FrancophonIA/ELRC3.0 huggingface dataset:
English: Eight-hundred and twenty-three patients (23% women) were randomised to receive 12 weeks of treatment with Ranexa 750 mg twice daily, 1000 mg twice daily, or placebo.
Croatian: Osamsto dvadeset tri bolesnika (od toga 23% žena) nasumce je odabrano da 12 tjedana primaju Ranexu 750 mg dvaput dnevno, 1000 mg dvaput dnevno ili placebo.
English: Elderly may have increased ranolazine exposure due to age-related decrease in renal function (see section 5.2).
Croatian: Ekspozicija starijih osoba ranolazinu može biti povećana zbog smanjene funkcije bubrega uzrokovane životnom dobi (vidjeti dio 5.2).
English: - if you have heart failure.
Croatian: - ako bolujete od zatajivanja srca.
English: Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
Croatian: Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
English: In a pharmacokinetic study in healthy volunteers, steady-state Cmax was, on average, approximately 1770 (SD 1040) ng/ml, and steady-state AUC0-12 was, on average, 13,700 (SD 8290) ng x h/ml following a dose of 500 mg twice daily.
Croatian: U farmakokinetičkom istraživanju na zdravim dobrovoljcima, Cmax u stanju dinamičke ravnoteže bila je u prosjeku oko 1770 (SD 1040) ng/ml, dok je AUC0-12 u stanju dinamičke ravnoteže bio u prosjeku 13700 (SD 8290) ng x h/ml nakon doze od 500 mg dvaput dnevno.
English: Inhibitors of CYP3A4 increase plasma concentrations of ranolazine.
Croatian: Inhibitori CYP3A4 povećavaju koncentraciju ranolazina u plazmi.
English: Renal impairment: In a study evaluating the influence of renal function on ranolazine pharmacokinetics, ranolazine AUC was on average 1.7- to 2-fold higher in subjects with mild, moderate, and severe renal impairment compared with subjects with normal renal function.
Croatian: Oštećenje funkcije bubrega: U istraživanju u kojem je procjenjivan utjecaj funkcije bubrega na farmakokinetiku ranolazina, AUC ranolazina bio je u prosjeku 1,7 do 2 puta veći kod ispitanika s blagim, umjerenim i teškim oštećenjem funkcije bubrega u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: Do not use this medicine after the expiry date which is stated on each blister strip of tablets and on the outside of the carton and bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru tableta, vanjskom dijelu kutije i bočici iza oznake „Rok valjanosti“.
English: It is important that you tell your doctor if you get side effects such as dizziness or feeling or being sick.
Croatian: Važno je da svom liječniku kažete ako imate nuspojave kao što je omaglica ili ako osjećate mučninu ili povraćate.
English: This is also recommended for other CYP3A4 substrates with a narrow therapeutic range (e.g., ciclosporin, sirolimus, everolimus).
Croatian: Isto se preporučuje i za druge CYP3A4 supstrate s uskom terapijskom širinom (npr. ciklosporin, sirolimus, everolimus).
English: Given the dose-dependent side effects and similar efficacy at 750 and 1000 mg twice daily, a maximum dose of 750 mg twice daily is recommended.
Croatian: Uzimajući u obzir nuspojave ovisne o dozi i sličnu djelotvornost doza od 750 i 1000 mg dvaput dnevno, preporučuje se maksimalna doza od
English: Pregnancy: There are limited amount of data from the use of ranolazine in pregnant women.
Croatian: Trudnoća: Podaci o primjeni ranolazina u trudnica su ograničeni.
English: Adults: The recommended initial dose of Ranexa is 375 mg twice daily.
Croatian: Odrasli: Preporučena početna doza Ranexe je 375 mg dva puta dnevno.
English: Ελλάδα MENARINI HELLAS AE Τηλ: +30 210 8316111-13
Croatian: MENARINI HELLAS AE Τηλ: +30 210 8316111-13
English: The risk for increased exposure leading to adverse events in these different subgroups is higher in patients lacking CYP2D6 activity (poor metabolisers, PM) than subjects with CYP2D6 metabolising capacity (extensive metabolisers, EM) (see section 5.2).
Croatian: Rizik povećane ekspozicije koja bi mogla dovesti do nuspojava kod ovih podskupina bolesnika veći je kod bolesnika kod kojih ne postoji aktivnost CYP2D6 (slabi metabolizatori) nego kod osoba sa sposobnošću metaboliziranja CYP2D6 (jaki metabolizatori) (vidjeti dio 5.2).
English: However, the elderly may have increased ranolazine exposure due to age-related decrease in renal function.
Croatian: Međutim, kod starijih osoba može postojati povećana ekspozicija ranolazinu zbog smanjenja bubrežne funkcije povezanog sa životnom dobi.
English: This reduction in cellular calcium overload is expected to improve myocardial relaxation and thereby decrease left ventricular diastolic stiffness.
Croatian: Očekuje se da ovo smanjenje nakupljanja unutarstaničnog kalcija poboljšava relaksaciju miokarda i time smanjuje dijastolički tonus lijeve klijetke.
English: No significant difference occurred in the composite primary endpoint (time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation) in the ranolazine group (26.2%) versus the placebo group (28.3%), hazard ratio 0.95, 95% CI 0.82-1.10 p= 0.48.
Croatian: Nije došlo do značajnih razlika u mjeri kompozitnog primarnog ishoda (vrijeme do prvog pojavljivanja revaskularizacije potaknute ishemijom ili hospitalizacije potaknute ishemijom bez revaskularizacije) u skupini na ranolazinu (26,2%) u odnosu na skupinu na placebu (28,3%), omjer hazarda 0,95, 95% CI 0,82-1,10 p=0,48.
English: Careful dose titration of Ranexa is recommended in patients treated with diltiazem and other moderately potent CYP3A4 inhibitors (e.g. erythromycin, fluconazole).
Croatian: Preporučuje se pažljivo prilagođavanje doze Ranexe kod bolesnika liječenih diltiazemom i drugim umjereno snažnim inhibitorima CYP3A4 (npr. eritromicinom, flukonazolom).
English: Simvastatin: Simvastatin metabolism and clearance are highly dependent on CYP3A4.
Croatian: Simvastatin: Metabolizam i klirens simvastatina izrazito su ovisni o CYP3A4.
English: Ranexa may cause dizziness, blurred vision, diplopia, confusional state, coordination abnormal, and hallucination (see section 4.8), which may affect the ability to drive and use machines.
Croatian: Ranexa može uzrokovati omaglicu, zamagljen vid, diplopiju, konfuzno stanje, poremećenu koordinaciju pokreta i halucinacije (vidjeti dio 4.8), što može utjecati na sposobnost upravljanja vozilima i strojevima.
English: - if you have ever had an abnormal electrocardiogram (ECG).
Croatian: - ako ste ikada imali abnormalni elektrokardiogram (EKG). - ako ste starija osoba. - ako imate nisku tjelesnu težinu (60 kg ili manje).
English: LIST OF EXCIPIENTS Contains colouring agent E102 and lactose; see package leaflet for further information.
Croatian: Sadrži bojilo E102 i laktozu; vidjeti uputu o lijeku za dodatne informacije.
English: Ireland A. Menarini Pharmaceuticals Ltd Tel: +353 1 284 6744
Croatian: Menarini Pharmaceuticals Ltd Tel: +353 1 284 6744
English: There was a significantly lower incidence of arrhythmias in patients treated with Ranexa (80%) versus placebo (87%), including ventricular tachycardia ≥ 8 beats (5% versus 8%).
Croatian: Postojala je značajno manja incidencija aritmija kod bolesnika liječenih Ranexom (80%) u odnosu na placebo (87%), uključujući ventrikularnu tahikardiju
English: Ranexa was significantly superior to placebo in prolonging exercise time, time to angina, and time to 1 mm ST segment depression at all doses studied with an observed dose-response relationship.
Croatian: Ranexa je bila značajno superiorna placebu u produljenju vremena opterećenja, vremena do nastanka angine te vremena do spuštanja ST spojnice za 1 mm u svim ispitivanim dozama uz uočen odnos doza-odgovor.
English: Effects of ranolazine on other medicinal products
Croatian: Utjecaj ranolazina na druge lijekove
English: Elderly: Dose titration in elderly patients should be exercised with caution (see section 4.4).
Croatian: Starije osobe: Prilagođavanje doze kod starijih bolesnika treba provoditi pažljivo (vidjeti dio 4.4).
English: The other ingredients are: hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide and carnauba wax.
Croatian: Pomoćne tvari su: hipromeloza, magnezijev stearat, metakrilatna kiselina/etilakrilat kopolimer, mikrokristalična celuloza, natrijev hidroksid, titanijev dioksid i karnauba vosak.
English: • Patients with low weight (≤ 60 kg) (see sections 4.2, 4.8, and 5.2).
Croatian: • Kod osoba niske tjelesne težine (≤ 60 kg) (vidjeti dijelove 4.2, 4.8 i 5.2).
English: At 500 mg twice daily, subjects lacking CYP2D6 activity (poor metabolisers, PM) had 62% higher AUC than subjects with CYP2D6 metabolising capacity (extensive metabolisers, EM).
Croatian: Kod doze od 500 mg dvaput dnevno, osobe kod kojih nije prisutna aktivnost CYP2D6 (slabi metabolizatori) imale su 62% viši AUC od osoba s kapacitetom metaboliziranja CYP2D6 (jaki metabolizatori).
English: The maximum dose of Ranexa is 750 mg twice a day.
Croatian: Najviša doza Ranexe je 750 mg dvaput dnevno.
English: MARKETING AUTHORISATION HOLDER Menarini International Operations Luxembourg S.A.
Croatian: Menarini International Operations Luxembourg S.A.
English: Each tablet contains 375 mg, 500 mg, or 750 mg ranolazine.
Croatian: Jedna tableta sadrži 375 mg, 500 mg ili 750 mg ranolazina.
English: Tell your doctor if you experience common side effects such as dizziness or feeling sick or vomiting.
Croatian: Obavijestite svog liječnika ako ste osjetili česte nuspojave poput omaglice, mučnine ili povraćanja.
English: Dose adjustment of sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin) and CYP3A4 substrates with a narrow therapeutic range (e.g. ciclosporin, tacrolimus, sirolimus, everolimus) may be required as RANEXA may increase plasma concentrations of these drugs.
Croatian: Može biti potrebna prilagodba doze osjetljivih CYP3A4 supstrata (npr. simvastatina, lovastatina) i CYP3A4 supstrata s uskom terapijskom širinom (npr. ciklosporina, takrolimusa, sirolimusa, everolimusa) jer Ranexa može povisiti koncentraciju tih lijekova u plazmi.
English: Drug-drug interactions: Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy.
Croatian: Interakcije s drugim lijekovima: Očekuje se da će istovremena primjena induktora CYP3A4 umanjiti djelotvornost.
English: Renal impairment: Renal function decreases with age and it is therefore important to check renal function at regular intervals during treatment with ranolazine (see sections 4.2, 4.3, 4.8, and 5.2).
Croatian: Oštećena funkcija bubrega: Funkcija bubrega smanjuje se sa životnom dobi i zato je važno tijekom liječenja ranolazinom provjeravati funkciju bubrega u redovnim intervalima (vidjeti dijelove 4.2, 4.3, 4.8, i 5.2).
English: Tacrolimus, ciclosporin, sirolimus, everolimus: Increased plasma concentrations of tacrolimus, a CYP3A4 substrate, have been observed in patients after ranolazine administration.
Croatian: Takrolimus, ciklosporin, sirolimus, everolimus: nakon primjene ranolazina u plazmi bolesnika primijećene su povišene koncentracije takrolimusa, CYP3A4 supstrata.
English: In the pivotal study, CARISA, Ranexa was added to treatment with atenolol 50 mg once daily, amlodipine 5 mg once daily, or diltiazem 180 mg once daily.
Croatian: U pivotalnom istraživanju, CARISA, Ranexa je bila dodatni lijek uz atenolol 50 mg jednom dnevno, amlodipin 5 mg jednom dnevno i diltiazem 180 mg jednom dnevno.
English: QT prolongation was more pronounced in these patients.
Croatian: Kod tih je bolesnika bilo izraženije produljenje QT intervala.
English: You should not take Ranexa if you are breast-feeding.
Croatian: Ne biste smjeli uzimati Ranexu ako dojite.
English: In vitro studies using human liver microsomes indicate that ranolazine is metabolised primarily by CYP3A4, but also by CYP2D6.
Croatian: In vitro istraživanja uz korištenje humanih jetrenih mikrosoma upućuju na to da se ranolazin metabolizira prvenstveno putem CYP3A4, ali i putem
English: Ranolazine AUC was unaffected in patients with mild hepatic impairment but increased 1.8-fold in patients with moderate impairment.
Croatian: AUC ranolazina bio je nepromijenjen kod bolesnika s blagim oštećenjem jetrene funkcije, međutim bio je 1,8 puta povećan kod bolesnika s umjerenim oštećenjem jetrene funkcije.
English: These medicines may cause an increase in the number of side effects, such as dizziness, nausea, or vomiting, which are possible side effects of Ranexa (see section 4).
Croatian: Ti lijekovi mogu izazvati povećanje broja nuspojava kao što su omaglica, mučnina ili povraćanje, a koje su moguće nuspojave Ranexe
English: Caution is advised during co-administration with CYP2B6 substrates (e.g. bupropion, efavirenz, cyclophosphamide).
Croatian: Preporučuje se oprez tijekom istovremene primjene sa supstratima CYP2B6 (npr. bupropionom, efavirenzom, ciklofosfamidom).
English: - medicines to treat epilepsy or another neurologic disorder (e.g. phenytoin, carbamazepine, or phenobarbital); are taking rifampicin for an infection (e.g. tuberculosis); or are taking the herbal remedy St. John's Wort, as these medicines may cause Ranexa to be less effective.
Croatian: - lijekove za liječenje epilepsije ili drugog neurološkog poremećaja (npr. fenitoin, karbamazepin ili fenobarbital); ako uzimate rifampicin za infekciju (npr. tuberkulozu); ili ako uzimate biljni lijek gospinu travu, budući da ti lijekovi mogu smanjiti učinak Ranexe.
English: Eesti OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001
Croatian: OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001
English: Common: dizziness, headache.
Croatian: Često: omaglica, glavobolja.
English: 375 mg tablet: macrogol, polysorbate 80, Blue #2/Indigo Carmine Aluminium Lake (E132) 500 mg tablet: macrogol, talc, polyvinyl alcohol-part hydrolyzed, iron oxide yellow (E172), iron oxide red (E172)
Croatian: tableta od 375 mg: makrogol, polisorbat 80, plava boja #2/Indigo Carmine Aluminium Lake (E132) tableta od 500 mg: makrogol, talk, djelomično hidroliziran poli(vinilni alkohol), žuti željezov oksid (E172), crveni željezov oksid (E172) tableta od 750 mg: gliceroltriacetat, laktoza hidrat, plava boja #1/Brilliant Blue FCF Aluminium Lake
English: NN: {number}
Croatian: Ελλάδα
English: • Elderly (see sections 4.2, 4.8, and 5.2).
Croatian: • Kod starijih osoba (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Haemodynamic effects: Minimal decreases in mean heart rate (< 2 beats per minute) and mean systolic blood pressure (< 3 mm Hg) were observed in patients treated with ranolazine either alone or in combination with other antianginal medicinal products in controlled studies.
Croatian: Hemodinamički učinci: Minimalno smanjenje srednjeg broja srčanih otkucaja (< 2 otkucaja u minuti) i srednjeg sistoličkog krvnog tlaka (< 3 mm Hg) uočeno je u kontroliranim istraživanjima kod bolesnika liječenih samo ranolazinom ili u kombinaciji s drugim lijekovima protiv angine pektoris.
English: Contents of the pack and other information
Croatian: Sadržaj pakiranja idruge informacije
English: Rare: peripheral coldness, orthostatic hypotension.
Croatian: Rijetko: periferna hladnoća, ortostatska hipotenzija.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati RANEXU Lijek čuvajte izvan pogleda i dohvata djece.
English: Verapamil (120 mg three times daily) increases ranolazine steady-state concentrations 2.2-fold.
Croatian: Verapamil (120 mg tri puta dnevno) povećava koncentraciju ranolazina u stanju dinamičke ravnoteže 2,2 puta.
English: After oral administration of Ranexa, peak plasma concentrations (Cmax) are typically observed between 2 and 6 hours.
Croatian: Nakon peroralne primjene Ranexe, vršne koncentracije u plazmi (Cmax) uobičajeno se bilježe nakon 2 i
English: PHARMACEUTICAL FORM AND CONTENTS 30 prolonged-release tablets 60 prolonged-release tablets 100 prolonged-release tablets
Croatian: 30 tableta s produljenim oslobađanjem 60 tableta s produljenim oslobađanjem 100 tableta s produljenim oslobađanjem
English: Rare: acute renal failure, urinary retention.
Croatian: Rijetko: akutno bubrežno zatajenje, retencija urina.
English: Dose titration in patients with low weight should be exercised with caution (see sections 4.4, 4.8, and 5.2).
Croatian: Prilagođavanje doze kod bolesnika niske tjelesne težine treba provoditi pažljivo (vidjeti dijelove 4.4, 4.8, i 5.2).
English: Evaluations in patients who may be considered at higher risk of adverse events when treated with other antianginal medicinal products, e.g. patients with diabetes, Class I and II heart failure, or obstructive airway disease, confirmed that these conditions were not associated with clinically meaningful increases in the incidence of adverse events.
Croatian: Procjene kod bolesnika za koje se može smatrati da imaju veći rizik od nuspojava tijekom liječenja drugim lijekovima protiv angine pektoris, npr. kod bolesnika s dijabetesom, zatajenjem srca NYHA klase I i II ili opstruktivnom bolesti dišnih putova, potvrdile su da ta stanja nisu bila povezana s klinički značajnim povećanjem incidencije nuspojava.
English: Concomitant administration of potent CYP3A4 inhibitors is contraindicated (see sections 4.3 and 4.5).
Croatian: Istodobna primjena sa snažnim inhibitorima CYP3A4 je kontraindicirana (vidjeti dijelove 4.3 i 4.5).
English: Danmark Berlin-Chemie/A.Menarini Danmark ApS Tlf: +4548 217 110
Croatian: Berlin-Chemie/A.Menarini Danmark ApS Tlf: +4548 217 110
English: United Kingdom A. Menarini Farmaceutica Internazionale S.R.L.
Croatian: Menarini Farmaceutica Internazionale S.R.L.
English: There was no renal toxicity related to these findings.
Croatian: S tim nalazima nije bila povezana bubrežna toksičnost.
English: The improvement in exercise duration in women was about 33% of the improvement in men at the 1000 mg twice-daily dose level.
Croatian: Produljenje trajanja opterećenja kod žena iznosilo je oko 33% produljenja kod muškaraca pri dozi od
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/PVDC/Aluminium blisters
Croatian: PVC/PVDC/Aluminij blisteri
English: Do not take Ranexa - if you are allergic to ranolazine or any of the other ingredients of this medicine listed in section 6 of this leaflet.
Croatian: - ako ste alergični na ranolazin ili neki drugi sastojak ovog lijeka naveden u dijelu 6. ove upute. - ako imate teške probleme s bubrezima.
English: In general, the type and frequency of adverse events reported in patients with low body weight (≤ 60 kg) were similar to those of patients with higher weight (> 60 kg); however, the placebocorrected frequencies of the following common adverse events were higher in low body weight than heavier patients: nausea (14% versus 2%), vomiting (6% versus 1%), and hypotension (4% versus
Croatian: Općenito, vrsta i učestalost nuspojava zabilježenih kod bolesnika s niskom tjelesnom težinom (≤ 60 kg) bile su slične kao kod bolesnika veće tjelesne težine (> 60 kg); međutim, učestalosti korigirane u odnosu na placebo sljedećih čestih nuspojava bile su veće kod bolesnika niske tjelesne težine nego kod bolesnika veće tjelesne težine: mučnina (14% u odnosu na 2%), povraćanje (6% u odnosu na 1%) i hipotenzija (4% u odnosu na 2%).
English: Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.
Croatian: Istovremena primjena antiaritmika skupine Ia (npr. kinidina) ili skupine III (npr. dofetilida, sotalola), osim amiodarona.
English: In a phase 3, double-blind, placebo-controlled, event-driven trial (RIVER-PCI) in 2604 patients aged ≥18 years with a history of chronic angina and incomplete revascularisation after percutaneous coronary intervention (PCI) patients were up-titrated to 1000 mg twice daily (dosage not approved in the current SmPC).
Croatian: U fazi 3, dvostruko slijepog, placebom kontroliranog, događajima uvjetovanog ispitivanja (RIVERPCI) na 2604 bolesnika u dobi od ≥18 godina, s anamnezom kronične angine i nepotpune revaskularizacije nakon perkutane koronarne intervencije (PCI), bolesnicima je postupno povećavana doza do 1000 mg dvaput dnevno (neodobreno doziranje u važećem SmPC-u).
English: Ranolazine is a moderate to potent inhibitor of P-gp and a mild inhibitor of CYP3A4, and may increase plasma concentrations of P-gp or CYP3A4 substrates.
Croatian: Ranolazin je umjeren do snažan inhibitor P-gp-a i blag inhibitor CYP3A4 pa može povećati koncentracije P-gp-a ili CYP3A4 supstrata u plazmi.
English: No proarrhythmic effects were observed in 3,162 patients treated with Ranexa based on 7-day Holter monitoring in the MERLIN-TIMI 36 study.
Croatian: Tijekom 7-dnevnog praćenja Holterom 3162 bolesnika liječenih Ranexom u istraživanju MERLINTIMI 36 nisu uočeni proaritmijski učinci.
English: Suomi/Finland Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760
Croatian: Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760
English: There was a large inter-individual variability in AUC in subjects with renal impairment.
Croatian: Postojala je velika varijabilnost među pojedincima u pogledu AUC-a kod ispitanika s oštećenjem funkcije bubrega.
English: Ranexa 750 mg twice daily increased plasma concentrations of metoprolol by 1.8-fold.
Croatian: Uzimanje Ranexe 750 mg dvaput dnevno povećava koncentraciju metoprolola u plazmi 1,8 puta.
English: At the dose level 500 mg twice daily, co-administration of a potent inhibitor of CYP2D6 could result in an increase in ranolazine AUC of about 62%.
Croatian: Kod doze ranolazina od 500 mg dva puta dnevno, istovremena primjena snažnog inhibitora CYP2D6 može dovesti do povećanja površine ispod krivulje (PIK) ranolazina za oko 62%.
English: Ranexa resulted in significant decreases in the number of angina attacks per week (p = 0.028) and consumption of short-acting nitroglycerin (p = 0.014) compared to placebo.
Croatian: U usporedbi s placebom Ranexa je dovela do značajnog tjednog smanjenja broja napadaja angine pektoris (p = 0,028) i korištenja nitroglicerina kratkog djelovanja (p = 0,014).
English: A population-based analysis of combined data from patients and healthy volunteers demonstrated that the slope of the plasma concentration-QTc relationship was estimated to be 2.4 msec per 1000 ng/ml, which is approximately equal to a 2- to 7-msec increase over the plasma concentration range for ranolazine 500 to 1000 mg twice daily.
Croatian: Analiza temeljena na kombiniranim podacima dobivenim iz populacije bolesnika i zdravih dobrovoljaca pokazala je da je krivulja odnosa koncentracije u plazmi i QTc-a procijenjena na 2,4 msec na 1000 ng/ml, što je otprilike jednako povećanju od 2 do 7 msec iznad raspona koncentracije ranolazina u plazmi kod doze 500 do 1000 mg dvaput dnevno.
English: Uncommon: anxiety, insomnia, confusional state, hallucination.
Croatian: Manje često: anksioznost, nesanica, konfuzno stanje, halucinacije.
English: The corresponding difference at the 1000 mg twice-daily dose was 25%.
Croatian: Kod doze od 1000 mg dvaput dnevno ta je razlika bila 25%.
English: - certain medicines to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), and depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may affect your ECG.
Croatian: - određene lijekove za liječenje alergija (npr. terfenadin, astemizol, mizolastin), poremećaja srčanog ritma (npr. disopiramid, prokainamid) i depresije (npr. imipramin, doksepin, amitriptilin), budući da ti lijekovi mogu utjecati na Vaš EKG.
English: CYP3A4 or P-gp inhibitors: Ranolazine is a substrate of cytochrome CYP3A4.
Croatian: Inhibitori CYP3A4 ili P-gp: Ranolazin je supstrat citokroma CYP3A4.
English: Your doctor may decide to give you a lower dose or take other precautions if any of these apply to you.
Croatian: Ako se bilo što od navedenog odnosi na Vas, liječnik može odlučiti dati Vam manju dozu ili poduzeti druge preventivne mjere.
English: - if you have mild liver problems.
Croatian: - ako imate blage probleme s jetrom.
English: QT prolongation: Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner.
Croatian: Produljeni QT interval: Ranolazin blokira IKr i produljuje QTc interval, ovisno o dozi.
English: Additional excipients for 750 mg tablet:
Croatian: Dodatne pomoćne tvari u tabletama od 750 mg: