FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or pharmacist before you take Ranexa if you use: - certain medicines to treat a bacterial infection (erythromycin), or a fungal infection (fluconazole), a medicine used to prevent rejection of a transplanted organ (ciclosporin), or if you are taking some heart tablets such as diltiazem or verapamil.
Croatian: - određene lijekove za liječenje bakterijske infekcije (eritromicin) ili gljivične infekcije (flukonazol), lijek za sprječavanje odbacivanja presađenog organa (ciklosporin) ili ako uzimate neke tablete za srce kao što su diltiazem ili verapamil.
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.
Croatian: Petsto šezdeset pet bolesnika nasumce je odabrano da primaju početnu dozu Ranexe 500 mg dvaput dnevno ili placebo tijekom 1 tjedna, nakon čega je slijedilo 6
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: - If you get any side effects talk to your doctor.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
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%).
Croatian: U velikom istraživanju ishoda (MERLIN-TIMI 36) na 6560 bolesnika s nestabilnom anginom ili akutnim koronarnim sindromom bez elevacije ST-segmenta (NSTEMI), nije bilo razlike između Ranexe i placeba u pogledu mortaliteta svih uzroka (relativni rizik ranolazin:placebo 0,99), nagle srčane smrti (relativni rizik ranolazin:placebo 0,87) niti učestalosti simptomatski dokumentiranih aritmija (3,0% u odnosu na 3,1%).
English: Menarini Kft. Tel.: +36 23501301
Croatian: Tel.: +36 23501301
English: Pale green oval-shaped tablet engraved with 750 on one side.
Croatian: Blijedozelene ovalne tablete s utisnutim natpisom 750 s jedne strane.
English: Posology Ranexa is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets.
Croatian: Ranexa je dostupna u obliku tableta s produljenim oslobađanjem od 375 mg, 500 mg i 750 mg.
English: Limit the dose of simvastatin to 20 mg once daily in patients taking any dose of Ranexa.
Croatian: Kod bolesnika koji uzimaju bilo koju dozu Ranexe treba ograničiti dozu simvastatina na 20 mg jednom dnevno.
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).
Croatian: ≥75 godina liječenih ranolazinom u odnosu na placebo (17,0% u odnosu na 11,3%); dodatno, brojčano se povećala smrtnost od bilo kojeg uzroka kod bolesnika u dobi ≥75 godina (9,2% u odnosu na 5,1%), p=0,074).
English: Methacrylic acid-ethyl acrylate copolymer (1:1) Microcrystalline cellulose
Croatian: karnauba vosak hipromeloza magnezijev stearat metakrilatna kiselina/etilakrilat kopolimer (1:1)
English: • Mild hepatic impairment (see sections 4.2 and 5.2).
Croatian: • Kod blagog oštećenja jetrene funkcije (vidjeti dijelove 4.2 i 5.2).
English: There was a 2.5- to 3-fold increase in steady-state AUC as the dose was increased from 500 mg to 1000 mg twice daily.
Croatian: S povećanjem doze od 500 mg na 1000 mg dvaput dnevno, došlo je do povećanja AUC u stanju dinamičke ravnoteže od 2,5 do 3 puta.
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).
Croatian: Istodobna primjena s inhibitorima CYP3A4 i P-glikoproteina (P-gp): Preporučuje se pažljivo prilagođavanje doze kod bolesnika liječenih umjerenim inhibitorima CYP3A4 (npr. diltiazemom,
English: România Berlin-Chemie A. Menarini S.R.L.
Croatian: Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
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
Croatian: EU/1/08/462/007 30 tableta u blister pakiranju EU/1/08/462/008 100 tableta u blister pakiranju
English: T waves, have been observed in patients treated with Ranexa.
Croatian: Uočena je povećana incidencija štetnih događaja kod bolesnika liječenih ranolazinom u ispitivanju
English: Additional excipients for 375 mg tablet: Macrogol
Croatian: Dodatne pomoćne tvari u tabletama od 375 mg:
English: • Mild to moderate renal impairment (creatinine clearance 30-80 ml/min) (see sections 4.2, 4.8,
Croatian: • Kod blagog do umjerenog oštećenja funkcije bubrega (klirens kreatinina 30-80 ml/min)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 375 mg ranolazine.
Croatian: Jedna tableta s produljenim oslobađanjem sadržava 375 mg ranolazina.
English: NAME OF THE MEDICINAL PRODUCT Ranexa 500 mg prolonged-release tablets Ranolazine
Croatian: Ranexa 500 mg tablete s produljenim oslobađanjem ranolazin
English: NAME OF THE MEDICINAL PRODUCT Ranexa 750 mg prolonged-release tablets Ranolazine
Croatian: Ranexa 750 mg tablete s produljenim oslobađanjem ranolazin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 500 mg ranolazine.
Croatian: Jedna tableta s produljenim oslobađanjem sadržava 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
Croatian: EU/1/08/462/011 30 tableta u blister pakiranju EU/1/08/462/012 100 tableta u blister pakiranju
English: NAME OF THE MEDICINAL PRODUCT Ranexa 375 mg prolonged-release tablets Ranolazine
Croatian: Ranexa 375 mg tablete s produljenim oslobađanjem ranolazin
English: Dose limitation of other statins, metabolised by CYP3A4 (e.g. lovastatin), may be considered when taking Ranexa.
Croatian: Kod bolesnika koji uzimaju Ranexu treba razmotriti ograničenje doza drugih statina koji se metaboliziraju CYP3A4 enzimima (npr. lovastatin).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 750 mg ranolazine.
Croatian: Jedna tableta s produljenim oslobađanjem sadržava 750 mg ranolazina.
English: Do not use the following medicines if you take Ranexa: - certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections
Croatian: Nemojte uzimati sljedeće lijekove ako uzimate Ranexu: - određene lijekove za liječenje bakterijskih infekcija (klaritromicin, telitromicin), gljivičnih infekcija (itrakonazol, ketokonazol, vorikonazol, posakonazol), HIV infekcije (inhibitori proteaza), depresije (nefazodon) ili poremećaja srčanog ritma (npr. kinidin, dofetilid ili sotalol).
English: Additional excipients for 500 mg tablet: Macrogol
Croatian: Dodatne pomoćne tvari u tabletama od 500 mg:
English: Inflammation of pancreas or intestine
Croatian: Poremećaji kože i potkožnog tkiva
English: What Ranexa contains
Croatian: Kako Ranexa izgleda i sadržaj pakiranja
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).
Croatian: 1,2 puta kod ispitanika s umjerenim oštećenjem bubrega (klirens kreatinina 40 ml/min).
English: Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o Tel: +421 2 544 30 730
Croatian: Berlin-Chemie/A.Menarini Ceska republika s.r.o. Tel: +420 267 199 333
English: Dehydration
Croatian: Dojenje
English: NAME OF THE MEDICINAL PRODUCT Ranexa 750 mg prolonged-release tablets
Croatian: Ranexa 750 mg tablete s produljenim oslobađanjem
English: A lack of ability to urinate
Croatian: • poteškoće s gutanjem
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of ranolazine.
Croatian: Jedna tableta sadrži 500 mg ranolazina.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 750 mg of ranolazine.
Croatian: Jedna tableta sadrži 750 mg ranolazina.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 375 mg of ranolazine.
Croatian: Jedna tableta sadrži 375 mg ranolazina.
English: In addition to these adverse events, diplopia, lethargy, and syncope were observed in an intravenous overdose study in healthy volunteers.
Croatian: U intravenskom ispitivanju predoziranja kod zdravih dobrovoljaca, pored tih nuspojava uočena je diplopija, letargija i sinkopa.
English: NAME OF THE MEDICINAL PRODUCT Ranexa 500 mg prolonged-release tablets
Croatian: Ranexa 500 mg tablete s produljenim oslobađanjem
English: NAME OF THE MEDICINAL PRODUCT Ranexa 375 mg prolonged-release tablets
Croatian: Ranexa 375 mg tablete s produljenim oslobađanjem
English: Talk to your doctor before taking Ranexa: - if you have mild or moderate kidney problems.
Croatian: Obratite se svom liječniku prije nego počnete uzimati Ranexu:
English: In an oral high-dose tolerability study in angina patients, the incidence of dizziness, nausea, and vomiting increased in a dose-dependent manner.
Croatian: U istraživanju podnošljivosti visokih peroralno primijenjenih doza kod bolesnika od angine pektoris,
English: Skin and subcutaneous tissue disorders Uncommon: pruritus, hyperhydrosis.
Croatian: Manje često: pruritus, hiperhidroza.
English: C]-ranolazine.
Croatian: Često: astenija.
English: Lot
Croatian: Lietuva
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Tel: +39-055 56801
Croatian: Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39-055 56801
English: Ranexa may cause side effects such as dizziness (common), blurred vision (uncommon), confusional state (uncommon), hallucination (uncommon), double vision (uncommon), coordination problems
Croatian: konfuzno stanje (manje često), halucinacije (manje često), dvoslike (manje često), poteškoće s koordinacijom pokreta (rijetko) koje mogu utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors),
Croatian: (npr. itrakonazolom, ketokonazolom, vorikonazolom, posakonazolom, inhibitorima HIV proteaze, klaritromicinom, telitromicinom, nefazodonom) je kontraindicirana (vidjeti dio 4.3).
English: - if you are elderly.
Croatian: I DOHVATA DJECE
English: Many feel normal.
Croatian: Mnogi se osjećaju normalno.
English: if you are unable to produce urine (anuria).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: In some cases you may have to stop using one of the medicines.
Croatian: U nekim slučajevima ćete možda morati prekinuti uzimati jedan od lijekova.
English: Swallow the tablet whole with a glass of water.
Croatian: Progutajte cijelu tabletu s čašom vode.
English: It is best to take the tablet at the same time each day.
Croatian: Tabletu je najbolje uzeti svaki dan u isto vrijeme.
English: Talk to your doctor before drinking alcohol.
Croatian: Porazgovarajte sa svojim liječnikom prije konzumacije alkohola.
English: This is especially important if you are using any of the medicines listed below:
Croatian: To je posebno važno ako uzimate bilo koji od niže navedenih lijekova:
English: In other patients, one or the other effect may be dominant.
Croatian: U drugih bolesnika, jedan od ovih dvaju učinaka može biti dominantan.
English: antipsychotics, antiepileptics;
Croatian: antipsihotici, antiepileptici;
English: Shock (including cardiogenic shock).
Croatian: Šok (uključujući kardiogeni šok).
English: If you experience these symptoms, do not drive or use tools or machines.
Croatian: Ako osjetite ove simptome, nemojte voziti ni koristiti alate ili strojeve.
English: Other side effects may include:
Croatian: Ostale nuspojave mogu uključivati:
English: Always take this medicine, even if you are feeling well People who have high blood pressure often do not notice any signs of the problem.
Croatian: Redovito uzimajte ovaj lijek, čak i ako se osjećate dobro Osobe s povišenim krvnim tlakom često ne osjećaju bilo kakve znakove ovog problema.
English: Morning is the best time.
Croatian: Najbolje je to učiniti ujutro.
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Croatian: Postoji ograničeno iskustvo s hidroklorotiazidom tijekom trudnoće, posebno tijekom prvog tromjesečja.
English: • liver enzyme increase which may have an effect on some medical tests
Croatian: • povišeni jetreni enzimi što može imati učinak na neke medicinske testove
English: The clinical significance of this effect is uncertain and not sufficient to preclude their use.
Croatian: Klinički značaj tog učinka nije siguran i nije dostatan da bi se isključila njihova primjena.
English: If it is almost time for your next dose you should simply take the next tablet at the usual time.
Croatian: Ako je već blizu vrijeme za sljedeću dozu, jednostavno uzmite sljedeću tabletu u uobičajeno vrijeme.
English: If you forget to take a dose of this medicine, take it as soon as you remember and then take the next dose at its usual time.
Croatian: Ako zaboravite uzeti dozu ovog lijeka, uzmite ju čim se sjetite i zatim uzmite sljedeću dozu u uobičajeno vrijeme.
English: Volume of distribution is approximately 21 l/kg.
Croatian: Volumen distribucije je otprilike 21 l/kg.
English: The tablets should be swallowed whole with some water, at the same time of the day and preferably in the morning.
Croatian: Tablete treba progutati cijele s nešto vode, u isto doba dana, po mogućnosti ujutro.
English: • inability to achieve or maintain erection
Croatian: • nemogućnost postizanja ili održavanja erekcije
English: • increased need to urinate at night
Croatian: • pojačana potreba za mokrenjem noću
English: Alcohol, barbiturates or narcotics
Croatian: Alkohol, barbiturati ili narkotici
English: * See section 4.4 Photosensitivity ** Mostly consistent with cholestasis
Croatian: * Vidjeti dio 4.4 Fotosenzitivnost ** Uglavnom upućuje na kolestazu
English: Keep your appointments with the doctor even if you are feeling well.
Croatian: Obavljajte planirane posjete liječniku, čak i ako se osjećate dobro.
English: Very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000, not known (cannot be estimated from the available data).
Croatian: Vrlo često: ≥1/10; često: ≥1/100 i <1/10; manje često: ≥1/1000 i <1/100; rijetko: ≥1/10 000 i <1/1000; vrlo rijetko: <1/10 000, nepoznato (ne može se procijeniti iz dostupnih podataka).
English: It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects.
Croatian: Vrlo je važno da ovaj lijek uzimate točno onako kako Vam je rekao liječnik radi postizanja najboljih rezultata i smanjenja rizika od nuspojava.
English: This metabolite is pharmacologically inactive.
Croatian: Taj metabolit je farmakološki inaktivan.
English: • swelling of the tongue and throat which causes great difficulty breathing
Croatian: • oticanje jezika i grla koje uzrokuje velike teškoće pri disanju
English: Consult a doctor immediately if you experience any of the following serious side effects after taking this medicine:
Croatian: Odmah se javite liječniku ako osjetite bilo koju od sljedećih ozbiljnih nuspojava nakon uzimanja ovog lijeka:
English: Valsartan shows multiexponential decay kinetics (t½α <1 h and t½ß about 9 h).
Croatian: Valsartan pokazuje multieksponencijalnu kinetiku raspadanja (t½α <1 h i t½ß oko 9 h).
English: A total of 33,357 hypertensive patients aged 55 or older were randomised and followed for a mean of 4.9 years.
Croatian: Ukupno 33 357 hipertenzivnih bolesnika u dobi od 55 godina ili starijih randomizirano je u terapijske skupine i praćeno u prosjeku 4,9 godina.
English: if you suffer from aldosteronism.
Croatian: ako bolujete od aldosteronizma.
English: All of these substances help to control high blood pressure.
Croatian: Sve te tvari pomažu u kontroli povišenog krvnog tlaka.
English: Caution should be used with:
Croatian: Potreban je oprez s:
English: • increased sensitivity of skin to sun
Croatian: • povećana osjetljivost kože na sunce
English: if you experience a decrease in vision or eye pain.
Croatian: ako osjetite smanjenje vida ili bol u oku.
English: The apparent volume of distribution is 4-8 l/kg.
Croatian: Prividni volumen distribucije je 4-8 l/kg.
English: As for any combination containing three active substances, side effects associated with each individual component cannot be excluded.
Croatian: Kao za bilo koju kombinaciju koja sadrži tri djelatne tvari, nuspojave vezane za svaku pojedinačnu komponentu ne mogu se isključiti.
English: All these changes were reversible after a 4-week recovery period and were considered to be exaggerated pharmacological effects.
Croatian: Sve navedene promjene bile su reverzibilne nakon 4-tjednog razdoblja oporavka te ih se smatra pretjeranim farmakološkim učincima.
English: • lack of energy
Croatian: • nedostatak energije
English: if you suffer from a disease called systemic lupus erythematosus (also called “lupus” or “SLE”).
Croatian: ako bolujete od bolesti zvane sistemski eritematozni lupus (također zvana „lupus“ ili „SLE“).
English: Dafiro HCT with food, drink and alcohol
Croatian: Dafiro HCT s hranom, pićem i alkoholom
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Croatian: Epidemiološki dokaz rizika teratogenosti nakon izlaganja ACE-inhibitorima tijekom prvog tromjesečja trudnoće ne omogućuje zaključak; međutim, mali porast rizika se ne može isključiti.
English: Paediatric patients (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Croatian: Pedijatrijski bolesnici (ispod 18 godina starosti) Nisu dostupni farmakokinetički podaci u pedijatrijskoj populaciji.
English: Photosensitivity reaction*
Croatian: Fotosenzitivna reakcija *
English: Elderly people (age 65 years and older)
Croatian: Starije osobe (u dobi od 65 i više godina)
English: The most common signs and symptoms of overdose are nausea and somnolence.
Croatian: Najčešći znaci i simptomi predoziranja su mučnina i somnolencija.
English: There is no change in the kinetics of hydrochlorothiazide on repeated dosing, and accumulation is minimal when dosed once daily.
Croatian: Nema promjene u kinetici hidroklorotiazida pri ponovljenom doziranju, a akumulacija je minimalna kad se dozira jednom dnevno.
English: if you have diabetes (high level of sugar in your blood).
Croatian: ako imate šećernu bolest (visoku razinu šećera u krvi).
English: • dizziness on standing up or after exercising
Croatian: • omaglica pri ustajanju ili nakon vježbanja
English: Biotransformation Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites.
Croatian: Biotransformacija Amlodipin se u velikoj mjeri (otprilike 90%) metabolizira u jetri do inaktivnih metabolita.
English: • alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and other procedures);
Croatian: • alkoholom, tabletama za spavanje i anesteticima (lijekovi koji bolesnicima omogućuju podvrgavanje kirurškim i drugim zahvatima);
English: • inability to either stand or walk in a normal manner
Croatian: • nemogućnost ili stajanja ili hodanja na normalan način
English: Thus, only information on interactions with other medicinal products that are known for the individual active substances is provided in this section.
Croatian: Stoga su u ovom dijelu navedene samo one informacije o interakcijama koje su poznate za pojedinačne djelatne tvari.
English: • ACE inhibitors or aliskiren -(see also information under the headings “Do not take Dafiro HCT” and “Warnings and precautions”) .
Croatian: ACE inhibitori ili aliskiren (vidjeti također informacije pod naslovom „Nemojte uzimati Dafiro HCT“ i „Upozorenja i mjere opreza“).
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Croatian: Dok nema kontroliranih epidemioloških podataka o riziku s antagonistima angiotenzin II receptora (AIIRA), slični rizici mogu postojati i za ovu skupinu lijekova.
English: The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Croatian: Primarno liječenje je prekinuti primjenu hidroklorotiazida što je brže moguće.
English: Date of first authorisation: 04 November 2009 Date of latest renewal: 04 July 2014
Croatian: Datum posljednje obnove odobrenja: 04. rujan 2014.
English: Do not take Dafiro HCT if you are more than 3 months pregnant.
Croatian: Nemojte uzimati Dafiro HCT ako ste trudni više od 3 mjeseca.
English: The combination of these substances has an additive antihypertensive effect.
Croatian: Kombinacija ovih lijekova ima dodatni antihipertenzivni učinak.
English: Do not take together with: lithium (a medicine used to treat some types of depression); medicines or substances that increase the amount of potassium in your blood.
Croatian: Ne uzimajte zajedno s: litijem (lijek koji se koristi za liječenje nekih vrsta depresije); lijekovima ili tvarima koje povećavaju količinu kalija u krvi.
English: • spontaneous bleeding
Croatian: • spontano krvarenje
English: • muscle relaxants (medicines to relax the muscles which are used during operations);
Croatian: • mišićnim relaksansima (lijekovi koji se koriste za opuštanje mišića tijekom operacija);
English: Alcohol may make your blood pressure fall too much and/or increase the possibility of dizziness or fainting.
Croatian: Alkohol može prouzročiti pretjerani pad Vašeg krvnog tlaka i/ili povećati mogućnost pojave omaglice ili nesvjestice.
English: Systemic lupus erythematosus
Croatian: Sistemski eritemski lupus
English: As a result of all three mechanisms, the blood vessels relax and blood pressure is lowered.
Croatian: Kao rezultat sva tri mehanizma, krvne žile se opuštaju i krvni tlak je snižen.
English: Children and adolescents The use of Dafiro HCT in children and adolescents under 18 years of age is not recommended.
Croatian: Djeca i adolescenti Primjena Dafiro HCT-a u djece i adolescenata mlađih od 18 godina se ne preporučuje.
English: This medicine may make you feel dizzy, drowsy, nauseous or have a headache.
Croatian: Od ovog lijeka možete osjetiti omaglicu, pospanost, mučninu ili imati glavobolju.
English: Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
Croatian: Pokazano je da primjena aktivnog ugljena zdravim dobrovoljcima odmah nakon ili do dva sata nakon ingestije amlodipina značajno smanjuje apsorpciju amlodipina.
English: More than 95% of the absorbed dose is being excreted as unchanged compound in the urine.
Croatian: Više od 95% apsorbirane doze se izlučuje kao nepromijenjen lijek mokraćom.
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Croatian: U plazmi je nađen hidroksi-metabolit u niskoj koncentraciji (manje od 10% AUC valsartana).
English: Effect of the interaction with other medicinal products
Croatian: Učinak interakcije s drugim lijekovima