FrancophonIA/ELRC3.0 huggingface dataset:
English: The highest atosiban subcutaneous dose not producing any adverse effects was approximately two times the therapeutic human dose.
Croatian: Najveća supkutana doza atosibana koja nije dovela do nepoželjnih učinaka bila je otprilike dva puta veća od humane terapijske doze.
English: Plasma protein binding of atosiban is 46 to 48% in pregnant women.
Croatian: Vezanje atosibana na proteine plazme u trudnica iznosi 46 do 48%.
English: Severe pre-eclampsia is when you have very high blood pressure, fluid retention and/or protein in your urine.
Croatian: Teška preeklampsija je kad imate visok krvni tlak, zadržavanje tekućine i/ili proteine u urinu.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može izazvati nuspojave iako se neće javiti kod svakoga.
English: • Whenever the risk management system is modified, especially as the result of new informationbeing received that may lead to a significant change to the benefit/risk profile or as the result ofan important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: What Tractocile is and what it is used for
Croatian: Što je Tractocile i za što se koristi
English: - if you have or could have an infection of your womb (uterus).
Croatian: - ako imate ili bi mogli imati infekciju maternice (uterusa).
English: Metabolite M1 is excreted in milk (see section 4.6).
Croatian: Metabolit M1 se izlučuje u mlijeku (vidjeti dio 4.6).
English: Mean value of volume of distribution was 18.3 ± 6.8 litres.
Croatian: Srednja vrijednost volumena distribucije iznosila je 18,3 ± 6,8 litara.
English: The safety and efficacy of Tractocile in pregnant women aged less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Tractocile u trudnica mlađih od 18 godina nisu ustanovljene.
English: Rare (affects less than 1 in 1,000 people) - Your womb may be less able to contract after your baby has been born.
Croatian: Rijetko (pojavljuje se u manje od 1 na 1000 osoba) - Vaša maternica može imati smanjenu sposobnost kontrakcije nakon poroda.
English: Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms.
Croatian: Opisano je svega nekoliko slučajeva predoziranja atosibanom, koji su prošli bez specifičnih znakova i simptoma.
English: Fetal and maternal outcome did apparently not differ between the atosiban and the -agonist group, but the clinical studies were not powered enough to rule out a possible difference.
Croatian: Čini se da ishod u fetusa i majke nije bio različit između skupina s atosibanom i -agonistom, ali klinička ispitivanja nisu imala dovoljnu snagu za isključivanje moguće razlike.
English: The following table shows the full posology of the bolus injection followed by the infusion:
Croatian: Sljedeća tablica prikazuje kompletno doziranje bolus injekcije, nakon koje slijedi infuzija:
English: There was no difference between the atosiban and betamimetic groups with regard to this parameter.
Croatian: Nije bilo razlike između skupina s atosibanom i betamimeticima s obzirom na ovaj parametar.
English: Of the 361 women who received atosiban treatment in the phase III studies, 73 received at least one retreatment, 8 received at least 2 re-treatments and 2 received 3 re-treatments (see section 4.4).
Croatian: Među 361 ženom koja je liječena atosibanom u ispitivanjima faze III, 73 su primile najmanje jedno ponovno liječenje, 8 je primilo najmanje 2 ponovna liječenja, dok su 2 primile najmanje 3 ponovna liječenja (vidjeti dio 4.4).
English: - if your unborn baby (foetus) has an abnormal heart rate.
Croatian: - ako nerođeno dijete (fetus) ima poremećen srčani ritam.
English: Other medicines and Tractocile
Croatian: Drugi lijekovi i Tractocile:
English: Re-treatment with Tractocile is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see section 4.2).
Croatian: Moguće je ponovno liječenje lijekom Tractocile, ali dostupno je samo ograničeno kliničko iskustvo s višekratnim liječenjem, do ukupno 3 ponovna liječenja (vidjeti dio 4.2).
English: In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials.
Croatian: Ukupno 48% bolesnica liječenih atosibanom opisalo je nuspojave za vrijeme kliničkih ispitivanja.
English: Tractocile can be used to delay the premature birth of your baby.
Croatian: Tractocile se može koristiti za odgađanje prijevremenog poroda Vašeg djeteta.
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).
Croatian: Budući da sigurnost i djelotvornost atosibana u žena s gestacijskom dobi od manje od navršena 24 tjedna nije utvrđena u kontroliranim randomiziranim ispitivanjima, ne preporučuje se liječenje atosibanom u ovoj skupini (vidjeti dio 4.3).
English: • Periodic Safety Update Reports requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: Tractocile must not be used in the following conditions:
Croatian: Tractocile se ne smije primjenjivati kod sljedećih stanja:
English: Prepare new 100 ml bags in the same way as described to allow the infusion to be continued.
Croatian: Pripremite nove vrećice od 100 ml na isti način, kako biste mogli nastaviti s infuzijom.
English: Admission to a neonatal intensive care unit (NICU) was similar for both treatment groups (approximately 30%), as was length of stay and ventilation therapy.
Croatian: Prijem u jedinicu neonatalnog intenzivnog liječenja također je bio sličan za obje liječene skupine (otprilike 30%), kao i trajanje boravka i terapije respiratorom.
English: In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Tractocile depends on the assessment of fetal maturity.
Croatian: U slučaju intrauterinog zastoja u rastu, odluka o nastavku ili ponovnom započinjanju liječenja lijekom Tractocile ovisi o procjeni zrelosti fetusa.
English: No systemic toxic effects were observed during the two-week intravenous toxicity studies (in rats and dogs) at doses which are approximately 10 times higher than the human therapeutic dose, and during the threemonths toxicity studies in rats and dogs (up to 20 mg/kg/day s.c.).
Croatian: Tijekom dvotjednih ispitivanja o toksičnosti kod intravenskog davanja nisu opaženi sistemski toksični učinci (u štakora i pasa) s dozama koje su bile otprilike 10 puta veće od ljudske terapijske doze, kao i tijekom tromjesečnih ispitivanja toksičnosti u štakora i pasa (do 20 mg/kg/dan s.c.).
English: Children and adolescents Tractocile has not been studied in pregnant women less than 18 years old.
Croatian: Djeca i adolescenti Tractocile nije ispitivan u trudnica mlađih od 18 godina.
English: The total dose given during a full course of Tractocile therapy should preferably not exceed 330.75 mg of atosiban.
Croatian: Ukupna primijenjena doza tijekom kompletnog tijeka terapije lijekom Tractocile ne bi smjela biti veća od 330,75 mg atosibana.
English: Atosiban was neither oncogenic nor mutagenic in in vitro and in vivo tests.
Croatian: Atosiban nije bio onkogen, niti mutagen u in vitro i in vivo ispitivanjima.
English: If other medicinal products need to be given intravenously at the same time, the intravenous cannula can be shared or another site of intravenous administration can be used.
Croatian: Ukoliko je potrebno istovremeno intravensko davanje drugih lijekova, venski put se može dijeliti s drugim otopinama, ili se može upotrijebiti drugo mjesto za intravensku primjenu.
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).
Croatian: Jedanaest od 15 smrtnih slučajeva u skupini s atosibanom odnosilo se na trudnoće u gestacijskoj dobi od 20 do 24 tjedna, iako je distribucija bolesnica u ovoj podskupini bila nejednaka (19 žena na atosibanu, 4 na placebu).
English: Small amounts of atosiban have been shown to pass from plasma into the breast milk of breast-feeding women.
Croatian: Dokazano je da male količine atosibana prelaze iz plazme u majčino mlijeko dojilja.
English: Atosiban does not partition into red blood cells.
Croatian: Atosiban ne ulazi u crvene krvne stanice.
English: Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Croatian: Bilo koje drugo stanje majke ili fetusa, kod kojeg je nastavak trudnoće opasan Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: What you need to know before you are given Tractocile
Croatian: Što morate znati prije nego počnete primjenjivati Tractocile
English: 24 ml/hour (300 µg/min)
Croatian: 24 ml/sat (300 µg/min)
English: 2300 København S
Croatian: 2300 København
English: Secondary endpoints: secondary efficacy parameters included the proportion of women remaining undelivered within 48 h of treatment initiation.
Croatian: Sekundarni ishodi: parametri sekundarne djelotvornosti uključivali su udio žena u kojih je porod izostao unutar 48 h od započinjanja liječenja.
English: There is only limited clinical experience in the use of atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated.
Croatian: Postoji samo ograničeno kliničko iskustvo s primjenom atosibana kod višestrukih trudnoća, ili u skupini s gestacijskom dobi između 24 i 27 tjedana, s obzirom na mali broj liječenih bolesnica.
English: The clearance, volume of distribution and half-life were found to be independent of the dose.
Croatian: Pokazano je da klirens, volumen distribucije i poluvrijeme života ne ovise o dozi.
English: Store in a refrigerator.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku
English: No studies were performed that covered fertility and early embryonic development.
Croatian: Nisu provedena ispitivanja koja obuhvaćaju fertilitet i rani embrionalni razvoj.
English: How to store Tractocile
Croatian: Kako čuvati Tractocile
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.
Croatian: U placebo-kontroliranom ispitivanju smrtnost fetusa/dojenčeta iznosila je 5/295 (1,7%) u skupini s placebom i 15/288 (5,2%) u skupini s atosibanom, pri čemu su dva slučaja zabilježena u petom i osmom mjesecu života.
English: The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocininduced uterine contractions in vitro.
Croatian: Čini se da je glavni metabolit M1 otprilike 10 puta manje potentan od atosibana u inhibiciji kontrakcija maternice uzrokovanih oksitocinom in vitro.
English: After three hours the infusion rate is reduced to 8 ml/hour.
Croatian: Nakon tri sata brzina infuzije se smanjuje na 8 ml/sat.
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.
Croatian: Nakon završetka infuzije koncentracija u plazmi brzo pada s početnim (tα) i terminalnim (tβ) poluvremenom života od 0,21 ± 0,01, odnosno 1,7 ± 0,3 sati.
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).
Croatian: Stoga se atosiban mora primjenjivati uz oprez u slučaju višeplodne trudnoće i/ili istodobne primjene drugih lijekova s tokolitičkim djelovanjem (vidjeti dio 4.8).
English: Atosiban was also shown to bind to the vasopressin receptor, thus inhibiting the effect of vasopressin.
Croatian: Također je pokazano da se atosiban veže na vazopresinski receptor, čime inhibira učinak vazopresina.
English: Psychiatric disorder
Croatian: Psihijatrijski poremećaji
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).
Croatian: Učestalost nuspojava navodi se prema sljedećim smjernicama: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000).
English: The side effects seen in the mother are generally of a mild severity.
Croatian: Nuspojave uočene u majki su općenito umjerene težine.
English: An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for Tractocile.
Croatian: Intravenska komorica s mikrokapaljkom može omogućiti prikladan raspon brzine infuzije unutar preporučenih razina doze za Tractocile.
English: Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Croatian: Liječenje lijekom Tractocile treba započeti i održavati liječnik s iskustvom u liječenju prijevremenog poroda.
English: Reproduction toxicity studies, with dosing from implantation up to late stage pregnancy, showed no effects on mothers and fetuses.
Croatian: Reprodukcijska ispitivanja toksičnosti, s primjenom od implantacije do kasne trudnoće nisu pokazale toksične učinke na majku niti na fetus.
English: Tractocile will be given to you in a hospital by a doctor, nurse or midwife.
Croatian: Tractocile će Vam primijeniti liječnik, medicinska sestra ili babica u bolnici.
English: If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Croatian: Ako koristite vrećicu za infuziju neke druge zapremine, za pripremu treba napraviti proporcionalni izračun.
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 drug metabolising cytochrome P450 enzymes.
Croatian: Malo je vjerojatno da je atosiban uključen u interakcije među lijekovima koje su posredovane citokromom P450, budući da su in vitro ispitivanja pokazala da atosiban nije supstrat za sustav citokroma P450, i također ne inhibira metabolizam lijekova putem enzima citokroma P450.
English: - if you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure.
Croatian: - ako nosite više od jednog djeteta i/ili primate lijekove koji mogu odgoditi porod, poput lijekova za visoki krvni tlak.
English: No studies were performed that covered fertility and early embryonic development (see section 5.3).
Croatian: Ispitivanja koja obuhvaćaju fertilitet i rani embrionalni razvoj nisu provedena (vidjeti dio 5.3).
English: Mean (SD) birth weight was 2491 (813) grams in the atosiban group and 2461 (831) grams in the -agonist group (p=0.58).
Croatian: Srednja (SD) porođajna težina iznosila je 2491 (813) grama u skupini s atosibanom i 2461 (831) grama u skupini s -agonistom (p=0,58).
English: Concentrate for solution for infusion (sterile concentrate).
Croatian: Koncentrat otopine za infuziju (sterilni koncentrat).
English: To achieve accurate dosing, a controlled infusion device is recommended to adjust the rate of flow in drops/min.
Croatian: Kako bi se postiglo točno doziranje preporučuje se upotreba kontroliranog uređaja za infuziju s prilagođavanjem brzine protoka u kapima/minuti.
English: The data show that 59.6% (n=201) and 47.7% (n=163) of atosiban- and -agonist-treated women (p=0.0004), respectively, were undelivered and did not require alternative tocolysis within 7 days of starting treatment.
Croatian: Podaci pokazuju da 59,6% (n=201) odnosno 47,7% (n=163) žena liječenih atosibanom odnosno -agonistom (p=0,0004), nije rodilo i nije zahtijevalo alternativnu tokolizu unutar 7 dana od početka liječenja.
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 -agonist (dose-titrated).
Croatian: Klinička ispitivanja faze III (CAP-001 ispitivanje) uključuju podatke od 742 žene u kojih je postavljena dijagnoza prijevremenih trudova u 23-33 tjedna trudnoće i koje su randomizirane prema davanju atosibana (sukladno ovoj uputi) ili -agonista (s titriranjem doze).
English: If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Tractocile.
Croatian: Ako ste trudni i dojite prethodno dijete, prestanite dojiti dok primate Tractocile.
English: 4]-oxytocin) to atosiban concentrations in plasma were 1.4 and 2.8 at the second hour and at the end of the infusion respectively.
Croatian: 4]-oksitocin) prema koncentraciji atosibana u plazmi iznosio je 1,4 odnosno 2,8 nakon dva sata i na kraju infuzije.
English: Once the bolus has been injected, proceed with the infusion.
Croatian: Nakon injiciranja bolusa, potrebno je nastaviti s infuzijom.
English: 8 ml/hour (100 µg/min)
Croatian: 8 ml/sat (100 µg/min)
English: Animal studies have shown inhibition of lactation as expected from the inhibition of action of oxytocin.
Croatian: Ispitivanja na životinjama pokazala su inhibiciju laktacije koja odgovara očekivanom inhibitornom djelovanju oksitocina.
English: Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour.
Croatian: Intravensku terapiju primjenom inicijalne bolus injekcije potrebno je započeti što je moguće ranije nakon postavljanja dijagnoze prijevremenih trudova.
English: The total duration of the treatment should be no more than 48 hours.
Croatian: Ukupno trajanje liječenja ne treba biti dulje od 48 sati.
English: Gestational age below 24 or over 33 completed weeks Premature rupture of the membranes >30 weeks of gestation Abnormal foetal heart rate
Croatian: Gestacijska dob ispod 24 ili iznad 33 navršena tjedna Prijevremena ruptura vodenjaka >30 gestacijskog tjedna Abnormalna fetalna frekvencija srca
English: It is unlikely that atosiban inhibits hepatic cytochrome P450 isoforms in humans (see section 4.5).
Croatian: Malo je vjerojatno da atosiban inhibira hepatalne izooblike citokroma P450 u ljudi (vidjeti dio 4.5).
English: Atosiban is found in only small quantities in urine, its urinary concentration is about 50 times lower than that of M1.
Croatian: Atosiban se nalazi samo u malim količinama u urinu, pri čemu je njegova koncentracija u urinu oko 50 puta niža od koncentracije M1. Udio atosibana koji se eliminira fecesom nije poznat.
English: Hydrochloric acid 1M Water for injections
Croatian: Kloridna kiselina 1M Voda za injekcije
English: No clinically relevant interaction was found between atosiban and bethamethasone or labetalol.
Croatian: Nisu opažene klinički relevantne interakcije između atosibana i betametazona ili labetalola.
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).
Croatian: Nije bilo razlike u stopi smrtnosti u žena s gestacijskom dobi većom od 24 tjedna (1,7% u skupini s placebom i 1,5% u skupini s atosibanom).
English: Preparation of the initial intravenous injection:
Croatian: Priprema početne intravenske injekcije:
English: Tractocile should not be mixed with other medicinal products in the infusion bag.
Croatian: Tractocile se u vrećici za infuziju ne smije miješati s drugim lijekovima.
English: Mean (SD) gestational age at delivery was the same in the two groups: 35.6 (3.9) and 35.3 (4.2) weeks for the atosiban and -agonist groups, respectively (p=0.37).
Croatian: Srednja (SD) gestacijska dob pri porodu bila je jednaka u obje skupine: 35,6 (3,9) odnosno 35,3 (4,2) tjedana za skupinu s atosibanom, odnosno -agonistom (p=0,37).
English: In the CAP-001 studies the probability of remaining undelivered and not requiring alternative tocolytics within 7 days of treatment initiation was similar for atosiban and beta-mimetics treated women at gestational age of 24-28 weeks.
Croatian: U CAP-001 ispitivanjima je vjerojatnost izostanka poroda i potrebe za alternativnom tokolizom unutar 7 dana od početka liječenja bila slična u žena liječenih atosibanom i beta-mimeticima u gestacijskoj dobi od 24-28 tjedana.
English: - The other ingredients are mannitol, hydrochloric acid and water for injections.
Croatian: - Drugi sastojci su manitol, kloridna kiselina i voda za injekcije.
English: If any of the above apply to you (or you are not sure), talk to your doctor, midwife or pharmacist before you are given Tractocile.
Croatian: Ako se nešto od gore navedenog odnosi na Vas (ili ako niste sigurni), obratite se svom liječniku, babici ili ljekarniku prije nego počnete primjenjivati Tractocile.
English: Following an infusion of 300 micrograms/min in healthy pregnant women at term, the fetal/maternal atosiban concentration ratio was 0.12.
Croatian: Nakon infuzije od 300 mikrograma/min u zdravih trudnica u terminu omjer koncentracije atosibana između fetusa i majke iznosio je 0,12.
English: You may experience shortness of breath or lung oedema (accumulation of fluid in the lungs), particularly if you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure.
Croatian: Može se pojaviti nedostatak zraka ili plućni edem (nakupljanje tekućine u plućima), osobito ako nosite više od jednoga djeteta i/ili primate lijekove koji mogu odgoditi porod, poput lijekova za visok krvni tlak.
English: Instructions for use Before using Tractocile, the solution should be examined to ensure it is clear and free from particles.
Croatian: Prije primjene lijeka Tractocile, otopinu treba pregledati kako biste bili sigurni da je bistra i bez čestica.
English: If you are not sure, talk to your doctor, midwife or pharmacist before you are given Tractocile.
Croatian: Ako niste sigurni, obratite se Vašem liječniku, babici ili ljekarniku prije primjene lijeka Tractocile.
English: Tractocile works by making the contractions in your womb (uterus) less strong.
Croatian: Tractocile djeluje tako što smanjuje kontrakcije Vaše maternice (uterusa).
English: Tractocile is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Croatian: Tractocile se koristi u odraslih trudnica od 24 do 33 tjedna trudnoće.
English: The onset of uterus relaxation following atosiban is rapid, uterine contractions being significantly reduced within 10 minutes to achieve stable uterine quiescence ( 4 contractions/hour) for
Croatian: Nastup relaksacije maternice nakon davanja atosibana je brz, pri čemu dolazi do značajnog smanjivanja kontrakcija maternice unutar 10 minuta i postizanja stabilnog smirivanja ( 4 kontrakcija/sat) tijekom 12 sati.
English: As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored.
Croatian: Atosiban, kao antagonist oksitocina, teoretski može olakšati relaksaciju maternice i postpartalno krvarenje te je stoga potrebno obratiti pozornost na gubitak krvi nakon poroda.