FrancophonIA/ELRC3.0 huggingface dataset:
English: Give the dose maximum 3 times a day, if possible before meals/feeding.
Croatian: Dozu dajte maksimalno 3 puta na dan, ako je moguće prije obroka/hranjenja.
English: If taken after meals, absorption of the drug is somewhat delayed.
Croatian: Ako se uzima poslije obroka, apsorpcija lijeka je malo odgođena.
English: The Cmax and AUC values of domperidone increased proportionally with dose in the 10 mg to 20 mg dose range.
Croatian: Cmax and AUC vrijednosti domperidona rastu proporcionalno dozi u rasponu doza od 10 mg do 20 mg
English: While taking domperidone, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, loss of consciousness.
Croatian: Obratite se svom liječniku ako tijekom uzimanja domperidona osjetite poremećaje srčanog ritma kao što je lupanje srca, teškoće pri disanju, gubitak svijesti.
English: Patients should be advised to promptly report any cardiac symptoms.
Croatian: Bolesniku treba savjetovati da odmahprijave bilo koji srčani simptom.
English: Section 5.3 Preclinical safety data
Croatian: Dio 5.3 Neklinički podaci o sigurnosti primjene
English: <Tablets>, <orodispersible tablets> and <suppositories>are not suitable for children weighing less than 35 kg.
Croatian: <Tablete>, <raspadljive tablete za usta > i <čepići> nisu prikladni za djecu sa tjelesnom težinom manjom od 35 kg.
English: Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see section 4.8).
Croatian: Epidemiološke studije su pokazale da je domperidon bio povezan s povećanim rizikom od ozbiljnih ventrikularnih aritmija ili iznenadne srčane smrti (vidjeti dio 4.8).
English: Neonates, infants, children (less than 12 years of age) and adolescents weighing less than 35 kg
Croatian: Novorođenčad, dojenčad, djeca (mlađa od 12 godina) i adolescenti sa tjelesnom težinom manjom od 35 kg
English: In subjects with severe renal insufficiency (creatinine clearance<30 ml/min/1.73m2) the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers.
Croatian: U ispitanika sa teškom bubrežnom insuficijencijom (klirens kreatinina <30 ml/min/1,73m2) poluvrijeme eliminacije domperidona je bilo povećano sa 7,4 na 20,8 sati, ali razine lijeka u plazmi su bile niže nego u zdravih dobrovoljaca.
English: ▼This medicine is subject to additional monitoring.
Croatian: Ovaj je lijek pod dodatnim praćenjem.
English: [The paragraph below is to be implemented where the marketing authorisation currently includes relief of the symptoms of nausea and vomiting in children under 12 years of age and adolescents weighing less than 35 kg:]
Croatian: [Odlomak naveden miže treba implementirati ako odobrenje za stavljanje lijeka u promet trenutno uključuje ublažavanje simptoma mučnine i povraćanja u djece ispod 12 godina i adolescenata sa tjelesnom težinom manjom od 35 kg:]
English: Adults, and adolescents (12 years of age and older and weighing 35 kg or more) [Tablets (Film-coated, Coated, Scored coated, Effervescent, Chewable), Orodispersible tablets, capsules]
Croatian: Odrasli i adolescenti (u dobi od 12 godina i stariji sa tjelesnom težinom od 35 kg ili više) [Tablete (filmom obložene, obložene, obložene s razdjelnom crtom, šumeće, za žvakanje), raspadljive tablete za usta , kapsule]
English: Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest.
Croatian: Uzimanje domperidona može biti povezano sa povećanim rizikom od poremećaja srčanog ritma i zastoja srca.
English: The dose should not be doubled to make up for a missed dose.
Croatian: Ne treba uzimati dvostruku dozu kako bi se nadoknadila propuštena doza.
English: This should be given up to three times per day with a maximum dose of 0.75 mg/kg per day.
Croatian: Treba se davati do tri puta na dan s maksimalnom dozom od 0,75 mg/kg na dan.
English: Section 1 ‘What X is and what it is used for' [This section should be amended to include the below wording] This medicine is used in adults and in children to treat nausea (feeling sick) and vomiting (being sick).
Croatian: Dio 1 “Što je X i za što se koristi” [Ovaj dio treba izmijeniti tako da se uključi dolje navedeni tekst] Ovaj lijek se koristi za liječenje mučnine i povraćanja u odraslih i djece.
English: Caution should be exercised in case of QTc prolongation risk factors in breast-fed infants.
Croatian: Potreban je oprez u slučaju faktora rizika za produljenje QTc intervala u dojenčadi
English: Reduced gastric acidity impairs the absorption of domperidone.
Croatian: Smanjena želučana kiselost smanjuje apsorpciju domperidona.
English: [This section should be amended to include the following wording]
Croatian: [Ovaj dio treba izmijeniti da uključuje sljedeći tekst]
English: A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors.
Croatian: Veći rizik je primijećen u bolesnika starijih od 60 godina, bolesnika koji su uzimali dnevne doze veće od 30 mg, i bolesnika koji su istodobno uzimali lijekove koji produljuju QT interval li inhibitore CУP3A4.
English: • depression (e.g., citalopram, escitalopram)
Croatian: • depresije (na primjer, citalopram, escitalopram)
English: These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors (see section 4.8).
Croatian: Ova izvješća su uključila bolesnike sa zbunjujućim faktorima rizika, poremećajima elektrolita i istodobnim liječenjem što bi mogli biti doprinoseći faktori (vidjeti dio 4.8).
English: Not known: ventricular arrhythmias, QTc prolongation, Torsade de Pointes, sudden cardiac death (see section 4.4)
Croatian: Nepoznato: ventrikularne aritmije, produljenje QTc intervala, Torsade de Pointes, iznenadna srčana smrt (vidjeti dio 4.4)
English: The usual dose is one tablet taken up to three times per day, if possible before meals.
Croatian: Uobičajena doza je jedna tableta koja se uzima do tri puta na dan, ako je moguće prije obroka.
English: Domperidone is rapidly absorbed after oral administration, with peak plasma concentrations occurring at approximately 1 hr after dosing.
Croatian: Domperidon se brzo apsorbira poslije peroralne primjene, s vršnim koncentracijama u plazmi približno 1 sat poslije doziranja.
English: [Throughout the document, whenever references are made to a particular pharmaceutical formulation they should only be implemented where the said formulation is authorised]
Croatian: [Gdje god se u dokumentu nalaze reference na određeni farmaceutski oblik, potrebno ih je implementirati samo ako je taj farmaceutski oblik odobren] Dio 4.1 Terapijske indikacije
English: Small amounts of domperidone have been detected in breast milk.
Croatian: U majčinom mlijeku su otkrivena male količine domperidona.
English: In subjects with moderate hepatic impairment (Pugh score 7 to 9, Child-Pugh rating B), the AUC and Cmax of domperidone is 2.9- and 1.5- fold higher, respectively, than in healthy subjects.
Croatian: U ispitanika sa umjerenim oštećenjem jetre (Pugh indeks 7 do 9, Child-Pugh stadij B), AUC i Cmax domperidona su 2,9, odnosno 1,5 puta viši nego u zdravih ispitanika.
English: This study included a placebo, an active comparator and a positive control and was conducted in healthy subjects with up to 80 mg per day 10 or 20 mg administered 4 times a day of domperidone.
Croatian: Ovo je ispitivanje uključivalo placebo, aktivni komparator i pozitivnu kontrolu i bilo je provedeno na zdravim ispitanicima sa dozama domperidona od 10 ili 20mg primijenjenim 4 puta na dan do 80 mg na dan.
English: Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.
Croatian: Poremećaji elektrolita (hipokalemija, hiperkalemija, hipomagnezemija) ili bradikardija su poznati kao stanja koja povećavajurizik od aritmije.
English: If taken after meals absorption of the drug is somewhat delayed.
Croatian: Ako se uzima nakon obroka apsorpcija lijeka je malo odgođena.
English: Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of <X> should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced.
Croatian: S obzirom da je poluvrijeme eliminacije domperidona produljeno kod teškog oštećenja bubrega, kod ponovljene primjene učestalost doziranja <X> se treba smanjiti na jedan ili dva puta na dan ovisno o težini oštećenja, a može biti potrebno i smanjiti dozu.
English: A 2- to 3-fold accumulation of domperidone AUC was observed with repeated four times daily (every 5 hr) dosing of domperidone for 4 days.
Croatian: . Zamijećena je dvostruka do trostruka akumulacija AUC domperidona kod ponovljenog doziranja domperidona od četiri puta na dan (svakih 5 sati) tijekom 4 dana.
English: • co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects) (see section 4.5)
Croatian: • istodobna primjena sa jakim inhibitorima CУP3A4 (bez obzira na njihov učinak na produljenje QT intervala) (vidjeti dio 4.5)
English: • gastro-intestinal disorders (e.g., cisapride, dolasetron, prucalopride)
Croatian: • gastrointestinalnih poremećaja (na primjer, cisaprid, dolasetron, prukaloprid)
English: However, on repeated administration, the dosing frequency should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced.
Croatian: Međutim, kod ponovljene primjene, učestalost doziranja treba se smanjiti na jedan ili dva puta na dan ovisno o težini oštećenja, a može biti potrebno i smanjiti dozu.
English: Section 4.3 Contraindications [This section should be amended to include the following contraindications] Domperidone is contraindicated in the following situations:
Croatian: [Ovaj dio treba izmijeniti da uključi sljedeće kontraindikacije] Domperidon je kontraindiciran u sljedećim situacijama:
English: Dose modification in mild hepatic impairment is however not needed (see section 5.2).
Croatian: Ipak prilagodba doze kod blagog oštećenja jetre nije potrebna. (vidjeti dio 5.2).
English: Before taking this medicine contact your doctor if you: - suffer from liver problems (liver function impairment or failure) (see “Do not take this medicinal product”) - suffer from kidney problems (kidney function impairment or failure).
Croatian: - patite od problema s jetrom (oštećenje funkcije ili zatajenje jetre) (pogledajte “Nemojte uzimati ovaj lijek”) - patite od problema s bubrezima (oštećenje funkcije ili zatajenje bubrega).
English: o certain antipsychotics (e.g., haloperidol, pimozide, sertindole) o certain antidepressants (e.g., citalopram, escitalopram) o certain antibiotics (e.g. , erythromycin, levofloxacin, moxifloxacin, spiramycin) o certain antifungal agents (e.g., pentamidine) o certain antimalarial agents (in particular halofantrine, lumefantrine) o certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride) o certain antihistaminics (e.g., mequitazine, mizolastine) o certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine) o certain other medicines (e.g., bepridil, diphemanil, methadone) (see section 4.3).
Croatian: o o određeni antidepresivi (npr. citalopram, escitalopram) o određeni antibiotici (npr. eritromicin, levofloksacin, moksifloksacin, spiramicin) o određeni antimikotici (npr. pentamidin) o određeni antimalarici (posebice halofantrin, lumefantrin) o određeni gastrointestinalni lijekovi (npr. cisaprid, dolasetron, prukaloprid) o određeni antihistaminici (npr. mekvitazin, mizolastin) o određeni lijekovi koji se koriste kod raka (npr. toremifen, vandetanib, vinkamin) o određeni drugi lijekovi (npr. bepridil, difemanil, metadon) (vidjeti dio 4.3).
English: Effervescent granules 5 mg [Instructions for use must be included]
Croatian: Šumeće granule 5 mg [Upute za uporabu moraju biti priložene]
English: This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day.
Croatian: Ovaj rizik je vjerojatniji u onih starijih od 60 godina ili pri uzimanju doza većih od 30 mg na dan.
English: Do not take more than three tablets per day.
Croatian: Nemojte uzeti više od tri tablete na dan.
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Croatian: Ovaj Sažetak opisa svojstava lijeka i Uputa o lijeku ishod su arbitražnog postupka.
English: Potent CYP3A4 inhibitors (regardless of their QT prolonging effects), i.e : o protease inhibitors o systemic azole antifungals o some macrolides (erythromycin, clarithromycin and telithromycin) (see section 4.3).
Croatian: Jaki inhibitori CУP3A4 (bez obzira na njihove učinke produljenja QT intervala), tj. : o inhibitori proteaze o sistemski azolni antimikotici o neki makrolidi (eritromicin, klaritromicin i telitromicin) (vidjeti dio 4.3).
English: Electrophysiological in vitro and in vivo studies indicate an overall moderate risk of domperidone to prolong the QTc interval in humans.
Croatian: Elektrofiziološka ispitivanja domperidona in vitro i in vivo ukazuju na sveukupno umjeren rizik za produljenje QTc intervala u ljudi.
English: Adults and adolescents 12 years of age and older with a body weight of 35 kg or more Tablets 10 mg [Instructions for use must be included]
Croatian: Odrasli i adolescenti od 12 godina i stariji sa tjelesnom težinom od 35 kg ili više Tablete 10 mg
English: Section 4.5 Interaction with other medicinal products and other forms of interaction [This section should be amended to include the following wording] Increased risk of occurrence of QT-interval prolongation, due to pharmacodynamic and/or pharmacokinetic interactions.
Croatian: [Ovaj dio treba izmijeniti da uključuje sljedeći tekst] Povećan rizik od pojave produljenja QT intervala , zbog farmakodinamičkih i/ili farmakokinetičkih interakcija.
English: Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patients with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia (see section 4.3.).
Croatian: Domperidon je kontraindiciran u bolesnika sa poznatim postojećim produljenjima intervala provodljivosti srca, osobito QTc intervala, u bolesnika sa značajnim poremećajima elektrolita (hipokalemijom, hiperkalemijom, hipomagnezemijom) ili bradikardijom, ili u bolesnika s osnovnom bolesti srca kao što je kongestivno zatajenje srca, zbog povećanog rizika od ventrikularne aritmije (vidjeti dio 4.3.).
English: An ECG monitoring could be undertaken, because of the possibility of a heart problem called prolonged QT interval.
Croatian: Može se provesti praćenje EKG−a zbog mogućnosti srčannog poremećaja koji se naziva produljeni QT interval.
English: • psychoses (e.g., haloperidol, pimozide, sertindole)
Croatian: • psihoze (na primjer, haloperidol, pimozid, sertindol)
English: Concomitant use of the following substances requires caution in use Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT-interval prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated as it is a potent CYP3A4 inhibitor).
Croatian: Zahtijeva se oprez s lijekovima koji izazivaju bradikardiju i hipokalemiju, kao i sa sljedećim makrolidima koji produljuju QT interval: azitromicin i roksitromicin (klaritromicin je kontraindiciran budući je jaki inhibitor CУP3A4 ).
English: Concomitant use of the following substances is not recommended Moderate CYP3A4 inhibitors i.e. diltiazem, verapamil and some macrolides.
Croatian: Istodobna primjena sljedećih tvari se ne preporučuje Umjereni inhibitori CУP3A4 npr. diltiazem, verapamil i neki makrolidi. (vidjeti dio 4.3)
English: • in patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure (see section 4.4)
Croatian: • u bolesnika koji imaju poznato postojeće produljenje intervala provodljivosti srca, osobito QTc intervala, bolesnika sa značajnim poremećajima elektrolita ili osnovnom bolesti srca kao što je kongestivno zatajenje srca (vidjeti dio 4.4)
English: 10 ml (of 1 mg/ml oral suspension) up to three times per day with a maximum dose of 30 ml per day.
Croatian: 10 ml (oralne suspenzije od 1 mg/ml) do tri puta na dan s maksimalnom dozom od 30 ml na dan.
English: During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking domperidone.
Croatian: Za vrijeme postmarketinškog praćenja, u bolesnika koji su uzimali domperidon bilo je vrlo rijetkih slučajeva produljenja QT intervala i torsades de pointes.
English: [Suppositories] One 30 mg suppository inserted into the rectum two times per day.
Croatian: Jedan čepić od 30 mg staviti u rektum dva puta na dan.
English: Section 4.2 Posology and method of administration [This section should be amended to reflect the following wording, as applicable:] <X> should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
Croatian: [Ovaj dio treba izmijeniti kako je odgovarajuće da odražava sljedeći tekst:] <X> treba koristiti u najnižoj djelotvornoj dozi i kroznajkraće vrijeeme potrebno za kontrolu mučnine i povraćanja.
English: The elimination half-life of domperidone is prolonged in severe renal impairment.
Croatian: Poluvijek eliminacije domperidona produljeno je kod teškog oštećenja bubrega.
English: For repeated administration, the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment.
Croatian: Kod ponovljene primjene, učestalost doziranja domperidona se treba smanjiti na jedan ili dva puta na dan, ovisno o težini oštećenja.
English: • in patients with moderate or severe hepatic impairment (see section 5.2).
Croatian: • u bolesnika s umjerenim ili teškim oštećenjem jetre (vidjeti dio 5.2).
English: • fungal infections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole
Croatian: • gljivičnih infekcija kao što su azolni antimikotici, posebice ketokonazol za primjenu kroz usta, flukonazol ili vorikonazol
English: • co-administration with QT-prolonging drugs (see section 4.5)
Croatian: • istodobna primjena sa lijekovima koji produljuju QT interval (vidjeti dio 4.5)
English: • bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin,
Croatian: • bakterijskih infekcija, posebice eritromicin, klaritromicin, telitromicin, moksifloksacin, pentamidin (ovo su antibiotici)
English: [Effervescent granules 5 mg]
Croatian: [Šumeće granule 5 mg]
English: However, two previous drug-drug interaction studies showed some evidence of QTc prolongation when domperidone was administered as monotherapy (10 mg 4 times a day).The largest time-matched mean difference of QTcF between domperidone and placebo was 5.4 msec (95 % CI: -1.7 to 12.4) and 7.5 msec (95 % CI: 0.6 to 14.4), respectively.
Croatian: Najveća vremenski usklađena srednja razlika QTcF između domperidona i placeba je bila 5,4 ms (95 % CI: -1,7 do 12,4), odnosno 7,5 ms (95 % CI: 0,6 do 14,4).
English: • allergy (e.g., mequitazine, mizolastine)
Croatian: • alergije (na primjer, mekvitazin, mizolastin)
English: One 10 mg tablet up to three times per day with a maximum dose of 30 mg per day.
Croatian: Jedna tableta od 10 mg do tri puta na dan sa maksimalnom dozom od 30 mg na dan.
English: [Effervescent granules 10 mg]
Croatian: [Šumeće granule 10 mg]
English: In accordance with ICH-E14 guidelines, a thorough QT study was performed.
Croatian: Temeljito ispitivanje QT intervala provedeno je u skladu sa smjernicama ICH-E14.
English: This study found a maximal difference of QTc between domperidone and placebo in LS-means in the change from baseline of 3.4 msec for 20 mg domperidone administered 4 times a day on Day 4.
Croatian: U ovom ispitivanju 4. dan je pronađena maksimalna razlika QTc intervala između domperidona i placeba u srednjoj vrijednosti promjene od početnih vrijednosti dobivenoj metodom najmanjih kvadrata od 3,4 ms za 20 mg domperidona primijenjenog 4 puta na dan.
English: In the anesthetized guinea pig model following slow intravenous infusions, there were no effects on QTc at total plasma concentrations of 45.4 ng/mL, which are 3-fold higher than the total plasma levels at in humans at maximum daily dose (10 mg administered 3 times a day).
Croatian: U modelu anesteziranih zamoraca nakon sporih intravenskih infuzija, nije bilo učinaka na QTc intervalpri ukupnim koncentracijama u plazmi od 45,4 ng/mL, što je 3struko više od ukupnih razina u humanoj plazmi pri maksimalnoj dnevnoj dozi (10 mg 3 puta na dan).
English: Section 4.1 Therapeutic indications
Croatian: Dio 4.3 Kontraindikacije
English: • heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide,
Croatian: • srčanih tegoba ili visokog krvnog tlaka (na primjer, amiodaron, dronedaron, kinidin, dizopiramid, dofetilid, sotalol, diltiazem, verapamil)
English: The usual dose is one or two sachet(s) (with 5 mg domperidone per sachet) taken up to three times per day.
Croatian: Uobičajena doza je jedna ili dvije vrećice (s 5 mg domperidona po vrećici) koje se uzimaju do tri puta na dan.
English: Hepatic Impairment <X> is contraindicated in moderate or severe hepatic impairment (see section 4.3).
Croatian: <X> je kontraindiciran kod umjerenog ili teškog oštećenja jetre (vidjeti dio 4.3).
English: The usual dose is one sachet (with 10 mg domperidone per sachet) taken up to three times per day.
Croatian: Uobičajena doza je jedna vrećica (s 10 mg domperidona po vrećici) koje se uzimaju do tri puta na dan.
English: Domperidone is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).
Croatian: Domperidon je kontraindiciran u bolesnika sa umjerenim ili teškim oštećenjem jetre (vidjeti dio 4.3).
English: One or two sachet(s) (containing 5 mg domperidone per sachet) up to three times per day with a maximum dose of 6 sachets per day.
Croatian: Jedna ili dvije vrećice (koje sadrže 5mg domperidona po vrećici) do tri puta na dan s maksimalnom dozom od 6 vrećica na dan.
English: {X} is indicated for the relief of the symptoms of nausea and vomiting.
Croatian: [Tekst ovog dijela treba glasiti kako slijedi:] {X} je indiciran za ublažavanje simptoma mučnine i povraćanja.
English: In in vitro experiments on isolated cells transfected with hERG and on isolated guinea pig myocytes, exposure ratios ranged between 26 - 47-fold, based on IC50 values inhibiting currents through IKr ion channels in comparison to the free plasma concentrations in humans after administration of the maximum daily dose of 10 mg administered 3 times a day.
Croatian: U in vitro eksperimentima na izoliranim stanicama u koje je transfekcijom unesen gen hERG i na izoliranim stanicama miocita zamorca, izloženost je bila 2647 puta veća na osnovu vrijednosti IC50 koje inhibiraju struju kroz IKr ionske kanale, u odnosu na koncentracije slobodnog lijeka u plazmi kod ljudi poslije primjene maksimalne dnevne doze od 10 mg 3 puta na dan.
English: Do not take more than six sachets per day.
Croatian: Nemojte uzeti više od šest vrećica na dan.
English: Hepatic impairment
Croatian: Srčani poremećaji
English: Section 4.8 Undesirable effects [This following wording should be reflected in this section] Cardiac disorders
Croatian: Dio 4.8 Nuspojave [U Ovaj dio treba uključiti sljedeći tekst]