FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean value for clearance was 41.8 ± 8.2 litres/h.
Croatian: Srednja vrijednost klirensa iznosila je 41,8 ± 8,2 litara/h.
English: The infant adverse reactions were in the range of normal variation and were comparable with both placebo and betamimetic group incidences.
Croatian: Nuspojave u djeteta bile su u rasponu normalne varijacije i usporedive s incidencijom i u skupina s placebom i s beta-mimeticima.
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.
Croatian: Poznato je da su višeplodna trudnoća i lijekovi s tokolitičkim djelovanjem, poput blokatora kalcijevih kanala i beta-mimetika, povezani s povećanim rizikom od plućnoga edema.
English: Antepartum uterine haemorrhage requiring immediate delivery Eclampsia and severe pre-eclampsia requiring delivery Intrauterine foetal death
Croatian: Antepartalno krvarenje iz maternice, koje zahtijeva trenutni porod Eklampsija i teška preeklampsija koja zahtijeva porod Intrauterina fetalna smrt
English: In animals atosiban did not exhibit cardiovascular effects.
Croatian: Atosiban nije imao kardiovaskularnih učinaka u životinja.
English: Very common (affects more than 1 in 10 people) - feeling sick (nausea)
Croatian: Vrlo često (pojavljuje se u više od 1 na 10 osoba) - osjećaj mučnine.
English: Withdraw 10 ml solution from a 100 ml infusion bag and discard.
Croatian: Izvucite 10 ml otopine iz infuzijske vrećice od 100 ml i zbrinite.
English: Atosiban passes the placenta.
Croatian: Atosiban prolazi placentu.
English: It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.
Croatian: Djeluje na način da blokira sposobnost prirodnog hormona tijela koji se zove “oksitocin”, a koji izaziva kontrakcije Vaše maternice (uterusa).
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%).
Croatian: Neuspjeh liječenja uzrokovan nedovoljnom djelotvornošću bio je značajno (p=0,0003) češći s atosibanom (n=48; 14,2%), nego u žena liječenih -agonistom (n=20; 5,8%).
English: Up to 45 hours subsequent intravenous infusion
Croatian: 54 mg sljedeća intravenska infuzija do 45 sati
English: The diluted solution must be used within 24 hours.
Croatian: Razrijeđena otopina mora se upotrijebiti unutar 24 sata
English: Once the vial has been opened, the product must be used immediately.
Croatian: Nakon otvaranja bočice proizvod se mora odmah upotrijebiti.
English: Do not use this medicine if you notice particulate matter and discoloration prior to administration.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite čestice ili promjenu boje prije primjene.
English: The observed adverse reactions were generally of a mild severity.
Croatian: Uočene nuspojave općenito su bile umjerene težine.
English: Concentrate for solution for infusion (7.5 mg/ml)
Croatian: Koncentrat za otopinu za infuziju (7,5 mg/ml)
English: Atosiban dose
Croatian: Doza atosibana
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.
Croatian: Pokazano je da se atosiban u štakora i zamoraca veže na receptore za oksitocin, smanjuje frekvenciju kontrakcija i tonus muskulature maternice, što rezultira supresijom kontrakcija maternice.
English: The duration of the treatment should not exceed 48 hours.
Croatian: Liječenje ne smije trajati duže od 48 sati.
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.
Croatian: Primarni ishod: primarni ishod djelotvornosti bio je udio žena koje nisu rodile i koje nisu zahtijevale dodatnu tokolizu unutar 7 dana od početka liječenja.
English: - If you have any further questions, ask your doctor, midwife or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku, babici ili ljekarniku.
English: Colourless glass vials, clear borosilicated (type I) sealed with grey siliconised bromo-butyl rubber stopper, type I, and flip-off cap of polypropylene and aluminium.
Croatian: Bezbojna staklena bočica, prozirna borosilikatna (tip I) zatvorena sivim silikoniziranim bromo-butil gumenim zatvaračem, tip I, polipropilenskom „flip off“ kapicom i aluminijskim zaštitnim prstenom.
English: Embryo-fetal toxicity studies have not shown toxic effects of atosiban.
Croatian: Ispitivanje embrio-fetalne toksičnosti s atosibanom nisu pokazale njegov toksični učinak.
English: In patients with impaired hepatic function, atosiban should be used with caution.
Croatian: U bolesnica s oštećenjem funkcije jetre atosiban treba primjenjivati s oprezom.
English: - allergic reactions
Croatian: - alergijske reakcije.
English: Interaction studies have been performed with labetalol and betamethasone in healthy, female volunteers.
Croatian: Ispitivanja interakcija provedena su u zdravih ženskih dobrovoljaca s labetalolom i betametazonom.
English: There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Croatian: Nema iskustva s liječenjem atosibanom u bolesnika s oštećenom funkcijom jetre ili bubrega.
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.
Croatian: Infuzija zasićenja se daje brzinom od 24 ml/sat (tj. 18 mg/h) gore navedene pripremljene otopine tijekom 3 sata pod adekvatnim medicinskim nadzorom na odjelu porodništva.
English: Treatment with Tractocile can be repeated up to three more times.
Croatian: Liječenje lijekom Tractocile može se ponoviti do 3 puta.
English: 0.9 ml intravenous bolus injection given over 1 minute
Croatian: 0,9 ml intravenska bolus injekcija tijekom 1 minute nije primjenjivo
English: - A continuous infusion at a rate of 8 ml/hour is given for up to 45 hours, or until the contractions of the uterus have subsided.
Croatian: - Kontinuirana infuzija u dozi od 8 ml/sat daje se u trajanju od 45 sati, ili dok se kontrakcije maternice ne smire.
English: - Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.
Croatian: - Zatim kontinuirana infuzija (drip) daje se u dozi od 18 mg na sat u trajanju od 3 sata.
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).
Croatian: U žena s prijevremenim trudovima koje su primale infuziju atosibana (300 mikrograma/min tijekom 6 do 12 sati), stanje dinamičke ravnoteže koncentracija u plazmi postignuto je unutar jednog sata nakon početka infuzije (srednja vrijednost 442 ± 73 ng/ml, raspon 298 do 533 ng/ml).
English: 3 hours intravenous loading infusion
Croatian: 3 sata intravenske infuzije udarne doze
English: They will also make sure the solution is clear and free from particles.
Croatian: Također će pregledati otopinu da bi bili sigurni da je bistra i bez čestica.
English: In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 5.2).
Croatian: U bolesnika s oštećenjem jetre atosiban treba primjenjivati s oprezom (vidjeti dio 4.2 i 5.2).
English: After dilution, the concentration of atosiban is 0.75 mg/ml.
Croatian: Nakon razrjeđivanja, koncentracija atosibana je 0,75 mg/ml.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza »Rok valjanosti».
English: Abruptio placenta
Croatian: Abrupcija placente
English: Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials.
Croatian: Opisane su moguće nuspojave na majku tijekom primjene atosibana u kliničkim ispitivanjima.
English: It is recommended that no more than three re-treatments should be used during a pregnancy.
Croatian: Tijekom jedne trudnoće ne preporučuje se više od tri tretmana.
English: Clear, colourless solution without particles.
Croatian: Prozirna, bezbojna otopina bez čestica.
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
Croatian: Tractocile je indiciran za odgađanje prijetećeg prijevremenog poroda u odraslih trudnica sa: pravilnim kontrakcijama maternice u trajanju od najmanje 30 sekundi i frekvencijom od  4 u 30 minuta dilatacijom cerviksa od 1 do 3 cm (0-3 za nulipare) i skraćenjem za  50% gestacijska dob od 24 do 33 navršena tjedna uredna fetalna frekvencija srca
English: It is recommended that no more than three retreatments should be used during a pregnancy.
Croatian: Tijekom jedne trudnoće ne preporučuje se primjena više od tri tretmana.
English: Monitoring of uterine contractions and fetal heart rate during administration of atosiban and in case of persistent uterine contractions should be considered.
Croatian: Treba pratiti kontrakcije maternice i fetalne frekvencije srca tijekom primjene atosibana kao i u slučaju perzistentnih kontrakcija maternice.
English: Dilutions for intravenous administration must be used within 24 hours after preparation.
Croatian: Otopina za intravensku primjenu mora se upotrijebiti unutar 24 sata nakon pripreme.
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.
Croatian: Ako za vrijeme trudnoće žena već doji mlađe dijete, treba prestati s dojenjem tijekom trajanja liječenja lijekom Tractocile budući da se tijekom trudnoće otpušta oksitocin koji može pojačati kontrakcije maternice i smanjiti učinak tokolitičke terapije.
English: - A continuous infusion at a rate of 24 ml/hour is given for 3 hours.
Croatian: - Kontinuirana infuzija u dozi od 24 ml/sat daje se u trajanju od 3 sata.
English: - A reaction at the site where the injection was given - high blood sugar
Croatian: Znakovi mogu uključivati osjećaj omaglice. - reakcije na mjestu primjene injekcije. - visok šećer u krvi.
English: - if your contractions start again, treatment with Tractocile can be repeated up to three more times.
Croatian: - ako imate višeplodnu trudnoću. - ako Vaše kontrakcije ponovno započnu, liječenje lijekom Tractocile može se ponoviti još tri puta.
English: The reconstituted product is a clear, colourless solution without particles.
Croatian: Pripremljena otopina je bistra, bezbojna otopina bez čestica.
English: Talk to your doctor, midwife or pharmacist before you are given Tractocile: - if you think your waters might have broken (premature rupture of your membranes).
Croatian: Obratite se svom liječniku, babici ili ljekarniku prije nego primijenite Tractocil: - ako mislite da vam je pukao vodenjak (prijevremeno puknuće plodovih ovoja). - ako imate problema s bubrezima ili jetrom.
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.
Croatian: Kada se atosiban koristi u bolesnica u kojih se ne može isključiti prijevremena ruptura vodenjaka, potrebno je procijeniti korist odgode poroda s obzirom na potencijalni rizik korioamnionitisa.
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.
Croatian: Intravensku terapiju primjenom inicijalne bolus injekcije Tractocile 6,75 mg/0,9 ml, otopine za injekciju (vidjeti Sažetak opisa svojstava lijeka) potrebno je započeti što je moguće ranije nakon postavljanja dijagnoze prijevremenih trudova.
English: In the case of persistence of uterine contractions during treatment with Tractocile, alternative therapy should be considered.
Croatian: Ukoliko su kontrakcije maternice i dalje prisutne za vrijeme liječenja lijekom Tractocile, potrebno je razmisliti o drugoj terapiji.
English: This will mean your unborn baby needs to be delivered straight away.
Croatian: To znači da je potrebno odmah obaviti porod. - ako je nerođeno dijete umrlo.
English: Τηλ: +30 210 68 43 449
Croatian: Ferring Ελλάς ΜΕΠΕ Τηλ: +30 210 68 43 449
English: In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 4.4).
Croatian: U bolesnica s oštećenjem funkcije jetre atosiban treba primjenjivati s oprezom (vidjeti dio 4.2 i 5.2).
English: Diluted solution for intravenous administration should be used within 24 hours after preparation.
Croatian: Razrijeđena otopina za intravensku primjenu mora se upotrijebiti unutar 24 sata nakon pripreme.
English: Preparation of the intravenous infusion
Croatian: Priprema intravenske infuzije
English: Pharmacotherapeutic group: Other gynecologicals, ATC code: G02CX01
Croatian: Farmakoterapijska skupina: Ostali ginekološki lijekovi, ATK oznaka: G02CX01 Tractocile sadrži atosiban (INN), sintetski peptid ([Mpa
English: Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and betamimetics, and/or in women with multiple pregnancy, have been reported post-marketing.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su događaji povezani s dišnim sustavom, poput dispneje i plućnoga edema, osobito kod istodobne primjene drugih lijekova s tokolitičkim djelovanjem, poput antagonista kalcija i beta-mimetika, i/ili u žena s višeplodnom trudnoćom.
English: For storage conditions after first opening and dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon prvog otvaranja i razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Croatian: Način primjene Za uputu o pripremi lijeka prije primjene, vidjeti dio 6.6.
English: 6.75 mg of atosiban in 0.9 ml.
Croatian: 6,75 mg atosibana u 0,9 ml.
English: One pack contains one vial containing 0.9 ml solution.
Croatian: Jedno pakovanje sadrži jednu bočicu s 0,9 ml otopine.
English: In atosiban clinical trials no effects were observed on breast-feeding.
Croatian: U kliničkim ispitivanjima s atosibanom nisu opaženi učinci na dojenje.
English: In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of Tractocile 6.75 mg/0.9 ml, solution for injection followed by infusion with Tractocile 37.5 mg/5 ml, concentrate for solution for infusion.
Croatian: Ukoliko je potrebno ponovljeno liječenje atosibanom, ono također treba započeti s bolus injekcijom Tractocile 6,75 mg/0,9 ml, otopina za injekciju nakon čega slijedi infuzija Tractocile 37,5 mg/5 ml, koncentrata za otopinu za infuziju.
English: Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine.
Croatian: Nije vjerojatno da će zbog oštećenja bubrega biti potrebna prilagodba doze jer se samo mala količina atosibana izlučuje urinom.
English: Mannitol, Hydrocloric acid, water for injections
Croatian: POPIS POMOĆNIH TVARI Manitol, kloridna kiselina, voda za injekcije
English: 8, Gly-NH2
Croatian: 8, Gly
English: The intravenous infusion is prepared by diluting Tractocile 37.5 mg/5 ml, concentrate for solution for infusion in sodium chloride 9 mg/ml (0.9%) solution for injection, Ringer's lactate solution or 5% w/v glucose solution.
Croatian: Intravenska infuzija priprema se otapanjem Tractocile 37,5 mg/5 ml, koncentrata za otopinu za infuziju u natrijevom kloridu 9 mg/ml (0.9%) otopina za injekciju, otopini Ringerovog laktata ili 5% otopini glukoze.
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).
Croatian: Nakon injiciranja bolusa, potrebno je nastaviti s infuzijom (vidjeti Sažetak opisa svojstava lijeka Tractocile 37,5 mg/5 ml, koncentrat za otopinu za infuziju).
English: Uncommon (affects less than 1 in 100 people) - high temperature (fever) - difficulty sleeping (insomnia) - itching - rash
Croatian: Manje često (pojavljuje se u manje od 1 na 100 osoba) - visoka temperatura. - teškoće sa spavanjem (nesanica). - svrbež. - osip.
English: This may increase the risk of lung oedema
Croatian: To može povećati rizik od plućnoga edema (nakupljanja tekućine u plućima).
English: Tractocile is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Tractocile 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Tractocile 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Tractocile 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours.
Croatian: Tractocile se daje intravenski u tri uzastopne faze: inicijalna bolus doza (6,75 mg), s Tractocile 6,75 mg/0,9 ml otopinom za injekcije, nakon čega odmah slijedi kontinuirana infuzija visoke doze (infuzija udarne doze 300 mikrograma/min) Tractocile 37,5 mg/5 ml koncentrata za otopinu za infuziju tijekom tri sata, te potom niža doza Tractocile 37,5 mg/5 ml koncentrata za otopinu za infuziju (naredna infuzija od 100 mikrograma/min) sve do 45 sati.
English: One pack contains one vial containing 5 ml solution.
Croatian: Jedno pakovanje sadrži jednu bočicu s 5 ml otopine.
English: However, inadequate uterus contraction postpartum was not observed during the clinical trials.
Croatian: Međutim, tijekom kliničkih ispitivanja nisu opažene neprikladne kontrakcije maternice nakon poroda.
English: What Tractocile contains - The active substance is atosiban.
Croatian: Sadržaj pakiranja i druge informacije Što Tractocile sadrži - Djelatna tvar je atosiban.
English: One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.
Croatian: Jedna bočica otopine za injekciju sadrži 0,9 ml otopine što odgovara 6,75 mg atosibana.
English: Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation.
Croatian: Atosiban se smije primijeniti samo kod dijagnoze prijevremenih trudova između navršenog 24 i 33 tjedna trudnoće.
English: Each ml of solution contains 7.5 mg atosiban.
Croatian: Jedan ml otopine sadrži 7,5 mg atosibana.
English: How Tractocile will be given
Croatian: Kako primjenjivati Tractocile
English: The Tractocile 6.75 mg/0.9 ml, solution for injection should be used immediately.
Croatian: Tractocile 6,75 mg/0,9 ml, otopina za injekciju mora se odmah upotrijebiti.
English: Tractocile 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution without particles.
Croatian: Tractocile 37,5 mg/5 ml koncentrat za otopinu za infuziju je prozirna, bezbojna otopina bez čestica.
English: Tractocile will be given into a vein (intravenously) in three stages: - The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute.
Croatian: Tractocile se primjenjuje u venu (intravenski) u tri koraka: - Početna injekcija od 6,75 mg u 0,9 ml polako se daje u venu u trajanju od jedne minute.
English: In human pre-term labour, atosiban at the recommended dosage antagonises uterine contractions and induces uterine quiescence.
Croatian: U slučaju prijevremenih trudova u žena, atosiban u preporučenoj dozi antagonizira kontrakcije maternice i inducira smirivanje maternice.
English: Withdraw 0.9 ml of a 0.9 ml labelled vial of Tractocile 6.75 mg/0.9 ml, solution for injection and administer slowly as an intravenous bolus dose over one minute, under adequate medical supervision in an obstetric unit.
Croatian: Tractocile 6,75 mg/0,9 ml, otopine za injekciju označene s 0,9 ml i primijenite polako u venu u obliku bolusa tijekom jedne minute, uz prikladni medicinski nadzor na odjelu porodništva.
English: In healthy non-pregnant subjects receiving atosiban infusions (10 to 300 micrograms/min over 12 hours), the steady state plasma concentrations increased proportionally to the dose.
Croatian: Koncentracije u plazmi u stanju dinamičke ravnoteže zdravih žena koje nisu bile trudne i primale su infuziju atosibana (10 do 300 mikrograma/min tijekom 12 sati), povećavale su se razmjerno dozi.
English: For the newborn, the clinical trials did not reveal any specific adverse reactions of atosiban.
Croatian: Klinička ispitivanja nisu otkrila nikakve specifične nuspojave atosibana na novorođenče.
English: Tractocile is given intravenously in three successive stages: - The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
Croatian: Tractocile se daje intravenski u tri koraka: - Početna intravenska injekcija od 6,75 mg u 0,9 ml polako se daje intravenski u trajanju od jedne minute.
English: One vial of concentrate for solution for infusion contains 5 ml solution, corresponding to 37.5 mg atosiban.
Croatian: Jedna bočica koncentrata za otopinu za infuziju sadrži 5 ml otopine što odgovara 37,5 mg atosibana.
English: This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Tractocile 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Croatian: To učinite zamjenom 10 ml otopine iz vrećice za infuziju od 100 ml s 10 ml Tractocile 37,5 mg/5 ml koncentrata za otopinu za infuziju iz dvije bočice od po 5 ml da biste dobili koncentraciju od 75 mg atosibana na 100 ml.
English: - Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to 45 hours, or until your contractions have stopped.
Croatian: - Zatim druga kontinuirana infuzija (drip) u dozi od 6 mg na sat primjenjuje se u trajanju do 45
English: Replace it by 10 ml Tractocile 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Croatian: Zamijenite ih s 10 ml Tractocile 37,5 mg/5 ml koncentrata za otopinu za infuziju iz dvije bočice od 5 ml, kako biste dobili koncentraciju od 75 mg atosibana u 100 ml.
English: For intravenous infusion, following the bolus dose, Tractocile 37.5 mg/5 ml, concentrate for solution for infusion should be diluted in one of the following solutions: sodium chloride 9 mg/ml (0.9%) solution for injection Ringer's lactate solution
Croatian: Tractocile 37,5 mg/5 ml, koncentrat za otopinu za infuziju, koji se daje kao intravenska infuzija nakon bolus doze, potrebno je razrijediti u jednoj od sljedećih otopina: natrijev klorid 9 mg/ml (0,9%) otopina za injekciju otopini Ringerovog laktata
English: - if you have bleeding from your vagina and your doctor wants your unborn baby to be delivered straight away.
Croatian: - ako imate krvarenje iz rodnice zbog kojeg liječnik želi odmah obaviti porod. - ako imate stanje koje se zove “teška preeklampsija” i Vaš liječnik želi odmah obaviti porod.
English: - Each vial of Tractocile 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
Croatian: Tractocile 37,5 mg/5 ml koncentrata za otopinu za infuziju sadrži atosibanacetat što odgovara 37,5 mg atosibana u 5 ml.
English: 6.1 List of excipients
Croatian: 6.1 Popis pomoćnih tvari Manitol
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji probavnog sustava Mučnina Povraćanje Poremećaji kože i potkožnog tkiva