FrancophonIA/ELRC3.0 huggingface dataset:
English: Following oral administration of Imprida HCT in normal healthy adults, peak plasma concentrations of amlodipine, valsartan and hydrochlorothiazide are reached in 6-8 hours, 3 hours, and 2 hours, respectively.
Slovenian: Po peroralni uporabi zdravila Imprida HCT pri normalnih zdravih odraslih doseže amlodipin najvišjo koncentracijo v plazmi v 6-8 urah, valsartan v 3 urah, hidroklorotiazid pa v 2 urah.
English: The combination resulted in expected reduction of red blood cell mass (erythrocytes, haemoglobin, haematocrit, and reticulocytes), increase in serum urea, increase in serum creatinine, increase in serum potassium, juxtaglomerular (JG) hyperplasia in the kidney and focal erosions in the glandular stomach in rats.
Slovenian: Ta kombinacija je povzročila pričakovano zmanjšanje vrednosti parametrov rdeče krvne slike (eritrocitov, hemoglobina, hematokrita in retikulocitov), zvišanje koncentracij sečnine, kreatinina in kalija v serumu, jukstaglomerulno hiperplazijo v ledvicah in fokalne erozije žleznega želodca pri podganah.
English: In the controlled trial of Imprida HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients.
Slovenian: V kontroliranem preskušanju zdravila Imprida HCT sta bila pri številnih bolnikih nasprotna učinka valsartana 320 mg in hidroklorotiazida 25 mg na koncentracijo kalija v serumu približno v ravnovesju.
English: Side effects reported with amlodipine or valsartan or hydrochlorothiazide alone, but not observed with Imprida HCT or observed in a higher frequency:
Slovenian: Neželeni učinki, ki so jih opisovali pri uporabi amlodipina, valsartana ali hidroklorotiazida posamezno, niso pa jih opažali pri uporabi zdravila Imprida HCT oziroma ne z večjo pogostnostjo:
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Slovenian: Zdravniku morate povedati, če dojite ali nameravate začeti z dojenjem.
English: Amlodipine belongs to a group of substances called “calcium channel blockers”.
Slovenian: Amlodipin sodi med zdravila, ki jih imenujemo zaviralci kalcijevih kanalčkov.
English: Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and raise serum levels of cholesterol, triglycerides and uric acid.
Slovenian: Tiazidni diuretiki, vključno s hidroklorotiazidom, lahko vplivajo na toleranco za glukozo in zvišajo koncentracije holesterola, trigliceridov in sečne kisline v serumu.
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.
Slovenian: Največji odmerek (pri miših je ta v mg/m izražen odmerek podoben največjemu priporočenemu kliničnemu odmerku 10 mg, pri podganah pa predstavlja dvakratnik* tega odmerka) je bil blizu največjega odmerka, ki ga miši še prenašajo, to pa ni veljalo za podgane.
English: Pharmacotherapeutic group: Angiotensin II antagonists, plain (valsartan), combinations with dihydropyridine derivatives (amlodipine) and thiazide diuretics (hydrochlorothiazide), ATC code: C09DX01 valsartan, amlodipine and hydrochlorothiazide.
Slovenian: Farmakoterapevtska skupina: antagonisti angiotenzina II, monokomponentna zdravila (valsartan), kombinacije z dihidropiridinskimi derivati (amlodipin) in tiazidni diuretiki (hidroklorotiazid), oznaka ATC: C09DX01 valsartan, amlodipin in hidroklorotiazid.
English: Arrhythmias (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Slovenian: Srčne bolezni palpitacije pogosti tahikardija aritmije (vključno z bradikardijo, ventrikularno tahikardijo in atrijsko fibrilacijo)
English: In case severe or rapid hyponatraemia develops during Imprida HCT therapy, the treatment should be discontinued until normalisation of natraemia.
Slovenian: Če se v času zdravljenja z zdravilom Imprida HCT razvije huda ali nenadna hiponatriemija, je treba zdravljenje prekiniti do normalizacije vrednosti natrija v krvi.
English: However, amlodipine, valsartan and hydrochlorothiazide have been tested individually for genotoxicity and carcinogenicity with negative results.
Slovenian: Posamezno pa so glede genotoksičnosti in kancerogenosti testirali amlodipin, valsartan in hidroklorotiazid, pri čemer so bili rezultati negativni.
English: These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
Slovenian: Med njimi so kalijevi nadomestki ali soli, ki vsebujejo kalij, zdravila, ki varčujejo s kalijem in heparin.
English: Fertility There are no clinical studies on fertility with Imprida HCT.
Slovenian: Plodnost Kliničnih študij glede plodnosti pri uporabi zdravila Imprida HCT ni.
English: If you forget to take Imprida HCT
Slovenian: Če ste pozabili vzeti zdravilo Imprida HCT
English: 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).
Slovenian: Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (ledvična odpoved, hipotenzija, hiperkaliemija) (glejte poglavje 5.3).
English: Not known
Slovenian: neznana:
English: There is no experience of overdose with Imprida HCT.
Slovenian: Izkušenj s prevelikim odmerjanjem zdravila Imprida HCT ni.
English: Amlodipine Grapefruit or grapefruit juice
Slovenian: amlodipin grenivka ali grenivkin sok
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Slovenian: V primeru izpostavljenosti antagonistom angiotenzina II od drugega trimesečja nosečnosti dalje je priporočen ultrazvočni pregled lobanje in delovanja ledvic.
English: Very rare Not known
Slovenian: Pogostnost neznana
English: Ciclosporin
Slovenian: ciklosporin
English: Due to the hydrochlorothiazide component, Imprida HCT is contraindicated in symptomatic hyperuricaemia.
Slovenian: Zaradi vsebnosti hidroklorotiazida je pri bolnikih s simptomatsko hiperurikemijo uporaba zdravila Imprida HCT kontraindicirana.
English: 98 x 1 film-coated tablet (unit dose) 280 film-coated tablets
Slovenian: 98 x 1 filmsko obložena tableta (za enkratni odmerek) 280 filmsko obloženih tablet
English: • fever (pyrexia)
Slovenian: • zvišana telesna temperatura (pireksija)
English: • urination disorders
Slovenian: • težave pri uriniranju
English: Treatment with hydrochlorothiazide should only be started after correction of pre-existing hyponatraemia.
Slovenian: Zdravljenje s hidroklorotiazidom je mogoče uvesti šele po korekciji že prisotne hiponatriemije.
English: 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]).
Slovenian: Tiazidi okrepijo antihipertenzivno delovanje drugih antihipertenzivnih zdravil (na primer gvanetidina, metildope, zaviralcev adrenergičnih receptorjev beta, vazodilatatorjev, zaviralcev kalcijevih kanalčkov, zaviralcev ACE, zaviralcev angiotenzinskih receptorjev in neposrednih zaviralcev renina (Direct Renin Inhibitors = DRI).
English: Do not use any Imprida HCT pack that is damaged or shows signs of tampering.
Slovenian: Zdravila Imprida HCT ne uporabljajte, če je ovojnina poškodovana ali opazite, da je bila že odprta.
English: The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Slovenian: Okvara ledvic na farmakokinetiko amlodipina ne vpliva pomembno.
English: The reductions in systolic/diastolic blood pressure with Imprida HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide.
Slovenian: Znižanje sistoličnega/diastoličnega krvnega tlaka je bilo z zdravilom Imprida HCT za 7,6/5,0 mmHg večje kot s kombinacijo valsartan/hidroklorotiazid, za 6,2/3,3 mmHg večje kot s kombinacijo amlodipin/valsartan in za 8,2/5,3 mmHg večje kot s kombinacijo amlodipin/hidroklorotiazid.
English: When Imprida HCT is used in patients with renal impairment periodic monitoring of serum electrolytes (including potassium), creatinine and uric acid serum levels is recommended.
Slovenian: Pri bolnikih z okvaro ledvic, ki jemljejo zdravilo Imprida HCT, je priporočljivo periodično kontrolirati koncentracije elektrolitov v serumu (vključno s koncentracijami kalija), kreatinina in sečne kisline.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: • swelling, reddening and pain along a vein
Slovenian: • otekanje, rdečina in bolečina v poteku vene
English: Valsartan Valsartan is unlikely to be removed by haemodialysis.
Slovenian: Valsartan Ni verjetno, da bi valsartan odstranili z dializo.
English: Information on Imprida HCT
Slovenian: Podatki o zdravilu Imprida HCT
English: Administration of thiazide diuretics, including hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium.
Slovenian: Sočasna uporaba tiazidnih diuretikov, vključno s hidroklorotiazidom, in vitamina D ali kalcijevih soli lahko stopnjuje zviševanje koncentracije kalcija v serumu.
English: Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Slovenian: Valsartan spada med zdravila, ki jih imenujemo antagonisti angiotenzina II.
English: • heart attack
Slovenian: • srčni napad (infarkt)
English: Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure
Slovenian: Sočasna uporaba zaviralcev privzemnega prenašalca (rifampicina, ciklosporina) ali zaviralcev izlivnega prenašalca (ritonavirja) lahko poveča sistemsko izpostavljenost valsartanu.
English: No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2).
Slovenian: Bolnikom z blago do zmerno okvaro ledvic začetnega odmerka ni treba prilagajati (glejte poglavji 4.4 in 5.2).
English: Due to the valsartan component, Imprida HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Slovenian: Zaradi vsebnosti valsartana je zdravilo Imprida HCT kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m basis (calculations assume an oral dose of
Slovenian: Ti odmerki pri podganah (200 do 600 mg/kg/dan) so približno 6-krat in 18-krat večji od največjega priporočenega odmerka za ljudi na osnovi mg/m
English: Caution is indicated in long-term administration of these
Slovenian: Pri dolgotrajni uporabi teh zdravil je potrebna previdnost.
English: Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham
Slovenian: Imetnik dovoljenja za promet z zdravilom Novartis Europharm Limited Wimblehurst Road
English: There is no experience on the use of Imprida HCT in pregnant women.
Slovenian: Z uporabo zdravila Imprida HCT pri nosečnicah ni nobenih izkušenj.
English: • irregular heart beat
Slovenian: • nepravilen srčni utrip
English: Before switching to Imprida HCT patients should be controlled on stable doses of the monocomponents taken at the same time.
Slovenian: Preden bolnik preide na uporabo zdravila Imprida HCT, mora biti njegov krvni tlak urejen s sočasno uporabo stabilnih odmerkov posameznih učinkovin.
English: Due to the valsartan component, Imprida HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Slovenian: Zaradi vsebnosti valsartana je zdravilo Imprida HCT kontraindicirano pri bolnikih z okvaro jeter (glejte poglavji 4.2 in 4.3).
English: Amlodipine/valsartan/hydrochlorothiazide
Slovenian: Amlodipin/valsartan/hidroklorotiazid
English: A total of 2,271 patients with moderate to severe hypertension (mean baseline systolic/diastolic blood pressure was 170/107 mmHg) received treatments of amlodipine/valsartan/hydrochlorothiazide 10 mg/320 mg/25 mg, valsartan/hydrochlorothiazide 320 mg/25 mg, amlodipine/valsartan 10 mg/320 mg, or hydrochlorothiazide/amlodipine 25 mg/10 mg. At study initiation patients were assigned lower doses of their treatment combination and were titrated to their full treatment dose by week 2.
Slovenian: Skupno je 2.271 bolnikov z zmerno do hudo hipertenzijo (njihovo povprečje sistoličnega/diastoličnega krvnega tlaka ob izhodišču je bilo 170/107 mmHg) prejemalo kombinacije amlodipin/valsartan/hidroklorotiazid 10 mg/320 mg/25 mg, valsartan/ hidroklorotiazid 320 mg/25 mg, amlodipin/valsartan 10 mg/320 mg ali hidroklorotiazid/amlodipin 25 mg/10 mg. Na začetku študije so bolniki prejemali manjše odmerke svoje kombinacije zdravil, do konca 2. tedna pa so jim odmerke zvišali do polne terapevtske višine.
English: Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day.
Slovenian: Valsartan v peroralnih odmerkih do 200 mg/kg/dan ni neugodno vplival na sposobnost razmnoževanja podganjih samic in samcev.
English: • low level of magnesium in the blood
Slovenian: • znižana raven magnezija v krvi
English: • inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
Slovenian: • vnetje krvnih žil s simptomi, kot so izpuščaj, vijolično-rdeče pike, zvišana telesna temperatura (vaskulitis)
English: if you have or have had heart failure or coronary artery disease, particularly if you are taking the maximum dose of Imprida HCT (10 mg/320 mg/25 mg) if your doctor has told you that you have a narrowing of the valves in your heart (called “aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”).
Slovenian: če imate težave z ledvicami, če so vam presadili ledvico ali so vam povedali, da imate zoženje ledvičnih arterij; če imate težave z jetri; če imate ali ste imeli kdaj prej srčno popuščanje ali koronarno bolezen, zlasti če jemljete najvišji odmerek zdravila Imprida HCT (10 mg/320 mg/25 mg); če vam je zdravnik povedal, da imate zožene srčne zaklopke (t.i. aortno ali mitralno stenozo) ali nenormalno zadebeljeno srčno mišico (t.i. obstruktivno hipertrofično kardiomiopatijo); če imate aldosteronizem, to je bolezen, pri kateri nadledvični žlezi tvorita preveč hormona aldosterona.
English: 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.
Slovenian: Antiholinergične zdravilne učinkovine (na primer atropin, biperiden) lahko povečajo biološko uporabnost diuretikov tiazidnega tipa, verjetno zaradi zmanjšanja motilitete prebavil in hitrosti praznjenja želodca.
English: At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Imprida HCT, 32.0/19.7 mmHg with valsartan/hydrochlorothiazide, 33.5/21.5 mmHg with amlodipine/valsartan, and 31.5/19.5 mmHg with amlodipine/hydrochlorothiazide.
Slovenian: Po 8 tednih je bilo povprečno znižanje sistoličnega/diastoličnega krvnega tlaka 39,7/24,7 mmHg z zdravilom Imprida HCT, 32,0/19,7 mmHg s kombinacijo valsartan/hidroklorotiazid, 33,5/21,5 mmHg s kombinacijo amlodipin/valsartan in 31,5/19,5 mmHg s kombinacijo amlodipin/ hidroklorotiazid.
English: • inability to either stand or walk in a normal manner
Slovenian: • nezmožnost normalnega stanja ali hoje
English: The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Slovenian: Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
English: • liver disorders which can occur together with yellow skin and eyes, or dark-coloured urine
Slovenian: • bolezen jeter, ki jo lahko spremljajo rumena koža in oči ali temno obarvan urin
English: The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Imprida HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually.
Slovenian: Spodaj navedeni neželeni učinki, ki so našteti po MedDRA razvrstitvi organskih sistemov in po pogostnosti, se nanašajo na zdravilo Imprida HCT (amlodipin/valsartan/hidroklorotiazid) in na amlodipin, valsartan in hidroklorotiazid posamezno.
English: Imprida HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide.
Slovenian: Tablete Imprida HCT vsebujejo tri učinkovine: amlodipin, valsartan in hidroklorotiazid.
English: 280 x 1 film-coated tablet (unit dose)
Slovenian: 280 x 1 filmsko obložena tableta (za enkratni odmerek)
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Imprida HCT is not suitable in this group of patients (see sections 4.2, 4.3 and 5.2).
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter brez holestaze je najvišji priporočeni odmerek valsartana 80 mg, zato zdravilo Imprida HCT ni primerno za to skupino bolnikov (glejte poglavja 4.2, 4.3 in 5.2).
English: Kidney transplantation
Slovenian: Presaditev ledvice
English: In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.
Slovenian: Pri sladkornih bolnikih je včasih treba prilagoditi odmerjanje insulina ali peroralnih hipoglikemičnih zdravil.
English: • runny nose
Slovenian: • izcedek iz nosu
English: • increase of creatinine in the blood
Slovenian: • zvišana koncentracija kreatinina v krvi
English: Medicinal products affecting serum sodium level
Slovenian: zdravila, ki vplivajo na koncentracijo natrija v serumu
English: Valsartan Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Slovenian: valsartan diuretiki, ki varčujejo s kalijem, kalijevi dodatki, nadomestki soli, ki vsebujejo kalij in druge učinkovine, ki lahko zvišajo koncentracijo kalija
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Imprida HCT is not suitable in this group of patients (see sections 4.3, 4.4 and 5.2).
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter brez holestaze je najvišji priporočeni odmerek valsartana 80 mg, zato zdravilo Imprida HCT ni primerno za to skupino bolnikov (glejte poglavja 4.3, 4.4 in 5.2).
English: Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Slovenian: Tiazidi, vključno s hidroklorotiazidom, lahko povečajo tveganje za neželene učinke, ki jih povzroča amantadin.
English: • rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
Slovenian: • izpuščaj, srbenje, koprivnica, oteženo dihanje ali požiranje, omotičnost (preobčutljivostne reakcije)
English: Treatment with Imprida HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Slovenian: Zdravljenje z zdravilom Imprida HCT je mogoče uvesti šele po korekciji hipokaliemije in morebitne sočasne hipomagneziemije.
English: Imprida HCT is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or was born prematurely.
Slovenian: Če želite dojiti, bo zdravnik za vas izbral drugo zdravilo, še posebno če je vaš otrok še novorojenček ali je bil rojen prezgodaj.
English: • fever, sore throat or mouth ulcers, more frequent infections (lack or low level of white blood cells)
Slovenian: • zvišana telesna temperatura, vneto žrelo ali razjede v ustih, pogostejše okužbe (pomanjkanje ali znižana koncentracija levkocitov)
English: It is recommended to limit the dose of simvastatin to 20 mg daily in patients on amlodipine.
Slovenian: Pri bolnikih, ki prejemajo amlodipin, je priporočeno znižati odmerek simvastatina na 20 mg dnevno.
English: Serum electrolyte changes
Slovenian: Spremembe elektrolitov v serumu
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Imprida HCT, 10 mg/320 mg/25 mg.
Slovenian: Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je priporočena previdnost, zlasti pri uporabi najvišjega odmerka zdravila Imprida HCT 10 mg/320 mg/25 mg.
English: Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers.
Slovenian: Pri nekaterih bolnikih, ki so jih zdravili z zaviralci kalcijevih kanalčkov, so poročali o reverzibilnih biokemijskih spremembah v glavah semenčic.
English: The active substances of Imprida HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Slovenian: Zdravilne učinkovine v zdravilu Imprida HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
English: 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.
Slovenian: Tiazidi delujejo tako, da verjetno tekmujejo za vezavno mesto za Cl in Cl ionov in ga na ta način zavirajo, s tem pa vplivajo na mehanizme reabsorpcije elektrolitov: neposredno povečajo izločanje natrija in klorida v približno enaki meri, posredno pa s takim diuretičnim delovanjem zmanjšajo volumen plazme, s tem povzročijo zvišanje delovanja renina v plazmi, izločanje aldosterona in izgubljanje kalija z urinom ter znižano koncentracijo kalija v serumu.
English: Hydrochlorothiazide crosses the placenta.
Slovenian: Hidroklorotiazid prehaja preko posteljice.
English: Marked and potentially prolonged systemic hypotension, including shock with fatal outcome, have been reported with amlodipine.
Slovenian: Pri uporabi amlodipina poročali o izraziti in potencialno dolgotrajni obliki sistemske hipotenzije, vključno s šokom s smrtnim izidom.
English: These doses in rats (600 mg/kg/day) are approximately 18 times the maximum recommended human dose on a mg/m basis (calculations assume an oral dose of
Slovenian: Ti odmerki pri podganah (600 mg/kg/dan) so približno 18-krat večji od največjega priporočenega odmerka za ljudi na osnovi mg/m
English: If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, frequent monitoring of potassium plasma levels is
Slovenian: Če kaže, da je treba v kombinaciji z valsartanom nujno uporabljati zdravilo, ki vpliva na koncentracijo kalija, je priporočljivo pogosto kontrolirati koncentracijo kalija v plazmi.
English: Thiazide diuretics can precipitate new onset hyponatraemia and hypochloroaemic alkalosis or exacerbate pre-existing hyponatraemia.
Slovenian: Pri uporabi tiazidnih diuretikov se lahko pojavita hiponatriemija in hipokloremična alkaloza ali pa se že prisotna hiponatriemija poslabša.
English: Not known • stiff limbs and trembling hands
Slovenian: Pogostnost neznana • okorelost okončin in tresenje rok