FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of ADASUVE resulted in rapid absorption of loxapine with a median time of maximum plasma concentration (Tmax) by 2 minutes.
Croatian: Primjena lijeka ADASUVE rezultirala je brzom apsorpcijom loksapina s medijanom vrijednosti vremena maksimalne koncentracije u plazmi (Tmax) od 2 minute.
English: Consequently, monitoring of new-borns should be considered.
Croatian: Posljedično, potrebno je razmotriti motrenje novorođenčadi.
English: • any breathing symptoms such as wheezing, cough, shortness of breath, or chest tightness, as these could mean that the medicine is irritating your airways (uncommon occurrence unless you have asthma or COPD);
Croatian: • bilo koje simptome disanja kao što su piskanje, kašalj, nedostatak zraka ili pritisak u prsnom košu, jer to može značiti da lijek nadražuje Vaše dišne putove (što je manje česta pojava osim ako ne bolujete od astme ili KOPB-a);
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, ADASUVE must be discontinued.
Croatian: Ako bolesnik razvije znakove i simptome koji ukazuju na MNS ili dobije neočekivanu vrućicu bez dodatnih kliničkih manifestacija MNS-a, mora se prekinuti davanje lijeka ADASUVE.
English: Adrenaline
Croatian: Adrenalin
English: 30 min post dose 27.8% 46.6% 57.1% 23.8% 59.6% 61.9%
Croatian: % CGI-I bolesnici s odgovorom 35,7% 57,4% 67,0% 27,6% 66,3% 74,3%
English: Because of the potential for sedation/somnolence, fatigue, or dizziness, patients should not operate hazardous machines, including motor vehicles, until they are reasonably certain that loxapine has not affected them adversely (see section 4.8).
Croatian: Radi moguće sedacije/somnolencije, zamora ili vrtoglavice, bolesnici ne smiju upravljati opasnim strojevima, uključujući i motorna vozila, sve dok nije razumno vjerojatno da loksapin više nema štetni utjecaj (vidjeti dio 4.8).
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Croatian: Kliničke manifestacije MNS-a su hiperpireksija, krutost mišića, promijenjeno psihičko stanje i dokazi autonomne nestabilnosti (nepravilni otkucaji srca ili krvni tlak, tahikardija, dijaforeza i kardijalna disritmija).
English: ADASUVE should not be re-administered in patients who develop any respiratory signs/symptoms (see section 4.3).
Croatian: ADASUVE se ne bi trebao davati bolesnicima koji razviju bilo koje respiratorne znakove/simptome (vidjeti dio 4.3).
English: The pharmacokinetic parameters of loxapine were determined in subjects on chronic, stable antipsychotic regimens following repeat administration of ADASUVE every 4 hours for a total of 3 doses (either 4.5 mg or 9.1 mg).
Croatian: Farmakokinetički parametri loksapina su određeni kod ispitanika na kroničnim, stabilnim režimima antipsihotika nakon ponovljenog davanja lijeka ADASUVE svaka 4 sata, za ukupno 3 doze (ili 4,5 mg ili 9,1 mg).
English: Becoming familiar with ADASUVE: The pictures below show the important features of ADASUVE.
Croatian: Upoznavanje s lijekom ADASUVE: Donje slike prikazuju važna obilježja lijeka ADASUVE.
English: • ADASUVE should be used with caution in patients who are intoxicated or delirious.
Croatian: • ADASUVE je potrebno davati oprezno kod bolesnika koji su intoksicirani ili delirantni.
English: Adrenaline should not be used since its use in a patient with partial adrenergic blockage may further lower the blood pressure (see sections 4.4 and 4.5).
Croatian: Adrenalin se ne bi trebao primjenjivati jer upotrebljen kod bolesnika s djelomično adrenergičkom blokadom može dodatno smanjiti krvni tlak (vidjeti dijelove 4.4 i 4.5).
English: Patients were randomised to placebo, ADASUVE 4.5 mg and ADASUVE 9.1 mg.
Croatian: Bolesnici su randomizirani u skupine koje su primale placebo, ADASUVE od 4,5 mg i ADASUVE od 9,1 mg.
English: 8-OH-loxapine is not pharmacologically active at the D2 receptor while the minor metabolite, 7-OH-loxapine, has high binding affinity to D2 receptors.
Croatian: 8-OH-loksapin nije farmakološki aktivan na D2 receptorima dok manji metabolit, 7-OH-loksapin, ima visoku sklonost vezanju na D2 receptore.
English: Uncommon: hypotension
Croatian: Manje često: hipotenzija
English: ADASUVE with alcohol Because ADASUVE affects the nervous system, alcohol should be avoided when using ADASUVE.
Croatian: Budući da ADASUVE utječe na središnji žičani sustav, alkohol se mora izbjegavati za vrijeme uzimanja lijeka ADASUVE.
English: Seizures / convulsions
Croatian: Epileptički napadaji / konvulzije
English: Anticholinergic activity
Croatian: Antikolinergijsko djelovanje
English: Most of these events occurred within 25 minutes of dosing, were mild to moderate in severity, and could be relieved with an inhaled bronchodilator.
Croatian: Većina ovih događaja koji su se dogodili u roku od 25 minuta od uzimanja lijeka su bili blagi do umjereni te su se mogli olakšati inhalirajućim bronhodilatorom.
English: This product is packaged in a sealed pouch and should remain in the pouch until ready to use
Croatian: Inhalator je pakiran u hermetički zatvorenu vrećicu i mora ostati u vrećici do uporabe
English: Loxapine is removed rapidly from the plasma and distributed in tissues.
Croatian: Loksapin se brzo odstranjuje iz plazme i distribuira u tkivo.
English: • have or had seizures (convulsions)
Croatian: • imate ili ste imali epileptičke napadaje (konvulzije)
English: You should not breast-feed for a period of 48 hours after receiving ADASUVE and should discard the milk produced in the meantime.
Croatian: Ne smijete dojiti tijekom do 48 sati nakon uzimanja lijeka ADASUVE i trebate odbaciti mlijeko proizvedeno za to vrijeme.
English: Typically, this will occur within 25 minutes of use.
Croatian: To se obično događa unutar 25 minuta od uzimanja lijeka.
English: PEC Responders = > 40% change from PEC Baseline; CGI-I Responders = Score of 1 (Very Much Improved) or 2 (Much Improved) PBO = placebo SD=Standard Deviation
Croatian: PEC bolesnici s odgovorom = > 40% promjene od PEC ishodišne vrijednosti; CGI-I bolesnici s odgovorom = rezultat od 1 (jako veliko poboljšanje) ili 2 (veliko poboljšanje) PBO = placebo SD = standardna devijacija
English: Uncommon (may affect up to 1 in 100 people): muscle or eye movements you can't control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still.
Croatian: Manje često (može se javiti kod do 1 na 100 osoba): pokreti mišića ili oka koje ne možete kontrolirati, nedostatak koordinacije, kontinuirano grčenje mišića, osjećaj nemira ili nesposobnost mirnog sjedenja.
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Croatian: Dodatni znaci mogu uključiti povišenu kreatin fosfokinazu, mioglobinuriju (rabdomioliza) i akutno zatajenje bubrega.
English: The green light turns on indicating that the inhaler is ready for use.
Croatian: Upalit će se zeleno svjetlo koje pokazuje da je inhalator spreman za upotrebu.
English: The potential for loxapine and its metabolites (amoxapine, 7-OH-loxapine, 8-OH-loxapine, and loxapine-N-oxide) to inhibit CYP450 - mediated drug metabolism has been examined in vitro for CYPs 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4.
Croatian: Potencijal loksapina i njegovih metabolita (amoksapina, 7-OH-loksapina, 8-OH-loksapina i loksapinN-oksida) za inhibiciju metabolizma lijekova posredovanog s CYP450 ispitan je in vitro za CYP 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 i 3A4.
English: In addition, in vitro studies indicate that loxapine and 8-OH loxapine are not inhibitors of UGT1A1, 1A3, 1A4, 2B7 and 2B15.
Croatian: Osim toga, in vitro ispitivanja pokazala su da loksapin i 8-OH loksapin nisu inhibitori UGT1A1, 1A3, 1A4, 2B7 i 2B15.
English: Potential for ADASUVE to affect other medicinal products
Croatian: Mogućnost utjecaja lijeka ADASUVE na ostale lijekove
English: ADASUVE is not recommended in patient populations with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions which would predispose patients to hypotension (dehydration, hypovolaemia, and treatment with antihypertensive medicinal products).
Croatian: ADASUVE se ne preporučuje bolesnicima oboljelim od poznatih kardiovaskularnih bolesti (povijest infarkta miokarda, ishemičke bolesti srca, zatajenja srca ili poremećaja srčane provodljivosti), cerebrovaskularnih bolesti ili stanja koja bi predisponirala bolesnike na hipotenziju (dehidracija, hipovolemija i liječenje antihipertenzivnim lijekovima).
English: Adrenaline should not be used, since beta-adrenoceptor stimulation may worsen hypotension in the setting of loxapine-induced partial alpha-adrenoceptor blockade (see section 4.5).
Croatian: Adrenalin se ne smije upotrebljavati jer stimulacija betaadrenoceptora može pogoršati hipotenziju u okolnostima djelomične blokade alfa-adrenoceptora izazvane loksapinom (vidjeti dio 4.5).
English: Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects (bronchospasm).
Croatian: Brzodjelujući beta-agonistički bronhodilatator bi trebao biti dostupan za liječenje mogućih teških respiratornih nuspojava (bronhospazam).
English: Seizures have been reported in patients receiving oral loxapine at antipsychotic dose levels, and may occur in epileptic patients even with maintenance of routine anticonvulsant drug therapy (see section 4.5).
Croatian: Prijavljeni su epileptički napadaji kod bolesnika koji su oralno primali loksapin pri razinama antipsihotičkih doza te se mogu dogoditi u bolesnika s epilepsijom čak i pri održavanju rutinske terapije antikonvulzivima (vidjeti dio 4.5).
English: Should bronchospasm occur after treatment with ADASUVE, it can be treated with a short-acting beta-agonist bronchodilator, e.g., salbutamol (see sections 4.2 and 4.8).
Croatian: Ako dođe do pojave bronhospazma nakon liječenja lijekom ADASUVE, on se može liječiti pomoću brzodjelujućeg beta-agonističkog bronhodilatatora, npr. salbutamol (vidjeti dijelove 4.2 i 4.8).
English: Patients should be advised not to breast feed for a period of 48 hours after receiving loxapine and discard the milk produced in the meantime.
Croatian: Bolesnice treba upozoriti da ne doje tijekom do 48 sati nakon uzimanja loksapina i da odbace mlijeko proizvedeno za to vrijeme.
English: Tear open the foil pouch and remove the inhaler from the package.
Croatian: Otvorite vrećicu od folije kidanjem i izvadite inhalator iz pakiranja.
English: Caution is advised if loxapine is combined with other medicinal products known to lower the seizure threshold, e.g. phenothiazines or butyrophenones, clozapine, tricyclics or selective serotonine reuptake inhibitors (SSRIs), tramadol, mefloquine (see section 4.4).
Croatian: Potreban je oprez ako se loksapin kombinira s drugim lijekovima za koje je poznato da smanjuju prag epileptičkih napadaja, kao što su primjerice fenotiazini ili butirofenoni, klozapin, triciklici ili selektivni inhibitori ponovne pohrane serotonina (eng. selective serotonine reuptake inhibitors, SSRIs), tramadol, meflokin (vidjeti dio 4.4).
English: ADASUVE has not been studied in elderly patients, including those with dementia-related psychosis.
Croatian: ADASUVE nije ispitan u starijih bolesnika, uključujući i one oboljele od psihoze povezane s demencijom.
English: A study of inhaled loxapine and intramuscular lorazepam 1 mg in combination found no significant effects on respiratory rate, pulse oximetry, blood pressure, or heart rate compared with either drug administered alone.
Croatian: Studija s inhaliranim loksapinom u kombinaciji s 1 mg intramuskularnog lorazepama pokazala je da nema značajnih učinaka na frekvenciju disanja, pulsnu oksimetriju, krvni tlak ili srčanu frekvenciju u usporedbi s tim lijekovima primijenjenim zasebno.
English: See the SmPC for more information.
Croatian: Pogledajte sažetak opisa svojstava lijeka za više informacija.
English: Extrapyramidal symptoms
Croatian: Ekstrapiramidalni simptomi
English: New-born infants exposed repeatedly to antipsychotics during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Croatian: Kod novorođenčadi opetovano izloženoj antipsihoticima za vrijeme posljednja 3 mjeseca trudnoće, postoji rizik nuspojava uključujući ekstrapiramidalne simptome i/ili simptome apstinencijske krize koji nakon poroda mogu varirati u težini i trajanju.
English: Co-administration of loxapine and adrenaline may cause worsening of hypotension (see section 4.4).
Croatian: Istodobna primjena loksapina i adrenalina može uzrokovati pogoršanje hipotenzije (vidjeti dio 4.4).
English: Primary endpoint was absolute change in PEC score from baseline to 2 hours following Dose 1 for both doses of ADASUVE compared with placebo.
Croatian: Primarna krajnja točka je apsolutna promjena PEC rezultata od početne točke 2 sata nakon Doze 1 za obje doze lijeka ADASUVE u usporedbi s placebom.
English: Given the primary CNS effects of loxapine, ADASUVE should be used with caution in combination with alcohol or other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc.
Croatian: Uzevši u obzir primarni utjecaj loksapina na SŽS, ADASUVE treba primjenjivati s oprezom u kombinaciji s alkoholom ili drugim lijekovima koji djeluju na SŽS, kao što su primjerice anksiolitici, većina antipsihotika, hipnotici, opijati itd.
English: As would be expected from the pharmacologic actions of loxapine, the clinical findings may range from mild depression of the CNS and cardiovascular systems to profound hypotension, respiratory depression, and unconsciousness (see section 4.4).
Croatian: Kao što se može očekivati od farmakološkog djelovanja loksapina, klinički nalazi mogu varirati od blage depresije SŽS-a i kardiovaskularnog sustava do duboke hipotenzije, respiratorne depresije i gubitka svijesti (vidjeti dio 4.4).
English: In studies in agitated patients, bronchospasm was reported as an uncommon, but serious adverse reaction, while in subjects with active airways disease, bronchospasm was commonly reported and often required treatment with a short-acting beta-agonist bronchodilator.
Croatian: U ispitivanjima agitiranih bolesnika, bronhospazam je prijavljen kao manje česta, ali ozbiljna nuspojava, dok je u ispitanika s aktivnom bolesti dišnih putova, bronhospazam prijavljen kao čest i često zahtjeva liječenje brzodjelujućim beta-agonističkim bronhodilatorom.
English: ADASUVE has not been investigated in patients with other forms of lung disease.
Croatian: ADASUVE nije ispitan u bolesnika koji boluju od drugih oblika plućnih bolesti.
English: Additional side effects which have been related to long term use of loxapine by mouth and which may be relevant for ADASUVE include faintness upon standing, increased heart rate, increased blood pressure, blurred vision, dry eyes, and decreased urination.
Croatian: Dodatne nuspojave koje su povezane s dugoročnom upotrebom loksapina kroz usta i koje se mogu odnositi na ADASUVE uključuju nesvjesticu nakon ustajanja, ubrzani puls, povišen krvni tlak, zamućen vid, suhe oči i smanjeno mokrenje.
English: Among the other endpoints were PEC and Clinical Global ImpressionImprovement (CGI-I) responders at 2 hours after dose 1, and total number of patients per group who received 1, 2, or 3 doses of study medication with and without rescue medication.
Croatian: Clinical Global Impression - Improvement, CGI-I) kod respondera 2 sata nakon doze 1 i ukupni broj bolesnika po grupi koji su dobili 1, 2 ili 3 doze lijeka u ispitivanju sa i bez simptomatskog lijeka.
English: Concomitant use of CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin, enoxacin, propranolol and refecoxib) should be avoided, if possible.
Croatian: Potrebno je, ako je moguće, izbjegavati istodobnu primjenu inhibitora CYP1A2 (npr. fluvoksamina, ciprofloksacina, enoksacina, proprandolola i refekoksiba).
English: Loxapine may cause severe respiratory depression if combined with other CNS-depressants (see section 4.4).
Croatian: Loksapin može uzrokovati tešku respiratornu depresiju ako se kombinira s depresorima SŽS-a (vidjeti dio 4.4).
English: Upon completion of the inhalation, the patient removes the mouthpiece from mouth and holds breath briefly.
Croatian: Nakon inhalacije, bolesnik vadi nastavak za usta iz usta i kratko zadržava dah.
English: Patients who have been given more ADASUVE than they should may experience any of the following symptoms: extreme tiredness or sleepiness, trouble breathing, low blood pressure, throat irritation or a bad taste in the mouth, muscle or eye movements you can't control.
Croatian: Bolesnici koji su uzeli više lijeka ADASUVE nego što su trebali mogu iskusiti bilo koji od sljedećih simptoma: izniman umor ili pospanost, probleme s disanjem, nizak krvni tlak, nadraženost grla ili loš okus u ustima, pokrete mišića ili oka koje ne možete kontrolirati.
English: Respiratory, thoracic and mediastinal disorders Common: throat irritation
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Često: iritacija grla
English: There were no important differences in the exposure or disposition of loxapine following administration of ADASUVE due to age, gender, race, weight, or body mass index (BMI).
Croatian: Ne postoje značajne razlike u izlaganju ili dispoziciji loksapina nakon davanja lijeka ADASUVE u ovisnosti o dobi, spolu, rasi, težini ili indeksu tjelesne mase (eng.
English: The use of loxapine in patients with alcohol or medicinal product intoxication (either with prescribed or illicit medicinal products) has not been evaluated.
Croatian: Upotreba loksapina kod bolesnika pod utjecajem alkohola ili lijekova (propisanih ili nedopuštenih), nije ispitana.
English: In vitro studies indicate that loxapine and 8-OH-loxapine are not inducers of CYP1A2, 2B6 or 3A4 enzymes at clinically relevant concentrations.
Croatian: In vitro ispitivanja pokazala su da loksapin i 8-OH-loksapin nisu induktori enzima CYP 1A2, 2B6 ili 3A4 u klinički relevantnim koncentracijama.
English: Adverse reactions seen with chronic oral loxapine use
Croatian: Nuspojave opažene uz kroničnu peroralnu upotrebu loksapina
English: ADASUVE is used to treat acute symptoms of mild-to-moderate agitation that may occur in adult patients who have schizophrenia or bipolar disorder.
Croatian: ADASUVE se upotrebljava za liječenje akutnih simptoma blage do umjerene uznemirenosti koji se mogu pojaviti u odraslih bolesnika oboljelih od shizofrenije ili bipolarnog poremećaja.
English: The active substance is loxapine.
Croatian: Djelatna tvar je loksapin.
English: Mild hypotension was reported in short-term (24-hour), placebo-controlled trials in agitated patients administered ADASUVE.
Croatian: Prijavljeni su slučajevi blage hipotenzije kod agitiranih bolesnika kojima je davan ADASUVE u kratkoročnim (24 sata) ispitivanjima kontroliranima placebom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ADASUVE in the subset of the paediatric population from birth to less than 12 years of age for the treatment of schizophrenia and in the subset from birth to less than 10 years of age for the treatment of bipolar disorder (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka ADASUVE u podskupini pedijatrijske populacije od rođenja do dobi od 12 godina za liječenje shizofrenije i u podskupini od rođenja do dobi od 10 godina za liječenje bipolarnog poremećaja (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Each inhaler is packaged in a sealed foil pouch.
Croatian: Svaki inhalator je pakiran u hermetički zatvorenu vrećicu od folije.
English: Given the primary Central Nervous System (CNS) effects of loxapine, ADASUVE should be used with caution in patients with compromised respiration, such as hypovigilant patients or patients with CNS-depression due to alcohol or other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. (see section 4.5).
Croatian: S obzirom na primarne utjecaje loksapina na središnji živčani sustav (SŽS), ADASUVE je potrebno oprezno primjenjivati kod bolesnika s dišnim problemima, kao što su bolesnici s hipovigilancijom ili bolesnici s depresijom SŽS-a uzrokovanom alkoholom ili drugim lijekovima koji djeluju na SŽS, kao što su primjerice anksiolitici, većina antipsihotika, hipnotici, opijati itd. (vidjeti dio 4.5).
English: Hold the inhaler away from the mouth and breathe out fully to empty lungs.
Croatian: Drži inhalator podalje od usta i izdahne u potpunosti kako bi ispraznio pluća.
English: ADASUVE should be used with caution in patients who are intoxicated or delirious (see section 4.5).
Croatian: ADASUVE je potrebno oprezno primjenjivati u bolesnika koji su intoksicirani ili delirantni (vidjeti dio 4.5).
English: • Introductory statement on the purpose of the educational material
Croatian: • Uvodna izjava koja objašnjava svrhu edukacijskog materijala • Izjava o akutnim okolnostima indikacija
English: ADASUVE is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.
Croatian: ADASUVE je indiciran za brzu kontrolu blage do umjerene agitacije u odraslih osoba oboljelih od shizofrenije ili bipolarnog poremećaja.
English: Embryo/fetal developmental and perinatal studies have shown indications of developmental delay (reduced weights, delayed ossification, hydronephrosis, hydrourether, and/or distended renal pelvis with reduced or absent papillae) as well as increased numbers of perinatal and neonatal deaths in offspring of rats treated from mid-pregnancy with oral doses below the maximum recommended human dose for ADASUVE on a mg/m basis (see section 4.6).
Croatian: Embrio/fetalni razvoj i perinatalna ispitivanja su pokazala indikacije zaostajanja u razvoju (smanjena težina, odgođena osifikacija, hidronefroza, hidroureter, i/ili distendirani renalni pelvis sa smanjenom papilom ili bez nje) kao i povećani broj perinatalnih i neonatalnih smrti kod potomaka štakora kojima su od sredine trudnoće davane oralne doze ispod maksimalnih preporučenih doza lijeka ADASUVE za ljude na osnovu mg/m
English: The main metabolic pathways include hydroxylation to form 8-OH-loxapine and 7-OH-loxapine, N-oxidation to form loxapine N-oxide, and de-methylation to form amoxapine.
Croatian: Glavni metabolički putovi uključuju hidroksilaciju za formiranje 8-OH-loksapina i 7-OH-loksapina, N-oksidaciju za formiranje loksapin N-oksida i demetilaciju za formiranje amoksapina.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ADASUVE in the subset of the paediatric population from 12 to less than 18 years of age for the treatment of schizophrenia and in the subset from 10 years to less than 18 years of age in bipolar disorder (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka ADASUVE u podskupini pedijatrijske populacije u dobi od 12 do 18 godina za liječenje shizofrenije i u podskupini u dobi od 10 do 18 godina za liječenje bipolarnog poremećaja (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: To deliver the medicinal product, the patient inhales through the mouthpiece with a steady deep breath.
Croatian: Za uzimanje lijeka, bolesnik udiše kroz nastavak za usta kontinuiranim dubokim udahom.
English: When needed, the product is removed from the pouch.
Croatian: Kad je potrebno, inhalator se vadi iz vrećice.
English: Loxapine is a substrate for flavin-containing mono-oxygenases (FMOs), and for several CYP450 isozymes (see section 5.2).
Croatian: Loksapin je supstrat flavinskih monoksigenaza (eng. flavin-containing mono-oxygenases, FMOs) i nekoliko CYP450 izoenzima (vidjeti dio 5.2).