FrancophonIA/ELRC3.0 huggingface dataset:
English: An additional study looked at the effectiveness of Tygacil in patients who had caught pneumonia in hospital.
Estonian: Lisauuringus vaadeldi Tygacili efektiivsust patsientidel, kellel oli pneumoonia tekkinud haiglas.
English: Tygacil is an antibiotic that is already used to treat adults with complicated infections of the skin or soft tissue (the tissue below the skin) and complicated infections in the abdomen.
Estonian: Tygacil on antibiootikum, mida kasutatakse nende täiskasvanud patsientide raviks, kel on naha ja pehmete kudede (nahaaluste kudede) ning kõhukoopa tüsistunud infektsioonid.
English: This is expected to help in the treatment of community-acquired pneumonia.
Estonian: Eelduste kohaselt peaks see aitama ravida keskkonnatekkelist pneumooniat.
English: The effects of Tygacil were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Tygacili toimet muude katsetega.
English: What are the consequences of the refusal for patients in clinical trials using Tygacil?
Estonian: Kuidas mõjutab tagasivõtmine praegu Tygacili kliinilistes uuringutes osalevaid patsiente?
English: Tygacil was also expected to be used to treat adults with community-acquired pneumonia.
Estonian: Tygacili kavatseti kasutada ka täiskasvanud patsientide keskkonnatekkelise pneumoonia raviks.
English: The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
Estonian: Pärast müügiloa muutmise taotluse saamist kulub inimravimite komiteel arvamuse vastuvõtmiseni tavaliselt kuni 90 päeva.
English: What was Tygacil expected to be used for?
Estonian: Milleks kavatseti Tygacili kasutada?
English: Further information on Procoralan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Procoralan.
Estonian: Lisateave Procoralani kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Procoralan.
English: Procoralan received a marketing authorisation valid throughout the EU on 25 October 2005.
Estonian: Procoralan on saanud müügiloa, mis kehtib kogu ELis, 25. oktoobril 2005.
English: Procoralan (ivabradine)
Estonian: Procoralan (ivabradiin)
English: What measures are being taken to ensure the safe and effective use of Procoralan?
Estonian: Mis meetmed võetakse, et tagada Procoralani ohutu ja efektiivne kasutamine?
English: Procoralan must not be taken with a number of other medicines.
Estonian: Procoralani ei tohi kasutada koos teatud teiste ravimitega.
English: What is Procoralan and what is it used for?
Estonian: Mis on Procoralan ja milleks seda kasutatakse?
English: The Agency decided that Procoralan's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Procoralani kasulikkus on suurem kui sellega kaasnevad riskid, ja lubati ravimi kasutamine ELis.
English: As for all medicines, data on the use of Procoralan are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Procoralani kasutamise kohta pidevat järelevalvet.
English: Side effects reported with Procoralan are carefully evaluated and any necessary action taken to protect patients.
Estonian: Procoralani kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Procoralan have been included in the summary of product characteristics and the package leaflet.
Estonian: Procoralani ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Other information about Procoralan
Estonian: Muu teave Procoralani kohta
English: For more information about using Procoralan, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Procoralani kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: In stable angina, these symptoms appear during physical effort.
Estonian: Stabiilse stenokardia korral tekivad sümptomid füüsilise pingutuse tõttu.
English: Procoralan contains the active substance ivabradine.
Estonian: Procoralan sisaldab toimeainena ivabradiini.
English: However it should be noted that patients in this study were given doses higher than the recommended dose (up to 10 mg twice a day).
Estonian: Samas kasutasid selles uuringus osalenud patsiendid soovitatavast annusest suuremaid annuseid (kuni 10 mg kaks korda ööpäevas).
English: However, a fifth study in 728 patients showed that adding Procoralan to amlodipine did not provide an additional benefit.
Estonian: Seevastu viiendas uuringus (728 patsienti) ei suurendanud Procoralani lisamine amlodipiinile ravi kasulikkust.
English: Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue despite dose reduction.
Estonian: Ravi tuleb katkestada, kui südame löögisagedus on pidevalt alla 50 löögi minutis või kui bradükardia (südame aeglane löögisagedus) sümptomid jätkuvad vaatamata annuse vähendamisele.
English: The European Medicines Agency concluded that Procoralan was shown to be effective in long-term angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta blockers or whose disease is not controlled with them.
Estonian: Euroopa Ravimiamet järeldas, et Procoralan on pikaajalise stenokardia ravis efektiivne ning selle ohutusprofiil on vastuvõetav kasutamiseks alternatiivse ravimina patsientidel, kelle haigus ei allu ravile beetablokaatoritega või kes ei saa neid kasutada.
English: It also concluded that Procoralan was effective in long-term heart failure with an acceptable safety profile.
Estonian: Amet järeldas ka, et Procoralan on efektiivne pikaajalise südamepuudulikkuse ravis ja selle ohutusprofiil on vastuvõetav.
English: Procoralan is available as tablets (5 and 7.5 mg) and it can only be obtained with a prescription.
Estonian: Procoralani turustatakse tablettidena (5 ja 7,5 mg).
English: Procoralan must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Estonian: Procoralani ei tohi kasutada patsiendid, kelle südame löögisagedus on puhkeolekus alla 70 löögi minutis, kellel on väga madal vererõhk, mitmesugused südamehäired (sh kardiogeenne šokk, rütmihäired, südameinfarkt, ebastabiilne või äge (äkiline) südamepuudulikkus ja ebastabiilne stenokardia) või rasked maksaprobleemid.
English: By lowering the heart rate, Procoralan reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Estonian: Südame löögisagedust aeglustades vähendab Procoralan südame koormust, pidurdades südamepuudulikkuse kulgu ja leevendades sümptomeid.
English: The symptoms of heart failure are caused by the heart not pumping enough blood around the body.
Estonian: Südamepuudulikkuse sümptomid tulenevad sellest, et süda ei suuda pumbata organismi piisavalt verd.
English: What are the risks associated with Procoralan?
Estonian: Mis riskid Procoralaniga kaasnevad?
English: The most common side effect with Procoralan (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Estonian: Procoralani kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10st) on helendav nägemisfenomen (fosfeenid, nägemisvälja mööduv helendus).
English: Procoralan is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute.
Estonian: Procoralani kasutatakse ka pikaajalise südamepuudulikkusega (süda ei suuda pumbata organismi piisavalt verd) patsientidel, kellel on normaalne südamerütm ja südame löögisagedus on vähemalt 75 lööki minutis.
English: In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates).
Estonian: Selles uuringus täheldati sümptomaatilise stenokardiaga patsientide spetsiifilises alarühmas Procoralani korral väikest, aga olulist kardiovaskulaarse surma või mittefataalse südameinfarkti riski suurenemist võrreldes platseeboga (sagedus aastas vastavalt 3,4% ja 2,9%).
English: Results showed that Procoralan was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Procoralan died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Estonian: Procoralan ennetas kardiovaskulaarset surma või haiglaravi progresseerunud südamepuudulikkuse tõttu efektiivsemalt kui platseebo: patsiente, kes surid või said haiglaravi progresseerunud südamepuudulikkuse tõttu, oli Procoralaniga ravitud patsientidest 24,5% (793 patsienti 3241st) ja platseebot kasutanud patsientidest 28,7% (937 patsienti 3264st).
English: Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing angina symptoms or reducing the heart rate within 3 months.
Estonian: Arst peab kaalutlema ravi lõpetamist ka siis, kui ravimi toime stenokardiasümptomite leevendamisele või südame löögisageduse vähendamisele on 3 kuu jooksul väike.
English: However, the use was later restricted to patients whose heart rate is at least 70 beats per minute.1
Estonian: Hiljem piirati selle kasutamine ainult patsientidele, kelle südame löögisagedus on vähemalt 70 lööki minutis.1
English: Procoralan was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Estonian: Procoralani võrreldi platseeboga ühes põhiuuringus, milles osales üle 6500 mõõduka või raske pikaajalise südamepuudulikkusega patsiendi.
English: In a fourth study in 889 patients, Procoralan was more effective than placebo, when both were added to atenolol.
Estonian: Neljandas uuringus (889 patsienti) oli atenoloolile lisatud Procoralan efektiivsem kui atenoloolile lisatud platseebo.
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Estonian: Arst võib annust patsiendi südame löögisagedusest ja sümptomitest olenevalt suurendada annuseni 7,5 mg kaks korda ööpäevas või vähendada annuseni 2,5 mg (pool 5 mg tabletti) kaks korda ööpäevas.
English: A sixth study compared Procoralan with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Estonian: Kuuendas uuringus võrreldi Procoralani platseeboga 19 102 patsiendil, kellel oli südame isheemiatõbi, aga ei olnud kliinilist südamepuudulikkust.
English: Procoralan was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Estonian: Procoralani võrreldi platseeboga (näiv ravim) ja teiste ravimitega viies põhiuuringus, milles osales üle 4000 pikaajalise stabiilse stenokardiaga täiskasvanu.
English: How is Procoralan used?
Estonian: Kuidas Procoralani kasutatakse?
English: Results showed that the medicine was more effective than placebo in one of the studies in 360 patients.
Estonian: Põhiuuringute tulemustest selgus, et ühes uuringus (360 patsienti) oli ravim efektiivsem kui platseebo.
English: It must not be used in women who are pregnant, breast-feeding or by women who could become pregnant and who are not using appropriate contraceptives.
Estonian: Procoralani ei tohi kasutada raseduse ega imetamise ajal; samuti ei tohi ravimit kasutada fertiilses eas naised, kes ei kasuta efektiivseid rasestumisvastaseid vahendeid.
English: For the full list of restrictions with Procoralan, see the package leaflet.
Estonian: Procoralani kohta teatatud piirangute täielik loetelu on pakendi infolehel.
English: Procoralan therefore reduces or prevents the symptoms of angina.
Estonian: Sellega vähendab Procoralan stenokardiasümptomeid või ennetab neid.
English: It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients.
Estonian: Ühes uuringus (939 patsienti) oli Procoralan sama efektiivne kui atenolool (beetablokaator) ja ühes uuringus (1195 patsienti) sama efektiivne kui amlodipiin (samuti stenokardiaravim).
English: For the treatment of angina, Procoralan was originally authorised for patients whose heart rate is at least 60 beats per minute.
Estonian: Stenokardia ravi korral oli Procoralan esmase müügiloa alusel näidustatud patsientidele, kelle südame löögisagedus on vähemalt 60 lööki minutis.
English: An overview of Procoralan and why it is authorised in the EU
Estonian: Ülevaade ravimist Procoralan ja ELis müügiloa väljastamise põhjendus
English: How does Procoralan work?
Estonian: Kuidas Procoralan toimib?
English: For the full list of all side effects reported with Procoralan, see the package leaflet.
Estonian: Procoralani kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The active substance in Procoralan, ivabradine, works by blocking the ‘If currents' in the sinus node, the ‘pacemaker' for the heart that controls the heart's contractions and regulates the heart rate.
Estonian: Procoralani toimeaine ivabradiin blokeerib siinussõlmes (südame kokkutõmbeid juhtiv ja löögisagedust reguleeriv südamepiirkond ehk loomulik rütmur) tekkiva nn If-voolu.
English: What benefits of Procoralan have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Procoralani kasulikkus?
English: Procoralan is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute.
Estonian: Procoralan on südameravim, mida kasutatakse täiskasvanutel pikaajalise stabiilse stenokardia (füüsilise pingutuse tõttu tekkiv rindkere-, lõua- ja seljavalu) sümptomaatiliseks raviks südame isheemiatõvega (südamelihast verega varustavate veresoonte ummistusest põhjustatud haigus).
English: It is used in combination with standard therapy including beta blockers, or in patients who cannot be treated with beta blockers.
Estonian: Procoralani kasutatakse koos beetablokaatoreid sisaldava tavaraviga või patsientidel, keda ei saa ravida beetablokaatoritega.
English: It is used in those who cannot be treated with beta blockers (another type of medicine to treat angina) or in combination with a beta blocker in patients whose disease is not controlled by beta blockers alone.
Estonian: Procoralani kasutatakse patsientidel, keda ei saa ravida beetablokaatoritega (samuti stenokardiaravim), või kombinatsioonis beetablokaatoriga patsientidel, kellel ainult beetablokaatorite kasutamine ei ole andnud tulemusi.
English: What measures are being taken to ensure the safe and effective use of Zubsolv?
Estonian: Mis meetmed võetakse, et tagada Zubsolvi ohutu ja efektiivne kasutamine?
English: The full EPAR for Zubsolv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Zubsolvi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The tablets are taken once a day by placing them under the tongue and allowing them to dissolve for up to 10 minutes.
Estonian: Tablette võetakse üks kord ööpäevas, asetades tableti keele alla ja lastes sellel 10 minuti vältel lahustuda.
English: Zubsolv is available as tablets of various strengths (0.7 mg/0.18 mg, 1.4 mg/0.36 mg, 2.9 mg/0.71 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg, 11.4 mg/2.9 mg).
Estonian: Zubsolvi turustatakse eri tugevustega tablettidena (0,7 mg / 0,18 mg, 1,4 mg / 0,36 mg, 2,9 mg / 0,71 mg, 5,7 mg / 1,4 mg, 8,6 mg / 2,1 mg, 11,4 mg / 2,9 mg).
English: Once the patient has been stabilised, the maintenance dose may be reduced gradually if the patients agrees, and eventually treatment may be stopped.
Estonian: Kui patsiendi seisund on stabiliseerunud, tohib säilitusannust patsiendi nõusolekul järk-järgult vähendada ja lõpuks ravi lõpetada.
English: What is Zubsolv and what is it used for?
Estonian: Mis on Zubsolv ja milleks seda kasutatakse?
English: Zubsolv buprenorphine / naloxone
Estonian: Zubsolv buprenorfiin/naloksoon
English: What are the risks associated with Zubsolv?
Estonian: Mis riskid Zubsolviga kaasnevad?
English: Zubsolv is used in individuals who are also receiving medical, social and psychological support and who have agreed to be treated for their addiction.
Estonian: Zubsolvi kasutatakse inimestel, kes saavad ka meditsiinilist, sotsiaalset ja psühholoogilist abi ning kes on andnud nõusoleku sõltuvuse raviks.
English: Sublingual tablets containing buprenorphine alone have been available in the EU since the mid-1990s for the treatment of opioid addiction.
Estonian: Ainult buprenorfiini sisaldavaid keelealuseid opioidisõltuvuse tablette on Euroopa Liidus turustatud alates 1990. aastate keskpaigast.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Zubsolv contains these at different strengths.
Estonian: See tähendab, et Zubsolv on sarnane võrdlusravimiga, mis sisaldab samu toimeaineid, kuid Zubsolv sisaldab neid teistsugustes tugevustes.
English: The study also showed that Zubsolv tablets dissolved faster and had a better taste than the reference medicine.
Estonian: Samuti nähtus uuringust, et Zubsolvi tabletid lahustusid kiiremini ja et need olid parema maitsega kui võrdlusravimil.
English: A study involving 125 healthy volunteers showed that some strengths of the Zubsolv tablets produced a lower level of the active substances in the body than the reference product and therefore the two medicines cannot be used interchangeably.
Estonian: Uuringus, milles osales 125 tervet vabatahtlikku, tõendati, et Zubsolvi tablettide teatavate tugevustega oli toimeainete sisaldus organismis väiksem kui võrdlusravimi korral ning et seetõttu ei saa kaht ravimit teineteisega asendada.
English: As for Suboxone, the European Medicines Agency decided that Zubsolv's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et nagu ka Suboxone korral, on Zubsolvi kasulikkus suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Because Zubsolv can be misused or cause addiction, it can only be obtained by ‘special' prescription and must be used under the supervision of a doctor who has experience in the management of opioid addiction.
Estonian: Kuna Zubsolvi võidakse väärkasutada või sellest võib tekkida sõltuvus, saab seda üksnes eriretsepti alusel ning seda tuleb kasutada opioidisõltuvuse ravis kogenud arsti järelevalve all.
English: Other information about Zubsolv
Estonian: Muu teave Zubsolvi kohta
English: Since Zubsolv does not produce the same amounts of buprenorphine and naloxone in the blood as the reference medicine, the medicines cannot be used interchangeably.
Estonian: Kuna Zubsolv ei tekita veres samasugust buprenorfiini ja naloksooni sisaldust nagu võrdlusravim, ei saa ravimeid teineteisega asendada.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zubsolv have been included in the summary of product characteristics and the package leaflet.
Estonian: Zubsolvi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Why is Zubsolv approved?
Estonian: Miks Zubsolv heaks kiideti?
English: The company provided data from studies with the reference medicine Suboxone and from the published literature showing the benefits of buprenorphine and naloxone in the treatment of opioid dependence.
Estonian: Ettevõte esitas võrdlusravimiga Suboxone tehtud uuringutest ja kirjandusväljaannetest pärit andmed, mis tõendasid buprenorfiini ja naloksooni kasulikkust opioidisõltuvuse ravis.
English: It contains the active substances buprenorphine and naloxone.
Estonian: See sisaldab toimeainena buprenorfiini ja naloksooni.
English: Zubsolv must not be used in patients with severe respiratory insufficiency (inability to breathe properly), severe liver problems, acute alcoholism (excessive alcohol consumption) or delirium tremens (a condition caused by alcohol withdrawal).
Estonian: Zubsolvi ei tohi kasutada patsiendid, kellel on raske hingamispuudulikkus, rasked maksaprobleemid, äge alkoholism (alkoholi liigtarvitamine) või delirium tremens (alkoholi ärajätmisel tekkiv seisund).
English: Zubsolv contains two active substances: buprenorphine, a partial opioid agonist (it acts like an opioid drug but less powerfully), and naloxone, an opioid antagonist (it counteracts the effects of opioid drugs).
Estonian: Zubsolv sisaldab kahte toimeainet: buprenorfiini, mis on opioidi osaline agonist (toime sarnaneb opioidi toimega, kuid on väiksem), ja naloksooni, mis on opioidi antagonist (st sellel on opioidile vastupidine toime).
English: Zubsolv is a ‘hybrid medicine'.
Estonian: Zubsolv on hübriidravim.
English: The reference medicine for Zubsolv is Suboxone.
Estonian: Zubsolvi võrdlusravim on Suboxone.
English: Serious side effects include seizures (fits), vomiting, diarrhoea and abnormal results of blood tests for liver function.
Estonian: Rasked kõrvalnähud on krambihood, oksendamine, kõhulahtisus ja kõrvalekalded maksafunktsiooni vereanalüüsides.
English: It must also not be used with the medicines naltrexone and nalmefene, other opioid antagonists used for the treatment of alcohol or opioid dependence.
Estonian: Peale selle ei tohi seda kasutada koos naltreksooni ega nalmefeeniga (samuti alkoholi- või opioidisõltuvuse raviks kasutatavad opioidi antagonistid).
English: The most common side effects with Zubsolv (which may affect more than 1 in 10 people) are constipation and symptoms of drug withdrawal such as insomnia (difficulty sleeping), headache, nausea (feeling sick), hyperhidrosis (excessive sweating) and pain.
Estonian: Zubsolvi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on kõhukinnisus ja võõrutussümptomid, nagu unetus, peavalu, iiveldus, hüperhidroos (liighigistamine) ja valu.
English: Combining buprenorphine and naloxone is an established strategy for managing opioid dependence which prevents misuse of the medicine.
Estonian: Buprenorfiini ja naloksooni kombinatsioon on kindlakskujunenud strateegia opioidisõltuvuse raviks ning see aitab ära hoida ravimi väärkasutamist.
English: On the first day of treatment, the recommended daily dose is one or two tablets of Zubsolv 1.4 mg/0.36 mg or 2.9 mg/0.71 mg. During the next days, the doctor may increase the dose depending on the patient's response, but the daily dose should not be higher than 17.2 mg buprenorphine.
Estonian: Esimesel ravipäeval on soovitatav annus üks või kaks Zubsolvi 1,4 mg / 0,36 mg või 2,9 mg / 0,71 mg tabletti ööpäevas.
English: This is a summary of the European public assessment report (EPAR) for Zubsolv.
Estonian: See on ravimi Zubsolv Euroopa avaliku hindamisaruande kokkuvõte.