FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of latest renewal: 28 May 2018
Slovenian: Datum zadnjega podaljšanja: 28. maj 2018
English: - If your placenta is covering the birth canal.
Slovenian: - Če posteljica (placenta) prekriva porodni kanal.
English: Atosiban must not be used in the following conditions:
Slovenian: Atozibana se ne sme uporabljati v naslednjih primerih:
English: - Allergic reactions.
Slovenian: - Alergijske reakcije.
English: The benefit of atosiban in these subgroups is therefore uncertain.
Slovenian: Koristi atozibana v teh podskupinah so zato negotove.
English: Do not throw away any medicines in wastewater or household waste.
Slovenian: Nobenega zdravila ne smete odvreči med odpadne vode ali gospodinjske odpadke.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 July 2013
Slovenian: Datum prve odobritve: 31 julij 2013
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Pred uporabo zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 - 8°C).
English: - High blood sugar.
Slovenian: - Zvišana vrednost krvnega sladkorja.
English: Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, babico ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: This may increase the risk of lung oedema (accumulation of fluid in the lungs).
Slovenian: To lahko poveča tveganje za pljučni edem (nabiranje tekočine v pljučih).
English: Atosiban is found in only small quantities in urine, its urinary concentration is about 50 times lower than that of M1.
Slovenian: Atoziban se v urinu pojavi le v majhni količini; njegova koncentracija v urinu je približno 50-krat manjša od koncentracije M1.
English: - Difficulty sleeping (insomnia).
Slovenian: - Motnje spanja (nespečnost).
English: The highest atosiban subcutaneous dose not producing any adverse effects was approximately two times the therapeutic human dose.
Slovenian: Največji subkutani odmerek atozibana, ki ni povzročil nobenih neželenih učinkov, je bil približno dvakrat večji od terapevtskega odmerka pri človeku.
English: In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of atosiban depends on the assessment of fetal maturity.
Slovenian: V primeru intrauterinega zavrtja rasti je odločitev za nadaljevanje ali ponoven začetek uporabe atozibana odvisna od ocene zrelosti ploda.
English: Pharmacotherapeutic group: Other gynecologicals, ATC code: G02CX01
Slovenian: Farmakoterapevtska skupina: Druga ginekološka zdravila, oznaka ATC: G02CX01
English: Atosiban SUN will be given to you in a hospital by a doctor, nurse or midwife.
Slovenian: Zdravilo Atoziban SUN vam bo v bolnišnici dal zdravnik, medicinska sestra ali babica.
English: - If you have or could have an infection of your womb (uterus).
Slovenian: - Če imate ali bi lahko imeli okužbo maternice (uterusa).
English: Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms.
Slovenian: Opisanih je bilo nekaj primerov prevelikega odmerjanja atozibana; potekali so brez specifičnih znakov ali simptomov.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not use if shrink wrap is tampered.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Ne uporabljajte, če je skrčljiva ovojnina poškodovana.
English: - If you are between 24 and 27 weeks pregnant.
Slovenian: - Če ste med 24. in 27. tednom nosečnosti.
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).
Slovenian: Pogostnost v nadaljevanju navedenih neželenih učinkov je navedena v skladu z naslednjim dogovorom: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000).
English: Mean value of volume of distribution was 18.3 ± 6.8 litres.
Slovenian: Srednja vrednost volumna porazdelitve je bila 18,3 ± 6,8 litrov.
English: Step
Slovenian: Korak
English: For women with a gestational age greater than 24 weeks there was no difference in mortality rate (1.7% in the placebo group and 1.5% in the atosiban group).
Slovenian: Pri ženskah z gestacijsko starostjo nad 24 tednov ni bilo razlik v umrljivosti (1,7 % v skupini s placebom in 1,5 % v skupini z atozibanom).
English: - If you are more than 33 weeks pregnant.
Slovenian: - Če ste noseči več kot 33 tednov.
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).
Slovenian: Ponovno zdravljenje z atozibanom je mogoče, vendar so klinične izkušnje z večkratnimi ponovitvami omejene (do 3 ponovitve zdravljenja) (glejte poglavje 4.2).
English: It also makes the contractions happen less often.
Slovenian: Prav tako zmanjša njihovo pogostnost.
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.
Slovenian: - Če ste noseči z več kot enim otrokom in/ali jemljete zdravila, ki lahko odložijo porod vašega otroka, kot so zdravila, ki se uporabljajo za zdravljenje povišanega krvnega tlaka.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Slovenian: 9 POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku.
English: Ranbaxy Pharmacie Generiques 11-15, Quai de Dion Bouton 92800 Puteaux
Slovenian: Ranbaxy Pharmacie Generiques 11-15, Quai de Dion Bouton
English: Treatment with atosiban should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Slovenian: Zdravljenje z atozibanom mora uvesti in voditi zdravnik, ki ima izkušnje z zdravljenjem prezgodnjega poroda.
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).
Slovenian: Ker pri ženskah z gestacijsko starostjo manj kot 24 dopolnjenih tednov varnost in učinkovitost atozibana nista bili dokazani z nadzorovanimi randomiziranimi študijami, pri tej skupini bolnic uporaba atozibana ni priporočljiva (glejte poglavje 4.3).
English: Do not use this medicine after the expiry date which is stated on the label after EXP {MM/YYYY}.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake Uporabno do {MM/LLLL}.
English: Atosiban SUN should not be mixed with other medicinal products in the infusion bag.
Slovenian: Zdravila Atoziban SUN ne smete mešati z drugimi zdravili v isti infuzijski vrečki.
English: Intravenous use For instructions on preparation of the medicinal product before administration, see section 6.6.
Slovenian: Intravenska uporaba Za navodilo glede priprave zdravila pred dajanjem glejte poglavje 6.6.
English: Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour.
Slovenian: Intravensko zdravljenje z začetno bolusno injekcijo je treba začeti čim prej po diagnozi prezgodnjega poroda.
English: Plasma protein binding of atosiban is 46 to 48% in pregnant women.
Slovenian: Pri nosečnicah se od 46 do 48 % atozibana veže na beljakovine v plazmi.
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).
Slovenian: Zato je treba atoziban v primeru večplodne nosečnosti in/ali sočasne uporabe drugih zdravil s tokolitičnim delovanjem uporabljati previdno (glejte poglavje 4.8).
English: - Fast heart beat.
Slovenian: - Hitro utripanje srca.
English: An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for atosiban.
Slovenian: Intravenska mikrokapalna komora lahko zagotavlja ustrezen razpon hitrosti infundiranja v priporočenih odmernih mejah za infundiranje atozibana.
English: - If you or your unborn baby have any other conditions where it would be dangerous to continue with your pregnancy.
Slovenian: - Če imate vi ali plod katero koli drugo bolezensko stanje, zaradi katerega je nadaljevanje nosečnosti tvegano.
English: - If you have kidney or liver problems.
Slovenian: - Če imate težave z ledvicami ali jetri.
English: When atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis.
Slovenian: Če se atoziban uporablja pri bolnicah, pri katerih ni mogoče izključiti prezgodnjega razpoka plodnega mehurja, je treba koristi odloženega poroda pretehtati v primerjavi z možnim tveganjem za horioamnionitis.
English: Following completion of the infusion, plasma concentration rapidly declined with an initial (tα) and terminal (tβ) half-life of 0.21 ± 0.01 and 1.7 ± 0.3 hours, respectively.
Slovenian: Po koncu infundiranja je koncentracija v plazmi hitro upadla z začetnim (tα) in s končnim razpolovnim časom (tβ) 0,21 ± 0,01 in 1,7 ± 0,3 ure.
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).
Slovenian: Klinična preskušanja III. faze (študije CAP-001) vključujejo podatke o 742 ženskah, pri katerih je bil diagnosticiran prezgodnji porod v obdobju od 23. do 33. tedna gestacije in so bile naključno razporejene tako, da so prejemale atoziban (odmerjanje v skladu s tem dokumentom) ali β-agonist (titracija odmerka).
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: 6.2 Inkompatibilnosti Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: Mean value for clearance was 41.8 ± 8.2 litres/h.
Slovenian: Srednja vrednost očistka je bila 41,8 ± 8,2 litrov/uro.
English: Eleven out of the 15 deaths in the atosiban group occurred in pregnancies with a gestational age of 20 to 24 weeks, although in this subgroup patient distribution was unequal (19 women on atosiban, 4 on placebo).
Slovenian: Enajst od 15 smrtnih primerov v skupini z atozibanom je bilo pri nosečnostih z gestacijsko starostjo od 20 do 24 tednov, čeprav je bila porazdelitev bolnic v tej podskupini neenakomerna (19 prejemnic atozibana, 4 prejemnice placeba).
English: In a placebo-controlled study, fetal/infant deaths were 5/295 (1.7%) in the placebo group and 15/288 (5.2%) in the atosiban group, of which two occurred at five and eight months of age.
Slovenian: V študiji, kontrolirani s placebom, je bilo v skupini s placebom 5 smrtnih primerov pri plodu/dojenčku (5/295; 1,7 %), v skupini z atozibanom pa 15 (15/288; 5,2 %), od tega dva v starosti pet in osem mesecev.
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).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: - If your unborn baby is small for the time of your pregnancy.
Slovenian: - Če je plod premajhen za pretečeni čas nosečnosti.
English: Children and adolescents Atosiban SUN has not been studied in pregnant women less than 18 years old.
Slovenian: Otroci in mladostniki Zdravilo Atoziban SUN ni bilo preskušeno pri nosečnicah, starih manj kot 18 let.
English: - If you are less than 24 weeks pregnant.
Slovenian: - Če ste noseči manj kot 24 tednov.
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.).
Slovenian: Pri dvotedenskih študijah toksičnosti (pri podganah in psih) z intravenskimi odmerki, ki so bili približno 10-krat večji od terapevtskega odmerka pri človeku, in pri trimesečnih študijah toksičnosti pri podganah in psih (do 20 mg/kg/dan s.c.) niso ugotovili sistemskih toksičnih učinkov.
English: Small amounts of atosiban have been shown to pass from plasma into the breast milk of breast-feeding women.
Slovenian: Atoziban v majhnih količinah prehaja iz plazme v materino mleko.
English: 8 ml/hour (100 μg/min)
Slovenian: 8 ml/uro (100 µg/min)
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%).
Slovenian: Neuspešno zdravljenje zaradi nezadostne učinkovitosti je bilo značilno pogostejše (p = 0,0003) pri ženskah, ki so dobivale atoziban (n = 48, 14,2 %), kot pri ženskah, ki so dobivale β-agonist (n = 20, 5,8 %).
English: What Atosiban SUN is and what it is used for
Slovenian: Kaj je zdravilo Atoziban SUN in za kaj ga uporabljamo
English: Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine.
Slovenian: V primeru okvare ledvic odmerka verjetno ni treba prilagajati, saj se atoziban le v majhnem obsegu izloča z urinom.
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.
Slovenian: Sprostitev maternice se po atozibanu pojavi hitro in kontrakcije se v 10 minutah pomembno zmanjšajo, tako da je dosežena stabilna umiritev maternice (≤ 4 kontrakcije/uro) za 12 ur.
English: There was no difference between the atosiban and beta-mimetic groups with regard to this parameter.
Slovenian: Skupini, ki sta prejemali atoziban in beta-mimetik, se v tem pogledu nista razlikovali.
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.
Slovenian: Znano je, da sta mnogoplodna nosečnost in uporaba zdravil s tokolitičnim delovanjem, kot so zaviralci kalcijevih kanalčkov in beta-mimetiki, povezani z večjim tveganjem za pljučni edem.
English: No clinically relevant interaction was found between atosiban and bethamethasone or labetalol.
Slovenian: Klinično pomembnih interakcij med atozibanom in betametazonom ali labetalolom niso opazili.
English: Following an infusion of 300 micrograms/min in healthy pregnant women at term, the fetal/maternal atosiban concentration ratio was 0.12.
Slovenian: Po infuziji 300 mikrogramov/min zdravim nosečnicam ob roku je bilo razmerje med koncentracijo atozibana pri plodu in materi 0,12.
English: The safety and efficacy of atosiban in pregnant women aged less than 18 years have not been established.
Slovenian: Varnost in učinkovitost atozibana pri nosečnicah, starih manj kot 18 let, nista bili dokazani.
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.
Slovenian: Razmerje med koncentracijo glavnega presnovka M1 (des-(Orn8, Gly-NH2 9) -29)-[Mpa1, D-Tyr(Et)2, Thr4]-oksitocin) in atozibana v plazmi je bilo po dveh urah 1,4 in na koncu infundiranja 2,8.
English: Clear, colourless solution without particles.
Slovenian: Bistra, brezbarvna raztopina brez delcev.
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).
Slovenian: Od 361 žensk, zdravljenih z atozibanom v študijah III. faze, je bilo zdravljenje ponovljeno vsaj enkrat pri 73 ženskah, vsaj dvakrat pri 8 ženskah, vsaj trikrat pa pri 2 ženskah (glejte poglavje 4.4).
English: There is only limited clinical experience in the use of atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated.
Slovenian: Klinične izkušnje z uporabo atozibana pri mnogoplodnih nosečnostih ali v gestacijski starosti od 24. do 27. tedna so zaradi majhnega števila zdravljenih bolnic omejene.
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).
Slovenian: - Če ste alergični na atoziban ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Up to 270 mg intravenous infusion
Slovenian: do 270 mg
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.
Slovenian: Izid za plod in mater se v skupini z atozibanom po vsem sodeč ni razlikoval od izida v skupini z β agonistom, toda moč kliničnih preskušanj ni bila tolikšna, da bi izključila možno razliko.
English: UB3 4AZ HAYES United Kingdom tel. +44 (0) 208 848 8688
Slovenian: United Kingdom tel. +44 (0) 208 848 8688
English: Diluted solution for intravenous administration should be used within 24 hours after preparation.
Slovenian: Razredčeno raztopino za intravensko aplikacijo je treba uporabiti v 24 urah po pripravi.
English: In rats and guinea pigs, atosiban was shown to bind to oxytocin receptors, to decrease the frequency of contractions and the tone of the uterine musculature, resulting in a suppression of uterine contractions.
Slovenian: Pri podganah in budrah je dokazano, da se atoziban veže na receptorje za oksitocin, zmanjša pogostnost kontrakcij in tonus materničnega mišičja in tako zavre kontrakcije maternice.
English: Other medicines and Atosiban SUN
Slovenian: Druga zdravila in zdravilo Atoziban SUN
English: In women in pre-term labour receiving atosiban by infusion (300 micrograms/min for 6 to 12 hours), steady state plasma concentrations were reached within one hour following the start of the infusion (mean 442 ± 73 ng/ml, range 298 to 533 ng/ml).
Slovenian: Pri ženskah s prezgodnjim porodom, ki so dobile infuzijo atozibana (300 mikrogramov/min od 6 do12 ur), so bile plazemske koncentracije v stanju dinamičnega ravnovesja dosežene v eni uri po začetku infuzije (povprečno 442 ± 73 ng/ml, razpon od 298 do 533 ng/ml).
English: The total dose given during a full course of atosiban therapy should preferably not exceed 330.75 mg of atosiban.
Slovenian: Skupni odmerek atozibana med celotnim ciklusom zdravljenja z atozibanom naj ne bi presegel 330,75 mg.
English: In patients with impaired hepatic function, atosiban should be used with caution.
Slovenian: Pri bolnicah z okvaro delovanja jeter je treba atoziban uporabljati previdno.
English: Atosiban SUN is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Slovenian: Zdravilo Atoziban SUN se uporablja pri odraslih nosečnicah od 24. do 33. tedna nosečnosti.
English: After dilution, the concentration of atosiban is 0.75 mg/ml.
Slovenian: Po razredčenju je koncentracija atozibana 0,75 mg/ml.
English: In animals atosiban did not exhibit cardiovascular effects.
Slovenian: Pri živalih atoziban ni imel kardiovaskularnih učinkov.
English: There are no known side effects on the unborn or newborn baby.
Slovenian: Pri plodu ali novorojenčku ni znanih neželenih učinkov.
English: As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored.
Slovenian: Atoziban bi kot antagonist oksitocina teoretično lahko povzročil atonijo maternice in poporodno krvavitev, zato je po porodu treba nadzirati izgubo krvi.
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.
Slovenian: Če se karkoli od navedenega nanaša na vas (ali ste negotovi), se posvetujte s svojim zdravnikom, z babico ali s farmacevtom preden prejmete zdravilo Atoziban SUN.
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
Slovenian: Kaj je zdravilo Atoziban SUN in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Atoziban SUN Kako vam bo zdravilo Atoziban SUN dano
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Slovenian: FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje (sterilni koncentrat)
English: - If you have bleeding from your vagina and your doctor wants your unborn baby to be delivered straight away.
Slovenian: - Če krvavite iz nožnice in zdravnik meni, da je treba porod opraviti takoj.
English: - If your placenta is detaching from the wall of your womb.
Slovenian: - Če se je posteljica odluščila od stene maternice.
English: Cluj-Napoca, Judeţul Cluj România tel. +40 (264) 501 500
Slovenian: România tel. +40 (264) 501 500
English: Before using Atosiban SUN, the solution should be examined to ensure it is clear and free from particles.
Slovenian: Pred uporabo zdravila Atoziban SUN morate raztopino pregledati in se prepričati, da je bistra in ne vsebuje trdnih delcev.
English: The infant adverse reactions were in the range of normal variation and were comparable with both placebo and beta-mimetic group incidences.
Slovenian: Neželeni učinki pri dojenčkih so bili v območju normalnih variacij in po pogostnosti primerljivi s tistimi v skupini, ki je prejemala placebo in v skupini, ki je prejemala beta-mimetik.
English: In the case of persistence of uterine contractions during treatment with atosiban, alternative therapy should be considered.
Slovenian: Če se kontrakcije maternice med zdravljenjem z atozibanom nadaljujejo, je treba razmisliti o alternativni terapiji.
English: The diluted solution must be used within 24 hours.
Slovenian: Razredčeno raztopino morate porabiti v 24 urah.
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).
Slovenian: Povprečna (SD) porodna masa je bila v skupini z atozibanom2.491 (813) gramov in v skupini z β-agonistom 2.461 (831) gramov (p = 0,58).
English: The proportion of atosiban eliminated in faeces is not known.
Slovenian: Delež v blatu izločenega atozibana ni znan.
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.
Slovenian: Če nosečnica še doji prejšnjega otroka, mora med zdravljenjem z atozibanom prenehati dojiti, saj lahko izločanje oksitocina med dojenjem okrepi maternične kontrakcije in nasprotuje učinkom tokolitičnega zdravljenja.
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.
Slovenian: Pri zdravih, nenosečih preiskovankah, ki so dobile infuzijo atozibana (od 10 do 300 mikrogramov/min v 12 urah), so se plazemske koncentracije v stanju dinamičnega ravnovesja povečevale sorazmerno z odmerkom.
English: The side effects seen in the mother are generally mild.
Slovenian: Pri materi so neželeni učinki običajno blagi.