FrancophonIA/ELRC3.0 huggingface dataset:
English: ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Croatian: *** Prema Nacionalnom institutu za rak CTC (v2.0; NCI 1998), poremećaj osjeta okusa i alopecija prijavljuju se isključivo kao nuspojave stupnja 1 ili 2.
English: *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Croatian: *** Prema Nacionalnom Institutu za rak CTC (v2.0; NCI 1998), poremećaj osjeta okusa i alopecija prijavljuju se isključivo kao nuspojave stupnja 1 ili 2.
English: Side effects with pemetrexed may include:
Croatian: Moguće nuspojave premetrekseda su:
English: Grade 3 toxicity
Croatian: Toksičnost stupnja 3
English: Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetreksed Hospira 100 mg prašak za koncentrat za otopinu za infuziju Pemetreksed Hospira 500 mg prašak za koncentrat za otopinu za infuziju Pemetreksed Hospira 1000 mg prašak za koncentrat za otopinu za infuziju
English: Type I glass vial with rubber stopper containing 100 mg, 500 mg or 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: I s gumenim čepom sadrži 100 mg, 500 mg ili 1000 mg pemetrekseda (u obliku pemetrekseddinatrija hemipentahidrata).
English: Pemetrexed Hospira in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Croatian: Pemetreksed Hospira je u kombinaciji s cisplatinom indiciran u prvoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice (vidjeti dio 5.1).
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with
Croatian: - ako dojite; tijekom liječenja lijekom Pemetreksed Hospira morate prestati dojiti
English: Dose modification table for Pemetrexed Hospira (as single agent or in combination) and cisplatin - Neurotoxicity
Croatian: Tablica 3. - Tablica za prilagodbu doze lijeka Pemetreksed Hospira (u monoterapiji ili u kombinaciji) i cisplatina - neurotoksičnost
English: Pemetrexed*** (N = 800)
Croatian: Učestalost* Događaj** Pemetreksed*** (N = 800)
English: A multi-centre, randomised, double-blind, placebo-controlled Phase-3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed plus best supportive care (BSC) (N = 441) with that of placebo plus BSC (N = 222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first-line doublet therapy containing cisplatin or carboplatin in combination with gemcitabine, paclitaxel, or docetaxel.
Croatian: uz najbolju potpornu njegu (eng. best supportive care, BSC) (N = 441) s djelotvornošću i sigurnošću primjene placeba uz BSC (N = 222) u bolesnika s lokalno uznapredovalim (stadij IIIB) ili metastatskim (stadij IV) rakom pluća nemalih stanica (NSCLC) u kojih nije došlo do progresije nakon 4 ciklusa prve linije dvojne terapije cisplatinom ili karboplatinom u kombinaciji s gemcitabinom, paklitakselom ili docetakselom.
English: Hospira and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Croatian: Ovi kriteriji odgovaraju definiciji krvarenja stupnja ≥ 2 prema Zajedničkim kriterijima toksičnosti Nacionalnog instituta za rak (National Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998).
English: For intravenous use
Croatian: Za primjenu u venu.
English: After reconstitution as directed, the solution contains 25 mg/ml of pemetrexed.
Croatian: Nakon rekonstitucije prema uputama, jedna bočica sadrži 25 mg/ml pemetrekseda.
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (N = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60, 95% CI = 0.49-0.73, p < 0.00001).
Croatian: Ispitivanje je ispunilo primarni ishod i pokazalo statistički značajno poboljšanje PFS-a u skupini koja je primala pemetreksed u odnosu na skupinu koja je primala placebo (N=581, neovisno procijenjena populacija; medijan od 4 odnosno 2 mjeseca) (omjer hazarda = 0,60, 95% CI = 0,49-0,73, p < 0,00001).
English: For patients with NSCLC other than predominantly squamous cell histology (N = 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio = 0.47 (95% CI = 0.37-0.60, p = 0.00001).
Croatian: U bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice (N=430, neovisno procijenjena populacija), medijan PFS-a bio je 4,4 mjeseci u skupini koja je primala pemetreksed te 1,8 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,47 (95% CI = 0,37-0,60, p = 0,00001).
English: Pemetrexed Hospira is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Croatian: Pemetreksed Hospira je indiciran kao monoterapija u drugoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice (vidjeti dio 5.1).
English: The recommended dose of Pemetrexed Hospira is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Croatian: Pemetreksed Hospira u kombinaciji s cisplatinom Preporučena doza lijeka Pemetreksed Hospira je 500 mg/m2 tjelesne površine, a primjenjuje se u obliku intravenske infuzije tijekom 10 minuta, prvog dana svakog 21-dnevnog ciklusa.
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first-line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59, 95% CI = 0.47-0.74).
Croatian: Prema procjeni ispitivača medijan PFS-a randomiziranih bolesnika, mjeren od početka prve linije uvodnog liječenja pemetreksedom i cisplatinom, iznosio je 6,9 mjeseci za skupinu koja je primala pemetreksed i 5,6 mjeseci za skupinu s placebom (omjer hazarda = 0,59, 95% CI = 0,47-0,74).
English: Stomatitis/Pharyngitis 23.2 Nausea
Croatian: Poremećaji probavnog sustava vrlo često proljev povraćanje stomatitis/faringitis 23,2 mučnina anoreksija konstipacija često dispepsija
English: Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Pemetreksed Hospira 100 mg prašak za koncentrat za otopinu za infuziju: jedna bočica sadrži 100 mg pemetrekseda (u obliku pemetrekseddinatrija hemipentahidrata).
English: Pemetrexed Hospira in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Croatian: Pemetreksed Hospira je u kombinaciji s cisplatinom indiciran za liječenje bolesnika s neoperabilnim malignim pleuralnim mezoteliomom koji prethodno nisu primali kemoterapiju.
English: Pemetrexed / Cisplatin (N = 226)
Croatian: Parametar djelotvornosti pemetreksed / cisplatin (N = 226)
English: Common Neuropathy-sensory Taste disturbance
Croatian: Poremećaji živčanog sustava često senzorna neuropatija 8,5* poremećaj okusa
English: Leucocytes decreased 53.0 Haemoglobin decreased 26.2 Platelets decreased
Croatian: Poremećaji krvi i limfnog sustava vrlo često snižen broj neutrofila/granulocita snižen broj leukocita 53,0 snižene vrijednosti hemoglobina snižen broj trombocita 23,2
English: Pemetrexed/Cisplatin (N = 839)
Croatian: Pemetreksed/Cisplatin (n = 839)
English: • If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon) (may indicate a blood clot in the blood vessels of the lungs).
Croatian: • ako iskusite iznenadni nedostatak zraka, osjećate intenzivnu bol u prsima ili iskašljavate krv
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari manitol (E421) kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH)
English: Read the package leaflet for the shelf life of the reconstituted product.
Croatian: Rok valjanosti Pročitajte uputu o lijeku za navode o roku valjanosti pripremljenog lijeka.
English: Pemetrexed (N = 265)
Croatian: Pemetreksed (N = 265)
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Each 100 mg vial contains approximately 11 mg sodium.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna bočica od 100 mg sadrži približno 11 mg natrija.
English: Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Pemetreksed Hospira 500 mg prašak za koncentrat za otopinu za infuziju: jedna bočica sadrži 500 mg pemetrekseda (u obliku pemetrekseddinatrija hemipentahidrata).
English: How to use Pemetrexed Hospira
Croatian: Kako primjenjivati Pemetreksed Hospira
English: From the start of pemetrexed plus cisplatin first-line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96).
Croatian: Medijan ukupnog preživljenja od početka prve linije uvodnog liječenja pemetreksedom i cisplatinom iznosio je 16,9 mjeseci u skupini koja je primala pemetreksed te 14,0 mjeseci u skupini koja je primala placebo (omjer hazarda = 0,78, 95% CI = 0,64-0,96).
English: How to store Pemetrexed Hospira
Croatian: Kako čuvati Pemetreksed Hospira
English: Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion: Each vial contains 1,000 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Pemetreksed Hospira 1000 mg prašak za koncentrat za otopinu za infuziju: jedna bočica sadrži 1000 mg pemetrekseda (u obliku pemetrekseddinatrija hemipentahidrata).
English: Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
Croatian: Bočice od 500 mg rekonstituirajte s 20 ml otopine natrijevog klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa.
English: Clinically relevant CTC toxicities that were reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Croatian: Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed, ubrajaju se: zatajenje bubrega, infekcija, vrućica, neutropenijska vrućica, povišene vrijednosti AST-a, ALT-a i GGT-a, urtikarija i bol u prsima.
English: A multi-centre, randomised, open-label Phase-3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent-To-Treat [ITT] population N = 283) and 7.9 months for patients treated with docetaxel (ITT N = 288).
Croatian: U multicentričnom, randomiziranom, otvorenom ispitivanju faze III pemetrekseda u odnosu na docetaksel u bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om nakon prethodne kemoterapije medijan preživljenja bolesnika liječenih pemetreksedom iznosio je 8,3 mjeseca (populacija svih uključenih bolesnika, engl.
English: Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
Croatian: Bočice od 100 mg rekonstituirajte s 4,2 ml otopine natrijevog klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa.
English: Pemetrexed/Cisplatin (N = 168)
Croatian: Pemetreksed/Cisplatin (n = 168)
English: Pemetrexed / Cisplatin (N = 168)
Croatian: pemetreksed / cisplatin (N = 168)
English: Reconstitute 1,000 mg vials with 40 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
Croatian: Bočice od 1000 mg rekonstituirajte s 40 ml otopine natrijevog klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa.
English: Each 500 mg vial contains approximately 54 mg sodium.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna bočica od 500 mg sadrži približno 54 mg natrija.
English: Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion
Croatian: Pemetreksed Hospira 100 mg prašak za koncentrat za otopinu za infuziju
English: Each 1,000 mg vial contains approximately 108 mg sodium.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna bočica od 1000 mg sadrži približno 108 mg natrija.
English: Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Jedna bočica sadrži 100 mg pemetrekseda (u obliku pemetrekseddinatrija hemipentahidrata).
English: After reconstitution, each vial contains 25 mg/ml of pemetrexed
Croatian: Nakon rekonstitucije, jedna bočica sadrži 25 mg/ml pemetrekseda.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetreksed Hospira 1000 mg prašak za koncentrat za otopinu za infuziju
English: 9 l/m2.
Croatian: 50 000/mm
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetreksed Hospira 500 mg prašak za koncentrat za otopinu za infuziju
English: Blood clots in the lung blood vessels (pulmonary embolism)
Croatian: Primjenom ljestvice simptoma raka pluća (eng.
English: Manufacturer
Croatian: Pemetreksed
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single use only
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality.
Croatian: Dobivena otopina je bistra i u rasponu boja od bezbojne do žute ili zeleno-žute, što ne utječe nepovoljno na kvalitetu lijeka. pH pripremljene otopine je između 6,6 i 7,8.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetreksed Hospira 100 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 1,000 mg presentation
Croatian: Vanjska kutija za 1000 mg
English: Hypernatraemia - increased sodium in blood Inflammation of the skin, mainly of the lower limb with swelling, pain and redness
Croatian: Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka) oticanje donjih udova praćeno boli i crvenilom povećano stvaranje mokraće žeđ i povećan unos vode hipernatremija - povećana razina natrija u krvi upala kože koja se uglavnom javlja na donjim udovima, a praćena je oticanjem, boli i crvenilom
English: How to store Pemetrexed Hospira 6.
Croatian: Kako primjenjivati Pemetreksed Hospira Moguće nuspojave
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Croatian: Svaku bočicu od 500 mg rekonstituirajte s 20 ml otopine natrijevog klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,000 mg
Croatian: Naljepnica bočice za 1000 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 mg presentation
Croatian: Vanjska kutija za 100 mg
English: Creatinine elevation 10.7 Creatinine clearance decreased**
Croatian: Poremećaji bubrega i mokraćnog sustava vrlo često povišene vrijednosti kreatinina smanjen klirens kreatinina**
English: Contact our press officers Monika Benstetter or Martin Harvey
Croatian: Kontaktirajte s našim službenicima za medije Monika Benstetter ili Martin Harvey
English: 1 September 2014 EMA/465179/2014
Croatian: 1. rujna 2014. EMA/465179/2014
English: • Data in support of other indications were extremely limited.
Croatian: • Podaci koji podržavaju druge indikacije bili su iznimno ograničeni.
English: They are available as tablets, oral suspension and suppositories under various trade names (such as Motilium).
Croatian: Dostupni su kao tablete, peroralna suspenzija i supozitoriji pod različitim trgovačkim nazivima (poput Motilium).
English: This helps to prevent nausea (feeling sick) and vomiting.
Croatian: Ovo pomaže pri sprječavanju mučnine (osjećaja slabosti) i povraćanju.
English: Appropriate risk minimisation measures have therefore been included in the product information to address this issue.
Croatian: Odgovarajuće mjere minimiziranja rizika stoga su uključene u informacije o proizvodu kako bi se riješio ovaj problem.
English: In general, safety reviews indicate that about 40% of such reports are in patients over 60 years of age.
Croatian: Načelno, pregledi sigurnosti primjene lijeka ukazuju na to da je otprilike 40% takvih događaja prijavljeno u bolesnika starijih od 60 godina.
English: The available evidence of efficacy was not sufficient to support its use for other indications.
Croatian: Dostupni dokazi djelotvornosti nisu bili dostatni kako bi podržali primjenu u drugim indikacijama.
English: The review of domperidone was initiated on 1 March 2013 at the request of the Belgian medicines authority, the Federal Agency for Medicines and Health Products (FAGG-AFMPS), under Article 31 of Directive 2001/83/EC.
Croatian: Pregled domperidona pokrenut je 1. ožujka 2013. na zahtjev belgijske agencije za lijekove, Savezne agencije za lijekove i zdravstvene proizvode (FAGG-AFMPS), sukladno članku 31. Direktive 2001/83/EZ.
English: • Domperidone should be used at the lowest effective dose for the shortest possible duration.
Croatian: • Domperidon treba uvijek koristiti u najmanjoj djelotvornoj dozi tijekom najkraćeg mogućeg trajanja.
English: Some products will be withdrawn from the market because their strength does not match the new doses.
Croatian: Određeni proizvodi bit će povučeni iz prometa budući da njihova jačina ne odgovara novoj dozi.
English: The benefits in these indications were therefore not considered to outweigh the risk.
Croatian: Stoga se ne smatra da koristi u ovim indikacijama nadmašuju rizik.
English: • Patients or carers who have any concerns should speak to a healthcare professional.
Croatian: • Bolesnici ili pružatelji skrbi koji imaju razloge za zabrinutost trebaju se obratiti zdravstvenim djelatnicima.
English: The recommendations were originally made by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 3-6 March, after a careful evaluation of the available evidence on the benefits and risks of such medicines.
Croatian: Preporuke je izvorno izdalo Povjerenstvo za ocjenu rizika na području farmakovingilacije (PRAC) pri EMA-i na svojem sastanku održanom od 3. do 6. ožujka, nakon detaljne ocjene dostupnih dokaza vezanih uz prednosti i rizike takvih lijekova.
English: The injectable form of domperidone was withdrawn in 1985 because of such side effects.
Croatian: Injektibilan oblik domperidona povučen je 1985. zbog navedenih nuspojava.
English: The product information has been amended appropriately.
Croatian: Informacije o proizvodu dopunjene su na odgovarajući način.
English: Of 57 reported cardiovascular fatalities, 27 had other risk factors, while 13 had either an implausible relationship to domperidone administration or an alternative aetiology.
Croatian: Od 57 prijavljenih kardiovaskularnih žrtava, 27 je imalo i druge rizične faktore, dok je kod 13 uočen nevjerodostojan odnos s primjenom domperidona ili alternativnu etiologiju.
English: These recommendations are based on careful consideration of data on the safety and efficacy of domperidone from various sources.
Croatian: Ove se preporuke temelje na pažljivom pregledu podataka o sigurnoj primjeni i djelotvornosti domperidona dostupnih iz različitih izvora.
English: There were limited data to support paediatric use in this indication, and although the mechanism of action is not expected to differ between adults and children studies to provide further data to support efficacy in the paediatric population have been requested.
Croatian: Dostupni su ograničeni podaci koji podržavaju pedijatrijsku primjenu u ovoj indikaciji, a iako se ne očekuje različit mehanizam djelovanja u odraslih osoba i djece, zatražena su ispitivanja s ciljem prikupljanja dodatnih podataka koji podržavaju djelotvornost u pedijatrijskoj populaciji.
English: • Formulations not consistent with the new dosage recommendations will be withdrawn from the market, as will combinations of domperidone with cinnarizine.
Croatian: • Formulacije koje nisu u skladu s novim preporukama za doziranje bit će povučene s tržišta, kao i kombinacije domperidona i cinarizina.
English: The review of domperidone was carried out at the request of the Belgian medicines authority over concerns about the medicine's effects on the heart.
Croatian: Pregled domperidona proveden je na zahtjev belgijske agencije za lijekove zbog zabrinutosti o djelovanju lijekova na srce.
English: This is in line with the data coming from drug-drug interaction studies, and from spontaneous reporting.
Croatian: Ovo je u skladu s podacima koji potječu iz ispitivanja o interakciji među lijekovima i iz spontanih prijava.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: CMDh, tijelo koje predstavlja države članice EU-a, odgovorno je za osiguravanje usklađenog standarda sigurne primjene za lijekove odobrene putem nacionalnih postupaka diljem EU-a.
English: A combination product with cinnarizine (an antihistamine) is available in some Member States for the treatment of motion sickness.
Croatian: Kombinirani proizvod s cinarizinom (antihistaminom) dostupan je u pojedinim državama članicama za liječenje bolesti kretanja.
English: In addition, it should not be used with other medicines that have similar effects on the heart or reduce the breakdown of domperidone in the body (thus increasing the risk of side effects).
Croatian: Nadalje, ne smije se koristiti zajedno s drugim lijekovima koji imaju slično djelovanje na srce ili smanjuju razgradnju domperidona u tijelu (te tako ujedno povećavaju rizik od nuspojava).
English: Some of these studies also supported a greater risk in patients over 60 years of age or who were taking high doses (over 30 mg/day).
Croatian: Neka od ovih ispitivanja podržavaju veći rizik u bolesnika starijih od 60 godina ili onih koji uzimaju velike doze (više od 30 mg/dan).
English: However, cases of heart problems in patients using the medicine continued to be reported, and the PRAC was therefore asked to examine whether the benefits still outweighed the risks for these medicines in their approved uses and forms, and whether their marketing authorisations should be maintained or changed across the EU.
Croatian: No, i dalje se prijavljuju slučajevi srčanih problema u bolesnika koji koriste lijek, te je stoga od PRAC-a zatraženo da provjeri nadmašuju li koristi od ovih lijekova još uvijek rizike povezane s ovim lijekovima u njihovim odobrenim primjenama i oblicima, te trebaju li odobrenja za stavljanje tih lijekova u promet ostati na snazi ili se promijeniti diljem EU-a.