FrancophonIA/ELRC3.0 huggingface dataset:
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.
Croatian: S obzirom na njihova slična farmakodinamička svojstva, ti su rezultati relevantni i za druge ACE inhibitore i blokatore receptora angiotenzina II.
English: The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.
Croatian: Poluvijek amlodipina je produljen i AUC vrijednosti su povišene u bolesnika s oštećenom funkcijom jetre; preporuke za doziranje nisu utvrđene.
English: Grapefruit juice and grapefruit should not be consumed when you take Twynsta.
Croatian: Grejp i sok od grejpa ne smiju se uzimati tijekom primjene Twynste.
English: Twynsta is contraindicated in patients with severe hepatic impairment (see section 4.3).
Croatian: Twynsta je kontraindicirana kod bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
English: • Rifampicin, erythromycin, clarithromycin (antibiotics).
Croatian: • Rifampicin, eritromicin, klaritromicin (antibiotici).
English: Twynsta 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 newborn, or was born prematurely.
Croatian: Twynsta se ne preporučuje majkama koje doje, a liječnik može odabrati drugo liječenje za Vas ako želite dojiti, osobito ako je vaša beba novorođenče ili je prijevremeno rođena.
English: The blood pressure lowering effect of telmisartan/amlodipine can be increased by concomitant use of other antihypertensive medicinal products.
Croatian: Učinak snižavanja krvnog tlaka kombinacije telmisartan/amlodipin se može povećati istodobnom primjenom drugih antihipertenzivnih lijekova.
English: See also “Do not take Twynsta”.
Croatian: Vidjeti također „Nemojte uzimati Twynstu”
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability of telmisartan up to nearly 100 %.
Croatian: Farmakokinetička ispitivanja bolesnika s oštećenjem jetre pokazala su povećanje apsolutne bioraspoloživosti telmisartana do gotovo 100 %.
English: • in adult patients whose blood pressure is not controlled enough with amlodipine alone.
Croatian: • kod odraslih bolesnika čiji krvni tlak nije dovoljno reguliran samo amlodipinom.
English: The clinical translation of these PK variations may be more pronounced in the elderly.
Croatian: Klinička manifestacija ovih farmakokinetičkih varijacija može biti izrazitija u starijih bolesnika.
English: There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 8 times* the maximum recommended human dose of 10 mg/day on an mg/m2 basis).
Croatian: Nije bilo učinka na plodnost štakora oralno liječenih amlodipinmaleatom (mužjaci 64 dana i ženke 14 dana prije parenja) pri dozama do 10 mg amlodipin/kg/dan (oko 8 puta* više od maksimalne preporučene doze za ljude od 10 mg/dan na mg/m2 baze).
English: What you need to know before you take Twynsta
Croatian: Što morate znati prije nego počnete uzimati Twynstu
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Twynsta.
Croatian: Povećana pojavnost sepse je primijećena samo uz telmisartan, ali ne može se isključiti za Twynstu.
English: Rare hypoglycaemia (in diabetic patients)
Croatian: Rijetko hipoglikemija (u dijabetičara)
English: Sepsis (often called "blood poisoning", is a severe infection of the whole-body with high fever and the feeling of being severely ill), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Croatian: Sepsa* (često se naziva “trovanje krvi”, teška je infekcija cijelog tijela popraćena visokom vrućicom i osjećajem stanja teške bolesti), vrlo brzo naticanje kože i sluznice (angioedem); ove nuspojave su rijetke (mogu se javiti kod do 1 na 1000 osoba), ali izuzetno ozbiljne, te bolesnici moraju prekinuti s primjenom lijeka i odmah se javiti liječniku.
English: In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine.
Croatian: U zdravih dobrovoljaca je pokazano da primjena aktivnog ugljena do 2 sata nakon primjene amlodipina od 10 mg smanjuje brzinu apsorpcije amlodipina.
English: In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalemia after administration of verapamil and intravenous dantrolene.
Croatian: U životinja su opaženi letalna ventrikularna fibrilacija i kardiovaskularni kolaps povezani s hiperkalijemijom nakon primjene verapamila i intravenskog dantrolena.
English: Rare back pain, pain in extremity (leg pain)
Croatian: Rijetko bol u leđima, bol u udovima (bol u nogama)
English: No drug interaction studies have been conducted with cyclosporine and amlodipine in healthy volunteers or other populations with the exception of renal transplant patients, where variable trough concentration increases (average 0% - 40%) of cyclosporine were observed.
Croatian: Nisu provedena ispitivanja interakcija s ciklosporinom i amlodipinom u zdravih dobrovoljaca ili u drugim populacijama, uz iznimku bolesnika s transplantacijom bubrega u kojih je primijećeno varijabilno povećanje koncentracija ciklosporina na kraju dozirnog intervala (prosjek 0 % - 40 %).
English: Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase of approximately 40-60 % in AUC.
Croatian: Bolesnici s insuficijencijom jetre imaju smanjen klirens amlodipina, s rezultirajućim porastom u AUC od oko 40-60 %.
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Croatian: Telmisartan istiskuje angiotenzin II s vrlo visokim afinitetom s njegova mjesta vezivanja na AT1 receptorskom podtipu, koji je odgovoran za poznato djelovanje angiotenzina II.
English: In this respect data concerning diastolic blood pressure are inconsistent.
Croatian: U vezi s tim, podaci koji se tiču dijastoličkog krvnog tlaka nisu dosljedni.
English: Interactions linked to the combination No drug interaction studies have been performed.
Croatian: Interakcije povezane s ovom kombinacijom Ispitivanja interakcija lijekova nisu provedena.
English: What Twynsta contains
Croatian: Što Twynsta sadrži
English: The following side effects have been observed with the components telmisartan or amlodipine and may occur also with Twynsta:
Croatian: Sljedeće nuspojave su primijećene uz komponente telmisartan ili amlodipin te se također mogu pojaviti uz Twynstu:
English: Twynsta tablets contain two active substances called telmisartan and amlodipine.
Croatian: Twynsta tablete sadrže dvije djelatne tvari koje se nazivaju telmisartan i amlodipin.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists and calcium channel blockers; ATC Code: C09DB04.
Croatian: Farmakoterapijska skupina: Lijekovi koji djeluju na sustav renin-angiotenzin, antagonisti angiotenzina II i blokatori kalcijevih kanala; ATK oznaka: C09DB04.
English: If any of the above applies to you, tell your doctor or pharmacist before taking Twynsta.
Croatian: Ako se nešto od navedenog odnosi na Vas, obavijestite liječnika ili ljekarnika prije početka primjene Twynste.
English: Twynsta has not been studied in any patient population other than hypertension.
Croatian: Twynsta nije ispitivana niti na jednoj drugoj skupini bolesnika osim bolesnika sa hipertenzijom.
English: Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day showed no evidence of carcinogenicity.
Croatian: U štakora i miševa koji su tijekom dvije godine primali amlodipin putem hrane u koncentracijama izračunatim da osiguraju dnevnu razinu doze od 0,5, 1,25 i 2,5 mg/kg na dan nisu opaženi dokazi kancerogenosti.
English: Remove your Twynsta tablet from the blister only directly prior to intake.
Croatian: Izvadite Vašu Twynsta tabletu iz blistera tek neposredno prije primjene.
English: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium,
Croatian: • Lijekovi koji mogu povisiti vrijednosti kalija u krvi kao što su zamjenske soli koje sadrže kalij,
English: Rare visual disturbance
Croatian: Rijetko poremećaj vida
English: : the event may be a chance finding or related to a mechanism currently not known : most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Croatian: : događaj može biti slučajno otkriće ili povezan s trenutno nepoznatim mehanizmom : većina slučajeva poremećene jetrene funkcije/poremećaja jetre iz iskustva nakon stavljanja lijeka u promet u vezi s telmisartanom se javilo kod japanskih bolesnika.
English: Twynsta once daily produces effective and consistent reductions in blood pressure across the 24-hour therapeutic dose range.
Croatian: Primjena Twynste jedanput dnevno dovodi do učinkovitog i stalnog sniženja krvnog tlaka tijekom 24satnog terapijskog raspona doziranja.
English: NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Croatian: NSAIL-i (tj. acetilsalicilatna kiselina u protuupalnim režimima doziranja, COX-2 inhibitori i neselektivni NSAIL-i) mogu smanjiti antihipertenzivan učinak antagonista receptora angiotenzina II.
English: “Warnings and precautions”).
Croatian: Twynstu“ i „Upozorenja i mjere opreza“).
English: Rare syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor
Croatian: Rijetko sinkopa, periferna neuropatija, hipoestezija, disgeuzija, tremor
English: • Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Croatian: • Telmisartan pripada skupini lijekova koji se nazivaju „antagonisti receptora angiotenzina II“.
English: In this same population amlodipine was associated with increased reports of pulmonary oedema.
Croatian: U istoj skupini amlodipin je bio povezan s povećanim brojem slučajeva plućnog edema.
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Croatian: U jednom ispitivanju istodobna primjena telmisartana i ramiprila dovela je do porasta od najviše 2,5 puta u AUC0-24 i Cmax ramiprila i ramiprilata.
English: Very rare myocardial infarction, arrhythmia, ventricular tachycardia, atrial fibrillation
Croatian: Vrlo rijetko infarkt miokarda, aritmija, ventrikularna tahikardija, atrijska fibrilacija
English: The safety of amlodipine in human pregnancy has not been established.
Croatian: Sigurnost primjene amlodipina u trudnoći nije ustanovljena.
English: Co-administration of multiple doses of 10 mg of amlodipine with simvastatin 80 mg resulted in an increase in exposure to simvastatin up to 77 % compared to simvastatin alone.
Croatian: Istodobna primjena višestrukih doza amlodipina od 10 mg i simvastatina od 80 mg rezultirala je povećanjem izloženosti simvastatinu do 77 % u usporedbi s monoterapijom simvastatina.
English: Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Croatian: Ukupni plazmatski klirens (Cltot) je visok (približno 1 000 ml/min) u usporedbi s protokom krvi u jetri (oko 1 500 ml/min).
English: Reproductive studies in rats and mice have shown delayed date of delivery, prolonged duration of labour and decreased pup survival at dosages approximately 50 times greater than the maximum recommended dosage for humans based on mg/kg.
Croatian: Ispitivanja na štakorima i miševima pokazala su odgođeni datum okota, produljeno trajanje okota i smanjeno preživljenje mladunčadi pri dozama koje su približno 50 puta veće od maksimalnog preporučenog doziranja u ljudi na temelju mg/kg.
English: There are limited data from the use of telmisartan/amlodipine in pregnant women.
Croatian: Postoje ograničeni podaci o primjeni kombinacije telmisartan/amlodipin u trudnoći.
English: Mutagenicity studies revealed no drug related effects at either the gene or chromosome levels.
Croatian: Ispitivanja mutageničnosti nisu otkrila učinke povezane s lijekom ni na razini gena ni na razini kromosoma.
English: Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids and is suitable for use in patients with asthma, diabetes, and gout.
Croatian: Amlodipin nije povezan sa štetnim metaboličkim učincima ili promjenama lipida plazme pa je prikladan za primjenu u bolesnika s astmom, dijabetesom i gihtom.
English: Very rare extrapyramidal syndrome, hypertonia
Croatian: Vrlo rijetko ekstrapiramidalni sindrom, hipertonija
English: With concomitant use of mTOR inhibitors, amlodipine may increase exposure of mTOR inhibitors.
Croatian: Pri istodobnoj primjeni s inhibitorima mTOR-a, amlodipin može povećati izloženost inhibitorima mTOR-a.
English: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours consistent with once daily dosing.
Croatian: Eliminacija amlodipina iz plazme je bifazna, s terminalnim poluvijek eliminacije od oko 30 do 50 sati uz jednokratno dnevno doziranje.
English: Very rare hepatitis, jaundice, hepatic enzyme elevations (mostly consistent with cholestasis)
Croatian: Vrlo rijetko hepatitis, žutica, povišene vrijednosti jetrenih enzima (uglavnom uvijek uz kolestazu)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2010
Croatian: Datum prvog odobrenja: 07. listopada 2010.
English: Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to Twynsta 40 mg/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.
Croatian: Bolesnici liječeni s 10 mg amlodipina, koji imaju nuspojave koje ograničavaju dozu, kao što je edem, mogu se prebaciti na Twynsta 40 mg/5 mg tablete jedanput dnevno, snižavajući dozu amlodipina bez smanjenja ukupnog očekivanog antihipertenzivnog učinka.
English: The increase of the amlodipine dosage should take place with care in the elderly patients (see section 4.2 and 5.2).
Croatian: Potreban je oprez kod povećanja doze amlodipina u starijih bolesnika (vidjeti dio 4.2 i 5.2).
English: Twynsta combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine.
Croatian: Twynsta kombinira dvije antihipertenzivne tvari s komplementarnim mehanizmima za kontrolu krvnog tlaka kod bolesnika s esencijalnom hipertenzijom: antagonist receptora angiotenzina II, telmisartan i dihidropiridinski blokator kalcijevih kanala, amlodipin.
English: Skin and subcutaneous tissue disorders Uncommon pruritus hyperhidrosis alopecia, purpura, skin discolouration, hyperhidrosis
Croatian: Poremećaji kože i potkožnog tkiva Manje često pruritus hiperhidroza alopecija, purpura, diskoloracija kože, hiperhidroza
English: However, lower plasma concentrations were observed in patients with renal insufficiency undergoing dialysis.
Croatian: Međutim, niže koncetracije u plazmi primijećene su kod bolesnika s insuficijencijom bubrega podvrgnutih dijalizi.
English: Eye disorders Common visual disturbance (including diplopia)
Croatian: Poremećaji oka Često smetnje vida (uključujući diplopiju)
English: Normal amlodipine dosage regimens are recommended in the elderly, but increase of dosage should take place with care (see section 4.4).
Croatian: Preporučuju se uobičajeni režimi doziranja amlodipina u starijih osoba, ali je potreban oprez kod povećanja doziranja (vidjeti dio 4.4).
English: ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage.
Croatian: ONTARGET je bilo ispitivanje provedeno u bolesnika s kardiovaskularnom ili cerebrovaskularnom bolešću, ili sa šećernom bolešću tipa 2 uz dokaze oštećenja ciljanih organa.
English: As with other blood pressure lowering medicines, the effect of Twynsta may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.
Croatian: Kao i kod drugih lijekova za snižavanje krvnog tlaka, učinak Twynste se može smanjiti kada uzimate NSAIL-e (nesteroidni protuupalni lijekovi, npr. acetilsalicilatna kiselina ili ibuprofen) ili kortikosteroide.
English: Psychiatric disorders Uncommon mood change
Croatian: Psihijatrijski poremećaji Manje često promjene raspoloženja
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system (RAAS).
Croatian: Postoji povećan rizik od teške hipotenzije i insuficijencije bubrega kada se bolesnici s bilateralnom stenozom bubrežne arterije ili stenozom arterije jedinog funkcionalnog bubrega liječe lijekovima koji utječu na sustav renin-angiotenzin-aldosteron (RAAS).
English: There is no experience regarding the administration of telmisartan/amlodipine in patients with a recent kidney transplant.
Croatian: Ne postoji iskustvo u pogledu primjene kombinacije telmisartan/amlodipin kod bolesnika s nedavno presađenim bubregom.
English: Very rare vasculitis
Croatian: Vrlo rijetko vaskulitis
English: There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure.
Croatian: Postoji očigledan trend odnosa doze s vremenom potrebnim za oporavak početne vrijednosti sistoličkog krvnog tlaka.
English: Due to risk of hyperkalemia, it is recommended that the coadministration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Croatian: Zbog rizika od hiperkalijemije, preporučuje se izbjegavati istodobnu primjenu blokatora kalcijevih kanala poput amlodipina u bolesnika podložnih malignoj hipertermiji i tijekom zbrinjavanja maligne hipertermije.
English: Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Croatian: Liječnik Vam może provjeravati bubrežnu funkciju, krvni tlak i količinu elektrolita (npr. kalija) u krvi u redovitim intervalima.
English: Pharmacokinetic of the fixed dose combination
Croatian: Farmakokinetika fiksne kombinacije
English: Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Croatian: Potreban je oprez kod primjene blokatora kalcijevih kanala, uključujući amlodipin, u bolesnika s kongestivnim zatajenjem srca jer ti lijekovi mogu povećati rizik od budućih kardiovaskularnih događaja i mortaliteta.
English: Adverse reactions previously reported with one of the individual components (telmisartan or amlodipine) may be potential adverse reactions with Twynsta as well, even if not observed in clinical trials or during the post-marketing period.
Croatian: Nuspojave koje su prethodno bile prijavljene uz jednu od pojedinih komponenti (telmisartan ili amlodipin) također predstavljaju potencijalne nuspojave uz Twynstu, čak iako nisu primijećene u kliničkim ispitivanjima ili tijekom razdoblja nakon stavljanja lijeka u promet.
English: potassium-sparing diuretics (certain ‘water tablets').
Croatian: diuretici koji štede kalij (pojedine ''tablete za izmokravanje'').
English: Because no information is available regarding the use of telmisartan during breast-feeding, telmisartan/amlodipine is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant.
Croatian: Zbog nedostupnih informacija o primjeni telmisartana tijekom dojenja, kombinacija telmisartan/amlodipin se ne preporučuje, već se preporučuje zamjensko liječenje sa sigurnim profilom primjene tijekom dojenja, osobito u dojenju novorođenčadi ili prijevremeno rođene djece.
English: In another rat study in which male rats were treated with amlodipine besilate for 30 days at a dose comparable with the human dose based on mg/kg, decreased plasma follicle-stimulating hormone and testosterone were found as well as decreases in sperm density and in the number of mature spermatids and Sertoli cells.
Croatian: U drugom ispitivanju na štakorima u kojem su mužjaci primali amlodipinbesilat tijekom 30 dana u dozi usporedivoj s dozom za ljude na temelju mg/kg, otkrivene su snižene razine u plazmi folikulostimulirajućeg hormona i testosterona te snižene vrijednosti gustoće sperme i broja zrelih spermatida i Sertolijevih stanica.
English: Unstable angina pectoris, acute myocardial infarction There are no data to support the use of telmisartan/amlodipine in unstable angina pectoris and during or within one month of a myocardial infarction.
Croatian: Nestabilna angina pektoris, akutni infarkt miokarda Ne postoje podaci koji idu u prilog primjeni kombinacije telmisartan/amlodipin u nestabilnoj angini pektoris te tijekom ili u roku 1 mjeseca nakon infarkta miokarda.
English: Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure resulting in an increased risk of hypotension.
Croatian: Istodobna primjena amlodipina s jakim ili umjerenim inhibitorima CYP3A4 (inhibitorima proteaze, azolnim antimikoticima, makrolidima poput eritromicina ili klaritromicina, verapamilom ili diltiazemom) može dovesti do značajnog povećanja izloženosti amlodipinu i rezultirati povećanim rizikom od hipotenzije.
English: Twynsta may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine, neuroleptics or antidepressants).
Croatian: Twynsta može povećati učinak snižavanja krvnog tlaka drugih lijekova koji se primjenjuju u liječenju visokog krvnog tlaka ili lijekova s potencijalom za snižavanje krvnog tlaka (npr. baklofen, amifostin, neuroleptici, ili antidepresivi).
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 te se liječite lijekom za snižavanje krvnog tlaka koji sadrži aliskiren.
English: This medicine contains 337.28 mg sorbitol in each tablet.
Croatian: Ovaj lijek sadrži 337,28 mg sorbitola u jednoj tableti.
English: If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.
Croatian: Ako je indicirana istodobna primjena zbog prijavljene hipokalijemije, oni se primjenjuju s oprezom i uz često praćenje vrijednosti kalija u serumu.
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1
Croatian: • Preosjetljivost na djelatne tvari, na derivate dihidropiridina ili neku od pomoćnih tvari navedenih u dijelu 6.1