FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of all cause mortality, CV death or major adverse cardiovascular events (MACE) and heart failure hospitalisation was similar between treatment groups in the overall population; however, MACE were reported more frequently in patients ≥ 75 years treated with ranolazine compared with placebo (17.0% vs 11.3%, respectively); in addition there was a numerical increase in all cause mortality in patients ≥ 75 years (9.2% vs. 5.1%, p = 0.074).
Slovenian: Tveganje za umrljivost zaradi vseh vzrokov, srčno-žilno umrljivost ali pomembne neželene kardiovaskularne dogodke (MACE - major adverse cardiovascular events) in hospitalizacijo zaradi srčnega popuščanja, je bilo podobno med zdravljenimi skupinami celotne populacije; vendar so bili pomembni neželeni kardiovaskularni dogodki (MACE) poročani bolj pogosto pri bolnikih starih ≥ 75 let, ki so se zdravili z ranolazinom kot v placebo skupini (17,0% oziroma 11,3%).
English: In a large outcome study (MERLIN-TIMI 36) in 6,560 patients with UA/NSTEMI ACS, there was no difference between Ranexa and placebo in the risk of all-cause mortality (relative risk ranolazine:placebo 0.99), sudden cardiac death (relative risk ranolazine:placebo 0.87), or the frequency of symptomatic documented arrhythmias (3.0% versus 3.1%).
Slovenian: V veliki študiji izida (MERLIN-TIMI 36), v kateri je sodelovalo 6560 bolnikov z akutnim koronarnim sindromom z nestabilno angino/infarktom miokarda brez povečanja intervala ST (unstable angina/nonST-elevation myocardial infarction acute coronary syndrome- UA/NSTEMI ACS), med zdravilom Ranexa in placebom ni bilo razlike pri tveganju za umrljivost zaradi vseh vzrokov (relativno tveganje ranolazin : placebo 0,99), nenadno srčno smrt (relativno tveganje ranolazin : placebo 0,87) ali pogostnost dokumentiranih simptomatskih aritmij (3,0% v primerjavi 3,1%).
English: The 375 mg tablets are pale blue and are engraved with 375 on one side.
Slovenian: 375-miligramske tablete so bledo modre z vtisnjenim napisom 375 na eni strani.
English: If you get any any side effects talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Light orange oval-shaped tablet engraved with 500 on one side.
Slovenian: Svetlo oranžne ovalne tablete z vtisnjenim napisom 500 na eni strani.
English: The potent CYP2D6 inhibitor paroxetine, at a dose of 20 mg once daily, increased steady-state plasma concentrations of ranolazine 1000 mg twice daily by an average of 1.2-fold.
Slovenian: Paroksetin, močan zaviralec encima CYP2D6, je pri odmerku 20 mg na dan povečal koncentracijo ranolazina v plazmi v stanju dinamičnega ravnovesja pri odmerku 1000 mg dvakrat na dan za približno 1,2-krat.
English: AUTHORISATION
Slovenian: Κύπρος
English: Inhibitors of P-gp (e.g. ciclosporin, verapamil) increase plasma levels of ranolazine.
Slovenian: Zaviralci P-gp (npr. ciklosporin, verapamil) zvišajo koncentracijo ranolazina v plazmi.
English: The 500 mg tablets are light orange and are engraved with 500 on one side.
Slovenian: 500-miligramske tablete so svetlo oranžne z vtisnjenim napisom 500 na eni strani.
English: Renal impairment: Careful dose titration is recommended in patients with mild to moderate renal impairment (creatinine clearance 30-80 ml/min) (see sections 4.4, 4.8, and 5.2).
Slovenian: Ledvična okvara: Pri bolnikih z blago do zmerno ledvično okvaro (kreatininski očistek 30-80 ml/min) je priporočeno previdno titriranje odmerka (glejte poglavja 4.4, 4.8 in 5.2).
English: Concomitant treatment with CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended in patients treated with moderate CYP3A4 inhibitors (e.g. diltiazem, fluconazole, erythromycin) or P-gp inhibitors (e.g. verapamil, ciclosporin) (see sections 4.4 and 4.5).
Slovenian: Sočasno zdravljenje z zaviralci encima CYP3A4 in glikoproteina P (P-gp): Pri bolnikih, ki jemljejo zmerne zaviralce encima CYP3A4 (npr. diltiazem, flukonazol in eritromicin) ali zaviralce P-gp (npr. verapamil, ciklosporin), je priporočeno previdno titriranje odmerka (glejte poglavji 4.4 in 4.5).
English: PVC/PVDC/Aluminium blisters of 15 or 20 tablets per blister card. Each carton contains 2, 3, or 5 blister cards (30, 60, or 100 tablets) or one HDPE bottle containing 60 tablets.
Slovenian: Ena škatla vsebuje 2, 3 ali 5 ploščic (30, 60 ali 100 tablet) ali eno plastenko iz HDPE, ki vsebuje 60 tablet.
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.
Slovenian: Hemodinamični učinki: Pri bolnikih, ki so jih v nadzorovanih študijah zdravili samo z ranolazinom ali v kombinaciji z drugimi antianginoznimi zdravili, so opazili majhno zmanjšanje povprečne hitrosti srčnega utripa (< 2 utripa/minuto) in povprečnega sistoličnega krvnega tlaka (< 3 mm Hg).
English: Severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.2 and 5.2).
Slovenian: Huda ledvična okvara (kreatininski očistek < 30 ml/min) (glejte poglavji 4.2 in 5.2).
English: - certain medicines used to prevent transplanted organ rejection (e.g. tacrolimus, ciclosporin, sirolimus, everolimus) as your doctor may decide to change the dose of this medicine while you are taking Ranexa.
Slovenian: Vaš zdravnik se bo morda odločil spremeniti odmerek teh zdravil med jemanjem zdravila Ranexa; - nekatera zdravila za preprečevanje zavrnitve presadka (npr. takrolimus, ciklosporin, sirolimus, everolimus), saj se lahko vaš zdravnik odloči spremeniti odmerek teh zdravil med jemanjem zdravila Ranexa.
English: Laboratory findings: Small, clinically insignificant, reversible elevations in serum creatinine levels have been observed in healthy subjects and patients treated with Ranexa.
Slovenian: Laboratorijski rezultati: Pri zdravih osebah in bolnikih, ki so jih zdravili z zdravilom Ranexa, so opazili majhno, klinično nepomembno, reverzibilno zvišanje ravni serumskega kreatinina.
English: INFORMATION IN BRAILLE Ranexa 500 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ranexa 500 mg
English: Dose limitation of atorvastatin and appropriate clinical monitoring may be considered when taking Ranexa.
Slovenian: Morda bo pri jemanju zdravila Ranexa potrebno razmisliti o omejitvi odmerkov atorvastatina in ustreznem kliničnem nadzoru.
English: The improvement in exercise duration in women was about 33% of the improvement in men at the 1000 mg twice-daily dose level.
Slovenian: Pri odmerku 1000 mg dvakrat na dan je bilo izboljšanje trajanja telesne vadbe pri ženskah približno 33 odstotkov v primerjavi z izboljšanjem pri moških.
English: The 750 mg tablets are pale green and are engraved with 750 on one side.
Slovenian: 750-miligramske tablete so bledo zelene z vtisnjenim napisom 750 na eni strani.
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.
Slovenian: Pri vseh odmerkih, ki so jih raziskovali, je bilo zdravilo Ranexa pomembno učinkovitejše od placeba pri podaljšanju časa telesne vadbe, časa do angine in časa do 1-milimetrske depresije spojnice ST, opazili pa so tudi razmerje med odmerkom in učinkom.
English: Five-hundred and sixty-five patients were randomised to receive an initial dose of Ranexa 500 mg twice daily or placebo for 1 week, followed by 6 weeks of treatment with Ranexa 1000 mg twice daily or placebo, in addition to concomitant treatment with amlodipine 10 mg once daily.
Slovenian: 565 bolnikov so naključno razporedili tako, da so ob sočasni uporabi 10 mg amlodipina enkrat na dan, en teden prejemali začetni odmerek zdravila Ranexa 500 mg dvakrat na dan ali placebo, nato pa 6 tednov 1000 mg zdravila Ranexa dvakrat na dan ali placebo.
English: Blue #2/Indigo Carmine Aluminium Lake (E132)
Slovenian: Modro aluminijevo barvilo indigotin št. 2 (E132)
English: Ranexa 375 mg prolonged-release tablets Ranexa 500 mg prolonged-release tablets Ranexa 750 mg prolonged-release tablets
Slovenian: Ranexa 375 mg tablete s podaljšanim sproščanjem Ranexa 500 mg tablete s podaljšanim sproščanjem Ranexa 750 mg tablete s podaljšanim sproščanjem ranolazin
English: Ranexa 750 mg prolonged-release tablets contain the azo colouring agent E102.
Slovenian: Zdravilo Ranexa 750-miligramske tablete s podaljšanim sproščanjem vsebujejo azo barvilo E102.
English: What Ranexa contains
Slovenian: Kaj vsebuje zdravilo Ranexa
English: (47 metabolites), urine (> 100 metabolites), and faeces (25 metabolites).
Slovenian: urinu ( 100 presnovkov) in blatu (25 presnovkov).
English: Ranexa should not be used in patients treated with CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort) (see section 4.5).
Slovenian: Zdravila Ranexa se ne sme uporabljati pri bolnikih, ki jemljejo spodbujevalce encima CYP3A4 (npr. rifampicin, fenitoin, fenobarbital, karbamazepin, šentjanževko) (glejte poglavje 4.5).
English: Rare: peripheral coldness, orthostatic hypotension.
Slovenian: Redki: hladne okončine, ortostatska hipotenzija.
English: Caution is advised during co-administration with CYP2B6 substrates (e.g. bupropion, efavirenz, cyclophosphamide).
Slovenian: Med sočasno uporabo substratov encima CYP2B6 (npr. bupropiona, efavirenza in ciklofosfamida) je priporočena previdnost.
English: Ranexa can be taken with or without food.
Slovenian: Zdravilo Ranexa skupaj s hrano, pijačo in alkoholom Zdravilo Ranexa se lahko jemlje s hrano ali brez nje.
English: Ranexa 750 mg twice daily increased plasma concentrations of metoprolol by 1.8-fold.
Slovenian: Jemanje zdravila Ranexa 750 mg dvakrat na dan je 1,8-krat povečalo plazemske koncentracije metoprolola.
English: Pale blue oval-shaped tablet engraved with 375 on one side.
Slovenian: Bledo modre ovalne tablete z vtisnjenim napisom 375 na eni strani.
English: INFORMATION IN BRAILLE Ranexa 375 mg
Slovenian: NAVODILA ZA UPORABO PODATKI V BRAILLOVI PISAVI Ranexa 375 mg
English: You should stop taking Ranexa and see your doctor immediately if you experience the following symptoms of angioedema, which is a rare condition but can be severe:
Slovenian: Če se pojavijo naslednji simptomi angioedema, ki je redko stanje, vendar je lahko resno, morate prenehati jemati zdravilo Ranexa in takoj obiskati zdravnika:
English: Low weight: The incidence of adverse events was higher in patients with low weight (≤ 60 kg).
Slovenian: Majhna telesna masa: Pri bolnikih z majhno telesno maso ( 60 kg) je bila pogostnost neželenih učinkov večja.
English: Respiratory, thoracic, and mediastinal disorders Uncommon: dyspnoea, cough, epistaxis.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni: dispneja, kašelj, epistaksa.
English: Ranexa may cause side effects such as dizziness (common), blurred vision (uncommon), confusional state (uncommon), hallucination (uncommon), double vision (uncommon), coordination problems
Slovenian: Zdravilo Ranexa lahko povzroči neželene učinke, kot sta omotica (pogosto), zamegljen vid (občasno), stanje zmedenosti (občasno), halucinacije (občasno), dvojni vid (občasno), težave v koordinaciji (redko), ki lahko vplivajo na sposobnost vožnje in upravljanja strojev.
English: MARKETING AUTHORISATION HOLDER Menarini International Operations Luxembourg S.A.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Menarini International Operations Luxembourg S.A.
English: Verapamil (120 mg three times daily) increases ranolazine steady-state concentrations 2.2-fold.
Slovenian: Verapamil (120 mg trikrat na dan) zviša koncentracijo ranolazina v stanju dinamičnega ravnovesja 2,2-krat.
English: In the population pharmacokinetic analysis, a 1.2-fold increase in ranolazine exposure was estimated in subjects with moderate impairment (creatinine clearance 40 ml/min).
Slovenian: V populacijski analizi farmakokinetike so pri osebah z zmerno okvaro (kreatininski očistek 40 ml/min) ocenili, da je povečanje izpostavljenosti ranolazinu 1,2-krat večje.
English: The following has also been reported:
Slovenian: Kaj vsebuje navodilo:
English: Blue #1/Brilliant Blue FCF Aluminium Lake (E133) and Yellow #5/Tartrazine Aluminium Lake (E102)
Slovenian: Modro aluminijevo barvilo FCF št.1 (E133) in rumeno aluminijevo barvilo tartrazin št. 5 (E102) 6.2 Inkompatibilnosti
English: Common: constipation, vomiting, nausea.
Slovenian: Pogosti: obstipacija, bruhanje, navzeja.
English: Hepatic impairment: Careful dose titration is recommended in patients with mild hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Jetrna okvara: Pri bolnikih z blago jetrno okvaro je priporočeno previdno titriranje odmerka (glejte poglavji 4.4 in 5.2).
English: You should not take Ranexa if you are breast-feeding.
Slovenian: Dojenje Zdravila Ranexa ne smete jemati, če dojite.
English: Pale green oval-shaped tablet engraved with 750 on one side.
Slovenian: Bledo zelene ovalne tablete z vtisnjenim napisom 750 na eni strani.
English: How to take Ranexa
Slovenian: Kako jemati zdravilo RANEXA
English: Eye disorders Uncommon: blurred vision, visual disturbance, diplopia.
Slovenian: Očesne bolezni Občasni: zamegljen vid, motnje vida, diplopija.
English: Uncommon: hot flush, hypotension.
Slovenian: Občasni: vročinski obliv, hipotenzija.
English: Electrocardiographic effects: Dose and plasma concentration-related increases in the QTc interval (about 6 msec at 1000 mg twice daily), reductions in T wave amplitude, and in some cases notched T waves, have been observed in patients treated with Ranexa.
Slovenian: Učinki na elektrokardiogram: Pri bolnikih, zdravljenih z zdravilom Ranexa, so opazili od odmerka in plazemske koncentracije odvisno povečanje intervala QTc (približno 6 ms pri odmerku 1000 mg dvakrat na dan), zmanjšanje amplitude vala T in v nekaterih primerih zarezane valove T. Učinki ranolazina na površinski elektrokardiogram so domnevno posledica zaviranja hitro uravnavanega kalijevega toka, ki podaljša akcijski potencial ventrikla in zaviranja poznega toka natrija, ki skrajša akcijski potencial ventrikla.
English: Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5).
Slovenian: Sočasna uporaba močnih zaviralcev encima CYP3A4 (npr. itrakonazola, ketokonazola, vorikonazola, posakonazola, zaviralcev proteaze virusa HIV, klaritromicina, telitromicina in nefazodona) (glejte poglavji 4.2 in 4.5).
English: Initiation of treatment with Ranexa should be avoided during administration of inducers of CYP3A4 (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort) (see section 4.4).
Slovenian: Uvedbi zdravljenja z zdravilom Ranexa se je treba izogibati med uporabo spodbujevalcev encima CYP3A4 (npr. rifampicina, fenitoina, fenobarbitala, karbamazepina in šentjanževke) (glejte poglavje 4.4).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of ranolazine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 500 mg ranolazina.
English: EU/1/08/462/005 60 tablets in blister pack EU/1/08/462/006 60 tablets in bottle EU/1/08/462/011 30 tablets in blister pack EU/1/08/462/012 100 tablets in blister pack
Slovenian: EU/1/08/462/005 60 tablet v pretisnem omotu EU/1/08/462/006 60 tablet v steklenici EU/1/08/462/011 30 tablet v pretisnem omotu EU/1/08/462/012 100 tablet v pretisnem omotu
English: • Mild hepatic impairment (see sections 4.2 and 5.2).
Slovenian: • Blaga jetrna okvara (glejte poglavji 4.2 in 5.2).
English: There was a large inter-individual variability in AUC in subjects with renal impairment.
Slovenian: Pri bolnikih z ledvično okvaro so bile razlike med vrednostmi AUC pri posameznikih velike.
English: Clinical evidence of inhibition of the late sodium current by ranolazine is provided by a significant shortening of the QTc interval and an improvement in diastolic relaxation in an open-label study of 5 patients with a long QT syndrome (LQT3 having the SCN5A ΔKPQ gene mutation).
Slovenian: V odprti študiji pri 5 bolnikih s sindromom dolgega intervala QT (bolniki z LQT3, ki so imeli mutacijo gena SCN5A ΔKPQ) sta klinični dokaz zaviranja poznega toka natrija, ki ga povzroči ranolazin, bila pomembno skrajšanje intervala QTc in izboljšanje diastolične relaksacije.
English: Polyvinyl alcohol-part hydrolyzed Iron oxide yellow (E172) Iron oxide red (E172) Talc
Slovenian: rumen (E 172), železov oksid, rdeč (E 172)
English: Combining ranolazine with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba močnih zaviralcev encima CYP3A4 (npr. itrakonazola, ketokonazola, vorikonazola, posakonazola, zaviralcev proteaze virusa HIV, klaritromicina, telitromicina in nefazodona) je kontraindicirana (glejte poglavje 4.3).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 375 mg of ranolazine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 375 mg ranolazina.
English: Rhabdomyolysis has been associated with high doses of simvastatin and cases of rhabdomyolysis have been observed in patients receiving Ranexa and simvastatin, in postmarketing experience.
Slovenian: Prav tako so v izkušnjah iz obdobja trženja bili opaženi primeri rabdomiolize pri bolnikih, ki prejemajo zdravilo Ranexa in simvastatin.
English: Common side effects (occur in 1 to 10 users in 100) are: Constipation
Slovenian: Pogosti neželeni učinki (pojavijo se pri 1 do 10 uporabnikov od 100) so: zaprtje; omotica; glavobol; slabost, bruhanje; šibkost.
English: C]-ranolazine to healthy subjects, 73% of the radioactivity was recovered in urine and 25% in faeces.
Slovenian: Pri zdravih prostovoljcih so po enkratnem, 500-miligramskem peroralnem odmerku [14C]-ranolazina 73% radioaktivnosti zaznali v urinu, 25 % pa v blatu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 750 mg of ranolazine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 750 mg ranolazina.
English: - if you are using certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazol, posaconazol), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).
Slovenian: Druga zdravila in zdravilo Ranexa Če uporabljate zdravilo Ranexa, ne uporabljajte naslednjih zdravil: - nekaterih zdravil za zdravljenje bakterijskih okužb (klaritromicina ali telitromicina), glivičnih okužb (itrakonazola, ketokonazola, vorikonazola ali posakonazola), okužbe z virusom HIV (zaviralcev proteaze), depresije (nefazodona) ali motenj srčnega ritma (npr. kinidina, dofetilida ali sotalola).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Menarini International O.L.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Menarini International O.L.S.A.
English: Posology Ranexa is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets.
Slovenian: Zdravilo Ranexa je na voljo v obliki 375-miligramskih, 500-miligramskih in 750-miligramskih tablet s podaljšanim sproščanjem.
English: Hypromellose
Slovenian: smukec
English: Marketing Authorisation Holder Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Slovenian: Imetnik dovoljenja za promet z zdravilom Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luksemburg
English: Limit the dose of simvastatin to 20 mg once daily in patients taking any dose of Ranexa.
Slovenian: Pri bolnikih, ki jemljejo kateri koli odmerek zdravila Ranexa, je potrebno omejiti odmerek simvastatina na 20 mg enkrat na dan.
English: MARKETING AUTHORISATION HOLDER Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luksemburg
English: INFORMATION IN BRAILLE Ranexa 750 mg
Slovenian: Ranexa 750 mg
English: Uncommon: increased blood creatinine, increased blood urea, prolonged QT corrected interval,
Slovenian: Občasni: zvišan kreatinin v krvi, zvišana sečnina v krvi, podaljšan interval QTc, povečano število trombocitov ali belih krvnih celic, zmanjšana telesna masa.
English: Grapefruit juice is also a potent CYP3A4 inhibitor.
Slovenian: Močan zaviralec encima CYP3A4 je tudi sok grenivke.
English: In addition to these adverse events, diplopia, lethargy, and syncope were observed in an intravenous overdose study in healthy volunteers.
Slovenian: V študiji prevelikega intravenskega odmerjanja pri zdravih prostovoljcih so poleg teh neželenih dogodkov opazili diplopijo, letargijo in sinkopo.
English: One-hundred and ninety-one patients were randomised to treatment with Ranexa 500 mg twice daily, 1000 mg twice daily, 1500 mg twice daily, and matching placebo, each for 1 week in a crossover design.
Slovenian: 191 bolnikov so naključno razporedili tako, da so v navzkrižno zasnovani študiji po en teden dvakrat na dan prejemali 500 mg, 1000 mg in 1500 mg ranolazina ali enakovreden placebo.
English: Careful dose titration of Ranexa is recommended in patients treated with P-gp inhibitors.
Slovenian: Pri bolnikih, ki jemljejo zaviralce P-gp je priporočljivo odmerek zdravila Ranexa titrirati previdno.
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.
Slovenian: Ne jemljite zdravila Ranexa - če ste alergični na ranolazin ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate hude težave z ledvicami; - če imate zmerne ali hude težave z jetri; - če uporabljate nekatera zdravila za zdravljenje bakterijskih okužb (klaritromicin ali telitromicin),
English: Inflammation of pancreas or intestine
Slovenian: Bolezni kože in podkožja
English: Ranexa is contraindicated in patients with moderate or severe hepatic impairment (see sections 4.3 and 5.2).
Slovenian: Pri bolnikih z zmerno ali hudo jetrno okvaro je uporaba zdravila Ranexa kontraindicirana (glejte poglavji 4.3 in 5.2).
English: A large number of metabolites has been identified in human plasma (47 metabolites), urine (> 100 metabolites), and faeces (25 metabolites).
Slovenian: Veliko presnovkov so odkrili v plazmi (47 presnovkov),
English: Methacrylic acid-ethyl acrylate copolymer (1:1) Microcrystalline cellulose
Slovenian: Pomožne snovi v vseh tabletah ranolazina s podaljšanim sproščanjem: karnauba vosek hipromeloza magnezijev stearat kopolimer metakrilne kisline in etilakrilata (1 : 1) mikrokristalna celuloza natrijev hidroksid titanov dioksid
English: EU/1/08/462/001 60 tablets in blister pack EU/1/08/462/002 60 tablets in bottle EU/1/08/462/007 30 tablets in blister pack EU/1/08/462/008 100 tablets in blister pack
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/462/001 60 tablet v pretisnem omotu EU/1/08/462/002 60 tablet v steklenici EU/1/08/462/007 30 tablet v pretisnem omotu EU/1/08/462/008 100 tablet v pretisnem omotu
English: NAME OF THE MEDICINAL PRODUCT Ranexa 375 mg prolonged-release tablets
Slovenian: IME ZDRAVILA Ranexa 375 mg tablete s podaljšanim sproščanjem
English: EU/1/08/462/003 60 tablets in blister pack EU/1/08/462/004 60 tablets in bottle EU/1/08/462/009 30 tablets in blister pack EU/1/08/462/010 100 tablets in blister pack
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/462/003 60 tablet v pretisnem omotu EU/1/08/462/004 60 tablet v steklenici EU/1/08/462/009 30 tablet v pretisnem omotu EU/1/08/462/010 100 tablet v pretisnem omotu
English: NAME OF THE MEDICINAL PRODUCT Ranexa 500 mg prolonged-release tablets
Slovenian: IME ZDRAVILA Ranexa 500 mg tablete s podaljšanim sproščanjem
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije