natgillin/translations-raw huggingface dataset:
(Starter pack 21 tablets, valproate add-on therapy - calender pack showing day numbers): 1 3 5 7 9 11 13 (one pocket)
(Začetno pakiranje z 21 tabletami, dodatek zdravljenja z valproatom - koledarsko pakiranje z označenimi številkami dni):
25 mg Dispersible / Chewable Tablet
25 mg Disperzibilna/žvečljiva tableta
Other information about Tredaptive:
Druge informacije o zdravilu Tredaptive:
The European Commission granted a marketing authorisation valid throughout the European Union for Tredaptive to Merck Sharp & Dohme Ltd. on 3 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Tredaptive, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharp & Dohme Ltd dne 3. julija 2008.
Tredaptive is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group.
Zdravilo Tredaptive ni priporočeno za zdravljenje otrok, starih manj kot 18 let, saj ni zadostnih informacij o varnosti in učinkovitosti v tej skupini.
The tablets must be swallowed whole, and should not be split, broken, crushed or chewed.
Tableto je treba pogoltniti celo, ne sme se jo prelomiti, zlomiti, zdrobiti ali zgristi.
The starting dose of Tredaptive is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day.
Začetni odmerek zdravila Tredaptive je ena tableta enkrat dnevno štiri tedne, nato pa se odmerek poveča na dve tableti enkrat dnevno.
It is taken by mouth, with food, in the evening or before going to bed.
Tableta se jemlje peroralno, s hrano, zvečer ali pred spanjem.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TREDAPTIVE EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) TREDAPTIVE Povzetek EPAR za javnost
The Committee recommended that Tredaptive be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Tredaptive odobri dovoljenje za promet.
The effects of Tredaptive were first tested in experimental models before being studied in humans.
Učinki zdravila Tredaptive so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
What benefit has Tredaptive shown during the studies?
Kakšne koristi je zdravilo Tredaptive izkazalo med študijami?
The most common side effect with Tredaptive (seen in more than 1 patient in 10) is flushing.
Najpogostejši neželeni učinek zdravila Tredaptive (opažen pri več kot 1 bolniku od 10) je zardevanje.
Tredaptive is used on its own only in patients who cannot take statins.
Zdravilo Tredaptive se samostojno uporablja samo pri bolnikih, ki ne morejo jemati statina.
Tredaptive is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Tredaptive je zdravilo, ki vsebuje dve aktivni učinkovini: nikotinsko kislino (znano tudi kot niacin ali vitamin B3 ) in laropiprant.
Two studies looked at the effectiveness of Tredaptive in modifying blood fat levels.
Dve študiji sta preučevali učinkovitost zdravila Tredaptive pri uravnavanju ravni maščob v krvi.
What is the risk associated with Tredaptive?
Kakšna tveganja so povezana z zdravilom Tredaptive?
Patients with combined mixed dyslipidaemia have high blood levels of ‘bad' LDL cholesterol and triglycerides (a type of fat), and low levels of ‘good' HDL cholesterol.
Bolniki s kombinirano mešano dislipidemijo imajo v krvi visoko raven „slabega“ LDL holesterola in trigliceridov (vrsta maščobe) in nizko raven „dobrega“, HDL holesterola.
They included a total of 2,349 patients who were taking either Tredaptive or nicotinic acid.
Študiji sta vključevali vsega skupaj 2349 bolnikov, ki so jemali zdravilo Tredaptive ali nikotinsko kislino.
Tredaptive was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Zdravilo Tredaptive je bilo raziskano v štirih glavnih študijah pri bolnikih z hiperholesterolemijo ali mešano dislipidemijo.
The second study showed that the LDL cholesterol levels were further reduced when Tredaptive was taken with simvastatin (48% reduction), compared with Tredaptive alone (17% reduction) or simvastatin alone (37% reduction).
V drugi študiji so dokazali, da je prišlo še do večjega znižanja ravni LDL-holesterola v skupini, ki je jemala zdravilo Tredaptive skupaj s simvastatinom (48 % znižanje), v primerjavi s tisto, ki je jemala zdravilo Tredaptive samostojno (17 % znižanje) ali samo simvastatin (37 % znižanje).
Tredaptive is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Zdravilo Tredaptive se navadno daje skupaj s statinom (standardno zdravilo za zniževanje holesterola), kadar statin samostojno ni dovolj učinkovit.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Tredaptive, compared with 1% in those taking placebo.
V prvi študiji so se ravni LDL pri bolnikih, ki so jemali zdravilo Tredaptive, znižale za 19 % v primerjavi z 1 % pri tistih, ki so jemali placebo.
Tredaptive should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients.
Zdravila Tredaptive ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) nikotinsko kislino, laropiprant ali katero koli drugo sestavino zdravila.
For the full list of all side effects reported with Tredaptive, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tredaptive , glejte navodilo za uporabo.
Why has Tredaptive been approved?
Zakaj je bilo zdravilo Tredaptive odobreno?
In Tredaptive tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
En sloj tablet zdravila Tredaptive vsebuje laropiprant, drugi sloj pa vsebuje nikotinsko kislino.
The two active substances in Tredaptive, nicotinic acid and laropiprant, have different modes of action.
Zdravilni učinkovini v zdravilu Tredaptive, nikotinska kislina in laropiprant, imata različna načina delovanja.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tredaptive's benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Tredaptive pri zdravljenju dislipidemije, zlasti pri bolnikih s kombinirano mešano dislipidemijo in pri bolnikih s primarno hiperholesterolemijo, večje od z njim povezanih tveganj.
The first study compared the effectiveness of Tredaptive with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
V prvi študiji so primerjali učinkovitost zdravila Tredaptive s samostojno nikotinsko kislino ali placebom (zdravilom brez zdravilne učinkovine) pri zniževanju ravni LDL-holesterola pri vsega skupaj 1613 bolnikih.
In the first and third studies, fewer patients taking Tredaptive reported moderate, severe or extreme flushing than patients taking nicotinic acid alone.
V prvi in tretji študiji je o zmernem, hudem ali skrajnem zardevanju poročalo manj tistih bolnikov, ki so jemali Tredaptive, kot tistih, ki so jemali samo nikotinsko kislino.
Tredaptive was effective in reducing the blood levels of LDL cholesterol.
Zdravilo Tredaptive je bilo učinkovito pri zniževanju ravni LDL-holesterola.
In the fourth study, flushing was seen on fewer days in patients taking Tredaptive than in those taking nicotinic acid alone.
V četrti študiji je bilo število dni opaženega zardevanja manjše pri tistih bolnikih, ki so jemali zdravilo Tredaptive kot pri tistih, ki so jemali samo nikotinsko kislino.
The full EPAR for Tredaptive can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tredaptive je na voljo tukaj.
Tredaptive is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘combined mixed dyslipidaemia' and ‘primary hypercholesterolaemia'.
Zdravilo Tredaptive se uporablja kot dodatek k prehrani in telesni vadbi pri bolnikih z dislipidemijo (nenormalno visoka raven maščobe v krvi), zlasti pri tistih s kombinirano mešano dislipidemijo in primarno hiperholesterolemijo.
It should be used with caution in patients who have problems with their kidneys and should not be used in patients with liver problems.
Pri bolnikih z ledvičnimi težavami je potrebna posebna previdnost pri uporabi zdravila Tredaptive, pri bolnikih z jetrnimi težavami pa se zdravilo Tredaptive ne sme uporabljati.
How has Tredaptive been studied?
Kako je bilo zdravilo Tredaptive raziskano?
The second study compared the combination of Tredaptive and simvastatin (a statin) with Tredaptive alone or simvastatin alone in 1,398 patients.
V drugi študiji so pri 1398 bolnikih primerjali kombinacijo zdravila Tredaptive in simvastatin (vrsta statina) s samostojnim zdravilom Tredaptive ali simvastatinom.
What is Tredaptive used for?
Za kaj se zdravilo Tredaptive uporablja?
How is Tredaptive used?
Kako se zdravilo Tredaptive uporablja?
What is Tredaptive?
Kaj je zdravilo Tredaptive?
How does Tredaptive work?
Kako zdravilo Tredaptive deluje?
These measures will help protect the environment.
S temi ukrepi boste pomagali pri varovanju okolja.
This may cause bleeding.
To lahko povzroči krvavitev.
- Low blood pressure.
- Nizek krvni tlak.
Ask your pharmacist how to throw away medicines you no longer use.
Vprašajte svojega farmacevta, kako odstraniti zdravila, ki jih ne potrebujete več.
Date of latest renewal: 28 May 2018
Datum zadnjega podaljšanja: 28. maj 2018
- If your placenta is covering the birth canal.
- Če posteljica (placenta) prekriva porodni kanal.
Atosiban must not be used in the following conditions:
Atozibana se ne sme uporabljati v naslednjih primerih:
- Allergic reactions.
- Alergijske reakcije.
The benefit of atosiban in these subgroups is therefore uncertain.
Koristi atozibana v teh podskupinah so zato negotove.
Do not throw away any medicines in wastewater or household waste.
Nobenega zdravila ne smete odvreči med odpadne vode ali gospodinjske odpadke.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 July 2013
Datum prve odobritve: 31 julij 2013
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Pred uporabo zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 - 8°C).
- High blood sugar.
- Zvišana vrednost krvnega sladkorja.
Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, babico ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
This may increase the risk of lung oedema (accumulation of fluid in the lungs).
To lahko poveča tveganje za pljučni edem (nabiranje tekočine v pljučih).
Atosiban is found in only small quantities in urine, its urinary concentration is about 50 times lower than that of M1.
Atoziban se v urinu pojavi le v majhni količini; njegova koncentracija v urinu je približno 50-krat manjša od koncentracije M1.
- Difficulty sleeping (insomnia).
- Motnje spanja (nespečnost).
The highest atosiban subcutaneous dose not producing any adverse effects was approximately two times the therapeutic human dose.
Največji subkutani odmerek atozibana, ki ni povzročil nobenih neželenih učinkov, je bil približno dvakrat večji od terapevtskega odmerka pri človeku.
In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of atosiban depends on the assessment of fetal maturity.
V primeru intrauterinega zavrtja rasti je odločitev za nadaljevanje ali ponoven začetek uporabe atozibana odvisna od ocene zrelosti ploda.
Pharmacotherapeutic group: Other gynecologicals, ATC code: G02CX01
Farmakoterapevtska skupina: Druga ginekološka zdravila, oznaka ATC: G02CX01
Atosiban SUN will be given to you in a hospital by a doctor, nurse or midwife.
Zdravilo Atoziban SUN vam bo v bolnišnici dal zdravnik, medicinska sestra ali babica.
- If you have or could have an infection of your womb (uterus).
- Če imate ali bi lahko imeli okužbo maternice (uterusa).
Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms.
Opisanih je bilo nekaj primerov prevelikega odmerjanja atozibana; potekali so brez specifičnih znakov ali simptomov.
OTHER SPECIAL WARNING(S), IF NECESSARY Do not use if shrink wrap is tampered.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Ne uporabljajte, če je skrčljiva ovojnina poškodovana.
- If you are between 24 and 27 weeks pregnant.
- Če ste med 24. in 27. tednom nosečnosti.
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).
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).
Mean value of volume of distribution was 18.3 ± 6.8 litres.
Srednja vrednost volumna porazdelitve je bila 18,3 ± 6,8 litrov.
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).
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).
- If you are more than 33 weeks pregnant.
- Če ste noseči več kot 33 tednov.
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).
Ponovno zdravljenje z atozibanom je mogoče, vendar so klinične izkušnje z večkratnimi ponovitvami omejene (do 3 ponovitve zdravljenja) (glejte poglavje 4.2).
It also makes the contractions happen less often.
Prav tako zmanjša njihovo pogostnost.
- 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.
- 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.
SPECIAL STORAGE CONDITIONS Store in a refrigerator.
9 POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku.
Treatment with atosiban should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Zdravljenje z atozibanom mora uvesti in voditi zdravnik, ki ima izkušnje z zdravljenjem prezgodnjega poroda.
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).
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).
Do not use this medicine after the expiry date which is stated on the label after EXP {MM/YYYY}.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake Uporabno do {MM/LLLL}.
Atosiban SUN should not be mixed with other medicinal products in the infusion bag.
Zdravila Atoziban SUN ne smete mešati z drugimi zdravili v isti infuzijski vrečki.
Intravenous use For instructions on preparation of the medicinal product before administration, see section 6.6.
Intravenska uporaba Za navodilo glede priprave zdravila pred dajanjem glejte poglavje 6.6.
Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour.
Intravensko zdravljenje z začetno bolusno injekcijo je treba začeti čim prej po diagnozi prezgodnjega poroda.
Plasma protein binding of atosiban is 46 to 48% in pregnant women.
Pri nosečnicah se od 46 do 48 % atozibana veže na beljakovine v plazmi.
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).
Zato je treba atoziban v primeru večplodne nosečnosti in/ali sočasne uporabe drugih zdravil s tokolitičnim delovanjem uporabljati previdno (glejte poglavje 4.8).
- Fast heart beat.
- Hitro utripanje srca.
An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for atosiban.
Intravenska mikrokapalna komora lahko zagotavlja ustrezen razpon hitrosti infundiranja v priporočenih odmernih mejah za infundiranje atozibana.
- If you or your unborn baby have any other conditions where it would be dangerous to continue with your pregnancy.
- Če imate vi ali plod katero koli drugo bolezensko stanje, zaradi katerega je nadaljevanje nosečnosti tvegano.
- If you have kidney or liver problems.
- Če imate težave z ledvicami ali jetri.
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.
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.
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.
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.
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).
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).
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.2 Inkompatibilnosti Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
Mean value for clearance was 41.8 ± 8.2 litres/h.
Srednja vrednost očistka je bila 41,8 ± 8,2 litrov/uro.
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).
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).
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.
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.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
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).
- If your unborn baby is small for the time of your pregnancy.
- Če je plod premajhen za pretečeni čas nosečnosti.
Children and adolescents Atosiban SUN has not been studied in pregnant women less than 18 years old.
Otroci in mladostniki Zdravilo Atoziban SUN ni bilo preskušeno pri nosečnicah, starih manj kot 18 let.
- If you are less than 24 weeks pregnant.
- Če ste noseči manj kot 24 tednov.
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.).
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.
Small amounts of atosiban have been shown to pass from plasma into the breast milk of breast-feeding women.
Atoziban v majhnih količinah prehaja iz plazme v materino mleko.
8 ml/hour (100 μg/min)
8 ml/uro (100 µg/min)
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%).
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 %).
What Atosiban SUN is and what it is used for
Kaj je zdravilo Atoziban SUN in za kaj ga uporabljamo
Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine.
V primeru okvare ledvic odmerka verjetno ni treba prilagajati, saj se atoziban le v majhnem obsegu izloča z urinom.
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.
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.
There was no difference between the atosiban and beta-mimetic groups with regard to this parameter.
Skupini, ki sta prejemali atoziban in beta-mimetik, se v tem pogledu nista razlikovali.
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.
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.
No clinically relevant interaction was found between atosiban and bethamethasone or labetalol.
Klinično pomembnih interakcij med atozibanom in betametazonom ali labetalolom niso opazili.
Following an infusion of 300 micrograms/min in healthy pregnant women at term, the fetal/maternal atosiban concentration ratio was 0.12.
Po infuziji 300 mikrogramov/min zdravim nosečnicam ob roku je bilo razmerje med koncentracijo atozibana pri plodu in materi 0,12.
The safety and efficacy of atosiban in pregnant women aged less than 18 years have not been established.
Varnost in učinkovitost atozibana pri nosečnicah, starih manj kot 18 let, nista bili dokazani.
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.
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.
Clear, colourless solution without particles.
Bistra, brezbarvna raztopina brez delcev.