FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine is the same as Puregon, which is already authorised in the European Union (EU).
Estonian: See ravim on samane Puregoniga, millel juba on Euroopa Liidus müügiluba.
English: Fertavid was as effective as the comparator in all of the studies.
Estonian: Fertavid oli kõikides uuringutes sama efektiivne kui võrdlusravim.
English: It must not be used in men with testicular failure.
Estonian: Ravimit ei tohi kasutada testikulaarpuudulikkusega meestel.
English: Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment.
Estonian: Munasarjade hüperstimulatsiooni sündroom tekib, kui munasarjad reageerivad ravile liiga palju.
English: Fertavid is used to treat infertility in women in the following situations:
Estonian: Fertavidi kasutatakse naiste infertiilsuse raviks järgmistel juhtudel:
English: Fertavid's use in women undergoing fertility treatment has been studied in 981 patients.
Estonian: Fertavidi kasutamist viljakusravi saavatel naistel on uuritud 981 patsiendil.
English: Fertavid should only be administered by people who have been trained by the doctor and have access to expert advice.
Estonian: Fertavidi tohivad manustada vaid isikud, kes on saanud arstilt asjakohase väljaõppe ning kellel on juurdepääs asjatundja nõuannetele.
English: The dose and frequency of administration of Fertavid depend on its use (see above) and the patient's response to treatment.
Estonian: Fertavidi annus ja manustamissagedus sõltub kasutuseesmärgist (vt eespool) ning patsiendi ravivastusest.
English: The patient or their partner may carry out the injections.
Estonian: Süstida võib kas patsient ise või tema partner.
English: Fertavid can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Estonian: Fertavidi tohib kasutada ka sperma tekke stimuleerimiseks meestel, kellel on hüpogonadotroopne hüpogonadism (hormoonpuudulikkusest tingitud haruldane haigus).
English: For more information about treatment with Fertavid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Fertavidiga toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The CHMP decided that Fertavid's benefits are greater than its risks and recommended that Fertavid be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Fertavidi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The company that makes Puregon has agreed that its scientific data can be used for Fertavid.
Estonian: Puregoni tootja on andnud nõusoleku, et tema teaduslikke andmeid võib kasutada ka Fertavidi toetuseks.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fertavid.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: In the body, FSH regulates reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles.
Estonian: Organismis reguleerib folliikuleid stimuleeriv hormoon reproduktiivfunktsiooni: naistel stimuleerib see hormoon munasarjades munarakkude eraldumist ja meestel munandites sperma teket.
English: In women, it must not be used when there is ovarian failure, ovarian enlargement or the presence of cysts that are not due to polycystic ovarian disease, or vaginal bleeding.
Estonian: Naised ei tohi ravimit kasutada munasarjade puudulikkuse, laienenud munasarjade või tsüstide korral, mis ei ole tingitud munasarjade polütsüstilisest haigusest, ega tupeverejooksu korral.
English: In all of the studies, Fertavid was compared with the natural FSH hormone that was extracted from urine.
Estonian: Kõikides uuringutes võrreldi Fertavidi loodusliku folliikuleid stimuleeriva hormooniga, mis oli eraldatud uriinist.
English: Why has Fertavid been approved?
Estonian: Miks Fertavid heaks kiideti?
English: • women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation);
Estonian: • anovulatoorsed naised (kellel ei teki munarakke), kelle ravi klomifeentsitraadiga (samuti ovulatsiooni stimuleeriv ravim) ei ole andnud tulemusi;
English: Fertavid was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate.
Estonian: Fertavidi uuriti 172 anovulatoorsel naisel, uuringus loendati ovulatsiooni tekkeks vajalikke ravitsükleid.
English: In 4% of the women treated with Fertavid in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain and diarrhoea) have been reported.
Estonian: Kliinilistes uuringutes teatati, et Fertavidiga ravitud naistest 4%-l tekkisid munasarja hüperstimulatsiooni sündroomi sümptomid (nt iiveldus, kehakaalu suurenemine ja kõhulahtisus).
English: Fertavid should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients.
Estonian: Fertavidi ei tohi kasutada patsiendid, kes võivad olla beetafollitropiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Fertavid must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus.
Estonian: Fertavidi ei tohi kasutada patsiendid, kellel on munasarja, rinna-, emaka-, munandi-, hüpofüüsi- (ajuripatsi-) või hüpotalamusekasvaja.
English: This is a summary of the European public assessment report (EPAR) for Fertavid.
Estonian: See on ravimi Fertavid Euroopa avaliku hindamisaruande kokkuvõte.
English: The most common side effects with Fertavid are a reaction and pain at the injection site.
Estonian: Fertavidi kõige sagedamad kõrvalnähud on süstekoha reaktsioon ja valu.
English: What is the risk associated with Fertavid?
Estonian: Mis riskid Fertavidiga kaasnevad?
English: Fertavid is given as an injection under the skin or into a muscle.
Estonian: Fertavidi manustatakse nahaaluse süstina või süstina lihasesse.
English: Fertavid is administered to stimulate the ovaries to produce more than one egg at a time.
Estonian: Fertavidi manustatakse munasarjade stimuleerimiseks, et neis tekiks korraga mitu munarakku.
English: What is Fertavid?
Estonian: Mis on Fertavid?
English: The number of eggs recovered and the ongoing pregnancy rate were the main measures of effectiveness.
Estonian: Efektiivsuse põhinäitajad olid ravi tulemusel munasarjadest eraldunud munarakkude arv ning püsimajäänud raseduste arv.
English: Treatment with Fertavid should be carried out by a doctor who has experience in the treatment of fertility problems.
Estonian: Ravi Fertavidiga peab tegema viljakusprobleemide ravis kogenud arst.
English: The follitropin beta in Fertavid is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Estonian: Fertavidis sisalduv beetafollitropiin valmistatakse rekombinant-DNA-tehnika abil: seda toodab rakk, millele on lisatud inimese folliikuleid stimuleeriva hormooni tekkimist võimaldav geen (DNA).
English: In men, Fertavid was studied to see its effect on sperm production in 49 patients.
Estonian: Fertavidi toimet meeste spermatekkele uuriti 49 patsiendil.
English: For a full list of all side effects reported with Fertavid, see the package leaflet.
Estonian: Fertavidi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: • women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation).
Estonian: • viljatusravi saavad naised (tehisviljastamine, näiteks katseklaasis viljastamine).
English: Fertavid was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.
Estonian: Fertavid oli viljakusravis, ovulatsiooni tekitamisel ja spermatekke stimuleerimisel sama efektiivne kui uriinist eraldatud folliikuleid stimuleeriv hormoon.
English: Fertavid is a solution for injection that contains the active substance follitropin beta.
Estonian: Fertavid on süstelahus, mis sisaldab toimeainena beetafollitropiini.
English: The active substance in Fertavid, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH).
Estonian: Fertavidi toimeaine beetafollitropiin on loodusliku follitropiini ehk folliikuleid stimuleeriva hormooni (FSH) tehisteisend.
English: What benefit has Fertavid shown during the studies?
Estonian: Milles seisneb uuringute põhjal Fertavidi kasulikkus?
English: How is Fertavid used?
Estonian: Kuidas Fertavidi kasutatakse?
English: Previously, the FSH used as a medicine was extracted from urine.
Estonian: Varem eraldati ravimina kasutatav folliikuleid stimuleeriv hormoon uriinist.
English: Fertavid can only be obtained with a prescription.
Estonian: Fertavid on retseptiravim.
English: What is Fertavid used for?
Estonian: Milleks Fertavidi kasutatakse?
English: How has Fertavid been studied?
Estonian: Kuidas Fertavidi uuriti?
English: How does Fertavid work?
Estonian: Kuidas Fertavid toimib?
English: For a full description of the doses, see the package leaflet.
Estonian: Annuste täielik kirjeldus on pakendi infolehel.
English: EPAR summary for the public follitropin beta
Estonian: Kokkuvõte üldsusele
English: What you need to know before you take [x]
Estonian: Mida on vaja teada enne [x] võtmist
English: The decision to prescribe [x] should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [x] compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Estonian: [x] väljakirjutamisel tuleb võtta arvesse konkreetsel naisel käesoleval hetkel esinevaid riskifaktoreid, eriti venoosse trombemboolia (VTE) riskifaktoreid ning VTE riski selle ravimiga, võrreldes teiste kombineeritud hormonaalsete kontratseptiividega (KHK) (vt lõigud 4.3 ja 4.4).
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Estonian: Olemasolevat ravimiteavet muudetakse (teksti lisamine, asendamine või kustutamine), et see vastaks alljärgnevale kokkulepitud sõnastusele.
English: What [x] is and what it is used for
Estonian: Mis ravim on [x] ja milleks seda kasutatakse
English: • Treatment of moderate acne after failure of suitable topical therapies or oral antibiotic treatment in women who elect to use an oral contraceptive.
Estonian: • Mõõduka akne ravi pärast sobiva paikse ravi või suukaudse antibiootikumravi ebaõnnestumist naistel, kes soovivad kasutada suukaudset kontratseptiivi.
English: Women should be assessed 3-6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
Estonian: Naisi tuleb kontrollida 3...6 kuu möödudes ravi alustamisest ja seejärel perioodiliselt, hindamaks ravi jätkamise vajadust.
English: Apparent improvement of acne usually takes at least three months and further improvement has been reported after six months of treatment.
Estonian: Akne märgatavaks paranemiseks kulub tavaliselt vähemalt kolm kuud, edasisest paranemisest on teatatud ka pärast 6-kuulist ravi.
English: You should discuss with your doctor the need to continue your treatment three to six months after the start and regularly thereafter.
Estonian: Pidage oma arstiga nõu ravi jätkamise vajaduse üle 3…6 kuu möödumisel ravi alustamisest ja seejärel regulaarselt.
English: C. Package Leaflet This wording regarding the acne indication should be revised to read as follows:
Estonian: C. Pakendi infoleht Akne näidustuse sõnastust tuleb muuta järgmiselt.
English: Your acne will usually improve between three and six months of treatment, and could continue to improve even after six months.
Estonian: Teie akne paraneb tavaliselt 3…6-kuulise ravi järel, paranemine võib jätkuda ka pärast 6. kuud.
English: Annex III Amendments to relevant sections of the Product Information
Estonian: III lisa Ravimi omaduste kokkuvõtte ja pakendi infolehe asjakohaste lõikude muudatused
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Estonian: Käesolevad ravimi omaduste kokkuvõtte ja pakendi infolehe muudatused on koostatud esildismenetluse tulemusel.
English: • Oral contraception
Estonian: • Raseduse vältimine.
English: Amendments to relevant sections of the Product Information
Estonian: Ravimi omaduste kokkuvõtte ja pakendi infolehe asjakohaste lõikude muudatused
English: [x] is a medicinal product o to prevent pregnancy (contraceptive “pill”).
Estonian: [x] on ravim, mida kasutatakse: o rasestumise ärahoidmiseks (nn rasestumisvastane pill); o mõõduka akne raviks pärast sobiva paikse ravi või suukaudse antibiootikumravi ebaõnnestumist naistel, kes on nõus kasutama rasestumisvastaseid tablette.
English: Section 4.1 Therapeutic indications The acne indication should be revised to read as follows:
Estonian: Lõik 4.1 Näidustused
English: Section 4.2 Posology and method of administration In relation to the acne indication the posology should be revised with the addition of the following statement:
Estonian: Lõik 4.2 Annustamine ja manustamisviis
English: The applicant was requested to provide the following information:
Estonian: Müügiloa taotlejal paluti esitada järgmised andmed:
English: Consequently, the same conclusions on efficacy and safety apply to both products.
Estonian: Seega kehtivad efektiivsuse ja ohutuse järeldused mõlema ravimi suhtes.
English: Conclusions and Recommendations
Estonian: Järeldused ja soovitused
English: Calves and pigs oral
Estonian: Vasikas ja siga suukaudne
English: Ireland considers that, due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
Estonian: Iirimaa leiab, et ravimi efektiivsuse dokumentide puudumise tõttu ei ole võimalik eeldada selle tõhusust ning ravim võib sellisena ohustada loomade tervist.
English: The aim of the assessment is to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral.
Estonian: Hindamise eesmärk on määrata kindlaks, kas esildismenetluse objektiks olevate veterinaarravimite müügiload tuleb esildise aluseid silmas pidades säilitada, peatada, muuta või tühistada.
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter was referred to the CVMP.
Estonian: Küsimus suunati nõukogu muudetud direktiivi 2001/82/EÜ artikli 33 lõike 4 kohaselt läbivaatamiseks veterinaarravimite komiteele.
English: In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and the supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
Estonian: Vastuseks esimesele küsimusele esitas taotleja algandmete toimiku koopia, mille ta oli esitanud detsentraliseeritud menetluse taotluse toetuseks, ja täiendavad andmed, mis olid esitatud detsentraliseeritud menetluse käigus vastusena I ja II etapi hindamisele ja seejärel toimunud esildismenetluseks CMD(v)-rühmas.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE INSERT
Estonian: LISA III RAVIMI OMADUSTE KOKKUVÕTE, PAKENDI MÄRGISTUS JA PAKENDI INFOLEHT
English: Administration: orally in drinking water or milk(replacer).
Estonian: Manustamine: suukaudselt joogiveega või piima(asendaja)ga.
English: The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 26 November 2007 that the Co-ordination Group for Mutual Recognition and Decentralised ProceduresVeterinary (CMD(v)) failed to reach an agreement for Solacyl 100% powder for oral solution.
Estonian: Detsentraliseeritud menetluse viiteliikmesriik Madalmaad teatas 26. novembril 2007 Euroopa Ravimiametile, et veterinaarravimite komitee vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühm (CMD(v)-rühm) ei jõudnud ravimi Solacyl 100% (suukaudse lahuse pulber) suhtes kokkuleppele.
English: The applicant submitted written responses to the List of Questions on 10 January 2008 and the clock was re-started.
Estonian: 10. jaanuaril 2008 esitas taotleja loetelu küsimustele kirjalikud vastused ja menetlus jätkus.
English: CVMP started the referral procedure on 11 December 2007 and agreed on a 37 day time frame.
Estonian: Veterinaarravimite komitee alustas esildismenetlust 11. detsembril 2007 ja määras ajakavaks 37 päeva.
English: A List of Questions was adopted by CVMP and sent to the applicant on 12 December 2007.
Estonian: Veterinaarravimite komitee kinnitas küsimuste loetelu ja saatis selle 12. detsembril 2007 taotlejale.
English: Half of the calculated total daily amount of powder is mixed with 5-10 litres of clean water and stirred until evenly dispersed.
Estonian: Pool pulbri arvutatud üldkogusest päevas segatakse 5-10 liitri puhta veega ja segatakse ühtlaselt läbi.
English: Administration: orally in drinking water.
Estonian: Manustamine: suukaudselt joogiveega.
English: The application dossier and any data added to it up to Day 60 of the referral procedure in CMD(v) to be provided to all CVMP Members and the EMEA.
Estonian: Taotluse toimik ja kõik andmed, mis sellele lisati CMD(v)-rühmas toimunud esildismenetluse 60. päevani, et esitada need kõikidele veterinaarravimite komitee liikmetele ja Euroopa Ravimiametile.
English: This solution is then added, whilst stirring, into an amount of drinking water that will be consumed within approximately 3-4 hours and administered twice daily.
Estonian: Lahus lisatakse, seda samal ajal segades, joogiveekogusele, mida loom tarbib ligikaudu 3-4 tunni jooksul; selliselt manustatakse ravimit kaks korda päevas.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except Ireland) at day 210 of the decentralised procedure.
Estonian: Kehtivateks ravimi omaduste kokkuvõtteks, pakendi märgistuseks ja pakendi infoleheks on versioonid, mis lepiti kokku detsentraliseeritud menetluse 210. päeval viiteliikmesriigi ja asjaomaste liikmesriikide (välja arvatud Iirimaa) vahel.
English: Calves: 20 mg sodium salicylate per kg bodyweight twice daily, for 1 to 3 days.
Estonian: Vasikad: 20 mg naatriumsalitsülaati kehamassi kg kohta kaks korda päevas 1-3 päeva.
English: Alternatively Solacyl can also be administered with the drinking water as pulse medication.
Estonian: Solacyli võib alternatiivselt manustada ka joogiveega lühikeste perioodidena.
English: Solacyl 100% powder for oral solution proved to be essentially similar to the reference product, Natrium salicylaat 100%.
Estonian: Solacyl 100% (suukaudse lahuse pulber) osutus sisuliselt sarnaseks viiteravimiga Natrium salicylaat 100%.
English: The objections raised by Ireland should not prevent the granting of a marketing authorisation for Solacyl 100% powder for oral solution for calves and pigs.
Estonian: Iirimaa tõstatatud vastuväited ei tohiks takistada müügiloa väljastamist ravimile Solacyl 100% (suukaudse lahuse pulber vasikatele ja sigadele).
English: Pigs: 35 mg sodium salicylate per kg bodyweight per day, for 3 to 5 days.
Estonian: Siga: 35 mg naatriumsalitsülaati kehamassi kg kohta päevas 3-5 päeva.
English: CVMP noted that Solacyl 100% powder for oral solution is a generic of Natrium salicylaat (authorised in The Netherlands) and that the concerns raised by Ireland could only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy.
Estonian: Veterinaarravimite komitee märkis, et Solacyl 100% (suukaudse lahuse pulber) on geneeriline ravim, mille viiteravim on Madalmaades müügiluba omav Natrium salicylaat, ning Iirimaa tõstatatud probleemi saab käsitleda käesoleva menetluse raames vaid sel juhul, kui nende kahe ravimi vahel on erinevusi, mille põhjal saab teha nende ohutuse ja efektiivsuse kohta erinevaid järeldusi.
English: Strength
Estonian: pulber
English: It is recommended that Solacyl 100% powder for oral solution for calves and pigs should follow the outcome of the Community Referral according to Article 35(2) for sodium salicylate-containing oral soluble powders.
Estonian: Ravimi Solacyl 100% (suukaudse lahuse pulber vasikatele ja sigadele) puhul on soovitatav järgida artikli 35 lõike 2 põhjal läbi viidud ühenduse esildismenetluse tulemusi naatriumsalitsülaati sisaldavate suukaudsete lahustuvate pulbrite kohta.
English: Solacyl powder for oral solution powder
Estonian: Solacyl (suukaudse lahuse pulber)
English: In response to question 2, the applicant answered that Solacyl 100% powder for oral solution is identical to the reference product and that there is no reason to reach different conclusions on the efficacy of the two products.
Estonian: Vastuseks teisele küsimusele märkis taotleja, et Solacyl 100% (suukaudse lahuse pulber) on viiteravimiga identne ning nende kahe ravimi efektiivsuse kohta erinevate järelduste tegemiseks puudub põhjus.
English: To indicate and to substantiate where necessary, any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Estonian: Tuua esile ja vajaduse korral tõestada kõiki Solacyl 100% pulbri ja viiteravimi vahelisi erinevusi, mille põhjal saab teha nende ohutuse ja efektiivsuse kohta erinevaid järeldusi.
English: Frequency and route of administration
Estonian: Loomaliigid Manustamise sagedus ja viis
English: On the basis of the grounds for referral CVMP considered any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Estonian: Veterinaarravimite komitee vaatles esildise põhjal, kas Solacyl 100% pulbri ja viiteravimi vahel on erinevusi, mille põhjal saab teha nende ohutuse ja efektiivsuse kohta erinevaid järeldusi.
English: Content (concentration)
Estonian: Pakendi sisu (kontsentrats ioon)
English: PC: {number} SN: {number} NN:
Estonian: PC: {number} SN: {number}
English: You should not do both.
Estonian: Mõlemat korraga teha ei tohi.
English: Each carton contains one bottle.
Estonian: Üks karp sisaldab ühte pudelit.
English: 95% Confidence Interval
Estonian: 95% usaldusintervall
English: These metabolites are not pharmacologically active.
Estonian: Need metaboliidid ei ole farmakoloogiliselt aktiivsed.
English: MedDRA System organ class
Estonian: MedDRA Organsüsteemi klass
English: Treatment for overdose should be symptomatic and supportive.
Estonian: Üleannustamise ravi peab olema sümptomaatiline ja toetav.
English: Mild: Child-Pugh Class A; Moderate: Child-Pugh Class B.
Estonian: Kerge: Child-Pugh' klass A; mõõdukas: Child-Pugh' klass B.
English: The bottle may not be available in your country.
Estonian: Pudel ei pruugi teie riigis müügil olla.
English: Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy of Betmiga in this age group has not been established.
Estonian: Ärge andke seda ravimit alla 18-aastastele lastele ja noorukitele, sest Betmiga ohutus ja tõhusus ei ole selles vanuserühmas kindlaks tehtud.
English: Tell your doctor right away if you are unable to empty your bladder.
Estonian: Rääkige kohe oma arstile, kui te ei saa tühjendada oma põit.
English: You should continue taking your tablets.
Estonian: Te peate tablettide võtmist jätkama.