FrancophonIA/ELRC3.0 huggingface dataset:
English: It can also be used on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.
Estonian: Seda tohib kasutada ka ainsa ravimina, kui ravi antratsükliinide ja taksaanidega (teised vähiravimid) ei ole andnud tulemust või kui kordusravi antratsükliinidega patsiendile ei sobi.
English: Capecitabine SUN is a ‘generic medicine'.
Estonian: Capecitabine SUN on geneeriline ravim.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Capecitabine SUN, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Strateegiast lähtudes lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Capecitabine SUNi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavate ettevaatusmeetmete teave.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Capecitabine SUN has been shown to have comparable quality and to be bioequivalent to Xeloda.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Capecitabine SUN võrdväärne kvaliteet ja bioekvivalentsus ravimiga Xeloda.
English: It is not intended to provide practical advice on how to use Capecitabine SUN.
Estonian: Hindamisaruandes ei anta Capecitabine SUNi kasutamise praktilisi nõuandeid.
English: Because Capecitabine SUN 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 Capecitabine SUN on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: What is Capecitabine SUN and what is it used for?
Estonian: Mis on Capecitabine SUN ja milleks seda kasutatakse
English: This means that Capecitabine SUN is similar to a ‘reference medicine' already authorised in the European Union (EU) called Xeloda.
Estonian: See tähendab, et Capecitabine SUN on sarnane võrdlusravimiga Xeloda, millel juba on Euroopa Liidus müügiluba.
English: For practical information about using Capecitabine SUN, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Capecitabine SUNi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, mainly in tumour cells.
Estonian: Capecitabine on eelravim, mis muundub organismis, põhiliselt kasvajarakkudes fluorouratsiil5-ks (5-FU).
English: Because Capecitabine SUN is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Xeloda.
Estonian: Et Capecitabine SUN on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati ravimi bioekvivalentsust võrdlusravimiga Xeloda.
English: Other information about Capecitabine SUN
Estonian: Muu teave Capecitabine SUNi kohta
English: For more information about treatment with Capecitabine SUN, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Capecitabine SUNiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This is a summary of the European public assessment report (EPAR) for Capecitabine SUN.
Estonian: See on ravimi Capecitabine SUN Euroopa avaliku hindamisaruande kokkuvõte.
English: Capecitabine SUN is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Estonian: • käärsoole- ehk jämesoolevähk: Capecitabine SUNi kasutatakse koos teiste vähiravimitega või ilma nendeta, et ravida käärsoolevähki patsientidel, kellele on tehtud III staadiumi ehk Dukes'i skaala C-staadiumi käärsoolevähi operatsioon;
English: Why has Capecitabine SUN been approved?
Estonian: Miks Capecitabine SUN heaks kiideti?
English: Capecitabine SUN is an anticancer medicine that contains the active substance capecitabine.
Estonian: Capecitabine SUN on ravim, mis sisaldab toimeainena kapetsitabiini.
English: The active substance in Capecitabine SUN, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Estonian: Capecitabine SUNi toimeaine kapetsitabiin on antimetaboliitide (raku normaalset ainevahetust pärssivad ained) hulka kuuluv tsütotoksiline ravim (poolduvaid rakke, näiteks vähirakke hävitav ravim).
English: How has Capecitabine SUN been studied?
Estonian: Kuidas Capecitabine SUNi uuriti?
English: How does Capecitabine SUN work?
Estonian: Kuidas Capecitabine SUN toimib?
English: How is Capecitabine SUN used?
Estonian: Kuidas Capecitabine SUNi kasutatakse?
English: Capecitabine SUN is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Estonian: • kaugelearenenud maovähk: Capecitabine SUNi kasutatakse koos teiste vähiravimitega, sealhulgas plaatinat sisaldava vähiravimiga (näiteks tsisplatiiniga);
English: It can only be obtained with a prescription and must be prescribed by a doctor who is experienced in the use of anticancer medicines.
Estonian: Capecitabine SUN on retseptiravim ja seda tohib määrata üksnes vähiravimite kasutamise kogemusega arst.
English: • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Estonian: • metastaatiline kolorektaalvähk (jämesoolevähk, mis on levinud organismis ka mujale): Capecitabine SUNi kasutatakse koos teiste vähiravimitega või ilma nendeta;
English: What are the benefits and risks of Capecitabine SUN?
Estonian: Milles seisneb Capecitabine SUNi kasulikkus ja mis riskid ravimiga kaasnevad?
English: • locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body).
Estonian: • paikne kaugelearenenud või metastaatiline rinnanäärmevähk (rinnavähk, mis on hakanud levima organismis ka mujale): Capecitabine SUNi kasutatakse koos dotsetakseeliga (samuti vähiravim) pärast tulemusteta ravi antratsükliinidega (teised vähiravimid).
English: 31 March 2016
Estonian: 31. märts 2016
English: This section should also include literature case reports and review.
Estonian: See jaotis peab sisaldama ka kirjanduses avaldatud juhtumiteateid ja ülevaadet.
English: Furthermore the discussion on the adverse events in this group should be compared with the pattern of adverse events in other age groups.
Estonian: Lisaks tuleb selle rühma kõrvalnähtude arutelus võrrelda kõrvalnähtude esinemist esinemisega teistes vanuserühmades.
English: • discuss the usage in elderly, taking into account the naturally lower level of testosterone in this age group of patients.
Estonian: • Arutama kasutamist eakatel, arvestades testosterooni looduslikult madalat taset selles patsientide vanuserühmas.
English: The spontaneous reports shall not be presented as a listing of the individual cases, but rather as a general discussion of the aggregated cases, and include all relevant information, e.g. time to onset (when available), haematocrit/haemoglobin level (when available), indication, age, confounding factors and other.
Estonian: Spontaanseid teateid ei esitata üksikjuhtumite loeteluna, vaid pigem kõigi juhtumite üldise aruteluna, ja see sisaldab kogu asjakohast teavet, näiteks avaldumise aega (kui teada), hematokriti/hemoglobiini taset (kui teada), näidustust, vanust, soodustavaid tegureid jt.
English: • submit the PSUR within 90 days following the DLP of 31 December
Estonian: • Esitama perioodilise ohutusaruande 90 päeva jooksul pärast andmete esitamise tähtaega 31. detsembril 2015.
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Estonian: Liikmesriikide või viiteliikmesriikide (kui asjakohane) pädevad asutused peavad tagama, et müügiloa hoidjad täidavad järgmisi tingimusi.
English: • monitor cardiovascular risk (including literature review, clinical trials data and all other relevant data) and discuss the finding in the next PSUR.
Estonian: • Jälgima kardiovaskulaarset riski (sh kirjandusülevaatr, kliiniliste uuringute andmete ja kõigi muude asjakohaste andmete alusel) ning arutama tulemusi järgmises perioodilises ohutusaruandes.
English: • discuss a possible mechanism of VTE and the potential association between CV/VTE events and testosterone levels (whether low or high levels compared to eugonadal level may contribute to the risk), and discuss if the information should be included in the product information.
Estonian: • Arutama venoosse tromboosi juhtumite võimalikku mehhanismi ning kardiovaskulaarsete / venoosse tromboosi juhtumite ja testosterooni tasemete võimalikku seost (kas madal või kõrge tase võrreldes eugonadaali tasemega võib riski suurendada), ja arutama, kas see teave tuleb lisada ravimiteabesse.
English: The Marketing Authorisation Holders of testosterone-containing medicinal products should, with the next PSUR:
Estonian: Testosterooni sisaldavate ravimite müügiloa hoidjad peavad seoses järgmise perioodilise ohutusaruandega tegema järgmist.
English: • report on venous thrombolic events (VTE) including deep venous thrombosis (VTE) and pulmonary embolism (PE) in a separate section in the next PSUR.
Estonian: • Teatama järgmise perioodilise ohutusaruande eraldi jaotises venoosse tromboosi juhtumitest, sh süvaveenide tromboos ja kopsuarteri trombemboolia juhtumitest.
English: The full EPAR and risk management plan summary for Zoledronic acid Teva Generics can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte ravimi Zoledronic acid Teva Generics kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used in patients who are at risk of fractures (broken bones) and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).
Estonian: Seda kasutatakse patsientidel, kellel on luumurru risk, ja patsientidel, kelle osteoporoos on seotud pikaajalise glükokortikoidraviga (teatud steroidraviga).
English: This leads to less bone loss in osteoporosis and less disease activity in Paget's disease.
Estonian: Selle tulemuseks on luukoe väiksem hävimine osteoporoosi korral ning haiguse väiksem aktiivsus luu Pageti tõve korral.
English: In Paget's disease, the bone breaks down more quickly, and when it grows back, it is weaker than normal.
Estonian: Luu Pageti tõve korral laguneb luukude kiiremini ning kui see uuesti moodustub, on see normaalsest luukoest nõrgem.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva Generics on 27 March 2014.
Estonian: Euroopa Komisjon andis ravimi Zoledronic acid Teva Generics müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 27. märtsil 2014.
English: A risk management plan has been developed to ensure that Zoledronic acid Teva Generics is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada ravimi Zoledronic acid Teva Generics võimalikult ohutu kasutamine.
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Estonian: Osteoporoos tekib, kui looduslikul teel laguneva luukoe asemele ei kasva piisavalt uut luukude.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva Generics?
Estonian: Mis meetmed võetakse, et tagada ravimi Zoledronic acid Teva Generics ohutu ja efektiivne kasutamine?
English: No additional studies were needed as Zoledronic acid Teva Generics is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.
Estonian: Lisauuringuid ei olnud vaja, sest Zoledronic acid Teva Generics on infusioonina manustatav geneeriline ravim, mis sisaldab sama toimeainet kui võrdlusravim Aclasta.
English: See the package leaflet for full details.
Estonian: Täielik teave on pakendi infolehel.
English: The Committee recommended that Zoledronic acid Teva Generics be approved for use in the EU.
Estonian: Komitee soovitas ravimi Zoledronic acid Teva Generics kasutamise Euroopa Liidus heaks kiita.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Generics, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi Zoledronic acid Teva Generics omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zoledronic acid Teva Generics has been shown to be comparable to Aclasta.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Zoledronic acid Teva Generics võrreldavus Aclastaga.
English: This means that Zoledronic acid Teva Generics is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aclasta.
Estonian: See tähendab, et Zoledronic acid Teva Generics on sarnane võrdlusravimiga Aclasta, millel on juba Euroopa Liidus müügiluba.
English: In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Estonian: Naistel on osteoporoos sagedam pärast menopausi, kui naissuguhormooni östrogeeni sisaldus organismis väheneb.
English: Zoledronic acid Teva Generics is given as an infusion lasting at least 15 minutes.
Estonian: Ravimit Zoledronic acid Teva Generics manustatakse vähemalt 15 minutit kestva infusioonina.
English: Because Zoledronic acid Teva Generics is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Zoledronic acid Teva Generics on geneeriline ravim, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: This is a disease where the normal process of bone growth is altered.
Estonian: Selle haiguse korral on luukoe normaalne moodustumine häiritud.
English: For practical information about using Zoledronic acid Teva Generics, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate ravimi Zoledronic acid Teva Generics kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: In the treatment of Paget's disease, Zoledronic acid Teva Generics must only be used by a doctor who has experience in the treatment of the disease.
Estonian: Luu Pageti tõve raviks tohib ravimit Zoledronic acid Teva Generics manustada üksnes selle haiguse ravis kogenud arst.
English: For more information about treatment with Zoledronic acid Teva Generics, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga Zoledronic acid Teva Generics toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Zoledronic acid Teva Generics is a medicine that contains zoledronic acid (5mg).
Estonian: Zoledronic acid Teva Generics on ravim, mis sisaldab toimeainena soledroonhapet (5 mg).
English: It is not intended to provide practical advice on how to use Zoledronic acid Teva Generics.
Estonian: Hindamisaruandes ei anta ravimi Zoledronic acid Teva Generics kasutamise praktilisi nõuandeid.
English: What is Zoledronic acid Teva Generics and what is it used for?
Estonian: Mis on Zoledronic acid Teva Generics ja milleks seda kasutatakse
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Estonian: Toimeaine peatab osteoklastide ehk luukoe lagundamises osalevate rakkude tegevuse.
English: Zoledronic acid Teva Generics is also used to treat Paget's disease of the bone in adults.
Estonian: Ravimit Zoledronic acid Teva Generics kasutatakse ka luu Pageti tõve raviks täiskasvanutel.
English: Why is Zoledronic acid Teva Generics approved?
Estonian: Miks Zoledronic acid Teva Generics heaks kiideti?
English: This can be repeated once a year in patients being treated for osteoporosis.
Estonian: Osteoporoosi ravimisel tohib infusiooni korrata üks kord aastas.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Generics.
Estonian: See on ravimi Zoledronic acid Teva Generics Euroopa avaliku hindamisaruande kokkuvõte.
English: Other information about Zoledronic acid Teva Generics
Estonian: Muu teave ravimi Zoledronic acid Teva Generics kohta
English: Zoledronic acid Teva Generics zoledronic acid
Estonian: Zoledronic acid Teva Generics soledroonhape
English: How does Zoledronic acid Teva Generics work?
Estonian: Kuidas Zoledronic acid Teva Generics toimib?
English: Therefore, the CHMP's view was that, as for Aclasta, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu Aclasta korral, ületab ravimi Zoledronic acid Teva Generics kasulikkus sellega kaasnevad riskid.
English: Zoledronic acid Teva Generics is usually given, but additional infusions can be considered if the patient's disease comes back.
Estonian: Luu Pageti tõvega patsientidele tehakse ainult üks ravimi Zoledronic acid Teva Generics infusioon, kuid haiguse taastudes tohib infusioone korrata.
English: Zoledronic acid Teva Generics is a ‘generic medicine'.
Estonian: Zoledronic acid Teva Generics on geneeriline ravim.
English: How has Zoledronic acid Teva Generics been studied?
Estonian: Kuidas ravimit Zoledronic acid Teva Generics uuriti?
English: The active substance in Zoledronic acid Teva Generics, zoledronic acid, is a bisphosphonate.
Estonian: Ravimi Zoledronic acid Teva Generics toimeaine soledroonhape on bisfosfonaat.
English: Zoledronic acid Teva Generics is available as a solution for infusion (drip) into a vein; the medicine can only be obtained with a prescription.
Estonian: Ravimit Zoledronic acid Teva Generics turustatakse infusioonilahusena (veeni tilgutatava lahusena).
English: How is Zoledronic acid Teva Generics used?
Estonian: Kuidas ravimit Zoledronic acid Teva Generics kasutatakse?
English: Unopened vial: 30 months After opening: Use immediately
Estonian: Avamata viaal: 30 kuud Pärast avamist: kasutada kohe
English: • Take it with or without food.
Estonian: • Võtke seda koos toiduga või ilma.
English: Detailed information is presented below.
Estonian: Täpsem teave on esitatud allpool.
English: CMV is a virus that a lot of people have without knowing.
Estonian: CMV on viirus, mis on paljudel inimestel, ilma et nad seda teaksid.
English: • Compatible medicinal products are listed below.
Estonian: • Kokkusobivad ravimpreparaadid on loetletud allpool.
English: Take your next dose at the usual time.
Estonian: Võtke järgmine annus tavalisel ajal.
English: # (see section 4.4).
Estonian: # (vt lõik 4.4).
English: Parameter n (%)
Estonian: Parameeter n (%)
English: Other medicines and PREVYMIS
Estonian: Muud ravimid ja PREVYMIS
English: • Take PREVYMIS at the same time every day.
Estonian: • Võtke PREVYMIS't iga päev samal kellaajal.
English: This difference is not clinically relevant.
Estonian: See erinevus ei ole kliiniliselt oluline.
English: The tablet should be swallowed whole and may be taken with or without food.
Estonian: Tablett tuleb neelata tervelt, selle võib võtta koos toiduga või ilma.
English: Additional blood tests may be needed to monitor the following medicinal products:
Estonian: Võite vajada täiendavaid vereanalüüse järgmiste ravimite kontsentratsioonide jälgimiseks:
English: Median (90% Prediction Interval)*
Estonian: Mediaan (90% usaldusintervall)*
English: Note that the table is not extensive but provides examples of clinically relevant interactions.
Estonian: Pange tähele, et tabelis olevad andmed ei ole ulatuslikud, kuid sisaldavad näiteid kliiniliselt oluliste koostoimete kohta.
English: There is a theoretical risk of reduced exposure due to induction but the size of the effect and thus clinical relevance is presently unknown.
Estonian: Esineb teoreetiline risk ekspositsioonide vähenemiseks indutseerimise tagajärjel, kuid selle mõju ulatus ja seega ka kliiniline tähendus on praegu teadmata.
English: *This table is not all inclusive.
Estonian: * Tabelis antud info ei ole täielik.
English: Normally, CMV just stays in their body and it does not hurt them.
Estonian: Tavaliselt püsib CMV inimese organismis ega kahjusta neid.
English: Clinically significant CMV infection
Estonian: Kliiniliselt oluline CMV infektsioon
English: The potential interaction between letermovir and these medicinal products have not been investigated.
Estonian: Võimalikke koostoimeid letermoviiri ja nende ravimpreparaatide vahel ei ole uuritud.
English: Monitoring of CMV DNA
Estonian: CMV DNA jälgimine
English: General information
Estonian: Üldine teave
English: The adverse reactions are listed below by body system organ class and frequency.
Estonian: Allpool on loetletud kõrvaltoimed organsüsteemi klassi ja esinemissageduse järgi.
English: The net effect in vivo on the other listed enzymes and transporters is not known.
Estonian: In vivo kombineeritud mõju teistele loetletud ensüümidele ja transporteritele ei ole teada.
English: • If you forget a dose, take it as soon as you remember.
Estonian: • Kui unustate annuse võtmata, võtke see niipea kui see teile meenub.
English: n (%) = Number (percent) of subjects in each sub-category.
Estonian: n (%) = patsientide arv (protsent) igas alamkategoorias.
English: N = number of subjects in each treatment group.
Estonian: N = patsientide arv igas ravirühmas.
English: The inter-individual variability for CL is estimated to be 24.6%.
Estonian: Üksikisikutevaheline kliirensite erinevus on hinnanguliselt 24,6%.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from PREVYMIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Estonian: Tuleb langetada otsus, kas katkestada rinnaga toitmine või katkestada/loobuda ravist PREVYMIS'ega, võttes arvesse imetamise kasulikkust lapsele ja ravist saadavat kasu naisele.
English: If you are also taking a medicine for high cholesterol (see list of medicines in section “Other medicines and PREVYMIS” below) you must tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever.
Estonian: Kui te võtate ka ravimeid kõrge kolesteroolitaseme tõttu (vt ravimite loetelu allpool lõigus „Muud ravimid ja PREVYMIS“), siis peate otsekohe rääkima oma arstile, kui teil esineb selge põhjuseta lihaste hellust või lihasvalusid, eriti juhul kui teil on halb enesetunne või palavik.
English: If you experience any of these effects, do not drive or use machines until the effect wears off.
Estonian: Kui teil tekib mõni neist kõrvaltoimetest, ärge juhtige autot ega käsitsege masinaid, kuni need toimed on möödunud.
English: EC50 values for these mutations are 13- to 8,262-fold higher than those for the wild-type reference virus.
Estonian: Nende mutatsioonide EC50 väärtused on 13 kuni 8262 korda suuremad võrreldes metsikut tüüpi referentsviirusega.
English: Pack size: 1 vial.
Estonian: Pakendi suurus: 1 viaal.
English: Your doctor or pharmacist will tell you if it is safe to take PREVYMIS with other medicines.
Estonian: Teie arst või apteeker ütleb teile, kas on ohutu kasutada PREVYMIS't koos teiste ravimitega.
English: This change is not clinically relevant.
Estonian: See muutus ei ole kliiniliselt oluline.