natgillin/translations-raw huggingface dataset:
If these medicinal products are to be prescribed with the amlodipine /valsartan /hydrochlorothiazide combination, monitoring of potassium plasma levels is advised.
Ako će se ti lijekovi propisivati s kombinacijom amlodipin/valsartan/hidroklorotiazid, savjetuje se praćenje razina kalija u plazmi.
After oral administration of therapeutic doses of amlodipine alone, peak plasma concentrations of amlodipine are reached in 6-12 hours.
Nakon peroralne primjene terapijskih doza samog amlodipina, vršne koncentracije amlodipina u plazmi postižu se za 6-12 sati.
• heart attack
• srčani udar
In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Dafiro HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Dafiro HCT for clinical use in humans.
U nizu nekliničkih ispitivanja sigurnosti, provedenih na nekoliko vrsta životinja s amlodipinom, valsartanom, hidroklorotiazidom, valsartanom/hidroklorotiazidom, amlodipinom/valsartanom te amlodipinom/valsartanom/hidroklorotiazidom (Dafiro HCT), nije bilo dokaza sistemske toksičnosti ili toksičnosti za pojedini ciljni organ koji bi negativno utjecali na razvoj Dafiro HCT-a za kliničku primjenu u ljudi.
• sudden, temporary loss of consciousness
• nagli, prolazni gubitak svijesti
The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Dafiro HCT are the same as when administered as individual dosage forms.
Brzina i opseg apsorpcije amlodipina, valsartana i hidroklorotiazida iz Dafiro HCT-a jednaki su onima pri primjeni pojedinačnih dozirnih oblika.
Clinically significant hypotension due to Dafiro HCT 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 Dafiro HCT-om zahtijeva aktivnu kardiovaskularnu potporu, uključujući često praćenje srčane i respiratorne funkcije, podizanje ekstremiteta, uz praćenje volumena cirkulirajuće tekućine i mokrenja.
The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and of the hepatic efflux transporter MRP2.
Rezultati in vitro ispitivanja na ljudskom tkivu jetre pokazuju da je valsartan supstrat jetrenog unosnog prijenosnika OATP1B1 i jetrenog efluksnog prijenosnika MRP2.
Preclinical safety studies of up to 13 weeks in duration were conducted with amlodipine/valsartan/hydrochlorothiazide in rats.
Neklinička ispitivanja sigurnosti, u trajanju do 13 tjedana, provedena su s amlodipinom/ valsartanom/hidroklorotiazidom u štakora.
Hypokalaemia may result in muscle spasms and or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Hipokalijemija može rezultirati spazmima mišića i/ili pojačati aritmiju povezanu s istodobnom primjenom glikozida digitalisa ili određenih antiaritmijskih lijekova.
Amlodipine
Amlodipin
Abasia, gait disturbance
Abazija, poremećaj načina hoda
Photosensitivity
Fotosenzitivnost
Dafiro HCT can be taken with or without food.
Dafiro HCT se može uzimati s hranom ili bez nje.
Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Dafiro HCT.
Budući da je bubrežni klirens litija smanjen s tiazidima, rizik od toksičnosti litija vjerojatno se može povećati s Dafiro HCT-om.
Two large randomised, controlled trials (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] and VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) have examined the use of the combination of an ACE inhibitor with an ARB.
ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) i VA NEPHRON-D (eng. The Veterans Affairs Nephropathy in Diabetes)) ispitivala su primjenu kombinacije ACE inhibitora s ARB-ovima.
The amlodipine component of Dafiro HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipinska komponenta Dafiro HCT-a inhibira transmembranski ulaz iona kalcija u srčani mišić i glatki mišić krvnih žila.
• worsening of the diabetic metabolic state
• pogoršanje dijabetičkog metaboličkog stanja
High hydrochlorothiazide use (≥50000 mg cumulative) was associated with an adjusted odds ratio (OR) of 1.29 (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Velika primjena hidroklorotiazida (≥50 000 mg kumulativno) bila je povezana s prilagođenim omjerom izgleda (eng. odds ratio, OR) od 1,29 (95% CI: 1,23-1,35) za BCC i 3,98 (95% CI: 3,68-4,31) za SCC.
• high level of sugar in the blood
• visoka razina šećera u krvi
Dafiro HCT combines three 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 and hydrochlorothiazide belongs to the thiazide diuretics class of medicines.
Dafiro HCT kombinira tri antihipertenzivna sastojka s komplementarnim mehanizmima kontrole krvnog tlaka u bolesnika s esencijalnom hipertenzijom: amlodipin pripada skupini kalcijevih antagonista, valsartan pripada skupini antagonista angiotenzina II, a hidroklorotiazid pripada skupini tiazidnih diuretika.
Exposure to AIIRAs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Poznato je da izloženost terapiji AIIRA-ima tijekom drugog i trećeg tromjesečja u ljudi izaziva fetotoksičnost (smanjenu funkciju bubrega, oligohidramnione, retardaciju okoštavanja lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenziju, hiperkalijemiju) (vidjeti dio 5.3).
Dantrolene (infusion) 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.
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Bioraspoloživost tiazidnih diuretika može se povećati antikolinergijskim lijekovima (npr. atropin, biperiden), vjerojatno zbog smanjenja gastrointestinalnog motiliteta i brzine pražnjenja želuca.
Dafiro HCT 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 HCT 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.
All patients receiving thiazide diuretics should be periodically monitored for imbalances in electrolytes, particularly potassium, sodium and magnesium.
Sve bolesnike koji primaju tiazidske diuretike potrebno je periodički pratiti zbog moguće neravnoteže elektrolita, osobito kalija, natrija i magnezija.
Hydrochlorothiazide is excreted in human milk in small amounts.
Hidroklorotiazid se izlučuje u majčino mlijeko u malim količinama.
Valsartan Valsartan is unlikely to be removed by haemodialysis.
Valsartan Valsartan se ne može ukloniti hemodijalizom.
The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle, causing reductions in peripheral vascular resistance and in blood pressure.
Mehanizam antihipertenzivnog djelovanja amlodipina je direktni relaksirajući učinak na glatke mišiće krvnih žila, što uzrokuje smanjenje perifernog vaskularnog otpora i krvnog tlaka.
Based on the existing data with the components, the use of Dafiro HCT is not recommended during first trimester and contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Na temelju postojećih podataka o komponentama, primjena Dafiro HCT-a ne preporučuje se tijekom prvog tromjesečja, dok je tijekom drugog i trećeg tromjesečja trudnoće kontraindicirana (vidjeti dijelove 4.3 i 4.4).
• pale skin, tiredness, breathlessness, dark-coloured urine (haemolytic anaemia, abnormal breakdown of red blood cells either in the blood vessels or elsewhere in the body)
• blijeda koža, umor, nedostatk zraka, tamno obojana mokraća (hemolitička anemija, abnormalno raspadanje crvenih krvnih stanica ili u krvnim žilama ili drugdje u tijelu)
Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus
Reakcije slične kožnom eritematoznom lupusu, reaktivacija kožnog eritematoznog lupusa
• inflammation of blood vessels often with skin rash
• upala krvnih žila često s kožnim osipom
Hydrochlorothiazide, a sulphonamide, has been associated with an idiosyncratic reaction resulting in acute transient myopia and acute angle-closure glaucoma.
Sulfonamid hidroklorotiazid povezuje se s idiosinkrazijskom reakcijom koja rezultira akutnom prolaznom miopijom i akutnim glaukomom zatvorenog kuta.
Heart failure and coronary artery disease
Zatajenje srca i bolest koronarnih arterija
Medicinal products used in the treatment of gout (probenecid, sulfinpyrazone and allopurinol)
Lijekovi koji se koriste za liječenje gihta (probenecid, sulfinpirazon i alopurinol)
Thiazides reduce urinary calcium excretion and may cause intermittant and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Tiazidi smanjuju izlučivanje kalcija urinom i mogu uzrokovati povremeno i blago povišenje kalcija u serumu u odsutnosti poznatih poremećaja metabolizma kalcija.
If hypokalaemia develops during hydrochlorothiazide therapy, Dafiro HCT should be discontinued until stable correction of the potassium balance.
Ako se hipokalijemija razvije tijekom terapije hidroklorotiazidom, potrebno je prekinuti uzimanje Dafiro HCT-a sve dok se postigne stabilna korekcija ravnoteže kalija.
The patients had at least one additional coronary heart disease risk factor, including: previous myocardial infarction or stroke (>6 months prior to enrollment) or documentation of other atherosclerotic cardiovascular disease (overall 51.5%), type 2 diabetes (36.1%), high density lipoprotein - cholesterol <35 mg/dl or <0.906 mmol/l (11.6%), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9%), current cigarette smoking (21.9%).
Bolesnici su imali najmanje jedan dodatni faktor rizika za koronarnu bolest srca, uključujući prethodni infarkt miokarda ili moždani udar (>6 mjeseci prije uključivanja u ispitivanje) ili dokumentaciju o drugoj aterosklerotskoj kardiovaskularnoj bolesti (ukupno 51,5%), šećernu bolest tipa 2 (36,1%), lipoprotein visoke gustoće - kolesterol <35 mg/dl ili <0,906 mmol/l (11,6%), hipertrofiju lijevog ventrikula dijagnosticiranu elektrokardiogramom ili ehokardiografijom (20,9%), aktivni status pušača (21,9%).
A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100000 mg) (see also section 4.4).
Povezanost odgovora i kumulativne doze dokazan je s prilagođenim OR 2,1 (95% CI: 1,7-2,6) s povećanjem na OR 3,9 (3,0-4,9) za veliku primjenu hidroklorotiazida (~25 000 mg) i OR 7,7 (5,7-10,5) za najvišu kumulativnu dozu (~100 000 mg) (vidjeti i dio 4.4).
Known interactions with the following agents
Poznate interakcije sa sljedećim lijekovima
In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and increases in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
U hipertenzivnih bolesnika s normalnom bubrežnom funkcijom, terapijske doze amlodipina rezultiraju smanjenjem bubrežne vaskularne rezistencije i povećanjem brzine glomerularne filtracije te učinkovitim protokom plazme kroz bubreg, bez promjene u filtracijskom udjelu ili proteinurije.
Non-melanoma skin cancer: based on available data from epidemiological studies, cumulative dose-dependent association between hydrochlorothiazide and NMSC has been observed (see also sections 4.4 and 5.1).
Nemelanomski rak kože: Na temelju dostupnih podataka iz epidemioloških ispitivanja, između hidroklorotiazida i NMSC-a primijećena je povezanost ovisna o kumulativnoj dozi (vidjeti također dijelove 4.4 i 5.1).
+Cl symporter perhaps by competing for the Cl site,
+Cl simportera, pretpostavlja se nadmetanjem za mjesto vezanja Cl
Dual blockage 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).
Worsening of diabetic metabolic state
Pogoršanje dijabetičkog metaboličkog stanja
Non-depolarising skeletal muscle relaxants (e.g. tubocurarine)
Nedepolarizirajući relaksansi skeletnih mišića (npr. tubokurarin)
Furthermore, concomitant use of Dafiro HCT and NSAIDs may lead to worsening of renal function and an increase in serum potassium.
Osim toga, istodobna primjena Dafiro HCT-a i NSAIL-a može dovesti do pogoršanja bubrežne funkcije i povećanja kalija u serumu.
• inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling of being very unwell
• upalu gušterače koja može uzrokovati jake bolove u trbuhu i leđima pri čemu se bolesnik općenito osjeća vrlo loše
Thiazides potentiate the antihypertensive action of other antihypertensive drugs (e.g. guanethidine, methyldopa, beta-blockers, vasodilators, calcium channel blockers, ACE inhibitors, ARBs and Direct Renin Inhibitors [DRIs]).
Tiazidi pojačavaju antihipertenzivno djelovanje drugih antihipertenzivnih lijekova (npr. gvanetidin, metildopa, beta-blokatori, vazodilatatori, blokatori kalcijevih kanala, ACE inhibitori, ARB-i i direktni inhibitori renina).
Concomitant treatment with ciclosporin may increase the risk of hyperuricaemia and gout-type complications.
Istodobno liječenje ciklosporinom može povećati rizik od hiperuricemije i komplikacija gihta.
In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Dafiro HCT were dizziness and hypotension (0.7%).
Najčešći razlozi prekida terapije Dafiro HCT-om u ovom aktivno kontroliranom kliničkom ispitivanju bili su omaglica i hipotenzija (0,7%).
Other medicines and Dafiro HCT
Drugi lijekovi i Dafiro HCT
In patients with severe renal impairment an 8-fold increase in AUC has been observed.
U bolesnika s teškim oštećenjem bubrega opaženo je 8-puta povećanje AUC-a.
In the controlled trial of Dafiro HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients.
U kontroliranom ispitivanju Dafiro HCT-a, suprotni učinci 320 mg valsartana i 25 mg hidroklorotiazida na kalij u serumu su se približno uravnotežili u mnogih bolesnika.
When Dafiro HCT is used in patients with renal impairment periodic monitoring of serum electrolytes (including potassium), creatinine and uric acid serum levels is recommended.
Kada se Dafiro HCT primjenjuje u bolesnika s oštećenjem bubrega preporučuje se periodičko praćenje serumskih elektrolita (uključujući kalij), razina kreatinina i mokraćne kiseline u serumu.
Amlodipine Valsartan HCT
Amlodipin Valsartan HCT
Dafiro HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances.
Dafiro HCT se primjenjuje za liječenje povišenog krvnog tlaka u odraslih bolesnika čiji je krvni tlak već kontroliran dok uzimaju amlodipin, valsartan i hidroklorotiazid te kojima uzimanje jedne tablete koja sadrži sve tri djelatne tvari može biti od koristi.
Periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
Radi otkrivanja moguće neravnoteže elektrolita potrebno je provoditi periodičko određivanje elektrolita u serumu u odgovarajućim vremenskim intervalima.
Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Može biti potrebno prilagođavanje doze urikozuričkih lijekova budući da hidroklorotiazid može povisiti razinu mokraćne kiseline u serumu.
Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Liječenje esencijalne hipertenzije kao nadomjesna terapija u odraslih bolesnika čiji je krvni tlak odgovarajuće kontroliran kombinacijom amlodipina, valsartana i hidroklorotiazida (HCT), uzetih bilo u obliku tri jednokomponentne formulacije ili u obliku dvokomponentne i jednokomponentne formulacije.
• rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• rifampicinom (koji se koristi, primjerice, za liječenje tuberkuloze), eritromicin, klaritromicin
Adverse reactions were generally mild and transient in nature and only infrequently required discontinuation of therapy.
Nuspojave su općenito bile blage i prolazne naravi te su iziskivale prekid terapije samo u rijetkim slučajevima.
Caution should be exercised in patients who have shown prior hypersensitivity to other angiotensin II receptor antagonists.
Nužan je oprez u bolesnika koji su već bili preosjetljivi na druge antagoniste angiotenzin II receptora.
Therefore careful monitoring of serum lithium concentrations is recommended during concomitant use.
Stoga, tijekom istodobne primjene preporučuje se pažljivo praćenje koncentracija litija u serumu.
The use of hydrochlorothiazide may also need to be reconsidered in patients who have experienced previous NMSC (see also section 4.8).
Također, u bolesnika koji su prethodno imali NMSC može biti potrebno razmotriti opravdanost primjene hidroklorotiazida (vidjeti također dio 4.8).
In sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur after initiation of treatment with Dafiro HCT.
U bolesnika sa sniženom razinom natrija i/ili smanjenjem volumena tekućine, poput onih koji primaju visoke doze diuretika, nakon početka liječenja Dafiro HCT-om moguća je pojava simptomatske hipotenzije.
What you need to know before you take Dafiro HCT
Što morate znati prije nego počnete uzimati Dafiro HCT
thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly, by this diuretic action, reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
-, čime se utječe na mehanizme reapsorpcije elektrolita: direktnim povećanjem izlučivanja natrija i klorida u otprilike podjednakoj mjeri, a indirektno smanjenjem volumena plazme putem ovog diuretskog djelovanja, s posljedičnim povećanjem aktivnosti renina u plazmi, lučenja aldosterona i gubitka kalija mokraćom te sniženja kalija u serumu.
You can take Dafiro HCT with or without food.
Dafiro HCT možete uzimati s hranom ili bez nje.
Multipack: 280 (4 packs of 70x1) film-coated tablets.
Višestruko pakiranje: 280 (4 pakiranja od 70x1) filmom obloženih tableta.
• dizziness, fainting on standing up
• omaglica, nesvjestica pri ustajanju
• sudden wheeziness, chest pain, shortness of breath or difficulty breathing
• iznenadno piskanje pri disanju, bol u prsima, nedostatak zraka ili teškoće pri disanju
Valsartan and HCT
Valsartan i HCT
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 unosa (rifampicin, ciklosporin) ili efluksnog prijenosnika (ritonavir) može povećati sistemsku izloženost valsartanu.
Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and hypovolaemia resulting from excessive diuresis.
Predoziranje hidroklorotiazidom povezano je sa smanjenjem elektrolita (hipokalijemijom, hipokloremijom) i hipovolemijom kao rezultatom obilne diureze.
• swelling, reddening and pain along a vein
• oticanje, crvenilo i bol uzduž vene
No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2).
Nije potrebna prilagodba početne doze u bolesnika s blagim do umjerenim oštećenjem bubrega (vidjeti dijelove 4.4 i 5.2).
In a subgroup of 283 patients focusing on ambulatory blood pressure monitoring, clinically and statistically superior reductions in 24-hour systolic and diastolic blood pressures were observed with the triple combination compared to valsartan/hydrochlorothiazide, valsartan/amlodipine, and hydrochlorothiazide/amlodipine.
U podskupini od 283 bolesnika u kojih se usredotočilo na praćenje ambulantno izmjerenog krvnog tlaka, opaženo je klinički i statistički superiornije sniženje sistoličkog i dijastoličkog krvnog tlaka unutar 24 sata uz trojnu kombinaciju u usporedbi s valsartanom/hidroklorotiazidom, valsartanom/amlodipinom i hidroklorotiazidom/amlodipinom.
Heart failure and coronary artery disease/post-myocardial infarction
Zatajivanje srca i bolest koronarnih arterija/poslije infarkta miokarda
• iodine contrast media (agents used for imaging examinations);
• jodnim kontrastnim sredstvima (sredstva koja se koriste za pretrage snimanjem);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• lijekovi za liječenje gljivičnih infekcija (npr. ketokonazol, itrakonazol);
There is evidence that the concomitant use of ACE inhibitors, ARBs or aliskiren increases the risk of hypotension, hyperkalaemia, and decreased renal function (including acute renal failure).
Postoje dokazi da istodobna primjena ACE inhibitora, ARB-ova ili aliskirena povećava rizik od hipotenzije, hiperkalemije i smanjene bubrežne funkcije (uključujući akutno zatajenje bubrega).
Thiazide diuretics should be administered with caution in patients with conditions involving enhanced potassium loss, for example salt-losing nephropathies and prerenal (cardiogenic) impairment of kidney function.
Tiazidske diuretike treba s oprezom primjenjivati u bolesnika sa stanjima koji uključuju pojačani gubitak kalija, na primjer nefropatije s gubitkom soli i prerenalnog (kardiogenog) oštećenja bubrežne funkcije.
The safety profile of Dafiro HCT presented below is based on clinical studies performed with Dafiro HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.
Niže prikazani sigurnosni profil Dafiro HCT-a temelji se na kliničkim ispitivanjima Dafiro HCT-a i poznatom sigurnosnom profilu pojedinačnih komponenti amlodipina, valsartana i hidroklorotiazida.
If excessive hypotension occurs with Dafiro HCT, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Ako se uz Dafiro HCT pojavi izrazita hipotenzija, bolesnika treba poleći na leđa i po potrebi, mu dati intravensku infuziju fiziološke otopine.
• depression
• depresija
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• citotoksičnim lijekovima (koriste se za liječenje raka), kao što su metotreksat ili ciklofosfamid;