natgillin/translations-raw huggingface dataset:
Loxapine is a substrate for several CYP450 isozymes; in vitro studies demonstrated that 7-OHloxapine is formed mainly by CYPs 3A4 and 2D6, 8-OH-loxapine is formed mainly by CYP1A2, amoxapine is formed mainly by CYP3A4, 2C19, and 2C8, and loxapine N-oxide is formed by FMOs. 
Loksapin je supstrat nekoliko CYP450 izoenzima; in vitro ispitivanja su pokazala da se 7-OH-loksapin u najvećoj mjeri formira pomoću CYPs 3A4 i 2D6, 8-OH-loksapin pomoću CYP1A2, amoksapin pomoću CYP3A4, 2C19 i 2C8 dok se loksapin N-oksid u najvećoj mjeri formira pomoću FMO.
Renal and/or hepatic impairment ADASUVE has not been studied in patients with renal or hepatic impairment. 
Oštećenje funkcije bubrega i/ili jetre ADASUVE nije ispitan na bolesnicima s oštećenjem funkcije bubrega ili jetre.
Loxapine exposure in the first 2 hours after administration (AUC0-2h, a measure of early exposure that is relevant to the onset of therapeutic effect) was 25.6 ng*h/mL for the 4.5 mg dose and 66.7 ng*h/mL for the 9.1 mg dose in healthy subjects. 
Izloženost loksapinu u prva 2 sata nakon primjene (AUC0-2h, mjera rane izloženosti koja je važna za početak terapijskih učinaka) je iznosila 25,6 ng*h/ml za dozu od 4,5 mg i 66,7 ng*h/ml za dozu od 9,1 mg kod zdravih ispitanika.
Hold breath Remove the mouthpiece from the mouth and hold breath briefly. 
Zadrži dah Ukloni nastavak za usta iz usta i kratko zadrži dah.
• lorazepam or other centrally acting medicines (to treat anxiety, depression, pain, or to help you sleep) or any other medicines that cause sleepiness 
depresije, bolova ili za pomoć pri spavanju) ili bilo koje druge lijekove koji uzrokuju pospanost
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE KUĆIŠTE UREĐAJA
Inhale through the mouthpiece with a steady, deep breath. 
Udahne kroz nastavak za usta kontinuiranim, dubokim udahom.
With chronic oral administration of loxapine, the reported adverse reactions include sedation and drowsiness; extrapyramidal symptoms (e.g., tremor, akathisia, rigidity, and dystonia); cardiovascular effects (e.g., tachycardia, hypotension, hypertension, orthostatic hypotension, light-headedness, and syncope); and anticholinergic effects (e.g., dry eyes, blurred vision, and urinary retention). 
Kronično peroralno davanje loksapina uzrokovalo je prijavljene nuspojave kao što su sedacija i ošamućenost, ekstrapiramidalni simptomi (npr. tremor, akatizija, krutost, distonija); kardiovaskularne nuspojave (npr. tahikardija, hipotenzija, hipertenzija, ortostatska hipotenzija, omamljenost i sinkopa), kao i antikolinergijske učinke (npr. suhe oči, zamućeni vid i urinarna retencija).
Because of anticholinergic action, ADASUVE should be used cautiously in patients with glaucoma or a tendency to urinary retention, particularly with concomitant administration of anticholinergic-type antiparkinson medicinal products. 
Zbog svog antikolinergijskog djelovanja, bolesnici s glaukomom ili tendencijom urinarne retencije, naročito kod istodobne primjene antikolinergijskih antiparkinsonika, trebaju oprezno uzimati ADASUVE.
Loxapine is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are either metabolised by cytochrome P450 (CYP450) isozymes or glucuronidated by human uridine 5'-diphosphoglucuronosyl transferases (UGTs). 
Ne očekuje se da bi loksapin mogao uzrokovati klinički značajne farmakokinetičke interakcije s drugim lijekovima koji se metaboliziraju pomoću citokrom P450 (CYP450) izoenzima ili koji prolaze glukuronidaciju putem ljudskih uridin 5'-difosfoglukuronoziltransferaza (UGT).
Loxapine is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are either metabolised by cytochrome P450 (CYP450) isozymes or glucuronidated by human uridine 5'-diphosphoglucuronosyl transferases (UGTs) . 
Ne očekuje se da bi loksapin mogao uzrokovati klinički značajne farmakokinetičke interakcije s drugim lijekovima koji se metaboliziraju pomoću citokrom P450 (CYP450) izoenzima ili koji prolaze glukuronidacijuputem ljudskih uridin 5'-difosfoglukuronoziltransferaza (UGT).
One 
Jedna
How to use ADASUVE 
Kako primjenjivati ADASUVE
In placebo-controlled clinical trials in subjects with asthma or COPD, bronchospasm was very commonly observed. 
U placebom kontroliranom kliničkom ispitivanju u kojem su sudjelovali ispitanici oboljeli od astme ili KOPB-a, bronhospazam je bio učestalo opažan.
In the two Phase 3 studies patients were enrolled who had acute agitation of at least moderate level (14 or higher on Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) scale (poor impulse control, tension, hostility, uncooperativeness, and excitement). 
U dvama ispitivanjima Faze 3, bolesnici su uključeni prema akutnoj agitaciji najmanje umjerene razine (14 ili više bodova na ljestvici pozitivnih i negativnih sindroma (eng.
Directions for use inside 
Upute za uporabu se nalaze unutar pakiranja
Hypoventilation 
Hipoventilacija
• ever had muscle or eye movements you can't control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still 
• ste ikada imali pokrete mišića ili oka koje niste mogli kontrolirati, nedostatak koordinacije,
General: 
NAPOMENA:
How to store ADASUVE 
Kako čuvati ADASUVE
Uncommon: dystonia, dyskinesia, oculogyration, tremor, akathisia/restlessness 
Manje često: distonija, diskinezija, okulogiracija, tremor, akatizija/nemir Krvožilni poremećaji
However, in placebo-controlled clinical trials in subjects with mild-to-moderate persistent asthma or moderate-to-severe COPD, adverse reactions of bronchospasm were reported very commonly. 
Međutim, u placebom kontroliranim kliničkim ispitivanjima u ispitanika s blagom do umjerenom perzistentnom astmom ili umjerenim to teškim KOPD-om, nuspojave bronhospazma prijavljene su vrlo često.
• Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling • Educational material for the healthcare professionals 
• Sažetak opisa svojstava lijeka, Uputu o lijeku i označavanje
What ADASUVE looks like and contents of the pack ADASUVE 9.1 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine. 
ADASUVE 9,1 mg prašak inhalata, dozirani, sastoji se od jednodoznog bijelog plastičnog inhalatora za jednokratnu upotrebu koji sadrži loksapin.
For ADASUVE, the order of metabolites observed in humans (based on systemic exposure) was 8-OH-loxapine >> loxapine N oxide > 7-OH-loxapine > amoxapine, with plasma levels of 8-OH-loxapine similar to the parent compound. 
Poredak metabolita za ADASUVE opažen kod ljudi (na osnovi sistemske izloženosti) je bio 8-OH-loksapin >> loksapin
• Administration of a maximum of 2 doses 
Rizik od produljenja QT intervala: • Primjena najviše 2 doze lijeka
Two 
Dvije
Renal failure following oral loxapine overdosage has also been reported. 
Također su prijavljeni slučajevi zatajenja bubrega nakon predoziranja oralno primjenjivanim loksapinom.
None 
Nema.
Each single-dose inhaler contains 5 mg loxapine and delivers 4.5 mg of loxapine. 
Svaki jednodozni inhalator sadrži 5 mg loksapina i osigurava dozu od 4,5 mg loksapina.
Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg of loxapine. 
Svaki jednodozni inhalator sadrži 10 mg loksapina i osigurava dozu od 9,1 mg loksapina.
Each inhaler is provided in a sealed, multilaminate aluminum foil pouch. 
Inhalator se isporučuje u hermetički zatvorenoj, višeslojnoj vrećici od aluminijske folije.
AOP Orphan Pharmaceuticals AG BG Teл. 
Lietuva AOP Orphan Pharmaceuticals AG LT
2 hr post dose 
2 sata nakon doze
One single-dose inhaler 
Prašak inhalata Jedan jednodozni inhalator
These symptoms can be high fever, rigid muscles, 
Ti simptomi mogu biti visoka temperatura, krutost mišića, nepravilan ili ubrzan rad srca ili otkucaja srca.
What ADASUVE looks like and contents of the pack ADASUVE 4.5 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine. 
ADASUVE 4,5 mg prašak inhalata, dozirani, sastoji se od jednodoznog bijelog plastičnog inhalatora za jednokratnu upotrebu koji sadrži loksapin.
• if you have lung problems like asthma or chronic obstructive pulmonary disease (which your doctor may have called “COPD”). 
• ako imate poteškoća s plućima kao što su astma ili kronična opstruktivna plućna bolest (koju
Common: dizziness 
Često: omaglica
• medicines to treat schizophrenia, depression, or pain since you may be more at risk for seizures Using ADASUVE and adrenaline together may cause your blood pressure to drop. 
• lijekove za liječenje shizofrenije, depresije ili boli jer možete biti izloženiji riziku epileptičkih napadaja
Rescue 
Zbrinjavanje
Pull tab. 
Povucite trakicu.
ADASUVE 9.1 mg inhalation powder, pre-dispensed 
ADASUVE 9,1 mg prašak inhalata, dozirani
General disorders and administration site conditions Common: fatigue 
Opći poremećaji i reakcije na mjestu primjene Često: zamor
ADASUVE 4.5 mg inhalation powder, pre-dispensed 
ADASUVE 4,5 mg prašak inhalata, dozirani
Severe hypotension might be expected to respond to the administration of noradrenaline or phenylephrine. 
Kao odgovor na davanje noradrenalina i fenilefrina može se očekivati teška hipotenzija.
Name and address of the manufacturer responsible for batch release 
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet FERRER INTERNACIONAL, S.A.
Each inhaler delivers 9.1 mg loxapine. 
Svaki inhalator osigurava dozu od 9,1 mg loksapina.
1 single dose inhaler 
Prašak inhalata, dozirani 1 jednodozni inhalator
% CGI-I Responders 
CGI-I bolesnici s odgovorom
PEC Responders 
PEC bolesnici s odgovorom
The recommended initial dose of ADASUVE is 9.1 mg. A second dose can be given after 2 hours, if necessary. 
Preporučena početna doza lijeka ADASUVE je 9,1 mg.
ADASUVE 9.1 mg is supplied in a carton of 1 or 5 single dose inhalers. 
ADASUVE 9,1 mg se isporučuje u kutiji s 1 ili 5 jednodoznih inhalatora.
ADASUVE 9.1 mg inhalation powder, pre-dispensed loxapine 
ADASUVE 9,1 mg prašak inhalata, dozirani loksapin
ADASUVE 4.5 mg inhalation powder, pre-dispensed loxapine 
ADASUVE 4,5 mg prašak inhalata, dozirani loksapin
ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units. 
ADASUVE 9,1 mg se isporučuje u kutiji od 1 ili 5 inhalatora.
Each inhaler delivers 4.5 mg loxapine. 
Svaki inhalator osigurava dozu od 4,5 mg loksapina.
ADASUVE 4.5 mg is supplied in a carton of 1 or 5 single dose inhalers. 
ADASUVE 4,5 mg se isporučuje u kutiji s 1 ili 5 jednodoznih inhalatora.
The product is packaged in a sealed pouch. 
Inhalator je pakiran u hermetički zatvorenoj vrećici.
ADASUVE should be used with caution in patients with a known history of extrapyramidal symptoms. 
Kod bolesnika s poznatom povijesti ekstrapiramidalnih simptoma treba oprezno primjenjivati ADASUVE.
ADASUVE 4.5 mg is supplied in a carton of 1 or 5 units. 
ADASUVE 4,5 mg se isporučuje u kutiji od 1 ili 5 inhalatora.
Inhale Inhale through the mouthpiece with a steady deep breath. 
Udahne Udahne kroz nastavak za usta kontinuiranim dubokim udahom.
Tardive dyskinesia 
Ishodišna vrijednost
Open pouch. 
Otvorite vrećicu.
tramadol, mefloquine) 
meflokin)
LABELLING AND PACKAGE LEAFLET 
Sadržaj pakiranja i drugeinformacije
Vascular disorders 
Tardivna diskinezija
They will decide how much you need. 
Oni će odlučiti koliko Vam je potrebno.
(See also section 3) 
(također vidjeti dio 3)
This may cause bleeding. 
To može izazvati krvarenje.
D-24109 Kiel Germany 
D-24109 Kiel Njemačka
However, this finding is based on a very small sample (n=129 patients). 
Međutim, ovaj nalaz se temelji na vrlo malom uzorku (n=129 bolesnika).
- if your placenta is covering the birth canal. 
- ako placenta pokriva porođajni kanal.
Most of the treatment failures in CAP-001 were caused by poor tolerability. 
Većina slučajeva neuspješnog liječenja u CAP-001 bila je uzrokovana slabom podnošljivošću.
The following side effects may happen with this medicine: 
Sljedeće nuspojave mogu se dogoditi s ovim lijekom:
It is not known whether M1 accumulates in tissues. 
Nije poznato da li se M1 nakuplja u tkivima.
Tractocile contains atosiban. 
Tractocile sadrži atosiban.
Up to 270 mg 
sve do 270 mg
Do not use Tractocile: - if you are less than 24 weeks pregnant. 
Nemojte primjenjivati Tractocile: - ako ste trudni manje od 24 tjedna.
The benefit of atosiban in these subgroups is therefore uncertain. 
Stoga nije sigurna korist od atosibana u ovim podskupinama nesigurna.
Date of first authorisation: 20 January 2000 Date of latest renewal: 20 January 2010 
Datum posljednje obnove odobrenja: 20. siječnja 2010.
- if you are more than 33 weeks pregnant. 
- ako ste trudni više od 33 tjedna.
8]-oxytocin) which is a competitive antagonist of human oxytocin at receptor level. 
8]-oksitocin) koji je kompetitivni antagonist ljudskog oksitocina na razini receptora.
Do not use Tractocile if any of the above apply to you. 
Ne primjenjujte Tractocile ako se nešto od gore navedenog odnosi na Vas.
There are no known side effects on the unborn or new-born baby. 
Nisu poznate nuspojave u nerođenog ili novorođenog djeteta.
The most commonly reported adverse reaction in the mother is nausea (14 %). 
Najčešća prijavljena nuspojava kod majki je mučnina (14%).
The ratios of the main metabolite M1 (des-(Orn 
Omjer glavnog metabolita M1 (des-(Orn
- if you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6). 
- ako ste alergični na atosiban ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
It is not known whether the free fraction in the maternal and fetal compartments differs substantially. 
Nije poznato da li se slobodna frakcija odjeljka majke i fetusa značajno razlikuje.
- if you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you would also have fits (convulsions). 
- ako imate stanje koje se zove “eklampsija” koje je slično “teškoj preeklampsiji” ali također imate napadaje (konvulzije).
What Tractocile looks like and contents of the pack 
Kako Tractocile izgleda i sadržaj pakiranja
There is no known specific treatment in case of an overdose. 
Nije poznata specifična terapija u slučaju predoziranja.
- if you are between 24 and 27 weeks pregnant. 
- ako ste trudni između 24 i 27 tjedana.
Two metabolites were identified in the plasma and urine from human subjects. 
Dva su metabolita identificirana u plazmi i urinu ljudi.
Suspected intrauterine infection 
Suspektna intrauterina infekcija
Step Regimen 
Korak Režim
5% w/v glucose solution. 
5% w/v otopini glukoze.
MedDRA System Organ Class (SOC) 
MedDRA klasifikacija po organskim sustavima (SOC)
2300 København S Denmark 
2300 København S Danska
Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obavijestite svog liječnika, babicu ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
The exposure of the rat fetus was approximately four times that received by the human fetus during intravenous infusions in women. 
Izloženost fetusa štakora bila je otprilike četiri puta veća od one koju je primio ljudski fetus tijekom intravenske infuzije u žena.
This permits the continued independent control of the rate of infusion. 
Time se omogućava kontinuirani neovisni nadzor nad brzinom infuzije.
The highest atosiban subcutaneous dose not producing any adverse effects was approximately two times the therapeutic human dose. 
Najveća supkutana doza atosibana koja nije dovela do nepoželjnih učinaka bila je otprilike dva puta veća od humane terapijske doze.
Plasma protein binding of atosiban is 46 to 48% in pregnant women. 
Vezanje atosibana na proteine plazme u trudnica iznosi 46 do 48%.
Severe pre-eclampsia is when you have very high blood pressure, fluid retention and/or protein in your urine. 
Teška preeklampsija je kad imate visok krvni tlak, zadržavanje tekućine i/ili proteine u urinu.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Kao i svi lijekovi, ovaj lijek može izazvati nuspojave iako se neće javiti kod svakoga.
• Whenever the risk management system is modified, especially as the result of new informationbeing received that may lead to a significant change to the benefit/risk profile or as the result ofan important (pharmacovigilance or risk minimisation) milestone being reached. 
• Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
What Tractocile is and what it is used for 
Što je Tractocile i za što se koristi
- if you have or could have an infection of your womb (uterus). 
- ako imate ili bi mogli imati infekciju maternice (uterusa).
Metabolite M1 is excreted in milk (see section 4.6). 
Metabolit M1 se izlučuje u mlijeku (vidjeti dio 4.6).
Mean value of volume of distribution was 18.3 ± 6.8 litres. 
Srednja vrijednost volumena distribucije iznosila je 18,3 ± 6,8 litara.
The safety and efficacy of Tractocile in pregnant women aged less than 18 years have not been established. 
Sigurnost i djelotvornost lijeka Tractocile u trudnica mlađih od 18 godina nisu ustanovljene.
Rare (affects less than 1 in 1,000 people) - Your womb may be less able to contract after your baby has been born. 
Rijetko (pojavljuje se u manje od 1 na 1000 osoba) - Vaša maternica može imati smanjenu sposobnost kontrakcije nakon poroda.
Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms. 
Opisano je svega nekoliko slučajeva predoziranja atosibanom, koji su prošli bez specifičnih znakova i simptoma.
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. 
Čini se da ishod u fetusa i majke nije bio različit između skupina s atosibanom i -agonistom, ali klinička ispitivanja nisu imala dovoljnu snagu za isključivanje moguće razlike.
The following table shows the full posology of the bolus injection followed by the infusion: 
Sljedeća tablica prikazuje kompletno doziranje bolus injekcije, nakon koje slijedi infuzija:
There was no difference between the atosiban and betamimetic groups with regard to this parameter. 
Nije bilo razlike između skupina s atosibanom i betamimeticima s obzirom na ovaj parametar.
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). 
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).
- if your unborn baby (foetus) has an abnormal heart rate. 
- ako nerođeno dijete (fetus) ima poremećen srčani ritam.
Other medicines and Tractocile 
Drugi lijekovi i Tractocile:
Re-treatment with Tractocile is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see section 4.2). 
Moguće je ponovno liječenje lijekom Tractocile, ali dostupno je samo ograničeno kliničko iskustvo s višekratnim liječenjem, do ukupno 3 ponovna liječenja (vidjeti dio 4.2).
In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials. 
Ukupno 48% bolesnica liječenih atosibanom opisalo je nuspojave za vrijeme kliničkih ispitivanja.
Tractocile can be used to delay the premature birth of your baby. 
Tractocile se može koristiti za odgađanje prijevremenog poroda Vašeg djeteta.
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). 
Budući da sigurnost i djelotvornost atosibana u žena s gestacijskom dobi od manje od navršena 24 tjedna nije utvrđena u kontroliranim randomiziranim ispitivanjima, ne preporučuje se liječenje atosibanom u ovoj skupini (vidjeti dio 4.3).
• Periodic Safety Update Reports requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
Tractocile must not be used in the following conditions: 
Tractocile se ne smije primjenjivati kod sljedećih stanja:
Prepare new 100 ml bags in the same way as described to allow the infusion to be continued. 
Pripremite nove vrećice od 100 ml na isti način, kako biste mogli nastaviti s infuzijom.
Admission to a neonatal intensive care unit (NICU) was similar for both treatment groups (approximately 30%), as was length of stay and ventilation therapy. 
Prijem u jedinicu neonatalnog intenzivnog liječenja također je bio sličan za obje liječene skupine (otprilike 30%), kao i trajanje boravka i terapije respiratorom.
In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Tractocile depends on the assessment of fetal maturity. 
U slučaju intrauterinog zastoja u rastu, odluka o nastavku ili ponovnom započinjanju liječenja lijekom Tractocile ovisi o procjeni zrelosti fetusa.
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.). 
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.).
Children and adolescents Tractocile has not been studied in pregnant women less than 18 years old. 
Djeca i adolescenti Tractocile nije ispitivan u trudnica mlađih od 18 godina.
The total dose given during a full course of Tractocile therapy should preferably not exceed 330.75 mg of atosiban. 
Ukupna primijenjena doza tijekom kompletnog tijeka terapije lijekom Tractocile ne bi smjela biti veća od 330,75 mg atosibana.
Atosiban was neither oncogenic nor mutagenic in in vitro and in vivo tests. 
Atosiban nije bio onkogen, niti mutagen u in vitro i in vivo ispitivanjima.
If other medicinal products need to be given intravenously at the same time, the intravenous cannula can be shared or another site of intravenous administration can be used. 
Ukoliko je potrebno istovremeno intravensko davanje drugih lijekova, venski put se može dijeliti s drugim otopinama, ili se može upotrijebiti drugo mjesto za intravensku primjenu.
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). 
Jedanaest od 15 smrtnih slučajeva u skupini s atosibanom odnosilo se na trudnoće u gestacijskoj dobi od 20 do 24 tjedna, iako je distribucija bolesnica u ovoj podskupini bila nejednaka (19 žena na atosibanu, 4 na placebu).
Small amounts of atosiban have been shown to pass from plasma into the breast milk of breast-feeding women. 
Dokazano je da male količine atosibana prelaze iz plazme u majčino mlijeko dojilja.
Atosiban does not partition into red blood cells. 
Atosiban ne ulazi u crvene krvne stanice.