FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised when ADASUVE is administered in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products known to prolong the QT interval.
Slovenian: Previdnost je potrebna, kadar se zdravilo ADASUVE daje bolnikom z znano srčno-žilno boleznijo ali z družinsko anamnezo podaljšanja intervala QT ter pri sočasni uporabi z drugimi zdravili, za katera je znano, da podaljšajo interval QT.
English: Respiratory, thoracic and mediastinal disorders Common: throat irritation
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti: draženje žrela
English: % CGI-I Responders
Slovenian: % bolnikov z odzivom CGII
English: To deliver the medicinal product, the patient inhales through the mouthpiece with a steady deep breath.
Slovenian: Zdravilo bolnik vdihne skozi ustnik z neprekinjenim globokim vdihom.
English: Renal failure following oral loxapine overdosage has also been reported.
Slovenian: Poročali so tudi o ledvični odpovedi po prevelikem peroralnem odmerku loksapina.
English: • Observation of patients for 1 hour after each dose of ADASUVE
Slovenian: • opazovanje bolnikov 1 uro po vsakem odmerku zdravila ADASUVE; Tveganje za podaljšanje intervala QT:
English: • lorazepam or other centrally acting medicines (to treat anxiety, depression, pain, or to help you sleep) or any other medicines that cause sleepiness
Slovenian: • lorazepam ali druga zdravila, ki delujejo na osrednje živčevje (za zdravljenje tesnobe, depresije,
English: When needed, the product is removed from the pouch.
Slovenian: Ko zdravilo potrebujete, ga vzemite iz vrečke.
English: 5 single-dose inhalers
Slovenian: 5 inhalatorjev z enkratnim odmerkom
English: With chronic oral administration of loxapine, the reported adverse reactions include sedation and drowsiness; extrapyramidal symptoms (e.g., tremor, akathisia, rigidity, and dystonia); cardiovascular effects (e.g., tachycardia, hypotension, hypertension, orthostatic hypotension, light-headedness, and syncope); and anticholinergic effects (e.g., dry eyes, blurred vision, and urinary retention).
Slovenian: Neželeni učinki, o katerih so poročali pri dolgotrajni peroralni uporabi loksapina, vključujejo sedacijo in dremavost; ekstrapiramidne simptome (npr. tremor, akatizijo, rigidnost in distonijo); srčno-žilne učinke (npr. tahikardijo, hipotenzijo, hipertenzijo, ortostatsko hipotenzijo, vrtoglavico in sinkopo); in antiholinergično delovanje (npr. suhe oči, zamegljen vid in zadrževanje urina).
English: ADASUVE should be used with caution in patients with a known history of extrapyramidal symptoms.
Slovenian: Zdravilo ADASUVE je pri bolnikih z znano anamnezo ekstrapiramidnih simptomov treba uporabljati previdno.
English: In a supportive Phase 2 single dose study enrolling a total of 129 patients with schizophrenia and schizoaffective disorder the decrease in PEC change after 2 hours was -5.0 for placebo, -6.7 for ADASUVE 4.5 mg, and -8.6 (p<0.001) for ADASUVE 9.1 mg.
Slovenian: V podporni študiji faze 2 z enkratnim odmerkom, ki je vključevala 129 bolnikov s shizofrenijo in shizoafektivno motnjo, je zmanjšanje v spremembi PEC po 2 urah znašalo −5,0 za placebo, −6,7 za zdravilo ADASUVE 4,5 mg in −8,6 (p < 0,001) za zdravilo ADASUVE 9,1 mg. Olajševalno zdravilo je bilo dano 32,6 %, 11,1 % in 14,6 % bolnikov.
English: What ADASUVE looks like and contents of the pack ADASUVE 9.1 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine.
Slovenian: Izgled zdravila ADASUVE in vsebina pakiranja Zdravilo ADASUVE 9,1 mg prašek za inhaliranje, odmerjeni, sestoji iz belega plastičnega inhalatorja za enkratno uporabo z enkratnim odmerkom, ki vsebuje loksapin.
English: What ADASUVE looks like and contents of the pack ADASUVE 4.5 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine.
Slovenian: Izgled zdravila ADASUVE in vsebina pakiranja Zdravilo ADASUVE 4,5 mg prašek za inhaliranje, odmerjeni, sestoji iz belega plastičnega inhalatorja za enkratno uporabo z enkratnim odmerkom, ki vsebuje loksapin.
English: Common: dizziness
Slovenian: Pogosti: omotičnost
English: • medicines that may put you at a risk for seizures (for example, clozapine, tricyclics or SSRIs,
Slovenian: • zdravila, zaradi katerih se pri vas pojavi tveganje za napade (na primer: klozapin, triciklični antidepresivi ali selektivni zaviralci ponovnega privzema serotonina, tramadol, meflokin);
English: Directions for use
Slovenian: NAVODILA ZA UPORABO
English: Mild hypotension was reported in short-term (24-hour), placebo-controlled trials in agitated patients administered ADASUVE.
Slovenian: Pri agitiranih bolnikih, ki so prejeli zdravilo ADASUVE, so v okviru kratkotrajnih (24-urnih) preskušanj, nadzorovanih s placebom, poročali o blagi hipotenziji.
English: What ADASUVE is and what it is used for
Slovenian: Kaj je zdravilo ADASUVE in za kaj ga uporabljamo
English: A short-acting beta-agonist bronchodilator should be available for treatment of possible bronchospasm.
Slovenian: Za zdravljenje morebitnega bronhospazma mora biti na voljo kratkotrajno delujoči bronhodilatator tipa agonistov beta-adrenergičnih receptorjev.
English: These symptoms can be high fever, rigid muscles,
Slovenian: Ti simptomi so lahko visoka vročina, rigidne mišice, neredna ali hitra srčna frekvenca ali utrip.
English: Read the following 5 steps before administering ADASUVE to a patient:
Slovenian: Preden date zdravilo ADASUVE bolniku, preberite naslednjih 5 korakov:
English: In placebo-controlled clinical trials in subjects with asthma or COPD, bronchospasm was very commonly observed.
Slovenian: V kliničnih preskušanjih, nadzorovanih s placebom, so pri bolnikih z astmo ali KOPB zelo pogosto opazili bronhospazem.
English: Adverse reactions seen with chronic oral loxapine use
Slovenian: Neželeni učinki, ki so jih opazili pri dolgotrajni peroralni uporabi loksapina
English: Hypoventilation
Slovenian: Hipoventilacija
English: Angelini S.p.A. Tel: +39 06 780531
Slovenian: Tel: +39 06 780531
English: However, in placebo-controlled clinical trials in subjects with mild-to-moderate persistent asthma or moderate-to-severe COPD, adverse reactions of bronchospasm were reported very commonly.
Slovenian: V kliničnih preskušanjih, ki so bila nadzorovana s placebom in izvedena pri bolnikih z blago do zmerno dolgotrajno astmo ali zmerno do hudo KOPB, pa so o neželenih učinkih bronhospazma zelo pogosto poročali.
English: Severe hypotension might be expected to respond to the administration of noradrenaline or phenylephrine.
Slovenian: Kot reakcijo na dajanje noradrenalina ali fenilefrina je mogoče pričakovati hudo hipotenzijo.
English: Hold breath Remove the mouthpiece from the mouth and hold breath briefly.
Slovenian: 5. zadržati dih: Vzemite ustnik iz ust in za kratek čas zadržite dih.
English: Read the following 5 steps before administering ADASUVE to a patient.
Slovenian: Preden daste zdravilo ADASUVE bolniku, preberite naslednjih 5 korakov.
English: The active substance is loxapine.
Slovenian: Učinkovina je loksapin.
English: Each single-dose inhaler contains 5 mg loxapine and delivers 4.5 mg of loxapine.
Slovenian: En inhalator z enkratnim odmerkom vsebuje 5 mg loksapina in dovaja 4,5 mg loksapina.
English: • ever had muscle or eye movements you can't control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still
Slovenian: • ste kadar koli opazili gibanje mišic ali očesa, ki ga ne morete nadzirati, pomanjkanje koordinacije,
English: Marketing Authorisation Holder Ferrer Internacional, S.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom Ferrer Internacional, S.A.
English: ADASUVE should not be re-administered in patients who develop any respiratory signs/symptoms (see section 4.3).
Slovenian: Bolniki, ki razvijejo kakršne koli znake/simptome motenj dihanja, zdravila ADASUVE ne smejo ponovno prejeti (glejte poglavje 4.3).
English: For single use only
Slovenian: za inhaliranje samo za enkratno uporabo
English: Each inhaler delivers 9.1 mg loxapine.
Slovenian: En inhalator dostavi 9,1 mg loksapina.
English: Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg of loxapine.
Slovenian: En inhalator z enkratnim odmerkom vsebuje 10 mg loksapina in dovaja 9,1 mg loksapina.
English: What ADASUVE contains
Slovenian: Kaj vsebuje zdravilo ADASUVE
English: • have or had seizures (convulsions)
Slovenian: • imate ali ste imeli epileptične napade (krče);
English: • medicines to treat schizophrenia, depression, or pain since you may be more at risk for seizures Using ADASUVE and adrenaline together may cause your blood pressure to drop.
Slovenian: • zdravila za zdravljenje shizofrenije, depresije ali bolečine, saj bi lahko povečala tveganja za napade.
English: Risk of bronchospasm:
Slovenian: • izjava o akutnem nastopu indikacije; Tveganje za bronhospazem:
English: 1 single dose inhaler
Slovenian: 1 inhalator z enkratnim odmerkom
English: Each inhaler delivers 4.5 mg loxapine.
Slovenian: En inhalator dostavi 4,5 mg loksapina.
English: How to store ADASUVE
Slovenian: Shranjevanje zdravila ADASUVE
English: Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects (bronchospasm).
Slovenian: Za zdravljenje morebitnih resnih neželenih učinkov na dihalih (bronhospazem) mora biti na voljo zdravljenje s kratkotrajno delujočim bronhodilatatorjem tipa agonistov betaadrenergičnih receptorjev.
English: Inhale through the mouthpiece with a steady, deep breath.
Slovenian: 4. vdihniti: Vdihnite skozi ustnik z neprekinjenim globokim vdihom.
English: ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units.
Slovenian: Zdravilo ADASUVE 9,1 mg je dobavljeno v škatli z 1 ali 5 enotami.
English: ADASUVE 4.5 mg is supplied in a carton of 1 or 5 units.
Slovenian: Zdravilo ADASUVE 4,5 mg je dobavljeno v škatli z 1 ali 5 enotami.
English: Inhalation powder, pre-dispensed
Slovenian: Prašek za inhaliranje, odmerjeni
English: ADASUVE 9.1 mg inhalation powder, pre-dispensed
Slovenian: ADASUVE 9,1 mg prašek za inhaliranje, odmerjeni
English: ADASUVE 4.5 mg is supplied in a carton of 1 or 5 single dose inhalers.
Slovenian: Zdravilo ADASUVE 4,5 mg je na voljo v škatli z 1 ali 5 inhalatorji z enkratnim odmerkom.
English: ADASUVE 4.5 mg inhalation powder, pre-dispensed
Slovenian: ADASUVE 4,5 mg prašek za inhaliranje, odmerjeni
English: One single-dose inhaler
Slovenian: prašek za inhaliranje en inhalator z enkratnim odmerkom
English: ADASUVE 9.1 mg is supplied in a carton of 1 or 5 single dose inhalers.
Slovenian: Zdravilo ADASUVE 9,1 mg je na voljo v škatli z 1 ali 5 inhalatorji z enkratnim odmerkom.
English: See the SmPC for more information.
Slovenian: Za več informacij glejte povzetek glavnih značilnosti zdravila.
English: ADASUVE 4.5 mg inhalation powder loxapine
Slovenian: ADASUVE 4,5 mg prašek za inhaliranje loksapin
English: ADASUVE 9.1 mg inhalation powder loxapine
Slovenian: ADASUVE 9,1 mg prašek za inhaliranje loksapin
English: Rescue
Slovenian: Zdravljenje
English: Ireland Ferrer Internacional, S.A.
Slovenian: Sverige Ferrer Internacional, S.A.
English: Tardive dyskinesia
Slovenian: Tardivna diskinezija
English: The recommended initial dose of ADASUVE is 9.1 mg. A second dose can be given after 2 hours, if necessary.
Slovenian: Priporočeni začetni odmerek zdravila ADASUVE je 9,1 mg.
English: ADASUVE 9.1 mg inhalation powder, pre-dispensed loxapine
Slovenian: ADASUVE 9,1 mg prašek za inhaliranje, odmerjeni loksapin
English: ADASUVE 4.5 mg inhalation powder, pre-dispensed loxapine
Slovenian: ADASUVE 4,5 mg prašek za inhaliranje, odmerjeni loksapin
English: DEVICE HOUSING
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: (See also section 3)
Slovenian: (glejte tudi poglavje 3)
English: D-24109 Kiel Germany
Slovenian: D-24109 Kiel Nemčija
English: However, this finding is based on a very small sample (n=129 patients).
Slovenian: Toda ta izsledek temelji na zelo majhnem vzorcu (n = 129 bolnic).
English: - if your placenta is covering the birth canal.
Slovenian: - Če posteljica (placenta) prekriva porodni kanal.
English: It is not known whether the free fraction in the maternal and fetal compartments differs substantially.
Slovenian: Ni znano, ali se prosti delež v maternalnem in fetalnem razdelku bistveno razlikuje.
English: The benefit of atosiban in these subgroups is therefore uncertain.
Slovenian: Koristi atosibana v teh podskupinah so zato negotove.
English: Re-treatment:
Slovenian: Ponovno zdravljenje:
English: Date of first authorisation: 20 January 2000 Date of latest renewal: 20 January 2010
Slovenian: Datum prve pridobitve dovoljenja za promet: 20.januar 2000 Datum zadnjega podaljšanja dovoljenja za promet: 20.januar 2010
English: It is not known whether M1 accumulates in tissues.
Slovenian: Ni znano, ali se M1 kopiči v tkivih.
English: 2300 København S Denmark
Slovenian: 2300 København S Danska
English: For intravenous use only.
Slovenian: Le za intravensko uporabo.
English: - if you are more than 33 weeks pregnant.
Slovenian: - Če ste noseči več kot 33 tednov.
English: Up to 270 mg
Slovenian: do 270 mg
English: - if you are between 24 and 27 weeks pregnant.
Slovenian: - Če ste med 24. in 27. tednom nosečnosti.
English: Step Regimen
Slovenian: Korak Režim
English: • Whenever the risk management system is modified, especially as the result of new informationbeing received that may lead to a significant change to the benefit/risk profile or as the result ofan important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: - if you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - Če ste alergični na atosiban ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: Do not use Tractocile: - if you are less than 24 weeks pregnant.
Slovenian: Zdravila Tractocile ne smete prejeti: - Če ste noseči manj kot 24 tednov.
English: Once the bolus has been injected, proceed with the infusion.
Slovenian: Ko je bolus injiciran, nadaljujte z infuzijo.
English: The highest atosiban subcutaneous dose not producing any adverse effects was approximately two times the therapeutic human dose.
Slovenian: Največji subkutani odmerek atosibana, ki ni povzročil nobenih neželenih učinkov, je bil približno dvakrat večji od terapevtskega odmerka pri človeku.
English: This permits the continued independent control of the rate of infusion.
Slovenian: To omogoča stalen neodvisen nadzor nad hitrostjo infundiranja.
English: Tractocile must not be used in the following conditions:
Slovenian: Zdravila Tractocile se ne sme uporabljati v naslednjih primerih:
English: There is no known specific treatment in case of an overdose.
Slovenian: Specifično zdravljenje v primeru prevelikega odmerjanja ni znano.
English: The ratios of the main metabolite M1 (des-(Orn
Slovenian: Razmerje med koncentracijo glavnega presnovka M1 (des-(Orn
English: Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, babico ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: • Periodic Safety Update Reports requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: - if your waters have broken (premature rupture of your membranes) and you have completed 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: In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Tractocile depends on the assessment of fetal maturity.
Slovenian: V primeru intrauterinega zavrtja rasti je odločitev za nadaljevanje ali ponoven začetek uporabe zdravila Tractocile odvisna od ocene zrelosti ploda.
English: - high blood sugar
Slovenian: - Zvišana vrednost krvnega sladkorja.
English: The most commonly reported adverse reaction in the mother is nausea (14 %).
Slovenian: Pri materah so najpogosteje poročali o siljenju na bruhanje (14 %).
English: Re-treatment with Tractocile is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see section 4.2).
Slovenian: Ponovno zdravljenje z zdravilom Tractocile je mogoče, vendar so klinične izkušnje z večkratnimi ponovitvami omejene (do 3 ponovitve zdravljenja) (glejte poglavje 4.2).
English: Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms.
Slovenian: Opisanih je bilo nekaj primerov prevelikega odmerjanja atosibana; potekali so brez specifičnih znakov ali simptomov.
English: Atosiban is found in only small quantities in urine, its urinary concentration is about 50 times lower than that of M1.
Slovenian: Atosiban se v urinu pojavi le v majhni količini; njegova koncentracija v urinu je približno 50-krat manjša od koncentracije M1.
English: - if you have or could have an infection of your womb (uterus).
Slovenian: - Če imate ali bi lahko imeli okužbo maternice (uterusa).
English: Tractocile will be given to you in a hospital by a doctor, nurse or midwife.
Slovenian: Zdravilo Tractocile vam bo v bolnišnici dal zdravnik, medicinska sestra ali babica.
English: Signs may include feeling dizzy or light-headed.
Slovenian: Znaki lahko vključujejo omotico ali vrtoglavico.
English: Tractocile should not be mixed with other medicinal products in the infusion bag.
Slovenian: Zdravila Tractocile ne smete mešati z drugimi zdravili v isti infuzijski vrečki.
English: Pharmacotherapeutic group: Other gynecologicals, ATC code: G02CX01
Slovenian: Farmakoterapevtska skupina: druga ginekološka zdravila, oznaka ATC: G02CX01
English: Admission to a neonatal intensive care unit (NICU) was similar for both treatment groups (approximately 30%), as was length of stay and ventilation therapy.
Slovenian: Delež sprejemov v neonatalno enoto za intenzivno nego je bil v obeh zdravljenih skupinah podoben (približno 30 %), prav tako trajanje bivanja in ventilacijska terapija.
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: The clearance, volume of distribution and half-life were found to be independent of the dose.
Slovenian: Očistek, volumen porazdelitve in razpolovni čas niso odvisni od odmerka.
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 atosibanom).
English: The safety and efficacy of Tractocile in pregnant women aged less than 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Tractocile pri nosečnicah, starih manj kot 18 let, nista bili dokazani.
English: If other medicinal products need to be given intravenously at the same time, the intravenous cannula can be shared or another site of intravenous administration can be used.
Slovenian: Če je sočasno treba intravensko aplicirati tudi druga zdravila, je mogoče uporabiti isto intravensko kanilo ali pa intravensko aplikacijo opraviti na drugem mestu.
English: Interaction studies have been performed with labetalol and betamethasone in healthy, female volunteers.
Slovenian: Izvedene so bile študije medsebojnega delovanja z labetalolom in betametazonom pri zdravih prostovoljkah.
English: 8]-oxytocin) which is a competitive antagonist of human oxytocin at receptor level.
Slovenian: 4,Orn oksitocin), ki je kompetitivni antagonist človeškega oksitocina na receptorski ravni.
English: What Tractocile is and what it is used for
Slovenian: Kaj je zdravilo Tractocile in za kaj ga uporabljamo
English: Plasma protein binding of atosiban is 46 to 48% in pregnant women.
Slovenian: Pri nosečnicah se od 46 do 48 % atosibana veže na beljakovine v plazmi.
English: Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Slovenian: Zdravljenje z zdravilom Tractocile mora uvesti in voditi zdravnik, ki ima izkušnje z zdravljenjem prezgodnjega poroda.
English: Tractocile contains atosiban (INN), a synthetic peptide ([Mpa
Slovenian: Zdravilo Tractocile vsebuje atosiban (INN), sintetičen peptid ([Mpa
English: - if you have kidney or liver problems.
Slovenian: - Če imate težave z ledvicami ali jetri.
English: Most of the treatment failures in CAP-001 were caused by poor tolerability.
Slovenian: V študijah CAP-001 je bilo neuspešno zdravljenje večinoma posledica slabega prenašanja zdravila.
English: Secondary endpoints: secondary efficacy parameters included the proportion of women remaining undelivered within 48 h of treatment initiation.
Slovenian: Sekundarni opazovani dogodki: Sekundarna merila učinkovitosti so vključevala delež žensk, ki niso rodile v 48 urah po začetku zdravljenja.
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: An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for Tractocile.
Slovenian: Intravenska mikrokapalna komora lahko zagotavlja ustrezen razpon hitrosti infundiranja v priporočenih odmernih mejah za infundiranje zdravila Tractocile.
English: Colourless glass vials, clear borosilicated (type I) sealed with grey siliconised bromo-butyl rubber stopper, type I, and flip-off cap of polypropylene and aluminium.
Slovenian: Viala iz brezbarvnega, prozornega borosilikatnega stekla (tipa I), zaprta s sivim, silikoniziranim brombutilnim gumijastim zamaškom (tipa I) in »flip-off« zaporko iz polipropilena in aluminija.
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 atosiban v primeru večplodne nosečnosti in/ali sočasne uporabe drugih zdravil s tokolitičnim delovanjem uporabljati previdno (glejte poglavje 4.8).
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 atosibana nista bili dokazani z nadzorovanimi randomiziranimi študijami, pri tej skupini bolnic uporaba atosibana ni priporočljiva (glejte poglavje 4.3).