natgillin/translations-raw huggingface dataset:
Valsartan is primarily eliminated in faeces (about 83% of dose) and urine (about 13% of dose), mainly as unchanged drug. 
Valsartan se primarno eliminira stolicom (oko 83% doze) i mokraćom (oko 13% doze), uglavnom kao nepromijenjen lijek.
The safety and efficacy of Dafiro in children aged below 18 years have not been established. 
Sigurnost i djelotvornost Dafira u djece u dobi ispod 18 godina nisu ustanovljene.
If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Dafiro. 
Ako se diuretik također koristi, rizik od toksičnosti litija vjerojatno se može povećati i više s Dafirom.
Some side effects can be serious and need immediate medical attention: 
Neke nuspojave mogu biti ozbiljne i zahtijevati neodgodivo liječenje:
In vitro studies with amlodipine have shown that approximately 97.5% of circulating drug is bound to plasma proteins. 
In vitro ispitivanja s amlodipinom pokazala su da se u otprilike 97,5% cirkulirajućeg lijeka veže na proteine plazme.
You must tell your doctor if you think you are (or might become) pregnant. 
Morate obavijestiti svog liječnika ako mislite da ste (ili biste mogli postati) trudni.
Thrombocytopenia, sometimes with purpura 
Trombocitopenija, ponekad s purpurom
Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported. 
Prijavljena je izražena i potencijalno produljena sistemska hipotenzija uključujući šok sa smrtnim ishodom.
This reduction in AUC is not, however, accompanied by a clinically significant reduction in the therapeutic effect, and valsartan can therefore be given either with or without food. 
Međutim, to smanjenje AUC-a nije praćeno klinički značajnim smanjenjem terapijskog učinka, te se stoga valsartan može davati s hranom ili bez nje.
The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3-7%, with a maximum of 15%. 
Procijenjen je udio majčine doze koju primi dojenče, i njegov interkvartilni raspon iznosio je od 3 - 7 %, uz maksimum od 15 %.
It is recommended to limit the dose of simvastatin to 20 mg daily in patients on amlodipine. 
Preporučuje se ograničiti dozu simvastatina na 20 mg dnevno u bolesnika na amlodipinu.
Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. 
Valsartan se ne veže niti blokira druge hormonske receptore ili ionske kanale, za koje se zna da su važni u kardiovaskularnoj regulaciji.
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. 
Dok nema kontroliranih epidemioloških podataka o riziku s antagonistima receptora angiotenzina II (AIIRA), slični rizici mogu postojati i za ovu skupinu lijekova.
Consult a doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine: - Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing. 
Odmah se javite liječniku ako osjetite bilo koju od sljedećih vrlo rijetkih, teških nuspojava nakon uzimanja ovog lijeka: - Iznenadno piskanje pri disanju, bol u prsima, nedostatak zraka ili teškoće pri disanju.
Primary hyperaldosteronism 
Primarni hiperaldosteronizam
A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC). 
U plazmi je identificiran hidroksi-metabolit u niskoj koncentraciji (manje od 10% AUC valsartana).
Do not take Dafiro with grapefruit or grapefruit juice. 
Ne uzimajte Dafiro s grejpom ili sokom od grejpa.
Dry mouth 
Suha usta
Do not stop taking your medicine unless your doctor tells you to. 
Nemojte prestati uzimati lijek osim po uputi liječnika.
* Based on patient weight of 50 kg 
* na temelju tjelesne težine bolesnika od 50 kg Valsartan
if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors). 
ako ste uočili pojavu oticanja, osobito lica i grla, dok ste uzimali druge lijekove (uključujući inhibitore angiotenzin konvertirajućeg enzima).
Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient. 
Stoga se preporučuje praćenje bubrežne funkcije na početku liječenja, kao i odgovarajuća hidracija bolesnika.
Correction of this condition prior to administration of Dafiro or close medical supervision at the start of treatment is recommended. 
Preporučuje se korigiranje ovog stanja prije primjene Dafira ili pažljiv liječnički nadzor na početku liječenja.
Plasma concentrations correlate with effect in both young and elderly patients. 
Koncentracije u plazmi koreliraju s učinkom i u mladih i u starijih bolesnika.
if you have a condition affecting the renal glands called “primary hyperaldosteronism”. 
ako bolujete od stanja koje utječe na nadbubrežne žlijezde, a naziva se „primarni hiperaldosteronizam“.
Both of these substances help to control high blood pressure. 
Obje tvari pomažu u kontroli povišenog krvnog tlaka.
Adverse reactions have been ranked under headings of frequency using the following convention: 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). 
Nuspojave su podijeljene prema učestalosti koja se definira kao: 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 podatka).
All changes were considered to be caused by the pharmacological action of valsartan which produces prolonged hypotension, particularly in marmosets. 
Za sve se promjene smatralo da ih je uzrokovalo farmakološko djelovanje valsartana koji stvara produljenu hipotenziju, osobito u marmoseta.
Valsartan works by blocking the effect of angiotensin II. 
Valsartan djeluje tako što blokira učinak angiotenzina II.
To date there is no experience of the safe use of Dafiro in patients who have had a recent kidney transplantation. 
Do danas ne postoji iskustvo o sigurnoj primjeni Dafira u bolesnika kojima je nedavno transplantiran bubreg.
During repeated administration, the maximum reduction in blood pressure with any dose is generally attained within 2-4 weeks and is sustained during long-term therapy. 
Tijekom ponovljene primjene, maksimalno se sniženje krvnog tlaka s bilo kojom dozom općenito se postiže unutar 2-4 tjedna te se održava tijekom dugotrajne terapije.
Hypertrophy of the renal juxtaglomerular cells was also seen in both species. 
Hipertrofija jukstaglomerularnih bubrežnih stanica također je viđena u obje vrste.
Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to 
Dob, spol, rasa ili indeks tjelesne mase (≥30 kg/m2, <30 kg/m2) nisu utjecali na odgovor na Dafiro.
What Dafiro is and what it is used for What you need to know before you take Dafiro How to take Dafiro 
Što je Dafiro i za što se koristi Što morate znati prije nego počnete uzimati Dafiro Kako uzimati Dafiro
The usual dose of Dafiro is one tablet per day. 
Uobičajena doza Dafira je jedna tableta na dan.
Distribution: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively. 
Distribucija: Volumen distribucije valsartana u stanju dinamičke ravnoteže nakon intravenske primjene je oko 17 litara, što upućuje na to da se valsartan ne distribuira u većoj mjeri u tkiva.
Exceptional cases of extrapyramidal syndrome have been reported. 
Prijavljeni su izolirani slučajevi ekstrapiramidnog sindroma.
Amlodipine/Valsartan 
Amlodipin/Valsartan
Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication particularly with strong CYP3A4 inducers (e.g. rifampicin, hypericum perforatum). 
Stoga je potrebno pratiti krvni tlak i razmotriti reguliranje doze tijekom i nakon istodobnog liječenja, osobito s jakim induktorima CYP3A4 (npr. rifampicin, Hypericum perforatum).
It acts selectively on the receptor subtype AT1, which is responsible for the known actions of angiotensin II. 
Djeluje selektivno na podvrstu receptora AT1, odgovornu za poznata djelovanja angiotenzina II.
Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young therefore caution is required when increasing the dosage. 
Srednja sistemska vrijednost AUC valsartana viša je za 70% u starijih osoba nego u mladih osoba, te je stoga nužan oprez pri povećavanju doze.
If any of the following happen, tell your doctor straight away: 
Ako se dogodi nešto od sljedećeg, odmah obavijestite svog liječnika:
Patients taking Dafiro and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur. 
Bolesnici koji uzimaju Dafiro i upravljaju vozilima ili rade na strojevima trebaju imati na umu da se katkada mogu javiti omaglica ili iscrpljenost.
Children and adolescents The use of Dafiro in children and adolescents is not recommended (aged below 18 years old). 
Primjena Dafira u djece i adolescenata se ne preporučuje (ispod 18 godina starosti).
• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1. 
• Preosjetljivost na djelatne tvari, derivate dihidropiridina, ili neku od pomoćnih tvari navedenih u dijelu 6.1.
Other possible side effects of Dafiro: 
Ostale moguće nuspojave Dafira:
Some of these patients previously experienced angioedema with other medicinal products, including ACE inhibitors. 
Neki od tih bolesnika imali su angioedem i ranije, s drugim lijekovima, uključujući i ACE inhibitore.
What Dafiro contains 
Što Dafiro sadrži
Photosensitivity reaction 
Fotosenzitivna reakcija
The antihypertensive effect persists over 24 hours after administration. 
Antihipertenzivni učinak traje više od 24 sata nakon primjene.
Amlodipine belongs to a group of substances called “calcium channel blockers”. 
Amlodipin pripada skupini tvari koje se nazivaju „blokatori kalcijevih kanala“.
if you are allergic to valsartan or any of the other ingredients of Dafiro this medicine (listed in section 6). 
ako ste alergični na valsartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
As with all other vasodilators, special caution is indicated in patients suffering from mitral stenosis or significant aortic stenosis that is not high grade. 
Kao i sa svim drugim vazodilatatorima, nužan je poseban oprez u bolesnika koji boluju od mitralne stenoze ili značajne stenoze aorte koja nije visokog stupnja.
Elimination: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours. 
Eliminacija: Eliminacija amlodipina iz plazme je bifazna, s poluvijekom eliminacije od otprilike 30 do 50 sati.
Stopping your treatment with Dafiro may cause your disease to get worse. 
Prestanak liječenja Dafirom može dovesti do pogoršanja bolesti od koje bolujete.
In animal studies, reproductive toxicity was observed at high doses (see section 5.3). 
U ispitivanjima na životinjama opažena je reproduktivna toksičnost pri visokim dozama (vidjeti dio 5.3).
an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems. 
ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću.
OUTER CARTON OF MULTIPACK (WITH BLUE BOX) 
VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (S PLAVIM OKVIROM)
Dafiro is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. 
Dafiro se ne preporučuje majkama koje doje, a ako želite dojiti liječnik Vam može odabrati drugo liječenje, posebno ako je Vaše dijete novorođenče ili je prijevremeno rođeno.
At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males. 
Pri višim izloženostima, nastale su ulceracije i erozije sluznice želuca i u ženki i u mužjaka.
The recommended dose of Dafiro is one tablet per day. 
Preporučena doza Dafira je jedna tableta na dan.
In marmosets at comparable doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy including raised blood urea nitrogen and creatinine. 
U marmoseta su pri usporedivim dozama promjene bile slične iako teže, osobito u bubrezima, gdje su se promjene razvile u nefropatiju uključujući povišen dušik iz ureje u krvi i kreatinin.
Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day. 
Valsartan nije imao štetnih učinaka na reprodukciju mužjaka ili ženki štakora pri peroralnim dozama od najviše 200 mg/kg/dan.
The increased plasma levels of angiotensin II following AT1 receptor blockade with valsartan may stimulate the unblocked receptor subtype AT2, which appears to counterbalance the effect of the AT1 receptor. 
Povišene razine angiotenzina II u plazmi, nakon blokade AT1 receptora valsartanom, mogu stimulirati neblokiran podtip AT2 receptora, što, čini se, djeluje kao protuteža učinku AT1 receptora.
Interactions linked to amlodipine 
Interakcije povezane s amlodipinom
Arrhythmias (including bradycardia, ventricular tachycardia, and atrial fibrillation) 
Aritmije (uključujući bradikardiju, ventrikularnu tahikardiju i fibrilaciju atrija)
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. 
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.
The antihypertensive effect of a single dose of the combination persisted for 24 hours. 
Antihipertenzivni učinak jednokratne doze kombinacije održan je tijekom 24 sata.
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. 
Budući da nema učinka na ACE, ne pojačava djelovanje bradikinina ni supstance P, antagonisti angiotenzina II vrlo vjerojatno ne mogu biti povezani s kašljanjem.
PVC/PVDC perforated unit dose blisters. 
PVC/PVDC perforirani blisteri djeljivi na jedinične doze.
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. 
Sigurnost Dafira je ispitivana u pet kontroliranih kliničkih ispitivanja s 5175 bolesnika, od kojih je 2613 primalo valsartan u kombinaciji s amlodipinom.
If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired. 
Ako bolesnici koji uzimaju amlodipin pate od omaglice, glavobolje, umora ili mučnine, njihova sposobnost reagiranja mogla bi biti narušena.
Biotransformation: Valsartan is not transformed to a high extent as only about 20% of dose is recovered as metabolites. 
Biotransformacija: Valsartan se ne transformira u većoj mjeri, budući da se svega 20% doze može naći u obliku metabolita.
Caution required with concomitant use 
Oprez potreban kod istodobne primjene
This may involve itching, reddening of the skin or difficulty in breathing. 
To može uključivati svrbež, crvenilo kože ili teškoće pri disanju.
The safety and efficacy of amlodipine in hypertensive crisis have not been established. 
Sigurnost i djelotvornost amlodipina u hipertenzivnoj krizi nisu utvrđene.
Dafiro has not been studied in any patient population other than hypertension. 
Dafiro nije ispitivan ni u jednoj drugoj populaciji bolesnika, osim u bolesnika s hipertenzijom.
Reproductive toxicology 
Reproduktivna toksikologija
When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered. 
Kada je klinički opravdano, može se uzeti u obzir direktni prijelaz iz monoterapije na fiksnu kombinaciju doza.
Oedema peripheral 
Periferni edemi
The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. 
Kombinacija ovih lijekova ima dodatni antihipertenzivni učinak, čime u većoj mjeri snižava krvni tlak nego svaka od pojedinih komponenti samostalno.
Amlodipine (mg) 
Amlodipin (mg)
Interactions linked to valsartan 
Interakcije povezane s valsartanom
Liver function test abnormal, including blood bilirubin increase 
Poremećeni testovi jetrene funkcije, uključujući povišen bilirubin u krvi
Time to peak plasma amlodipine concentrations is similar in young and elderly patients. 
Vrijeme do postizanja vršnih koncentracija amlodipina u plazmi slično je u mladih i starijih bolesnika.
The effect of amlodipine on infants is unknown. 
Učinak amlodipina na dojenčad nije poznat.
14 film-coated tablets. 
14 filmom obloženih tableta.
(calculations assume an oral dose of 320 mg/day and a 60-kg patient). 
(u izračunima je korištena pretpostavka da je peroralna doza 320 mg/dan i da je tjelesna težina bolesnika 60 kg).
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). 
Alergijska reakcija sa simptomima poput osipa, svrbeža, oticanja lica ili usnica ili jezika, teškoće pri disanju, niski krvni tlak (osjećaj nesvjestice, ošamućenost).
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. 
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.
Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. 
Reverzibilne biokemijske promjene u glavi spermija prijavljene su u nekih bolesnika liječenih blokatorima kalcijevih kanala.
These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing. 
Ova sniženja krvnog tlaka nisu praćena značajnim promjenama srčane frekvencije ili razina katekolamina u plazmi kod kroničnog doziranja.
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. 
Kontraktilni procesi srčanog mišića i glatkog mišića krvnih žila ovise o kretanju izvanstaničnih iona kalcija u ove stanice kroz specifične ionske kanale.
If you get these symptoms, stop taking Dafiro and contact your doctor straight away. 
Ako dobijete ove simptome, prekinite uzimati Dafiro i odmah se javite svom liječniku.
Toxic Epidermal Necrolysis 
Toksična epidermalna nekroliza
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. 
Bolesnici s primarnim hiperaldosteronizmom se ne bi trebali liječiti antagonistom angiotenzina II valsartanom, jer njihova primarna bolest utječe na sustav renin-angiotenzin.
Alopecia 
Alopecija
Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function. 
Evaluacija bolesnika sa zatajivanjem srca ili poslije infarkta miokarda uvijek mora uključivati i procjenu funkcije bubrega.
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. 
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.
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists, combinations; angiotensin II antagonists and calcium channel blockers, ATC code: C09DB01 
Farmakoterapijska skupina: Lijekovi koji djeluju na renin-angiotenzinski sustav, antagonisti angiotenzina II, kombinacije; antagonisti angiotenzina II i blokatori kalcijevih kanala, ATK oznaka: C09DB01
Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events. 
Nagli prekid liječenja valsartanom nije bio povezan s pojavom povratne hipertenzije ili drugih klinički štetnih događaja.
The safety of amlodipine in human pregnancy has not been established. 
Sigurnost amlodipina u ljudskoj trudnoći nije utvrđen.
• Severe hypotension. 
• Teška hipotenzija.
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. 
Istodobna primjena višestrukih doza od 10 mg amlodipina s 80 mg simvastatina rezultirala je povećanjem izloženosti simvastatinu za 77% u usporedbi sa samim simvastatinom.
The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established. 
Poluvijek amlodipina je produljen i vrijednosti AUC-a su više u bolesnika s oštećenom jetrenom funkcijom; preporuke za doziranje nisu utvrđene.
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). 
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).
Not known Toxic Epidermal Necrolysis * mostly consistent with cholestasis 
Nepoznato Toksična epidermalna nekroliza * uglavnom upućuje na kolestazu
Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans. 
Amlodipin ne mijenja funkciju sinoatrijskog čvora ili atrioventrikularno provođenje u zdravih životinja ili ljudi.
The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4). 
Primjena antagonista angiotenzin II receptora (AIIRA) se ne preporučuje tijekom prvog tromjesečja trudnoće (vidjeti dio 4.4).
Abrupt withdrawal of Dafiro has not been associated with a rapid increase in blood pressure. 
Nagli prekid primjene Dafira nije bio povezan s naglim povišenjem krvnog tlaka.
This medicine may make you feel dizzy. 
Ovaj lijek može uzrokovati omaglicu.
Amlodipine can have mild or moderate influence on the ability to drive and use machines. 
Amlodipin može blago ili umjereno utjecati na sposobnost upravljanja vozilima i rada na strojevima.
This means that both of these substances help to stop the blood vessels tightening. 
To znači da oba ova lijeka pomažu u sprečavanju sužavanja krvnih žila.
Amlodipine and valsartan exhibit linear pharmacokinetics. 
Amlodipin i valsartan pokazuju linearnu farmakokinetiku.
To be taken into account with concomitant use 
Što treba uzeti u obzir kod istodobne primjene
For therapeutic doses of valsartan in humans, the hypertrophy of the renal juxtaglomerular cells does not seem to have any relevance. 
Kod terapijskih doza valsartana u ljudi čini se da hipertrofija jukstaglomerularnih bubrežnih stanica nema nikakav značaj.
• Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis). 
• Opstrukcija istisnog dijela lijevog ventrikula (npr. hipertrofična opstruktivna kardiomiopatija i aortalna stenoza visokog stupnja).
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: 
Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: