FrancophonIA/ELRC3.0 huggingface dataset:
English: This reduces the risk of a blood clot forming and helps prevent another heart attack or stroke.
Estonian: See vähendab trombide tekke ohtu ja aitab vältida järgmist südameinfarkti või insulti.
English: Ref. EMEA/254399/2009
Estonian: London, 29. mai 2009 Viide: EMEA/410306/2009 EMEA/H/C/1052
English: What is Clopidogrel Teva Pharma?
Estonian: Mis on Clopidogrel Teva Pharma?
English: It was to be used in patients who had recently had a myocardial infarction (heart attack) or an ischaemic stroke (non-bleeding stroke), or in patients with peripheral arterial disease (problems with blood flow in the arteries).
Estonian: Ravimit kavatseti kasutada patsientidel, kellel on hiljuti olnud südameinfarkt või isheemiline insult (ajupiirkonna verevarustuse vaegus veresoone sulguse tõttu), või patsientidel, kellel on perifeersete arterite haigus (arteriverevoolu probleemid).
English: Because Clopidogrel Teva Pharma was developed as a generic medicine, the company presented the results of studies carried out to investigate whether it is ‘bioequivalent' to the reference medicine.
Estonian: Kuna Clopidogrel Teva Pharma töötati välja geneerilise ravimina, esitas ettevõte nende uuringute tulemused, milles uuriti ravimi bioekvivalentsust võrdlusravimiga.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Clopidogrel Teva Pharma could not have been approved for the prevention of atherothrombotic events in patients who have had myocardial infarction, ischaemic stroke or who have established peripheral arterial disease.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ning oli esialgsel seisukohal, et Clopidogrel Teva Pharmale ei või anda müügiluba südameisheemiatõvega, isheemilise insuldi või perifeersete arterite haigusega patsientidel aterotrombootiliste nähtude ennetamiseks.
English: Questions and answers on the withdrawal of the marketing authorisation application for Clopidogrel Teva Pharma clopidogrel
Estonian: Teave müügiloa taotluse tagasivõtmise kohta Clopidogrel Teva Pharma klopidogreel
English: This means that Clopidogrel Teva Pharma was intended to be similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Estonian: See tähendab, et Clopidogrel Teva Pharma pidi olema sarnane võrdlusravimiga Plavix, millel juba on Euroopa Liidus müügiluba.
English: Clopidogrel Teva Pharma was expected to be used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Estonian: Clopidogrel Teva Pharmat kavatseti kasutada aterotromboosi nähtude (trombide moodustumisest ja arterite lubjastumisest põhjustatud probleemide) ennetamiseks täiskasvanutel.
English: This means that it helps to prevent blood clots from forming.
Estonian: See peatab vereliistakute muutumise kleepuvaks.
English: The CHMP concluded that the studies presented did not provide enough evidence to show that Clopidogrel Teva Pharma was bioequivalent to the reference medicine Plavix.
Estonian: Inimravimite komitee jõudis järeldusele, et uuringutetulemused ei tõendanud piisavalt Clopidogrel Teva Pharma bioekvivalentsust võrdlusravimiga Plavix.
English: Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Estonian: Clopidogrel Teva Pharma on ravim, mis sisaldab toimeainena klopidogreeli.
English: Clopidogrel Teva Pharma was developed as a ‘generic medicine'.
Estonian: Clopidogrel Teva Pharma töötati välja geneerilise ravimina.
English: When the blood clots, this is due to special cells in the blood called platelets sticking together (aggregating).
Estonian: Veri hüübib teatud vererakkude - vereliistakuteagregatsiooni (kokkukleepumise) tõttu.
English: At this point in time, the CHMP was of the opinion that Clopidogrel Teva Pharma could not be considered a generic medicine of Plavix, the reference medicinal product.
Estonian: Inimravimite komitee jäi seisukohale, et Clopidogrel Teva Pharmat ei saa pidada võrdlusravimi Plavixi geneeriliseks ravimiks.
English: The active substance in Clopidogrel Teva Pharma and in Plavix, clopidogrel, is an inhibitor of platelet aggregation.
Estonian: Clopidogrel Teva Pharma ja Plavixi toimeaine klopidogreel on trombotsüütide agregatsiooni inhibiitor.
English: Clopidogrel Teva Pharma is expected to work in the same way as the reference medicine, Plavix.
Estonian: Clopidogrel Teva Pharma eeldatav toime on samasugune nagu võrdlusravimil Plavix.
English: On 22 April 2009, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Clopidogrel Teva Pharma, for the prevention of atherothrombotic events in patients who have myocardial infarction, ischaemic stroke or established peripheral arterial disease.
Estonian: ametlikult inimravimite komiteed oma soovist võtta tagasi südameisheemiatõvega, isheemilise insuldi või perifeersete arterite haigusega patsientidel aterotrombootiliste nähtude ennetamiseks ettenähtud ravimi Clopidogrel Teva Pharma müügiloa taotlus.
English: What was Clopidogrel Teva Pharma expected to be used for?
Estonian: Milline oli Clopidogrel Teva Pharma eeldatav toime?
English: London, 29 May 2009 Doc.
Estonian: 22. aprillil 2009 teavitas Teva Pharma B.V.
English: Additional data from an extension of this study in children aged 13 to 18 years confirmed the initial results.
Estonian: Selle uuringu pikendusest 13-18aastaste laste kohta saadud lisaandmed kinnitasid algseid tulemusi.
English: What measures are being taken to ensure the safe and effective use of Strensiq?
Estonian: Mis meetmed võetakse, et tagada Strensiqi ohutu ja efektiivne kasutamine?
English: Strensiq received a marketing authorisation valid throughout the EU on 28 August 2015.
Estonian: Strensiq on saanud müügiloa, mis kehtib kogu ELis, 28. augustil 2015.
English: The study also looked at other measures of effectiveness such as growth in height.
Estonian: Uuringus vaadeldi ka teisi efektiivsusnäitajaid, nagu kasv.
English: What is Strensiq and what is it used for?
Estonian: Mis on Strensiq ja milleks seda kasutatakse?
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu308594.
Estonian: Lisateave harvikravimiks nimetatud ravimi kohta on leitav: ema.europa.eu/medicines/human/orphandesignations/eu308594.
English: Although the main study was small and did not directly compare Strensiq with another treatment or with untreated patients, the Agency considered that the improvement seen in the bones and the apparent growth was relevant.
Estonian: Kuigi põhiuuring oli väike ja selles ei võrreldud otseselt Strensiqit muu raviga ega ravimata patsientidega, leidis amet, et luude seisundi paranemine ja nähtav kasv olid olulised.
English: The effectiveness of Strensiq was also generally supported by several additional small studies.
Estonian: Strensiqi efektiivsust toetasid üldjoontes ka mitu väikest lisauuringut.
English: The Agency noted that hypophosphatasia is a serious and life-threatening disease for which no treatment is authorised.
Estonian: Amet märkis, et hüpofosfataasia on raske ja eluohtlik haigus, millel puudub heakskiidetud ravi.
English: Given that hypophosphatasia is an extremely rare disease, data in this population will likely remain limited.
Estonian: Et hüpofosfataasia on äärmiselt harvaesinev haigus, jäävad tõenäoliselt selle patsiendipopulatsiooni andmed piiratuks.
English: Strensiq (asfotase alfa)
Estonian: Strensiq (alfaasfotaas)
English: Strensiq has been studied in one main study in 13 children between 6 and 12 years of age.
Estonian: Strensiqit uuriti ühes põhiuuringus, milles osales 13 last vanuses 6-12 aastat.
English: The European Medicines Agency decided that Strensiq's benefits are greater than its risks and it be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Strensiqi kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: As for all medicines, data on the use of Strensiq is continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Strensiqi kasutamise kohta pidevat järelevalvet.
English: Patients were given either 2 mg/kg or 3 mg/kg Strensiq three times a week for 24 weeks.
Estonian: Patsientidele manustati kas 2 mg/kg või 3 mg/kg Strensiqit 3 korda nädalas 24 nädala jooksul.
English: This is because it has not been possible to obtain complete information about Strensiq due to the rarity of the disease.
Estonian: See tähendab, et harvaesineva haiguse tõttu ei olnud võimalik saada Strensiqi kohta täielikku teavet.
English: Since Strensiq has been authorised under exceptional circumstances, the company that markets Strensiq will set up a registry of patients with hypophosphatasia to collect information on the disease and on the long-term safety and effectiveness of Strensiq.
Estonian: Et Strensiq on saanud müügiloa erandlikel asjaoludel, loob Strensiqit turustav ettevõte hüpofosfataasiaga patsientide registri, et koguda teavet haiguse ning Strensiqi pikaajalise ohutuse ja efektiivsuse kohta.
English: The company that markets Strensiq will provide patients and carers with educational materials to ensure that the medicine is used correctly and to minimise the risk of medication errors.
Estonian: Strensiqit turustav ettevõte varustab patsiendid ja hooldajad õppematerjalidega, et tagada ravimi õige kasutamine ja minimeerida ravivigade riski.
English: Regarding safety, injection site reactions and other side effects were considered manageable with the recommendations in place.
Estonian: Ohutuse aspektist peeti süstekoha reaktsioone ja muid kõrvalnähte hallatavaks, kui järgitakse kehtivaid soovitusi.
English: The most common side effects with Strensiq (which may affect more than 1 in 10 people) are headache, erythema (reddening of the skin), pain in arms and legs, fever, irritability, injection site reactions (such as pain, rash and itching) and contusion (bruising).
Estonian: Strensiqi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on peavalu, erüteem (nahapunetus), valu kätes ja jalgades, palavik, ärrituvus, süstekoha reaktsioonid (nt valu, lööve ja sügelus) ning verevalumid.
English: The main measure of effectiveness of the medicine was the improvement in x-ray appearance of the wrists and knee joints before and after treatment with Strensiq.
Estonian: Ravimi efektiivsuse põhinäitaja oli röntgenipiltide põhjal patsientide randmete ja põlveliigeste paranemine enne ja pärast ravi Strensiqiga.
English: As the amount given depends on the patient's bodyweight, the doctor will need to adjust the dose as the patient's weight changes, particularly in growing children.
Estonian: Et manustatav annus oleneb kehakaalust, peab arst kohandama annust vastavalt patsiendi kehakaalu muutustele, eelkõige kasvavate laste puhul.
English: Hypophosphatasia is a rare inherited disease of the bones which can lead to early loss of teeth, malformed bones, frequent bone fractures, and difficulty breathing.
Estonian: Hüpofosfataasia on harvaesinev pärilik luuhaigus, mis võib põhjustada hammaste varajast väljalangemist, luude väärarengut, sagedaid luumurde ja hingamisraskusi.
English: What are the risks associated with Strensiq?
Estonian: Mis riskid Strensiqiga kaasnevad?
English: Other information about Strensiq
Estonian: Muu teave Strensiqi kohta
English: Side effects reported with Strensiq are carefully evaluated and any necessary action taken to protect patients.
Estonian: Strensiqi kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: X-rays of children given Strensiq were also compared with similar x-rays available from 16 children who had not received Strensiq (‘historical controls').
Estonian: Strensiqit saanud laste röntgenipilte võrreldi ka 16 Strensiqit mittesaanud lapse sarnaste röntgenipiltidega (varasemad andmed).
English: Strensiq is a medicine used long-term to treat patients with hypophosphatasia that started in childhood.
Estonian: Strensiq on ravim, mida kasutatakse lapseeas alanud hüpofosfataasia pikaajaliseks raviks.
English: What information is still awaited for Strensiq?
Estonian: Mis teavet Strensiqi kohta veel oodatakse?
English: For more information about using Strensiq, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Strensiqi kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Strensiq have also been included in the summary of product characteristics and the package leaflet.
Estonian: Strensiqi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: This material will include a self-injection guide for patients, as well as an injection guide for parents or caregivers of children with the condition.
Estonian: See hõlmab enesesüstimise juhendit patsientidele ning süstimisjuhendit haigete laste vanematele või hooldajatele.
English: It is given by injection under the skin either six times a week (in a dose of 1 mg per kilogram bodyweight) or three times a week (in a dose of 2 mg/kg).
Estonian: Seda manustatakse nahaaluse süstena kas 6 korda nädalas (annuses 1 mg kehakaalu kg kohta) või 3 korda nädalas (annuses 2 mg/kg).
English: Patients with hypophosphatasia cannot make enough working ALP, which leads to weak bones.
Estonian: Hüpofosfataasiaga patsientidel ei teki organismis piisavalt toimivat ALP-d, mis nõrgestab luukude.
English: The enzyme ‘tissue non-specific alkaline phosphatase' (ALP) plays a key role in creating and maintaining healthy bones, and managing calcium and phosphate in the body.
Estonian: Mittekoespetsiifiline aluseline fosfataas (ALP) on ensüüm, millel on oluline roll terve luukoe tekkel ja säilitamisel ning organismi kaltsiumi- ja fosfaadisisalduse reguleerimisel.
English: Further information on Strensiq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Strensiq
Estonian: Lisateave Strensiqi kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Strensiq Kokkuvõtte viimane uuendus: 10.2018.
English: For the full list of side effects and restrictions with Strensiq, see the package leaflet.
Estonian: Strensiqi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: How is Strensiq used?
Estonian: Kuidas Strensiqit kasutatakse?
English: Some of the studies also looked at the dose of 1 mg/kg Strensiq given six times a week.
Estonian: Mõnes uuringus vaadeldi ka 6 korda nädalas manustatava Strensiqi 1 mg/kg annuse toimet.
English: Strensiq contains the active substance asfotase alfa.
Estonian: Strensiq sisaldab toimeainena alfaasfotaasi.
English: Strensiq can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing metabolic or bone disorders.
Estonian: Strensiq on retseptiravim ja ravi peab alustama ainevahetus- või luuhäirete ravis kogenud arst.
English: In the historical controls, most children did not experience similar improvements in their joints or gain in height over a comparable period of time.
Estonian: Varasematest andmetest ilmnes, et võrreldava ajaperioodi vältel ei tugevnenud enamiku laste liigesed ega suurenenud laste kehapikkus samal määral.
English: Hypophosphatasia is rare, and Strensiq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 December 2008.
Estonian: Hüpofosfataasia esineb harva ja Strensiq nimetati 3. detsembril 2008 harvikravimiks.
English: Asfotase alfa, the active substance in Strensiq, is a version of the human ALP enzyme and serves as a replacement, thereby increasing levels of working ALP.
Estonian: Strensiqi toimeaine alfaasfotaas on inimensüümi ALP versioon, mis asendab defektset ensüümi, suurendades nii toimiva ALP kogust.
English: What benefits of Strensiq have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Strensiqi kasulikkus?
English: This study showed that children given Strensiq had an improvement in their joint structure as demonstrated by x-rays and most of them seemed to gain in height.
Estonian: Uuringus tõendati röntgenipiltide põhjal, et Strensiqit saanud laste liigeste struktuur tugevnes ja enamiku laste kehapikkus suurenes.
English: An overview of Strensiq and why it is authorised in the EU
Estonian: Ülevaade ravimist Strensiq ja ELis müügiloa väljastamise põhjendus
English: Strensiq has been authorised under ‘exceptional circumstances'.
Estonian: Strensiqi müügiluba anti erandkorras.
English: How does Strensiq work?
Estonian: Kuidas Strensiq toimib?
English: The medicine is available as a solution for injection.
Estonian: Strensiqit turustatakse süstelahusena.
English: These medicines include:
Estonian: Need ravimid on:
English: if you are pregnant
Estonian: • kui olete rase.
English: Patients should be observed and given supportive treatment.
Estonian: Patsiende tuleb jälgida ja anda toetavat ravi.
English: Remember to take the pack with you so that it is clear what medicine you have taken.
Estonian: Pidage meeles kaasa võtta pakend, et oleks selge, millist ravimit olete võtnud.
English: Always take your tablets with a drink of water.
Estonian: Võtke tablette alati koos veega.
English: The expiry date refers to the last date of the month.
Estonian: Kõlblikkusaeg viitab selle kuu viimasele päevale.
English: - stroke in the past six months.
Estonian: − insult viimase kuue kuu jooksul;
English: Refer to sections 4.3 and 4.5.
Estonian: Vt lõigud 4.3 ja 4.5.
English: You should tell your doctor as soon as possible:
Estonian: Teatage neist arstile niipea kui võimalik.
English: If your blood pressure falls too low, this could cause a fast heartbeat.
Estonian: Kui teie vererõhk langeb liiga madalale, võib see põhjustada südametegevuse kiirenemist.
English: Safety and efficacy in children have not been established.
Estonian: Ravimi ohutus ja efektiivsus lastel ei ole tõestatud.
English: This medicine has been prescribed for you.
Estonian: − Ravim on välja kirjutatud üksnes teile.
English: Refer also to section 4.8.
Estonian: Vt ka lõik 4.8.
English: You may need to have some blood tests and your doctor will decide on your further treatment.
Estonian: Võib osutuda vajalikuks teha teile teatud vereanalüüse ning teie arst otsustab teie edasise ravi üle.
English: Based on these data, no dose adjustment is necessary.
Estonian: Nende andmete põhjal ei ole annuse kohandamine vajalik.
English: You should also tell your doctor immediately if you have a fever or sore throat.
Estonian: Öelge ka kohe arstile, kui teil tekib palavik või kurguvalu.
English: The remainder is excreted as metabolites, none of which exceed 5% of the total excreted.
Estonian: Ülejäänud osa eritub metaboliitidena, millest ühegi osakaal ei ületa 5% kogu erituvast hulgast.
English: (≥1/10,000 to <1/1000)
Estonian: (≥ 1/1000 kuni < 1/100)
English: If any of the following side effects happen, you may need urgent medical attention.
Estonian: Mis tahes järgmise kõrvaltoime tekkimisel võite vajada kiiresti arstiabi.
English: The frequencies of reactions observed in the post-marketing period are considered unknown (cannot be estimated from the available data).
Estonian: Turule toomise järgselt esinenud kõrvaltoimete esinemissagedus on teadmata (ei saa hinnata olemasolevate andmete alusel).
English: 20 tablets 28 tablets 30 tablets 50 tablets 56 tablets 100 tablets 112 tablets 168 tablets
Estonian: 20 tabletti 28 tabletti 30 tabletti 50 tabletti 56 tabletti 100 tabletti 112 tabletti 168 tabletti
English: The apparent elimination half-life of cilostazol is 10.5 hours.
Estonian: Tsilostasooli näiv eritumise poolväärtusaeg on 10,5 tundi.
English: This corresponds to a relative improvement of 100% over placebo.
Estonian: See vastab 100%-lisele suhtelisele paranemisele platsebeoga võrreldes.
English: Other potential interactions
Estonian: Muud võimalikud koostoimed
English: CONTENTS OF THE PACK AND OTHER INFORMATION
Estonian: Pakendi sisu ja muu teave
English: These reactions were usually of mild to moderate intensity and were sometimes alleviated by reducing the dose.
Estonian: Need kõrvaltoimed olid tavaliselt kerge kuni mõõduka raskusastmega ja annuse vähendamisel need mõnikord leevendusid.
English: Information on acute overdose in humans is limited.
Estonian: Teave ägeda üleannustamise kohta inimestel on piiratud.
English: Allergic reaction
Estonian: • allergiline reaktsioon
English: There are no special dosage requirements for the elderly.
Estonian: Eakate suhtes ei ole erilisi annustamisnõudeid kehtestatud.
English: Other frequent causes of discontinuation included palpitation and diarrhoea (both 1.1%).
Estonian: Muud sagedad ravi katkestamise põhjused olid südamepekslemine ja kõhulahtisus (mõlemad 1,1%).
English: Studies in animals have shown reproductive toxicity (see Section 5.3).
Estonian: Loomkatsed on näidanud kahjulikku toimet reproduktiivsusele (vt lõik 5.3).
English: Such lesions were not seen in rats or monkeys and are considered species specific.
Estonian: Rottidel ega ahvidel neid kahjustusi ei esinenud ja neid loeti liigispetsiifilisteks.
English: Like all medicines, <Cilostazol-containing medicinal product> can cause side effects, although not everybody gets them.
Estonian: Nagu kõik ravimid, võib ka see ravim põhjustada kõrvaltoimeid, kuigi kõigil neid ei teki.
English: Cilostazol is 95-98% protein bound, predominantly to albumin.
Estonian: Tsilostasool seondub 95-98% ulatuses valkudega, valdavalt albumiiniga.
English: It is important that you continue the modifications you have made to your life-style whilst taking cilostazol.
Estonian: Tähtis on jätkata muudatustega oma elustiilis ka tsilostasoolravi ajal.
English: The primary route of elimination is urinary (74%) with the remainder excreted in the faeces.
Estonian: Põhiline eritumistee on uriini kaudu (74%) ja ülejäänud osa eritub väljaheitega.
English: • clopidogrel
Estonian: • klopidogreel
English: This dose does not need to be changed for elderly people.
Estonian: Eakatel ei ole vaja seda annust muuta.
English: The suitability of treatment with cilostazol should be carefully considered alongside other treatment options such as revascularisation.
Estonian: Tsilostasoolravi sobivust tuleb hoolikalt kaaluda võrreldes teiste ravivõimalustega, näiteks revaskulariseerimisega.
English: Your doctor will assess your progress after 3 months of treatment and may recommend that you discontinue cilostazol if the effect of treatment is insufficient.
Estonian: Arst hindab teie ravi tulemusi pärast 3-kuulist ravi ja võib soovitada teil tsilostasoolravi lõpetada, kui ravi toime on ebapiisav.
English: If you feel dizzy after taking <Cilostazol-containing medicinal product> tablets, DO NOT drive and do not use any tools or machines and inform your doctor or pharmacist.
Estonian: Kui tunnete pärast tsilostasooli sisaldava ravimpreparaadi tablettide võtmist pearinglust, ÄRGE juhtige autot ega kasutage tööriistu või masinaid ning teatage sellest oma arstile või apteekrile.
English: If you are taking such medicines with <Cilostazol-containing medicinal product> your doctor may perform some routine blood tests.
Estonian: Kui te kasutate selliseid ravimeid samaaegselt <Tsilostasooli sisaldava ravimpreparaadiga>, võib teie arst teha teile teatavaid rutiinseid vereanalüüse.
English: Therefore, you should only stop taking <Cilostazol-containing medicinal product> if you notice side effects requiring urgent medical attention (see section 4) or if your doctor tells you to.
Estonian: Seetõttu võite katkestada <Tsilostasooli sisaldava ravimpreparaadi> võtmise ainult sel juhul, kui märkate kõrvaltoimeid, mis vajavad kiiret arstiabi (vt lõik 4) või kui teie arst on seda soovitanud.