FrancophonIA/ELRC3.0 huggingface dataset:
English: During clinical development, two transient ECG abnormalities were observed in one test subject and reported as serious possibly adverse reactions.
Croatian: Tijekom kliničkog razvoja opažene su dvije prolazne abnormalnosti EKG-a u jednog testiranog ispitanika i zabilježene kao moguće ozbiljne nuspojave.
English: • cystic fibrosis (lumacaftor)
Croatian: • cistične fibroze (lumakaftor)
English: The level of negative and positive agreement between the results of the ITT and the MAC test was used to evaluate the performance of the MAC test.
Croatian: Razina negativnog i pozitivnog slaganja rezultata dobivenih ITT i MAC testom upotrijebljena je za procjenu učinkovitosti MAC testa.
English: One LDPE/Alu/LDPE/paper sachet containing 1,817 mg granules placed in cardboard box.
Croatian: Jedna LDPE/Al/LDPE/papirnata vrećica koja sadrži 1817 mg granula u kartonskoj kutiji.
English: Any remaining suspension must be discarded by your doctor or nurse according to local regulations.
Croatian: Svu preostalu suspenziju mora baciti liječnik ili medicinska sestra sukladno nacionalnim propisima.
English: In case a patient should be reporting dizziness as side effect, the patient should be instructed to neither drive nor use machines.
Croatian: U slučaju da bolesnik navede omaglicu kao nuspojavu, potrebno mu je reći da ne vozi i ne rukuje strojevima.
English: As with all GH stimulation tests, also the macimorelin test results should always be interpreted on basis of the outcome of all examinations within the diagnostic work-up for a patient.
Croatian: Kao i kod drugih testova stimulacije hormona rasta, rezultate macimorelinskog testa treba uvijek interpretirati na temelju ishoda svih pretraga provedenih u bolesnika u sklopu dijagnostičkog postupka.
English: Based on current understanding, this potential is unlikely to decrease the specificity of the test.
Croatian: Na temelju postojećih saznanja, nije vjerojatno da će ta mogućnost smanjiti specifičnost testa.
English: If you are breast-feeding or intend to breast-feed, a risk to the suckling child cannot be excluded.
Croatian: Ako dojite ili namjeravate dojiti, ne može se isključiti rizik za dojenče.
English: Based on current understanding, this is unlikely to decrease the specificity of the test.
Croatian: Na temelju postojećih saznanja, nije vjerojatno da će to smanjiti specifičnost testa.
English: Four groups of individuals were evaluated: three groups of adult patients with different pre-test probability of growth hormone deficiency (Group A (high likelihood), Group B (intermediate likelihood), Group C (low likelihood) and healthy control subjects (Group D)).
Croatian: Procjenjivane su četiri skupine osoba: tri skupine odraslih bolesnika s različitom vjerojatnošću nedostatka hormona rasta prije testa (skupina A (velika vjerojatnost), skupina B (umjerena vjerojatnost), skupina C (mala vjerojatnost) i zdravi kontrolni ispitanici (skupina D)).
English: Pharmacotherapeutic group: Diagnostic agents, Tests for pituitary function, ATC code: V04CD06
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: dijagnostička sredstva, testovi funkcije hipofize, ATK oznaka: V04CD06
English: The mechanism for the observed QTcF prolongation is unknown.
Croatian: Mehanizam opaženog produljenja QTcF intervala nije poznat.
English: Potentially re-test needed in early disease
Croatian: Mogućnost potrebe za ponovljenim testom u ranoj fazi bolesti
English: If the adult growth hormone deficiency just recently started and if it is due to an injury in a section of the brain called hypothalamus, then the test result could be negative although you have the disease.
Croatian: Ako se nedostatak hormona rasta u odraslih tek pojavio i ako je nastao zbog ozljede u dijelu mozga koji se naziva hipotalamus, tada bi rezultati testa mogli biti negativni iako imate tu bolest.
English: Other hormone deficiencies if untreated could lead to inaccurate results in the growth hormone stimulation test.
Croatian: Nedostatak drugih hormona, ako se ne liječi, može dovesti do netočnih rezultata testa stimulacije hormona rasta
English: For oral use after reconstitution.
Croatian: Za primjenu kroz usta nakon rekonstitucije.
English: These results are based on peak GH values (maximum GH concentrations across all measurement timepoints).
Croatian: Ti rezultati temelje se na vršnim vrijednostima hormona rasta (maksimalne koncentracije hormona rasta u svim vremenskim točkama mjerenja).
English: This corresponds to a volume of 1 mL of the prepared suspension per kg body weight.
Croatian: To odgovara volumenu od 1 ml pripremljene suspenzije po kg tjelesne težine.
English: Macimorelin is not recommended during pregnancy.
Croatian: Macimorelin se ne preporučuje tijekom trudnoće.
English: • changes in the electrocardiogram (ECG)
Croatian: • promjene u elektrokardiogramu (EKG) Prijavljivanje nuspojava
English: If either of these conditions is not met, the growth hormone stimulation test must be re-scheduled for a new test day.
Croatian: Ako jedan od ta dva uvjeta nije ispunjen, test stimulacije hormona rasta mora se odgoditi za neki drugi dan.
English: Please ask your doctor whether to discontinue breast-feeding or to abstain from the macimorelin test.
Croatian: Upitajte svojeg liječnika trebate li prekinuti dojenje ili odustati od macimorelinskog testa.
English: Sufficient washout time (five elimination half-lives) of medicinal products prior to administration of macimorelin is recommended.
Croatian: Preporučuje se dovoljno dugo vrijeme ispiranja (pet poluvjekova eliminacije) lijeka prije primjene macimorelina.
English: There are no data available on animal (see section 5.3) or human male and female fertility.
Croatian: Nema dostupnih podataka o plodnosti mužjaka i ženki u životinja (vidjeti dio 5.3) kao ni o plodnosti muškaraca i žena.
English: A sufficient washout time of five elimination half-lives of the CYP3A4 inducer prior to administration of the test is recommended (see section 4.2 and section 4.4).
Croatian: Preporučuje se dovoljno dugo vrijeme ispiranja od pet poluvjekova eliminacije induktora enzima CYP3A4 prije primjene testa (vidjeti dio 4.2 i dio 4.4).
English: Growth hormone medicinal products should be discontinued at least 1 month before administering macimorelin.
Croatian: Primjenu lijekova za hormon rasta treba prekinuti najmanje 1 mjesec prije primjene macimorelina.
English: Reconstituted suspension should be administered orally to patients fasting for at least 8 hours and who did not have strenuous physical exercises 24 hours before the test, since both could affect growth hormone levels.
Croatian: Rekonstituiranu suspenziju treba dati peroralno bolesnicima koji su natašte najmanje 8 sati i koji nisu imali naporne tjelesne aktivnosti 24 sata prije testa jer i jedno i drugo može utjecati na razine hormona rasta.
English: Tell your doctor if you are taking medicines that could increase the breakdown of macimorelin such as specific medicines to treat:
Croatian: Obavijestite liječnika ako uzimate lijekove koji mogu pojačati razgradnju macimorelina, kao što su specifični lijekovi za liječenje:
English: Macimorelin Aeterna Zentaris granules are to be reconstituted with water and must be used within 30 minutes after preparation.
Croatian: Granule lijeka Macimorelin Aeterna Zentaris treba rekonstituirati s vodom, a uzeti ih se mora unutar 30 minuta od pripreme.
English: It is used when your doctor thinks that you may not have enough growth hormone (adult growth hormone deficiency).
Croatian: Primjenjuje se onda kada liječnik smatra da možda nemate dovoljno hormona rasta
English: • infections (antibiotics such as rifabutin, rifampicin)
Croatian: • infekcija (antibiotici kao što je rifabutin, rifampicin)
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Macimorelin is moderately bound to plasma proteins.
Croatian: Macimorelin se umjereno veže za proteine plazme.
English: No studies have been conducted to evaluate the pharmacokinetics of macimorelin in paediatric patients or in patients with renal or hepatic impairment.
Croatian: Nisu provedena ispitivanja za procjenu farmakokinetike macimorelina u pedijatrijskih bolesnika ili bolesnika s oštećenjem bubrežne ili jetrene funkcije.
English: Measure the required volume using a 50 mL graduated syringe without a needle.
Croatian: Potreban volumen izmjerite pomoću graduirane štrcaljke bez igle od 50 ml.
English: Women of childbearing potential must use adequate contraceptive methods at the time when macimorelin will be administered.
Croatian: Žene reproduktivne dobi moraju primjenjivati odgovarajuće metode kontracepcije u vrijeme primjene macimorelina.
English: • type 2 diabetes (pioglitazone)
Croatian: • šećerne bolesti tipa 2 (pioglitazon)
English: Paediatric population The safety and efficacy of macimorelin in children and adolescents below 18 years have not yet been established (see also section 5.2).
Croatian: Sigurnost i djelotvornost macimorelina u djece i adolescenata mlađih od 18 godina nisu još ustanovljene (vidjeti također dio 5.2).
English: Growth hormone secretion normally decreases with age.
Croatian: Starije osobe Lučenje hormona rasta normalno se smanjuje s dobi.
English: It is unknown whether macimorelin or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se macimorelin ili njegovi metaboliti u majčino mlijeko.
English: QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases.
Croatian: Produljenje QT intervala može dovesti do razvoja ventrikularne tahikardije tipa torsades de pointes, a rizik se povećava kako se povećava stupanj produljenja.
English: Potential for false negative test results in recent onset hypothalamic disease
Croatian: Mogućnost lažno negativnih rezultata testa u ranoj fazi bolesti hipotalamusa
English: Macimorelin Aeterna Zentaris can cause changes in the ECG (electrocardiogram) including QT prolongation that are associated with an increased risk for arrhythmias.
Croatian: Macimorelin Aeterna Zentaris može prouzročiti promjene u EKG-u (elektrokardiogramu), uključujući produljenje QT intervala, koje su povezane s povećanim rizikom od aritmija.
English: Medicinal products affecting growth hormone release
Croatian: Lijekovi koji utječu na otpuštanje hormona rasta
English: Macimorelin was absorbed rapidly and the maximum plasma macimorelin concentrations (Cmax) were observed approximately 30 minutes to 1 hour and 10 minutes after oral administration of 0.5 mg/kg macimorelin after fasting for at least 8 hours.
Croatian: Macimorelin se apsorbirao brzo, a maksimalne koncentracije macimorelina u plazmi (Cmax) opažene su približno od 30 minuta do 1 sata i 10 minuta nakon peroralne primjene 0,5 mg/kg macimorelina u stanju natašte od najmanje 8 sati.
English: • mild to moderate depressive episodes (St. John´s wort (Hypericum perforatum))
Croatian: • blagih do umjerenih epizoda depresije (gospina trava (Hypericum perforatum))
English: Therefore, the diagnostic performance of the test may by affected in patients with Cushing's disease or on supra-physiologic glucocorticoid therapy (e.g. systemic administration of doses of hydrocortisone (or its equivalent) in excess of 15 mg/m2/day) and lead to false positive test results.
Croatian: Stoga dijagnostička uspješnost testa može biti promijenjena u bolesnika s Cushingovom bolešću ili u onih na suprafiziološkoj glukokortikoidnoj terapiji (npr. sistemska primjena doza hidrokortizona (ili njegova ekvivalenta) većih od 15 mg/m2 na dan) i dovesti do lažno pozitivnih rezultata testa.
English: Determine the volume of suspension needed for the recommended macimorelin dose of 0.5 mg/kg.
Croatian: Odredite volumen suspenzije potreban za preporučenu dozu macimorelina od 0,5 mg/kg.
English: If you are given more Macimorelin Aeterna Zentaris than you should, tell your doctor or nurse.
Croatian: Ako ste primili više lijeka Macimorelin Aeterna Zentaris nego što ste trebali, obratite se liječniku ili medicinskoj sestri.
English: Potential for false positive test results with use of strong CYP3A4 inducers
Croatian: Mogućnost lažno pozitivnih rezultata uz primjenu snažnih induktora enzima CYP3A4
English: Clinical studies have established that a maximally stimulated serum GH level of less than 2.8 ng/mL (at the 45, 60 and 90 minutes timepoints) following macimorelin administration confirms a diagnosis of adult growth hormone deficiency.
Croatian: U kliničkim ispitivanjima utvrđeno je da razina maksimalno stimuliranog hormona rasta u serumu manja od 2,8 ng/ml (u vremenskim točkama 45, 60 i 90 minuta) nakon primjene macimorelina potvrđuje dijagnozu nedostatka hormona rasta u odraslih.
English: The suspension must be prepared and administered by a healthcare professional.
Croatian: UPUTE ZA PRIPREMU I UPOTREBU Suspenziju mora pripremiti i primijeniti zdravstveni radnik.
English: Therefore, ECG controls may be indicated prior to the administration of macimorelin and 1 hour, 2 hours, 4 hours and 6 hours after administration of macimorelin (see also section 4.4).
Croatian: Stoga mogu biti indicirane kontrole EKG-a prije primjene macimorelina te 1 sat, 2 sata, 4 sata i 6 sati poslije primjene macimorelina (vidjeti također dio 4.4).
English: There are no data for the use of macimorelin in pregnant women.
Croatian: Nema podataka o primjeni macimorelina u trudnica.
English: You must be fasting for at least 8 hours before you are given Macimorelin Aeterna Zentaris.
Croatian: Morate biti natašte najmanje 8 sati prije nego što primite lijek Macimorelin Aeterna Zentaris.
English: • sleep disorder (modafinil, pitolisant)
Croatian: • poremećaja spavanja (modafinil, pitolizant)
English: • cancer (dabrafenib, enzalutamide)
Croatian: • karcinoma (dabrafenib, enzalutamid).
English: • seizures/epilepsy (carbamazepine, esclicarbazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone)
Croatian: • napadaja/epilepsije (karbamazepin, eslikarbazepin, fosfenitoin, okskarbazepin, fenobarbital, fenitoin, primidon)
English: Studies to detect macimorelin metabolites did not identify any metabolites.
Croatian: U ispitivanjima provedenima kako bi se detektirali metaboliti macimorelina nije pronađen nijedan metabolit.
English: Items needed: Macimorelin Aeterna Zentaris sachet, tap water in decanter, graduated glass or transparent plastic container, stirring device, 50 mL graduated syringe without needle, drinking glass
Croatian: Potreban pribor: vrećica lijeka Macimorelin Aeterna Zentaris, voda iz slavine u staklenoj posudi (dekanteru), graduirana staklena ili prozirna plastična posuda, pribor za miješanje, graduirana štrcaljka od 50 ml bez igle, čaša.
English: If you are not sure, talk to your doctor or nurse before you are given Macimorelin Aeterna Zentaris.
Croatian: Ako niste sigurni, obratite se liječniku ili medicinskoj sestri prije nego što primite Macimorelin
English: All three dose levels studied showed a similar magnitude of QTcF prolongation in the Thorough QT study, suggesting an absence of dose dependent changes.
Croatian: U temeljitom ispitivanju QT intervala sve tri ispitivane razine doze pokazale su sličnu magnitudu produljenja QTcF-a, što upućuje na odsutnost promjena ovisnih o dozi.
English: Instructions are given at the end of this leaflet on how to prepare the test.
Croatian: Upute o tome kako se priprema test nalaze se na kraju ove upute o lijeku.
English: Unopened sachet
Croatian: Neotvorena vrećica
English: Macimorelin Aeterna Zentaris is used in adults to test the body´s ability to produce growth hormone.
Croatian: Macimorelin Aeterna Zentaris upotrebljava se u odraslih za testiranje sposobnosti tijela da proizvodi hormon rasta.
English: Adult growth hormone (GH) deficiency caused by a hypothalamic lesion may not be detected early in the disease process.
Croatian: Nedostatak hormona rasta u odrasloj dobi prouzročen hipotalamičkom lezijom možda neće biti otkriven rano u procesu bolesti.
English: Both co-primary endpoints as pre-defined in Study 052 (lower limit of the 95% CI for negative agreement ≥ 75%, lower limit of the 95% CI for positive agreement ≥ 70%) are met when using an ITT cut-off point of 3.0 ng/mL and the pre-defined cut-off point for the MAC of 2.8 ng/mL.
Croatian: Obje koprimarne mjere ishoda unaprijed definirane u ispitivanju 052 (donja granica 95 %-tnog intervala pouzdanosti za negativno slaganje ≥ 75 %, donja granica 95 %-tnog intervala pouzdanosti za pozitivno slaganje ≥ 70 %) bile su ispunjene uz upotrebu granične vrijednosti ITT testa od 3,0 ng/ml i uz unaprijed definiranu graničnu vrijednost MAC testa od 2,8 ng/ml.
English: • HIV (efavirenz, nevirapine)
Croatian: • HIV-a (efavirenz, nevirapin)
English: Possible side effects in cases of overdosing could include headache, nausea, vomiting and diarrhoea.
Croatian: Moguće nuspojave u slučaju predoziranja mogu uključivati glavobolju, mučninu, povraćanje i proljev.
English: In patients between 18 and 25 years of age, the diagnostic performance of MAC and of ITT were comparable.
Croatian: U bolesnika u dobi od 18 do 25 godina dijagnostička uspješnost testova MAC i ITT bile su slične.
English: • you have recently been treated for Cushing's disease (disorder which results in high levels of the hormone cortisol) or if you are receiving a high dose of hydrocortisone medicine, the test may lead to false positive test results.
Croatian: • ako ste nedavno bili liječeni zbog Cushingove bolesti (poremećaj koji ima za posljedicu visoke razine hormona kortizola) ili ako primate visoke doze hidrokortizona; u tom slučaju test može dovesti do lažno pozitivnih rezultata
English: Further possible undesirable effects in case of overdosing could include headache, nausea, vomiting and diarrhoea.
Croatian: Daljnje moguće nuspojave u slučaju predoziranja mogu uključivati glavobolju, mučninu, povraćanje i proljev.
English: Administration of a CYP3A4 inducer (such as carbamazepine, dabrafenib, efavirenz, enzalutamide, eslicarbazepine, fosphenytoin, lumacaftor, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, pitolisant, primidone, rifabutin, rifampicin and St John's wort (Hypericum perforatum)) may reduce the plasma macimorelin concentrations and may affect the diagnostic performance of the test and therefore should be avoided.
Croatian: Primjena induktora enzima CYP3A4 (kao što su karbamazepin, dabrafenib, efavirenz, enzalutamid, eslikarbazepin, fosfenitoin, lumakaftor, modafinil, nevirapin, okskarbazepin, fenobarbital, fenitoin, pioglitazon, pitolizant, primidon, rifabutin, rifampicin i gospina trava (Hypericum perforatum)) može sniziti koncentracije macimorelina u plazmi i utjecati na dijagnostičku uspješnost testa, pa je stoga treba izbjegavati.
English: Macimorelin acts like a natural hormone and causes the pituitary gland to release growth hormone into the blood stream.
Croatian: Macimorelin djeluje kao prirodni hormon i potiče žlijezdu hipofizu na otpuštanje hormona rasta u krvotok.
English: The test was considered positive (i.e., growth hormone deficiency (GHD) diagnosed) if the maximum serum GH level observed after stimulation was less than the pre-specified cut-off point of 2.8 ng/mL for the MAC test or 5.1 ng/mL for the ITT.
Croatian: Test se smatrao pozitivnim (tj. dijagnosticiran je nedostatak hormona rasta) ako je maksimalna razina hormona rasta u serumu opažena nakon stimulacije bila niža od unaprijed određene granične vrijednosti od 2,8 ng/ml u MAC testu ili 5,1 ng/ml u ITT testu.
English: Before using Macimorelin Aeterna Zentaris it is important to ensure that the patient is in fasting condition for at least 8 hours and did not have strenuous physical exercises 24 hours before the test, since both could affect GH levels.
Croatian: Prije primjene lijeka Macimorelin Aeterna Zentaris važno je potvrditi da je bolesnik natašte najmanje 8 sati te da nije poduzimao naporne tjelesne aktivnosti 24 sata prije testa jer oboje može utjecati na razine hormona rasta.
English: At the clinically relevant concentration of 0.1 µM (clinical Cmax = 11.2 ng/ml = approx. 0.02 µM), the unbound fraction of macimorelin in human plasma is
Croatian: Pri klinički relevantnoj koncentraciji od 0,1 µM (klinički Cmax = 11,2 ng/ml = približno 0,02 µM), nevezana frakcija macimorelina u ljudskoj plazmi iznosi 22 %.
English: Any unused medicine or waste material should be disposed in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: In patients with a QTc > 500 ms, an ECG monitoring should be applied (see section 4.4 and 5.1).
Croatian: QTc > 500 ms, potrebno je praćenje EKG-a (vidjeti dijelove 4.4 i 5.1).
English: Macimorelin Aeterna Zentaris is indicated for the diagnosis of growth hormone deficiency (GHD) in adults (see section 5.1).
Croatian: Lijek Macimorelin Aeterna Zentaris indiciran je za dijagnosticiranje nedostatka hormona rasta (engl. growth hormone deficiency, GHD) u odraslih (vidjeti dio 5.1).
English: This study showed a mean baseline- and placebo-adjusted change (upper single-sided 95% confidence interval) in QTcF of 9.6 ms (11.4 ms) at 4 h post-dose (see also section 4.4), which occurred after the mean maximum macimorelin plasma concentration (0.5 h).
Croatian: Ispitivanje je pokazalo srednju vrijednost promjene prilagođene u odnosu na početnu vrijednost i placebo (gornja granica jednostranog intervala pouzdanosti od 95 %) u QTcF-u od 9,6 ms (11,4 ms) 4 sata poslije doze (vidjeti također dio 4.4), što se pojavilo nakon srednje vrijednosti maksimalne koncentracije macimorelina u plazmi (0,5 h).
English: Macimorelin Aeterna Zentaris is not recommended during pregnancy.
Croatian: Macimorelin Aeterna Zentaris ne preporučuje se tijekom trudnoće.
English: For such patients, ECG controls may be indicated prior to the administration of macimorelin and 1 hour, 2 hours, 4 hours and 6 hours after administration of macimorelin.
Croatian: U takvih bolesnika mogu biti indicirane kontrole EKG-a prije primjene macimorelina te 1 sat, 2 sata, 4 sata i 6 sati poslije primjene macimorelina.
English: Maximal GH release has been observed at macimorelin plasma concentrations of ≥ 7 ng/mL.
Croatian: Maksimalno otpuštanje hormona rasta opaženo je pri koncentracijama macimorelina u plazmi od ≥ 7 ng/ml.
English: Dissolve the entire contents of the sachet in water: one sachet in 120 mL, two sachets in 240 mL, as applicable.
Croatian: Rastopite cijeli sadržaj vrećice u vodi: jednu vrećicu u 120 ml, dvije vrećice u 240 ml, prema potrebi.
English: The EMA has deferred the obligation to submit the results of studies with Macimorelin Aeterna Zentaris in one or more subsets of the paediatric population in the diagnosis of growth hormone deficiency (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Macimorelin Aeterna Zentaris u jednoj ili više podskupina pedijatrijske populacije u dijagnosticiranju nedostatka hormona rasta (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • your body is lacking any other hormone e.g. cortisol, thyroid or sex hormones, vasopressin (in diabetes insipidus), this should be adequately replaced before testing for growth hormone deficiency.
Croatian: • ako Vašem tijelu nedostaje neki drugi hormon, npr. kortizol, hormoni štitnjače ili spolni hormoni, vazopresin (kod insipidnog dijabetesa); to treba odgovarajuće nadomjestiti prije provedbe testa na nedostatak hormona rasta.
English: These ECG abnormalities consisted of T wave abnormalities and QT prolongation (see also section 4.4).
Croatian: Te abnormalnosti EKG-a činila su odstupanja T-vala i produljenje QT intervala (vidjeti također dio 4.4).
English: Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after EXP.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza oznake