FrancophonIA/ELRC3.0 huggingface dataset:
English: Keeping the vial inverted position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe.
Croatian: Pri uvlačenju otopine u štrcaljku, potrebno je držati bočicu u preokrenutom položaju te postaviti vršak igle pri samom dnu otopine u bočici.
English: One syringe of 0.5 ml solution contains 75 mg omalizumab.
Croatian: Jedna štrcaljka s 0,5 ml otopine sadrži 75 mg omalizumaba.
English: 225 mg 1 blue (75 mg)
Croatian: 225 mg 1 plava (75 mg)
English: It is used to prevent asthma from getting worse by controlling symptoms of severe allergic asthma in adults, adolescents and children (6 years of age and older) who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high-dose steroid inhalers or beta-agonist inhalers.
Croatian: Xolair se koristi za sprječavanje pogoršanja astme tako što kontrolira simptome teške alergijske astme u odraslih osoba, adolescenata i djece (u dobi od 6 i više godina) koji već uzimaju lijekove za astmu, ali čiji se simptomi astme ne mogu dobro kontrolirati lijekovima poput inhalacijskih kortikosteroida u visokim dozama ili inhalacijskih beta-agonista.
English: Syringe guard
Croatian: Štitnik igle
English: How Xolair is given
Croatian: Koliko Xolaira ćete primijeniti
English: 150 mg solution for injection in pre-filled syringe
Croatian: 150 mg otopina za injekciju u napunjenoj štrcaljki
English: One vial contains 75 mg omalizumab.
Croatian: Jedna bočica sadrži 75 mg omalizumaba.
English: 75 mg solution for injection in pre-filled syringe (10 x 1)
Croatian: 75 mg otopina za injekciju u napunjenoj štrcaljki (10 x 1)
English: 75 mg solution for injection in pre-filled syringe (4 x 1)
Croatian: 75 mg otopina za injekciju u napunjenoj štrcaljki (4 x 1)
English: Xolair 75 mg powder for solution for injection is supplied in a single-use vial.
Croatian: Xolair 75 mg prašak za otopinu za injekciju dolazi u bočici za jednokratnu uporabu.
English: 1 purple (150 mg)
Croatian: 1 ljubičasta (150 mg)
English: Multipack: 4 (4 x 1) pre-filled syringes Multipack: 6 (6 x 1) pre-filled syringes Multipack: 10 (10 x 1) pre-filled syringes
Croatian: Otopina za injekciju u napunjenoj štrcaljki Višestruko pakiranje: 4 (4 x 1) napunjene štrcaljke Višestruko pakiranje: 6 (6 x 1) napunjenih štrcaljki Višestruko pakiranje: 10 (10 x 1) napunjenih štrcaljki
English: One syringe of 1 ml solution contains 150 mg omalizumab.
Croatian: Jedna štrcaljka s 1 ml otopine sadrži 150 mg omalizumaba.
English: Xolair 150 mg powder for solution for injection is supplied in a single-use vial.
Croatian: Xolair 150 mg prašak za otopinu za injekciju dolazi u bočici za jednokratnu uporabu.
English: 150 mg solution for injection in pre-filled syringe (6 x 1)
Croatian: 150 mg otopina za injekciju u napunjenoj štrcaljki (6 x 1)
English: Syringe guard wings
Croatian: Kvačice štitnika igle
English: 75 mg solution for injection in pre-filled syringe
Croatian: 75 mg otopina za injekciju u napunjenoj štrcaljki
English: The strata were baseline weekly itch severity score (<13 vs. ≥13) and baseline weight (<80 kg vs. ≥80 kg).
Croatian: Stratumi su bili početni tjedni rezultat za težinu svrbeža (<13 naspram.
English: Laryngoedema
Croatian: Trombociti
English: 4 purple (150 mg)
Croatian: 4 ljubičaste (150 mg)
English: 2 purple (150 mg)
Croatian: 2 ljubičaste (150 mg)
English: Storage of the Xolair pre-filled syringe
Croatian: Čuvanje Xolair napunjene štrcaljke
English: Multipack: 4 (4 x 1) vials and 4 (4 x 1) ampoules Multipack: 10 (10 x 1) vials and 10 (10 x 1) ampoules
Croatian: Prašak i otapalo za otopinu za injekciju Višestruko pakiranje: 4 (4 x 1) bočice i 4 (4 x 1) ampule Višestruko pakiranje: 10 (10 x 1) bočica i 10 (10 x 1) ampula
English: PRE-FILLED SYRINGE LABEL
Croatian: OZNAČIVANJE NAPUNJENE ŠTRCALJKE
English: Xolair 150 mg powder for solution for injection omalizumab
Croatian: Xolair 150 mg prašak za otopinu za injekciju omalizumab
English: Xolair 75 mg powder for solution for injection omalizumab
Croatian: Xolair 75 mg prašak za otopinu za injekciju omalizumab
English: One vial contains 150 mg omalizumab.
Croatian: Jedna bočica sadrži 150 mg omalizumaba.
English: One vial contains 75 mg of omalizumab*.
Croatian: Jedna bočica sadrži 75 mg omalizumaba*.
English: 150 mg solution for injection in pre-filled syringe (10 x 1)
Croatian: 150 mg otopina za injekciju u napunjenoj štrcaljki (10 x 1)
English: Xolair 150 mg powder and solvent for solution for injection
Croatian: Xolair 150 mg prašak i otapalo za otopinu za injekciju
English: Xolair 75 mg powder and solvent for solution for injection
Croatian: Xolair 75 mg prašak i otapalo za otopinu za injekciju
English: Xolair 75 mg solution for injection in pre-filled syringe omalizumab
Croatian: Xolair 75 mg otopina za injekciju u napunjenoj štrcaljki omalizumab
English: Xolair 75 mg solution for injection in pre-filled syringe
Croatian: Xolair 75 mg otopina za injekciju u napunjenoj štrcaljki
English: Xolair 150 mg solution for injection in pre-filled syringe omalizumab
Croatian: Xolair 150 mg otopina za injekciju u napunjenoj štrcaljki omalizumab
English: 150 mg solution for injection in pre-filled syringe (4 x 1)
Croatian: 150 mg otopina za injekciju u napunjenoj štrcaljki (4 x 1)
English: 3 purple (150 mg)
Croatian: 3 ljubičaste (150 mg)
English: Keep taking your current asthma medicine during Xolair treatment.
Croatian: Tijekom liječenja Xolairom morate nastaviti s primjenom lijekova za astmu koje ste i dotada koristili.
English: Treatment of atopic subjects with omalizumab resulted in a marked down-regulation of FcRI receptors on basophils.
Croatian: Liječenje atopičara omalizumabom rezultiralo je izrazitim smanjenjem aktivnosti
English: Xolair 150 mg solution for injection in pre-filled syringe
Croatian: Xolair 150 mg otopina za injekciju u napunjenoj štrcaljki
English: Age, Race/Ethnicity, Gender, Body Mass Index
Croatian: Starost, rasa/etnička pripadnost, spol, indeks tjelesne mase Populacijska farmakokinetika Xolaira analizirana je radi procjene učinaka demografskih karakteristika.
English: One vial contains 150 mg of omalizumab*.
Croatian: Jedna bočica sadrži 150 mg omalizumaba*.
English: Draw 1.4 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
Croatian: U štrcaljku opremljenu s iglom velikog promjera od 18 G izvući 1,4 ml vode za injekcije iz ampule.
English: Do not stop treatment with Xolair unless your doctor tells you to. Interrupting or stopping the treatment with Xolair may cause your asthma or CSU symptoms to come back.
Croatian: Privremeni ili trajni prekid liječenja Xolairom može izazvati povratak simptoma astme.
English: Xolair 150 mg powder and solvent for solution for injection omalizumab
Croatian: Xolair 150 mg prašak i otapalo za otopinu za injekciju omalizumab
English: Xolair 75 mg powder and solvent for solution for injection omalizumab
Croatian: Xolair 75 mg prašak i otapalo za otopinu za injekciju omalizumab
English: Postural hypotension, flushing Respiratory, thoracic and mediastinal disorders Uncommon
Croatian: Krvožilni poremećaji Manje često posturalna hipotenzija, navale crvenila Poremećaji dišnog sustava, prsišta i sredoprsja Manje često alergijski bronhospazam, kašalj
English: Keep taking your current medicine for CSU during Xolair treatment.
Croatian: Tijekom liječenja Xolairom nastavite uzimati lijek za kroničnu spontanu urtikariju koji ste i dotada koristili.
English: Photosensitivity, urticaria, rash, pruritus
Croatian: • mučninu, proljev, probavne smetnje
English: - The other ingredients are L-arginine hydrochloride, L-histidine hydrochloride, L-histidine,
Croatian: - Drugi sastojci su L-argininklorid, L-histidinklorid, L-histidin, polisorbat 20 i voda za injekcije.
English: Draw 0.9 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
Croatian: U štrcaljku opremljenu s iglom velikog promjera od 18 G izvući 0,9 ml vode za injekcije iz ampule.
English: Allergic bronchospasm, coughing
Croatian: Nepoznato alergijski granulomatozni vaskulitis (tj.
English: Anaphylactic reaction, other serious allergic conditions, antiomalizumab antibody development
Croatian: Poremećaji krvi i limfnog sustava Nepoznato idiopatska trombocitopenija, uključujući teške slučajeve Poremećaji imunološkog sustava Rijetko anafilaktička reakcija, druga ozbiljna alergijska stanja, stvaranje antiomalizumab protutijela
English: WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
Croatian: U FOLIJU (UKLJUČUJUĆI PLAVI OKVIR)
English: Syringe guard wings Plunger
Croatian: Kvačice štitnika igle Klip
English: Children (under 6 years of age) Xolair should not be given to children under 6 years of age.
Croatian: Xolair nemojte davati djeci mlađoj od 6 godina.
English: - Low blood pressure.
Croatian: - nizak krvni tlak.
English: - If your unborn baby has died.
Croatian: - Ako je vaše nerođeno dijete umrlo.
English: Date of latest renewal: 28 May 2018
Croatian: Datum posljednje obnove odobrenja: 28. svibnja 2018
English: Do not throw away any medicines in wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: - High blood sugar.
Croatian: - visok šećer u krvi.
English: - Difficulty sleeping (insomnia).
Croatian: - teškoće sa spavanjem (nesanica). - svrbež.
English: Ranbaxy (Poland) Sp. Z. o. o. ul.
Croatian: Ranbaxy (Poland) Sp. Z. o. o.
English: The benefit of atosiban in these subgroups is therefore uncertain.
Croatian: Stoga nije sigurna korist od atosibana u ovim podskupinama.
English: - If your placenta is covering the birth canal.
Croatian: Ako placenta pokriva porođajni kanal.
English: The following information is intended for healthcare professionals only: (See also section 3)
Croatian: UPUTE ZA ZDRAVSTVENE RADNIKE Sljedeće informacije namijenjene su samo zdravstvenim radnicima: (također vidjeti dio 3)
English: Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, primalju ili ljekarnika ukoliko uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: - Allergic reactions.
Croatian: - alergijske reakcije.
English: MedDRA system organ class (SOC)
Croatian: MedDRA klasifikacija po organskim sustavima (SOC)
English: - If you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you would also have fits (convulsions).
Croatian: - Ako imate stanje koje se zove “eklampsija” koje je slično “teškoj preeklampsiji” ali također imate napadaje (konvulzije).
English: There are no known side effects on the unborn or newborn baby.
Croatian: Nisu poznate nuspojave u nerođenog ili novorođenog djeteta.
English: Signs may include feeling dizzy or light-headed.
Croatian: Znakovi mogu uključivati osjećaj omaglice ili ošamućenosti.
English: - If you or your unborn baby have any other conditions where it would be dangerous to continue with your pregnancy.
Croatian: - Ako Vi ili Vaše nerođeno dijete imate bilo koje drugo stanje zbog kojih se nastavak vaše trudnoće smatra opasnim.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not use if shrink wrap is tampered.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Nemojte koristiti ukoliko je omot oštećen.
English: This may increase the risk of lung oedema (accumulation of fluid in the lungs).
Croatian: To može povećati rizik od edema pluća (nakupljanje tekućine u plućima).
English: Pharmacotherapeutic group: Other gynecologicals, ATC code: G02CX01
Croatian: Farmakoterapijska skupina: Ostali ginekološki lijekovi, ATK oznaka: G02CX01
English: It is not known whether the free fraction in the maternal and fetal compartments differs substantially.
Croatian: Nije poznato da li se slobodna frakcija u majčinom i fetalnom dijelu značajno razlikuje.
English: 30 weeks of your pregnancy or more.
Croatian: tjedana trudnoće ili više.
English: Do not use Atosiban SUN - If you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Atosiban SUN - Ako ste alergični na atosiban ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Do not use Atosiban SUN if any of the above apply to you.
Croatian: Ne primjenjujte Atosiban SUN ako se nešto od gore navedenog odnosi na Vas.
English: Hyde Park, Hayes 3
Croatian: Hyde Park, Hayes 3 5th Floor
English: United Kingdom Ranbaxy UK Ltd a Sun Pharma Company Millington Road 11
Croatian: Ranbaxy UK Ltd a Sun Pharma Company Millington Road 11
English: Fetal and maternal outcome did apparently not differ between the atosiban and the β-agonist group, but the clinical trials were not powered enough to rule out a possible difference.
Croatian: Čini se da ishod u fetusa i majke nije bio različit između skupina s atosibanom i β-agonistom, ali klinička ispitivanja nisu imala dovoljnu snagu za isključivanje moguće razlike.
English: - If your unborn baby (foetus) has an abnormal heart rate.
Croatian: - Ako nerođeno dijete (fetus) ima poremećen srčani ritam.
English: Atosiban SUN contains atosiban.
Croatian: Atosiban SUN sadrži atosiban.
English: Of the 361 women who received atosiban treatment in the phase III studies, 73 received at least one re-treatment, 8 received at least 2 re-treatments and 2 received 3 re-treatments (see section 4.4).
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 you are more than 33 weeks pregnant.
Croatian: - Ako ste trudni više od 33 tjedna.
English: - If you have or could have an infection of your womb (uterus).
Croatian: Ako imate ili bi mogli imati infekciju maternice (uterusa).
English: What Atosiban SUN is and what it is used for
Croatian: Što je Atosiban SUN i za što se koristi
English: There was no difference between the atosiban and beta-mimetic groups with regard to this parameter.
Croatian: Nije bilo razlike između skupina s atosibanom i beta mimeticima s obzirom na ovaj parametar.
English: Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms.
Croatian: Opisano je nekoliko slučajeva predoziranja atosibanom, koji su se dogodili bez ikakvih specifičnih znakova ili simptoma.
English: Atosiban does not partition into red blood cells.
Croatian: Atosiban ne raspodjeljuje u crvene krvne stanice.
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 three-months 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: INFORMATION IN BRAILLE Justification for not including Braille accepted
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za ne navođenje Braillea
English: Hydrochloric acid 1M
Croatian: Kloridna kiselina 1M
English: Step
Croatian: Korak
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 July 2013
Croatian: Datum prvog odobrenja: 31. srpanj 2013.
English: Ranbaxy Pharmacie Generiques 11-15, Quai de Dion Bouton 92800 Puteaux
Croatian: Ranbaxy Pharmacie Generiques 11-15, Quai de Dion Bouton
English: Children and adolescents Atosiban SUN has not been studied in pregnant women less than 18 years old.
Croatian: Djeca i adolescenti Atosiban SUN nije se istraživao u trudnica mlađih od 18 godina.
English: Re-treatment with atosiban is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see section 4.2).
Croatian: Moguće je ponovno liječenje lijekom atosiban, ali dostupno je samo ograničeno kliničko iskustvo s višekratnim ponovnim liječenjem, do ukupno 3 ponovna liječenja (vidjeti dio 4.2).
English: In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of atosiban depends on the assessment of fetal maturity.
Croatian: U slučaju intrauterinog zastoja u rastu, odluka o nastavku ili ponovnom započinjanju liječenja lijekom atosiban ovisi o procjeni zrelosti fetusa.
English: Atosiban SUN will be given to you in a hospital by a doctor, nurse or midwife.
Croatian: Atosiban SUN će Vam primijeniti liječnik, medicinska sestra ili primalja u bolnici.
English: Atosiban SUN contains atosiban (INN), a synthetic peptide ([Mpa1, D-Tyr(Et)2, Thr4,Orn8]-oxytocin) which is a competitive antagonist of human oxytocin at receptor level.
Croatian: Atosiban SUN sadrži atosiban (INN), sintetski peptid ([Mpa1, D-Tyr(Et)2, Thr4,Orn8]-oksitocin) koji je kompetitivni antagonist ljudskog oksitocina na razini receptora.
English: It is unlikely that atosiban is involved in cytochrome P450 mediated drug-drug interactions as in vitro investigations have shown that atosiban is not a substrate for the cytochrome P450 system, and does not inhibit the medicinal product metabolising cytochrome P450 enzymes.
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 ne inhibira metabolizam lijekova putem enzima citokroma P450.
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 višeplodnih trudnoća, ili u skupini s gestacijskom dobi između 24 i 27 tjedana, s obzirom na mali broj liječenih bolesnica.
English: There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Croatian: Ne postoje iskustva s liječenjem atosibanom u bolesnica s oštećenom funkcijom jetre ili bubrega.
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: Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and beta-mimetics are known to be associated with increased risk of pulmonary oedema.
Croatian: Višeplodna trudnoća i medicinski proizvodi s tokolitičkom aktivnosti kao što su blokatori kalcijskih kanala i beta-mimetici povezani su s povećanim rizikom od edema pluća.
English: The data show that 59.6% (n=201) and 47.7% (n=163) of atosiban- and β-agonist-treated women (p=0.0004), respectively, were undelivered and did not require alternative tocolysis within 7 days of starting treatment.
Croatian: Podaci pokazuju da 59,6% (n=201) odnosno 47,7% (n=163) žena liječenih atosibanom odnosno β-agonistom (p=0,0004), nije rodilo i nije zahtijevalo alternativnu tokolizu unutar 7 dana od početka liječenja.
English: Treatment failures caused by insufficient efficacy were significantly (p=0.0003) more frequent in atosiban (n=48, 14.2%) than in the β-agonist-treated women (n=20, 5.8%).
Croatian: Neuspjeh liječenja uzrokovan nedovoljnom djelotvornošću bio je značajno (p=0,0003) češći s atosibanom (n=48; 14,2%), nego u žena liječenih β-agonistom (n=20; 5,8%).
English: - If you are between 24 and 27 weeks pregnant.
Croatian: - Ako ste trudni između 24 i 27 tjedana.
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 za očekivati da kod oštećenja bubrega treba prilagoditi dozu jer se samo mala količina atosibana izlučuje urinom.
English: - If you have something called “severe pre-eclampsia” and your doctor wants your unborn baby to be delivered straight away.
Croatian: - Ako imate stanje koje se zove “teška preeklampsija” i vaš liječnik želi odmah dovršiti porod.
English: The diluted solution must be used within 24 hours.
Croatian: Razrijeđena otopina mora se upotrijebiti unutar 24 sata.
English: The reconstituted medicinal product is a clear, colourless solution without particles.
Croatian: Rekonstituirana otopina lijeka je bistra, bezbojna otopina bez čestica.
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 preporuča se upotreba kontroliranog uređaja za infuziju da bi se prilagodila brzina protoka u kapima/minuti.
English: Atosiban SUN works by making the contractions in your womb (uterus) weaker.
Croatian: Atosiban SUN djeluje tako što smanjuje kontrakcije vaše maternice (uterusa).
English: What Atosiban SUN is and what it is used for What you need to know before you are given Atosiban SUN How Atosiban SUN will be given Possible side effects
Croatian: Što je Atosiban SUN i za što se koristi Što morate znati prije nego primite Atosiban SUN Kako će Atosiban SUN biti primijenjen
English: - Fast heart beat.
Croatian: - ubrzani otkucaji srca.
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 manjom od navršena 24 tjedna nije utvrđena u kontroliranim randomiziranim ispitivanjima, ne preporučuje se liječenje atosibanom u ovoj skupini bolesnica (vidjeti dio 4.3).
English: Atosiban SUN is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Croatian: Atosiban SUN se koristi u odraslih trudnica od 24 do 33 tjedna trudnoće.
English: An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for atosiban.
Croatian: Intravenska komorica s mikrokapaljkom može omogućiti prikladan raspon brzine infuzije unutar preporučenih razina doze za atosiban.
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 prijevremenog poroda.
English: Other medicines and Atosiban SUN
Croatian: Drugi lijekovi i Atosiban SUN
English: The side effects seen in the mother are generally mild.
Croatian: Nuspojave uočene u majki su općenito umjerene težine.
English: 8 ml/hour (100 μg/min)
Croatian: 8 ml/sat (100 µg/min)
English: The safety and efficacy of atosiban in pregnant women aged less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost atosibana u trudnica starosne dobi manje od 18 godina nisu još ustanovljene.
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 Atosiban SUN.
Croatian: Ako se nešto od gore navedenog odnosi na Vas (ili ako niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego počnete primjenjivati Atosiban SUN.
English: - If your unborn baby is small for the time of your pregnancy.
Croatian: Ako je nerođeno dijete premalo u odnosu na trajanje trudnoće.
English: If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Croatian: Ukoliko primjenjujete infuzijsku vrećicu s drugačijim volumenom, potrebno je proporcionalno izračunati koncentraciju u otopini.
English: Before using Atosiban SUN, the solution should be examined to ensure it is clear and free from particles.
Croatian: Prije primjene Atosiban SUN-a, otopinu treba pregledati kako biste bili sigurni da je bistra i bez čestica.
English: Up to 270 mg intravenous infusion
Croatian: Sve do 270 mg