natgillin/translations-raw huggingface dataset:
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 -agonist groups, respectively (p=0.37).
Povprečna (SD) gestacijska starost ob porodu je bila v obeh skupinah enaka: 35,6 (3,9) tedna v skupini z atosibanom in 35,3 (4,2) tedna v skupini z -agonistom (p = 0,37).
How Tractocile will be given
Kako vam bo zdravilo Tractocile dano
- if you have bleeding from your vagina and your doctor wants your unborn baby to be delivered straight away.
- Če krvavite iz nožnice in zdravnik meni, da je treba porod opraviti takoj.
It is recommended that no more than three re-treatments should be used during a pregnancy.
Priporočljivo je, da se med nosečnostjo ponovno zdravljenje ne ponovi več kot trikrat.
Concentrate for solution for infusion (7.5 mg/ml)
koncentrat za raztopino za infundiranje (7,5 mg/ml)
In animals atosiban did not exhibit cardiovascular effects.
Pri živalih atosiban ni imel kardiovaskularnih učinkov.
The duration of the treatment should not exceed 48 hours.
Zdravljenje ne sme trajati več kot 48 ur.
For instructions on preparation of the medicinal product before administration, see section 6.6.
Način uporabe Za navodilo glede priprave zdravila pred dajanjem glejte poglavje 6.6.
There was no difference between the atosiban and betamimetic groups with regard to this parameter.
Skupini, ki sta prejemali atosiban in beta-mimetik, se v tem pogledu nista razlikovali.
In the case of persistence of uterine contractions during treatment with Tractocile, alternative therapy should be considered.
Če se kontrakcije maternice med zdravljenjem z zdravilom Tractocile nadaljujejo, je treba razmisliti o alternativni terapiji.
In patients with impaired hepatic function, atosiban should be used with caution.
Pri bolnicah z okvaro delovanja jeter je treba atosiban uporabljati previdno.
Other medicines and Tractocile
Druga zdravila in zdravilo Tractocile:
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
Sprostitev maternice se po atosibanu pojavi hitro in kontrakcije se v 10 minutah pomembno zmanjšajo, tako da je dosežena stabilna umiritev maternice ( 4 kontrakcije/uro) za 12 ur.
The infant adverse reactions were in the range of normal variation and were comparable with both placebo and betamimetic group incidences.
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.
If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Če uporabite infuzijsko vrečko z drugačnim volumnom, morate potrebne količine ustrezno preračunati.
The diluted solution must be used within 24 hours.
Razredčeno raztopino je treba uporabiti v 24-ih urah.
Tractocile is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Zdravilo Tractocile se uporablja pri odraslih nosečnicah od 24. do 33. tedna nosečnosti.
Intravenous therapy using the initial bolus injection of Tractocile 6.75 mg/0.9 ml, solution for injection (see Summary of Product Characteristics of this product) should be started as soon as possible after diagnosis of pre-term labour.
Intravensko zdravljenje z začetno bolusno injekcijo zdravila Tractocile 6,75 mg/0,9 ml raztopina za injiciranje (glejte povzetek glavnih značilnosti zdravila za to zdravilo) je treba začeti čimprej po diagnozi prezgodnjega poroda.
In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 5.2).
Pri bolnicah z okvaro delovanja jeter je treba atosiban uporabljati previdno (glejte poglavji 4.2 in 5.2).
The following side effects may happen with this medicine:
Pri uporabi tega zdravila se lahko pojavijo naslednji neželeni učinki:
Primary endpoint: the primary efficacy outcome was the proportion of women remaining undelivered and not requiring alternative tocolysis within 7 days of treatment initiation.
Primarni opazovani dogodek: Glavno merilo učinkovitosti je bil delež žensk, ki niso rodile in v 7 dneh od začetka zdravljenja niso potrebovale alternativnega tokolitičnega zdravljenja.
Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation.
Atosiban se sme uporabiti le, če je postavljena diagnoza prezgodnjega poroda med 24. in 33. dopolnjenim tednom gestacije.
Atosiban was neither oncogenic nor mutagenic in in vitro and in vivo tests.
V raziskavah in vitro ter in vivo atosiban ni deloval onkogeno ali mutageno.
Hydrochloric acid 1M Water for injections
1M klorovodikova kislina voda za injekcije
Withdraw 10 ml solution from a 100 ml infusion bag and discard.
Iz 100 ml infuzijske vrečke izvlecite 10 ml raztopine in jo zavrzite.
- if your unborn baby (foetus) has an abnormal heart rate.
- Če ima plod (fetus) nepravilen srčni utrip.
Tractocile 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
Zdravilo Tractocile je indicirano 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.
If any of the above apply to you (or you are not sure), talk to your doctor, midwife or pharmacist before you are given Tractocile.
Če se karkoli od navedenega nanaša na vas (ali ste negotovi), se posvetujte s svojim zdravnikom, z babico ali s farmacevtom preden prejmete zdravilo Tractocile.
The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocininduced uterine contractions in vitro.
Glavni presnovek M1 je pri in vitro zaviranju z oksitocinom povzročene kontrakcije maternice približno 10-krat manj učinkovit od atosibana.
- if you are pregnant with more than one baby.
- Če pričakujete več kot enega otroka (mnogoplodna nosečnost).
One pack contains one vial containing 0.9 ml solution.
Eno pakiranje vsebuje eno vialo z 0,9 ml raztopine.
One pack contains one vial containing 5 ml solution.
Eno pakiranje vsebuje eno vialo s 5 ml raztopine.
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.
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.
Mannitol, Hydrocloric acid, water for injections
Manitol, klorovodikova kislina in voda za injekcije.
Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of Tractocile 37.5 mg/5 ml, concentrate for solution for infusion).
Ko je bolus injiciran, je treba nadaljevati z infuzijo (glejte povzetek glavnih značilnosti zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje).
Dilutions for intravenous administration must be used within 24 hours after preparation.
Razredčeno raztopino za intravensko aplikacijo je treba uporabiti v 24 urah po pripravi.
What Tractocile contains - The active substance is atosiban.
Kaj vsebuje zdravilo Tractocile - Zdravilna učinkovina je atosiban.
After dilution, the concentration of atosiban is 0.75 mg/ml.
Po razredčenju je koncentracija atosibana 0,75 mg/ml.
No studies were performed that covered fertility and early embryonic development.
Študije, ki bi ocenile vpliv na plodnost in zgodnji razvoj zarodkov, niso bile izvedene.
- A reaction at the site where the injection was given.
- Reakcija na mestu injiciranja zdravila.
In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 4.4).
Pri bolnicah z okvaro delovanja jeter je treba atosiban uporabljati previdno (glejte poglavji 4.2 in 4.4).
- if your contractions start again, treatment with Tractocile can be repeated up to three more times.
- Če se popadki začnejo znova, se lahko zdravljenje z zdravilom Tractocile ponovi še največ trikrat.
The data show that 59.6% (n=201) and 47.7% (n=163) of atosiban- and -agonist-treated women (p=0.0004), respectively, were undelivered and did not require alternative tocolysis within 7 days of starting treatment.
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 atosiban, in 47,7 % (n = 163) žensk, ki so dobivale -agonist (p = 0,0004).
Mean value of volume of distribution was 18.3 ± 6.8 litres.
Srednja vrednost očistka je bila 41,8 ± 8,2 litrov/uro, srednja vrednost volumna porazdelitve pa 18,3 ± 6,8 litrov.
Psychiatric disorder
Psihiatrične motnje nespečnost
Talk to your doctor, midwife or pharmacist before you are given Tractocile: - if you think your waters might have broken (premature rupture of your membranes).
Preden prejmete zdravilo Tractocile, se posvetujte s svojim zdravnikom, z babico ali s farmacevtom: - Če menite, da vam je odtekla voda (predčasni razpok plodovega mehurja).
- Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.
- Nato boste prejeli kontinuirano (kapalno) infuzijo v odmerku 18 mg na uro.
To achieve accurate dosing, a controlled infusion device is recommended to adjust the rate of flow in drops/min.
Za natančno odmerjanje je priporočljivo uporabiti pripomoček za kontrolirano infundiranje, tako da je hitrost mogoče prilagajati v kapljicah na minuto.
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.
Pri zdravih, nenosečih preiskovankah, ki so dobile infuzijo atosibana (od 10 do 300 mikrogamov/min v 12 urah), so se plazemske koncentracije v stanju dinamičnega ravnovesja povečevale sorazmerno z odmerkom.
Embryo-fetal toxicity studies have not shown toxic effects of atosiban.
Pri študijah toksičnosti na zarodek/plod niso odkrili škodljivih vplivov atosibana.
The side effects seen in the mother are generally of a mild severity.
Pri materi so neželeni učinki običajno blagi.
Up to 45 hours subsequent intravenous infusion
3 Nadaljnja intravenska infuzija, ki traja do 45 ur
If you are not sure, talk to your doctor, midwife or pharmacist before you are given Tractocile.
Če ste kakorkoli negotovi, se posvetujte s svojim zdravnikom, z babico ali s farmacevtom, preden prejmete zdravilo Tractocile.
Rare (affects less than 1 in 1,000 people) - Your womb may be less able to contract after your baby has been born.
Redki (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 1.000 bolnic) - Manjša sposobnost krčenja maternice po porodu, kar lahko povzroči krvavitev.
Do not use this medicine if you notice particulate matter and discoloration prior to administration.
Ne uporabljajte tega zdravila, če opazite trdne delce ali spremembo barve.
Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and betamimetics, and/or in women with multiple pregnancy, have been reported post-marketing.
V obdobju po prihodu zdravila na trg so poročali o respiratornih zapletih, kot so dispneja in pljučni edem, še posebej v povezavi s sočasno uporabo drugih zdravil s tokolitičnim delovanjem, kot so antagonisti kalcijevih kanalčkov in beta-mimetiki, in/ali pri ženskah z večplodno nosečnostjo.
Tractocile is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Tractocile 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Tractocile 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Tractocile 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours.
Zdravilo Tractocile se aplicira intravensko v treh zaporednih korakih: začetni bolusni odmerek (6,75 mg) zdravila Tractocile 6,75 mg/0,9 ml raztopina za injiciranje, ki mu takoj sledi kontinuirana visokoodmerna infuzija (polnilna infuzija 300 mikrogramov/min) zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje, ki traja tri ure, in nato še infuzija z manjšim odmerkom zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje (nadaljnja infuzija 100 mikrogramov/min), ki traja do 45 ur.
Instructions for use Before using Tractocile, the solution should be examined to ensure it is clear and free from particles.
Pred uporabo zdravila Tractocile morate raztopino pregledati in se prepričati, da je bistra in ne vsebuje trdnih delcev.
How to store Tractocile
Shranjevanje zdravila Tractocile
It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.
Zdravilo zavira učinek naravnega hormona oksitocina, ki povzroča krčenje maternice (uterusa).
- A continuous infusion at a rate of 24 ml/hour is given for 3 hours.
- Kontinuirana infuzija v odmerku 24 ml/uro.
3 hours intravenous loading infusion
2 Intravenska polnilna infuzija, ki traja 3 ure
- If you have any further questions, ask your doctor, midwife or pharmacist.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, z babico (pomočnico pri porodu) ali s farmacevtom.
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.
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 pri uporabi atosibana podobna, kot pri uporabi beta-mimetikov.
0.9 ml intravenous bolus injection given over 1 minute
1 0,9 ml intravenska injekcija v obliki enominutnega bolusa
Tractocile can be used to delay the premature birth of your baby.
Zdravilo Tractocile se lahko uporabi za preprečitev prezgodnjega poroda.
Withdraw 0.9 ml of a 0.9 ml labelled vial of Tractocile 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.
Izvlecite 0,9 ml iz 0,9-ml označene viale zdravila Tractocile 6,75 mg/0,9 ml raztopina za injiciranje in aplicirajte počasi v intravenskem bolusu eno minuto pod ustreznim zdravniškim nadzorom na porodnem oddelku.
It is unlikely that atosiban inhibits hepatic cytochrome P450 isoforms in humans (see section 4.5).
Verjetnost, da bi atosiban pri človeku zaviral izoencime jetrnega citokroma P450, je majhna (glejte poglavje 4.5).
The reconstituted product is a clear, colourless solution without particles.
Zdravilo, pripravljeno za uporabo, je bistra, brezbarvna raztopina brez delcev.
Solution for injection (6.75 mg/0.9 ml) 1 vial
raztopina za injiciranje (6,75 mg/0,9 ml) 1 viala
In atosiban clinical trials no effects were observed on breast-feeding.
V kliničnih preskušanjih atosibana učinkov na dojenje niso opazili.
(accumulation of fluid in the lungs).
To lahko poveča tveganje za pljučni edem (nabiranje tekočine v pljučih).
In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials.
Med kliničnimi preskušanji so se neželeni učinki pojavili pri 48 % vseh bolnic, ki so se zdravile z atosibanom.
In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of Tractocile 6.75 mg/0.9 ml, solution for injection followed by infusion with Tractocile 37.5 mg/5 ml, concentrate for solution for infusion.
Če je potrebno ponovno zdravljenje z atosibanom, ga je treba zopet začeti z bolusno injekcijo zdravila Tractocile 6,75 mg/0,9 ml raztopina za injiciranje, ki ji sledi infuzija zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje.
During treatment with Tractocile, your contractions and your unborn baby's heart rate may be monitored.
Med zdravljenjem z zdravilom Tractocile bodo po potrebi nadzirali kontrakcije vaše maternice in srčno frekvenco ploda.
For the newborn, the clinical trials did not reveal any specific adverse reactions of atosiban.
Pri novorojenčkih klinična preskušanja niso pokazala nobenih specifičnih neželenih učinkov atosibana.
Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials.
V kliničnih preskušanjih so bili med uporabo atosibana opisani možni neželeni učinki atosibana pri materi.
One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.
Ena viala z raztopino za injiciranje vsebuje 0,9 ml raztopine, kar ustreza 6,75 mg atosibana.
Hypotension, Hot flush
Žilne bolezni hipotenzija, navali vročine
- if you have something called “severe pre-eclampsia” and your doctor wants your unborn baby to be delivered straight away.
- Če imate hudo preeklampsijo in zdravnik meni, da je treba porod opraviti takoj.
However, inadequate uterus contraction postpartum was not observed during the clinical trials.
Vendar med kliničnimi preskušanji niso poročali o nezadostnih kontrakcijah maternice po porodu.
Monitoring of uterine contractions and fetal heart rate during administration of atosiban and in case of persistent uterine contractions should be considered.
Med uporabo atosibana in v primeru trajnih kontrakcij maternice je treba razmisliti o nadziranju kontrakcij in spremljanju plodovega srčnega utripa.
In human pre-term labour, atosiban at the recommended dosage antagonises uterine contractions and induces uterine quiescence.
Pri prezgodnjem porodu pri človeku atosiban v priporočenem odmerjanju zavira kontrakcije maternice in maternico umiri.
The intravenous infusion is prepared by diluting Tractocile 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.
Raztopino zdravila za intravensko infuzijo se pripravi tako, da se zdravilo Tractocile 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.
Replace it by 10 ml Tractocile 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.
Nadomestite jo z 10 ml zdravila Tractocile 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 atosibana v 100 ml.
One vial of concentrate for solution for infusion contains 5 ml solution, corresponding to 37.5 mg atosiban.
Ena viala s koncentratom za raztopino za infundiranje vsebuje 5 ml raztopine, kar ustreza 37,5 mg atosibana.
Very common (affects more than 1 in 10 people) - feeling sick (nausea)
Zelo pogosti (neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnic) - Siljenje na bruhanje (navzea).
Tractocile 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.
Zdravilo Tractocile aplicirajte intravensko v treh zaporednih korakih: - Začetna intravenska injekcija 6,75 mg v 0,9 ml. Injicirajte počasi (tj. eno minuto) v veno.
Tractocile 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.
Zdravilo Tractocile 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.
12 hours.
ure.
- if your unborn baby has died.
- Če je plod odmrl.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja srbenje, kožni izpuščaj
Each ml of solution contains 7.5 mg atosiban.
En ml raztopine vsebuje 7,5 mg atosibana.
Atosiban passes the placenta.
Atosiban prehaja skozi placento.
6.1 List of excipients
6.1 Seznam pomožnih snovi manitol
This will mean your unborn baby needs to be delivered straight away.
V tem primeru je treba porod opraviti takoj.
- A continuous infusion at a rate of 8 ml/hour is given for up to 45 hours, or until the contractions of the uterus have subsided.
Infundiranje traja do 45 ur ali dokler kontrakcije uterusa ne popustijo.
The Tractocile 6.75 mg/0.9 ml, solution for injection should be used immediately.
Zdravilo Tractocile 6,75 mg/0,9 ml raztopina za injiciranje morate uporabiti takoj.
What Tractocile looks like and contents of the pack Tractocile 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles.
Zdravilo Tractocile 6,75 mg/0,9 ml raztopina za injiciranje je bistra, brezbarvna raztopina brez delcev.
Tractocile works by making the contractions in your womb (uterus) less strong.
Zdravilo Tractocile ublaži in zmanjša pogostnost materničnih kontrakcij (popadkov).
For intravenous infusion, following the bolus dose, Tractocile 37.5 mg/5 ml, concentrate for solution for infusion should be diluted in one of the following solutions: sodium chloride 9 mg/ml (0.9%) solution for injection Ringer's lactate solution
Za pripravo intravenske infuzije, ki sledi bolusnemu odmerku, je treba zdravilo Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje razredčiti z eno od naslednjih raztopin: - 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida, - raztopino Ringerjevega laktata, - 5-odstotno (w/v) raztopino glukoze.
Preparation of the intravenous infusion solution:
Priprava raztopine za intravensko infundiranje:
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Pri bolnicah z okvaro delovanja jeter ali ledvic ni izkušenj z uporabo atosibana.
Clear, colourless solution without particles.
raztopina za injiciranje (injekcija) Bistra, brezbarvna raztopina brez delcev.
One vial of 5 ml contains 37.5 mg of atosiban (as acetate).
Ena viala s 5 ml vsebuje 37,5 mg atosibana (v obliki acetata).
This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Tractocile 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.
Iz 100 ml infuzijske vrečke odstranite 10 ml raztopine in jo nadomestite z 10 ml zdravila Tractocile 37,5 mg/5 ml koncentrat za raztopino za infundiranje iz dveh 5 ml vial.
If you get any side effects, talk to your doctor, midwife or pharmacist.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, babico ali farmacevtom.
Once the vial has been opened, the dilution must be performed immediately.
Raztopino je treba uporabiti takoj po odprtju viale.
One vial of 0.9 ml contains 6.75 mg of atosiban (as acetate).
Ena viala z 0,9 ml vsebuje 6,75 mg atosibana (v obliki acetata).
Preparation of the intravenous infusion
Priprava raztopine za intravensko infundiranje
Österreich Ferring Arzneimittel Ges.m.b.H
Deutschland Ferring Arzneimittel GmbH
Reproductive system and breast disorder
Motnje reprodukcije in dojk maternična krvavitev, atonija maternice
- if you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you would also have fits (convulsions).
Bolezenski znaki eklampsije so podobni kot pri hudi preeklampsiji,
Nausea Vomiting
Bolezni prebavil navzea bruhanje
Concentrate for solution for infusion (sterile concentrate).
koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra, brezbarvna raztopina brez delcev.