FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Intravensko zdravljenje z začetno bolusno injekcijo zdravila atozibana 6,75 mg/0,9 ml raztopina za injiciranje (glejte povzetek glavnih značilnosti zdravila za to zdravilo) je treba začeti čim prej po diagnozi prezgodnjega poroda.
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.
Slovenian: P450 je majhna, saj in vitro raziskave kažejo, da atoziban ni substrat za encime citokrom P450 in ne zavira encimov citokrom P450, ki presnavljajo zdravila.
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).
Slovenian: Povprečna (SD) gestacijska starost ob porodu je bila v obeh skupinah enaka: 35,6 (3,9) tedna v skupini z atozibanom in 35,3 (4,2) tedna v skupini z β-agonistom (p = 0,37).
English: Treatment with Atosiban SUN can be repeated up to three more times.
Slovenian: Zdravljenje z zdravilom Atoziban SUN se lahko ponovi še največ trikrat.
English: - If your unborn baby (foetus) has an abnormal heart rate.
Slovenian: - Če ima plod (fetus) nepravilen srčni utrip.
English: In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 5.2).
Slovenian: Pri bolnicah z okvaro delovanja jeter je treba atoziban uporabljati previdno (glejte poglavji 4.2 in 5.2).
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
Slovenian: Atoziban je indiciran za odložitev iminentnega prezgodnjega poroda pri odraslih nosečnicah z: - rednimi kontrakcijami maternice, ki trajajo vsaj 30 sekund, s pogostnostjo ≥ 4 na 30 minut; - odprtjem materničnega vratu od 1 do 3 cm (od 0 do 3 cm pri ženskah, ki še niso rodile) in stanjšanjem za ≥ 50 %; - gestacijsko starostjo od 24 do 33 dopolnjenih tednov - normalno srčno frekvenco ploda
English: 1 vial (6.75 mg/0.9 ml)
Slovenian: 1 viala (6,75 mg/0,9 ml)
English: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/ Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Slovenian: 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: - The other ingredients are mannitol, hydrochloric acid 1M and water for injections.
Slovenian: - Pomožne snovi so manitol, klorovodikova kislina 1M in voda za injekcije.
English: Atosiban was neither oncogenic nor mutagenic in in vitro and in vivo tests.
Slovenian: V raziskavah in vitro in in vivo atoziban ni deloval onkogeno ali mutageno.
English: The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocin-induced uterine contractions in vitro.
Slovenian: Glavni presnovek M1 je pri in vitro zaviranju z oksitocinom povzročene kontrakcije maternice približno 10-krat manj učinkovit od atozibana.
English: Rare (may affect less than 1 in 1,000 people) - Your womb may be less able to contract after your baby has been born.
Slovenian: Redki (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 1.000 bolnic) - Po porodu se lahko zmanjša sposobnost maternice za skrčitev.
English: The reconstituted medicinal product is a clear, colourless solution without particles.
Slovenian: Zdravilo, pripravljeno za uporabo, je bistra, brezbarvna raztopina brez delcev.
English: One pack contains one vial containing 5 ml solution.
Slovenian: Eno pakiranje vsebuje eno vialo z 5 ml raztopine.
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).
Slovenian: Ko je bolus injiciran, je treba nadaljevati z infuzijo (glejte povzetek glavnih značilnosti zdravila Atoziban SUN 37,5 mg/5 ml koncentrat za raztopino za infundiranje).
English: In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 4.4).
Slovenian: Pri bolnicah z okvaro delovanja jeter je treba atoziban uporabljati previdno (glejte poglavji 4.2 in 4,4).
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.
Slovenian: Podatki kažejo, da ni rodilo in v 7 dneh po začetku zdravljenja ni potrebovalo alternativnega tokolitičnega zdravljenja 59,6 % (n = 201) žensk, ki so dobivale atoziban, in 47,7 % (n = 163) žensk, ki so dobivale β-agonist (p = 0,0004).
English: The loading infusion is given by infusing 24 ml/hour (i.e. 18 mg/h) of the above prepared solution over the 3 hour period under adequate medical supervision in an obstetric unit.
Slovenian: Polnilna infuzija se aplicira z infundiranjem tako pripravljene raztopine s hitrostjo 24 ml/uro (tj.18 mg/uro) v 3 urah pod ustreznim zdravniškim nadzorom na porodnem oddelku.
English: - If your waters have broken (premature rupture of your membranes) and you have completed
Slovenian: - Če menite, da vam je odtekla voda (predčasni razpok plodovega mehurja).
English: LIST OF EXCIPIENTS Excipients: mannitol, hydrochloric acid 1M, water for injections.
Slovenian: Pomožne snovi: manitol, klorovodikova kislina 1M, voda za injekcije.
English: Colourless tubular glass vial (type I) with bromobutyl flange grey rubber stopper and sealed with flip off violet colour aluminium seal.
Slovenian: Viala iz brezbarvnega, prozornega cevkastega stekla (tip I) zaprta s sivim bromobutilnim gumijastim zamaškom in zatesnjena z aluminijasto zaporko »flip off« vijolične barve.
English: - If your contractions start again, treatment with Atosiban SUN can be repeated up to three more times.
Slovenian: - Če se popadki začnejo znova, se lahko zdravljenje z zdravilom Atoziban SUN ponovi še največ trikrat.
English: It is unlikely that atosiban inhibits hepatic cytochrome P450 isoforms in humans (see section 4.5).
Slovenian: Verjetnost, da bi atoziban pri človeku zaviral izoencime jetrnega citokroma P450, je majhna (glejte poglavje 4.5).
English: Embryo-fetal toxicity studies have not shown toxic effects of atosiban.
Slovenian: Pri študijah toksičnosti na zarodek/plod niso odkrili škodljivih vplivov atozibana.
English: Severe pre-eclampsia is when you have very high blood pressure,
Slovenian: Bolezenski znaki eklampsije so podobni kot pri hudi preeklampsiji,
English: The following information is intended for healthcare professionals only: (See also section 3)
Slovenian: NAVODILA ZA ZDRAVSTVENO OSEBJE Naslednje informacije so namenjene samo zdravstvenemu osebju:
English: - If you have any further questions, ask your doctor, midwife or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, z babico (pomočnico pri porodu) ali farmacevtom.
English: 45 hours, or until your contractions have stopped.
Slovenian: Ta infuzija bo trajala do 45 ur ali dokler kontrakcije maternice ne bodo minile.
English: In the CAP-001 studies the probability of remaining undelivered and not requiring alternative tocolytics within 7 days of treatment initiation was similar for atosiban and beta-mimetics treated women at gestational age of 24-28 weeks.
Slovenian: Verjetnost, da ne pride do poroda in da v 7 dneh od začetka zdravljenja niso potrebni alternativni tokolitiki, je bila v študijah CAP-001 pri ženskah, zdravljenih v obdobju od 24. do 28. tedna gestacije,
English: Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation.
Slovenian: Atoziban se sme uporabiti le, če je postavljena diagnoza prezgodnjega poroda med 24. in33.
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.
Slovenian: Če je potrebno ponovno zdravljenje z atozibanom, ga je treba zopet začeti z bolusno injekcijo atozibana 6,75 mg/0,9 ml raztopina za injiciranje, ki ji sledi infuzija atozibana 37,5 mg/5 ml koncentrat za raztopino za infundiranje.
English: 02-954 Warszawa Polska tel. +48 22 642 07 75
Slovenian: Polska tel. +48 22 642 07 75
English: - If you are pregnant with more than one baby.
Slovenian: - Če pričakujete več kot enega otroka (mnogoplodna nosečnost).
English: SPECIAL STORAGE CONDITIONS
Slovenian: 9 POSEBNA NAVODILA ZA SHRANJEVANJE
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.
Slovenian: Izvlecite 0,9 ml iz 0,9-ml označene viale atozibana 6,75 mg/0,9 ml raztopina za injiciranje in aplicirajte počasi v intravenskem bolusu eno minuto pod ustreznim zdravniškim nadzorom na porodnem oddelku.
English: In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials.
Slovenian: Med kliničnimi preskušanji so se neželeni učinki pojavili pri 48 % vseh bolnic, ki so se zdravile z atozibanom.
English: Uncommon (may affect less than 1 in 100 people) - High temperature (fever).
Slovenian: Občasni (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 100 bolnic) - Zvišana telesna temperatura (vročina).
English: For the newborn, the clinical trials did not reveal any specific adverse reactions of atosiban.
Slovenian: Pri novorojenčkih klinična preskušanja niso pokazala nobenih specifičnih neželenih učinkov atozibana.
English: Common (may affect less than 1 in 10 people) - Headache.
Slovenian: Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 10 bolnic) - Glavobol.
English: - Being sick (vomiting).
Slovenian: - Slabost (bruhanje).
English: If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Atosiban SUN.
Slovenian: Nosečnost in dojenje Če ste noseči in dojite starejšega otroka, boste morali prenehati z dojenjem, dokler dobivate zdravilo
English: - Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to
Slovenian: - Nato boste prejeli še drugo kontinuirano (kapalno) infuzijo v odmerku 6 mg na uro.
English: Atosiban SUN works by making the contractions in your womb (uterus) weaker.
Slovenian: Zdravilo Atoziban SUN ublaži maternične kontrakcije (popadke).
English: 54 mg infusion Up to 45 hours subsequent
Slovenian: Nadaljnja do 45 ur intravenska infuzija
English: OTHER EU/1/13/852/001
Slovenian: DRUGI PODATKI EU/1/13/852/001
English: Atosiban passes the placenta.
Slovenian: Atoziban prehaja skozi placento.
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.
Slovenian: Raztopino zdravila za intravensko infuzijo se pripravi tako, da se zdravilo Atobisan SUN 37,5 mg/5 ml koncentrat za raztopino za infundiranje razredči v 9 mg/ml (0,9 %) raztopini natrijevega klorida za injiciranje, raztopini Ringerjevega laktata ali 5 % (w/v) raztopini glukoze.
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.
Slovenian: Zdravilo Atoziban SUN vsebuje atoziban (INN), sintetičen peptid ([Mpa1, D-Tyr(Et)2, Thr4,Orn8]
English: OTHER EU/1/13/852/002
Slovenian: DRUGI PODATKI EU/1/13/852/002
English: - If you have something called “severe pre-eclampsia” and your doctor wants your unborn baby to be delivered straight away.
Slovenian: - Če imate hudo preeklampsijo in zdravnik meni, da je treba porod opraviti takoj.
English: The atosiban 6.75 mg/0.9 ml solution for injection should be used immediately.
Slovenian: Atoziban 6,75 mg/0,9 ml raztopina za injiciranje morate uporabiti takoj.
English: How to store Atosiban SUN
Slovenian: Shranjevanje zdravila Atoziban SUN
English: What you need to know before you are given Atosiban SUN
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Atoziban SUN Ne smete prejeti zdravila Atoziban SUN
English: During treatment with Atosiban SUN, your contractions and your unborn baby's heart rate may be monitored.
Slovenian: Med zdravljenjem z zdravilom Atoziban SUN bodo po potrebi nadzirali kontrakcije vaše maternice in srčno frekvenco ploda.
English: For storage conditions after first opening and dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po prvem odprtju in redčenju zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: In atosiban clinical trials no effects were observed on breast-feeding.
Slovenian: V kliničnih preskušanjih atozibana učinkov na dojenje niso opazili.
English: Do not use Atosiban SUN if you notice particulate matter and discoloration prior to administration.
Slovenian: Ne uporabljajte zdravila Atoziban SUN, če opazite trdne delce ali spremembo barve.
English: Atosiban dose
Slovenian: po razredčitvi
English: Reproductive system and breast disorder
Slovenian: Motnje reprodukcije in dojk maternična krvavitev,
English: Monitoring of uterine contractions and fetal heart rate during administration of atosiban and in case of persistent uterine contractions should be considered.
Slovenian: Med uporabo atozibana in v primeru trajnih kontrakcij maternice je treba razmisliti o nadziranju kontrakcij in spremljanju plodovega srčnega utripa.
English: Atosiban SUN is used to delay the premature birth of your baby.
Slovenian: Zdravilo Atoziban SUN se uporablja za preprečitev prezgodnjega poroda.
English: Very common (may affect more than 1 in 10 people) - Feeling sick (nausea).
Slovenian: Zelo pogosti (neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnic) - Siljenje na bruhanje (navzea).
English: Ranbaxy Italia S.p.A. Viale Giulio Richard, 1 20143 Milano Italia tel. +39 02 33 49 07 93
Slovenian: Viale Giulio Richard, 1 20143 Milano
English: If you get any side effects, talk to your doctor, midwife or pharmacist.
Slovenian: Če opazite katerega koli izmedneželenih učinkov, se posvetujte z zdravnikom, z babico ali farmacevtom.
English: It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.
Slovenian: Zdravilo zavira učinek naravnega hormona oksitocina, ki povzroča krčenje maternice
English: One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.
Slovenian: Ena viala z raztopino za injiciranje vsebuje 0,9 ml raztopine, kar ustreza 6,75 mg atozibana.
English: Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials.
Slovenian: V kliničnih preskušanjih so bili med uporabo atozibana opisani možni neželeni učinki atozibana pri materi.
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.
Slovenian: - Ena viala zdravila Atoziban SUN 6,75 mg/0,9 ml raztopina za injiciranje vsebuje atozibanijev acetat, ki ustreza 6,75 mg atozibana v 0,9 ml.
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.
Slovenian: Izgled zdravila Atoziban SUN in vsebina pakiranja Zdravilo Atoziban SUN 37,5 mg/5 ml koncentrat za raztopino za infundiranje je bistra, brezbarvna raztopina brez delcev.
English: In human pre-term labour, atosiban at the recommended dose antagonises uterine contractions and induces uterine quiescence.
Slovenian: Pri prezgodnjem porodu pri človeku atoziban v priporočenem odmerjanju zavira kontrakcije maternice in maternico umiri.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/852/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/852/001
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.
Slovenian: Nadomestite jo z 10 ml atozibana 37,5 mg/5 ml koncentrat za raztopino za infundiranje, ki jih dobite iz dveh 5 ml vial, tako da bo končna koncentracija 75 mg atozibana v 100 ml.
English: One vial of concentrate for solution for infusion contains 5 ml solution, corresponding to 37.5 mg atosiban.
Slovenian: Ena viala s koncentratom za raztopino za infundiranje vsebuje 5 ml raztopine, kar ustreza 37,5 mg atozibana.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/852/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/852/002
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Ολλανδία/Nizozemska/The Netherlands/Holland/
Slovenian: Nederlandene/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/
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.
Slovenian: - Ena viala zdravila Atoziban SUN 37,5 mg/5 ml koncentrat za raztopino za injiciranje vsebuje atozibanijev acetat, ki ustreza 37,5 mg atozibana v 5 ml.
English: 30 weeks of your pregnancy or more.
Slovenian: - Če vam je odtekla voda (predčasni razpok plodovega mehurja), noseči pa ste že 30 tednov ali dlje.
English: This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Atosiban SUN 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.
Slovenian: Iz 100 ml infuzijske vrečke odstranite 10 ml raztopine in jo nadomestite z 10 ml zdravila Atobisan SUN 37,5 mg/5 ml koncentrat za raztopino za infundiranje iz dveh 5 ml vial, da dobite koncentracijo 75 mg atozibana na 100 ml.
English: What Atosiban SUN contains - The active substance is atosiban.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Atoziban SUN - Učinkovina je atoziban.
English: Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/
Slovenian: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/
English: fluid retention and/or protein in your urine.
Slovenian: Za hudo preeklampsijo (nosečnostna toksemija) so značilni zelo visok krvni tlak, zastajanje tekočin in/ali prisotnost beljakovin v urinu.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po prvem odprtju zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: Patients with renal or liver impairment
Slovenian: Bolnice z okvaro ledvic ali jeter
English: Name and address of the manufacturer(s) responsible for batch release Sun Pharmaceutical Industries Europe B.V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sun Pharmaceutical Industries Europe B.V.
English: Atosiban must not be used in the following conditions: - 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.
Slovenian: Atozibana se ne sme uporabljati v naslednjih primerih: - gestacijska starost pod 24 ali nad 33 dopolnjenih tednov, - prezgoden razpok plodnega mehurja > 30 tednov gestacije, - nenormalna srčna frekvenca ploda, - predporodna maternična krvavitev, ki zahteva takojšen porod, - eklampsija ali huda preeklampsija, ki zahtevata porod,
English: - If your unborn baby has died.
Slovenian: - Če je plod odmrl.
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.
Slovenian: - gestacijska starost pod 24 ali nad 33 dopolnjenih tednov, - prezgoden razpok plodnega mehurja > 30 tednov gestacije, - nenormalna srčna frekvenca ploda, - predporodna maternična krvavitev, ki zahteva takojšen porod, - eklampsija ali huda preeklampsija, ki zahtevata porod,
English: Once the vial has been opened, the medicinal product must be used straight away.
Slovenian: Zdravilo je treba uporabiti takoj po odprtju viale.
English: France tel. +33 1 41 44 44 50
Slovenian: 92800 Puteaux France tel. +33 1 41 44 44 50 Italia
English: What Atosiban SUN looks like and contents of the pack Atosiban SUN 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles.
Slovenian: Zdravilo Atoziban SUN 6,75 mg/0,9 ml raztopina za injiciranje je bistra, brezbarvna raztopina brez delcev.
English: Each ml of solution contains 7.5 mg atosiban.
Slovenian: En mililiter raztopine vsebuje 7,5 mg atozibana.
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.
Slovenian: Zdravilo Atoziban SUN aplicirajte intravensko v treh zaporednih korakih: - Začetna intravenska injekcija 6,75 mg v 0,9 ml. Injicirajte počasi (tj. eno minuto) v veno.
English: - Your womb may be less able to contract after your baby has been born.
Slovenian: - Po porodu se lahko zmanjša sposobnost maternice za skrčitev.
English: - Rash.
Slovenian: - Srbenje.
English: There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Slovenian: Pri bolnicah z okvaro delovanja jeter ali ledvic ni izkušenj z uporabo atozibana.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje.
English: - Hot flushes.
Slovenian: - Navali vročine.
English: Atosiban does not partition into red blood cells.
Slovenian: Atoziban se ne porazdeli v eritrocite.
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.
Slovenian: Zdravilo Atoziban SUN boste prejeli v veno (intravensko) v treh korakih: - Najprej boste v veno prejeli počasno injekcijo s 6,75 mg v 0,9 ml. Injiciranje zdravila bo trajalo eno minuto.
English: Atosiban SUN contains atosiban.
Slovenian: Atoziban SUN.
English: Hydrochloric acid 1M
Slovenian: 1M klorovodikova kislina voda za injekcije
English: - Itching.
Slovenian: (uterusa).
English: If you are not sure, talk to your doctor, midwife or pharmacist before you are given Atosiban SUN.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom, z babico ali farmacevtom, preden prejmete zdravilo
English: Patients with renal or hepatic impairment
Slovenian: Posebne skupine bolnikov Bolnice z okvaro ledvic ali jeter