FrancophonIA/ELRC3.0 huggingface dataset:
English: Immune system disorders
Estonian: Väliskuulmekanali osteonekroos
English: VANTAVO 70 mg/2,800 IU tablets
Estonian: VANTAVO 70 mg/2800 RÜ tabletid
English: Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64 % for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast.
Estonian: Veenisisesele referentsannusele vastavalt oli öö läbi söömata olles ja kaks tundi enne standardset hommikueinet 5...70 mg annuste suukaudsel manustamisel alendronaadi keskmine biosaadavus naistel 0,64%.
English: Alendronate
Estonian: Abiained
English: EU/1/09/572/004 - 12 tablets
Estonian: EU/1/09/572/004 - 12 tabletti
English: • you suffer from kidney problems,
Estonian: • teil on mõni neeruhaigus;
English: It is important to maintain good oral hygiene when being treated with VANTAVO.
Estonian: Kui teid ravitakse VANTAVOga, on oluline järgida head suuhügieeni.
English: It reduces the risk of spine and hip fractures.
Estonian: See vähendab lülisamba ja reieluu proksimaalse osa murdude riski.
English: Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.
Estonian: Suukaudse üleannustamise korral võivad tekkida hüpokaltseemia, hüpofosfateemia ja seedetrakti ülaosa kõrvaltoimed, nagu maoärritus, kõrvetised, söögitoru-, maopõletik või -haavand.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Estonian: Farmakoloogilise ohutuse, korduvtoksilisuse, genotoksilisuse ja kartsinogeensuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: The most commonly reported adverse reactions are upper gastrointestinal adverse reactions including abdominal pain, dyspepsia, oesophageal ulcer, dysphagia, abdominal distension and acid regurgitation
Estonian: Kõige sagedamini on teatatud seedetrakti ülaosa kõrvaltoimetest, sh kõhuvalu, düspepsia, söögitoruhaavand, düsfaagia, kõhupuhitus ja maohappe regurgitatsioon (> 1%).
English: Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected.
Estonian: Kuid osteoklastide juurdetekkimine või kinnitumine ei muutu.
English: • narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach),
Estonian: • söögitoru (elund, mis ühendab suuõõnt maoga) ahenemine;
English: Elimination Following a single intravenous dose of [
Estonian: Eritumine Pärast ühekordset veenisisest
English: Consult your doctor before you begin any exercise programme.
Estonian: Enne spordiga tegelema hakkamist pidage nõu arstiga.
English: VANTAVO 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets.
Estonian: VANTAVO 70 mg/5600 RÜ tabletid on saadaval 2, 4 või 12 tabletti sisaldavates pakendites.
English: Choose the day of the week that best fits your schedule.
Estonian: Valige ravimi võtmiseks teie ajakavaga sobivaim nädalapäev.
English: PARTICULARS TO APPEAR WITHIN THE OUTER PACKAGING (CARTON)
Estonian: VÄLISPAKENDIS (KARBIS) PEAVAD OLEMA JÄRGMISED ANDMED
English: While no increased risk was observed in extensive clinical trials with alendronate, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some of which were severe and with complications (see section 4.8).
Estonian: Mao- ja kaksteistsõrmikuhaavandite tekkest on (turuletulekujärgselt) teatatud harva; mõned neist olid rasked ja komplitseerunud, kuigi laiahaardelistes kliinilistes uuringutes riski suurenemist ei täheldatud (vt lõik 4.8).
English: VANTAVO 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
Estonian: VANTAVO 70 mg/2800 RÜ tabletid on saadaval 2, 4, 6 või 12 tabletti sisaldavates pakendites.
English: Common (may affect up to 1 in 10 people):
Estonian: Sage (võivad tekkida kuni ühel inimesel 10-st):
English: Do not crush or chew the tablet or allow it to dissolve in your mouth because of the possibility of mouth ulceration.
Estonian: Vältimaks suus haavandite tekkimist ei tohi tabletti purustada ega suus närida ega lasta suus lahustuda.
English: How to store VANTAVO
Estonian: Kuidas VANTAVOt säilitada
English: †, peripheral oedema Uncommon transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment
Estonian: Üldised häired ja manustamiskoha reaktsioonid sage asteenia †, perifeersed tursed aeg-ajalt tüüpiliselt ravi algusega seotud mööduvad (nagu kiire ravivastuse faasi) sümptomid (lihasvalu, halb enesetunne ja harva palavik)
English: The body can only absorb calcium properly from our food if it has enough vitamin D. Very few foods contain vitamin D. The main source is through exposure to summer sunlight, which makes vitamin D in our skin.
Estonian: Põhiline allikas on suvine päikesevalgus, mis toodab D-vitamiini meie nahas.
English: The percentage of patients with vitamin D
Estonian: Väga vähesed toidud sisaldavad D-vitamiini.
English: As we get older our skin makes less vitamin D. Too little vitamin D may lead to bone loss and osteoporosis.
Estonian: D-vitamiini liiga madala sisalduse tagajärjel võib väheneda luumass ja tekkida osteoporoos.
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Estonian: Peamiselt pikaajaliselt osteoporoosi raviks bisfosfonaatravi saavatel patsientidel on teatatud reieluu subtrohhanteersetest ja diafüüsi atüüpilistest murdudest.
English: Each VANTAVO 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3)
Estonian: Üks VANTAVO 70 mg/5600 RÜ tablett sisaldab 70 mg alendroonhapet (naatriumtrihüdraadina) ja 140 mikrogrammi (5600 RÜ) kolekaltsiferooli (D3-vitamiin).
English: It reduces the risk of vertebral and hip fractures.
Estonian: Ravim vähendab lülisamba ja puusaluumurdude tekkeohtu.
English: VANTAVO 70 mg/5600 IU tablets alendronic acid /colecalciferol
Estonian: VANTAVO 70 mg/5600 RÜ tabletid alendroonhape/kolekaltsiferool
English: 70 mg/5600 IU tablets alendronic acid/colecalciferol
Estonian: 70 mg/5600 RÜ tabletid alendroonhape/kolekaltsiferool
English: • irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach,
Estonian: • söögitoru (elund, mis ühendab suuõõnt maoga) või mao ärritusnähud või põletik;
English: Each VANTAVO 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Estonian: Üks VANTAVO 70 mg/2800 RÜ tablett sisaldab 70 mg alendroonhapet (naatriumtrihüdraadina) ja 70 mikrogrammi (2800 RÜ) kolekaltsiferooli (D3-vitamiin).
English: VANTAVO 70 mg/2800 IU tablets alendronic acid /colecalciferol
Estonian: VANTAVO 70 mg/2800 RÜ tabletid alendroonhape/kolekaltsiferool
English: and cumulative dose
Estonian: Retseptiravim.
English: How to take VANTAVO
Estonian: Kuidas VANTAVOt võtta
English: insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with VANTAVO (70 mg/2800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15.
Estonian: 15. nädalal oli D-vitamiini vaegusega (seerumi 25-hüdroksüvitamiin D sisaldus < 37,5 nmol/l (< 15 ng/ml)) patsientide protsent VANTAVO (70 mg/2800 RÜ) rühmas 62,5% võrra väiksem kui ainult alendronaati saanute rühmas (12% vs. 32%).
English: Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Estonian: Iga tablett sisaldab 70 mg alendroonhapet (naatriumtrihüdraadina) ja 140 mikrogrammi (5600 RÜ) kolekaltsiferooli (D3-vitamiin).
English: 70 mg/2800 IU tablets alendronic acid/colecalciferol
Estonian: 70 mg/2800 RÜ tabletid alendroonhape/kolekaltsiferool
English: Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Estonian: Iga tablett sisaldab 70 mg alendroonhapet (naatriumtrihüdraadina) ja 70 mikrogrammi (2800 RÜ) kolekaltsiferooli (D3-vitamiin).
English: Contact your doctor and dentist if you experience such symptoms,
Estonian: Kui teil tekivad sellised sümptomid, võtke ühendust oma arsti ja hambaarstiga;
English: It is very important to follow instructions 2), 3), 4) and 5) to help the VANTAVO tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
Estonian: VANTAVO tableti kiire makku jõudmise tagamiseks ning söögitoru (söögitoru on elund, mis ühendab suuõõnt maoga) võimalike ärritusnähtude vältimiseks on väga tähtis, et te järgiksite punkte 2), 3), 4) ja
English: The mean half-life of vitamin D3 in the serum following an oral dose of VANTAVO (70 mg/2800 IU) is approximately 24 hours.
Estonian: Pärast VANTAVO (70 mg/2800 RÜ) suukaudse annuse manustamist on D3-vitamiini keskmine poolväärtusaeg seerumis ligikaudu 24 tundi.
English: Breast-feeding
Estonian: Alendronaat
English: BLISTER FOR VANTAVO 70 mg/5,600 IU
Estonian: VANTAVO 70 mg/5600 RÜ KARP
English: TUE
Estonian: Liikuge
English: Rare (may affect up to 1 in 1,000 people):
Estonian: Harv (võivad tekkida kuni ühel inimesel 1000-st):
English: Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain or new or worsening heartburn (see section 4.8).
Estonian: Patsientidele tuleb selgitada, et söögitoru ärritusnähtude (nagu düsfaagia, valu neelamisel või rinnaku taga või kõrvetised või nende ägenemine) tekkimisel tuleb alendronaadi kasutamine lõpetada ja pöörduda arsti poole (vt lõik 4.8).
English: BLISTER FOR VANTAVO 70 mg/2,800 IU
Estonian: VANTAVO 70 mg/2800 RÜ KARP
English: Uncommon (may affect up to 1 in 100 people):
Estonian: Aeg-ajalt (võivad tekkida kuni ühel inimesel 100-st):
English: MARKETING AUTHORISATION HOLDER(S)
Estonian: MÜÜGILOA HOIDJA
English: Eye disorders
Estonian: Lõualuu osteonekroos
English: • mouth ulcers.
Estonian: • liigeste turse;
English: For oral use.
Estonian: • suuõõnehaavandid.
English: Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates.
Estonian: Bisfosfonaate kasutavatel patsientidel on kirjeldatud luu-, liiges- ja/või lihasvalu.
English: It must not be injected into a vein or under the skin.
Estonian: Seda ei tohi süstida veeni või naha alla.
English: The recommended dose is 400 mg once a month.
Estonian: Soovitatav annus on 400 mg üks kord ööpäevas.
English: The Committee considered that the monthly administration may help patients to adhere to their treatment.
Estonian: Komitee oli arvamusel, et igakuine manustamine võib aidata patsientidel ravist kinni pidada.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Abilify Maintena on 15 November 2013.
Estonian: Euroopa Komisjon andis Abilify Maintena müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 15. novembril 2013.
English: In one main study involving adults whose disease had already been stabilised on treatment with aripiprazole taken by mouth, 22 out of the 265 patients (8.3%) treated with Abilify Maintena had symptoms coming back within 26 weeks, compared with 21 out of 266 (7.9%) patients treated with aripiprazole taken by mouth.
Estonian: Ühes põhiuuringus täiskasvanutega, kellel oli haigus juba suukaudse aripiprasooliga stabiliseeritud, tekkisid 22-l Abilify Maintenaga ravitud patsiendil 265-st (8,3%) sümptomid 26 nädala pärast uuesti, võrreldes 21 patsiendiga 266-st (7,9%), keda raviti suukaudse aripiprasooliga.
English: The full EPAR for Abilify Maintena can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Abilify Maintena kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: ‘Prolonged release' means that the active substance is released slowly over a few weeks after being injected.
Estonian: Prolongeeritult vabastav tähendab, et toimeaine vabaneb pärast süstimist aeglaselt paari nädala jooksul.
English: Schizophrenia is a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Estonian: Skisofreenia on vaimuhaigus, millel on erinevad sümptomid, sealhulgas häiritud mõtted ja kõne, hallutsinatsioonid (patsient näeb või kuuleb asju, mida pole olemas), kahtlustamine ja luulud.
English: A risk management plan has been developed to ensure that Abilify Maintena is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Abilify Maintena võimalikult ohutu kasutamine.
English: After the first injection, daily treatment with 10 to 20 mg aripiprazole by mouth should be continued for 2 weeks.
Estonian: Pärast esimest süsti tuleb kahe nädala jooksul jätkata igapäevast ravi suukaudse aripiprasooliga (10-20 mg).
English: Abilify Maintena is available as a powder (300 mg and 400 mg) and solvent to be made into a prolonged-release suspension for injection.
Estonian: Abilify Maintenat turustatakse pulbri (300 mg ja 400 mg) ja lahusena, mis tuleb segada toimeainet prolongeeritult vabastatavaks süstesuspensiooniks.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Abilify Maintena's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Abilify Maintena kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: What measures are being taken to ensure the safe and effective use of Abilify Maintena?
Estonian: Mis meetmed võetakse, et tagada Abilify Maintena ohutu ja efektiivne kasutamine?
English: It is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with aripiprazole taken by mouth.
Estonian: Ravimit kasutatakse skisofreenia säilitusraviks täiskasvanutel, kellel haigus on juba suukaudse aripiprasooliga stabiliseeritud.
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Estonian: See tähendab, et aripiprasool mõjub nagu dopamiin ja 5-hüdroksütrüptamiin, aktiveerides neid retseptoreid, kuid vähem kui neurotransmitterid.
English: Since dopamine and 5hydroxytryptamine are involved in schizophrenia, aripiprazole helps to normalise the activity of the brain, reducing psychotic symptoms and preventing them from returning.
Estonian: Kuna dopamiin ja 5hüdroksütrüptamiin on skisofreeniaga seotud, aitab aripiprasool ajutegevust normaliseerida, leevendades psühhoosi sümptomeid ja ennetades nende taasteket.
English: What is Abilify Maintena and what is it used for?
Estonian: Mis on Abilify Maintena ja milleks seda kasutatakse?
English: Treatment beyond 2 weeks with medicines that speed up the breakdown of aripiprazole should be avoided.
Estonian: Vältida tuleb pikemat kui kahenädalast ravi ravimitega, mis kiirendavad aripiprasooli lagunemist organismis.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abilify Maintena, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Abilify Maintena ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Abilify Maintena aripiprazole
Estonian: Abilify Maintena aripiprasool
English: The CHMP noted that Abilify Maintena is as effective as aripiprazole taken by mouth, and has a similar safety profile with the exception of injection pain, which was considered manageable.
Estonian: Inimravimite komitee märkis, et Abilify Maintena on sama efektiivne kui suukaudne aripiprasool ja sel on sarnane ohutusprofiil, mille ainus erand on süstekoha valu, ja seda peeti leevendatavaks.
English: Other information about Abilify Maintena
Estonian: Muu teave Abilify Maintena kohta
English: Why is Abilify Maintena approved?
Estonian: Miks Abilify Maintena heaks kiideti?
English: What are the risks associated with Abilify Maintena?
Estonian: Mis riskid Abilify Maintenaga kaasnevad?
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Estonian: Arvatakse, et aripiprasool mõjub põhiliselt neurotransmitterite dopamiini ja 5-hüdroksütrüptamiini (serotoniini) retseptorite osalise agonistina.
English: Abilify Maintena is a medicine that contains the active substance aripiprazole.
Estonian: Abilify Maintena on ravim, mis sisaldab toimeainena aripiprasooli.
English: For practical information about using Abilify Maintena, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Abilify Maintena kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Estonian: Abilify Maintena täpne toimemehhanism ei ole teada, kuid ravim seondub aju närvirakkude pinnal oleva mitme retseptoriga.
English: This is a summary of the European public assessment report (EPAR) for Abilify Maintena.
Estonian: See on ravimi Abilify Maintena Euroopa avaliku hindamisaruande kokkuvõte.
English: The most common side effects with Abilify Maintena (which may affect 5 or more people in 100) are increased weight, akathisia (a constant urge to move), insomnia (difficulty sleeping) and injection site pain.
Estonian: Abilify Maintena kõige sagedamad kõrvalnähud (võivad esineda enam kui 5 patsiendil 100st) on kehakaalu tõus, akatiisia (võimetus paigal püsida), unetus ja süstekoha valu.
English: The dose may also need to be lowered in patients who are taking certain other medicines that slow the breakdown of aripiprazole in the body.
Estonian: Kõrvalnähtude korral võib annust vähendada kuni annuseni 300 mg. Annust võib olla vaja vähendada ka patsientidel, kes võtavad teatud teisi ravimeid, mis aeglustavad aripiprasooli lagunemist organismis.
English: For more information about treatment with Abilify Maintena, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Abilify Maintenaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For the full list of all side effects reported with Abilify Maintena, see the package leaflet.
Estonian: Abilify Maintena kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: How is Abilify Maintena used?
Estonian: Kuidas Abilify Maintenat kasutatakse?
English: The medicine is given once a month by slow injection into the buttock or deltoid (shoulder) muscle by a doctor or nurse.
Estonian: Ravimit manustab arst või õde kord kuus aeglase süstina tuhara- või õlalihasesse.
English: It is not intended to provide practical advice on how to use Abilify Maintena.
Estonian: Hindamisaruandes ei anta Abilify Maintena kasutamise praktilisi nõuandeid.
English: The active substance in Abilify Maintena, aripiprazole, is an antipsychotic medicine.
Estonian: Abilify Maintena toimeaine aripiprasool on antipsühhootiline ravim.
English: Abilify Maintena was shown to be as effective as aripiprazole taken by mouth at preventing symptoms of schizophrenia from returning.
Estonian: Abilify Maintena oli uuringutes skisofreenia sümptomite taastekke ennetamisel sama efektiivne kui suukaudne aripiprasool.
English: How does Abilify Maintena work?
Estonian: Kuidas Abilify Maintena toimib?
English: What benefits of Abilify Maintena have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Abilify Maintena kasulikkus?
English: This summary was last updated in 09/2014.
Estonian: Kokkuvõtte viimane uuendus: 09-2014.
English: Doses should not be repeated more frequently than every 4 hours, and no more than three doses should be used in 24 hours.
Estonian: Annustamist ei tohi korrata sagedamini kui iga 4 tunni järel ja 24 tunni jooksul ei tohi kasutada üle 3 annuse.
English: Fortacin lidocaine / prilocaine
Estonian: Fortacin lidokaiin/prilokaiin
English: This reduces sensitivity to stimulation, helping to increase the time taken to ejaculate.
Estonian: See vähendab tundlikkust stimuleerimise suhtes ja aitab pikendada aega, mis kulub ejakulatsioonini.
English: The full EPAR for Fortacin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Fortacin kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Fortacin is used as safely as possible.
Estonian: Töötati välja riskijuhtimisstrateegia, et tagada Fortacin võimalikult ohutu kasutamine.
English: Other information about Fortacin
Estonian: Muu teave Fortacin kohta
English: Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.
Estonian: Osa patsiente jälgiti algsete uuringute pikendusuuringutes kuni 9 kuud ja neil jätkus samasugune kasulik toime.
English: What measures are being taken to ensure the safe and effective use of Fortacin?
Estonian: Mis meetmed võetakse, et tagada Fortacin ohutu ja efektiivne kasutamine?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fortacin on 15 November 2013.
Estonian: Euroopa Komisjon andis Fortacin müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 15. novembril
English: Fortacin must also not be used in patients whose partners are hypersensitive to these substances.
Estonian: Fortacint ei tohi samuti kasutada patsiendid, kelle partnerid on nende ainete suhtes ülitundlikud.
English: Why is Fortacin approved?
Estonian: Miks Fortacin heaks kiideti?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom ravimit platseebo (näiv ravim) spreiga 12 nädala jooksul.
English: There were positive psychological benefits to patients and their partners, and side effects were local and generally manageable.
Estonian: Patsientidel ja nende partneritel esines positiivne psühholoogiline kasu ning kõrvalnähud olid paiksed ja üldiselt kontrollitavad.
English: What are the risks associated with Fortacin?
Estonian: Mis riskid Fortacinga kaasnevad?
English: In the first study, the average time to ejaculation in patients treated with Fortacin was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study, average ejaculation time in patients using the medicine was 3.8 minutes compared with 1.1 minutes in the placebo group.
Estonian: Esimeses uuringus oli keskmine aeg ejakulatsiooni tekkimiseni Fortacinga ravitud patsientidel 2,6 minutit võrreldes 0,8 minutiga platseebot kasutanud patsientidel; teises uuringus oli ravimit kasutanud patsientidel keskmine aeg ejakulatsiooni tekkimiseni 3,8 minutit võrreldes 1,1 minutiga platseeborühmas.
English: The CHMP therefore decided that Fortacin's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Fortacin kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.