FrancophonIA/ELRC3.0 huggingface dataset:
English: How Atosiban SUN will be given
Croatian: Kako će Atosiban SUN biti primijenjen
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 12 hours.
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: 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.
Croatian: Omjer glavnog metabolita M1 (des-(Orn8, GlyNH2 9) -29)-[Mpa1, D-Tyr(Et)2, Thr4]-oksitocin) prema koncentraciji atosibana u plazmi iznosio je 1,4 odnosno 2,8 nakon dva sata i na kraju infuzije.
English: The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocin-induced 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: The following table shows the full posology of the bolus injection followed by the infusion: Step
Croatian: Sljedeća tablica prikazuje kompletno doziranje bolus injekcije, nakon koje slijedi infuzija: Korak
English: Treatment with atosiban should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Croatian: Liječenje lijekom atosiban treba započeti i voditi liječnik s iskustvom u liječenju prijevremenog poroda.
English: For intravenous use after dilution.
Croatian: Za intravensku primjenu nakon razrjeđivanja.
English: - If you have kidney or liver problems.
Croatian: - Ako imate problema s bubrezima ili jetrom.
English: Very common (may affect more than 1 in 10 people) - Feeling sick (nausea).
Croatian: Vrlo često (pojavljuje se u više od 1 na 10 osoba) - osjećaj mučnine.
English: Atosiban SUN should not be mixed with other medicinal products in the infusion bag.
Croatian: Atosiban SUN se u vrećici za infuziju ne smije miješati s drugim lijekovima.
English: What you need to know before you are given Atosiban SUN
Croatian: Što morate znati prije nego primite Atosiban SUN
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 koje nisu rodile unutar 48 h od započinjanja liječenja.
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 i fetus.
English: Mean (SD) birth weight was 2491 (813) grams in the atosiban group and 2461 (831) grams in the β-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 β-agonistom (p=0,58).
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 je padala s početnim (tα) i terminalnim (tβ) poluvremenom života od 0,21 ± 0,01, odnosno 1,7 ± 0,3 sati.
English: Clear, colourless solution without particles.
Croatian: Bistra, bezbojna otopina, bez čestica.
English: If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Atosiban SUN.
Croatian: Ako ste trudni ili dojite prijašnje dijete, prestanite dojiti dok dobivate Atosiban SUN.
English: Do not use this medicine after the expiry date which is stated on the label after EXP {MM/YYYY}.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza „Rok valjanosti“ {MM/GGGG}.
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 očekujete više od jednog djeteta i/ili ste dobili lijekove koje mogu odgoditi rođenje vašeg djeteta, npr. lijekove za visoki krvni tlak.
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: Zato je potrebno pažljivo koristiti atosiban u slučaju višeplodne trudnoće i/ili konkomitantne primjene drugih lijekova s tokolitičkom aktivnosti (vidjeti dio 4.8).
English: - If you are less than 24 weeks pregnant.
Croatian: - Ako ste trudni manje od 24 tjedna.
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 brzinom od 8 ml/sat daje se u trajanju do 45 sati, ili dok se kontrakcije maternice ne smire.
English: - If you have any further questions, ask your doctor, midwife or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku, primalji ili ljekarniku.
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: Možda će vam ponestajati daha ili će se pojaviti plućni edem (nakupljanje tekućina u plućima), posebno ako očekujete rođenje više od jednog djeteta i/ili ste dobili lijekove koje mogu odgoditi rođenje vašeg djeteta, npr. lijekove za visoki krvni tlak.
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 β-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 β-agonistom (p=0,37).
English: This will mean your unborn baby needs to be delivered straight away.
Croatian: To znači da je potrebno odmah dovršiti porod.
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.
Croatian: Ako za vrijeme trudnoće žena već doji starije dijete, treba prestati s dojenjem tijekom trajanja liječenja lijekom atosiban budući da otpuštanje oksitocina tijekom dojenja može pojačati kontrakcije maternice i djelovati suprotno učinku tokolitičke terapije.
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 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000).
English: 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: 45 hours, or until your contractions have stopped.
Croatian: sati ili dok se kontrakcije maternice ne smire.
English: Treatment with Atosiban SUN can be repeated up to three more times.
Croatian: Liječenje Atosiban SUN-om može se ponoviti do 3 puta.
English: Intravenous use For instructions on preparation of the medicinal product before administration, see section 6.6.
Croatian: Za intravensku primjenu Upute o pripremi lijeka prije primjene, vidjeti u dijelu 6.6.
English: How to store Atosiban SUN
Croatian: Kako čuvati Atosiban SUN
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 dovršiti porod.
English: Atosiban SUN is used to delay the premature birth of your baby.
Croatian: Atosiban SUN se može koristiti za odgađanje prijevremenog poroda vašeg djeteta.
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).
Croatian: Klinička ispitivanja faze III (CAP-001 ispitivanje) uključuju podatke od 742 žene u kojih je postavljena dijagnoza prijetećeg prijevremenog poroda u 23-33 tjedna trudnoće i koje su randomizirane prema davanju atosibana (sukladno ovoj uputi) ili β-agonista (s titriranjom dozom ).
English: - A continuous infusion at a rate of 24 ml/hour is given for 3 hours.
Croatian: - Kontinuirana infuzija brzinom od 24 ml/sat daje se u trajanju od 3 sata.
English: In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 5.2).
Croatian: U bolesnica s oštećenjem funkcije jetre atosiban treba primjenjivati s oprezom (vidjeti dio 4.2 i 5.2).
English: The infant adverse reactions were in the range of normal variation and were comparable with both placebo and beta-mimetic group incidences.
Croatian: Nuspojave u djeteta bile su u rasponu normalne varijacije i usporedive s incidencijomu obje skupine, s placebom i s beta-mimeticima.
English: - Hot flushes.
Croatian: - navale vrućine.
English: - If your contractions start again, treatment with Atosiban SUN can be repeated up to three more times.
Croatian: - Ako Vaše kontrakcije ponovno započnu, liječenje Atosiban SUN-om može se ponoviti još tri puta.
English: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/ Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Croatian: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/ Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/Norge/Österreich/Portugal/Slovenija/ Slovenská republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V.
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: U zdravih žena koje nisu bile trudne i primale su infuziju atosibana (10 do 300 mikrograma/min tijekom 12 sati), koncentracije u plazmi u stanju dinamičke ravnoteže povećavale su se razmjerno dozi.
English: - If your placenta is detaching from the wall of your womb.
Croatian: Ako se placenta odvaja od stijenke maternice.
English: OTHER EU/1/13/852/001
Croatian: DRUGO EU/1/13/852/001
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 4.4).
English: OTHER EU/1/13/852/002
Croatian: DRUGO EU/1/13/852/002
English: Intravenous therapy using the initial bolus injection of atosiban 6.75 mg/0.9 ml, solution for injection (see Summary of Product Characteristics of this medicinal product) should be started as soon as possible after diagnosis of pre-term labour.
Croatian: Intravensku terapiju primjenom inicijalne bolus injekcije atosibana 6,75 mg/0,9 ml, otopine za injekciju (vidjeti Sažetak opisa svojstava lijeka) potrebno je započeti što je moguće ranije nakon postavljanja dijagnoze prijevremenog poroda.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon prvog otvaranja lijeka, vidjeti u dijelu 6.3
English: Colourless tubular glass vial (type I) with bromobutyl flange grey rubber stopper and sealed with flip off violet colour aluminium seal.
Croatian: Bezbojna cjevasta staklena bočical (tip I) s bromo-butil sivim gumenim čepom s prirubnicom i zatvorena „flip off“ ljubičastom aluminijskom brtvom.
English: LIST OF EXCIPIENTS Excipients: mannitol, hydrochloric acid 1M, water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: manitol, kloridna kiselina 1M, voda za injekcije.
English: Do not use Atosiban SUN if you notice particulate matter and discoloration prior to administration.
Croatian: Atosiban SUN se ne smije upotrijebiti ako primijetite čestice ili promjenu boje prije primjene.
English: - The other ingredients are mannitol, hydrochloric acid 1M and water for injections.
Croatian: - Pomoćne tvari su manitol, kloridna kiselina 1M i voda za injekcije.
English: 1 vial (6.75 mg/0.9 ml)
Croatian: 1 bočica (6,75 mg/0,9 ml)
English: In the case of persistence of uterine contractions during treatment with atosiban, alternative therapy should be considered.
Croatian: Ukoliko su kontrakcije maternice i dalje prisutne za vrijeme liječenja lijekom atosiban, potrebno je razmisliti o drugoj terapiji.
English: Provides 0.75 mg/ml when diluted as recommended.
Croatian: 1 bočica (7,5 mg/ml) Sadrži 0,75 mg/ml kad se razrijedi kako je preporučeno.
English: Patients with renal or liver impairment
Croatian: Bolesnice s oštećenjima bubrega ili jetre
English: The atosiban 6.75 mg/0.9 ml solution for injection should be used immediately.
Croatian: Atosiban 6,75 mg/0,9 ml otopina za injekciju mora se odmah upotrijebiti.
English: The intravenous infusion is prepared by diluting Atosiban SUN 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 Atosiban SUN 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: One pack contains one vial containing 0.9 ml solution.
Croatian: Jedno pakiranje sadrži jednu bočicu s 0,9 ml otopine.
English: Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of Atosiban SUN 37.5 mg/5 ml, concentrate for solution for infusion).
Croatian: Nakon injiciranja bolusa, potrebno je nastaviti s infuzijom (vidjeti Sažetak opisa svojstava lijeka Atosiban SUN 37,5 mg/5 ml, koncentrat za otopinu za infuziju).
English: Once the vial has been opened, the medicinal product must be used immediately.
Croatian: Nakon otvaranja bočice lijek se mora odmah upotrijebiti.
English: In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of atosiban 6.75 mg/0.9 ml, solution for injection followed by infusion with atosiban 37.5 mg/5 ml, concentrate for solution for infusion.
Croatian: Ukoliko je potrebno ponovljeno liječenje atosibanom, ono također treba započeti s bolus injekcijom atosibana 6,75 mg/0,9 ml, otopina za injekciju nakon čega slijedi infuzija atosibana 37,5 mg/5 ml, koncentrata za otopinu za infuziju.
English: Name and address of the manufacturer(s) responsible for batch release Sun Pharmaceutical Industries Europe B.V.
Croatian: Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet Sun Pharmaceutical Industries Europe B.V.
English: 02-954 Warszawa Polska tel. +48 22 642 07 75
Croatian: +48 22 642 07 75 România
English: One pack contains one vial containing 5 ml solution.
Croatian: Jedno pakiranje sadrži jednu bočicu s 5 ml otopine.
English: - Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to
Croatian: - Zatim druga kontinuirana infuzija (drip) u dozi od 6 mg na sat primjenjuje se u trajanju do 45
English: NETHERLANDS
Croatian: NIZOZEMSKA
English: - A reaction at the site where the injection was given.
Croatian: - reakcije na mjestu primjene injekcije.
English: If you are not sure, talk to your doctor, midwife or pharmacist before you are given Atosiban SUN.
Croatian: obratite se svom liječniku, primalji ili ljekarniku prije primjene Atosiban SUN-a.
English: Talk to your doctor, midwife or pharmacist before you are given Atosiban SUN - If you think your waters might have broken (premature rupture of your membranes).
Croatian: Prije primjene Atosiban SUN-a provjerite s liječnikom, ljekarnikom ili medicinskom sestrom: - Ako mislite da vam je pukao vodenjak (prijevremeno prsnuće plodovih ovoja).
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: U razdoblju nakon stavljanja lijeka u promet bilježe se respiratorni događaji poput dispneje i edema pluća, posebno u slučaju istovremene primjene drugih lijekova s tokolitičkom aktivnosti kao što su kalcijevi antagonisti i beta-mimetici, i/ili višeplodna trudnoća u žena.
English: Replace it by 10 ml atosiban 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 ga za 10 ml atosibana 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: - If your waters have broken (premature rupture of your membranes) and you have completed
Croatian: - Ako imate prerano prsnuće vodenjaka (prijevremeno prsnuće plodovih ovoja), a navršili ste 30
English: Atosiban SUN 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: Atosiban SUN se primjenjuje u venu (intravenski) u tri uzastopna koraka: - Početna injekcija od 6,75 mg u 0,9 ml polako se daje u venu u trajanju od jedne minute.
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 prijevremenog poroda između navršenog 24 i 33
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).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica od 5 ml otopine sadrži 37,5 mg atosibana (u obliku atosibanacetata).
English: - Your womb may be less able to contract after your baby has been born.
Croatian: Nakon poroda mogla bi se smanjiti sposobnost kontrakcije vaše maternice.
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Ολλανδία/Nizozemska/The Netherlands/Holland/
Croatian: Nederlandene/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/
English: In human pre-term labour, atosiban at the recommended dose antagonises uterine contractions and induces uterine quiescence.
Croatian: U slučaju prijevremenog poroda 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 atosiban 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: Priprema početne intravenske injekcije: Izvucite 0,9 ml iz bočice atosibana 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: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica od 0,9 ml otopine sadrži 6,75 mg atosibana (u obliku atosibanacetata).
English: Atosiban SUN 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: Atosiban SUN se daje intravenski u tri uzastopna koraka: - Početna intravenska injekcija od 6,75 mg u 0,9 ml polako se injicira intravenski u trajanju od jedne minute.
English: Cluj-Napoca, Judeţul Cluj România tel. +40 (264) 501 500
Croatian: +40 (264) 501 500 United Kingdom
English: - Gestational age below 24 or over 33 completed weeks - Premature rupture of the membranes >30 weeks of gestation - Abnormal foetal heart rate - Antepartum uterine haemorrhage requiring immediate delivery - Eclampsia and severe pre-eclampsia requiring delivery - Intrauterine foetal death - Suspected intrauterine infection - Placenta praevia - Abruptio placenta - Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous - Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Croatian: - Placenta praevia - Abrupcija placente - 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: 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,
English: Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/
Croatian: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/
English: What Atosiban SUN looks like and contents of the pack Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution without particles.
Croatian: Atosiban SUN 37,5 mg/5 ml koncentrat za otopinu za infuziju je bistra, bezbojna otopina bez čestica.
English: - Each vial of Atosiban SUN 6.75 mg/0.9 ml solution for injection contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.
Croatian: - Jedna bočica Atosiban SUN-a 6,75 mg/0,9 ml otopine za injekciju sadrži atosibanacetat što odgovara 6,75 mg atosibana u 0,9 ml.
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 6.5 Vrsta i sadržaj spremnika
English: For intravenous infusion, following the bolus dose, atosiban 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 - 5% w/v glucose solution.
Croatian: Atosiban 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
English: Str. Fabricii nr 124
Croatian: Fabricii nr 124 Cluj-Napoca, Judeţul Cluj
English: Atosiban 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: - dilatacijom cerviksa od 1 do 3 cm (0-3 za nulipare) i skraćenjem za ≥ 50% - gestacijska dob od 24 do 33 navršena tjedna
English: Common (may affect less than 1 in 10 people) - Headache.
Croatian: Često (pojavljuje se u manje od 1 na 10 osoba)
English: - Each vial of Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
Croatian: - Jedna bočica Atosiban SUN 37,5 mg/5 ml koncentrata za otopinu za infuziju sadrži atosibanacetat što odgovara 37,5 mg atosibana u 5 ml.
English: Preparation of the initial intravenous injection:
Croatian: Priprema otopine za infuziju u venu: