natgillin/translations-raw huggingface dataset:
Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade. 
Intravenski kalcijev glukonat može pomoći u poništavanju učinaka blokade kalcijevih kanala.
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. 
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.
No drug-drug interaction studies have been performed with Dafiro and other medicinal products. 
Nisu provedena ispitivanja interakcija među lijekovima s Dafirom i drugim lijekovima.
70 film-coated tablets. 
70 filmom obloženih tableta.
Valsartan is an orally active, potent and specific angiotensin II receptor antagonist. 
Valsartan je aktivan, potentan i specifičan antagonist angiotenzin II receptora pri peroralnoj primjeni.
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. 
Primjena antagonista angiotenzin II receptora (AIIRA - engl. angiotensin II receptor antagonists) ne smije se započeti tijekom trudnoće.
Amlodipine has been shown to pass into breast milk in small amounts. 
Pokazalo se da amlodipin prelazi u majčino mlijeko u malim količinama.
What you need to know before you take Dafiro 
Što morate znati prije nego počnete uzimati Dafiro
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. 
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.
You can take Dafiro with or without food. 
Dafiro možete uzimati s hranom ili bez nje.
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). 
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).
Patients with hepatic impairment have decreased clearance of amlodipine with resulting increase of approximately 40-60% in AUC. 
Bolesnici s oštećenjem jetre imaju smanjeni klirens amlodipina s posljedičnim povećanjem AUC-a za otprilike 40-60%.
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. 
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.
In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene. 
U životinja su opaženi letalna ventrikularna fibrilacija i kardiovaskularni kolaps povezani s hiperkalijemijom nakon primjene verapamila i intravenskog dantrolena.
All packs are available with standard blisters; the 56, 98 and 280 tablet packs are additionally available with perforated unit dose blisters. 
Sva pakiranja su dostupna sa standardnim blisterima; pakiranja s 56, 98 i 280 tableta su dodatno dostupna s perforiranim blisterima djeljivim na jedinične doze.
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. 
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.
Multipack: 280 (4 packs of 70) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets 
Višestruko pakiranje: 280 (4 pakiranja od 70) filmom obloženih tableta Višestruko pakiranje: 280 (20 pakiranja od 14) filmom obloženih tableta
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). 
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).
As a result, the blood vessels relax and blood pressure is lowered. 
Rezultat toga je opuštanje krvnih žila i snižavanje krvnog tlaka.
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. 
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.
Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites. 
Eksperimentalni podaci ukazuju da se amlodipin veže i na dihidropiridinska i na ne-dihidropiridinska vezna mjesta.
Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. 
Angiotenzin II se stvara u tijelu i dovodi do sužavanja krvnih žila te na taj način povećava krvni tlak.
Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease. 
Amlodipin je ispitivan u bolesnika s kroničnom stabilnom anginom, vazospastičnom anginom i angiografski dokumentiranom bolešću koronarnih arterija.
• Haemodynamically unstable heart failure after acute myocardial infarction. 
• Hemodinamički nestabilno zatajivanje srca nakon akutnog infarkta miokarda.
The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/valsartan combination. 
Srednja vrijednost incidencije perifernih edema ravnomjerno raspoređena po svim dozama bila je 5,1% kod kombinacije amlodipin/valsartan.
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. 
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.
Do not use this medicine after the expiry date which is stated on the carton and blister. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake EXP.
Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin. 
Valsartan ne inhibira ACE, poznat i kao kininaza II, koji pretvara angiotenzin I u angiotenzin II te razgrađuje bradikinin.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4). 
Dojenčad čije su majke uzimale AIIRA-e treba pažljivo pratiti zbog hipotenzije (vidjeti dijelove 4.3 i
Erythema multiforme 
Multiformni eritrem
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. 
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.
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. 
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.
Dafiro can be used with or without food. 
Dafiro se može primjenjivati s hranom ili bez nje.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan. 
U bolesnika s blagim do umjerenim oštećenjem jetre, bez kolestaze, najviša preporučena doza valsartana je 80 mg.
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. 
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.
Dafiro tablets contain two substances called amlodipine and valsartan. 
Dafiro tablete sadrže dvije djelatne tvari koje se zovu amlodipin i valsartan.
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). 
Kada se trudnoća utvrdi, liječenje AIIRA-om treba odmah prekinuti te ako je prikladno, započeti alternativnu terapiju (vidjeti dijelove 4.3 i 4.6).
Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan. 
Istodobna primjena inhibitora prijenosnika pohrane (rifampicin, ciklosporin) ili efluksnog prijenosnika (ritonavir) može povećati sistemsku izloženost valsartanu.
Valsartan is mostly eliminated unchanged via the bile. 
Valsartan se najvećim dijelom eliminira nepromijenjen putem žuči.
If hypotension occurs with Dafiro, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. 
Ako se uz Dafiro pojavi hipotenzija, bolesnika treba poleći na leđa i po potrebi, mu dati intravensku infuziju fiziološke otopine.
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. 
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.
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.. 
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.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. 
Ako je do izloženosti AIIRA-ima došlo od drugog tromjesečja trudnoće nadalje, preporučuje se ultrazvučni pregled funkcije bubrega i lubanje.
If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised. 
Ako se u kombinaciji s valsartanom propisuje lijek koji utječe na razine kalija, savjetuje se praćenje razina kalija u plazmi.
The amlodipine component of Dafiro inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle. 
Amlodipinska komponenta Dafira inhibira transmembranski ulaz iona kalcija u srčani mišić i glatki mišić krvnih žila.
Dual blockade of RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is therefore not recommended (see sections 4.5 and 5.1). 
Dvostruka blokada RAAS-a kombiniranom primjenom ACE inhibitora, ARB-ova ili aliskirena stoga se ne preporučuje (vidjeti dijelove 4.5 i 5.1).
For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Dafiro containing the same component doses. 
Bolesnici koji primaju valsartan i amlodipin u odvojenim tabletama/kapsulama, mogu se radi jednostavnosti prebaciti na Dafiro koji sadrži iste doze sastojaka.
In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo. 
U dugotrajnom, placebo-kontroliranom ispitivanju (PRAISE-2) amlodipina u bolesnika sa zatajivanjem srca ne-ishemijske etiologije III. i IV. stupnja prema NYHA (New York Heart Association Classification), amlodipin je bio povezan s povećanim brojem izvještaja o plućnom edemu, unatoč beznačajnoj razlici u incidenciji pogoršanja zatajivanja srca u usporedbi s placebom.
Intrahepatic cholestasis, jaundice 
Intrahepatična kolestaza, žutica
There is no experience of overdose with Dafiro. 
Nema iskustva s predoziranjem Dafirom.
Clinical data are insufficient regarding the potential effect of amlodipine on fertility. 
Nema dovoljno kliničkih podataka o mogućem učinku amlodipina na plodnost.
In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death. 
U bolesnika s teškim zatajivanjem srca čija funkcija bubrega može ovisiti o aktivnosti sustava renin-angiotenzin-aldosteron, liječenje ACE inhibitorima i antagonistima receptora angiotenzina bilo je povezano s oligurijom i/ili progresivnom azotemijom, i (rijetko) s akutnim zatajenjem bubrega i/ili smrću.
As with other calcium channel blockers, haemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume. 
Kao i kod drugih blokatora kalcijevih kanala, hemodinamska mjerenja srčane funkcije u mirovanju i tijekom opterećenja (ili tempiranog hoda) u bolesnika s normalnom funkcijom ventrikula liječenih amlodipinom pokazala su općenito mali porast srčanog indeksa bez značajnog utjecaja na dP/dt ili na krajnji dijastolički tlak lijevog ventrikula ili volumen lijevog ventrikula.
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an ARB in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both. 
ALTITUDE (eng. Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) je bilo ispitivanje osmišljeno za testiranje koristi dodavanja aliskirena standardnoj terapiji s ACE inhibitorom ili ARB-ovima u bolesnika sa šećernom bolešću tipa 2 i kroničnom bolešću bubrega, kardiovaskularnom bolešću ili oboje.
Peripheral oedema, a recognised side effect of amlodipine, was generally observed at a lower incidence in patients who received the amlodipine/valsartan combination than in those who received amlodipine alone. 
Periferni edem, kao poznata nuspojava amlodipina, općenito je opažen s nižom incidencijom u bolesnika koji su primali kombinaciju amlodipina/valsartana, nego u onih koji su primali samo amlodipin.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started. 
Kada se trudnoća utvrdi, liječenje AIIRA-om treba odmah prekinuti te, ako je prikladno, započeti alternativnu terapiju.
Mutagenicity studies revealed no drug related effects at either the gene or chromosome levels. 
Ispitivanja mutagenosti nisu otkrila nikakve učinke povezane s lijekom bilo na razini gena ili kromosoma.
The rate and extent of absorption of Dafiro are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets. 
Brzina i opseg apsorpcije Dafira jednaki su bioraspoloživosti valsartana i amlodipina kada se primjenjuju kao pojedinačne tablete.
In one rat study, adverse effects were found on male fertility (see section 5.3). 
U jednom ispitivanju sa štakorima nađeni su štetni učinci na mušku plodnost (vidjeti dio 5.3).
Pack sizes: 56, 98 or 280 film-coated tablets. 
Veličina pakiranja: 56, 98 ili 280 filmom obloženih tableta.
Clinically significant hypotension due to Dafiro overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output. 
Klinički značajna hipotenzija zbog predoziranja Dafirom zahtijeva aktivnu kardiovaskularnu potporu, uključujući često praćenje srčane i respiratorne funkcije, podizanje ekstremiteta, uz praćenje volumena cirkulirajuće tekućine i mokrenja.
In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve (AUC) and elimination half-life. 
U starijih bolesnika postoji sklonost smanjenju klirensa amlodipina, što uzrokuje povećanja površine ispod krivulje (AUC) i poluvijeka eliminacije.
Quincke oedema 
Quinckeov edem
Dafiro should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients. 
Dafiro se treba primjenjivati s oprezom u liječenju hipertenzije u bolesnika s jednostranom ili obostranom stenozom bubrežne arterije ili stenozom bubrežne arterije kod postojanja samo jednog bubrega budući da se u ovih bolesnika može povisiti urea u krvi i serumski kreatinin.
Urticaria and other forms of rash 
Urtikarija i drugi vrste osipa
Confusion. 
Konfuzija.
Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”. 
Valsartan pripada skupini tvari koje se nazivaju „antagonisti angiotenzin II receptora“.
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure. 
Istodobna primjena amlodipina sa snažnim ili umjerenim inhibitorima CYP3A4 (inhibitori proteaze, azolni antifungalni lijekovi, makrolidi kao eritromicin ili klaritromicin, verapamil ili diltiazem) mogu izazvati značajno povećanje izloženosti amlodipinu.
Among secondary endpoints, the incidence of heart failure (component of a composite combined cardiovascular endpoint) was significantly higher in the amlodipine group as compared to the chlorthalidone group (10.2% versus 7.7%, RR 1.38, 95% CI [1.25-1.52] p<0.001). 
Među sekundarnim ishodima incidencija zatajivanja srca (komponenta kompozita kombiniranog kardiovaskularnog ishoda) bila je značajno viša u skupini na amlodipinu u usporedbi sa skupinom koja je uzimala klortalidon (10,2% naspram 7,7%, OR 1,38, 95% CI [1,25-1,52] p<0,001).
This dose is 6 times the maximum recommended human dose on a mg/m basis 
Ta je doza 6 puta veća od najviše preporučene doze za ljude izražene u mg/m
In haemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and humans, even when co-administered with beta blockers to humans. 
U hemodinamskim ispitivanjima, amlodipin nije bio povezan s negativnim inotropnim učinkom kada se primjenjivao u rasponu terapijskih doza zdravim životinjama i ljudima, čak i kada se u ljudi primjenjivao istodobno s beta-blokatorima.
In patients with an activated renin-angiotensin system (such as volume- and/or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur. 
U bolesnika s aktiviranim renin-angiotenzinskim sustavom (poput bolesnika sa smanjenim volumenom tekućine i/ili sniženom razinom soli na visokim dozama diuretika) koji primaju blokatore angiotenzinskih receptora, može doći do simptomatske hipotenzije.
ACE inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy. 
ACE inhibitori i ARB-ovi ne smiju se primjenjivati istodobno u bolesnika s dijabetičkom nefropatijom.
In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p <0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9%, respectively). 
U kliničkim ispitivanjima u kojima se valsartan uspoređivao s ACE inhibitorom, incidencija suhog kašlja bila je značajno (p <0,05) niža u bolesnika liječenih valsartanom, nego u onih liječenih ACE inhibitorom (2,6% naspram 7,9%).
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 
Primjena AIIRA je kontraindicirana tijekom drugog i trećeg tromjesečja trudnoće (vidjeti dijelove 4.3 i 4.4).
Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Dafiro as well, even if not observed in clinical trials or during the post-marketing period. 
Dodatne informacije o pojedinačnim komponentama Nuspojave koje su ranije prijavljene s jednom od pojedinačnih komponenti (amlodipinom ili valsartanom) mogu biti i moguće nuspojave Dafira, iako nisu uočene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet.
In another rat study in which male rats were treated with amlodipine besilate for 30 days at a dose comparable with the human dose based on mg/kg, decreased plasma follicle-stimulating hormone and testosterone were found as well as decreases in sperm density and in the number of mature spermatids and Sertoli cells. 
U drugom ispitivanju sa štakorima u kojem su mužjaci 30 dana primali amlodipin bezilat u dozi usporedivoj s dozom za ljude izraženoj u mg/kg, nađeni su sniženi folikulostimulirajući hormon i testosteron u plazmi, kao i smanjenja gustoće sperme i smanjeni broj zrelih spermija i Sertolijevih stanica.
The primary endpoint was a composite of fatal coronary heart disease or non-fatal myocardial infarction. 
Primarni ishod bio je kompozit koronarne bolesti srca sa smrtnim ishodom ili infarkta miokarda bez smrtnog ishoda.