FrancophonIA/ELRC3.0 huggingface dataset:
English: Envarsus is available as prolonged-released tablets containing tacrolimus (0.75, 1 and 4 mg).
Estonian: Envarsust turustatakse toimeainet prolongeeritult vabastava tabletina, mis sisaldab takroliimust (0,75, 1 ja 4 mg).
English: This means that Envarsus is similar to a ‘reference medicine' that contains the same active substance but Envarsus has been formulated in a different way and is available at different doses.
Estonian: See tähendab, et Envarsus sarnaneb sama toimeainet sisaldava võrdlusravimiga, aga Envarsus on teistmoodi formuleeritud ja see on saadaval erinevates annustes.
English: The Committee recommended that Envarsus be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi Envarsus müügiloa.
English: Because Envarsus is similar to the reference medicine Advagraf, the applicant provided comparative data on Advagraf.
Estonian: Kuna Envarsus on sarnane võrdlusravimiga Advagraf, esitas müügiloa taotleja võrdlevad andmed Advagrafi kohta.
English: Treatment failure occurred in 18.3% patients treated with Envarsus (49 out of 268), and 19.6% given Prograf (54 out of 275).
Estonian: Ebaõnnestumise määr oli Envarsusega ravitud patsientidel 18,3% (49 patsienti 268st) ja Prografiga ravitud patsientidel 19,6% (54 patsienti 275st).
English: The most commonly reported side effects with Envarsus (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
Estonian: Envarsuse kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on treemor (värinad), peavalu, iiveldus, kõhulahtisus, neeruprobleemid, hüperglükeemia (tavalisest kõrgem glükoosisisaldus veres), diabeet, hüperkaleemia (tavalisest kõrgem kaaliumisisaldus veres),
English: It is not intended to provide practical advice on how to use Envarsus.
Estonian: Hindamisaruandes ei anta Envarsuse kasutamise praktilisi nõuandeid.
English: The second study compared Envarsus with Prograf as part of standard treatment in 543 patients with a newly transplanted kidney.
Estonian: Teises uuringus võrreldi Envarsust Prografiga standardravi osana 543 patsiendil, kellele oli äsja neer siirdatud.
English: Failure rates were 2.5% in both groups (4 of 162 patients treated with Envarsus, and 4 of 162 treated with Prograf).
Estonian: Ebaõnnestumise määr oli mõlemas rühmas 2,5% (4 patsienti 162st Envarsusega ravitutest ja 4 patsienti 162st Prografiga ravitutest).
English: The first study involved 326 patients who had already had a kidney transplant and were being treated with Prograf and other immunosuppressants to prevent rejection.
Estonian: Esimeses uuringus osales 326 patsienti, kellele oli neer juba siirdatud ning keda raviti äratõukereaktsiooni ennetamiseks Prografi ja teiste immunosupressantidega.
English: These ‘prolonged-release' tablets allow tacrolimus to be released slowly from the tablet over several hours and in a form that the body can absorb easily, so that it need be given only once a day.
Estonian: Tänu toimeainet prolongeeritult vabastatavatele tablettidele vabastatakse takroliimust aeglaselt mitme tunni vältel ja hõlpsalt absorbeeritavana, nii et seda tuleb võtta ainult üks kord ööpäevas.
English: In addition, because of the formulation/dosage differences between Envarsus and Advagraf, clinical studies in patients were also provided.
Estonian: Kuna Envarsuse ja Advagrafi ravimvormid/annused on erinevad, esitati ka patsientidega tehtud kliinilised uuringud.
English: Envarsus is a medicine that contains the active substance tacrolimus.
Estonian: Envarsus on ravim, mis sisaldab toimeainena takroliimust.
English: Envarsus is a ‘hybrid medicine'.
Estonian: Envarsus on hübriidravim.
English: Therefore, the CHMP's view was that, as for other authorised forms of tacrolimus, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka takroliimuse teiste, müügiloa saanud ravimvormide korral, ületab kasulikkus ravimiga kaasnevad riskid.
English: Envarsus must not be used in patients who are hypersensitive (allergic) to tacrolimus or any of the other ingredients, nor in those who are allergic to substances called macrolides (which include antibiotics such as erythromycin).
Estonian: Envarsust ei tohi määrata patsientidele, kes on takroliimuse, ravimi teiste koostisosade või selliste ainete nagu makroliidid (sh antibiootikumid, nagu erütromütsiin) suhtes ülitundlikud (allergilised).
English: Envarsus can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.
Estonian: Envarsust võib kasutada organi äratõukereaktsiooni raviks täiskasvanud patsientidel ka siis, kui teised immunosupressandid (ravimid, mis suruvad immuunsüsteemi alla) ei mõju.
English: It is used for the long-term treatment of adult patients who have had a kidney or a liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Estonian: Seda kasutatakse pikaajaliseks raviks täiskasvanutel, kellele on siirdatud neer või maks, et ennetada äratõukereaktsiooni (immuunsüsteem ründab siirdatud organit).
English: How does Envarsus work?
Estonian: Kuidas Envarsus toimib?
English: Lower doses may be needed in patients with reduced liver function.
Estonian: Vähenenud maksafunktsiooniga patsientidel võib olla vaja kasutada madalamaid annuseid.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the approved doses of Envarsus have been shown to have a comparable quality, safety and effectiveness to Advagraf and Prograf.
Estonian: Inimravimite komitee otsustas, et Envarsuse heaks kiidetud annustel on ravimitega Advagraf ja Prograf võrreldav kvaliteet, ohutus ja efektiivsus.
English: Envarsus is often given with other immunosuppressive medicines following the transplant.
Estonian: Envarsust võetakse pärast siirdamist tihti koos teiste immunosupressantidega.
English: Patients were either switched to treatment with Envarsus once daily or continued Prograf treatment twice daily.
Estonian: Patsientide ravim vahetati kas Envarsuse vastu (üks kord ööpäevas) või nad jätkasid Prografi võtmist (kaks korda ööpäevas).
English: For practical information about using Envarsus, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Envarsuse kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Doses of Envarsus are calculated based on the patient's weight.
Estonian: Envarsuse annused arvutatakse patsiendi kehakaalu järgi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Envarsus, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Envarsuse omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: How is Envarsus used?
Estonian: Kuidas Envarsust kasutatakse?
English: The reference medicine for Envarsus is Advagraf.
Estonian: Envarsuse võrdlusravim on Advagraf.
English: What benefits of Envarsus have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Envarsuse kasulikkus?
English: For more information about treatment with Envarsus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Envarsusega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Envarsus can only be obtained with a prescription and should only be prescribed by doctors experienced in immunosuppressive medicines and in the management of transplant patients.
Estonian: Envarsus on retseptiravim ja seda tohivad määrata ainult immunosupressantide kasutamises ja siirdamispatsientide ravis kogenud arstid.
English: Envarsus has been shown to be at least as effective as Prograf in two main studies in patients with kidney transplants.
Estonian: Neerusiirdamise patsientidel on Envarsus kahe põhiuuringu järgi vähemalt sama efektiivne kui Prograf.
English: These starting doses may also be tried for the treatment of rejection.
Estonian: Neid algannuseid võib kasutada ka äratõukereaktsiooni raviks.
English: For the full list of all side effects reported with Envarsus see the package leaflet
Estonian: Envarsuse kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: This is a summary of the European public assessment report (EPAR) for Envarsus.
Estonian: See on ravimi Envarsus Euroopa avaliku hindamisaruande kokkuvõte.
English: Switching or changes in immunosuppressive medicines should be started and monitored by experienced transplant doctors.
Estonian: Immunosupressantravi tohivad muuta või ravimeid vahetada ainult kogenud siirdamisarstid, kelle jälgimise all ravi toimuma peab.
English: The company also provided studies on the levels of tacrolimus in the body after taking Envarsus, which showed that it produced levels of tacrolimus that have been previously shown to be effective in treating and preventing rejection, and reported results in 29 patients who were given Envarsus starting after a liver transplant, none of whom rejected the transplanted organ during the 360 days following transplantation.
Estonian: Lisaks esitati 29 patsiendi tulemused, kellele anti pärast maksa siirdamist Envarsust ja kellest ükski ei tõuganud siirdatud organit 360 päeva jooksul pärast siirdamist ära.
English: Patients may also have abnormal results in liver function tests.
Estonian: Patsientide maksafunktsiooni analüüside tulemustes võivad esineda kõrvalekalded.
English: Because tacrolimus is absorbed into the body differently from Envarsus than from other tacrolimus medicines, when switching patients who are already being treated with any other formulation of tacrolimus they should be given a dose of Envarsus 30% less than their existing dose.
Estonian: Seega kui patsienti ravitakse takroliimuse muu ravimvormiga, tuleb neile määrata selle ravimi annusest 30% madalam Envarsuse annus.
English: In addition, the company that markets Envarsus will provide educational material for healthcare professionals who are likely to prescribe or dispense Envarsus, reminding them of its authorised uses and dosage, and the need for care if switching patients between different forms of tacrolimus.
Estonian: Lisaks esitab Envarsust turustav ettevõte teabematerjalid tervishoiutöötajatele, kes Envarsust tõenäoliselt määravad või annustavad.
English: Tacrolimus, the active substance in Envarsus, is an immunosuppressive medicine.
Estonian: Envarsuse toimeaine takroliimus on immunosupressant.
English: Tacrolimus reduces the activity of certain cells in the immune system, called T-cells, that are primarily responsible for attacking the transplanted organ (organ rejection).
Estonian: Need rakud vastutavad peamiselt siirdatud organi ründamise eest (äratõukereaktsioon).
English: What measures are being taken to ensure the safe and effective use of Adynovi?
Estonian: Mis meetmed võetakse, et tagada Adynovi ohutu ja efektiivne kasutamine?
English: Patients or their carers may be able to inject Adynovi themselves at home once they have been trained appropriately.
Estonian: Patsiendid või nende hooldajad tohivad süstida Adynovit ise kodus, kui nad on saanud asjakohase väljaõppe.
English: The full EPAR for Adynovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Adynovi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Adynovi
Estonian: Muu teave Adynovi kohta
English: The European Medicines Agency decided that Adynovi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Adynovi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: It can be used in adults and children from 12 years of age.
Estonian: Ravimit tohib kasutada täiskasvanutel ja vähemalt 12aastastel lastel.
English: Since this could potentially cause problems especially in children below 12 years of age, Adynovi is only approved for use in adults and children from 12 years of age.
Estonian: Et see võib tekitada probleeme, eelkõige alla 12aastastel lastel, kiidetakse Adynovi heaks kasutamiseks üksnes täiskasvanutel ja vähemalt 12aastastel lastel.
English: This is a summary of the European public assessment report (EPAR) for Adynovi.
Estonian: See on ravimi Adynovi Euroopa avaliku hindamisaruande kokkuvõte.
English: What is Adynovi and what is it used for?
Estonian: Mis on Adynovi ja milleks seda kasutatakse?
English: Why is Adynovi approved?
Estonian: Miks Adynovi heaks kiideti?
English: Adynovi rurioctocog alfa pegol
Estonian: Adynovi alfa-rurioktokog-pegool
English: The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as on the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Estonian: Annus ja manustamissagedus sõltuvad sellest, kas ravimit kasutatakse verejooksu raviks või ennetamiseks, hemofiilia raskusastmest, verejooksu ulatusest ja asukohast ning patsiendi seisundist ja kehamassist.
English: During this period, around 38% of patients (25 out of 66) had no bleeding episodes, and none of the patients developed antibodies against Adynovi, which can cause the medicine to stop working.
Estonian: Selle aja jooksul ei esinenud verejookse ligikaudu 38%-l patsientidest (25 patsienti 66st) ning mitte ühelgi patsiendil ei tekkinud Adynovi-vastaseid antikehi, mille tõttu ravim ei pruugi enam toimida.
English: Hypersensitivity (allergic) reactions are uncommon with Adynovi (affecting up to 1 in 100 people) and may include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing.
Estonian: Ülitundlikkusreaktsioonid (allergilised reaktsioonid) esinevad Adynovi kasutamisel aeg-ajalt (võivad esineda kuni 1 inimesel 100st) ning need on näiteks turse või põletus- ja torkimistunne süstekohal, külmavärinad, õhetus, sügelev lööve, peavalu, nõgeslööve, madal vererõhk, letargia, iiveldus ja oksendamine, rahutus, kiirenenud südametegevus, rõhumistunne rinnus ning vilistav hingamine.
English: Adynovi must not be used in patients who are hypersensitive (allergic) to rurioctocog alfa pegol or the related substance octocog alfa or to any of the other ingredients of the medicine, nor in those with known allergy to mouse or hamster proteins.
Estonian: Adynovit ei tohi kasutada patsiendid, kes on ülitundlikud (allergilised) alfa-rurioktokog-pegooli või sarnase aine alfa-oktokogi või ravimi mis tahes muu koostisaine suhtes, ega patsiendid, kellel on teadaolev allergia hiire- või hamstrivalkude vastu.
English: In the second study in 66 children aged below 12 years, all patients were given Adynovi as a twiceweekly preventive treatment for around 6 months.
Estonian: Teises uuringus, milles osales 66 alla 12aastast last, said kõik patsiendid ligikaudu 6 kuu jooksul Adynovit kaks korda nädalas ennetava ravina.
English: In a study involving 138 adults and adolescents aged 12 years or above, 120 patients given Adynovi as a twice-weekly preventive treatment had, on average, around 4 bleeding episodes a year, and 17 patients given Adynovi for treating bleedings ‘on demand' had around 43 bleeding episodes a year.
Estonian: Uuringus, milles osales 138 täiskasvanut ja vähemalt 12aastast noorukit, esines 120 patsiendil, kellele manustati Adynovit kaks korda nädalas ennetava ravina, keskmiselt 4 verejooksu aastas ning 17 patsiendil, kellele manustati Adynovit verejooksude vajaduspõhiseks raviks, ligikaudu 43 verejooksu aastas.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adynovi have also been included in the summary of product characteristics and the package leaflet.
Estonian: Adynovi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: It is not intended to provide practical advice on how to use Adynovi.
Estonian: Hindamisaruandes ei anta Adynovi kasutamise praktilisi nõuandeid.
English: The active substance in Adynovi, rurioctocog alfa pegol, works in the body in the same way as human factor VIII.
Estonian: Adynovi toimeaine alfa-rurioktokog-pegool toimib organismis samamoodi kui inimese VIII hüübimisfaktor.
English: What are the risks associated with Adynovi?
Estonian: Mis riskid Adynoviga kaasnevad?
English: Around 96% of bleeding episodes resolved with one or two injections of Adynovi.
Estonian: Ligikaudu 96% verejooksudest lahenes Adynovi ühe või kahe süstiga.
English: The company that markets Adynovi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Estonian: Adynovi turustaja korraldab uuringu, milles jälgib PEGi peaaju soonepõimikus ja muudes elundites ladestumise võimalikku mõju.
English: For practical information about using Adynovi, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Adynovi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For more information about treatment with Adynovi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Adynoviga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Following treatment with factor VIII products, including Adynovi, some patients may develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Estonian: Mõnel patsiendil võivad pärast ravi VIII hüübimisfaktori preparaatidega, sealhulgas Adynoviga, tekkida VIII hüübimisfaktori inhibiitorid (antikehad), mis peatavad ravimi toime, nii et see ei peata enam verejooksu.
English: Studies show that Adynovi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products.
Estonian: Uuringud tõendavad, et Adynovi on efektiivne verejooksude ennetamisel ja ravis A-hemofiiliaga patsientidel ning selle ohutus on võrreldav teiste VIII hüübimisfaktori preparaatide ohutusega.
English: How is Adynovi used?
Estonian: Kuidas Adynovit kasutatakse?
English: What benefits of Adynovi have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Adynovi kasulikkus?
English: How does Adynovi work?
Estonian: Kuidas Adynovi toimib?
English: However, part of the active substance in Adynovi (called PEG) may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Estonian: Adynovi toimeaine teatud osa (PEG) võib aga pikaajalisel ravil hakata organismis, sealhulgas peaaju soonepõimikus ladestuma.
English: Adynovi contains the active substance rurioctocog alfa pegol.
Estonian: Ravim sisaldab toimeainena alfa-rurioktokog-pegooli.
English: Around 83% of bleeding episodes resolved with one injection.
Estonian: Ligikaudu 83% verejooksudest lahenes Adynovi ainsa süstiga.
English: Adynovi has been shown in two main studies to be effective at preventing and treating bleeding episodes in patients with severe haemophilia who were previously treated with other factor VIII products.
Estonian: Adynovi kasulikkust verejooksude ennetamisel ja ravis tõendati kahes põhiuuringus raske hemofiiliaga patsientidel, keda oli varem ravitud teiste VIII hüübimisfaktori preparaatidega.
English: Adynovi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII.
Estonian: Adynovi on ravim, mida kasutatakse verejooksude raviks ja ennetamiseks patsientidel, kellel on A-hemofiilia (VIII hüübimisfaktori vaegusest tingitud pärilik hüübimishäire).
English: When bleeding occurred, Adynovi was rated excellent or good at treating around 90% of episodes.
Estonian: Adynovi ravitoime hinnati ligikaudu 90% verejooksu episoodide korral suurepäraseks või heaks.
English: In addition, when bleeding did occur, Adynovi was rated excellent or good at treating around 96% of bleeding episodes.
Estonian: Adynovi ravitoime hinnati ligikaudu 96% verejooksu episoodide korral suurepäraseks või heaks.
English: For the full list of all side effects see the package leaflet.
Estonian: Adynovi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Adynovi can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Estonian: Ravi peab toimuma hemofiilia ravis kogenud arsti järelevalve all.
English: Adynovi is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Estonian: Adynovit turustatakse veenisüstelahuse pulbri ja lahustina.
English: EU/2/07/071/002 (50ml) EU/2/07/071/003 (150ml)
Estonian: EU/2/07/071/001 (20ml) EU/2/07/071/002 (50ml) EU/2/07/071/003 (150ml)
English: Slentrol may cause eye-irritation.
Estonian: Slentrol võib põhjustada silmade ärritust.
English: In a 14-day repeated dose study, AUC increased 3-fold from Day 1to Day 14.
Estonian: 14päevasel korduva doseerimise uuringul suurenes AUC 1. päevast 14. päevani 3 korda.
English: Interactions with other drug types have not been specifically investigated.
Estonian: Koostoimeid teiste ravimitüüpidega ei ole spetsiaalselt uuritud.
English: Some dogs (less than 10%) experienced repeated vomiting (i.e. more than once every 20 days on average).
Estonian: Mõnedel koertel (alla 10%) esines korduvat oksendamist (s.t. keskmiselt enam kui kord iga 20 päeva jooksul).
English: AUC and Cmax increased with increasing dose but not in a dose-proportional manner.
Estonian: Kõvera-alune piirkond (AUC) ja Cmax suurenesid koos doosi suurendamisega, kuid mitte proportsionaalselt doosiga.
English: Detailed information on this product is available on the website of the European Medicines Agency
Estonian: Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt
English: Mean oral bioavailability values were approximately 24% - 41% for fed dogs and 22% in fasted dogs.
Estonian: Keskmised suukaudse biosaadavuse väärtused olid umbes 24-41% söödetud koertel ja 22% söötmata koertel.
English: NATURE: 20 ml, 50 ml, 150 ml bottle
Estonian: OLEMUS: 20 ml, 50 ml, 150 ml pudel
English: Date of first authorisation: 13/04/2007
Estonian: Esmase müügiloa väljastamine: 13/04/2007 Müügiloa uuendamine: 10/04/2012
English: In a 3-month study, exposures were 2 times higher at Day 29 but returned to Day 1 values at days 56 and 87.
Estonian: 3-kuulisel uuringul olid mõjutasemed 29. päeval 2 korda suuremad, kuid 56. ja 87. päevadel pöördusid tagasi 1. päeva väärtuse juurde.
English: Oral dosing devices used for measuring the dose may be cleaned with water but must be dried before re-use.
Estonian: Suukaudseid doosi mõõtmiseks kasutatavaid dosaatoreid võib veega puhastada, kuid enne taaskasutamist peab neid kuivatama.
English: These measures should
Estonian: Need meetmed
English: If these changes were observed, treatment should be stopped.
Estonian: Nende muutuste ilmnemisel tuleb ravi lõpetada.
English: Use in dogs intended for breeding should be subject to a risk-benefit analysis (see section 4.7).
Estonian: Kasutamine aretuses kasutatavatel koertel peaks sõltuma kasu-riski analüüsist (vt. lõik 4.7).