FrancophonIA/ELRC3.0 huggingface dataset:
English: Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000-fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Croatian: Valsartan ne iskazuje parcijalnu agonističku aktivnost na AT1 receptor te ima znatno veći afinitet za AT1 receptor (oko 20 000 puta) nego za AT2 receptor.
English: The antihypertensive effect of a single dose of the combination persisted for 24 hours.
Croatian: Antihipertenzivni učinak jednokratne doze kombinacije održan je tijekom 24 sata.
English: Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.
Croatian: Budući da nema učinka na ACE, ne pojačava djelovanje bradikinina ni supstance P, antagonisti angiotenzina II vrlo vjerojatno ne mogu biti povezani s kašljanjem.
English: PVC/PVDC perforated unit dose blisters.
Croatian: PVC/PVDC perforirani blisteri djeljivi na jedinične doze.
English: The safety of Dafiro has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Croatian: Sigurnost Dafira je ispitivana u pet kontroliranih kliničkih ispitivanja s 5175 bolesnika, od kojih je 2613 primalo valsartan u kombinaciji s amlodipinom.
English: If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.
Croatian: Ako bolesnici koji uzimaju amlodipin pate od omaglice, glavobolje, umora ili mučnine, njihova sposobnost reagiranja mogla bi biti narušena.
English: Biotransformation: Valsartan is not transformed to a high extent as only about 20% of dose is recovered as metabolites.
Croatian: Biotransformacija: Valsartan se ne transformira u većoj mjeri, budući da se svega 20% doze može naći u obliku metabolita.
English: Caution required with concomitant use
Croatian: Oprez potreban kod istodobne primjene
English: This may involve itching, reddening of the skin or difficulty in breathing.
Croatian: To može uključivati svrbež, crvenilo kože ili teškoće pri disanju.
English: The safety and efficacy of amlodipine in hypertensive crisis have not been established.
Croatian: Sigurnost i djelotvornost amlodipina u hipertenzivnoj krizi nisu utvrđene.
English: Dafiro has not been studied in any patient population other than hypertension.
Croatian: Dafiro nije ispitivan ni u jednoj drugoj populaciji bolesnika, osim u bolesnika s hipertenzijom.
English: Reproductive toxicology
Croatian: Reproduktivna toksikologija
English: When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered.
Croatian: Kada je klinički opravdano, može se uzeti u obzir direktni prijelaz iz monoterapije na fiksnu kombinaciju doza.
English: Oedema peripheral
Croatian: Periferni edemi
English: The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Croatian: Kombinacija ovih lijekova ima dodatni antihipertenzivni učinak, čime u većoj mjeri snižava krvni tlak nego svaka od pojedinih komponenti samostalno.
English: Amlodipine (mg)
Croatian: Amlodipin (mg)
English: Interactions linked to valsartan
Croatian: Interakcije povezane s valsartanom
English: Liver function test abnormal, including blood bilirubin increase
Croatian: Poremećeni testovi jetrene funkcije, uključujući povišen bilirubin u krvi
English: Time to peak plasma amlodipine concentrations is similar in young and elderly patients.
Croatian: Vrijeme do postizanja vršnih koncentracija amlodipina u plazmi slično je u mladih i starijih bolesnika.
English: The effect of amlodipine on infants is unknown.
Croatian: Učinak amlodipina na dojenčad nije poznat.
English: 14 film-coated tablets.
Croatian: 14 filmom obloženih tableta.
English: (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Croatian: (u izračunima je korištena pretpostavka da je peroralna doza 320 mg/dan i da je tjelesna težina bolesnika 60 kg).
English: Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).
Croatian: Alergijska reakcija sa simptomima poput osipa, svrbeža, oticanja lica ili usnica ili jezika, teškoće pri disanju, niski krvni tlak (osjećaj nesvjestice, ošamućenost).
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Croatian: Ukoliko nastavak terapije AIIRA-om nije neophodan, bolesnice koje planiraju trudnoću treba prebaciti na alternativna antihipertenzivna liječenja koja imaju utvrđen sigurnosni profil za primjenu u trudnoći.
English: Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers.
Croatian: Reverzibilne biokemijske promjene u glavi spermija prijavljene su u nekih bolesnika liječenih blokatorima kalcijevih kanala.
English: These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.
Croatian: Ova sniženja krvnog tlaka nisu praćena značajnim promjenama srčane frekvencije ili razina katekolamina u plazmi kod kroničnog doziranja.
English: The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
Croatian: Kontraktilni procesi srčanog mišića i glatkog mišića krvnih žila ovise o kretanju izvanstaničnih iona kalcija u ove stanice kroz specifične ionske kanale.
English: If you get these symptoms, stop taking Dafiro and contact your doctor straight away.
Croatian: Ako dobijete ove simptome, prekinite uzimati Dafiro i odmah se javite svom liječniku.
English: Toxic Epidermal Necrolysis
Croatian: Toksična epidermalna nekroliza
English: Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
Croatian: Bolesnici s primarnim hiperaldosteronizmom se ne bi trebali liječiti antagonistom angiotenzina II valsartanom, jer njihova primarna bolest utječe na sustav renin-angiotenzin.
English: Alopecia
Croatian: Alopecija
English: Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function.
Croatian: Evaluacija bolesnika sa zatajivanjem srca ili poslije infarkta miokarda uvijek mora uključivati i procjenu funkcije bubrega.
English: As expected for a compound where renal clearance accounts for only 30% of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
Croatian: Kao što se i očekuje za lijek čiji bubrežni klirens iznosi samo 30% ukupnog klirensa iz plazme, nije uočena korelacija između funkcije bubrega i sistemske izloženosti valsartanu.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists, combinations; angiotensin II antagonists and calcium channel blockers, ATC code: C09DB01
Croatian: Farmakoterapijska skupina: Lijekovi koji djeluju na renin-angiotenzinski sustav, antagonisti angiotenzina II, kombinacije; antagonisti angiotenzina II i blokatori kalcijevih kanala, ATK oznaka: C09DB01
English: Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events.
Croatian: Nagli prekid liječenja valsartanom nije bio povezan s pojavom povratne hipertenzije ili drugih klinički štetnih događaja.
English: The safety of amlodipine in human pregnancy has not been established.
Croatian: Sigurnost amlodipina u ljudskoj trudnoći nije utvrđen.
English: • Severe hypotension.
Croatian: • Teška hipotenzija.
English: Co-administration of multiple doses of 10 mg amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Croatian: Istodobna primjena višestrukih doza od 10 mg amlodipina s 80 mg simvastatina rezultirala je povećanjem izloženosti simvastatinu za 77% u usporedbi sa samim simvastatinom.
English: The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.
Croatian: Poluvijek amlodipina je produljen i vrijednosti AUC-a su više u bolesnika s oštećenom jetrenom funkcijom; preporuke za doziranje nisu utvrđene.
English: There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human dose of 10 mg on a mg/m basis).
Croatian: Nije bilo učinka na plodnost štakora koji su primali amlodipin (mužjaci 64 dana i ženke 14 dana prije parenja) pri dozama od najviše 10 mg/kg/dan (8 puta* više od najviše preporučene doze za ljude od 10 mg izražene u mg/m2).
English: Not known Toxic Epidermal Necrolysis * mostly consistent with cholestasis
Croatian: Nepoznato Toksična epidermalna nekroliza * uglavnom upućuje na kolestazu
English: Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans.
Croatian: Amlodipin ne mijenja funkciju sinoatrijskog čvora ili atrioventrikularno provođenje u zdravih životinja ili ljudi.
English: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Croatian: Primjena antagonista angiotenzin II receptora (AIIRA) se ne preporučuje tijekom prvog tromjesečja trudnoće (vidjeti dio 4.4).
English: Abrupt withdrawal of Dafiro has not been associated with a rapid increase in blood pressure.
Croatian: Nagli prekid primjene Dafira nije bio povezan s naglim povišenjem krvnog tlaka.
English: This medicine may make you feel dizzy.
Croatian: Ovaj lijek može uzrokovati omaglicu.
English: Amlodipine can have mild or moderate influence on the ability to drive and use machines.
Croatian: Amlodipin može blago ili umjereno utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: This means that both of these substances help to stop the blood vessels tightening.
Croatian: To znači da oba ova lijeka pomažu u sprečavanju sužavanja krvnih žila.
English: Amlodipine and valsartan exhibit linear pharmacokinetics.
Croatian: Amlodipin i valsartan pokazuju linearnu farmakokinetiku.
English: To be taken into account with concomitant use
Croatian: Što treba uzeti u obzir kod istodobne primjene
English: For therapeutic doses of valsartan in humans, the hypertrophy of the renal juxtaglomerular cells does not seem to have any relevance.
Croatian: Kod terapijskih doza valsartana u ljudi čini se da hipertrofija jukstaglomerularnih bubrežnih stanica nema nikakav značaj.
English: • Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis).
Croatian: • Opstrukcija istisnog dijela lijevog ventrikula (npr. hipertrofična opstruktivna kardiomiopatija i aortalna stenoza visokog stupnja).
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere:
English: Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Croatian: Intravenski kalcijev glukonat može pomoći u poništavanju učinaka blokade kalcijevih kanala.
English: The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/m basis) was close to the maximum tolerated dose for mice but not for rats.
Croatian: Najviša doza (za miševe slična, a za štakore jednaka dvostrukoj,* najvišoj preporučenoj kliničkoj dozi od 10 mg izraženoj u mg/m2) bila je blizu najviše podnošljive doze za miševe, ali ne i za štakore.
English: No drug-drug interaction studies have been performed with Dafiro and other medicinal products.
Croatian: Nisu provedena ispitivanja interakcija među lijekovima s Dafirom i drugim lijekovima.
English: 70 film-coated tablets.
Croatian: 70 filmom obloženih tableta.
English: Valsartan is an orally active, potent and specific angiotensin II receptor antagonist.
Croatian: Valsartan je aktivan, potentan i specifičan antagonist angiotenzin II receptora pri peroralnoj primjeni.
English: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Croatian: Primjena antagonista angiotenzin II receptora (AIIRA - engl. angiotensin II receptor antagonists) ne smije se započeti tijekom trudnoće.
English: Amlodipine has been shown to pass into breast milk in small amounts.
Croatian: Pokazalo se da amlodipin prelazi u majčino mlijeko u malim količinama.
English: What you need to know before you take Dafiro
Croatian: Što morate znati prije nego počnete uzimati Dafiro
English: Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day showed no evidence of carcinogenicity.
Croatian: Štakori i miševi koji su dvije godine primali amlodipin s hranom u koncentracijama koje su prema izračunu osiguravale razine dnevnog doziranja od 0,5, 1,25 i 2,5 mg/kg/dan nisu pokazali nikakav dokaz karcinogenosti.
English: You can take Dafiro with or without food.
Croatian: Dafiro možete uzimati s hranom ili bez nje.
English: On average, in patients with mild to moderate chronic liver disease exposure (measured by AUC values) to valsartan is twice that found in healthy volunteers (matched by age, sex and weight).
Croatian: U bolesnika s blagom do umjerenom kroničnom bolešću jetre, izloženost (mjereno AUC vrijednostima) valsartanu u prosjeku je dva puta veća od one u zdravih dobrovoljaca (odgovarajuće uspoređenim s obzirom na dob, spol i težinu).
English: Patients with hepatic impairment have decreased clearance of amlodipine with resulting increase of approximately 40-60% in AUC.
Croatian: Bolesnici s oštećenjem jetre imaju smanjeni klirens amlodipina s posljedičnim povećanjem AUC-a za otprilike 40-60%.
English: Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Croatian: Osim toga, istodobna primjena antagonista angiotenzina II i NSAIL-a može dovesti do povećanog rizika od pogoršanja bubrežne funkcije i do povećanja kalija u serumu.
English: In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene.
Croatian: U životinja su opaženi letalna ventrikularna fibrilacija i kardiovaskularni kolaps povezani s hiperkalijemijom nakon primjene verapamila i intravenskog dantrolena.
English: All packs are available with standard blisters; the 56, 98 and 280 tablet packs are additionally available with perforated unit dose blisters.
Croatian: Sva pakiranja su dostupna sa standardnim blisterima; pakiranja s 56, 98 i 280 tableta su dodatno dostupna s perforiranim blisterima djeljivim na jedinične doze.
English: Dafiro is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Croatian: Dafiro je dostupan u pakiranjima koja sadrže 7, 14, 28, 30, 56, 90, 98 ili 280 tableta i u višestrukim pakiranjima koji sadrže 4 kutije, od kojih svaka sadrži 70 tableta, ili 20 kutija, od kojih svaka sadrži 14 tableta.
English: Multipack: 280 (4 packs of 70) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Croatian: Višestruko pakiranje: 280 (4 pakiranja od 70) filmom obloženih tableta Višestruko pakiranje: 280 (20 pakiranja od 14) filmom obloženih tableta
English: In rats, maternally toxic doses (600 mg/kg/day) during the last days of gestation and lactation led to lower survival, lower weight gain and delayed development (pinna detachment and ear-canal opening) in the offspring (see section 4.6).
Croatian: U štakora su doze pri kojima se javlja materinska toksičnost (600 mg/kg/dan) u posljednjim danima gestacije i laktacije dovele do nižeg preživljavanja, nižeg prinosa težine i odgođenog razvoja (odvojenost ušne školjke i otvaranje slušnog kanala) u mladunčadi (vidjeti dio 4.6).
English: As a result, the blood vessels relax and blood pressure is lowered.
Croatian: Rezultat toga je opuštanje krvnih žila i snižavanje krvnog tlaka.
English: Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
Croatian: Hrana smanjuje izloženost (mjereno pomoću AUC) valsartanu za oko 40% i vršnu koncentraciju u plazmi (Cmax) za oko 50%, premda su koncentracije valsartana u plazmi oko 8 h nakon doziranja slične u skupini koja je uzimala hranu i skupini koja je bila natašte.
English: Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Croatian: Eksperimentalni podaci ukazuju da se amlodipin veže i na dihidropiridinska i na ne-dihidropiridinska vezna mjesta.
English: Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure.
Croatian: Angiotenzin II se stvara u tijelu i dovodi do sužavanja krvnih žila te na taj način povećava krvni tlak.
English: Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Croatian: Amlodipin je ispitivan u bolesnika s kroničnom stabilnom anginom, vazospastičnom anginom i angiografski dokumentiranom bolešću koronarnih arterija.
English: • Haemodynamically unstable heart failure after acute myocardial infarction.
Croatian: • Hemodinamički nestabilno zatajivanje srca nakon akutnog infarkta miokarda.
English: The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/valsartan combination.
Croatian: Srednja vrijednost incidencije perifernih edema ravnomjerno raspoređena po svim dozama bila je 5,1% kod kombinacije amlodipin/valsartan.
English: Dafiro combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Croatian: Dafiro kombinira dva antihipertenzivna sastojka s komplementarnim mehanizmima kontrole krvnog tlaka u bolesnika s esencijalnom hipertenzijom: amlodipin pripada skupini kalcijevih antagonista, dok valsartan pripada skupini antagonista angiotenzina II.
English: Do not use this medicine after the expiry date which is stated on the carton and blister.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake EXP.
English: Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin.
Croatian: Valsartan ne inhibira ACE, poznat i kao kininaza II, koji pretvara angiotenzin I u angiotenzin II te razgrađuje bradikinin.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Croatian: Dojenčad čije su majke uzimale AIIRA-e treba pažljivo pratiti zbog hipotenzije (vidjeti dijelove 4.3 i
English: Erythema multiforme
Croatian: Multiformni eritrem
English: Reproductive studies in rats and mice have shown delayed date of delivery, prolonged duration of labour and decreased pup survival at dosages approximately 50 times greater than the maximum recommended dosage for humans based on mg/kg.
Croatian: Ispitivanja na reprodukciju štakora i miševa pokazala su odgodu okota, produljeno trajanje poroda i smanjeno preživljavanje mladunčadi pri dozama koje su otprilike 50 puta veće od najviše preporučene doze za ljude izražene u mg/kg.
English: Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Croatian: Zbog rizika od hiperkalijemije preporučuje se izbjegavati istodobnu primjenu blokatora kalcijevih kanala kao što je amlodipin u bolesnika podložnih na malignu hipertermiju i u zbrinjavanju maligne hipertermije.
English: Dafiro can be used with or without food.
Croatian: Dafiro se može primjenjivati s hranom ili bez nje.
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
Croatian: U bolesnika s blagim do umjerenim oštećenjem jetre, bez kolestaze, najviša preporučena doza valsartana je 80 mg.
English: Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.
Croatian: Često primjenjivani antihipertenzivni lijekovi (npr. alfa-blokatori, diuretici) i drugi lijekovi koji mogu uzrokovati hipotenzivne nuspojave (npr. triciklički antidepresivi, alfa-blokatori za liječenje benigne hiperplazije prostate) mogu povećati antihipertenzivni učinak ove kombinacije.
English: Dafiro tablets contain two substances called amlodipine and valsartan.
Croatian: Dafiro tablete sadrže dvije djelatne tvari koje se zovu amlodipin i valsartan.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Croatian: Kada se trudnoća utvrdi, liječenje AIIRA-om treba odmah prekinuti te ako je prikladno, započeti alternativnu terapiju (vidjeti dijelove 4.3 i 4.6).
English: Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
Croatian: Istodobna primjena inhibitora prijenosnika pohrane (rifampicin, ciklosporin) ili efluksnog prijenosnika (ritonavir) može povećati sistemsku izloženost valsartanu.
English: Valsartan is mostly eliminated unchanged via the bile.
Croatian: Valsartan se najvećim dijelom eliminira nepromijenjen putem žuči.
English: If hypotension occurs with Dafiro, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Croatian: Ako se uz Dafiro pojavi hipotenzija, bolesnika treba poleći na leđa i po potrebi, mu dati intravensku infuziju fiziološke otopine.
English: No information is available regarding the use of Dafiro during breast-feeding, therefore Dafiro is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Croatian: Budući da nisu dostupne informacije o primjeni Dafira tijekom dojenja, stoga se Dafiro tijekom dojenja ne preporučuje te se savjetuje alternativno liječenje s bolje utvrđenim sigurnosnim profilom tijekom dojenja, posebno kod dojenja novorođenčeta ili nedonoščeta.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan..
Croatian: Prijavljena su reverzibilna povećanja koncentracija litija u serumu i toksičnost tijekom istodobne primjene litija s inhibitorima angiotenzin konvertirajućeg enzima ili antagonistima receptora angiotenzina II, uključujući valsartan.
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Croatian: Ako je do izloženosti AIIRA-ima došlo od drugog tromjesečja trudnoće nadalje, preporučuje se ultrazvučni pregled funkcije bubrega i lubanje.