FrancophonIA/ELRC3.0 huggingface dataset:
English: Temozolomide Accord 180 mg hard capsules have a white body, a maroon cap, and are imprinted ‘TMZ' on cap and ‘180' on body with black ink.
Croatian: Temozolomid Accord 180 mg tvrde kapsule imaju bijelo tijelo, narančastu kapicu i crnom tintom otisnutu oznaku ˝TMZ˝na kapici i ˝180˝na tijelu.
English: Uncommon hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure†
Croatian: Manje često hiperbilirubinemija, kolestaza, hepatitis, oštećenje jetre, zatajenje jetre†
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 180 mg hard capsules temozolomide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE Temozolomid Accord 180 mg tvrde kapsule Temozolomid
English: The hard capsules are pink/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘100' on body.
Croatian: Tvrde kapsule su ružičasto/bijele tvrde želatinske kapsule s otisnutom oznakom ˝TMZ˝ na kapici i ˝100˝ na tijelu.
English: reduced, vision disorder, visual field defect, eye pain eyes dry
Croatian: zamagljen vid ispad vidnog polja, zamagljen vid, diplopija
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg temozolomide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 100 mg temozolomida.
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Croatian: Ovojnica kapsule želatina voda titanijev dioksid (E171) željezov oksid, žuti (E172)
English: Capsule shell Gelatine
Croatian: kalijev hidroksid
English: Table 4.
Croatian: Tablica 1.
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
Croatian: Davanje TMZ-a može se nastaviti tijekom 42 dana faze istodobnog liječenja (do najviše 49 dana) ako su zadovoljeni svi sljedeći uvjeti: - apsolutni broj neutrofila (ABN) ≥ 1,5 x 109/l
English: • the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Croatian: • ako se nakon smanjenja doze ponovno jave isti nehematološki toksični učinci stupnja 3 (osim alopecije, mučnine i povraćanja)
English: Each hard capsule contains 14.6 mg of anhydrous lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jednatvrda kapsula sadrži 14,6 mg laktoze, bezvodne.
English: Dyspnoea
Croatian: dispneja
English: The hard capsules are transparent blue/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘140' on body.
Croatian: Kapsule su prozirne plavo/bijele tvrde želatinske kapsule s otisnutom oznakom ˝TMZ˝ na kapici i ˝140˝ na tijelu.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 100 mg hard capsules temozolomide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE Temozolomid Accord 100 mg tvrde kapsule Temozolomid
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste
Croatian: alergijska reakcija, vrućica, ozljeda zbog zračenja, edem lica, bol, promjena osjeta okusa alergijska reakcija, vrućica, ozljeda zbog zračenja, bol,
English: OF THE SIGHT AND OF CHILDREN
Croatian: I DOHVATA DJECE
English: The hardcapsules are yellow/ white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘20' on body.
Croatian: Tvrde kapsule su žuto/bijele tvrde kapsule s otisnutom oznakom ˝TMZ˝ na kapici i ˝20˝ na tijelu.
English: Fever, asthenia, rigors, malaise, pain, taste perversion
Croatian: vrućica, astenija, tresavica, malaksalost, bol, promjena osjeta okusa
English: TMZ dose levels for monotherapy treatment
Croatian: Razine doze TMZ-a u fazi monoterapije
English: Titanium dioxide (E171)
Croatian: Ovojnica kapsule: želatina voda titanijev dioksid (E171)
English: There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Croatian: Kada se TMZ primjenjuje u duljem protokolu doziranja pojava PCP-a može biti veća.
English: Each hard capsule contains 102.2 mg of anhydrous lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 102,2 mg laktoze, bezvodne.
English: exanthema
Croatian: Dispneja
English: Capsule contents Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid
Croatian: Sadržaj kapsule laktoza, bezvodna silicijev dioksid, koloidni, bezvodni natrijev škroboglikolat, vrste
English: Each hard capsule contains 182.5 mg of anhydrous lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula mg sadrži 182,5 mg laktoze, bezvodne.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine (E132)
Croatian: Ovojnica kapsule od 5 mg želatina voda titanijev dioksid (E171) željezov oksid, žuti (E172) indigo karmin (E132).
English: condition aggravated, rigors, tongue discolouration, parosmia, thirst condition aggravated, rigors, tooth disorder
Croatian: astenija, navale crvenila, navale vrućine, pogoršanje stanja, tresavica, promjena boje jezika, parosmija, žeđ astenija, edem lica, bol, pogoršanje stanja, tresavica, promjene na zubima
English: Reporting of side effects
Croatian: NAVOĐENJE DJELATNE/IH
English: Based on your blood counts and how you tolerate temozolomide, the dose may be delayed or stopped.
Croatian: Doza se može se odgoditi ili prekinuti ovisno o broju Vaših krvnih stanica i o tome kako podnosite temozolomid.
English: - children 3 years and older and adult patients with specific forms of brain tumour (e.g. glioblastoma multiforme or anaplastic.
Croatian: Temozolomid se prvo primjenjuje u kombinaciji s radioterapijom (faza istodobnog liječenja), a zatim samostalno (faza monoterapije). - djece u dobi od 3 godine i starije te u odraslih bolesnika sa specifičnim oblikom tumora mozga (npr. multiformni glioblastom ili anaplastični astrocitom) kada se tumor ponovno pojavio ili se širi nakon standardne terapije.
English: Impotence
Croatian: OBLIK
English: • shingles, flu-like symptoms
Croatian: • herpes zoster, simptomi slični gripi
English: EU/1/10/615/022
Croatian: EU/1/10/615/021 EU/1/10/615/022
English: Malignancies
Croatian: FARMACEUTSKI
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakiranje
English: Always take this medicine exactly as your doctor has told you to.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik.
English: After 2−4 weeks, your doctor may increase the dose to get the right effect.
Croatian: Nakon 2 - 4 tjedna, vaš liječnik može povećati dozu kako bi se postigao pravi učinak.
English: If you forget to take a dose, take it as soon as you remember unless it is nearly time (less than 6 hours) to take your next dose.
Croatian: Ako ste zaboravili uzeti dozu uzmite je čim se sjetite, osim ako uskoro (za manje od 6 sati) ne morate uzeti sljedeću dozu.
English: Other side effects you may experience include the following:
Croatian: Druge nuspojave koje možete osjetiti uključuju sljedeće:
English: Ranexa with food and drink
Croatian: Ranexa s hranom i pićem
English: No similar changes have been identified in humans.
Croatian: Slične promjene nisu uočene kod ljudi.
English: You must talk to a doctor if you do not feel better or if you feel worse.
Croatian: Obavezno se obratite liječniku ako se ne osjećate bolje ili ako se osjećate lošije.
English: If you cannot contact your doctor, go to the nearest accident and emergency department.
Croatian: Ako ne možete kontaktirati svog liječnika obratite se najbližem odjelu hitne pomoći.
English: Always swallow the tablets whole with water.
Croatian: Uvijek progutajte cijele tablete s vodom.
English: 24041 Brembate (BG) Italy or
Croatian: 24041 Brembate (BG) Italija ili
English: If you take more Ranexa than you should
Croatian: Ako uzmete više Ranexe nego što ste trebali
English: Date of last renewal: 06 March 2013
Croatian: Datum posljednje obnove odobrenja: 06. ožujka 2013.
English: Less than 5% of the dose is excreted unchanged in the urine and faeces.
Croatian: Manje od 5% doze izlučuje se nepromijenjeno u urinu i stolici.
English: Additionally, 45% of the study population also received long-acting nitrates.
Croatian: Pored toga, 45% ispitanika također je primalo nitrate dugog djelovanja.
English: These medicines may cause muscle pain and muscle injury.
Croatian: Ti lijekovi mogu uzrokovati mišićnu bol i ozljedu mišića.
English: An updated RMP shall be submitted every three years.
Croatian: Dopunjeni RMP podnosi se svake tri godine.
English: They may be taken with or without food.
Croatian: Mogu se uzeti uz hranu ili bez nje.
English: This leaflet was last revised in
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: Depending on the tablet strength, the tablet coatings also contain:
Croatian: Ovisno o jačini tablete, ovojnice tableta sadrže i:
English: Blister pack: 5 years Bottle pack: 4 years
Croatian: Blister pakiranje: 5 godina Pakiranje u bočici: 4 godine
English: Do not crush, suck, or chew the tablets or break them in half, as this might affect the way the medicine is released from the tablets into your body.
Croatian: Tablete nemojte mrviti, cuclati, žvakati ili ih lomiti na pola jer bi to moglo utjecati na način na koji se lijek otpušta iz tablete u Vaše tijelo.
English: No special requirements
Croatian: Nema posebnih zahtjeva
English: The safety and efficacy of Ranexa in children below the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost Ranexe kod djece mlađe od 18 godina nije ustanovljena.
English: Ranexa can be taken with or without food.
Croatian: Ranexu možete uzimati sa ili bez hrane.
English: If you accidentally take too many Ranexa tablets or take a higher dose than recommended by your doctor, it is important that you tell your doctor at once.
Croatian: Ako slučajno uzmete previše tableta Ranexe ili uzmete veću dozu od one koju vam je propisao liječnik, važno je da o tome odmah obavijestite svog liječnika.
English: Do not chew.
Croatian: Ne žvakati.
English: Ranexa tablets should be swallowed whole and not crushed, broken, or chewed.
Croatian: Tablete Ranexa treba progutati cijele i ne smiju se drobiti, lomiti niti žvakati.
English: Your doctor may decide to give you a lower dose.
Croatian: Liječnik može odlučiti dati Vam manju dozu.
English: Lactose: This medicinal product contains lactose.
Croatian: Laktoza: Ovaj lijek sadrži laktozu.
English: In the event of overdose, the patient should be closely monitored and the treatment should be symptomatic and supportive.
Croatian: U slučaju predoziranja bolesnika treba pažljivo pratiti i liječenje treba biti simptomatsko i suportivno.
English: Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: If you experience these symptoms, do not drive or operate machinery until they have resolved completely.
Croatian: Ako osjetite navedene simptome nemojte upravljati vozilima ili strojevima sve dok ti simptomi u potpunosti ne nestanu.
English: In addition, an updated RMP should be submitted:
Croatian: Ažurirani RMP treba dostaviti:
English: If symptoms do not resolve after dose reduction, treatment should be discontinued.
Croatian: Ako simptomi ne nestanu nakon smanjenja doze, liječenje treba prekinuti.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A),AKO JE POTREBNO
English: Germany or
Croatian: Njemačka ili
English: In patients with a combination of these factors, additional exposure increases are expected.
Croatian: Kod bolesnika s kombinacijom ovih faktora može se očekivati dodatno povećana ekspozicija.
English: SN: {number}
Croatian: PC: {broj} SN: {broj} NN: {broj}
English: This colouring agent- may cause allergic reactions.
Croatian: Ovo bojilo može uzrokovati alergijske reakcije.
English: These effects do not depend upon changes in heart rate, blood pressure, or vasodilation.
Croatian: Ovi učinci ne ovise o promjenama brzine srčanih otkucaja, krvnog tlaka ili vazodilataciji.
English: While being treated with Ranexa, you should not drink grapefruit juice.
Croatian: Tijekom liječenja Ranexom nemojte piti sok od grejpa.
English: Менарини България” ЕООД тел.
Croatian: Менарини България” ЕООД
English: Elimination: Ranolazine is eliminated primarily by metabolism.
Croatian: Eliminacija: Ranolazin se prvenstveno eliminira metaboliziranjem.
English: Paediatric population: The pharmacokinetic parameters of ranolazine have not been studied in the paediatric population (< 18 years).
Croatian: Pedijatrijska populacija: Parametri farmakokinetike ranolazina nisu istraživani u pedijatrijskoj populaciji (< 18 godina).
English: No effect on the adreno-cortical axis was noted in humans.
Croatian: Nije primijećen učinak na adreno-kortikalnu os kod ljudi.
English: This effect is associated with increased plasma cholesterol concentrations.
Croatian: Ovaj učinak povezan je s povećanim koncentracijama kolesterola u plazmi.
English: Use in children and adolescents Children and adolescents under 18 years old should not take Ranexa.
Croatian: Djeca i adolescenti mlađi od 18 godina ne bi smjeli uzimati Ranexu.
English: Fourteen primary pathways have been identified of which O-demethylation and N-dealkylation are the most important.
Croatian: Identificirano je četrnaest primarnih puteva od kojih su najznačajniji O-demetilacija i N-dealkilacija.
English: Pregnancy You should not take Ranexa if you are pregnant unless your doctor has advised you to do so.
Croatian: Ne biste smjeli uzimati Ranexu ako ste trudni, osim ako Vam to nije preporučio liječnik.
English: Food does not affect the rate and extent of absorption of ranolazine.
Croatian: Hrana ne utječe na brzinu i opsežnost apsorpcije ranolazina.
English: Undesirable effects in patients receiving Ranexa are generally mild to moderate in severity and often develop within the first 2 weeks of treatment.
Croatian: Nuspojave kod bolesnika koji primaju Ranexu općenito su blage do umjerene i često se razvijaju tijekom prva 2 tjedna liječenja.
English: Therefore, digoxin levels should be monitored following initiation and termination of Ranexa therapy.
Croatian: Zbog toga treba pratiti razine digoksina nakon započinjanja i završetka liječenja Ranexom.
English: Caution should be exercised when prescribing or uptitrating ranolazine to patients in whom an increased exposure is expected:
Croatian: Potreban je oprez kod propisivanja ili povećavanja doze ranolazina bolesnicima kod kojih se očekuje povećana ekspozicija:
English: Ranolazine is a substrate for P-gp.
Croatian: Ranolazin je supstrat za P-gp.
English: Take along any tablets that are left, including the container and the carton, so that the hospital staff can easily tell what you have taken.
Croatian: Sa sobom ponesite preostale tablete, uključujući unutarnje i vanjsko pakiranje, kako bi bolnički djelatnici mogli lako utvrditi što ste uzeli.
English: No studies on the effects of Ranexa on the ability to drive and use machines have been performed.
Croatian: Nisu provođena ispitivanja utjecaja Ranexe na sposobnost upravljanja vozilima i strojevima.
English: There are no data in patients with severe hepatic impairment.
Croatian: Ne postoje podaci za bolesnike s teškim oštećenjem jetrene funkcije.
English: The adverse event profile was generally similar in the MERLIN-TIMI 36 study.
Croatian: Profil nuspojava općenito je bio sličan u ispitivanju MERLIN-TIMI 36.
English: Ranexa should not be used during pregnancy unless clearly necessary.
Croatian: Ranexa se ne bi smjela primjenjivati tijekom trudnoće osim ako nije neophodno.
English: Gender effects: Gender had no clinically relevant effect on pharmacokinetic parameters.
Croatian: Utjecaj spola: Spol nije imao klinički relevantan utjecaj na farmakokinetičke parametre.
English: What RANEXA is and what is used for
Croatian: Što je RANEXA i za što se koristi
English: A large number of metabolites has been identified in human plasma (47 metabolites), urine (> 100 metabolites), and faeces (25 metabolites).
Croatian: Velik broj metabolita identificiran je u humanoj plazmi (47 metabolita), urinu (> 100 metabolita) i stolici (25 metabolita).
English: Ranexa exposure increases more than in proportion to dose.
Croatian: Ekspozicija Ranexi povećava se više nego proporcionalno dozi.
English: Rare: hyponatremia
Croatian: Rijetko: hiponatremija
English: Ask your doctor for advice about driving or using machines.
Croatian: Obratite se svom liječniku za savjet prije upravljanja vozilima ili strojevima.
English: Your doctor may lower your dose or, if this is not sufficient, stop treatment with Ranexa.
Croatian: Liječnik Vam može smanjiti dozu ili, ako to nije dovoljno, prekinuti liječenje Ranexom.
English: Excipients: Each tablet contains 0.04 mg azo colouring agent E102 and 12.0 mg lactose monohydrate.
Croatian: Pomoćne tvari: svaka tableta sadrži 0,04 mg azo bojila E102 i 12,0 mg laktoza hidrata.
English: Azo colouring agent E102: This medicinal product contains the azo colouring agent E102 which may cause allergic reactions.
Croatian: Azo bojilo E102: Ovaj lijek sadrži azo bojilo E102 koje može izazvati alergijske reakcije.
English: Ranexa is supplied in cartons containing 30, 60, or 100 tablets in blister strips or 60 tablets in plastic bottles.
Croatian: Ranexa je dostupna u kutijama koje sadrže 30, 60 ili 100 tableta u blisterima ili 60 tableta u plastičnoj bočici.
English: For the full list of excipients see section 6.1.
Croatian: Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: Your doctor may decide to change the dose of this medicine while you are taking Ranexa.
Croatian: Liječnik može odlučiti promijeniti dozu tog lijeka dok uzimate Ranexu.
English: In the main dose-finding study, MARISA, ranolazine was used as monotherapy.
Croatian: U glavnom istraživanju provedenom radi određivanja doze, MARISA, ranolazin je korišten kao monoterapija.
English: Elderly patients: Age alone had no clinically relevant effect on pharmacokinetic parameters.
Croatian: Stariji bolesnici: Sama životna dob nije imala klinički relevantan učinak na farmakokinetičke parametre.
English: Biotransformation: Ranolazine undergoes rapid and extensive metabolism.
Croatian: Biotransformacija: Ranolazin je podložan brzom i opsežnom metaboliziranju.
English: Ranexa is a medicine used in combination with other medicines to treat angina pectoris, which is a chest pain or discomfort that you feel anywhere along the upper part of your body between your neck and upper abdomen, often brought on by exercise or too much activity.
Croatian: Ranexa je lijek koji se koristi u kombinaciji s drugim lijekovima za liječenje angine pektoris, što je bol u prsištu ili nelagoda koju osjećate bilo gdje u gornjem dijelu tijela između vrata i gornjeg dijela trbuha, a koja se često pojavljuje prilikom vježbanja ili prevelike aktivnosti.
English: Available pharmacodynamic/toxicological data in rats have shown excretion of ranolazine in milk (for details see Section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u štakora pokazali su da se ranolazin izlučuje u mlijeko (za detalje vidjeti dio 5.3).
English: Using other medicines and Ranexa
Croatian: Uzimanje drugih lijekova i Ranexe
English: In long-term carcinogenicity studies at doses of ranolazine up to 50 mg/kg/day (150 mg/m 2/day) in mice and 150 mg/kg/day (900 mg/m2/day) in rats, no relevant increases in the incidence of any tumour types were seen.
Croatian: U dugotrajnim ispitivanjima karcinogenosti kod doza ranolazina do 50 mg/kg/dnevno (150 mg/m2/dnevno) kod miševa i 150 mg/kg/dnevno (900 mg/m2/dnevno) kod štakora nije uočeno značajno povećanje incidencije bilo koje vrste tumora.
English: The potential for inhibition of CYP2B6 has not been evaluated.
Croatian: Moguća inhibicija CYP2B6 nije procjenjivana.
English: However, there was no difference in exercise duration between the two doses (24 seconds compared to placebo; p ≤ 0.03).
Croatian: Međutim, između dvije doze Ranexe nije bilo razlike u trajanju opterećenja (24 sekunde u odnosu na placebo; p ≤ 0,03).
English: Tissue distribution of drugs which are transported by P-gp may be increased.
Croatian: Distribucija u tkivima lijekova koji se prenose Pgp-om može biti povećana.
English: • hives or difficulty breathing
Croatian: • urtikarija ili poteškoće s disanjem
English: Both the average number of angina attacks and nitroglycerin tablets consumed decreased by approximately one per week.
Croatian: Prosječni broj napadaja angine pektoris i broj korištenih tableta nitroglicerina smanjio se za oko jedan tjedno.
English: The effect of ranolazine on human fertility is unknown.
Croatian: Učinak ranolazina na plodnost čovjeka nije poznat.
English: Adverse reactions not observed in clinical studies, but seen in animals at levels similar to clinical exposure, were as follows: Ranolazine was associated with convulsions and increased mortality in rats and dogs at plasma concentrations approximately 3-fold higher than at the proposed maximum clinical dose.
Croatian: Nuspojave koje nisu uočene u kliničkim istraživanjima, ali su uočene na životinjama kod koncentracija sličnih kliničkoj ekspoziciji bile su sljedeće: ranolazin je povezan s konvulzijama i povećanom smrtnosti kod štakora i pasa kod koncentracija u plazmi oko 3 puta većih od predložene maksimalne kliničke doze.
English: What you need to know before you take RANEXA
Croatian: Što morate znati prije nego počnete uzimati Ranexu
English: These doses are equivalent to 0.1 and 0.8 times, respectively, the maximum recommended human dose of 2 grams on a mg/m basis, and represent the maximum tolerated doses in these species.
Croatian: Te su doze ekvivalentne 0,1 odnosno 0,8 puta maksimalnoj preporučenoj dozi kod ljudi od 2 grama na mg/m2 i predstavljaju maksimalnu toleriranu dozu kod tih vrsta.
English: No adverse effects on newborn rats were observed at levels of exposures similar to those observed in humans.
Croatian: Nisu primijećeni štetni učinci na novorođene štakore pri razini izloženosti sličnoj kao kod ljudi.
English: If you forget to take Ranexa
Croatian: Ako ste zaboravili uzeti Ranexu
English: Studies in animals showed embryo toxicity (see Section 5.3).
Croatian: Ispitivanja na životinjama pokazala su embriotoksičnost (vidjeti dio 5.3).
English: C]-ranolazine to healthy subjects, 73% of the radioactivity was recovered in urine and 25% in faeces.
Croatian: [14C]-ranolazina kod zdravih ispitanika, 73% radioaktivnosti pronađeno je u urinu, a 25% u stolici.
English: Rare: elevated levels of hepatic enzyme.
Croatian: Rijetko: povišene vrijednosti jetrenih enzima.
English: Rare: disorientation.
Croatian: Rijetko: dezorijentiranost.
English: - heart medicines containing digoxin or metoprolol, as your doctor may want to change the dose of this medicine whilst you are taking Ranexa.
Croatian: - lijekove za srce koji sadrže digoksin ili metoprolol, budući da liječnik može odlučiti promijeniti dozu tih lijekova dok uzimate Ranexu.
English: After 2-4 weeks, the dose should be titrated to 500 mg twice daily and, according to the patient's response, further titrated to a recommended maximum dose of 750 mg twice daily (see section 5.1).
Croatian: Nakon 2-4 tjedna, dozu treba postupno povećavati na 500 mg dvaput dnevno i, ovisno o bolesnikovom odgovoru, postupno ju dalje povećavati do maksimalne doze od 750 mg dvaput dnevno (vidjeti dio 5.1).
English: Clinical efficacy and safety: Clinical studies have demonstrated the efficacy and safety of Ranexa in the treatment of patients with chronic angina, either alone or when the benefit from other antianginal medicinal products was sub-optimal.
Croatian: Klinička djelotvornost i sigurnost: Klinička ispitivanja su pokazala djelotvornost i sigurnost Ranexe u liječenju bolesnika s kroničnom anginom pektoris, bilo kao jedinog lijeka ili kad je korist od drugih lijekova protiv angine pektoris bila manja od optimalne.
English: Approximately one-half of the patients in MERLIN-TIMI 36 had a history of angina.
Croatian: Oko polovice bolesnika u istraživanju MERLIN-TIMI 36 imalo je anginu pektoris u anamnezi.