинална кандидоза
Estonian: Vaginaalne kandidiaas
Bulgarian: Да се съхранява при температура под 25°C.
Estonian: Hoida temperatuuril kuni 25 °C.
Bulgarian: Възможно е Fortacin да влезе в контакт и с други лигавици, като тези на устата, носа и гърлото на Вас или Вашия партньор и да причини леко изтръпване за кратък период.
Estonian: Fortacin võib samuti sattuda kontakti teiste limaskestadega, näiteks teie või teie partneri suu, nina ja kurk, põhjustades lühikese aja jooksul nende kerget tuimust.
Bulgarian: Свръхчувствителност на пациента или партньора към активните вещества или към някое от помощните вещества, изброени в точка 6.1.
Estonian: Patsiendi või tema partneri ülitundlikkus toimeainete või lõigus 6.1 loetletud mis tahes abiainete suhtes.
Bulgarian: Тези нежелани лекарствени реакции водят до прекъсване на лечението при съответно 0,2 и 0,5% от пациентите.
Estonian: Need kõrvaltoimed põhjustasid ravi katkestamise vastavalt 0,2% ja 0,5% patsientidest.
Bulgarian: други локални анестетици;
Estonian: • teised lokaalanesteetikumid;
Bulgarian: - Другата съставка е норфлуран.
Estonian: - Teiseks koostisosaks on norfluraan.
Bulgarian: 66,2% от участниците, лекувани с Fortacin, и 18,8% от участниците, лекувани с плацебо, постигат средно IELT > 2 минути.
Estonian: 66,2% osalejatest, keda raviti Fortacin, ja 18,8% platseeboga ravitud osalejatest saavutas keskmise IELT > 2 minuti.
Bulgarian: Fortacin не повлиява или повлиява незначително способността за шофиране и работа с машини.
Estonian: Fortacinl ei ole või on ebaoluline toime autojuhtimise ja masinate käsitsemise võimele.
Bulgarian: Какво представлява Fortacin и за какво се използва
Estonian: Mis ravim on Fortacin ja milleks seda kasutatakse
Bulgarian: Проучване при плъхове показва, че Fortacin причинява намаляване на подвижността на сперматозоидите.
Estonian: Rottidel läbi viidud uuring näitas, et Fortacin põhjustas spermatosoidide liikuvuse vähenemist.
Bulgarian: Да не се пробива, чупи или изгаря, дори когато е видимо празен.
Estonian: Ärge torgake, lõhkuge ega põletage seda isegi juhul, kui see on ilmselgelt tühi.
Bulgarian: Човешката експозиция е 1 000 пъти по-ниска от минималната проучвана доза.
Estonian: Plasmakontsentratsioon inimestel on 1000 korda väiksem kui minimaalne uuritud annus.
Bulgarian: Изчакайте 5 минути, след това избършете излишния спрей преди половия акт.
Estonian: Oodake 5 minutit ja pühkige ülemäärane sprei enne seksuaalvahekorda maha.
Bulgarian: Системният клирънс е 18 - 64 mL/min/kg.
Estonian: Süsteemne kliirens on 18…64 ml/min/kg.
Bulgarian: загуба на усещане в устата
Estonian: • tundlikkuse kaotus suus;