FrancophonIA/ELRC3.0 huggingface dataset:
English: Kinzalkomb is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Croatian: Kinzalkomb se ne preporučuje majkama koje doje, a liječnik može odabrati drugo liječenje za Vas ako želite dojiti.
English: Studies with hydrochlorothiazide have shown equivocal evidence for a genotoxic or carcinogenic effect in some experimental models.
Croatian: Studije s hidroklorotiazidom pokazale su nepouzdan dokaz genotoksičnog ili kancerogenog učinka kod pojedinih eksperimentalnih modela.
English: The safety and efficacy of Kinzalkomb in children and adolescents aged below 18 have not been established.
Croatian: Sigurnost i djelotvornost Kinzalkomba u djece i adolescenata u dobi do 18 godina nisu ustanovljene.
English: Plasma concentrations of telmisartan are generally 2 - 3 times higher in females than in males.
Croatian: Koncentracije telmisartana u plazmi su općenito 2-3 puta veće kod žena nego kod muškaraca.
English: Telmisartan showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Croatian: Telmisartan nije pokazao dokaze mutagenosti i relevantne klastogene aktivnosti u in vitro studijama, niti dokaze kancerogenosti kod štakora i miševa.
English: In clinical trials however, no significant increases in blood pressure response or in the incidence of orthostatic hypotension were found in women.
Croatian: Međutim, u kliničkim ispitivanjima nisu pronađena značajna povećanja u odgovoru krvnog tlaka ili incidenciji ortostatske hipotenzije kod žena.
English: Other medicines and Kinzalkomb:
Croatian: Drugi lijekovi i Kinzalkomb:
English: Rare cases have also been reported with angiotensin II receptor antagonists (including Kinzalkomb).
Croatian: Rijetki slučajevi također su zabilježeni uz antagoniste receptora angiotenzina II (uključujući Kinzalkomb).
English: Side effects of unknown frequency (frequency cannot be estimated from the available data):
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može utvrditi iz dostupnih podataka):
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Croatian: Bolesnici s primarnim aldosteronizmom općenito neće reagirati na antihipertenzive koji djeluju putem inhibicije sustava renin-angiotenzin.
English: You should consult with your doctor if you need to adjust the dose of your other medicine while taking Kinzalkomb.
Croatian: Potrebno je posavjetovati se s liječnikom ako trebate prilagođavanje doze drugog lijeka dok uzimate Kinzalkomb.
English: The apparent volume of distribution for telmisartan is approximately 500 litres indicating additional tissue binding.
Croatian: Prividni volumen distribucije za telmisartan je oko 500 litara, ukazujući na dodatno vezanje u tkivima.
English: Telmisartan is highly bound to plasma proteins (>99.5 %) mainly albumin and alpha l- acid glycoprotein.
Croatian: Telmisartan se uvelike veže na proteine plazme (>99,5 %), uglavnom albumin i alfa 1 kiseli glikoprotein.
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Croatian: Uz hidroklorotiazid, početak diureze javlja se za 2 sata, a vršni učinak pojavljuje se nakon otprilike 4 sata, dok djelovanje traje oko 6-12 sati.
English: The toxicological findings observed appear to have no relevance to human therapeutic use.
Croatian: Zabilježeni toksikološki nalazi nisu se pokazali relevantnima za terapijsku primjenu u ljudi.
English: The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Croatian: Kombinacija ovih sastojaka ima dodatan antihipertenzivni učinak, koji snižava krvni tlak u većoj mjeri nego što to čini svaka od komponenti zasebno.
English: Based on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60 %.
Croatian: Na osnovi kumulativne renalne ekskrecije hidroklorotiazida, apsolutna bioraspoloživost bila je oko 60 %.
English: Hydrochlorothiazide is not metabolised in man.
Croatian: Hidroklorotiazid se ne metabolizira u ljudi.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Kinzalkombs” and “Warnings and precautions”).
Croatian: - Ako uzimate ACE_inhibitor ili aliskiren (vidjeti također informacije pod naslovima „Nemojte uzimati Kinzalkomb i „Upozorenja i mjere opreza“).
English: If a readministration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Croatian: Ako se ponovna primjena diuretika smatra potrebnom, preporučuje se zaštita dijelova izloženih suncu ili umjetnom UVA zračenju.
English: • Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Kinzalkomb once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
Croatian: Kinzalkomb jedanput dnevno dovodi do učinkovitog i ujednačenog sniženja krvnog tlaka u rasponu terapijskih doza.
English: Renal clearance is about 250 - 300 ml/min.
Croatian: Renalni klirens je oko 250-300 ml/min.
English: If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.
Croatian: Ako Vaša jetra ne radi normalno, uobičajena doza ne smije prelaziti 40 mg/12,5 mg jedanput dnevno.
English: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Croatian: Kao kod svih bolesnika liječenih diureticima mora se periodično određivati serumske elektrolite u odgovarajućim intervalima.
English: • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
Croatian: • ako liječnik ustanovi da imate niske vrijednosti kalija ili visoke vrijednosti kalcija u krvi, a stanje se ne poboljšava s liječenjem.
English: Plasma aldosterone levels are decreased by telmisartan.
Croatian: Vrijednosti aldosterona u plazmi se smanjuju putem telmisartana.
English: However, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Croatian: Međutim, opsežno iskustvo primjene hidroklorotiazida u ljudi nije pokazalo vezu između njegove primjene i povećanja neoplazmi.
English: Amantadine (medicine used to treat Parkinson's disease and also used to treat or prevent certain illnesses caused by viruses).
Croatian: Amantadin (lijek koji se primjenjuje u liječenju Parkinsonove bolesti te se također primjenjuje u liječenju ili prevenciji određenih bolesti uzrokovanih virusima).
English: Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Croatian: Povećanje doze probenecida ili sulfinpirazona može se pokazati nužnim.
English: Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Croatian: Izražena hiperkalcemija može biti dokaz skrivenog hiperparatireoidizma.
English: Medicines to increase blood pressure, such as noradrenaline.
Croatian: Lijekovi za povišenje krvnog tlaka kao što je noradrenalin.
English: Elimination Telmisartan: Following either intravenous or oral administration of
Croatian: Eliminacija Telmisartan: Nakon i intravenske ili peroralne primjene
English: Bronchitis, pharyngitis, sinusitis
Croatian: Bronhitis, faringitis i sinusitis
English: Pharmacotherapeutic group: Angiotensin II antagonists and diuretics, ATC code: C09DA07
Croatian: Farmakoterapijska skupina: Antagonisti angiotenzina II s diureticima, ATK oznaka: C09DA07
English: Thiazides have an effect on the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
Croatian: Tiazidi imaju učinak na renalne tubularne mehanizme reapsorpcije elektrolita, izravno povećavajući ekskreciju natrija i klorida u približno jednakim količinama.
English: • Cholestasis and biliary obstructive disorders.
Croatian: • Kolestaza i bilijarni opstruktivni poremećaji.
English: Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su klasificirane po učestalosti koristeći sljedeću podjelu: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i <1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in Kinzalkomb, minimal or no effects were reported.
Croatian: Povećanje razine kolesterola i triglicerida povezano je s tiazidnom diuretskom terapijom; međutim, pri dozi od 12,5 mg koja je sadržana u Kinzalkombu, zabilježen je minimalan ili nikakav učinak.
English: Your doctor will normally advise you to stop taking Kinzalkomb before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kinzalkomb.
Croatian: Liječnik će Vam, u redovnom slučaju, savjetovati prekid primjene Kinzalkomba prije nego budete trudni ili čim saznate da ste trudni, te će Vam preporučiti drugi lijek umjesto Kinzalkomba.
English: C-labelled telmisartan the glucuronide represents approximately 11 % of the measured radioactivity in plasma.
Croatian: C-označenog telmisartana glukuronid predstavlja oko 11 % mjerene radioaktivnosti u plazmi.
English: The effects of fixed dose combination of telmisartan/HCTZ on mortality and cardiovascular morbidity are currently unknown.
Croatian: Učinci kombinacije fiksne doze telmisartana/HCTZ-a na smrtnost i kardiovaskularni morbiditet su trenutno nepoznati.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Kinzalkomb in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Kinzalkomb u svim podskupinama pedijatrijske populacije u hipertenziji (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of Kinzalkomb, hyperkalaemia might occur.
Croatian: Nasuprot tome, zahvaljujući antagonizmu receptora angiotenzina II (AT1) putem telmisartanske komponente Kinzalkomba, može doći do pojave hiperkalemije.
English: Therefore, the use of Kinzalkomb is not recommended.
Croatian: Stoga se ne preporučuje primjena Kinzalkomba.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti nuspojave su predstavljene u padajućem nizu prema ozbiljnosti.
English: Calcium supplements and/or vitamin D supplements.
Croatian: Nadomjesci kalcija i/ili nadomjesci vitamina D.
English: No action needs to be taken if this is observed.
Croatian: Ako se to primijeti, nije potrebno ništa poduzeti.
English: The following adverse reactions listed below have been accumulated from all clinical trials in patients treated with telmisartan for hypertension or in patients 50 years or older at high risk of cardiovascular events.
Croatian: Sljedeće nuspojave lijeka navedene u nastavku prikupljene su iz svih kliničkih ispitivanja na bolesnicima liječenim telmisartanom zbog hipertenzije ili na bolesnicima od 50 i više godina starosti s visokim rizikom od kardiovaskularnih događaja.
English: You should also tell your doctor, if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal.
Croatian: Također morate obavijestiti liječnika ako imate pojačanu osjetljivost kože na sunce sa simptomima opeklina (kao što su crvenilo, svrbež, oticanje, mjehurići) koji se pojavljuju brže nego što je normalno.
English: What you need to know before you take Kinzalkomb
Croatian: Što morate znati prije nego počnete uzimati Kinzalkomb
English: Pressor amines (e.g. noradrenaline)
Croatian: Presorni amini (npr. noradrenalin)
English: The mechanism of the antihypertensive effect of thiazide diuretics is not fully known.
Croatian: Mehanizam antihipertenzivnog učinka tiazidnih diuretika nije u potpunosti poznat.
English: As with all other angiotensin II receptor antagonists, telmisartan is apparently less effective in lowering blood pressure in black patients than in non blacks, possibly because of higher prevalence of low renin states in the black hypertensive population.
Croatian: Kao i kod svih drugih antagonista receptora angiotenzina II, telmisartan je očigledno manje učinkoviti kod snižavanja krvnog tlaka kod ljudi crne rase nego kod ljudi koji nisu crne rase, vjerojatno zbog veće prevalencije niskih razina renina kod populacije crne rase s hipertenzijom.
English: Telmisartan does not accumulate significantly in plasma on repeated administration.
Croatian: Telmisartan se značajno ne akumulira u plazmi pri ponavljanoj primjeni.
English: • Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product).
Croatian: • Preosjetljivost na druge derivate sulfonamida (s obzirom da je hidroklorotiazid derivat sulfonamida).
English: The glucuronide of the parent compound is the only metabolite that has been identified in humans.
Croatian: Glukuronid izvorne tvari je jedini metabolit koji je otkriven kod ljudi.
English: • if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines.
Croatian: • ako ste alergični na hidroklorotiazid ili neki od drugih derivata sulfonamida.
English: No dosage adjustment is necessary.
Croatian: Nije potrebno prilagođavanje doze.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Croatian: Bolesnici se moraju odgovarajuće hidrirati te se mora obratiti pažnju na praćenje bubrežne funkcije nakon početka istodobne terapije, kao i periodično nakon toga.
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Croatian: Farmakokinetičke studije na bolesnicima s oštećenjem funkcije jetre pokazale su povećanje u apsolutnoj bioraspoloživosti do gotovo 100 %.
English: The overall incidence of adverse reactions reported with telmisartan (41.4 %) was usually comparable to placebo (43.9 %) in placebo controlled trials.
Croatian: Ukupna incidencija nuspojava prijavljenih uz telmisartan (41,4%) obično je bila usporediva s placebom (43,9%) u placebom kontroliranim ispitivanjima.
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Croatian: Telmisartan ne inhibira enzim koji pretvara angiotenzin (kininaza II), enzim koji također degradira bradikinin.
English: Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.
Croatian: Alkohol može dodatno sniziti krvni tlak i/ili povećati rizik od omaglice ili osjećaja nesvjestice.
English: Triglycerides increased
Croatian: Povišeni trigliceridi
English: Kinzalkomb with food and alcohol
Croatian: Kinzalkomb s hranom i alkoholom
English: Hydrochlorothiazide is excreted almost entirely as unchanged substance in urine.
Croatian: Hidroklorotiazid se izlučuje gotovo u potpunosti u nepromijenjenom obliku putem urina.
English: • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Croatian: • ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren.
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).
Croatian: Ovo je potvrđeno mjerenjima napravljenima pri maksimalnom učinku i neposredno prije sljedeće doze (omjer između najnižih i vršnih vrijednosti neprekidno iznad 80 % nakon doza od 40 i 80 mg telmisartana u placebom kontroliranim kliničkim studijama).
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.
Croatian: Hrana u vrlo maloj mjeri reducira bioraspoloživost telmisartana, s redukcijom površine ispod krivulje plazmatske koncentracije u odnosu na vrijeme (AUC) od oko 6 % uz tabletu od 40 mg i oko 19 % nakon doze od 160 mg.
English: The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Croatian: Hiperglikemijski učinak beta-blokatora i diazoksida može se pojačati tiazidima.
English: Read the package leaflet for further information.
Croatian: Pročitati uputu o lijeku za dodatne informacije.
English: Telmisartan may increase the hypotensive effect of other antihypertensive agents.
Croatian: Telmisartan može povećati hipotenzivni učinak ostalih antihipertenzivnih lijekova.
English: There is limited information available for telmisartan with regard to overdose in humans.
Croatian: Postoje ograničeni dostupni podaci u vezi predoziranja telmisartanom u ljudi.
English: Kinzalkomb contains milk sugar (lactose) and sorbitol.
Croatian: Kinzalkomb sadrži mliječni šećer (laktoza) i sorbitol.
English: Cases of photosensitivity reactions have been reported with thiazide diuretics (see section 4.8).
Croatian: Prijavljeni su slučajevi reakcija fotoosjetljivosti uz tiazidske diuretike (vidjeti dio 4.8).
English: Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Croatian: Telmisartan ne pokazuje nikakvu djelomičnu agonističku aktivnost na AT1 receptoru.
English: If Kinzalkomb is used during breast feeding, doses should be kept as low as possible.
Croatian: Ako se Kinzalkomb primjenjuje tijekom dojenja, mora se primijeniti najniža moguća doza.
English: Dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Croatian: Utjecaj doza na nuspojave nije utvrđen, te one nisu pokazale korelaciju sa spolom, dobi ili rasom bolesnika.
English: Thrombocytopenia (sometimes with purpura)
Croatian: Trombocitopenija (ponekad s purpurom)
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.
Croatian: S obzirom da ne postoje raspoloživi podaci u vezi primjene Kinzalkomba tijekom dojenja, Kinzalkomb se ne preporučuje, te se preferiraju zamjenski lijekovi s utemeljenijim profilima sigurnosti tijekom dojenja, osobito u slučaju novorođenčeta ili prijevremeno rođenog djeteta.
English: Such conditions should be corrected before the administration of Kinzalkomb.
Croatian: Takva stanja moraju se korigirati prije primjene Kinzalkomba.
English: However, a causal relationship has not been established.
Croatian: Međutim, uzročno-posljedična veza nije utvrđena.
English: The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Croatian: Stopa smrtnosti od svih uzroka bila je 11,6 % među bolesnicima liječenih telmisartanom i 11,8 % među bolesnicima liječenih ramiprilom.
English: The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements.
Croatian: Antihipertenzivni učinak zadržava se neprekidno tijekom 24 sata nakon doziranja te uključuje posljednja 4 sata prije sljedeće doze, kao što je pokazano ambulantnim mjerenjima krvnog tlaka.
English: Management depends on the time since ingestion and the severity of the symptoms.
Croatian: Zbrinjavanje ovisi o vremenu proteklom od unosa i težini simptoma.
English: What Kinzalkomb is and what it is used for
Croatian: Što je Kinzalkomb i za što se koristi
English: In a typical study in patients with a mean creatinine clearance of 90 ml/min the elimination half-life of hydrochlorothiazide was increased.
Croatian: U tipičnoj studiji na bolesnicima s prosječnim klirensom kreatinina od 90 ml/min poluvrijeme eliminacije hidroklorotiazida se povećalo.
English: In functionally anephric patients the elimination half-life is about 34 hours.
Croatian: U bolesnika s nefunkcionalnim bubrezima poluvrijeme eliminacije je oko 34 sata.
English: Beta-blockers and diazoxide
Croatian: Beta-blokatori i diazoksid
English: Patients with rare hereditary problems of fructose intolerance and/or with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze i/ili s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatkom Lapp laktaze, ili malapsorpcijom glukoza-galaktoze ne smiju uzimati ovaj lijek.
English: Cholestyramine and colestipol, medicines for lowering blood fat levels.
Croatian: Kolestiramin i kolestipol, lijekovi za snižavanje vrijednosti masnoća u krvi.
English: Therefore, in these patients blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Croatian: Stoga se kod ovih bolesnika mora razmotriti praćenje glukoze u krvi; može biti potrebno prilagođavanje doze inzulina ili antidijabetika, kada postoji indikacija.
English: Kinzalkomb is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Croatian: Kinzalkomb se ne preporučuje u ranoj trudnoći, te se ne smije uzimati ako ste trudni dulje od 3 mjeseca, jer može izazvati ozbiljna oštećenja bebe ako se primjenjuje u tom stadiju (vidjeti dio o trudnoći).
English: Hydrochlorothiazide is 68 % protein bound in the plasma and its apparent volume of distribution is 0.83 - 1.14 l/kg.
Croatian: Hidroklorotiazid se 68 % veže na proteine u plazmi, a njegov prividni volumen distribucije je 0,831,14 l/kg.
English: Tablets should be taken out of the blister shortly before administration (see section 6.6).
Croatian: Tablete se vade iz blistera neposredno prije primjene (vidjeti dio 6.6).
English: Kinzalkomb can have influence on the ability to drive and use machines.
Croatian: Kinzalkomb može utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.
Croatian: Citokrom P450 izoenzimi nisu uključeni u metabolizam telmisartana.
English: High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness.
Croatian: Visoki krvni tlak, ako se ne liječi, može oštetiti krvne žile različitih organa, što ponekad može dovesti do srčanog udara, zatajenja srca ili bubrega, moždanog udara, ili sljepoće.
English: The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42 % and 58 %, respectively.
Croatian: Apsolutna bioraspoloživost telmisartana pri dozama od 40 mg i 160 mg bila je 42 % i 58 %, po istom redoslijedu.