FrancophonIA/ELRC3.0 huggingface dataset:
English: As a result, all tablet strengths have the same average weight (170 mg) and identical qualitative and quantitative composition in terms of functional excipients, with the exception of small differences in the quantity of the filler lactose monohydrate, which is used proportionally to compensate for the differences in the active substance content (less than 5 % of the total tablet weight) resulting from the range of tablet strengths.
Estonian: Selle tulemusel on kõigil ravimvormidel sama keskmine mass (170 mg) ning funktsionaalsete koostisainete täpselt ühesugune kvalitatiivne ja kvantitatiivne koostis, v.a väike erinevus täiteainena kasutatava laktoosmonohüdraadi koguses, mis kompenseerib proportsionaalselt toimeaine erinevat sisaldust eri tugevusega tablettides (tableti massist alla 5%).
English: the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Glimepirida Parke-Davis and associated names (see Annex I).
Estonian: soovitab inimravimite komitee anda müügiload, milles ravimi omaduste kokkuvõte, pakendi märgistus ja pakendi infoleht jäävad sellisteks nagu viimases versioonis, milleni jõuti kooskõlastusrühma menetluses, nagu on mainitud III lisas Glimepirida Parke-Davise ja sarnaste nimetustega ravimite jaoks (vt I lisa).
English: The Applicant submitted a marketing authorisation application for Glimepirida Parke-Davis, based on claims of essential similarity to the marketed reference product.
Estonian: Taotleja esitas müügiloa taotluse Glimepirida Parke-Davise jaoks, mille aluseks oli olemuslik sarnasus turustatava võrdlusravimiga.
English: The Applicant also stated that the proposed tablets are developed as look-alike formulations.
Estonian: Taotleja teatas ka, et kavandatavad ravimid on välja töötatud sarnaste ravimvormidena.
English: The Applicant investigated the solubility of drug substance across the physiological pH range and confirmed the very low solubility of glimepiride.
Estonian: Taotleja uuris ravimi lahustuvust kogu füsioloogilises pH-vahemikus ja kinnitas glimepiriidi väga väikest lahustuvust.
English: The CHMP was therefore of the view that differences between the different strengths with regard to the in vivo rate of drug release are very unlikely.
Estonian: Seetõttu oli inimravimite komitee seisukohal, et eri tugevuste erinev ravimi in vivo vabastamise kiirus on väga ebatõenäoline.
English: The Applicant also considered that the observed decrease in drug dissolution could be solely attributed to the inherent characteristics of glimepiride and not to formulation differences.
Estonian: Taotleja leidis ka, et lahustuvuse täheldatud vähenemine toimub üksnes glimepiriidi olemuslike omaduste ja mitte ravimvormi erinevuste tõttu.
English: The Applicant subsequently explored the acceptability of conducting a study using the 1 mg tablet in order to waive studies using the higher strengths.
Estonian: Seejärel uuris taotleja 1 mg tablettide uuringu korraldamise vastuvõetavust, et loobuda uuringutest suuremate tugevustega.
English: The CHMP considered that the dissolution studies confirmed that the low dissolution of glimepiride is related to the drug substance rather than to the formulation and that all strengths of the proposed product have similar qualitative and quantitative compositions, leading to similar in vivo absorption.
Estonian: Inimravimite komitee leidis, et lahustuvusuuringud kinnitasid, et glimepiriidi väike lahustuvus on seotud pigem ravimi koostise kui ravimvormiga ning kavandatava toote kõigil tugevustel on sarnane kvalitatiivne ja kvantitatiivne koostis, mille tulemusel on in vivo absorbtsioon sarnane.
English: The CHMP also considered the fact that the particle size of the active substance is controlled to be reassuring.
Estonian: Samuti pidas inimravimite komitee positiivseks asjaolu, et toimeaine osakeste suurus on kontrollitud.
English: Having reviewed the available literature, the Applicant concluded that fasting studies involving glimepiride appeared to be associated with a considerable risk of hypoglycaemia, even with the 1 mg dose.
Estonian: Olles läbi vaadanud olemasoleva kirjanduse, leidis taotleja, et tühja kõhuga võetava glimepiriidi uuringud näivad olevat seotud hüpoglükeemia märkimisväärse riskiga isegi 1 mg annuse korral.
English: The CHMP was therefore of the view that absorption is not dependent or limited by in vivo drug dissolution and that the low solubility of glimepiride does not prevent granting a biowaiver for the 2, 3 and 4 mg strengths.
Estonian: Inimravimite komitee oli seetõttu seisukohal, et imendumine ei sõltu ravimi in vivo lahustumisest ega ole sellega piiratud ning glimepiriidi väike lahustuvus ei takista loobumist 2, 3 ja 4 mg tugevuste bioekvivalentsusuuringutest.
English: The CHMP was therefore of the opinion that the benefit-risk ratio of Glimepirida Parke-Davis and associated names is favourable.
Estonian: Seepärast oli inimravimite komitee arvamusel, et Glimepirida Parke-Davise ning sarnaste nimetuste kasulikkuse ja riski suhe on soodne.
English: The CHMP assessed the Applicant justifications and agreed that glimepiride is associated with a risk of hypoglycaemic reactions, in particular in healthy subjects, including at the lowest 1 mg dose.
Estonian: Inimravimite komitee hindas taotleja põhjendusi ja nõustus, et glimepiriid on seotud hüpoglükeemiliste reaktsioonide riskiga, eelkõige tervetel, sealhulgas väikseimas 1 mg annuses.
English: Glimepiride is a second generation sulphonylurea anti-hyperglycaemic agent used in patients with type 2 diabetes mellitus insufficiently controlled by diet and exercise alone or in combination with insulin in patients in whom diet and exercise plus oral anti-hyperglycaemic therapy have failed to control blood glucose.
Estonian: Glimepiriid on teise põlvkonna sulfonüüluurearavimi tüüpi hüperglükeemiaravim, mida kasutatakse II tüüpi diabeediga patsientidel, kelle vere glükoosisisaldust ei saa rahuldavalt reguleerida üksnes dieedi ja füüsilise koormusega, samuti koos insuliiniga patsientidel, kellel vere glükoosisisaldus ei allu ravile dieedi, füüsilise koormuse ja suukaudse hüperglükeemiaraviga.
English: In addition, the fraction of absorbed glimepiride is consistently described as being non dose-dependent and close to 100%, as evidenced from the rapid and complete absorption from the gastro-intestinal tract with linear increase in Cmax and AUC.
Estonian: Samuti kirjeldatakse glimepiriidi imendunud fraktsiooni alati kui annusest mittesõltuvat ja ligi 100% fraktsioonina, mida näitab kiire ja täielik imendumine seedetraktist, kusjuures Cmax- ja AUC-väärtuste tõus on lineaarne.
English: • the CHMP considered the conducted bioequivalence study to be adequate to demonstrate bioequivalence between the proposed and the reference products,
Estonian: • inimravimite komitee pidas läbiviidud bioekvivalentsusuuringut adekvaatseks, et tõendada väljapakutud ja võrdlusravimite bioekvivalentsust;
English: The CHMP also reviewed the biopharmaceutical data and agreed that the proposed and the reference products have similar dissolution profiles, when comparing the 1 mg and the 4 mg strengths separately.
Estonian: Inimravimite komitee vaatas üle ka biofarmatseutikaandmed ja nõustus, et kavandatava toote ja võrdlustoote lahustuvusprofiilid sarnanevad, kui võrrelda 1 mg ja 4 mg tugevusi eraldi.
English: Regarding the risk for incomplete dissolution, the CHMP considered that the test and reference formulations exhibited a similar performance, indicating a similar risk for all formulations.
Estonian: Mittetäieliku lahustumise riski suhtes leidis inimravimite komitee, et katsetatavad ja võrdlusravimvormid käitusid sarnaselt, mis viitab kõigi ravimvormide ühetaolisele riskile.
English: However, concerns were raised regarding the evidence of bioequivalence, considering the study conducted with the 1 mg tablet to be insufficient to provide evidence of bioequivalence for the higher strengths, as bioequivalence studies for substances with low solubility should be conducted at the highest strength according to the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), unless the active substance is highly soluble or if there are safety/tolerability reasons.
Estonian: 1 mg tablettide uuringut ei peetud suuremate tugevuste bioekvivalentsuse tõendamisel piisavaks, sest inimravimite komitee suunise Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr) kohaselt tuleb väikese lahustuvusega ainete bioekvivalentsusuuringud korraldada kõige suurema tugevusega, v.a kui toimeaine on väga lahustuv või kui esinevad ohutuse/talutavusega seotud põhjused.
English: The CHMP also considered that the presented biopharmaceutical and pharmacokinetic data confirmed the adequate sensitivity of the bio-analytical method and further supported the acceptability of the requested biowaiver for the 2, 3 and 4 mg strengths.
Estonian: Samuti leidis inimravimite komitee, et esitatud biofarmatseutika- ja farmakokineetikaandmed kinnitasid bioanalüütilise meetodi adekvaatset tundlikkust ning toetasid ka 2, 3 ja 4 mg tugevuste bioloogilise ekvivalentsuse uuringu nõudest taotletud loobumist.
English: With such a low rate of dissolution, the Applicant considered that even the 1 mg strength possesses enough sensitivity to detect formulation differences.
Estonian: Taotleja leidis, et nii väikese lahustuvuse korral on isegi 1 mg kasutamine ravimvormide erinevuste avastamiseks piisava tundlikkusega.
English: In conclusion, the CHMP was of the opinion that the exceptional conditions relating to safety referred to in the Guideline on the Investigation of Bioequivalence are applicable to this particular application, despite the recommendation that bio-equivalence studies should be performed with the highest strength for substances with low solubility.
Estonian: Kokkuvõttes oli inimravimite komitee arvamusel, et bioekvivalentsusuuringute suuniste erandtingimused kehtivad ka praegusel juhul olenemata soovitusest, et bioekvivalentsusuuringud tuleb vähese lahustuvuse korral korraldada vähelahustuva aine kõige suurema tugevusega.
English: The CHMP therefore considered that the conducted fasting bioequivalence study using the 1 mg strength was acceptable and adequate to demonstrate bioequivalence between test and reference formulations, while ensuring the safety of the study subjects.
Estonian: Seetõttu leidis inimravimite komitee, et tühja kõhuga võetud 1 mg tugevuse bioekvivalentsusuuring oli vastuvõetav ja adekvaatne, et tõendada uuritava ja võrdlusravimvormi bioekvivalentsust, ning tagas ühtlasi uuringus osalejate ohutuse.
English: • the CHMP considered the requested biowaiver for the 2, 3 and 4 mg strengths to be acceptable,
Estonian: • inimravimite komitee pidas vastuvõetavaks 2, 3 ja 4 mg tugevuste bioloogilise ekvivalentsuse uuringu nõudest taotletud loobumist,
English: Finally, the Applicant stated that glimepiride exhibits linear pharmacokinetic properties.
Estonian: Taotleja teatas ka, et glimepiriidi farmakokineetikaomadused on lineaarsed.
English: The Applicant stated that it considered the ethical concerns linked to the risk of hypoglycaemia in healthy adults when designing the bioequivalence study.
Estonian: Taotleja teatas, et pidas bioekvivalentsuse uuringu kavandamisel silmas eetikakaalutlusi, mis on seotud hüpoglükeemiariskiga tervetel täiskasvanutel.
English: The CHMP assessed the open label, randomized, comparative bioavailability study of glimepiride 1 mg tablets under fasting conditions and the Applicant justifications for the design of the study.
Estonian: Inimravimite komitee hindas avatud randomiseeritud võrdlevat biosaadavusuuringut, mis käsitles tühja kõhuga võetavaid glimepiriidi 1 mg tablettide biosaadavust, ja taotleja põhjendusi uuringu ülesehituse kohta.
English: Regarding the drug substance particle size, the Applicant stated that a micronized grade of glimepiride is used, ensuring that 95% of the particles are below 10μm and 50% of the particles are below 4μm.
Estonian: See tagab, et 95% osakestest on <10 µm ja 50% osakestest <4 µm.
English: The CHMP considered that a further bioequivalence study using the 4 mg dose is not anticipated to provide significantly better discriminatory power between the different formulations, given the biopharmaceutical features of this glimepiride formulation and that such a study would therefore be unnecessary and ethically unacceptable, given the risk of hypoglycaemia.
Estonian: Inimravimite komitee leidis, et edasine bioekvivalentsusuuring 4 mg annusega ei anna eri ravimvormide paremat eristatavust, arvestades glimepiriidi ravimvormi biofarmatseutikaomadusi.
English: Route of administration Packaging
Estonian: Manustamistee Pakendi iseloomustus Pakendi suurus
English: ATCvet code: QI09AB03.
Estonian: ATCvet kood: QI09AB03
English: Date of first authorisation: 4/07/2014 Date of latest renewal:
Estonian: Esmase müügiloa väljastamise kuupäev: 4/07/2014 Müügiloa viimase uuendamise kuupäev:
English: Duration of immunity: six months.
Estonian: Immuunsuse kestus: kuus kuud.
English: Vaccinate only healthy animals.
Estonian: Vaktsineerida võib ainult terveid loomi.
English: Onset of immunity: three weeks after completion of the basic vaccination scheme.
Estonian: Immuunsuse tekkimine: kolm nädalat pärast baasvaktsineerimise lõppu.
English: LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Gerona) SPAIN
Estonian: LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral
English: Name and address of the manufacturers of the biological active substance
Estonian: Bioloogiliste toimeainete tootjate nimi nimed ja aadressid
English: Store and transport refrigerated Do not freeze.
Estonian: Hoida ja transportida külmas.
English: Do not use in case of hypersensitivity to the active substance, to the adjuvants or to any of the excipients.
Estonian: Mitte kasutada, kui esineb ülitundlikkust toimeainete, adjuvantide või ravimi ükskõik millise abiaine suhtes.
English: Aluminium hydroxide ..................................................................................... 5.29 mg (aluminium) DEAE-Dextran
Estonian: Alumiiniumhüdroksiid ......................................................................................... 5,29 mg (alumiinium) DEAE-dekstraan
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Estonian: Ettevaatusabinõud veterinaarravimit loomale manustavale isikule Juhuslikul ravimi süstimisel iseendale, pöörduda viivitamatult arsti poole ja näidata pakendi infolehte või pakendi etiketti.
English: Special precautions for use in animals None.
Estonian: Ettevaatusabinõud kasutamisel loomadel Ei ole.
English: Pharmacotherapeutic group: Immunologicals for suidae, Inactivated bacterial vaccines, erysipelothrix.
Estonian: Farmakoterapeutiline rühm: Immunoloogilised ained sigalastele.
English: ERYSENG suspension for injection for pigs
Estonian: ERYSENG süstesuspensioon sigadele
English: To stimulate active immunisation against swine erysipelas.
Estonian: Sigade erüsiipeli vastase aktiivse immunisatsiooni stimuleerimine.
English: EXP {month/year} Once broached use immediately.
Estonian: Kõlblik kuni {kuu/aasta} Pärast korgi läbistamist kasutada koheselt.
English: Cardboard box, (20 ml, 50 ml, 100ml, and 250ml) bottles (100 ml and 250 ml) and vials (100 ml)
Estonian: VÄLISPAKENDIL JA SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PAPPKARP, (20 ml, 50 ml, 100ml, ja 250ml) PUDELI (100 ml, 250 ml) JA VIAALI (100 ml)
English: PACKAGE LEAFLET: ERYSENG suspension for injection for pigs
Estonian: PAKENDI INFOLEHT ERYSENG süstesuspensioon sigadele
English: Whitish suspension.
Estonian: Süstesuspensioon Valkjas suspensioon
English: Inactivated Erysipelothrix rhusiopathiae, strain R32E11, ..................... ELISA > 3.34 log2 IE50%* * IE50% - Inhibition ELISA 50%.
Estonian: Inaktiveeritud Erysipelothrix rhusiopathiae, tüvi R32E11 .............. ELISA> 3.34 log2 IE 50%* * IE50% inhibeerimine ELISA 50%
English: Inactivated Erysipelothrix rhusiopathiae, strain R32E11, ....................... ELISA > 3.34 log2 IE50 %* * IE50% - Inhibition ELISA 50%.
Estonian: Inaktiveeritud Erysipelothrix rhusiopathiae, tüvi R32E11 ............. ELISA> 3.34 log2 IE 50% * * IE50% inhibeerimine ELISA 50%
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles (20 ml, 50 ml) and vials (20 ml, 50 ml)
Estonian: PUDELI (20 ml, 50 ml), VIAALI (20 ml, 50 ml)
English: Aluminium hydroxide DEAE-dextran
Estonian: .......................................... 5,29 mg (alumiinium) DEAE-dekstraan
English: • if the number of your white blood cells is too low.
Estonian: - kui teie valgete vereliblede arv on liiga madal.
English: 3 (see section 4.2).
Estonian: 3 (vt lõik 4.2).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28 August 2015
Estonian: Müügiloa esmase väljastamise kuupäev: 28 august 2015
English: Taxespira contains alcohol.
Estonian: Taxespira sisaldab alkoholi.
English: 1 to day 4.
Estonian: 1. päevast 4. päevani.
English: The name of this medicine is Taxespira.
Estonian: Selle ravimi nimi on Taxespira.
English: Cases of permanent alopecia (frequency not known) have been reported.
Estonian: On teatatud püsiva alopeetsia juhtudest (sagedus teadmata).
English: Hazard ratio (TAC/FAC)
Estonian: Riskide suhe (TAC/FAC)
English: ER/PR-negative or Grade 3 or tumour size >5 cm
Estonian: ER/PR-negatiivne või 3. aste või tuumori suurus > 5 cm
English: The safety and efficacy of Taxespira in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Estonian: Taxespira efektiivsust ja ohutust nasofarüngeaalse kartsinoomi ravis lastel vanuses 1 kuu kuni 18 eluaastat ei ole veel kindlaks tehtud.
English: All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Estonian: Kõik lahjendamise ning manustamise ajal kasutatud materjalid tuleb hävitada vastavalt standardprotseduuridele.
English: Taxespira will be administered to you by a healthcare professional.
Estonian: Taxespira't manustab teile tervishoiutöötaja.
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Estonian: Eakad Rahvastiku farmakokineetilisele analüüsile tuginedes ei ole erijuhiseid kasutamiseks eakatel.
English: This is because Taxespira or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Estonian: See on vajalik, sest Taxespira või teised ravimid ei pruugi toimida ootuspäraselt ning teil on suurem tõenäosus kõrvaltoimete tekkeks.
English: Each box contains 1 vial.
Estonian: Igas karbis on üks viaal.
English: Pharmacotherapeutic group: antineoplastic agents, taxanes, ATC Code: L01CD02
Estonian: Farmakoterapeutiline rühm: kasvajavastased ained, taksaanid, ATC kood: L01CD02
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Taxespira may be harmful for the unborn baby.
Estonian: Ravi ajal ei tohi te rasestuda ja te peate kasutama efektiivset rasestumisvastast vahendit, sest Taxespira võib kahjustada sündimata last.
English: Older people treated with TCF should be closely monitored.
Estonian: Eakaid, kes saavad TCF ravi, peab hoolikalt jälgima.
English: In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastro-intestinal disorders.
Estonian: Ligikaudu 20% juhtudest puudusid ägeda neerupuudulikkuse riskifaktorid nagu nefrotoksiliste ravimite samaaegne kasutamine ja seedetraktihäired.
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Taxespira.
Estonian: Teie arst võib muuta ravimi annust ja annustamissagedust sõltuvalt teie vereanalüüside tulemustest, organismi üldseisundist ja reaktsioonist Taxespira'le.
English: Unopened vial 24 months.
Estonian: Avamata viaal 2 aastat
English: Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomized.
Estonian: Esmane profülaktika G-CSF-iga muudeti kohustuslikuks TAC ravihaaras pärast 230 patsiendi randomiseerimist.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Estonian: Sagedused on määratletud järgmiselt: väga sage (≥ 1/10); sage (≥ 1/100 kuni < 1/10); aeg-ajalt (≥ 1/1000 kuni < 1/100); harv (≥ 1/10 000 kuni < 1/1000); väga harv (< 1/10 000), teadmata (ei saa hinnata olemasolevate andmete alusel).
English: Taxespira must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Estonian: Taxespira't EI TOHI manustada, kui te olete rase, välja arvatud selge arsti juhise olemasolul.
English: Congestive heart failure (CHF)
Estonian: Südame paispuudulikkus (CHF)
English: Between infusions of Taxespira the following may occur, and the frequency may vary with the combinations of medicines that are received:
Estonian: Taxespira infusioonide vahelisel ajal võivad tekkida järgmised kõrvaltoimed, mille esinemissagedus võib varieeruda sõltuvalt manustatud ravimite kombinatsioonist:
English: The amount of alcohol in this medicinal product may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).
Estonian: Selles ravimis sisalduv alkoholikogus võib mõjutada kesknärvisüsteemi (närvisüsteemi osa, kuhu kuuluvad peaaju ja seljaaju).
English: Progressive disease as best overall response (%) *Unstratified logrank test
Estonian: Progresseeruv haigus kui parim üldine ravivastus (%) *stratifitseerimata logaritmiline astaktest
English: MedDRA System Organ classes
Estonian: MedDRA organsüsteemi klass
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Estonian: Kui seda ei kasutata otsekohe, lasub vastutus kasutuseelsete säilitusaegade ja -tingimuste eest ravimi kasutajal ning ei tohi tavaliselt ületada 6 tundi temperatuuril kuni 25 °C, sh ühetunnine infusiooniaeg.
English: Name and address of the manufacturers responsible for batch release Hospira UK Limited
Estonian: Ravimipartii kasutamiseks vabastamise eest vastutavate tootjate nimed ja aadressid Hospira UK Limited
English: Other medicines and Taxespira
Estonian: Muud ravimid ja Taxespira
English: Before each treatment with Taxespira, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Taxespira.
Estonian: Iga kord enne ravi algust Taxespira'ga tuleb teil anda vereanalüüse veendumaks, et teie vererakkude hulk ja maksafunktsioon on Taxespira manustamiseks piisavad.
English: Taxespira contains ethanol (alcohol)
Estonian: Taxespira sisaldab etanooli (alkoholi)
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Estonian: Trükitud ravimi pakendi infolehel peab olema toodud vastava partii vabastaja nimi ja aadress.
English: Cases of hyponatraemia have been reported, mostly associated with dehydration, vomiting and pneumonia.
Estonian: Teatatud on hüponatreemia juhtudest, enamasti seotud dehüdratsiooni, oksendamise ja pneumooniaga.
English: The first interim analysis was planned 3 years after the date when half of study enrollment was done.
Estonian: Esimene vaheanalüüs oli plaanitud 3 aastat pärast poolte uuritavate kaasamist uuringusse.
English: Contraception in males and females An effective method of contraception should be used during treatment.
Estonian: Kontratseptsioon meestel ja naistel Ravi ajal peab kasutama efektiivset kontratseptsiooni meetodit.
English: This leaflet was last revised in {month YYYY}.
Estonian: Infoleht on viimati uuendatud <{KK/AAAA}> <{kuu AAAA}>.