FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Mylan on 23 August 2012.
Estonian: Euroopa Komisjon andis ravimi Zoledronic acid Mylan müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 23 augustil 2012.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Estonian: See hõlmab luumurde, seljaaju kompressiooni (kui seljaaju on luu poolt kokku surutud), radioteraapiat (kiiritusravi) või kirurgilist sekkumist vajavaid luukahjustusi ja hüperkaltseemiat (vere suur kaltsiumisisaldus).
English: Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Zometa korral, ületab ravimi kasulikkus sellega kaasnevad riskid.
English: It is not recommended for patients with severe kidney problems.
Estonian: Kasutamine raskete neeruprobleemidega patsientidel ei ole soovitatav.
English: The company provided data from the published literature on zoledronic acid.
Estonian: Ettevõte esitas zoledroonhappe kohta avaldatud kirjandusest pärinevad andmed.
English: The usual dose of Zoledronic acid Mylan is one infusion of 4 mg over at least 15 minutes.
Estonian: Ravimi Zoledronic acid Mylan tavaline annus on üks 4 mg infusioon manustatuna vähemalt 15 minuti jooksul.
English: For more information about treatment with Zoledronic acid Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga Zoledronic acid Mylan toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: It explains how 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 Zoledronic acid Mylan.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Because Zoledronic acid Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Zoledronic acid Mylan on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Mylan has been shown to have comparable quality and to be bioequivalent to Zometa.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Zoledronic acid Mylan võrdväärne kvaliteet ja bioekvivalentsus ravimiga Zometa.
English: No additional studies in patients were needed as Zoledronic acid Mylan is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Estonian: Lisauuringuid ei olnud vaja, sest Zoledronic acid Mylan on infusioonina manustatav geneeriline ravim, mis sisaldab sama toimeainet kui võrdlusravim Zometa.
English: Zoledronic acid Mylan must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Estonian: Ravimit Zoledronic acid Mylan tohib kasutada üksnes arst, kellel on kogemusi seda tüüpi ravimi manustamisel veeni.
English: This means that Zoledronic acid Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Estonian: See tähendab, et Zoledronic acid Mylan on sarnane võrdlusravimiga Zometa, millel juba on Euroopa Liidus müügiluba.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Mylan.
Estonian: See on ravimi Zoledronic acid Mylan Euroopa avaliku hindamisaruande kokkuvõte.
English: By preventing the breakdown of bones, Zoledronic acid Mylan also helps to reduce the amount of calcium released into the blood.
Estonian: Ennetades luukoe lagunemist, aitab Zoledronic acid Mylan vähendada verre vabaneva kaltsiumi hulka.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Estonian: Luukoe kao vähenemine aitab muuta luid tugevamaks ja on kasulik luumurdude ennetamiseks kasvaja luumetastaasidega patsientidel.
English: Patients with tumours can have high levels of calcium in their blood, released from the bones.
Estonian: Kasvajaga patsientidel võib olla veres suur kaltsiumisisaldus (luudest vabanenud kaltsium).
English: Other information about Zoledronic acid Mylan
Estonian: Muu teave ravimi Zoledronic acid Mylan kohta
English: Zoledronic acid Mylan is a medicine that contains the active substance zoledronic acid.
Estonian: Zoledronic acid Mylan on ravim, mis sisaldab toimeainena zoledroonhapet.
English: Zoledronic acid Mylan can also be used to treat the hypercalcaemia caused by tumours.
Estonian: Ravimit Zoledronic acid Mylan kasutatakse ka kasvajatest põhjustatud hüperkaltseemia raviks.
English: EPAR summary for the public zoledronic acid
Estonian: Kokkuvõte üldsusele zoledroonhape
English: Zoledronic acid Mylan is a ‘generic medicine'.
Estonian: Zoledronic acid Mylan on geneeriline ravim.
English: Zoledronic acid Mylan can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Estonian: Ravimit Zoledronic acid Mylan kasutatakse täiskasvanutel luid mõjutava kaugelearenenud vähi luutüsistuste ennetamiseks.
English: What is Zoledronic acid Mylan?
Estonian: Mis on Zoledronic acid Mylan?
English: Why has Zoledronic acid Mylan been approved?
Estonian: Miks Zoledronic acid Mylan heaks kiideti?
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Estonian: Kui luumetastaasidega (kui kasvaja on levinud luudesse) patsientidel on kerged kuni mõõdukad neeruprobleemid, on soovitatav väiksem annus.
English: How does Zoledronic acid Mylan work?
Estonian: Kuidas Zoledronic acid Mylan toimib?
English: The Committee recommended that Zoledronic acid Mylan be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi müügiloa.
English: How is Zoledronic acid Mylan used?
Estonian: Kuidas ravimit Zoledronic acid Mylan kasutatakse?
English: How has Zoledronic acid Mylan been studied?
Estonian: Kuidas ravimit Zoledronic acid Mylan uuriti?
English: What are the benefits and risks of Zoledronic acid Mylan?
Estonian: Milles seisneb ravimi Zoledronic acid Mylan kasulikkus ja mis riskid ravimiga kaasnevad?
English: What is Zoledronic acid Mylan used for?
Estonian: Milleks ravimit Zoledronic acid Mylan kasutatakse?
English: Annex
Estonian: Lisa
English: This educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Pradaxa and providing guidance on how to manage that risk.
Estonian: See õppepakend on mõeldud teadlikkuse tõstmiseks potentsiaalse veritsusriski kohta Pradaxa-ravi ajal ning juhendab, kuidas selle riskiga toime tulla.
English: The Member States shall ensure that the following conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: - The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa.
Estonian: Liikmesriigid garanteerivad, et täidetakse allpool kirjeldatud tingimusi või piiranguid, mis puudutavad ravimi ohutut ja efektiivset kasutamist: Müügiloa hoidja muretseb õppepakendi iga ravinäidustuse kohta, mis on suunatud kõigile arstidele, kes loodetavasti kirjutavad välja/ordineerivad Pradaxat.
English: - The educational pack must be available for distribution for both therapeutic indications prior to the launch of the new indication (prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors) in the Member State.
Estonian: Õppepakend peab olema liikmesriigis jaotamiseks kättesaadav mõlema ravinäidustuse kohta enne uue näidustuse (ajuinfarkti ja vähemalt ühe riskifaktoriga mittevalvulaarse kodade fibrillatsiooniga täiskasvanud patsientidel süsteemse emboolia preventsioon) esitamist.
English: o An instruction how to take Pradaxa
Estonian: o Pradaxa kasutusjuhend
English: The Prescriber Guide should contain the following key safety messages: - Details of populations potentially at higher risk of bleeding - Recommendation not to use Pradaxa in patients with prosthetic heart valves - Recommendation for kidney function measurement - Recommendations for dose reduction in at risk populations - Management of overdose situations - The use of coagulation tests and their interpretation - That all patients should be provided with a Patient alert card and be counselled about:
Estonian: Arsti õppepakendis peab sisalduma: - Ravimi omaduste kokkuvõte - Ordineerimisjuhend - Patsiendi hoiatuskaardid Ordineerimisjuhend peab sisaldama järgmisi ohutusalaseid võtmesõnumeid: Patsientide erirühmade detailne kirjeldus, kes võivad olla enim ohustatud verejooksudest Soovitus mitte kasutada Pradaxa't südameklapi proteesiga patsientidel Soovitus neerufunktiooni mõõtmiseks Soovitused annuse vähendamiseks riskirühmadel Ravi üleannustamise juhtudel Hüübivustestide kasutamine ja nende tõlgendamine Et kõigile patsientidele tuleb muretseda Patsiendi hoiatuskaart ning neid tuleb nõustada järgmistes küsimustes: o Verejooksu sümptomid ning millal pöörduda abi saamiseks meditsiinitöötaja poole o Ravisoostumuse tähtsus o Vajadus kanda Patsiendi hoiatuskaarti endaga kogu aeg kaasas o Vajadus teavitada meditsiinitöötajat Pradaxa kasutamisest, kui patsiendil tuleb sooritada mingi kirurgiline operatsioon või invasiivne protseduur.
English: - The content and format of the educational material, together with a communication plan, is agreed with the MAH prior to distribution of the educational pack.
Estonian: Enne õppepakendi levitamist lepitakse müügiloa hoidjaga kokku õppematerjali sisus, formaadis ning kommunikatsiooni plaanis.
English: o Importance of treatment compliance o The need to inform Health Care Professionals that they are taking Pradaxa if they need to have any surgery or invasive procedure.
Estonian: Pradaxa kasutusjuhend Patsiendi hoiatuskaart peab sisaldama järgmisi ohutusalaseid võtmesõnumeid: o Verejooksu sümptomid ning millal pöörduda abi saamiseks meditsiinitöötaja poole o Ravisoostumuse tähtsus o Vajadus kanda Patsiendi hoiatuskaarti endaga kogu aeg kaasas o Vajadus teavitada meditsiinitöötajat Pradaxa kasutamisest, kui patsiendil tuleb sooritada mingi kirurgiline operatsioon või invasiivne protseduur.
English: Member State EU/EEA
Estonian: EL/EMP Liikmesriik
English: All risks relating to the target animal, the user and the environment are adequately addressed in the product literature.
Estonian: Kõik sihtloomaliikide, kasutaja ja keskkonna riskid on ravimikirjanduses adekvaatselt käsitletud.
English: Add the following text in the relevant sections of the product information:
Estonian: Lisada järgnev tekst ravimi teabe asjakohastesse lõikudesse:
English: Netherlands Bayer B.V., Animal Health Division Energieweg 1
Estonian: Bayer B.V., Animal Health Division Energieweg 1
English: The dogs were each infested with 80 female sand flies on 13 occasions (D7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215, and 222).
Estonian: Kõik koerad infitseeriti 80 emase moskiitoga 13 korral (7., 14., 21., 28., 56., 84., 112., 140., 166., 196., 208., 215. ja 222. päeval).
English: The benefit-risk balance for the agreed indication is considered favourable.
Estonian: Heakskiidetud näidustuse kasulikkuse ja riski tasakaalu peetakse soodsaks.
English: Due to the use of a very low sample size in two of the studies, only one study was considered to have produced reliable results and so the following comments are based on just this study.
Estonian: Arvestades väga väikest loomade arvu kahes uuringus, peeti usaldusväärseteks ainult ühe uuringu tulemusi, mispärast põhinevad järgmised kommentaarid ainult sellel uuringul.
English: In summary, the UK considered that the efficacy of Seresto for the proposed indication has not been sufficiently demonstrated and that accepting the indication could pose a serious risk to animal and human health.
Estonian: Kokkuvõttes oli Ühendkuningriik arvamusel, et Seresto efektiivsus kavandatud näidustusel ei ole piisavalt tõendanud ja et näidustuse heakskiitmine tekitaks suure riski looma- ja inimtervisele.
English: The benefit-risk assessment is made on this basis.
Estonian: Kasulikkust ja riski hinnati selle põhjal.
English: Both Guideline 7AE17a and Guideline EMEA/CVMP/EWP/005/2000-Rev.2 state that field studies should be performed in at least two geographical regions and the animal population studied should be representative of the target population.
Estonian: Suunistes 7AE17A ja EMEA/CVMP/EWP/005/2000-Rev.2 märgitakse, et väliuuringud peavad toimuma vähemalt kahes geograafilises piirkonnas ja uuritav loomapopulatsioon peab esindama sihtpopulatsiooni.
English: Overall summary of the scientific evaluation of Seresto and its associated name Foresto (see Annex I)
Estonian: Seresto ja sarnase nimetuse Foresto (vt I lisa) teadusliku hindamise üldkokkuvõte
English: All three field studies were performed in animal shelter situations within a limited geographical area.
Estonian: Kõik kolm väliuuringut tehti geograafiliselt väikesel alal paiknevates loomavarjupaikades.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Estonian: Ravimi nimetuse, ravimvormi, tugevuse, loomaliikide, manustamisviisi, müügiloa hoidja loetelu liikmesriikides
English: However, as they were conducted in animal shelters in Southern Italy, the UK considered that it is not possible to extrapolate the findings from these studies relating to transmission of leishmaniosis to all areas of the EU where the disease is endemic.
Estonian: Et uuringud olid tehtud Lõuna-Itaalia loomavarjupaikades, oli Ühendkuningriik arvamusel, et nende uuringute tulemusi ei ole võimalik ekstrapoleerida leišmanioosi ülekandele kõigis Euroopa Liidu piirkondades, kus haigus on endeemiline.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Estonian: Kehtivad ravimi omaduste kokkuvõte, märgistus ja pakendi infoleht on koordineerimisrühma menetluse tulemusena saavutatud lõplikud versioonid järgmiste muudatustega:
English: In this laboratory study, 14 dogs were randomised to either treatment with Seresto collar (n=7) or untreated control (n=7).
Estonian: Selles laboriuuringus randomiseeriti 14 koera saama kas ravi Seresto ravimkaelarihmaga (n = 7) või ravitoimeta kontrollkaelarihmaga (n = 7).
English: Seresto contains the active substances imidacloprid 10% and flumethrin 4.5%.
Estonian: Seresto sisaldab toimeainetena 10% imidaklopriidi ja 4,5% flumetriini.
English: The use of fed to unfed female sand flies ratios in Abbott's formula is not considered acceptable as a method for calculation of percentage efficacy as ratios have been used incorrectly to approximate risks (probabilities).
Estonian: Toitunud ja toitumata emaste moskiitode arvu suhte kasutamist Abbotti valemis ei peeta protsentuaalse efektiivsuse arvutamiseks aktsepteeritavaks meetodiks, sest suhteid on riskide (tõenäosuste) ligikaudseks hindamiseks kasutatud ebaõigesti.
English: The study ran between April/May and December 2013 (approximately eight months), and there was a post-treatment phase which ran until April/May 2014.
Estonian: Uuring toimus ajavahemikus aprill/mai kuni detsember 2013 (ligikaudu 8 kuud), millele järgnes aprillini/maini 2014 kestev ravijärgne faas.
English: According to Guideline 7AE17a, the threshold of efficacy for Diptera should be 80-100% (preferably more than 90%).
Estonian: Suunise 7AE17a kohaselt peab Diptera-vastase efektiivsuse lävi olema 80…100% (eelistatavalt üle 90%).
English: Treated dogs were continually treated with Seresto throughout the study period, with the collar being replaced as necessary due to growth of the animal or according to the label instructions for the product.
Estonian: Ravitud koeri raviti kogu uuringu jooksul pidevalt Serestoga, vahetades ravimkaelarihma vajaduse korral lähtuvalt koera kasvamisest või vastavalt ravimi märgistusel olevatele juhistele.
English: Scientific conclusions and grounds for the granting of the variation of the marketing authorisations
Estonian: Teaduslikud järeldused ja müügilubade tingimuste muutmise alused
English: Furthermore, there are specific difficulties inherent in the demonstration of such a claim: there is, at present, no validated laboratory model which can determine the efficacy of a veterinary medicinal product against leishmaniosis.
Estonian: Peale selle on sellise väite tõendamisel erilised probleemid: praegu puudub valideeritud laborimudel, millega määrata veterinaarravimi efektiivsust leišmanioosi vastu.
English: Of the thirteen assessment time points, an anti-feeding efficacy above 80% was only achieved on three occasions.
Estonian: 13 hindamispunktist saavutati üle 80% moskiitode toitumist takistav efektiivsus ainult 3 juhul.
English: 400 South Oak Way Green Park Reading
Estonian: Ühendkuningriik Bayer plc, 400 South Oak Way Green Park
English: A total of 122 dogs, of several breeds aged between 1.5 and 6 months, were enrolled (mostly as litters) on individual start dates between March and May 2011.
Estonian: Uuringusse kaasati kokku 122 eri tõugudest koera vanuses 1,6-6 kuud (enamasti pesakondadena) eraldi alguskuupäevadel ajavahemikus märtsist maini 2011.
English: An animal was considered positive for leishmaniosis if positive to one or more tests used.
Estonian: Loom loeti leišmanioosi suhtes positiivseks, kui ühes või mitmes kasutatud analüüsis saadi positiivne tulemus.
English: Seresto and its associated name Foresto (thereinafter “Seresto”) is a medicated collar containing 10% imidacloprid and 4.5% flumethrin.
Estonian: Seresto ja sarnane nimetus Foresto (edaspidi: Seresto) on ravimkaelarihm, mis sisaldab 10% imidaklopriidi ja 4,5% flumetriini.
English: The collar should be applied just before the beginning of the period of activity of sand fly vectors corresponding to the Leishmania infantum transmission season and worn continuously throughout the risk period.
Estonian: Kaelarihm tuleks panna loomale kaela just enne moskiitodest vektorite aktiivsusperioodi, vastavalt Leishmania infantum'i leviku hooajale, ning hoida kaelas pidevalt kogu ohuperioodi kestel.
English: Animals were tested for leishmaniosis with samples of blood and skin tissue being collected on study day 0, in July 2011, September 2011, November 2011, April 2012, and October 2012.
Estonian: Loomi uuriti leišmanioosi suhtes vere ja nahakoe proovidest, mis võeti uuringupäeval 0, juulis 2011, septembris 2011, novembris 2011, aprillis 2012 ja oktoobris 2012.
English: It is indicated for the treatment and prevention of infestations with fleas, ticks, and lice in dogs and cats, and provides indirect protection against the transmission of the pathogens Babesia canis vogeli and Ehrlichia canis from the vector tick Rhipicephalus sanguineus, thereby reducing the risk of canine babesiosis and canine ehrlichiosis for 7 months.
Estonian: Ravim on näidustatud kirbu-, puugi- ja täiinfestatsioonide raviks ja ennetamiseks koertel ja kassidel ning tagab kaudse kaitse patogeenide Babesia canis vogeli ja Ehrlichia canis ülekande eest vektorpuugilt Rhipicephalus sanguineus, vähendades 7 kuud koerte babesioosi ja koerte erlihhioosi riski.
English: Most dogs in normal household situations in countries endemic for leishmaniosis would be expected to be exposed to sand flies infected with leishmaniosis to a substantially lower extent, and therefore it was considered possible to extrapolate the results with confidence to the general target population.
Estonian: Enamik leišmanioosi suhtes endeemilistes riikides tavapärastes kodumajapidamistes peetavaid koeri puutub leišmanioosiinfektsiooniga moskiitodega kokku eeldatavasti oluliselt vähem ja seega peeti võimalikuks tulemuste usaldusväärset ekstrapoleerimist üldisele sihtpopulatsioonile.
English: Relevant information relating to the supporting studies should be added to the SPC.
Estonian: Asjakohane teave väidet toetavate uuringute kohta tuleb lisada ravimi omaduste kokkuvõttesse.
English: As a result, bites by sand flies may occur, and the transmission of Leishmania infantum cannot be completely excluded.
Estonian: Seetõttu võib esineda moskiitode hammustusi ning Leishmania infantum'i ülekandumist ei saa täielikult välistada.
English: A total of 279 dogs, of several breeds and aged between 2 and 96 months, were enrolled on day 0, with 219 of these dogs included in the efficacy calculation.
Estonian: Päeval 0 kaasati uuringusse kokku 279 eri tõugudest koera vanuses 2-96 kuud, kellest efektiivsuse arvutamisse kaasati 219 koera.
English: The amended summary of product characteristics, labelling and package leaflet are set out in Annex III.
Estonian: Muudetud ravimi omaduste kokkuvõte, pakendi märgistus ja pakendi infoleht on III lisas.
English: The study ran between March 2011 and April 2012, with a post-treatment phase commencing April 2012 and completing October 2012.
Estonian: Uuring toimus märtsist 2011 aprillini 2012, kusjuures ravijärgne faas algas aprillis 2012 ja lõppes oktoobris 2012.
English: However, the ratio of fed to unfed sand flies in the laboratory study described above is lower in treated dogs (mean 0.3, range 0.1 to 0.4) when compared to untreated animals (mean 9.0, range 3.3 to 15.6).
Estonian: Samas on toitunud ja toitumata moskiitode arvu suhe eespool kirjeldatud laborianalüüsis ravitud koertel väiksem (keskmine 0,3, vahemik 0,1…0,4) kui ravimata loomadel (keskmine 9,0, vahemik 3,3…15,6).
English: However, it was agreed by the CVMP that the field situations used in the studies submitted represent a ‘worst case scenario' in terms of exposure to infected sand flies: there was a high level of exposure to infected sand flies (incidence density rates in untreated dogs varied between 46.2 to 67.0%); dogs were housed outside throughout the day and night leading to unrestricted contact between the host and the vector; untreated dogs housed at the study area but not enrolled in the study constituted an additional reservoir for leishmaniosis.
Estonian: Veterinaarravimite komitee oli arvamusel, et esitatud uuringutes kasutatud väliolukorrad esindasid infektsiooniga moskiitodega kokkupuute aspektist halvimat võimalikku stsenaariumi: esines suur kokkupuude infektsiooniga moskiitodega (esinemissagedus ravimata koertel oli 46,2…67,0%); koeri peeti kogu päeva õues, mistõttu esines piiramatu kontakt peremeesorganismi ja vektori vahel; uuringualas peetavad ravimata koerad, kes ei olnud kaasatud uuringusse, olid täiendav leišmanioosi reservuaar.
English: the CVMP has recommended the granting of the variation of the marketing authorisations for Seresto and its associated name Foresto with amendment to the summary of product characteristics, labelling and package leaflet of the reference Member State.
Estonian: soovitas veterinaarravimite komitee muuta Seresto ja sarnase nimetuse Foresto müügilube, muutes viiteliikmesriigi ravimi omaduste kokkuvõtet, pakendi märgistust ja infolehte.