FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional common side effects when Yervoy is used with nivolumab include fever, reduced or increased levels of thyroid hormones, colitis (inflammation of the lower gut), joint pain, headache and breathing difficulty.
Estonian: Koos nivolumaabiga kasutatava Yervoy muud sagedad kõrvalnähud on palavik, kilpnäärmehormoonide sisalduse vähenemine või suurenemine, koliit (jämesoolepõletik), liigesevalu, peavalu ja hingamisraskused.
English: For the full list of side effects and restrictions with Yervoy, see the package leaflet.
Estonian: Yervoy kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Other information about Yervoy
Estonian: Muu teave Yervoy kohta
English: Finally, two studies found the combination of Yervoy and nivolumab effective for treating advanced melanoma in adults who had not been treated previously, and whose cancer produced a protein called PD-L1.
Estonian: Kahes uuringus oli Yervoy ja nivolumaabi kombinatsioon kaugelearenenud melanoomi ravis efektiivne täiskasvanutel, keda ei olnud varem ravitud ja kelle vähirakud tootsid valku PD-L1.
English: In the treatment of advanced renal cell carcinoma, Yervoy in combination with nivolumab also increases patients' survival, and side effects are considered acceptable.
Estonian: Kaugelearenenud neerurakk-kartsinoomi ravis suurendab Yerivoy koos nivolumaabiga samuti patsientide elumust ja kõrvalnähte loetakse vastuvõetavaks.
English: What benefits of Yervoy have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Yervoy kasulikkus?
English: When Yervoy is used alone, the patient receives a dose every 3 weeks for a total of 4 doses.
Estonian: Kui Yervoyd kasutatakse ainuravimina, saab patsient annuse iga 3 nädala järel ning kokku 4 annust.
English: Ipilimumab increases the number and the activity of a type of white blood cells called T cells which form part of the immune system and which can kill cancer cells.
Estonian: T-rakud on teatud tüüpi leukotsüüdid (vere valgelibled), mis on immuunsüsteemi osa ja võivad hävitada vähirakke.
English: An overview of Yervoy and why it is authorised in the EU
Estonian: Ülevaade ravimist Yervoy ja ELis müügiloa väljastamise põhjendus
English: In the second study involving 142 adults, the disease was controlled in 56% of patients receiving Yervoy and nivolumab compared with 9% of patients receiving Yervoy alone.
Estonian: Teises uuringus, milles osales 142 täiskasvanut, oli patsiente, kelle haigus reageeris ravile, Yervoy ja nivolumaabi kasutanutest 56% ja ainult Yervoyd kasutanutest 9%.
English: In a study involving 676 adults in whom previous treatment for advanced melanoma had not worked or had stopped working, overall survival with Yervoy combined with an experimental medicine called ‘gp100' was 10 months, compared with 6 months in patients receiving gp100 alone.
Estonian: Uuringus, milles osales 676 täiskasvanut, kellel varasem kaugelearenenud melanooi ravi ei olnud efektiivne või ei toiminud enam, oli üldine elumus Yervoyd koos eksperimentaalravimiga gp100 kasutanud patsientidel 10 kuud ja ainult gp100-t kasutanud patsientidel 6 kuud.
English: Yervoy can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in treating cancer.
Estonian: Ravi peab alustama ja jälgima vähiravis kogenud eriarst.
English: In the first of these studies involving 945 adults, patients treated with Yervoy and nivolumab lived for 11.7 months on average without their disease getting worse compared with 6.9 months for those treated with nivolumab alone and 2.9 months for those treated with Yervoy alone.
Estonian: Neist esimeses (945 täiskasvanut) oli Yervoyd ja nivolumaabi kasutanud patsientide keskmine progresseerumiseta elumus 11,7 kuud, ainult nivolumaabi kasutanud patsientidel 6,9 kuud ja ainult Yervoyd kasutanud patsientidel 2,9 kuud.
English: Advanced renal cell carcinoma
Estonian: Kaugelearenenud neerurakk-kartsinoom
English: Several other studies involving previously untreated adults found that patients treated with Yervoy at 3 mg per kg lived for 13.5 months on average.
Estonian: Mitmes muus uuringus, milles osalesid varem ravimata täiskasvanud, oli Yervoyd annuses 3 mg/kg kasutanud patsientide keskmine elumus 13,5 kuud.
English: In a study involving 727 adults with advanced melanoma, patients treated with Yervoy 3 mg per kg lived for around 12 months on average compared with 16 months for those treated with 10 mg per kg.
Estonian: Uuringus, milles osales 727 kaugelearenenud melanoomiga täiskasvanut, oli Yervoyd annuses 3 mg/kg kasutanud patsientide keskmine elumus ligikaudu 12 kuud ja annuses 10 mg/kg kasutanud patsientide elumus 16 kuud.
English: It acts on T cells by attaching to and blocking the activity of CTLA-4, a protein that controls the activity of T cells.
Estonian: Ipilimumaab seondub Trakkude aktiivsust reguleeriva valguga CTLA-4 ning blokeerib selle toime.
English: The doctor may delay doses if certain side effects occur, and stop treatment altogether if side effects are severe.
Estonian: Teatud kõrvalnähtude ilmnemisel võib arst otsustada annustega viivitada ja raskete kõrvalnähtude korral ravi lõpetada.
English: Yervoy is a cancer medicine used in adults and adolescents from 12 years of age with advanced melanoma (a type of skin cancer) and in adults with advanced renal cell carcinoma (a kidney cancer).
Estonian: Yervoy on vähiravim, mida kasutatakse kaugelearenenud melanoomiga (nahavähi liik) täiskasvanutel ja vähemalt 12-aastastel noorukitel ning kaugelearenenud neerurakk-kartsinoomiga (teatud neeruvähk) täiskasvanutel.
English: When used with nivolumab, the patient receives a dose of Yervoy and of nivolumab every 3 weeks for 4 doses followed by treatment with nivolumab alone.
Estonian: Kasutamisel koos nivolumaabiga saab patsient Yervoyd ja nivolumaabi iga 3 nädala järel ning kokku 4 annust, millele järgneb nivolumaabi ainuravi.
English: In a study involving 502 adults whose advanced melanoma had not been treated previously, patients treated with high-dose Yervoy and dacarbazine lived for 11 months on average, compared with 9 months for those given placebo (a dummy treatment) plus dacarbazine.
Estonian: Uuringus, milles osales 502 varem ravimata kaugelearenenud melanoomiga patsienti, oli suures annuses Yervoyd ja dakarbasiini kasutanud patsientide keskmine elumus 11 kuud ning platseebot (näiv ravim) koos dakarbasiiniga kasutanud patsientide elumus 9 kuud.
English: One main study involving 1,096 adults with previously untreated advanced renal cell carcinoma compared treatment with Yervoy and nivolumab versus treatment with another cancer medicine for renal cell carcinoma, sunitinib.
Estonian: Ühes põhiuuringus, milles osales 1096 varem ravimata kaugelearenenud neerurakk-kartsinoomiga täiskasvanut, võrreldi Yerivoy ja nivolumaami kombinatsiooni sunitiniibiga, mis on samuti neerurakkkartsinoomi ravim.
English: The time patients lived before their disease got worse was 11.6 months with the combination compared with 8.4 with sunitinib.
Estonian: Progresseerumiseta elumus oli kombinatsioonravi rühmas 11,6 kuud ja sunitiniibravi rühmas 8,4 kuud.
English: Yervoy contains the active substance ipilimumab.
Estonian: Yervoy sisaldab toimeainena ipilimumaabi.
English: None.
Estonian: Ei kohaldata.
English: Protection starts three weeks after vaccination and lasts for 23 weeks after vaccination.
Estonian: Kaitse algab 3 nädalat pärast vaktsineerimist ja kestab kuni 23 nädalat pärast vaktsineerimist.
English: Affected pigs often have a cough and fail to thrive.
Estonian: Nakatunud sigadel on sageli köha ja nad ei kasva.
English: The full EPAR for Suvaxyn Circo+MH RTU can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Suvaxyn Circo+MH RTU kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: In the future, if the animals are exposed to the virus or the bacteria the immune system will be able to respond more quickly.
Estonian: Kui loomad puutuvad viiruse või bakteritega hiljem uuesti kokku, tekivad antikehad kiiremini.
English: porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
Estonian: sigade tsirkoviiruse ja sigade ensootilise pneumoonia vaktsiin (inaktiveeritud)
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Suvaxyn Circo+MH RTU's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Veterinaarravimite komitee järeldas, et Suvaxyn Circo+MH RTU kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas vaktsiini kasutamise Euroopa Liidus heaks kiita.
English: The most common side effect with Suvaxyn Circo+MH RTU (which may affect more than 1 in 10 pigs) are an increase in body temperature (on average 1 °C) in the first 24 hours after vaccination which resolves within 48 hours without treatment.
Estonian: Suvaxyn Circo+MH RTU kõige sagedam kõrvalnäht (võib esineda enam kui 1 seal 10st) on lühiajaline kehatemperatuuri tõus (keskmiselt 1 °C) esimese 24 tunni jooksul pärast vaktsineerimist, mis möödub 48 tunni jooksul ilma ravita.
English: The effectiveness of Suvaxyn Circo+MH RTU against PCV2 infection was also studied in three field studies.
Estonian: Suvaxyn Circo+MH RTU efektiivsust PCV2 infektsiooni vastu uuriti ka kolmes väliuuringus.
English: The studies showed that the vaccine had its full effect against PCV2 and Mycoplasma hyopneumonia by three weeks after vaccination.
Estonian: Uuringutes selgus, et vaktsiini täielik toime PCV2 ja Mycoplasma hyopneumonia vastu tekkis kolm nädalat pärast vaktsineerimist.
English: Porcine circovirus type 2 (PCV2) infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).
Estonian: Sigade tsirkoviiruse tüüp 2 (PCV2) infektsioonidel võivad olla järgmised kliinilised sümptomid: kehakaalu langus või kasvupeetus, lümfisõlmede suurenemine, hingamisraskused, naha kahvatus ja kollasus.
English: This will help protect the pigs against porcine circovirus and Mycoplasma hyopneumoniae infections.
Estonian: See aitab neid kaitsta sigade tsirkoviiruse ja bakteri Mycoplasma hyopneumoniae tekitatavate infektsioonide eest.
English: The European Commission granted a marketing authorisation valid throughout the EU for Suvaxyn Circo+MH RTU on 6 November 2015.
Estonian: Euroopa Komisjon andis Suvaxyn Circo+MH RTU müügiloa, mis kehtib kogu Euroopa Liidus, 6. novembril
English: The field studies showed that Suvaxyn Circo+MH RTU reduced the PCV2 viraemia (presence of virus in the blood) compared to pigs given dummy vaccination.
Estonian: Väliuuringud tõendasid, et Suvaxyn Circo+MH RTU vähendas sigadel PCV2 vireemiat (viiruse olemasolu veres) võrreldes sigadega, kellele manustati näivat vaktsiini.
English: Suvaxyn Circo+MH RTU also contains adjuvants (ingredients that strengthen the immune response) called squalene, poloxamer 401 and polysorbate 80.
Estonian: Suvaxyn Circo+MH RTU sisaldab sisaldab immuunvastuse tugevdamiseks adjuvante (skvaleen, poloksameer 401 ja polüsorbaat 80).
English: The vaccine contains small amounts of a protein from PCV2 and whole Mycoplasma hyopneumoniae bacteria that have been killed (inactivated) so that they do not cause disease.
Estonian: Vaktsiin sisaldab väikestes kogustes PCV2 valku ja bakteri Mycoplasma hyopneumoniae tervikrakke, mis on haiguse tekke takistamiseks inaktiveeritud (hävitatud).
English: Swelling, less than 2 cm in diameter, heat, redness at the injection site and pain to the touch which may last up to 2 days were also seen.
Estonian: Esines ka süstekoha turset (alla 2 cm läbimõõduga), kuumenemist, punetust ja puutetundlikkust; need nähud püsisid kuni 2 päeva.
English: Suvaxyn Circo+MH RTU contains inactivated (killed) active substances derived from porcine circovirus type 2 and Mycoplasma hyopneumoniae bacteria.
Estonian: Suvaxyn Circo+MH RTU sisaldab inaktiveeritud (hävitatud) toimeaineid, mis on saadud sigade tsirkoviiruse tüübist 2 ja bakterist Mycoplasma hyopneumoniae.
English: Suvaxyn Circo+MH RTU is a veterinary vaccine used to protect pigs over the age of 3 weeks against infections with porcine circovirus and the bacteria Mycoplasma hyopneumoniae.
Estonian: Suvaxyn Circo+MH RTU on veterinaarvaktsiin, mida kasutatakse üle 3 nädala vanuste sigade kaitsmiseks sigade tsirkoviiruse ja bakteri Mycoplasma hyopneumoniae põhjustatud infektsioonide eest.
English: The withdrawal period for meat from pigs treated with Suvaxyn Circo+MH RTU for is ‘zero' days, which means there is no mandatory waiting time.
Estonian: Vaktsiiniga Suvaxyn Circo+MH RTU ravitud sigade liha keeluaeg on 0 päeva, mis tähendab, et keeluaega ei ole.
English: The purpose of these studies was to establish how long it took pigs to be fully protected and how long the protection against PCV2 and Mycoplasma hyopneumonia lasted.
Estonian: Vaktsiini efektiivsust sigadel uuriti kõigepealt mitmes laboriuuringus, mille eesmärk oli vaadelda, kui kiiresti tekib sigadel täielik kaitse ning kui kaua püsib kaitse PCV2 ja Mycoplasma hyopneumoniae vastu.
English: Protection lasted 23 weeks after vaccination for PCV2 and Mycoplasma hyopneumonia.
Estonian: Pärast vaktsineerimist kestis kaitse PCV2 ja Mycoplasma hyopneumoniae vastu 23 nädalat.
English: Mycoplasma hyopneumoniae infection in pigs causes a disease of the airways called enzootic pneumonia.
Estonian: Bakteri Mycoplasma hyopneumoniae infektsioon põhjustab sigadel ensootilist pneumooniat (hingamisteede teatud haigust).
English: What is Suvaxyn Circo+MH RTU and what is it used for?
Estonian: Mis on Suvaxyn Circo+MH RTU ja milleks seda kasutatakse?
English: For practical information about using Suvaxyn Circo+MH RTU, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Estonian: Kui loomaomanikud või -pidajad vajavad Suvaxyn Circo+MH RTU kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
English: When Suvaxyn Circo+MH RTU is given to pigs the animals' immune system recognises the viral protein and bacteria as ‘foreign' and makes antibodies against them.
Estonian: Kui sigadele manustatakse vaktsiini Suvaxyn Circo+MH RTU, peab immuunsüsteem viiruse valku ja baktereid võõraks ning tekitab nende vastu antikehi.
English: This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo+MH RTU.
Estonian: See on vaktsiini Suvaxyn Circo+MH RTU Euroopa avaliku hindamisaruande kokkuvõte.
English: Suvaxyn Circo+MH RTU is a vaccine.
Estonian: Suvaxyn Circo+MH RTU on vaktsiin.
English: Why is Suvaxyn Circo+MH RTU approved?
Estonian: Miks Suvaxyn Circo+MH RTU heaks kiideti?
English: It is not intended to provide practical advice on how to use Suvaxyn Circo+MH RTU.
Estonian: Hindamisaruandes ei anta vaktsiini Suvaxyn Circo+MH RTU kasutamise praktilisi nõuandeid.
English: Other information about Suvaxyn Circo+MH RTU?
Estonian: Muu teave Suvaxyn Circo+MH RTU kohta
English: For the full list of all side effects reported with Suvaxyn Circo+MH RTU, see the package leaflet.
Estonian: Suvaxyn Circo+MH RTU kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: How is Suvaxyn Circo+MH RTU used?
Estonian: Kuidas Suvaxyn Circo+MH RTU toimib?
English: What are the risks associated with Suvaxyn Circo+MH RTU?
Estonian: Mis riskid vaktsiiniga Suvaxyn Circo+MH RTU kaasnevad?
English: What benefits of Suvaxyn Circo+MH RTU have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Suvaxyn Circo+MH RTU kasulikkus?
English: Suvaxyn Circo+MH RTU is only available on prescription.
Estonian: Suvaxyn Circo+MH RTU on retseptivaktsiin.
English: No further amendments were considered necessary.
Estonian: Muid muudatusi ei peetud vajalikuks.
English: After an initially higher risk during the first year of use, the risk decreases to a constant lower level.
Estonian: Pärast esialgset suuremat riski esimese kasutamisaasta vältel langeb risk edasi ühtlaselt madalale tasemele.
English: Scientific conclusions and grounds for the conclusions
Estonian: Teaduslikud järeldused ja nende alused
English: There was no evidence for differences between these medicinal products in terms of beneficial effects.
Estonian: Nende ravimite kasulike toimete erinevuste kohta andmed puuduvad.
English: 1 - Overall summary of the scientific evaluation
Estonian: Teadusliku hindamise üldkokkuvõte
English: Overall, venous thromboembolic events (VTE) could be fatal in 1-2% of the cases.
Estonian: Üldkokkuvõttes võib venoosne trombemboolia lõppeda surmaga 1-2% juhtudest.
English: Having assessed all the available data, the PRAC concluded that:
Estonian: Pärast kõigi olemasolevate andmete hindamist otsustas ravimiohutuse riskihindamise komitee, et:
English: Further changes to the product information will contribute to better inform the healthcare professionals and women on the risk of thromboembolism.
Estonian: Tooteinfosse tehtavad muudatused aitavad kaasa tervishoiutöötajate ja naiste paremale informeerimisele trombemboolia riskist;
English: For dienogest and nomegestrol studies are on going and results will be submitted when available.
Estonian: Dienogesti ja nomegestrooli puhul sarnased uuringud juba toimuvad ning andmed esitatakse kohe pärast nende kättesaadavaks muutumist.
English: For comparison, in women who are not using CHCs (no-users) and who are not pregnant, there will be around 2 cases of VTE each year per 10,000 women.
Estonian: Võrdluseks võib tuua, et naistel, kes ei kasuta kombineeritud hormonaalseid kontratseptiive (mittekasutajad) ja kes pole rasedad, esineb 10 000 naise kohta aastas umbes 2 venoosse trombemboolia juhtu.
English: Grounds for the variation to the terms of the marketing authorisations
Estonian: Müügilubade tingimuste muutmise alused
English: “The increased risk of VTE during the postpartum period should be considered when re-starting [invented name] (see section 4.2 and 4.4).”
Estonian: „[Väljamõeldud nimetus] kasutamise taasalustamisel tuleb arvestada suuremat venoosse trombemboolia riski sünnitusjärgsel perioodil (vt lõik 4.2 ja 4.4).”
English: Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions and grounds for recommendation.
Estonian: Olles tutvunud ravimiohutuse riskihindamise komitee soovitusega, nõustus inimravimite komitee üldiste teaduslike järeldustega ja soovituse alustega.
English: The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for Evra, Ioa and Zoely should be varied.
Estonian: Olles tutvunud ravimiohutuse riskihindamise komitee 10. oktoobri 2013. aasta soovitusega kooskõlas direktiivi 2001/83/EÜ artikli 107k lõikega 3, on inimravimite komitee arvamusel, et Evra, Ioa ja Zoely müügilubasid tuleb muuta.
English: In February 2013, the French medicines agency (ANSM) initiated a referral procedure under Article 31 of Directive 2001/83/EC on the basis that the benefit-risk balance of these combined hormonal contraceptives had become unfavourable in the currently authorised indication of contraception due to the increased risk of thromboembolism (TE) and therefore it was in the interest of the Union to refer the matter to the PRAC.
Estonian: 2013. aasta veebruaris algatas Prantsusmaa ravimiamet (ANSM) direktiivi 2001/83/EÜ artikli 31 alusel esildismenetluse põhjendusega, et nimetatud kombineeritud hormonaalsete kontratseptiivide kasulikkuse ja riski tasakaal praegu heakskiidetud rasestumisvastasel näidustusel oli muutunud negatiivseks tingituna trombemboolia suurenenud riskist, mistõttu Euroopa Liidu ühistes huvides oli suunata see küsimus arutamiseks ravimiohutuse riskihindamise komiteele.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation CHMP Members' Divergent Positions
Estonian: IV lisa Teaduslikud järeldused ja müügilubade tingimuste muutmise alused ning üksikasjalik selgitus ravimiohutuse riskihindamise komitee soovitusest erinevuste kohta
English: When diagnosis is not made and no treatment is started, or when clear symptoms of thrombosis are not identifiable, the clot can move upwards to the lung (pulmonary embolism, PE) or the brain (cerebral embolism, CE).
Estonian: Kui seda seisundit ei diagnoosita ega alustata ravi või kui tromboosi selgeid sümptomeid ei esine, võib tromb liikuda koos verevooluga kopsu (kopsuemboolia) või ajju (ajuemboolia).
English: It has been shown that risk of VTE is highest during the first year a woman starts hormonal contraceptives or when she re-starts after a period of non-use of at least one month (Dinger et al,.
Estonian: On näidatud, et venoosse trombemboolia risk on suurim esimese aasta vältel pärast seda, kui naine alustab hormonaalse kontratseptiivi kasutamist, või kui ta taasalustab selle kasutamist pärast enam kui 1 kuu pikkust mittekasutamise perioodi (Dinger et al., 2007, Sidney et al., 2013).
English: The revised Summary of Product Characteristics (SmPC) and Package Leaflet (PL) are set out in the respective annexes I and IIIB for Evra, Ioa and Zoely.
Estonian: Ajakohastatud ravimi omaduste kokkuvõte ja pakendi infoleht on toodud Evra, Ioa ja Zoely I ja IIIB lisas.
English: 2 - Detailed explanation for the differences from the PRAC recommendation
Estonian: Üksikasjalik selgitus ravimiohutuse riskihindamise komitee soovitusest erinevuste kohta
English: Considering that risk factors for VTE change over time the PRAC noted that an individual's risk should be re-evaluated periodically.
Estonian: Arvestades asjaolu, et venoosse trombemboolia riskifaktorid aja jooksul muutuvad, märkis ravimiohutuse riskihindamise komitee, et naise individuaalset riski tuleks regulaarsete ajavahemike tagant uuesti hinnata.
English: For chlormadinone this will be investigated through a post-authorisation safety study, which is further discussed below.
Estonian: Kloormadinooni puhul tuleb riski hinnata müügiloajärgses ohutusuuringus, mida on täpsemalt käsitletud allpool.
English: For some products (i.e. chlormadinone, dienogest, nomegestrol) there are currently insufficient data to establish the risk compares with the lower risk products.
Estonian: (näiteks kloormadinoon, dienogest, nomegestrool) on praegu ebapiisavalt andmeid, et kindlaks määrata nende risk võrreldes väiksema riskiga toodetega.
English: Also there are certain hereditary thrombophilic defects that increase the risk.
Estonian: Peale selle on olemas ka teatud pärilikud trombofiilsed defektid, mis suurendavad venoosse trombemboolia riski.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for the combined hormonal contraceptives containing medicinal products.
Estonian: • ravimiohutuse riskihindamise komitee vaatas läbi direktiivi nr 2001/83/EÜ artikli 31 kohaselt tehtud esildise kombineeritud hormonaalseid kontratseptiive sisaldavate ravimite kohta;
English: In addition the marketing authorisation holders of chlormadinone should perform a post-authorisation safety study.
Estonian: Samuti peavad toimeainena kloormadinooni sisaldavate ravimite müügiloa hoidjad korraldama müügiloajärgse ohutusuuringu.
English: Misdiagnosis is possible, since TE presents with diffuse symptoms and is a rare event in a population of healthy young women.
Estonian: Trombemboolia diagnoosimata jäämine on võimalik, sest selle haigusseisundi sümptomid võivad olla väga varieeruvad ning tromboos esineb tervete noorte naiste populatsioonis harva.
English: The following sentence was therefore inserted in the Pregnancy section of the SmPC:
Estonian: Seetõttu lisati ravimi omaduste kokkuvõtte raseduse alalõiku järgmine lause: