FrancophonIA/ELRC3.0 huggingface dataset:
English: Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia
Croatian: Anoreksija, smanjeni apetit, neravnoteža elektrolita, hiperkolesterolemija, hiperglikemija, hipovolemija
English: Non-steroidal anti-inflammatory medicinal products (NSAIDs) NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dose regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics and the antihypertensive effects of angiotensin II receptor antagonists.
Croatian: NSAIL-i (tj. acetilsalicilatna kiselina u protuupalnim režimima doziranja, COX-2 inhibitori i neselektivni NSAIL-i) mogu reducirati diuretski, natriuretski i antihipertenzivni učinak tiazidskih diuretika te antihipertenzivni učinak antagonista receptora angiotenzina II.
English: Actelsar HCT is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.
Croatian: Actelsar HCT se primjenjuje u liječenju visokog krvnog tlaka (esencijalna hipertenzija) kod odraslih osoba čiji krvni tlak nije dobro kontroliran uz primjenu samog telmisartana.
English: Adverse reactions previously reported with one of the individual components may be potential adverse reactions with Actelsar HCT, even if not observed in clinical trials with this product.
Croatian: Nuspojave prethodno prijavljene s jednom od individualnih komponenti mogu biti potencijalne nuspojave Actelsara HCT, čak iako nisu zabilježene u kliničkim ispitivanjima ovoga lijeka.
English: What you need to know before you take Actelsar HCT Do not take Actelsar HCT
Croatian: Što morate znati prije nego počnete uzimati Actelsar HCT
English: Other medicines and Actelsar HCT
Croatian: Drugi lijekovi i Actelsar HCT
English: Because no information is available regarding the use of telmisartan during breast-feeding, Actelsar HCT 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 Actelsara HCT tijekom dojenja, Actelsar HCT se ne preporučuje, te se preferiraju zamjenski lijekovi s utemeljenijim profilima sigurnosti tijekom dojenja, osobito u slučaju novorođenčeta ili prijevremeno rođenog djeteta.
English: If you forget to take Actelsar HCT
Croatian: Ako ste zaboravili uzeti Actelsar HCT
English: Gastric lesions could be prevented/ameliorated by oral sodium chloride solution supplementation and group housing of animals.
Croatian: Gastrične lezije mogu se spriječiti/ublažiti oralnim nadomjescima otopine natrijevog klorida i grupnim smještanjem životinja.
English: The effect of Actelsar HCT may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicyl acid or ibuprofen).
Croatian: Učinak Actelsara HCTse može smanjiti dok uzimate NSAIL-e (nesteroidni protuupalni lijekovi, npr. acetilsalicilatnu kiselinu ili ibuprofen).
English: Telmisartan: Following oral administration, peak concentrations of telmisartan are reached in 0.5-1.5 h after dosing.
Croatian: Telmisartan: nakon peroralne primjene vršne koncetracije telmisartana postižu se 0,5-1,5 h nakon doziranja.
English: Sepsis including fatal outcome3 Blood and lymphatic system disorders Uncommon:
Croatian: Sepsa uključujući fatalni ishod3 Poremećaji krvi i limfnog sustava Manje često:
English: 3 For further description, please see sub-section “Description of selected adverse reactions”.
Croatian: 3 Za dodatni opis, molimo pogledajte odlomak „Opis izabranih nuspojava“
English: Possible side effects of Actelsar HCT:
Croatian: Moguće nuspojave Actelsara HCT:
English: Actelsar HCT is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Croatian: Actelsar HCT je kombinacija antagonista receptora angiotenzina II, telmisartana i tiazidskog diuretika, hidroklorotiazida.
English: Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased
Croatian: Povišene vrijednosti kreatinina u krvi, povišene vrijednosti kreatin fosfokinaze, povišene vrijednosti jetrenih enzima
English: Angiotensin II receptor antagonists should not be initiated during pregnancy.
Croatian: Trudnoća Primjena antagonista receptora angiotenzina II ne smije se započinjati u trudnoći.
English: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria
Croatian: Angioedem (također s fatalnim ishodom), eritem, pruritus, osip,
English: Hypokalaemia may result in muscle spasms and/or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Croatian: Hipokalemija može rezultirati grčevima mišića i/ili izraženom aritmijom povezanom s istodobnom primjenom glikozida digitalisa ili određenih antiaritmika.
English: Hypoglycaemia (in diabetic patients)
Croatian: Hipoglikemija (kod dijabetičara)
English: Presumably through blockade of the reninangiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Croatian: Pretpostavlja se da putem blokade sustava renin-angiotenzin-aldosteron, istodobna primjena telmisartana ima tendenciju smanjenja gubitka kalija povezanog s ovim diureticima.
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
Croatian: Nuspojave su klasificirane po učestalosti koristeći sljedeću podjelu: vrlo često (≥1/10); često (≥1/100 i
English: Serious angioedema may occur rarely
Croatian: Ozbiljni angioedem može se pojaviti rijetko (≥1/10 000
English: - Severe renal impairment (creatinine clearance <30 ml/min).
Croatian: - Teško oštećenje funkcije bubrega (klirens kreatinina <30 ml/min).
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5% CI 0.93-1.10, p (non-inferiority)=0.0019 at a margin of 1.13).
Croatian: Omjer rizika za telmisartan naspram ramiprila bio je 1,01 (97,5% CI 0,93-1,10, p (za neinferiornost) = 0,0019 na margini od 1,13).
English: Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer.
Croatian: Bolesnicima je potrebno savjetovati moguće preventivne mjere kao što je ograničena izloženost sunčevoj svjetlosti i UV zrakama i, u slučaju izloženosti, odgovarajuća zaštita,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Al/Al blister
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za Al/Al blister
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.
Croatian: Toksikološki nalazi također dobro poznati iz pretkliničkih studija s inhibitorima enzima koji pretvara angiotenzin i s antagonistima receptora angiotenzina II bili su: smanjenje parametara crvenih krvnih stanica (eritrociti, hemoglobin, hematokrit), promjene u bubrežnoj hemodinamici (povišeni dušik iz uree u krvi (BUN - engl. blood urea nitrogen) i kreatinin), povećana aktivnost renina u plazmi, hipertrofija/hiperplazija jukstaglomerularnih stanica i ozljeda želučane sluznice.
English: There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24).
Croatian: Nije bilo dokaza pozitivnih učinaka na kardiovaskularnu smrtnost (omjer rizika 1,03, 95% CI 0,85-1,24).
English: The concomitant use of Actelsar HCT with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Croatian: Istodobna primjena lijeka Actelsar HCT s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem funkcije bubrega (GFR<60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
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,
English: pentamidine, sparfloxacine, terfenadine, vincamine IV)
Croatian: sparfloksacin, terfenadin, vinkamin i.v.)
English: The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Croatian: 11,6% među bolesnicima liječenih telmisartanom i 11,8% među bolesnicima liječenih ramiprilom.
English: Periodic monitoring of serum potassium and ECG is recommended when Actelsar HCT is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Croatian: Preporučuje se periodično praćenje kalija u serumu i EKG kada se Actelsar HCT uzima s lijekovima na koje utječu poremećaji kalija u serumu (npr. glikozidi digitalisa, antiaritmici) i sljedećim lijekovima koji induciraju torsades de pointes (što uključuje pojedine antiaritmike), s hipokalemijom kao predisponirajućim faktorom za torsades de pointes.
English: Tablet 30 tablets 90 tablets 250 tablets
Croatian: Tableta 30 tableta 90 tableta 250 tableta
English: Actelsar HCT is not indicated in patients with severe hepatic impairment.
Croatian: Actelsar HCT nije indiciran kod bolesnika s teškim oštećenjem funkcije jetre.
English: Infections and infestations Uncommon:
Croatian: Infekcije i infestacije Rijetko:
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.
Croatian: Prethodne pretkliničke studije o sigurnosti izvedene pri istodobnoj primjeni telmisartana i hidroklorotiazida na normotenzivnim štakorima i psima u dozama koje dovode do izloženosti usporedivoj s onim u kliničkom terapijskom rasponu nisu dale dodatna otkrića koja već ranije nisu bila primijećena u primjeni svake tvari zasebno.
English: Due to the hydrochlorothiazide component, markedly low blood pressure and low blood levels of potassium can also happen, which may result in nausea, sleepiness and muscle cramps and/or irregular heartbeat associated with the concomitant use of medicinal products such as digitalis or certain anti-arrhythmic treatments.
Croatian: Zbog hidroklorotiazida kao komponente, također može doći i do izrazitije niskog krvnog tlaka i niskih vrijednosti kalija u krvi, što može rezultirati mučninom, pospanošću i grčevima mišića i/ili nepravilnim otkucajima srca povezanim s istodobnom primjenom lijekova kao što su digitalis ili određeni antiaritmici.
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Croatian: Poznato je da izloženost terapiji antagonistom receptora angiotenzina II tijekom drugog i trećeg tromjesečja inducira fetotoksičnost u ljudi (smanjena bubrežna funkcija, oligohidramnion, kašnjenje osifikacije lubanje) kao i neonatalnu toksičnost (zatajenje bubrega, hipotenzija, hiperkalemija) (vidjeti dio 5.3).
English: In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Croatian: Kod bolesnika koji uzimaju monoterapiju hidroklorotiazida prijavljene su sljedeće dodatne nuspojave.
English: Abdominal pain, constipation, dyspepsia, vomiting, gastritis
Croatian: Bol u abdomenu, konstipacija, dispepsija, povraćanje, gastritis
English: Common (may affect up to 1 in 10 people): Dizziness
Croatian: Često (mogu se javiti u do 1 na 10 osoba): Omaglica
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe)
English: - Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as nonsteroidal anti-inflammatory drugs [NSAIDs]), medicines to treat cancer, gout, or arthritis.
Croatian: - drugi lijekovi koji se primjenjuju u liječenju visokog krvnog tlaka, kortikosteroidi, lijekovi protiv bolova (kao što su nesteroidni protuupalni lijekovi [NSAIL-ovi]), lijekovi za liječenje raka, gihta, ili artritisa.
English: - Medicines for the treatment of diabetes (insulins or oral agents such as metformin).
Croatian: - lijekovi za liječenje dijabetesa (inzulini ili lijekovi koji se primjenjuju kroz usta kao što je metformin).
English: Xanthopsia, acute myopia, acute angle-closure glaucoma
Croatian: Ksantopsija, akutna miopija, akutni glaukom zatvorenog kuta
English: For Al/Al blisters and HDPE tablet container: 2 years.
Croatian: Za Al/Al blistere i HDPE spremnik s tabletama: 2 godine.
English: In patients with mild to moderate hepatic impairment the posology should not exceed Actelsar HCT 40 mg/12.5 mg once daily.
Croatian: Kod bolesnika s blagim do umjerenim oštećenjem funkcije jetre doza ne smije prelaziti Actelsar HCT 40 mg/12,5 mg jedanput dnevno.
English: Syncope, paraesthesia
Croatian: Sinkopa, parestezija
English: Some people feel dizzy or tired when taking Actelsar HCT.
Croatian: Neke osobe mogu osjećati omaglicu ili umor tijekom primjene Actelsara HCT.
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING Label for HDPE tablet container
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica za HDPE spremnik s tabletama
English: There is no clinical experience with Actelsar HCT in patients with hepatic impairment.
Croatian: Nema kliničkog iskustva s Actelsarom HCT kod bolesnika s oštećenjem funkcije jetre.
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
English: In case of surgery or anaesthetics, you should tell your doctor that you are taking Actelsar HCT.
Croatian: Ako trebate na operaciju ili primati anestetik, morate biti sigurni da Vaš liječnik zna da uzimate
English: - class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide) - class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide) - some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
Croatian: - skupina Ia antiaritmika (npr. kinidin, hidrokinidin, disopiramid) - skupina III antiaritmika (npr. amiodaron, sotalol, dofetilid, ibutilid) - neki antipsihotici (npr. tioridazin, klorpromazin, levomepromazin, trifluoperazin, cijamemazin,
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and if appropriate, alternative therapy should be started.
Croatian: Kada se trudnoća dijagnosticira, liječenje antagonistima receptora angiotenzina II mora se trenutno prekinuti, te, prema potrebi, početi sa zamjenskom terapijom.
English: Actelsar HCT 40 mg/12.5 mg tablets EU/1/13/817/043
Croatian: Actelsar HCT 40 mg/12,5 mg tablete EU/1/13/817/043
English: Telmisartan Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients.
Croatian: Nuspojave su se pojavljivale s istom učestalošću kod osoba liječenih placebom i telmisartanom.
English: Sodium starch glycolate (type A) Microcrystalline cellulose Mannitol (E421)
Croatian: celuloza, mikrokristalična manitol (E421)
English: ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Croatian: inhibitori i blokatori angiotenzin II receptora ne smiju se primjenjivati istodobno u bolesnika s dijabetičkom nefropatijom.
English: Actelsar HCT 80 mg/12.5 mg tablets EU/1/13/817/014
Croatian: Actelsar HCT 80 mg/12,5 mg tablete EU/1/13/817/014
English: How to take Actelsar HCT
Croatian: Kako uzimati Actelsar HCT
English: Hypersensitivity, anaphylactic reactions Metabolism and nutrition disorders Uncommon:
Croatian: Preosjetljivost, anafilaktičke reakcije Poremećaji metabolizma i prehrane Manje često:
English: Actelsar HCT 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.
Croatian: Actelsar HCT je kombinacija fiksne doze (40 mg telmisartana/12,5 mg hidroklorotiazida i 80 mg telmisartana/12,5 mg hidroklorotiazida), indicirana kod odraslih bolesnika čiji se krvni tlak ne može adekvatno kontrolirati samo telmisartanom.
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Croatian: Trial) je usporedilo učinke telmisartana, ramiprila te kombinacije telmisartana i ramiprila na kardiovaskularne ishode na 25 620 bolesnika u dobi od 55 i više godina s anamnezom bolesti koronarnih arterija, moždanog udara, TIA-e, periferne arterijske bolesti, ili šećerne bolesti tipa 2 popraćenog dokazom o oštećenju perifernih organa (npr. retinopatija, hipertrofija lijevog ventrikula, makro- ili mikroalbuminurija), a koji su predstavljali populaciju pod rizikom za kardiovaskularne događaje.
English: In a pooled analysis of two similar 8 week double-blind placebo-controlled clinical trials vs. valsartan/hydrochlorothiazide 160 mg/25 mg (n=2,121 patients evaluated for efficacy) a significantly greater blood pressure lowering effect of 2.2/1.2 mm Hg (SBP/DBP) was demonstrated (difference in adjusted mean changes from baseline, respectively) in favour of telmisartan/hydrochlorothiazide 80 mg/25 mg combination.
Croatian: U združenoj analizi dvaju sličnih dvostruko-slijepih, placebom kontroliranih kliničkih ispitivanja, u trajanju 8 tjedana, u odnosu na valsartan/hidroklorotiazid 160 mg/25 mg (djelotvornost ocjenjivana na n=2 121 bolesnika, pokazao se značajno veći učinak snižavanja krvnog tlaka, u vrijednosti 2,2/1,2 mm Hg (SKT/DKT) (razlika u podešenim prosječnim promjenama u odnosu na početnu vrijednost, po istom redoslijedu) u korist kombinacije telmisartan/hidroklorotiazid 80 mg/25 mg.
English: - if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na telmisartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako ste alergični na hidroklorotiazid ili neki od drugih derivata sulfonamida.
English: Actelsar HCT is also available at the dose strength 80 mg/25 mg
Croatian: Actelsar HCT je također dostupan u jačini doze od 80 mg/25 mg.
English: Actelsar HCT is also available at the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg
Croatian: Actelsar HCT je također dostupan u jačinama doza od 40 mg/12,5 mg i 80 mg/12,5 mg.
English: Hypochloraemic alkalosis
Croatian: Hipokloremična alkaloza
English: Actelsar HCT 80 mg/25 mg tablets are white or almost white, 9.0 x 17.0 mm oval-shaped and biconvex tablets marked with “TH” on one side and “25” on the other side.
Croatian: Actelsar HCT 80 mg/25 mg tablete su bijele ili gotovo bijele ovalne bikonveksne tablete, dimenzija 9,0 x 17,0 mm, s jedne strane označene oznakom „TH“ i oznakom „25“ na drugoj strani.
English: The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups.
Croatian: (16,7%) i ramiprilu (16,5%).
English: Hepatic function abnormal/liver disorder
Croatian: Abnormalna jetrena funkcija / poremećaj jetre
English: Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5% CI 0.90-1.08), p (non-inferiority) =0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Croatian: Otkriveno je da telmisartan ima sličnu učinkovitost kao i ramipril u unaprijed određenom sekundarnom ishodu od kardiovaskularne smrti, nefatalnog infarkta miokarda i nefatalnog moždanog udara [0,99 (97,5% CI 0,90-1,08), p (za neinferiornost) = 0,0004], što je bio primarni ishod u referentnoj studiji HOPE (studija procjene prevencije ishoda povezanih sa srcem - engl.
English: In patients taking telmisartan alone the following additional side effects have been reported:
Croatian: Kod bolesnika koji uzimaju monoterapiju telmisartana prijavljene su sljedeće nuspojave.
English: Very rare (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**
Croatian: Progresivan nastanak ožiljaka u tkivu pluća (intersticijska bolest pluća)**
English: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis
Croatian: Aplastična anemija, hemolitička anemija, zatajenje koštane srži, leukopenija, neutropenija, agranulocitoza
English: Magnesium stearate (E470b) Potassium hydroxide Meglumine
Croatian: 6.1 Popis pomoćnih tvari magnezijev stearat (E470b) kalijev hidroksid meglumin povidon natrijev škroboglikolat (vrste A)
English: CV mortality and all cause mortality were numerically higher with the combination.
Croatian: Stopa smrtnosti od svih uzroka bila je
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for HDPE tablet container
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za HDPE spremnik s tabletama
English: Actelsar HCT must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Croatian: Oštećenje funkcije bubrega i presađen bubreg Actelsar HCT ne smije se primjenjivati kod bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina <30 ml/min) (vidjeti dio 4.3).
English: - Diabetes.
Croatian: - šećerna bolest.
English: There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95% CI 0.76-1.00, p=0.048)].
Croatian: Postojao je dokaz pozitivnih učinaka telmisartana u usporedbi s placebom u unaprijed određenom sekundarnom kompozitnom ishodu kardiovaskularne smrti, nefatalnog infarkta miokarda i nefatalnog moždanog udara [0,87 (95% CI 0,76-1,00, p = 0,048)].
English: Co-administration of lithium and Actelsar HCT is not recommended (see section 4.4).
Croatian: HCT se ne preporučuje (vidjeti dio 4.4).