FrancophonIA/ELRC3.0 huggingface dataset:
English: As CYP3A4 and, to a lesser extent, CYP2D6 are involved in the metabolism of haloperidol, the potential increase in haloperidol plasma concentrations when a CYP3A4 and/or CYP2D6 inhibitor is coadministered may range between 20 to 40%, although in some cases, increases of up to 100% have been reported, and has been added in section 4.5 Interaction with other medicinal products and other forms of interaction.
Croatian: Budući da su enzimi CYP3A4 i, u manjoj mjeri CYP2D6, uključeni u metabolizam haloperidola, moguće povećanje plazmatskih koncentracija haloperidola prilikom primjene zajedno s inhibitorima enzima CYP3A4 i/ili CYP2D6 može iznositi od 20 do 40 %, iako su u nekim slučajevima zabilježena povećanja od gotovo 100 %, što je dodano u odjeljak 4.5 (Interakcije s drugim lijekovima i drugi oblici interakcija).
English: The list of examples of contraindicated combinations considered essential for the prescriber to be informed of the risk of an additive QT prolonging effect of two or more QT prolonging antipsychotics, was moved to section 4.4.
Croatian: Popis primjera kontraindiciranih kombinacija koje se smatraju ključnima kako bi liječnici koji propisuju lijek bili obaviješteni o riziku od kumulativnog učinka produljenja QT intervala dvaju ili više antipsihotika koji uzrokuju produljenje QT intervala prebačen je u odjeljak 4.4.
English: Overall summary of the scientific evaluation by the CHMP Based on the review of all available data, the consultations with the Healthcare Professionals Organisations (HCPOs) and Scientific Advisory Group (SAG) Psychiatry, the CHMP recommended the following revisions to harmonise the product information for Haldol oral and injectable formulations.
Croatian: Na temelju pregleda svih dostupnih podataka, savjetovanja s organizacijama zdravstvenih radnika i znanstvenom savjetodavnom skupinom (SAG) za psihijatriju, CHMP je predložio sljedeće izmjene radi usklađivanja informacija o lijeku za oralne formulacije Haldola i formulacije za ubrizgavanje injekcijom.
English: In addition, the committee considered the advice of the consulted Healthcare Professionals Organisations (HCPOs) and SAG Psychiatry.
Croatian: Uz to, Odbor je razmotrio savjete organizacija zdravstvenih radnika i SAG-a za psihijatriju.
English: Caution is also recommended when using Haldol in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours
Croatian: Preporučuje se i oprez prilikom upotrebe Haldola u bolesnika s postojećom hiperprolaktinemijom i u bolesnika s mogućim tumorom ovisnim o prolaktinu.
English: The questions to the HCPOs mainly pertained to the clinical value of the indications (section 4.1) and dosing recommendations in clinical practice (section 4.2), as well as the contraindication for haloperidol due to central nervous system depression, and whether it was possible to define the severity/degree of central nervous system depression due to alcohol or other depressant medicinal products, and whether there specific cases where the use of haloperidol should be contraindicated.
Croatian: Pitanja postavljena organizacijama zdravstvenih radnika odnosila su se poglavito na kliničku vrijednost indikacija (odjeljak 4.1) i preporuke o doziranju u kliničkoj praksi (odjeljak 4.2), kao i na kontraindikacije za haloperidol zbog depresije središnjeg živčanog sustava te na mogućnost utvrđivanja težine/stupnja depresije središnjeg živčanog sustava izazvane alkoholom ili ostalim depresorima i na mogućnost postojanja određenih slučajeva u kojima bi upotreba haloperidola trebala biti kontraindicirana.
English: In section 5.2 Pharmacokinetic properties, a statement that back-conversion to haloperidol cannot be fully excluded has been included although it is not possible to quantitate the role of back-oxidation of reduced haloperidol to haloperidol on haloperidol half-life, clearance and activity.
Croatian: U odjeljak 5.2 (Farmakokinetička svojstva) uključena je izjava o tome da se ponovno pretvaranje u haloperidol ne može potpuno isključiti, iako nije moguće kvantificirati utjecaj ponovne oksidacije reduciranog haloperidola u haloperidol na vrijeme polueliminacije, uklanjanje i djelovanje haloperidola.
English: The discussion and conclusions reached by the HCPOs and SAG Psychiatry were taken into account in the evaluation by the CHMP, and are reflected in the relevant sections above.
Croatian: Rasprava i zaključci organizacija zdravstvenih radnika i SAG-a za psihijatriju uzeti su u obzir u okviru evaluacije CHMP-a te su izneseni u odgovarajućim navedenim odjeljcima.
English: As regards the posology, section 4.2 of the SmPC, the initial and maximum doses were clarified and listed for each indication, for all patient populations - adult, elderly and paediatric.
Croatian: Što se tiče doziranja, odnosno odjeljka 4.2 sažetka opisa svojstava lijeka, pojašnjene su i navedene početne i najveće doze za svaku indikaciju i za sve populacije bolesnika, tj. za odraslu, stariju i pedijatrijsku.
English: • The Committee agreed on a harmonised product information for Haldol and associated names.
Croatian: • Odbor se usuglasio oko usklađenih informacija o lijeku za Haldol i povezane nazive.
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC for Haldol and associated names;
Croatian: Direktive 2001/83/EZ za Haldol i povezane nazive;
English: • The Committee considered the divergences identified in the notification for Haldol and associated names, as well as the remaining sections of the product information;
Croatian: • Odbor je u obzir uzeo utvrđene razlike u prijavi za Haldol i povezane nazive, kao i u preostalim odjeljcima informacija o lijeku.
English: Angioedema was added to section 4.8 Undesirable effects and additional information on the site of action of injectable haloperidol in the treatment and prophylaxis of nausea and vomiting has been included in section 5.1 Pharmacodynamic properties.
Croatian: U odjeljak 4.8 (Nuspojave) dodan je angioedem, a dodatne informacije o mjestu djelovanja haloperidola za ubrizgavanje injekcijom prilikom liječenja i profilakse mučnine i povraćanja uključene su u odjeljak 5.1 (Farmakodinamička svojstva).
English: In view of the above, the Committee concluded that the benefit-risk balance of Haldol and associated names remains favourable, subject to the agreed amendments to the product information.
Croatian: Posljedično, Odbor je zaključio da omjer koristi i rizika za Haldol i povezane nazive ostaje povoljan pod uvjetom da se u informacije u lijeku unesu dogovorene izmjene.
English: - Acute treatment of delirium when non-pharmacological treatments have failed.
Croatian: - Akutno liječenje delirija ako se ostale vrste nefarmakološkog liječenja nisu pokazale uspješnima.
English: - Persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated.
Croatian: - Dugotrajne teške agresije u djece i adolescenata u dobi od šest do 17 godina s autizmom ili pervazivnim razvojnim poremećajima ako su se ostale vrste liječenja pokazale neuspješnima ili ih bolesnici ne podnose.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission (EC) notified the European Medicines Agency's secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve the divergences amongst the nationally approved SmPCs and thus to harmonise its divergent SmPCs across the EU.
Croatian: Zbog različitih odluka na nacionalnoj razini koje su donijele države članice u pogledu odobrenja za ovaj proizvod (i povezane nazive) Europska je komisija (EK) obavijestila tajništvo Europske agencije za lijekove o pokretanju službenog postupka upućivanja u skladu s člankom 30.
English: - Schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated.
Croatian: - Shizofrenije u adolescenata u dobi od 13 do 17 godina ako su se ostale vrste farmakološkog liječenja pokazale neuspješnima ili ih bolesnici ne podnose.
English: - Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer's dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others.
Croatian: - Liječenje dugotrajne agresije i psihotičnih simptoma u bolesnika s umjerenom do teškom Alzheimerovom demencijom i vaskularnom demencijom ako su se ostale vrste nefarmakološkog liječenja pokazale neuspješnima i ako postoji rizik da bi bolesnik mogao ozlijediti sebe ili druge.
English: - Tic disorders, including Tourette's syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed.
Croatian: - Tikovi, uključujući Touretteov sindrom, u djece i adolescenata u dobi od 10 do 17 godina s teškim oštećenjem nakon što su se edukacijske i psihološke vrste liječenja te ostale vrste farmakološkog liječenja pokazale neuspješnima.
English: The changes to the SmPC, when relevant for the user, have also been reflected in the PL and endorsed by the CHMP.
Croatian: Izmjene sažetka opisa svojstava lijeka koje su relevantne za korisnike navedene su i u uputi o lijeku te ih je podržao CHMP.
English: - Treatment of tic disorders, including Tourette's syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.
Croatian: - Liječenje tikova, uključujući Touretteov sindrom, u bolesnika s teškim oštećenjem nakon što su se edukacijske i psihološke vrste liječenja te ostale vrste farmakološkog liječenja pokazale neuspješnima.
English: Section 4.6 has been harmonised and the information presented under the separate subheadings of Pregnancy, Lactation and Fertility in compliance with the SmPC guideline.
Croatian: Odjeljak 4.6 je usklađen te su informacije navedene pod posebnim podnaslovima (trudnoća, dojenje i plodnost) u skladu s uputama o sažetku opisa svojstava lijeka.
English: • The Committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Croatian: • Odbor je ponovno pregledao sve podatke koje je u prilog predloženom usklađivanju informacija o lijeku dostavio nositelj odobrenja za stavljanje lijeka u promet.
English: - Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder.
Croatian: - Liječenje akutne psihomotorne agitacije povezane sa psihotičnim poremećajem ili maničnim epizodama bipolarnog poremećaja tipa I.
English: - Treatment of moderate to severe manic episodes associated with bipolar I disorder.
Croatian: - Liječenje umjerenih do teških maničnih epizoda povezanih s bipolarnim poremećajem tipa I.
English: - Single or combination prophylaxis in patients at moderate to high risk of postoperative nausea and vomiting, when other medicinal products are ineffective or not tolerated.
Croatian: - Profilaksa ili kombinirana profilaksa u bolesnika s umjerenim do visokim rizikom od postoperativne mučnine i povraćanja ako ostali lijekovi ne djeluju ili ih bolesnici ne podnose.
English: - Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated, and oral therapy is not appropriate.
Croatian: - Liječenje blage do umjerene koreje u bolesnika s Huntingtonovom bolešću ako ostali lijekovi ne djeluju ili ih bolesnici ne podnose i ako oralna terapija nije prikladna.
English: - Combination treatment of postoperative nausea and vomiting when other medicinal products are ineffective or not tolerated.
Croatian: - Kombinirano liječenje postoperativne mučnine i povraćanja ako ostali lijekovi ne djeluju ili ih bolesnici ne podnose.
English: - Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated.
Croatian: - Liječenje blage do umjerene koreje u bolesnika s Huntingtonovom bolešću ako ostali lijekovi ne djeluju ili ih bolesnici ne podnose.
English: A SAG and HCPOs consultations were carried out during this procedure at the request of the CHMP.
Croatian: U okviru tog postupka na zahtjev CHMP-a provedena su savjetovanja sa znanstvenom savjetodavnom skupinom i organizacijama zdravstvenih radnika.
English: Minor changes were included in the remaining sections of the SmPC.
Croatian: U ostalim odjeljcima sažetka opisa svojstava lijeka uključene su manje izmjene.
English: For the injectable formulations: - Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate.
Croatian: - Brza kontrola teške akutne psihomotorne agitacije povezane sa psihotičnim poremećajem ili maničnim epizodama bipolarnog poremećaja tipa
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: (Zaštićeni) naziv Doza Farmaceutski Oblik
English: These improvements were not statistically significant.
Croatian: Ova poboljšanja nisu bila statistički značajna.
English: Hazard ratio [95% CI]
Croatian: Omjer hazarda [95% CI]
English: Available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2 međutim nije moguće dati preporuku o doziranju..
English: AV 2nd degree block, AV 3rd degree block
Croatian: AV blok 2. stupnja, AV blok 3. stupnja
English: - This medicine has been prescribed for you.
Croatian: Ovaj je lijek propisan samo Vama.
English: If you forget to take a dose of Ivabradine Anpharm, take the next dose at the usual time.
Croatian: Ako zaboravite uzeti jednu dozu Ivabradina Anpharm, uzmite sljedeću dozu u uobičajeno vrijeme.
English: Ivabradine (N=3241) n (%)
Croatian: Ivabradin (N=3241) n (%)
English: In this way Ivabradine Anpharm helps to control and reduce the number of angina attacks.
Croatian: Na taj način, Ivabradine Anpharmpomaže u kontroliranju i smanjenju broja napadaja angine.
English: Treatment effect on the primary composite endpoint, its components and secondary endpoints
Croatian: Učinak liječenja na primarni kompozitni ishod, njegove pojedine komponente i sekundarne ishode.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog.
English: The absence of pharmacokinetic difference between the 2 formulations was shown in an openlabel randomised two-period cross-over study in 24 adult healthy volunteers.
Croatian: Izostanak razlike u farmakokinetici između dviju formulacija dokazan je u ovorenom, randomiziranom ukriženom ispitivanju s dva perioda na 24 odrasla zdrava dobrovoljca.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107 c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: If you are pregnant and have taken Ivabradine Anpharm, talk to your doctor.
Croatian: Ako ste trudni, a uzeli ste Ivabradine Anpharm, obratite se liječniku.
English: Ivabradine Anpharm should be taken during meals.
Croatian: Ivabradine Anpharm treba uzimati tijekom obroka.
English: If you think that the effect of Ivabradine Anpharm is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako mislite da je učinak Ivabradina Anpharmprejak ili preslab, razgovarajte s liječnikom ili ljekarnikom.
English: Patients should be informed of signs and symptoms of atrial fibrillation and be advised to contact their physician if these occur.
Croatian: Bolesnike treba upozoriti na znakove i simptome fibrilacije atrija te savjetovati da se obrate svom liječniku ukoliko se oni pojave.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/09/2015
Croatian: Datum prvog odobrenja: 08.rujna 2015.
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine Anpharm.
Croatian: Kalendar otisnut na blister pakiranju koje sadržava tablete, trebao bi Vam pomoći da zapamtite, kada ste zadnji put uzeli tabletu Ivabradina Anpharm.
English: The tablets are available in calendar packs (Aluminium/PVC blisters) of 14, 28, 56, 84, 98, 100 or 112 tablets.
Croatian: Tablete su dostupne u kalendarskim pakiranjima (aluminij/PVC blisterima) od 14, 28, 56, 84, 98, 100 ili 112 tableta.
English: In this study, ivabradine was administered as oral liquid formulation or tablet twice daily.
Croatian: U ovom ispitivanju ivabradin se primjenjivao kao tekuća oralna formulacija ili kao tableta dva puta na dan.
English: The most common adverse reactions with this medicine are dose dependent and related to its mode of action:
Croatian: Najčešće nuspojave zabilježene uz primjenu ovog lijeka su ovisne o dozi i povezane s s mehanizmom djelovanja lijeka:
English: It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers.
Croatian: Lijek se koristi kod odraslih bolesnika koji ne podnose ili ne smiju uzimati lijekove za srce koji se zovu beta blokatori.
English: Marketing Authorisation Holder and Manufacturer:
Croatian: Nositelj odobrenja za stavljanje u promet lijeka i proizvođač:
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza "Rok valjanosti" i oznake „EXP”.
English: Children Ivabradine Anpharm is not intended for use in children and adolescents younger than 18 years.
Croatian: Djeca Ivabradine Anpharmnije namijenjen djeci ni adolescentima mlađima od 18 godina.
English: Do not take Ivabradine Anpharm - if you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Ivabradine Anpharm - ako ste alergični na ivabradin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6);
English: Ivabradine is contraindicated in patients with severe hypotension (blood pressure < 90/50 mmHg) (see section 4.3).
Croatian: Ivabradin je kontraindiciran u bolesnika s teškim oblikom hipotenzije (krvni tlak < 90/50 mmHg) (vidjeti dio 4.3).
English: The safety and efficacy of ivabradine for the treatment of chronic heart failure in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost ivabradina u liječenju kroničnog zatajenja srca u djece u dobi do 18 godina nisu ustanovljene.
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common: may affect up to 1 in 10 people uncommon: may affect up to 1 in 100 people rare: may affect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Croatian: Učestalosti mogućih nuspojava mogu se svrstati prema sljedećoj podjeli: vrlo često: mogu se javiti u više od 1 na 10 osoba često: mogu se javiti u do 1 na 10 osoba manje često: mogu se javiti u do 1 na 100 osoba rijetko: mogu se javiti u do 1 na 1000 osoba vrlo rijetko: mogu se javiti u do 1 na 10 000 osoba nepoznato: učestalost se ne može procijeniti iz dostupnih podataka
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Croatian: halofantrin, pentamidin, cisaprid, intravenski eritromicin).
English: The safety profile, over one year, was similar to the one described in adult CHF patients.
Croatian: Sigurnosni profil tijekom godine dana bio je sličan onom opisanom kod odraslih bolesnika koji boluju od kroničnog zatajenja srca.
English: If atrial fibrillation develops during treatment, the balance of benefits and risks of continued ivabradine treatment should be carefully reconsidered.
Croatian: Ukoliko se razvije fibrilacija atrija tijekom liječenja, potrebno je pažljivo ponovno razmotriti omjer koristi i rizika kontinuiranog liječenja ivabradinom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ivabradine in all subsets of the paediatric population for the treatment of angina pectoris.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka ivabradin u svim podskupinama pedijatrijske populacije u liječenju angine pektoris.
English: Ventricular extrasystoles Atrial fibrillation
Croatian: Ventrikularne ekstrasistole Fibrilacija atrija
English: Verapamil, diltiazem or strong CYP 3A4 inhibitors were received by 7.1% of patients during the study.
Croatian: Verapamil, diltiazem ili snažni inhibitori CYP3A4 primijenjeni su u 7,1% bolesnika tijekom ispitivanja.
English: The total clearance is about 400 ml/min and the renal clearance is about 70 ml/min.
Croatian: Ukupni klirens je oko 400 ml/min, a renalni klirens oko 70
English: Symptomatic treatment of chronic stable angina pectoris
Croatian: Simptomatsko liječenje kronične stabilne angine pektoris.
English: What Ivabradine Anpharm contains - The active substance is ivabradine (as hydrochloride).
Croatian: Što Ivabradine Anpharm sadrži - Djelatna tvar je ivabradin (u obliku ivabradinklorida).
English: Analysis of heart rate reduction with doses up to 20 mg twice daily indicates a trend towards a plateau effect which is consistent with a reduced risk of severe bradycardia below 40 bpm (see section 4.8).
Croatian: Analiza usporenja srčane frekvencije s dozama do 20 mg dva puta na dan, ukazuje na postojanje trenda prema plato učinku, što se slaže sa smanjenim rizikom od teške bradikardije s manje od 40/min (vidjeti dio 4.8).
English: Ivabradine is indicated : - in adults unable to tolerate or with a contraindication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
Croatian: Ivabradin je indiciran: - u odraslih bolesnika koji ne podnose beta-blokatore ili je njihova primjena kontraindicirana - ili u kombinaciji s beta blokatorima u bolesnika koji nisu adekvatno kontrolirani s optimalnom dozom beta blokatora.
English: (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os,
Croatian: (ketokonazol, itrakonazol), makrolidni antibiotici (klaritromicin, eritromicin per os, jozamicin,
English: Laboratorios Servier S.L.
Croatian: Laboratorios Servier S.A.
English: If you take more Ivabradine Anpharm than you should:
Croatian: Ako uzmete više Ivabradina Anpharmnego što ste trebali:
English: It is used in combination with standard therapy, including beta-blocker therapy or when betablockers are contraindicated or not tolerated.
Croatian: Lijek se koristi u kombinaciji sa standardnom terapijom, uključujući beta-blokatore ili kada su beta-blokatori kontraindicirani ili se ne podnose.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2
English: The twice-daily dosing regimen of ivabradine gave uniform efficacy over 24 hours.
Croatian: Režim doziranja ivabradina od dva puta na dan rezultirao je ujednačenom djelotvornosti tijekom24 sata.