FrancophonIA/ELRC3.0 huggingface dataset:
English: Such conditions should be corrected before the administration of Kinzalkomb.
Slovak: Tovrstna stanja je treba uravnati pred zdravljenjem z zdravilom Kinzalkomb.
English: Treatment
Slovak: Zdravljenje
English: Concomitant administration of hydrochlorothiazide and telmisartan does not appear to affect the pharmacokinetics of either substance in healthy subjects.
Slovak: Kaže, da sočasno dajanje hidroklorotiazida in telmisartana pri zdravih osebah ne spremeni farmakokinetike ene ali druge snovi.
English: These patients can be expected to have reduced hepatic clearance for telmisartan.
Slovak: Pri njih lahko pričakujemo zmanjšan jetrni očistek telmisartana.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Kinzalkomb.
Slovak: Oba sta lahko tudi simptoma zvišanega očesnega tlaka, ki se pojavita nekaj ur do nekaj tednov po začetku jemanja zdravila Kinzalkomb.
English: Tabulated list of adverse reactions
Slovak: Tabelarični seznam neželenih učinkov
English: PHARMACEUTICAL FORM AND CONTENTS
Slovak: OBLIKA IN VSEBINA
English: Kinzalkomb 80 mg/12.5 mg tablets EU/1/02/214/006-010
Slovak: Kinzalkorb 80 mg/12,5 mg tablete EU/1/02/214/006-010
English: This medicinal product contains lactose monohydrate and sorbitol.
Slovak: To zdravilo vsebuje laktozo monohidrat in sorbitol.
English: The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.
Slovak: P450 pri presnavljanju telmisartana ne sodelujejo.
English: Toxicological findings also well known from preclinical studies with angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists were: a reduction of red cell parameters (erythrocytes, haemoglobin, haematocrit), changes of renal haemodynamics (increased blood urea nitrogen and creatinine), increased plasma renin activity, hypertrophy/hyperplasia of the juxtaglomerular cells and gastric mucosal injury.
Slovak: Toksikološki izvidi, ki so znani tudi iz predkliničnih raziskav o zaviralcih angiotenzinske konvertaze in antagonistih angiotenzina II, so bili: zmanjšanje parametrov rdečih krvničk (eritrocitov, hemoglobina, hematokrita); spremembe ledvične hemodinamike (povečana vsebnost dušika v sečnini v krvi in kreatinina); povečana aktivnost renina v plazmi; hipertrofija oz. hiperplazija jukstaglomerulnih celic in poškodba želodčne sluznice.
English: There is limited information available for telmisartan with regard to overdose in humans.
Slovak: O prevelikem odmerjanju telmisartana pri ljudeh je malo podatkov.
English: Because no information is available regarding the use of Kinzalkomb during breast-feeding, Kinzalkomb is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Slovak: Ker o uporabi zdravila Kinzalkomb med dojenjem ni podatkov, ga ne priporočajo, zato je treba med dojenjem, še zlasti med dojenjem novorojenčkov ali prezgodaj rojenih dojenčkov, dajati prednost alternativnim zdravilom, katerih varnostne lastnosti so bolj raziskane
English: This is confirmed by measurements made at the point of maximum effect and immediately prior to the next dose (through to peak ratios consistently above 80 % after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies).
Slovak: Enakomerno trajanje učinka so potrdile meritve pri največjem učinku in tik pred naslednjim odmerkom (v s placebom nadzorovanih kliničnih preskušanjih je bil količnik med pojemanjem učinka in največjim učinkom vedno nad 80 %).
English: Food slightly reduces the bioavailability of telmisartan with a reduction in the area under the plasma concentration time curve (AUC) of about 6 % with the 40 mg tablet and about 19 % after a 160 mg dose.
Slovak: Pri tem se območje pod krivuljo plazemske koncentracije v odvisnosti od časa (AUC) zmanjša za približno 6 % pri tabletah po 40 mg in za približno 19 % pri odmerkih po 160 mg. Tri ure po dajanju so koncentracije v plazmi pri jemanju na tešče in s hrano podobne.
English: Medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives)
Slovak: Zdravila, ki povzročajo izgubo kalija in hipokaliemijo (npr. drugi kaliuretični diuretiki, laksativi, kortikosteroidi, ACTH, amfotericin, karbenoksolon, natrijev benzilpenicilinat, salicilna kislina in derivati)
English: Non-melanoma skin cancer
Slovak: Nemelanomski kožni rak
English: No dose adjustment is necessary.
Slovak: Odmerka ni treba prilagoditi.
English: Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4).
Slovak: Tiazide moramo previdno dajati bolnikom z zmanjšanim delovanjem jeter (glejte poglavje 4.4).
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and
Slovak: Ob potrjeni nosečnosti je treba zdravljenje z antagonisti II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje (glejte poglavji 4.3 in 4.6).
English: Intravascular hypovolaemia
Slovak: Znotrajžilna hipovolemija
English: Interstitial lung disease
Slovak: Intersticijska pljučna bolezen
English: Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Slovak: Pri bolnikih, ki so jemali samo hidroklorotiazid, so poročali še o naslednjih neželenih učinkih:
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Slovak: Bolniki morajo biti ustrezno hidrirani na začetku sočasnega zdravljenja in v rednih razmikih med njim pa je treba presoditi tudi o spremljanju delovanja ledvic.
English: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Slovak: Enako kot za uporabo drugih vazodilatatorjev velja posebna previdnost pri dajanju zdravila Kinzalkomb bolnikom z zožitvijo aorte ali mitralne zaklopke ali obstruktivno hipertrofično kardiomiopatijo.
English: Other antihypertensive agents
Slovak: Drugi antihipertenzivi
English: Gender
Slovak: Spol
English: The effect of pressor amines may be decreased.
Slovak: Njihov učinek se lahko zmanjša.
English: One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively.
Slovak: Ena od študij je vključevala 71.533 bolnikov z bazalnoceličnim karcinomom in 8.629 bolnikov s ploščatoceličnim karcinomom, ki so jih primerjali s kontrolnim vzorcem 1.430.833 bolnikov z bazalnoceličnim karcinomom in 172.462 bolnikov s ploščatoceličnim karcinom.
English: Germany
Slovak: Nemčija
English: Kinzalkomb fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Slovak: Zdravilo Kinzalkomb, fiksna kombinacija (40 mg telmisartana/12,5 mg hidroklorotiazida in 80 mg telmisartana/12,5 mg hidroklorotiazida), je indicirano za odrasle, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim telmisartanom.
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Slovak: Kadar bolnikovo klinično stanje dopušča, se lahko odločimo za neposreden prehod z monoterapije na zdravljenje s fiksno kombinacijo.
English: - This medicine has been prescribed for you only.
Slovak: - Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Muscle relaxing medicines, such as tubocurarine.
Slovak: Nedepolarizirajoči mišični relaksanti s perifernim delovanjem (npr. tubokurarin)
English: • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder), or any other severe liver disease.
Slovak: • če imate hude jetrne težave, kot sta holestaza ali zapora žolčevoda (težave z odtekanjem žolča iz jeter in žolčnika), ali katerokoli drugo hudo jetrno bolezen,
English: • Periodic Safety Update Reports
Slovak: Redno posodobljena poročila o varnosti zdravila (PSUR)
English: In the "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.002.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14 - 3.76)].
Slovak: V preskušanju PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes) se je pri bolnikih, starih 50 let in starejših, ki so pred kratkim doživeli možgansko kap, med jemanjem telmisartana povečala pojavnost sepse, in sicer pri 0,70 % v primerjavi z 0,49 % pri zdravljenih s placebom [RR 1,43 (95-odstotni interval zaupanja 1,00 do 2,06)].
English: Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure.
Slovak: Telmisartan je podobno učinkovito kot ramipril zmanjšal primarni, sestavljeni opazovani dogodek, ki je zajemal srčnožilno smrt, neusodni miokardni infarkt, neusodno možgansko kap ali bolnišnično zdravljenje zaradi kongestivnega srčnega popuščanja.
English: Antidiabetic medicinal products (oral agents and insulin)
Slovak: Antidiabetiki (peroralni antidiabetiki in insulin)
English: Telmisartan does not accumulate significantly in plasma on repeated administration.
Slovak: Telmisartan se po ponovnem dajanju v plazmi pomembneje ne kopiči.
English: Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia.
Slovak: hipomagneziemija hiperkalciemija hipokloremična alkaloza anoreksija, zmanjšan apetit, elektrolitsko neravnovesje, hiperholesterolemija, hiperglikemija, hipovolemija
English: • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Slovak: • če imate hude jetrne težave, kot sta holestaza ali zapora žolčevoda (težave z odtekanjem žolča iz jeter in žolčnika) ali katerokoli drugo hudo jetrno bolezen,
English: Hydrochlorothiazide is excreted in human milk in small amounts.
Slovak: Majhna količina hidroklorotiazida se izloča v materino mleko.
English: In patients with mild to moderate hepatic impairment the posology should not exceed Kinzalkomb 40 mg/12.5 mg once daily.
Slovak: Odmerek za bolnike z blago do zmerno zmanjšanim jetrnim delovanjem ne sme prekoračiti odmerka zdravila Kinzalkomb 40 mg/12,5 mg 1-krat na dan.
English: You should store your medicine in the original package in order to protect the tablets from moisture.
Slovak: Zdravilo shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: What Kinzalkomb is and what it is used for What you need to know before you take Kinzalkomb How to take Kinzalkomb
Slovak: Kaj je zdravilo Kinzalkomb in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Kinzalkomb Kako jemati zdravilo Kinzalkomb Možni neželeni učinki
English: Previous preclinical safety studies performed with co-administration of telmisartan and hydrochlorothiazide in normotensive rats and dogs, in doses producing exposure comparable to that in the clinical therapeutic range, caused no additional findings not already observed with administration of either substance alone.
Slovak: Predklinične raziskave o varnosti, v katerih so telmisartan in hidroklorotiazid sočasno dajali normotenzivnim podganam in psom, odmerki, ki so ustrezali tistim v kliničnem terapevtskem razponu, niso imeli učinkov, ki bi se razlikovali od onih, ki so znani za posamezni snovi.
English: In dogs renal tubular dilation and atrophy were observed.
Slovak: Pri psih so zasledili razširitev ledvičnih tubulov in atrofijo.
English: Kinzalkomb may be less effective in lowering the blood pressure in black patients.
Slovak: Zdravilo Kinzalkomb lahko pri črni rasi manj učinkovito znižuje krvni tlak.
English: Kinzalkomb is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.
Slovak: Zdravilo Kinzalkomb je namenjeno za zdravljenje visokega krvnega tlaka (esencialne hipertenzije) pri odraslih, pri katerih s samim telmisartanom krvnega tlaka ne moremo dovolj uravnati.
English: If Kinzalkomb is used during breast feeding, doses should be kept as low as possible.
Slovak: Če doječe matere zdravilo Kinzalkomb uporabljajo med dojenjem, morajo biti njegovi odmerki karseda majhni.
English: If these medicinal products are to be prescribed with the hydrochlorothiazide-telmisartan combination, monitoring of potassium plasma levels is advised.
Slovak: Če moramo našteta zdravila predpisati hkrati s kombinacijo hidroklorotiazida in telmisartana, priporočamo spremljanje ravni kalija v plazmi.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer AG
Slovak: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer AG
English: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed.
Slovak: Pri sočasni uporabi telmisartana in digoksina je prišlo do srednje velikega povečanja največje koncentracije digoksina v plazmi (49
English: Based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of the above medicinal products may lead to increases in serum potassium and is, therefore, not recommended (see section
Slovak: Izkušnje z drugimi zdravili, ki zavirajo delovanje reninangiotenzinskega sistema, kažejo, da lahko sočasno dajanje teh zdravil poveča raven kalija v serumu, in jih zato ne priporočamo (glejte poglavje 4.4).
English: Store in the original package in order to protect from moisture.
Slovak: Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: Other
Slovak: Drugo
English: Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan.
Slovak: V obdobju po začetku trženja zdravila so poročali o primerih intersticijske pljučne bolezni, ki so bili časovno povezani z jemanjem telmisartana.
English: Each 40 mg/12.5 mg tablet contains 112 mg of lactose monohydrate and 169 mg sorbitol (E420).
Slovak: Ena 40 mg/12,5 mg tableta vsebuje 112 mg laktoze monohidrata in 169 mg sorbitola (E420).
English: Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of Kinzalkomb, hyperkalaemia might occur.
Slovak: Zaradi antagonističnega delovanja telmisartana v zdravilu Kinzalkomb na receptorje za angiotenzin II (AT1) je možna tudi hiperkaliemija.
English: Diarrhoea, dry mouth, flatulence Abdominal pain, constipation, dyspepsia, vomiting, gastritis
Slovak: abdominalna bolečina, zaprtje, dispepsija, bruhanje, gastritis
English: - If you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Slovak: Brez zdravljenja lahko pride do trajne okvare vida; - če ste imeli kožnega raka ali če se vam med zdravljenjem pojavijo nepričakovane kožne spremembe.
English: Each tablet contains 99 mg of lactose monohydrate and 338 mg sorbitol (E420).
Slovak: Ena tableta vsebuje 99 mg laktoze monohidrata in 338 mg sorbitola (E420).
English: Haemoglobin decreased
Slovak: znižan hemoglobin
English: What is in this leaflet
Slovak: Kaj vsebuje navodilo
English: Kinzalkomb is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Slovak: Zdravilo Kinzalkomb je kombinacija antagonista receptorjev angiotenzina II telmisartana in tiazidnega diuretika hidroklorotiazida.
English: Another study showed a possible association between lip cancer (SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, using a risk-set sampling strategy.
Slovak: S pomočjo strategije vzorčenja iz tveganih populacij so primerjali 633 primerov raka ustnice s kontrolno populacijo 63.067 bolnikov.
English: Tachycardia, arrhythmias
Slovak: tahikardija, aritmije
English: Dosage adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Slovak: Včasih je treba prilagoditi odmerek antidiabetika (glejte poglavje 4.4).
English: The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups.
Slovak: Podobno pojavnost primarnega opazovanega dogodka so ugotovili v obeh skupinah: s telmisartanom (16,7
English: There was a trend towards higher plasma concentrations of hydrochlorothiazide in female than in male subjects.
Slovak: Tudi plazemske koncentracije hidroklorotiazida se pri ženskah nagibajo k nekoliko večjim vrednostim.
English: Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart rate (faster than 100 beats per minute).
Slovak: Značilni simptomi neravnovesja tekočine ali elektrolitov so suha usta, šibkost, letargija, dremavost, nemir, mišična bolečina ali krči, slabost (siljenje na bruhanje), bruhanje, utrujene mišice in nenormalno hitro bitje srca (več kot 100 utripov na minuto).
English: Eczema, drug eruption, toxic skin eruption Musculoskeletal, connective tissue and bone disorders Rare:
Slovak: ekcem, medikamentni izpuščaj, toksični kožni izpuščaj Bolezni mišično-skeletega sistema, vezivnega tkiva in kosti Redki:
English: Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney failure, have also been reported.
Slovak: V poročilih navajajo še počasen srčni utrip, omotico, bruhanje in zmanjšano ledvično delovanje, tudi ledvično odpoved.
English: Hydrochlorothiazide
Slovak: Hidroklorotiazid
English: Kinzalkomb tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Slovak: Jemanje tablet Kinzalkomb je peroralno enkrat na dan s tekočino, s hrano ali brez nje.
English: CLINICAL PARTICULARS
Slovak: KLINIČNI PODATKI
English: The observed increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently known.
Slovak: Povečana pojavnost sepse med jemanjem telmisartana je lahko naključni dogodek ali pa je povezana s še neznanim mehanizmom.
English: How to take Kinzalkomb
Slovak: Kako jemati zdravilo Kinzalkomb
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/214/011-015
Slovak: ZA PROMET Z ZDRAVILOM EU/1/02/214/011-015
English: In addition, there was a significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the combination arm.
Slovak: Poleg tega je bila v skupini, ki je jemala kombinacijo zdravil, značilno večja pojavnost hiperkaliemije, ledvične odpovedi, hipotenzije in sinkope.
English: Upper respiratory tract infection, urinary tract infection including cystitis
Slovak: okužba zgornjih dihal, okužba sečil, tudi cistitis
English: The risk of hypokalaemia is greater in patients with cirrhosis of liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or Adrenocorticotropic hormone (ACTH) (see section 4.5).
Slovak: Možnost, da se bo hipokaliemija pojavila, je večja pri bolnikih z jetrno cirozo, s povečano diurezo ali pri bolnikih, ki peroralno ne dobivajo ustreznih odmerkov elektrolitov, in pri sočasnem zdravljenju s kortikosteroidi ali adrenokortikotropnim hormonom adenokortikotropni hormon (ACTH)
English: The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Slovak: Koliko hidroklorotiazida se odstrani s hemodializo, ni raziskano.
English: Renal excretion does not contribute to the clearance of telmisartan.
Slovak: Izločanje skozi ledvice ne poveča telmisartanovega očistka.
English: You must tell your doctor if you think you are (or might become) pregnant.
Slovak: Zdravniku morate povedati, če mislite, da ste noseči ali če načrtujete nosečnost.
English: In a double-blind controlled clinical trial (n=687 patients evaluated for efficacy) in non-responders to the 80 mg/12.5 mg combination, an incremental blood pressure lowering effect of the 80 mg/25 mg combination compared to continued treatment with the 80 mg/12.5 mg combination of 2.7/1.6 mm Hg (SBP/DBP) was demonstrated (difference in adjusted mean changes from baseline).
Slovak: V dvojno slepi, nadzorovani klinični raziskavi (n = 687 bolnikov, pri katerih so ocenili učinkovitost) pri bolnikih, ki se niso odzivali na zdravljenje s kombinacijo 80 mg/12,5 mg, je kombinacija 80 mg/25 mg v primerjavi s stalnim zdravljenjem s kombinacijo 80 mg/12,5 dodatno znižala krvni tlak za 2,7/1,6 mm Hg (SKT/DKT)
English: Elderly
Slovak: Starejši
English: Hyperkalaemia Hypoglycaemia (in diabetic patients)
Slovak: hipoglikemija (pri bolnikih s sladkorno boleznijo)
English: The effect of Kinzalkomb may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).
Slovak: Učinek zdravila Kinzalkomb se lahko zmanjša, če jemljete NSAR (nesteroidne antirevmatike, npr. acetilsalicilno kislino ali ibuprofen).
English: Visual disturbance, vision blurred
Slovak: motnje vida, meglen vid
English: Telmisartan is not removed from blood by haemodialysis.
Slovak: Telmisartan se s hemodializo ne odstrani.
English: Endocrine disorders Not known:
Slovak: Bolezni endokrinega sistema Neznana:
English: Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, asthenia, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting (see section 4.8).
Slovak: Opozorilni znaki, ki kažejo na motnje ravnovesja tekočin ali elektrolitov, so suha usta, žeja, astenija, brezvoljnost, dremavica, nemir, mišična bolečina ali krči, mišična utrujenost, hipotenzija, oligurija, tahikardija in prebavne motnje, npr. slabost ali bruhanje (glejte poglavje 4.8).
English: If you experience any of these you should tell your doctor.
Slovak: Če opazite katerikoli pojav od naštetih, obvestite svojega zdravnika.
English: Presumably through blockade of the reninangiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Slovak: Sočasno dajanje telmisartana domnevno deluje zaradi blokade renin-angiotenzin-aldosteronskega sistema, reverzibilno na izgubo kalija, do katere prihaja pri teh diuretikih.
English: 3: For further description, please see sub-section“Description of selected adverse reactions” Hydrochlorothiazide:
Slovak: Za podrobnejši opis glejte podpoglavje »Opis izbranih neželenih učinkov« Hidroklorotiazid
English: Hydrochlorothiazide: Following oral administration of Kinzalkomb peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Slovak: Po peroralnem dajanju zdravila Kinzalkomb doseže hidroklorotiazid največjo koncentracijo v plazmi približno v 1,0 do 3,0 urah.
English: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Slovak: Enako kot pri vseh bolnikih, ki se zdravijo z diuretiki, so potrebni periodični kontrolni pregledi ravni elektrolitov v serumu.
English: Only minute amounts were found in urine.
Slovak: V seču so izmerili le neznatno količino.
English: Very rare side effects (may affect up to 1 in 10,000 people):
Slovak: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):