FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tredaptive to Merck Sharp & Dohme Ltd. on 3 July 2008.
Estonian: Euroopa Komisjon andis Tredaptive müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Merck Sharp & Dohme Ltd. 3. juulil 2008.
English: The Committee recommended that Tredaptive be given marketing authorisation.
Estonian: Komitee soovitas anda Tredaptivele müügiloa.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TREDAPTIVE EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE TREDAPTIVE Kokkuvõte üldsusele
English: Other information about Tredaptive:
Estonian: Muu teave Tredaptive kohta
English: Tredaptive is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group.
Estonian: Alla 18-aastastel lastel ja noorukitel ei soovitata Tredaptivet kasutada, sest andmed ravimi kasutamise ohutuse ja efektiivsuse kohta selles patsiendirühmas puuduvad.
English: The starting dose of Tredaptive is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day.
Estonian: Tredaptive algannus on üks tablett üks kord ööpäevas nelja nädala jooksul; seejärel suurendatakse annust kahe tabletini üks kord ööpäevas.
English: The most common side effect with Tredaptive (seen in more than 1 patient in 10) is flushing.
Estonian: Tredaptive kõige sagedam kõrvalnäht (esinenud enam kui ühel patsiendil kümnest) on õhetus.
English: Tredaptive is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Estonian: Tredaptivet manustatakse tavaliselt koos statiiniga (kolesteroolisisalduse vähendamise tavaline ravim), kui ravi üksnes statiiniga ei ole efektiivne.
English: Two studies looked at the effectiveness of Tredaptive in modifying blood fat levels.
Estonian: Kahes uuringus uuriti Tredaptive efektiivsust vere rasvasisalduse mõjutamisel.
English: They included a total of 2,349 patients who were taking either Tredaptive or nicotinic acid.
Estonian: Uuringutes osales kokku 2349 patsienti, kes võtsid kas Tredaptivet või nikotiinhapet.
English: Tredaptive is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Estonian: Tredaptive on ravim, mis sisaldab kahte toimeainet: nikotiinhapet (teiste nimetustega niatsiin ja vitamiin B3) ning laropipranti.
English: Why has Tredaptive been approved?
Estonian: Miks Tredaptive heaks kiideti?
English: For the full list of all side effects reported with Tredaptive, see the Package Leaflet.
Estonian: Tredaptive kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: The second study showed that the LDL cholesterol levels were further reduced when Tredaptive was taken with simvastatin (48% reduction), compared with Tredaptive alone (17% reduction) or simvastatin alone (37% reduction).
Estonian: Teine uuring näitas, et LDL-kolesterooli sisaldus vähenes veelgi, kui Tredaptivet manustati koos simvastatiiniga (48% võrra), samas kui LDL-kolesterooli sisaldus vähenes Tredaptive kui ainuravimi korral 17% võrra ja simvastatiini kui ainuravimi korral 37% võrra.
English: Tredaptive should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients.
Estonian: Tredaptivet ei tohi kasutada patsiendid, kes võivad olla nikotiinhappe, laropiprandi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: What is Tredaptive?
Estonian: Mis on Tredaptive?
English: The second study compared the combination of Tredaptive and simvastatin (a statin) with Tredaptive alone or simvastatin alone in 1,398 patients.
Estonian: Teises uuringus võrreldi Tredaptive ja simvastatiini (statiin) kombinatsiooni toimet ainult Tredaptive või simvastatiiniga kokku 1398 patsiendil.
English: What is the risk associated with Tredaptive?
Estonian: Mis riskid Tredaptivega kaasnevad?
English: What benefit has Tredaptive shown during the studies?
Estonian: Milles seisneb uuringute põhjal Tredaptive kasulikkus?
English: The two active substances in Tredaptive, nicotinic acid and laropiprant, have different modes of action.
Estonian: Tredaptive kahel toimeainel (nikotiinhape ja laropiprant) on eri toimemehhanismid.
English: Tredaptive was effective in reducing the blood levels of LDL cholesterol.
Estonian: Tredaptive vähendas efektiivselt LDL-kolesterooli sisaldust veres.
English: In the first study, LDL cholesterol levels were reduced by 19% in patients taking Tredaptive, compared with 1% in those taking placebo.
Estonian: Esimeses uuringus vähenes LDLkolesterooli sisaldus Tredaptivet saanud patsientidel 19% võrra ja platseebot saanud patsientidel 1% võrra.
English: Tredaptive was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Estonian: Tredaptive neljas põhiuuringus uuriti hüperkolesteroleemia või segatüüpi düslipideemiga patsiente.
English: Tredaptive is used on its own only in patients who cannot take statins.
Estonian: Ilma statiinita kasutatakse Tredaptivet ainult juhul, kui patsient ei saa statiine võtta.
English: The effects of Tredaptive were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Tredaptive toimet muude katsetega.
English: In Tredaptive tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
Estonian: Tredaptive tablettides sisaldub laropiprant ühes kihis ja nikotiinhape teises.
English: The full EPAR for Tredaptive can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Tredaptive kohta leiate siit.
English: The first study compared the effectiveness of Tredaptive with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Estonian: Esimeses uuringus võrreldi Tredaptive efektiivsust LDL-kolesterooli sisalduse vähendamisel üksnes nikotiinhappe või platseebo (näiva ravimi) efektiivsusega kokku 1613 patsiendil.
English: Tredaptive is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘combined mixed dyslipidaemia' and ‘primary hypercholesterolaemia'.
Estonian: Tredaptivet kasutatakse düslipideemiaga (vere ebaharilikult suure rasvasisaldusega) patsientide ravis lisaks dieedile ja füüsilisele koormusele, eelkõige kombineeritud segatüüpi düslipideemia ja primaarse hüperkolesteroleemia korral.
English: In the fourth study, flushing was seen on fewer days in patients taking Tredaptive than in those taking nicotinic acid alone.
Estonian: Neljandas uuringus täheldati õhetust lühema perioodi vältel nende patsientide hulgas, kes said Tredaptivet, võrreldes patsientidega, kes said ainult nikotiinhapet.
English: How is Tredaptive used?
Estonian: Kuidas Tredaptivet kasutatakse?
English: How has Tredaptive been studied?
Estonian: Kuidas Tredaptivet uuriti?
English: In the first and third studies, fewer patients taking Tredaptive reported moderate, severe or extreme flushing than patients taking nicotinic acid alone.
Estonian: Esimeses ja kolmandas uuringus täheldati tugevat või ülitugevat õhetust vähem nende patsientide hulgas, kes said Tredaptivet, võrreldes patsientidega, kes said ainult nikotiinhapet.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Tredaptive's benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Estonian: Inimravimite komitee jõudis otsusele, et Tredaptive kasulikkus düslipideemia ravis (eelkõige kombineeritud segatüüpi düslipideemia ja primaarse hüperkolesteroleemia ravis) on suurem kui sellega kaasnevad riskid.
English: What is Tredaptive used for?
Estonian: Milleks Tredaptivet kasutatakse?
English: How does Tredaptive work?
Estonian: Kuidas Tredaptive toimib?
English: This may cause bleeding.
Estonian: See võib põhjustada verejookse.
English: MedDRA system organ class (SOC)
Estonian: MedDRA organsüsteem (SOC)
English: Atosiban must not be used in the following conditions:
Estonian: Atosibaani ei tohi kasutada järgmistes situatsioonides:
English: The following information is intended for healthcare professionals only: (See also section 3)
Estonian: Järgmine teave on ainult tervishoiutöötajatele: (vt lõik 3).
English: - Difficulty sleeping (insomnia).
Estonian: - Raskused uinumisel (unetus).
English: Date of latest renewal: 28 May 2018
Estonian: Müügiloa viimase uuendamise kuupäev: 28. mai 2018
English: Most of the treatment failures in CAP-001 were caused by poor tolerability.
Estonian: Enamus ravi ebaõnnestumistest uuringus CAP-001 oli põhjustatud ravimi halvast taluvusest.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 July 2013
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 31. juuli 2013
English: - Allergic reactions.
Estonian: - Allergilised reaktsioonid.
English: This permits the continued independent control of the rate of infusion.
Estonian: See võimaldab pidada infusiooni üle pidevat sõltumatut kontrolli.
English: Do not throw away any medicines in wastewater or household waste.
Estonian: Ärge visake ravimeid kanalisatsiooni ega olmejäätmete hulka.
English: Atosiban SUN will be given to you in a hospital by a doctor, nurse or midwife.
Estonian: Atosiban SUN-i manustatakse teile ainult haiglas arsti, meditsiiniõe või ämmaemanda poolt.
English: Store in a refrigerator (2°C - 8°C).
Estonian: Hoida külmkapis (2 ...8 °C).
English: As the safety and efficacy of atosiban in women with a gestational age of less than 24 completed weeks has not been established in controlled randomised studies, the treatment of this patient group with atosiban is not recommended (see section 4.3).
Estonian: Kuna atosibaan ohutust ja efektiivsust naistel alla 24 täiskantud rasedusnädala ei ole randomiseeritud kontrollitud uuringutega tõestatud, ei ole atosibaani kasutamine selles patsientide grupis soovitatav (vt lõik 4.3).
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Estonian: HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD Piiratud tingimustel väljastatav retseptiravim (vt I lisa: Ravimi omaduste kokkuvõte, lõik 4.2).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Estonian: Kõrvaltoimetest võite ka ise teavitada riikliku teavitussüsteemi, mis on loetletud V lisas, kaudu.. Teavitades aitate saada rohkem infot ravimi ohutusest.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Estonian: Sobivusuuringute puudumisel ei tohi seda ravimit manustada koos teiste ravimitega, välja arvatud punktis 6.6 toodud ravimid.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not use if shrink wrap is tampered.
Estonian: TEISED ERIHOIATUSED (VAJADUSEL) Ärge kasutage, kui kokkutõmbumisvastane pakend on omavoliline.
English: Atosiban is found in only small quantities in urine, its urinary concentration is about 50 times lower than that of M1.
Estonian: Uriinis on atosibaani leitud ainult väikestest kogustes, selle kontsentratsioon uriinis on 50 korda väiksem kui M1 kontsentratsioon.
English: It is unlikely that atosiban is involved in cytochrome P450 mediated drug-drug interactions as in vitro investigations have shown that atosiban is not a substrate for the cytochrome P450 system, and does not inhibit the medicinal product metabolising cytochrome P450 enzymes.
Estonian: On ebatõenäoline, et atosibaan oleks kaasatud tsütokroom P450 kaudu vahendatud ravim-ravim koostoimetesse, sest nagu in vitro uuringud on näidanud, ei ole atosibaan tsütokroom P450 süsteemi substraadiks ning ei inhibeeri ravimeid metaboliseeriva tsütokroom P450 ensüüme.
English: Hydrochloric acid 1M
Estonian: Vesinikkloriidhape 1M
English: INSTRUCTION FOR THE HEALTHCARE PROFESSIONAL
Estonian: JUHISED TERVISHOIUTÖÖTAJATELE
English: The frequency of adverse reactions listed below is defined using the following convention: 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).
Estonian: Allpool loetletud kõrvaltoimete esinemissagedused on defineeritud 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).
English: The total dose given during a full course of atosiban therapy should preferably not exceed 330.75 mg of atosiban.
Estonian: Atosibaani koguannus täieliku ravikuuri ajal ei tohiks eelistatult ületada 330,75 mg atosibaani.
English: In a placebo-controlled study, fetal/infant deaths were 5/295 (1.7%) in the placebo group and 15/288 (5.2%) in the atosiban group, of which two occurred at five and eight months of age.
Estonian: Platseebokontrollitud uuringus, oli loote/vastsündinu surmade suhe 5/295 (1,7%) platseebogrupis ja 15/288 (5,2%) atosibaani grupis, millest kaks juhtu olid 5 ja 8 kuu vanuses.
English: Up to 270 mg intravenous infusion
Estonian: Kuni 270 mg
English: Mean value of volume of distribution was 18.3 ± 6.8 litres.
Estonian: Jaotusruumala keskmine väärtus oli 18,3 ± 6,8 liitrit.
English: The side effects seen in the mother are generally mild.
Estonian: Emal täheldatud kõrvaltoimed on üldiselt kerged.
English: Following completion of the infusion, plasma concentration rapidly declined with an initial (tα) and terminal (tβ) half-life of 0.21 ± 0.01 and 1.7 ± 0.3 hours, respectively.
Estonian: Pärast infusiooni lõppu langes plasmakontsentratsioon kiiresti esialgsele (tα) ja lõplikule (tβ) poolväärtusajale, vastavalt 0,21 ± 0,01 ja 1,7 ± 0,3 tundi.
English: Do not use this medicine after the expiry date which is stated on the label after EXP {MM/YYYY}.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud sildil ”EXP” {KK/AAAA}.
English: Treatment failures caused by insufficient efficacy were significantly (p=0.0003) more frequent in atosiban (n=48, 14.2%) than in the β-agonist-treated women (n=20, 5.8%).
Estonian: Ravi ebaõnnestumine ebapiisava toime tõttu oli märkimisväärselt (p = 0,0003) sagedasem atosibaani (n = 48, 14,2%) kui beetaagonistiga ravitud naiste grupis (n = 20, 5,8%).
English: The data show that 59.6% (n=201) and 47.7% (n=163) of atosiban- and β-agonist-treated women (p=0.0004), respectively, were undelivered and did not require alternative tocolysis within 7 days of starting treatment.
Estonian: Andmed näitasid, et 59,6% (n = 201) ja 47,7% (n = 163) vastavalt atosibaaniga ja beetaagonistiga ravitud naistest (p = 0,0004), ei sünnitanud ega vajanud alternatiivset tokolüüsi 7 päeva jooksul alates ravi algusest.
English: Fetal and maternal outcome did apparently not differ between the atosiban and the β-agonist group, but the clinical trials were not powered enough to rule out a possible difference.
Estonian: Loote ja ema seisund atosibaani ja beetaagonisti grupi vahel märkimisväärselt ei erinenud, kuid kliinilised uuringud ei ole olnud piisavalt ulatuslikud, et neid võimalikke erinevusi välja tuua.
English: Of the 361 women who received atosiban treatment in the phase III studies, 73 received at least one re-treatment, 8 received at least 2 re-treatments and 2 received 3 re-treatments (see section 4.4).
Estonian: III-faasi uuringus atosibaan-ravi saanud 361 naisest said 73 vähemalt ühe korduvravikuuri, 8 said vähemalt 2 korduvravikuuri ja 2 said 3 korduvravikuuri (vt lõik 4.4).
English: Eleven out of the 15 deaths in the atosiban group occurred in pregnancies with a gestational age of 20 to 24 weeks, although in this subgroup patient distribution was unequal (19 women on atosiban, 4 on placebo).
Estonian: Üksteist 15-st surmajuhtumist atosibaani grupis esinesid raseduste korral gestatsiooniajaga 20...24 nädalat, kuigi selles alagrupis oli patsientide jaotus ebavõrdne (19 naist atosibaani grupis ja 4 platseebogrupis).
English: What Atosiban SUN is and what it is used for What you need to know before you are given Atosiban SUN How Atosiban SUN will be given Possible side effects
Estonian: Mis ravim on Atosiban SUN ja milleks seda kasutatakse Mida on vaja teada enne, kui teile Atosiban SUN-i manustatakse Kuidas Atosiban SUN-i manustatakse Võimalikud kõrvaltoimed
English: Therefore, atosiban should be used with caution in case of multiple pregnancy and/or concomitant administration of other medicinal products with tocolytic activity (see section 4.8).
Estonian: Seetõttu tuleb atosibaani kasutada mitmikraseduse ja/või teiste tokolüütilise toimega ravimite kaasuva manustamise korral ettevaatlikult (vt lõik 4.8).
English: Before using Atosiban SUN, the solution should be examined to ensure it is clear and free from particles.
Estonian: Enne Atosiban SUN-i kasutamist tuleb lahust visuaalselt kontrollida veendumaks, et see on selge ja osakestevaba.
English: 8 ml/hour (100 μg/min)
Estonian: 8 ml/tunnis (100 µg/min)
English: Atosiban SUN contains atosiban (INN), a synthetic peptide ([Mpa1, D-Tyr(Et)2, Thr4,Orn8]-oxytocin) which is a competitive antagonist of human oxytocin at receptor level.
Estonian: Atosiban SUN sisaldab atosibaani (INN), sünteetilist peptiidi ([Mpa1, D-Tyr(Et)2, Thr4, Orn8]oksütotsiin), mis on inimese osaline oksütotsiin-retseptori antagonist.
English: Rare (may affect less than 1 in 1,000 people) - Your womb may be less able to contract after your baby has been born.
Estonian: Harv (esineb vähem kui 1 inimesel 1000st) - Pärast lapse sündi võib emakas olla väiksema kokkutõmbevõimega.
English: The infant adverse reactions were in the range of normal variation and were comparable with both placebo and beta-mimetic group incidences.
Estonian: Vastsündinute kõrvatoimed olid normaalse varieeruvuse vahemikus ning olid võrreldavad nii platseebo kui beeta-mimeetikumide grupis esinenud juhtudega.
English: For women with a gestational age greater than 24 weeks there was no difference in mortality rate (1.7% in the placebo group and 1.5% in the atosiban group).
Estonian: Gestatsiooniajaga üle 24 nädala suremuse määras erinevusi ei olnud (1,7% platseebogrupis ja 1,5% atosibaani grupis).
English: This may increase the risk of lung oedema (accumulation of fluid in the lungs).
Estonian: See võib suurendada kopsuturse (vedeliku kogunemine kopsu) riski.
English: - Fast heart beat.
Estonian: - Kiire südamerütm.
English: Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and beta-mimetics are known to be associated with increased risk of pulmonary oedema.
Estonian: Mitmikrasedused ja tokolüütilise toimega ravimid (nagu kaltsiumikanali blokaatorid ja beetamimeetikumid) on teadaolevalt seotud kopsuturse riski suurenemisega.
English: Treatment with atosiban should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Estonian: Ravi atosibaaniga tohib alustada ja läbi viia arst, kellel on kogemusi enneaegsete sünnituste ravis.
English: Atosiban was also shown to bind to the vasopressin receptor, thus inhibiting the effect of vasopressin.
Estonian: Atosibaan seondus ka vasopressiinretseptoriga, inhibeerides sellega ka vasopressiini toime.
English: Re-treatment with atosiban is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see section 4.2).
Estonian: Korduvravi atosibaaniga on võimalik, kuid sellise ravimikasutuse kohta (kuni 3 ravikuuri) on vaid piiratud arv kliinilisi kogemusi (vt lõik 4.2).
English: Mean value for clearance was 41.8 ± 8.2 litres/h.
Estonian: Kliirensi keskmine väärtus oli 41,8 ± 8,2 liitrit/tunnis.
English: 1 vial (6.75 mg/0.9 ml)
Estonian: 1 viaal (6,75 mg/0,9 ml)
English: 54 mg infusion Up to 45 hours subsequent
Estonian: Järgnev intravenoosne infusioon kuni 45 tunni jooksul
English: What you need to know before you are given Atosiban SUN
Estonian: Mida on vaja teada enne, kui teile Atosiban SUN-i manustatakse
English: After three hours the infusion rate is reduced to 8 ml/hour.
Estonian: Kolme tunni pärast vähendatakse infusioonikiirust 8 ml-ni tunnis.
English: Ranbaxy Pharmacie Generiques 11-15, Quai de Dion Bouton 92800 Puteaux
Estonian: Ranbaxy Pharmacie Generiques 11-15, Quai de Dion Bouton
English: Do not use Atosiban SUN if any of the above apply to you.
Estonian: Ärge kasutage Atosiban SUN-i, kui midagi siin loetletust kehtib teie kohta.
English: Atosiban SUN should not be mixed with other medicinal products in the infusion bag.
Estonian: Atosiban SUN-i ei tohi segada ühes infusioonikotis teiste ravimitega.
English: The ratios of the main metabolite M1 (des-(Orn8, Gly-NH2 9) -29)-[Mpa1, D-Tyr(Et)2, Thr4]-oxytocin) to atosiban concentrations in plasma were 1.4 and 2.8 at the second hour and at the end of the infusion respectively.
Estonian: Peamise metaboliidi, M1 (des-(Orn8, Gly-NH2 9) -29)-[Mpa1, D-Tyr(Et)2, Thr4]-oksütotsiini), suhe atosibaani kontsentratsiooni plasmas oli teisel tunnil 1,4 ja ja infusiooni lõppedes 2,8.
English: The exposure of the rat fetus was approximately four times that received by the human fetus during intravenous infusions in women.
Estonian: Annused, mida manustati roti lootele, olid umbes 4 korda suuremad nendest, mida saab inimese loode emale tehtava intravenoosse infusiooni ajal.
English: Atosiban SUN is used to delay the premature birth of your baby.
Estonian: Atosiban SUN-i kasutatakse enneaegse sünnituse edasilükkamiseks.
English: The safety and efficacy of atosiban in pregnant women aged less than 18 years have not been established.
Estonian: Lapsed Atosibaani ohutus ja efektiivsus alla 18-aastastel rasedatel ei ole tõestatud.
English: Prepare new 100 ml bags in the same way as described to allow the infusion to be continued.
Estonian: Infusiooni jätkamiseks valmistage ette uus 100 ml-ne kott samal moel nagu kirjeldatud.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Estonian: Kontsentraat infusioonilahuse valmistamiseks (steriilne kontsentraat).
English: Treatment with Atosiban SUN can be repeated up to three more times.
Estonian: Ravi Atosiban SUN'iga tohib korrata kuni kolm korda.
English: In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of atosiban depends on the assessment of fetal maturity.
Estonian: Loote üsasisese kasvupeetuse korral sõltub otsus atosibaaniga teostatava ravi jätkamise või uuesti alustamise kohta loote küpsuse hindamise tulemustest.
English: During treatment with Atosiban SUN, your contractions and your unborn baby's heart rate may be monitored.
Estonian: Ravi ajal Atosiban SUN'iga jälgitakse teie emaka kokkutõmbeid ja sündimata lapse südamelööke.
English: If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding should be discontinued during treatment with atosiban, since the release of oxytocin during breast-feeding may augment uterine contractility, and may counteract the effect of tocolytic therapy.
Estonian: Kui naine raseduse ajal veel toidab eelmist last rinnaga, tuleb atosibaaniga teostatava ravi ajaks imetamine katkestada, sest imetamise ajal vabanev oksütotsiin võib kutsuda esile emaka kokkutõmbeid ning neutraliseerida tokolüütilise ravitoime.
English: Phase III clinical trials (CAP-001 studies) include data from 742 women who were diagnosed with pre-term labour at 23-33 weeks of gestation and were randomised to receive either atosiban (according to this labelling) or β-agonist (dose-titrated).
Estonian: III-faasi kliinilised uuringud (CAP-001 uuringud) sisaldavad 742 naise andmeid, kellel diagnoositi enneaegne sünnitus gestatsiooni 23...33 nädalal ja kes said randomiseeritult kas atosibaani (vastavalt siintoodud juhisele) või beetaagonisti (annuse-tiitrimisega).