FrancophonIA/ELRC3.0 huggingface dataset:
English: Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour.
Slovenian: Intravensko zdravljenje z začetno bolusno injekcijo je treba začeti čimprej po diagnozi prezgodnjega poroda.
English: No studies were performed that covered fertility and early embryonic development (see section 5.3).
Slovenian: Študije, ki bi ocenile vpliv na plodnost in zgodnji razvoj zarodkov, niso bile izvedene (glejte poglavje 5.3).
English: Atosiban was also shown to bind to the vasopressin receptor, thus inhibiting the effect of vasopressin.
Slovenian: Dokazano je tudi, da se veže na receptor za vazopresin in tako zavre učinek vazopresina.
English: 24 ml/hour (300 µg/min)
Slovenian: 24 ml/uro (300 µg/min)
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.
Slovenian: Izid za plod in mater se v skupini z atosibanom po vsem sodeč ni razlikoval od izida v skupini z -agonistom, toda moč kliničnih raziskav ni bila tolikšna, da bi izključila možno razliko.
English: Children and adolescents Tractocile has not been studied in pregnant women less than 18 years old.
Slovenian: Otroci in mladostniki Zdravilo Tractocile ni bilo preskušeno pri nosečnicah, starih manj kot 18 let.
English: - if you or your unborn baby have any other conditions where it would be dangerous to continue with your pregnancy.
Slovenian: - Če imate vi ali plod katerokoli drugo bolezensko stanje, zaradi katerega je nadaljevanje nosečnosti tvegano.
English: Preparation of the initial intravenous injection:
Slovenian: Priprava začetne intravenske injekcije:
English: Treatment failures caused by insufficient efficacy were significantly (p=0.0003) more frequent in atosiban (n=48, 14.2%) than in the -agonist-treated women (n=20, 5.8%).
Slovenian: Neuspešno zdravljenje zaradi nezadostne učinkovitosti je bilo značilno pogostejše (p = 0,0003) pri ženskah, ki so dobivale atosiban (n = 48, 14,2 %), kot pri ženskah, ki so dobivale agonist (n = 20, 5,8 %).
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).
Slovenian: Enajst od 15 smrtnih primerov v skupini z atosibanom je bilo pri nosečnostih z gestacijsko starostjo od 20 do 24 tednov, čeprav je bila porazdelitev bolnic v tej podskupini neenakomerna (19 prejemnic atosibana, 4 prejemnice placeba).
English: Severe pre-eclampsia is when you have very high blood pressure, fluid retention and/or protein in your urine.
Slovenian: Za hudo preeklampsijo (nosečnostna toksemija) so značilni zelo visok krvni tlak, zastajanje tekočin in/ali prisotnost beljakovin v urinu.
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.
Slovenian: V študiji, kontrolirani s placebom, je bilo v skupini s placebom 5 smrtnih primerov pri plodu/dojenčku (5/295; 1,7 %), v skupini z atosibanom pa 15 (15/288; 5,2 %), od tega dva v starosti pet in osem mesecev.
English: Reproduction toxicity studies, with dosing from implantation up to late stage pregnancy, showed no effects on mothers and fetuses.
Slovenian: Študije vplivov na sposobnost razmnoževanja z uporabo zdravila od nidacije do pozne nosečnosti niso pokazale nobenih učinkov na matere in zarodke.
English: When atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis.
Slovenian: Če se atosiban uporablja pri bolnicah, pri katerih ni mogoče izključiti prezgodnjega razpoka plodnega mehurja, je treba koristi odloženega poroda pretehtati v primerjavi z možnim tveganjem za horioamnionitis.
English: - if your unborn baby is small for the time of your pregnancy.
Slovenian: - Če je plod premajhen za pretečeni čas nosečnosti.
English: After three hours the infusion rate is reduced to 8 ml/hour.
Slovenian: Po 3 urah je treba hitrost infundiranja zmanjšati na 8 ml/uro.
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).
Slovenian: Klinična preskušanja III. faze (študije CAP-001) vključujejo podatke o 742 ženskah, pri katerih je bil diagnosticiran prezgodnji porod v obdobju od 22. do 33. tedna gestacije in so bile naključno razporejene tako, da so prejemale atosiban (odmerjanje v skladu s tem dokumentom) ali -agonist (titracija odmerka).
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.).
Slovenian: Pri dvotedenskih študijah toksičnosti (pri podganah in psih) z intravenskimi odmerki, ki so bili približno 10-krat večji od terapevtskega odmerka pri človeku, in pri trimesečnih študijah toksičnosti pri podganah in psih (do 20 mg/kg/dan s.c.) niso ugotovili sistemskih toksičnih učinkov.
English: Metabolite M1 is excreted in milk (see section 4.6).
Slovenian: Presnovek M1 se izloča z materinim mlekom (glejte poglavje 4.6).
English: The exposure of the rat fetus was approximately four times that received by the human fetus during intravenous infusions in women.
Slovenian: Izpostavljenost podganjih plodov je bila približno 4-krat večja od izpostavljenosti človeškega ploda med intravensko infuzijo pri materi.
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.
Slovenian: 4]-oksitocin) in atosibana v plazmi je bilo po dveh urah 1,4 in na koncu infundiranja 2,8.
English: - allergic reactions
Slovenian: - Alergijske reakcije.
English: Small amounts of atosiban have been shown to pass from plasma into the breast milk of breast-feeding women.
Slovenian: Atosiban v majhnih količinah prehaja iz plazme v materino mleko.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
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.
Slovenian: Po koncu infundiranja je koncentracija v plazmi hitro upadla z začetnim razpolovnim časom (tα) 0,21 ± 0,01 ure in s končnim razpolovnim časom (tβ) 1,7 ± 0,3 ure.
English: The observed adverse reactions were generally of a mild severity.
Slovenian: Opaženi neželeni učinki so bili običajno blagi.
English: What you need to know before you are given Tractocile
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Tractocile
English: Treatment with Tractocile can be repeated up to three more times.
Slovenian: Zdravljenje z zdravilom Tractocile se lahko ponovi še največ trikrat.
English: In rats and guinea pigs, atosiban was shown to bind to oxytocin receptors, to decrease the frequency of contractions and the tone of the uterine musculature, resulting in a suppression of uterine contractions.
Slovenian: Pri podganah in budrah je dokazano, da se atosiban veže na receptorje za oksitocin, zmanjša pogostnost kontrakcij in tonus materničnega mišičja in tako zavre kontrakcije maternice.
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).
Slovenian: Od 361 žensk, zdravljenih z atosibanom v študijah III. faze, je bilo zdravljenje ponovljeno vsaj enkrat pri 73 ženskah, vsaj dvakrat pri 8 ženskah, vsaj trikrat pa pri 2 ženskah (glejte poglavje 4.4).
English: Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine.
Slovenian: V primeru okvare ledvic odmerka verjetno ni treba prilagajati, saj se atosiban le v majhnem obsegu izloča z urinom.
English: There are no known side effects on the unborn or new-born baby.
Slovenian: Pri plodu ali novorojenčku ni znanih neželenih učinkov.
English: 8 ml/hour (100 µg/min)
Slovenian: 8 ml/uro (100 µg/min)
English: The following table shows the full posology of the bolus injection followed by the infusion:
Slovenian: V spodnji tabeli je prikazano celotno odmerjanje zdravila, ki se začne z injekcijo v obliki bolusa in nato nadaljuje z infuzijo:
English: Prepare new 100 ml bags in the same way as described to allow the infusion to be continued.
Slovenian: Na enak način, kot je opisan zgoraj, pripravite novo 100 ml vrečko, da se bo infuzija lahko nadaljevala.
English: The total dose given during a full course of Tractocile therapy should preferably not exceed 330.75 mg of atosiban.
Slovenian: Skupni odmerek atosibana med celotnim ciklusom zdravljenja z zdravilom Tractocile naj ne bi presegel 330,75 mg.
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.
Slovenian: Lahko se pojavi težko dihanje ali pljučni edem (nabiranje tekočine v pljučih), še posebej, če ste noseči z več kot enim otrokom in/ali dobivate druga zdravila, ki lahko odložijo porod vašega otroka, kot so zdravila, ki se uporabljajo za zdravljenje povišanega krvnega tlaka.
English: As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored.
Slovenian: Atosiban bi kot antagonist oksitocina teoretično lahko povzročil atonijo maternice in poporodno krvavitev, zato je po porodu treba nadzirati izgubo krvi.
English: Animal studies have shown inhibition of lactation as expected from the inhibition of action of oxytocin.
Slovenian: Raziskave na živalih so pokazale zaviralni učinek na dojenje, kar je pričakovano glede na zaviranje delovanja oksitocina.
English: If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Tractocile.
Slovenian: Če ste noseči in dojite starejšega otroka, boste morali prenehati z dojenjem, dokler dobivate zdravilo Tractocile.
English: Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and betamimetics are known to be associated with increased risk of pulmonary oedema.
Slovenian: Znano je, da sta mnogoplodna nosečnost in uporaba zdravil s tokolitičnim delovanjem, kot so zaviralci kalcijevih kanalčkov in beta-mimetiki, povezani z večjim tveganjem za pljučni edem.
English: - Keep this leaflet.
Slovenian: - Kožni izpuščaj.
English: What Tractocile looks like and contents of the pack
Slovenian: Izgled zdravila Tractocile in vsebina pakiranja
English: The proportion of atosiban eliminated in faeces is not known.
Slovenian: Delež v blatu izločenega atosibana ni znan.
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.
Slovenian: Verjetnost, da je atosiban vpleten v interakcije z drugimi zdravili, ki se presnavljajo z encimi citokrom P450 je majhna, saj in vitro raziskave kažejo, da atosiban ni substrat za encime citokrom P450 in ne zavira encimov citokrom P450, ki presnavljajo zdravila.
English: Treatment should last no longer than 48 hours in total.
Slovenian: Zdravljenje v celoti ne sme trajati dlje kot 48 ur.
English: In women in pre-term labour receiving atosiban by infusion (300 micrograms/min for 6 to 12 hours), steady state plasma concentrations were reached within one hour following the start of the infusion (mean 442 ± 73 ng/ml, range 298 to 533 ng/ml).
Slovenian: Pri ženskah s prezgodnjim porodom, ki so dobile infuzijo atosibana (300 mikrogramov/min od 6 do 12 ur), so bile plazemske koncentracije v stanju dinamičnega ravnovesja dosežene v eni uri po začetku infuzije (povprečno 442 ± 73 ng/ml, razpon od 298 do 533 ng/ml).
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.
Slovenian: Klinične izkušnje z uporabo atosibana pri mnogoplodnih nosečnostih ali v gestacijski starosti od 24. do 27. tedna so zaradi majhnega števila zdravljenih bolnic omejene.
English: - if your placenta is detaching from the wall of your womb.
Slovenian: - Če se je posteljica odluščila od stene maternice.
English: If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding should be discontinued during treatment with Tractocile, since the release of oxytocin during breast-feeding may augment uterine contractility, and may counteract the effect of tocolytic therapy.
Slovenian: Če nosečnica še doji prejšnjega otroka, mora med zdravljenjem z zdravilom Tractocile prenehati dojiti, saj lahko izločanje oksitocina med dojenjem okrepi maternične kontrakcije in nasprotuje učinkom tokolitičnega zdravljenja.
English: No clinically relevant interaction was found between atosiban and bethamethasone or labetalol.
Slovenian: Klinično pomembnih interakcij med atosibanom in betametazonom ali labetalolom niso opazili.
English: Following an infusion of 300 micrograms/min in healthy pregnant women at term, the fetal/maternal atosiban concentration ratio was 0.12.
Slovenian: Po infuziji 300 mikrogramov/min zdravim nosečnicam ob roku je bilo razmerje med koncentracijo atosibana pri plodu in materi 0,12.
English: Mean (SD) birth weight was 2491 (813) grams in the atosiban group and 2461 (831) grams in the -agonist group (p=0.58).
Slovenian: Povprečna (SD) porodna masa je bila v skupini z atosibanom 2.491 (813) gramov in v skupini z -agonistom 2.461 (831) gramov (p = 0,58).
English: Two metabolites were identified in the plasma and urine from human subjects.
Slovenian: V plazmi in urinu preiskovank so ugotovili dva presnovka.
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).
Slovenian: Povprečna (SD) gestacijska starost ob porodu je bila v obeh skupinah enaka: 35,6 (3,9) tedna v skupini z atosibanom in 35,3 (4,2) tedna v skupini z -agonistom (p = 0,37).
English: How Tractocile will be given
Slovenian: Kako vam bo zdravilo Tractocile dano
English: - if you have bleeding from your vagina and your doctor wants your unborn baby to be delivered straight away.
Slovenian: - Če krvavite iz nožnice in zdravnik meni, da je treba porod opraviti takoj.
English: It is recommended that no more than three re-treatments should be used during a pregnancy.
Slovenian: Priporočljivo je, da se med nosečnostjo ponovno zdravljenje ne ponovi več kot trikrat.
English: Concentrate for solution for infusion (7.5 mg/ml)
Slovenian: koncentrat za raztopino za infundiranje (7,5 mg/ml)
English: In animals atosiban did not exhibit cardiovascular effects.
Slovenian: Pri živalih atosiban ni imel kardiovaskularnih učinkov.
English: The duration of the treatment should not exceed 48 hours.
Slovenian: Zdravljenje ne sme trajati več kot 48 ur.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Slovenian: Način uporabe Za navodilo glede priprave zdravila pred dajanjem glejte poglavje 6.6.
English: There was no difference between the atosiban and betamimetic groups with regard to this parameter.
Slovenian: Skupini, ki sta prejemali atosiban in beta-mimetik, se v tem pogledu nista razlikovali.
English: In the case of persistence of uterine contractions during treatment with Tractocile, alternative therapy should be considered.
Slovenian: Če se kontrakcije maternice med zdravljenjem z zdravilom Tractocile nadaljujejo, je treba razmisliti o alternativni terapiji.
English: In patients with impaired hepatic function, atosiban should be used with caution.
Slovenian: Pri bolnicah z okvaro delovanja jeter je treba atosiban uporabljati previdno.
English: Other medicines and Tractocile
Slovenian: Druga zdravila in zdravilo Tractocile:
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
Slovenian: Sprostitev maternice se po atosibanu pojavi hitro in kontrakcije se v 10 minutah pomembno zmanjšajo, tako da je dosežena stabilna umiritev maternice ( 4 kontrakcije/uro) za 12 ur.
English: The infant adverse reactions were in the range of normal variation and were comparable with both placebo and betamimetic group incidences.
Slovenian: Neželeni učinki pri dojenčkih so bili v območju normalnih variacij in po pogostnosti primerljivi s tistimi v skupini, ki je prejemala placebo in v skupini, ki je prejemala beta-mimetik.
English: If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Slovenian: Če uporabite infuzijsko vrečko z drugačnim volumnom, morate potrebne količine ustrezno preračunati.
English: The diluted solution must be used within 24 hours.
Slovenian: Razredčeno raztopino je treba uporabiti v 24-ih urah.
English: Tractocile is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Slovenian: Zdravilo Tractocile se uporablja pri odraslih nosečnicah od 24. do 33. tedna nosečnosti.
English: Intravenous therapy using the initial bolus injection of Tractocile 6.75 mg/0.9 ml, solution for injection (see Summary of Product Characteristics of this product) should be started as soon as possible after diagnosis of pre-term labour.
Slovenian: Intravensko zdravljenje z začetno bolusno injekcijo zdravila Tractocile 6,75 mg/0,9 ml raztopina za injiciranje (glejte povzetek glavnih značilnosti zdravila za to zdravilo) je treba začeti čimprej po diagnozi prezgodnjega poroda.
English: In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 5.2).
Slovenian: Pri bolnicah z okvaro delovanja jeter je treba atosiban uporabljati previdno (glejte poglavji 4.2 in 5.2).
English: The following side effects may happen with this medicine:
Slovenian: Pri uporabi tega zdravila se lahko pojavijo naslednji neželeni učinki:
English: Primary endpoint: the primary efficacy outcome was the proportion of women remaining undelivered and not requiring alternative tocolysis within 7 days of treatment initiation.
Slovenian: Primarni opazovani dogodek: Glavno merilo učinkovitosti je bil delež žensk, ki niso rodile in v 7 dneh od začetka zdravljenja niso potrebovale alternativnega tokolitičnega zdravljenja.
English: Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation.
Slovenian: Atosiban se sme uporabiti le, če je postavljena diagnoza prezgodnjega poroda med 24. in 33. dopolnjenim tednom gestacije.
English: Atosiban was neither oncogenic nor mutagenic in in vitro and in vivo tests.
Slovenian: V raziskavah in vitro ter in vivo atosiban ni deloval onkogeno ali mutageno.
English: Hydrochloric acid 1M Water for injections
Slovenian: 1M klorovodikova kislina voda za injekcije
English: Withdraw 10 ml solution from a 100 ml infusion bag and discard.
Slovenian: Iz 100 ml infuzijske vrečke izvlecite 10 ml raztopine in jo zavrzite.
English: - if your unborn baby (foetus) has an abnormal heart rate.
Slovenian: - Če ima plod (fetus) nepravilen srčni utrip.
English: Tractocile is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 seconds duration at a rate of  4 per 30 minutes a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of  50% a gestational age from 24 until 33 completed weeks a normal foetal heart rate
Slovenian: Zdravilo Tractocile je indicirano za odložitev iminentnega prezgodnjega poroda pri odraslih nosečnicah z: - rednimi kontrakcijami maternice, ki trajajo vsaj 30 sekund, s pogostnostjo  4 na 30 minut; - odprtjem materničnega vratu od 1 do 3 cm (od 0 do 3 cm pri ženskah, ki še niso rodile) in stanjšanjem za  50 %; - gestacijsko starostjo od 24 do 33 dopolnjenih tednov; - normalno srčno frekvenco ploda.
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.
Slovenian: Če se karkoli od navedenega nanaša na vas (ali ste negotovi), se posvetujte s svojim zdravnikom, z babico ali s farmacevtom preden prejmete zdravilo Tractocile.
English: The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocininduced uterine contractions in vitro.
Slovenian: Glavni presnovek M1 je pri in vitro zaviranju z oksitocinom povzročene kontrakcije maternice približno 10-krat manj učinkovit od atosibana.
English: - if you are pregnant with more than one baby.
Slovenian: - Če pričakujete več kot enega otroka (mnogoplodna nosečnost).
English: One pack contains one vial containing 0.9 ml solution.
Slovenian: Eno pakiranje vsebuje eno vialo z 0,9 ml raztopine.
English: One pack contains one vial containing 5 ml solution.
Slovenian: Eno pakiranje vsebuje eno vialo s 5 ml raztopine.
English: The loading infusion is given by infusing 24 ml/hour (i.e. 18 mg/h) of the above prepared solution over the 3 hour period under adequate medical supervision in an obstetric unit.
Slovenian: Polnilna infuzija se aplicira z infundiranjem tako pripravljene raztopine s hitrostjo 24 ml/uro (tj. 18 mg/uro) v 3 urah pod ustreznim zdravniškim nadzorom na porodnem oddelku.
English: Mannitol, Hydrocloric acid, water for injections
Slovenian: Manitol, klorovodikova kislina in voda za injekcije.
English: Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of Tractocile 37.5 mg/5 ml, concentrate for solution for infusion).
Slovenian: Ko je bolus injiciran, je treba nadaljevati z infuzijo (glejte povzetek glavnih značilnosti zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje).
English: Dilutions for intravenous administration must be used within 24 hours after preparation.
Slovenian: Razredčeno raztopino za intravensko aplikacijo je treba uporabiti v 24 urah po pripravi.
English: What Tractocile contains - The active substance is atosiban.
Slovenian: Kaj vsebuje zdravilo Tractocile - Zdravilna učinkovina je atosiban.
English: After dilution, the concentration of atosiban is 0.75 mg/ml.
Slovenian: Po razredčenju je koncentracija atosibana 0,75 mg/ml.
English: No studies were performed that covered fertility and early embryonic development.
Slovenian: Študije, ki bi ocenile vpliv na plodnost in zgodnji razvoj zarodkov, niso bile izvedene.
English: - A reaction at the site where the injection was given.
Slovenian: - Reakcija na mestu injiciranja zdravila.
English: In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 4.4).
Slovenian: Pri bolnicah z okvaro delovanja jeter je treba atosiban uporabljati previdno (glejte poglavji 4.2 in 4.4).
English: - if your contractions start again, treatment with Tractocile can be repeated up to three more times.
Slovenian: - Če se popadki začnejo znova, se lahko zdravljenje z zdravilom Tractocile ponovi še največ trikrat.