FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean plasma loxapine concentrations following administration of ADASUVE were linear over the clinical dose range.
Croatian: Prosječne koncentracije loksapina u plazmi nakon davanja lijeka ADASUVE su bile linearne duž raspona kliničkih doza.
English: Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson medicinal products or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated.
Croatian: Teške ekstrapiramidalne nuspojave se trebaju liječiti antikolinergijskim antiparkinsonicima ili difenhidramin kloridom i potrebno je započeti antikonvulzivnu terapiju sukladno indikaciji.
English: FERRER INTERNACIONAL, S.A. Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès, Barcelona, Spain
Croatian: Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès, Barcelona, Španjolska
English: If signs and symptoms of tardive dyskinesia appear in a patient being treated with loxapine, discontinuation should be considered.
Croatian: Ako se kod bolesnika liječenih loksapinom pojave znakovi ili simptomi tardivne diskinezije, treba razmotriti mogućnost prekida liječenja.
English: Decreased agitation was evident 10 minutes after Dose 1, the first assessment time, and at all subsequent assessments during the 24 hour evaluation period, for both 4.5 mg and 9.1 mg doses in both schizophrenia and bipolar disorder patients.
Croatian: Smanjena razina agitacije je bila očita 10 minuta nakon prve doze, što je bilo prvo vrijeme procjene, kao i pri svakoj slijedećoj procjeni za vrijeme 24-satnog razdoblja procjene, za obje doze (od 4,5 mg i 9,1 mg) kako u bolesnika oboljelih od shizofrenije, tako i u onih oboljelih od bipolarnog poremećaja.
English: ADASUVE is not indicated for the treatment of patients with dementia-related psychosis.
Croatian: ADASUVE nije indiciran za liječenje bolesnika oboljelih od psihoze povezane s demencijom.
English: Change at 2 hr post dose
Croatian: Promjena 2 sata nakon doze
English: The recommended initial dose of ADASUVE is 9.1 mg. As this dose cannot be reach with this presentation (ADASUVE 4.5 mg), the presentation ADASUVE 9.1 mg should be used initially.
Croatian: Budući da se ovom jačinom lijeka (ADASUVE 4,5 mg) ne može postići ta doza, na početku je potrebno primijeniti ADASUVE 9,1 mg.
English: No loxapine specific human data on fertility are available.
Croatian: Nema posebnih podataka o utjecaju loksapina na plodnost u ljudi.
English: Responders were considered patients with a ≥40% decrease from baseline in the total PEC score or patients with CGI-I score of 1 (very much improved) or 2 (much improved).
Croatian: Bolesnici s odgovorom su smatrani oni kod kojih je pad od početne vrijednosti iznosio ≥40% u ukupnom PEC rezultatu ili ako je rezultat na CGI-I ljestvici iznosio 1 (jako veliko poboljšanje) ili 2 (veliko poboljšanje).
English: Assessment of adverse reactions from clinical study data is based on two Phase 3 and one Phase 2A short-term (24-hour) placebo-controlled clinical trials enrolling 524 adult patients with agitation associated with schizophrenia (including 27 patients with schizoaffective disorder) or bipolar disorder, treated with ADASUVE 4.5 mg (265 patients) or ADASUVE 9.1 mg (259 patients).
Croatian: Procjena nuspojava iz podataka kliničkih ispitivanja zasnovanih na dvije Faze 3 i jednoj Fazi 2A kratkotrajnih (24 sata) placebom kontroliranih kliničkih ispitivanja u 524 odraslih bolesnika s agitacijom povezanom sa shizofrenijom (uključujući 27 bolesnika sa shizoafektivnim poremećajem) ili bipolarnim poremećajem, liječenih lijekom ADASUVE u dozi od 4,5 mg (265 bolesnika) ili ADASUVE 9,1 mg (259 bolesnika).
English: • Caution to be exercised when ADASUVE is administered in patients with known cardiovascular disease or a family history of QT prolongation, and in cases of concomitant use with other medicial products known to prolong the QT interval
Croatian: • Potreban je oprez kad se ADASUVE primjenjuje bolesnicima s poznatim kardiovaskularnim bolestima ili obiteljskom anamnezom produljenja QT intervala kao i kod istodobne primjene drugih lijekova za koje je poznato da produljuju QT interval
English: • ADASUVE is provided in a sealed pouch.
Croatian: • ADASUVE se isporučuje u hermetički zatvorenoj vrećici.
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.
Croatian: Potreban je oprez kad se ADASUVE daje bolesnicima oboljelim od poznatih kardiovaskularnih bolesti ili s obiteljskom povijesti produljenja QT intervala kao i kod upotrebe pratećih lijekova za koje je poznato da produljuju QT interval.
English: The extent of the excretion of loxapine or its metabolites in human milk is not known.
Croatian: Nema podataka o lučenju loksapina ili njegovih metabolita u majčino mlijeko u ljudi.
English: Uncommon: bronchospasm (including shortness of breath) Gastrointestinal disorders
Croatian: Manje često: bronhospazam (uključujući nedostatak zraka)
English: • ADASUVE may cause narrowing of the airways (bronchospasm) and may cause you to wheeze, cough, feel chest tightness or have shortness of breath.
Croatian: • ADASUVE može uzrokovati suženje dišnih putova (bronhospazam), piskanje, kašalj, osjećaj pritiska u prsnom košu ili nedostatak zraka.
English: Common (may affect up to 1 in 10 people): dizziness, throat irritation, dry mouth or tiredness.
Croatian: Često (može se javiti kod do 1 na 10 osoba):omaglica, nadraženost grla, suha usta ili umor.
English: 5 single-dose inhalers
Croatian: 5 jednodoznih inhalatora
English: Marketing Authorisation Holder Ferrer Internacional, S.A.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Ferrer Internacional, S.A.
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.
Croatian: U Fazi 2 suportivnog ispitivanja jednokratne doze u koju je bilo uključeno ukupno 129 bolesnika oboljelih od shizofrenije i shizoafektivnog poremećaja, smanjenje PEC-a nakon 2 sata je iznosilo -5,0 za placebo, -6,7 za ADASUVE od 4,5 mg i -8,6 (p<0,001) za ADASUVE od 9,1 mg.
English: Main results of the pivotal efficacy studies: comparisons between ADASUVE 4.5 mg, 9.1 mg, and placebo
Croatian: Glavni rezultati najvažnijih ispitivanja djelotvornosti: usporedba između skupina koje su primale ADASUVE od 4,5 mg i od 9,1 mg te skupine na placebu Ispitivanje Bolesnici
English: Remove the mouthpiece from the mouth and hold breath briefly.
Croatian: Ukloni nastavak za usta iz usta i kratko zadrži dah.
English: Loxapine is a substrate for several CYP450 isozymes; in vitro studies demonstrated that 7-OHloxapine is formed mainly by CYPs 3A4 and 2D6, 8-OH-loxapine is formed mainly by CYP1A2, amoxapine is formed mainly by CYP3A4, 2C19, and 2C8, and loxapine N-oxide is formed by FMOs.
Croatian: Loksapin je supstrat nekoliko CYP450 izoenzima; in vitro ispitivanja su pokazala da se 7-OH-loksapin u najvećoj mjeri formira pomoću CYPs 3A4 i 2D6, 8-OH-loksapin pomoću CYP1A2, amoksapin pomoću CYP3A4, 2C19 i 2C8 dok se loksapin N-oksid u najvećoj mjeri formira pomoću FMO.
English: Renal and/or hepatic impairment ADASUVE has not been studied in patients with renal or hepatic impairment.
Croatian: Oštećenje funkcije bubrega i/ili jetre ADASUVE nije ispitan na bolesnicima s oštećenjem funkcije bubrega ili jetre.
English: Loxapine exposure in the first 2 hours after administration (AUC0-2h, a measure of early exposure that is relevant to the onset of therapeutic effect) was 25.6 ng*h/mL for the 4.5 mg dose and 66.7 ng*h/mL for the 9.1 mg dose in healthy subjects.
Croatian: Izloženost loksapinu u prva 2 sata nakon primjene (AUC0-2h, mjera rane izloženosti koja je važna za početak terapijskih učinaka) je iznosila 25,6 ng*h/ml za dozu od 4,5 mg i 66,7 ng*h/ml za dozu od 9,1 mg kod zdravih ispitanika.
English: Hold breath Remove the mouthpiece from the mouth and hold breath briefly.
Croatian: Zadrži dah Ukloni nastavak za usta iz usta i kratko zadrži dah.
English: • lorazepam or other centrally acting medicines (to treat anxiety, depression, pain, or to help you sleep) or any other medicines that cause sleepiness
Croatian: depresije, bolova ili za pomoć pri spavanju) ili bilo koje druge lijekove koji uzrokuju pospanost
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE KUĆIŠTE UREĐAJA
English: Inhale through the mouthpiece with a steady, deep breath.
Croatian: Udahne kroz nastavak za usta kontinuiranim, dubokim udahom.
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).
Croatian: Kronično peroralno davanje loksapina uzrokovalo je prijavljene nuspojave kao što su sedacija i ošamućenost, ekstrapiramidalni simptomi (npr. tremor, akatizija, krutost, distonija); kardiovaskularne nuspojave (npr. tahikardija, hipotenzija, hipertenzija, ortostatska hipotenzija, omamljenost i sinkopa), kao i antikolinergijske učinke (npr. suhe oči, zamućeni vid i urinarna retencija).
English: Because of anticholinergic action, ADASUVE should be used cautiously in patients with glaucoma or a tendency to urinary retention, particularly with concomitant administration of anticholinergic-type antiparkinson medicinal products.
Croatian: Zbog svog antikolinergijskog djelovanja, bolesnici s glaukomom ili tendencijom urinarne retencije, naročito kod istodobne primjene antikolinergijskih antiparkinsonika, trebaju oprezno uzimati ADASUVE.
English: Loxapine is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are either metabolised by cytochrome P450 (CYP450) isozymes or glucuronidated by human uridine 5'-diphosphoglucuronosyl transferases (UGTs).
Croatian: Ne očekuje se da bi loksapin mogao uzrokovati klinički značajne farmakokinetičke interakcije s drugim lijekovima koji se metaboliziraju pomoću citokrom P450 (CYP450) izoenzima ili koji prolaze glukuronidaciju putem ljudskih uridin 5'-difosfoglukuronoziltransferaza (UGT).
English: Loxapine is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are either metabolised by cytochrome P450 (CYP450) isozymes or glucuronidated by human uridine 5'-diphosphoglucuronosyl transferases (UGTs) .
Croatian: Ne očekuje se da bi loksapin mogao uzrokovati klinički značajne farmakokinetičke interakcije s drugim lijekovima koji se metaboliziraju pomoću citokrom P450 (CYP450) izoenzima ili koji prolaze glukuronidacijuputem ljudskih uridin 5'-difosfoglukuronoziltransferaza (UGT).
English: One
Croatian: Jedna
English: How to use ADASUVE
Croatian: Kako primjenjivati ADASUVE
English: In placebo-controlled clinical trials in subjects with asthma or COPD, bronchospasm was very commonly observed.
Croatian: U placebom kontroliranom kliničkom ispitivanju u kojem su sudjelovali ispitanici oboljeli od astme ili KOPB-a, bronhospazam je bio učestalo opažan.
English: In the two Phase 3 studies patients were enrolled who had acute agitation of at least moderate level (14 or higher on Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) scale (poor impulse control, tension, hostility, uncooperativeness, and excitement).
Croatian: U dvama ispitivanjima Faze 3, bolesnici su uključeni prema akutnoj agitaciji najmanje umjerene razine (14 ili više bodova na ljestvici pozitivnih i negativnih sindroma (eng.
English: Directions for use inside
Croatian: Upute za uporabu se nalaze unutar pakiranja
English: Hypoventilation
Croatian: Hipoventilacija
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
Croatian: • ste ikada imali pokrete mišića ili oka koje niste mogli kontrolirati, nedostatak koordinacije,
English: General:
Croatian: NAPOMENA:
English: How to store ADASUVE
Croatian: Kako čuvati ADASUVE
English: Uncommon: dystonia, dyskinesia, oculogyration, tremor, akathisia/restlessness
Croatian: Manje često: distonija, diskinezija, okulogiracija, tremor, akatizija/nemir Krvožilni poremećaji
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.
Croatian: Međutim, u placebom kontroliranim kliničkim ispitivanjima u ispitanika s blagom do umjerenom perzistentnom astmom ili umjerenim to teškim KOPD-om, nuspojave bronhospazma prijavljene su vrlo često.
English: • Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling • Educational material for the healthcare professionals
Croatian: • Sažetak opisa svojstava lijeka, Uputu o lijeku i označavanje
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.
Croatian: ADASUVE 9,1 mg prašak inhalata, dozirani, sastoji se od jednodoznog bijelog plastičnog inhalatora za jednokratnu upotrebu koji sadrži loksapin.
English: For ADASUVE, the order of metabolites observed in humans (based on systemic exposure) was 8-OH-loxapine >> loxapine N oxide > 7-OH-loxapine > amoxapine, with plasma levels of 8-OH-loxapine similar to the parent compound.
Croatian: Poredak metabolita za ADASUVE opažen kod ljudi (na osnovi sistemske izloženosti) je bio 8-OH-loksapin >> loksapin
English: • Administration of a maximum of 2 doses
Croatian: Rizik od produljenja QT intervala: • Primjena najviše 2 doze lijeka
English: Two
Croatian: Dvije
English: Renal failure following oral loxapine overdosage has also been reported.
Croatian: Također su prijavljeni slučajevi zatajenja bubrega nakon predoziranja oralno primjenjivanim loksapinom.
English: Angelini S.p.A. Tel: +39 06 780531
Croatian: Tel: +39 06 780531
English: None
Croatian: Nema.
English: Each single-dose inhaler contains 5 mg loxapine and delivers 4.5 mg of loxapine.
Croatian: Svaki jednodozni inhalator sadrži 5 mg loksapina i osigurava dozu od 4,5 mg loksapina.
English: Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg of loxapine.
Croatian: Svaki jednodozni inhalator sadrži 10 mg loksapina i osigurava dozu od 9,1 mg loksapina.
English: Each inhaler is provided in a sealed, multilaminate aluminum foil pouch.
Croatian: Inhalator se isporučuje u hermetički zatvorenoj, višeslojnoj vrećici od aluminijske folije.
English: AOP Orphan Pharmaceuticals AG BG Teл.
Croatian: Lietuva AOP Orphan Pharmaceuticals AG LT
English: 2 hr post dose
Croatian: 2 sata nakon doze
English: One single-dose inhaler
Croatian: Prašak inhalata Jedan jednodozni inhalator
English: These symptoms can be high fever, rigid muscles,
Croatian: Ti simptomi mogu biti visoka temperatura, krutost mišića, nepravilan ili ubrzan rad srca ili otkucaja srca.
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.
Croatian: ADASUVE 4,5 mg prašak inhalata, dozirani, sastoji se od jednodoznog bijelog plastičnog inhalatora za jednokratnu upotrebu koji sadrži loksapin.
English: • if you have lung problems like asthma or chronic obstructive pulmonary disease (which your doctor may have called “COPD”).
Croatian: • ako imate poteškoća s plućima kao što su astma ili kronična opstruktivna plućna bolest (koju
English: Common: dizziness
Croatian: Često: omaglica
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.
Croatian: • lijekove za liječenje shizofrenije, depresije ili boli jer možete biti izloženiji riziku epileptičkih napadaja
English: Rescue
Croatian: Zbrinjavanje
English: Pull tab.
Croatian: Povucite trakicu.
English: ADASUVE 9.1 mg inhalation powder, pre-dispensed
Croatian: ADASUVE 9,1 mg prašak inhalata, dozirani
English: General disorders and administration site conditions Common: fatigue
Croatian: Opći poremećaji i reakcije na mjestu primjene Često: zamor
English: ADASUVE 4.5 mg inhalation powder, pre-dispensed
Croatian: ADASUVE 4,5 mg prašak inhalata, dozirani
English: Severe hypotension might be expected to respond to the administration of noradrenaline or phenylephrine.
Croatian: Kao odgovor na davanje noradrenalina i fenilefrina može se očekivati teška hipotenzija.
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet FERRER INTERNACIONAL, S.A.
English: Each inhaler delivers 9.1 mg loxapine.
Croatian: Svaki inhalator osigurava dozu od 9,1 mg loksapina.
English: 1 single dose inhaler
Croatian: Prašak inhalata, dozirani 1 jednodozni inhalator
English: % CGI-I Responders
Croatian: CGI-I bolesnici s odgovorom
English: PEC Responders
Croatian: PEC bolesnici s odgovorom
English: The recommended initial dose of ADASUVE is 9.1 mg. A second dose can be given after 2 hours, if necessary.
Croatian: Preporučena početna doza lijeka ADASUVE je 9,1 mg.
English: ADASUVE 9.1 mg is supplied in a carton of 1 or 5 single dose inhalers.
Croatian: ADASUVE 9,1 mg se isporučuje u kutiji s 1 ili 5 jednodoznih inhalatora.
English: ADASUVE 9.1 mg inhalation powder, pre-dispensed loxapine
Croatian: ADASUVE 9,1 mg prašak inhalata, dozirani loksapin
English: ADASUVE 4.5 mg inhalation powder, pre-dispensed loxapine
Croatian: ADASUVE 4,5 mg prašak inhalata, dozirani loksapin
English: ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units.
Croatian: ADASUVE 9,1 mg se isporučuje u kutiji od 1 ili 5 inhalatora.
English: Each inhaler delivers 4.5 mg loxapine.
Croatian: Svaki inhalator osigurava dozu od 4,5 mg loksapina.
English: ADASUVE 4.5 mg is supplied in a carton of 1 or 5 single dose inhalers.
Croatian: ADASUVE 4,5 mg se isporučuje u kutiji s 1 ili 5 jednodoznih inhalatora.
English: The product is packaged in a sealed pouch.
Croatian: Inhalator je pakiran u hermetički zatvorenoj vrećici.
English: ADASUVE should be used with caution in patients with a known history of extrapyramidal symptoms.
Croatian: Kod bolesnika s poznatom povijesti ekstrapiramidalnih simptoma treba oprezno primjenjivati ADASUVE.
English: ADASUVE 4.5 mg is supplied in a carton of 1 or 5 units.
Croatian: ADASUVE 4,5 mg se isporučuje u kutiji od 1 ili 5 inhalatora.
English: Inhale Inhale through the mouthpiece with a steady deep breath.
Croatian: Udahne Udahne kroz nastavak za usta kontinuiranim dubokim udahom.
English: Tardive dyskinesia
Croatian: Ishodišna vrijednost
English: Open pouch.
Croatian: Otvorite vrećicu.
English: tramadol, mefloquine)
Croatian: meflokin)
English: LABELLING AND PACKAGE LEAFLET
Croatian: Sadržaj pakiranja i drugeinformacije
English: Vascular disorders
Croatian: Tardivna diskinezija
English: They will decide how much you need.
Croatian: Oni će odlučiti koliko Vam je potrebno.
English: (See also section 3)
Croatian: (također vidjeti dio 3)
English: This may cause bleeding.
Croatian: To može izazvati krvarenje.
English: D-24109 Kiel Germany
Croatian: D-24109 Kiel Njemačka
English: However, this finding is based on a very small sample (n=129 patients).
Croatian: Međutim, ovaj nalaz se temelji na vrlo malom uzorku (n=129 bolesnika).
English: - if your placenta is covering the birth canal.
Croatian: - ako placenta pokriva porođajni kanal.
English: Most of the treatment failures in CAP-001 were caused by poor tolerability.
Croatian: Većina slučajeva neuspješnog liječenja u CAP-001 bila je uzrokovana slabom podnošljivošću.
English: The following side effects may happen with this medicine:
Croatian: Sljedeće nuspojave mogu se dogoditi s ovim lijekom:
English: It is not known whether M1 accumulates in tissues.
Croatian: Nije poznato da li se M1 nakuplja u tkivima.
English: Tractocile contains atosiban.
Croatian: Tractocile sadrži atosiban.
English: Up to 270 mg
Croatian: sve do 270 mg
English: Do not use Tractocile: - if you are less than 24 weeks pregnant.
Croatian: Nemojte primjenjivati Tractocile: - ako ste trudni manje od 24 tjedna.
English: The benefit of atosiban in these subgroups is therefore uncertain.
Croatian: Stoga nije sigurna korist od atosibana u ovim podskupinama nesigurna.
English: Date of first authorisation: 20 January 2000 Date of latest renewal: 20 January 2010
Croatian: Datum posljednje obnove odobrenja: 20. siječnja 2010.
English: - if you are more than 33 weeks pregnant.
Croatian: - ako ste trudni više od 33 tjedna.
English: 8]-oxytocin) which is a competitive antagonist of human oxytocin at receptor level.
Croatian: 8]-oksitocin) koji je kompetitivni antagonist ljudskog oksitocina na razini receptora.
English: Do not use Tractocile if any of the above apply to you.
Croatian: Ne primjenjujte Tractocile ako se nešto od gore navedenog odnosi na Vas.
English: There are no known side effects on the unborn or new-born baby.
Croatian: Nisu poznate nuspojave u nerođenog ili novorođenog djeteta.
English: The most commonly reported adverse reaction in the mother is nausea (14 %).
Croatian: Najčešća prijavljena nuspojava kod majki je mučnina (14%).
English: The ratios of the main metabolite M1 (des-(Orn
Croatian: Omjer glavnog metabolita M1 (des-(Orn
English: - if you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na atosiban ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: It is not known whether the free fraction in the maternal and fetal compartments differs substantially.
Croatian: Nije poznato da li se slobodna frakcija odjeljka majke i fetusa značajno razlikuje.
English: - if you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you would also have fits (convulsions).
Croatian: - ako imate stanje koje se zove “eklampsija” koje je slično “teškoj preeklampsiji” ali također imate napadaje (konvulzije).
English: What Tractocile looks like and contents of the pack
Croatian: Kako Tractocile izgleda i sadržaj pakiranja
English: There is no known specific treatment in case of an overdose.
Croatian: Nije poznata specifična terapija u slučaju predoziranja.
English: - if you are between 24 and 27 weeks pregnant.
Croatian: - ako ste trudni između 24 i 27 tjedana.
English: Two metabolites were identified in the plasma and urine from human subjects.
Croatian: Dva su metabolita identificirana u plazmi i urinu ljudi.
English: Suspected intrauterine infection
Croatian: Suspektna intrauterina infekcija
English: Step Regimen
Croatian: Korak Režim
English: 5% w/v glucose solution.
Croatian: 5% w/v otopini glukoze.
English: MedDRA System Organ Class (SOC)
Croatian: MedDRA klasifikacija po organskim sustavima (SOC)
English: 2300 København S Denmark
Croatian: 2300 København S Danska
English: Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, babicu ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The exposure of the rat fetus was approximately four times that received by the human fetus during intravenous infusions in women.
Croatian: Izloženost fetusa štakora bila je otprilike četiri puta veća od one koju je primio ljudski fetus tijekom intravenske infuzije u žena.
English: This permits the continued independent control of the rate of infusion.
Croatian: Time se omogućava kontinuirani neovisni nadzor nad brzinom infuzije.
English: 9)-[Mpa
Croatian: NH2 9)-[Mpa