FrancophonIA/ELRC3.0 huggingface dataset:
English: At least 61 % of the oral dose is eliminated unchanged within 24 hours.
Croatian: Najmanje 61% oralno primijenjene doze eliminira se nepromijenjeno unutar 24 sata.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Croatian: Bolesnika je potrebno pomno nadzirati, a liječenje treba biti simptomatsko i suportivno.
English: For these reasons, CHMP could not identify cancer screening methods that patients would benefit from.
Croatian: Iz tih razloga CHMP nije mogao utvrditi metode probira na rak od kojih bi bolesnici imali koristi.
English: Manufacturers:
Croatian: Proizvođači:
English: Assessment of the excess risk of cancer
Croatian: Procjena prekomjernog rizika od nastanka raka
English: Treatment of essential hypertension.
Croatian: Liječenje esencijalne hipertenzije.
English: Primary aldosteronism
Croatian: Primarni aldosteronizam
English: The most common signs and symptoms of overdose are nausea and somnolence.
Croatian: Najčešći znakovi i simptomi predoziranja su mučnina i somnolencija.
English: The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
Croatian: Do maksimalnog učinka na sniženje krvnog tlaka trebalo bi doći 6-8 tjedana nakon početka liječenja.
English: If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Croatian: Ako se tijekom liječenja pojavi reakcija fotoosjetljivosti, preporučuje se prekid terapije.
English: Max. daily dose (mg)
Croatian: Maksimalna dnevna doza (mg)
English: Metabolic and endocrine effects
Croatian: Metabolički i endokrini učinci
English: Considerations on monitoring of exposed patients
Croatian: Razmatranja u pogledu praćenja izloženih bolesnika
English: The primary treatment is to discontinue drug intake as rapidly as possible.
Croatian: Primarno liječenje je prekid primjene lijeka što je prije moguće.
English: NDMA and NDEA are two of the most potent mutagenic carcinogens known.
Croatian: NDMA i NDEA dvije su najjače poznate mutagene tvari karcinogenih svojstava.
English: Irbesartan does not require metabolic activation for its activity.
Croatian: Irbesartan ne treba metaboličku aktivaciju za svoje djelovanje.
English: Date of first authorisation: 26 November 2009 Date of latest renewal: 11 November 2014
Croatian: Datum posljednje obnove: 11. studeni 2014.
English: The impact of NDMA and NDEA on human health is currently only extrapolated from animal studies.
Croatian: Učinak koji NDMA i NDEA imaju na ljudsko zdravlje trenutačno se samo ekstrapolira iz ispitivanja na životinjama.
English: Efficacy and safety of sartancontaining medicines in these indications are per se well-established and are not questioned in this referral.
Croatian: Djelotvornost i sigurnost lijekova koji sadržavaju sartan dobro su poznate u tim indikacijama te se u ovom postupku upućivanja ne dovode u pitanje.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Croatian: Dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS)
English: If you experience these, talk to your doctor before attempting to drive or use machines.
Croatian: Ako osjetite te simptome, trebate se savjetovati sa svojim liječnikom prije nego što pokušate voziti ili upravljati strojevima.
English: The mean age of patients was 52.5 years, 13 % were ≥ 65 years of age, and just 2 % were ≥ 75 years of age.
Croatian: Srednja dob bolesnika bila je 52,5 godina; 13% ispitanika bilo je u dobi od 65 godina ili više, a samo 2% u dobi od 75 godina ili više.
English: The terminal elimination half-life of irbesartan is 11-15 hours.
Croatian: Terminalno poluvrijeme eliminacije irbesartana iznosi 11 - 15 sati.
English: Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Croatian: Tablete treba progutati s dovoljnom količinom tekućine (npr. s jednom čašom vode).
English: Ísland ratiopharm Oy Finnland
Croatian: Ísland ratiopharm Oy
English: Thiazides in high doses causing intense diuresis can inhibit the milk production.
Croatian: Tiazidi u visokim dozama, koje uzrokuju intenzivnu diurezu, mogu inhibirati proizvodnju mlijeka.
English: Similar effects have been very rarely reported with irbesartan so far.
Croatian: Za sada su slični učinci s irbesartanom zabilježeni veoma rijetko.
English: This could be a sign that you are developing glaucoma, increased pressure in your eye(s).
Croatian: To može biti znak nastanka glaukoma, povišenog tlaka u oku (očima).
English: The major circulating metabolite is irbesartan glucuronide (approximately 6 %).
Croatian: Glavni cirkulirajući metabolit je irbesartan glukuronid (oko 6%).
English: Specifically, CHMP considered that NDMA and NDEA limits should be as low as technically possible.
Croatian: Konkretno, CHMP je zaključio da granične vrijednosti tvari NDMA i NDEA trebaju biti što je tehnički moguće niže.
English: The frequency of adverse reactions listed below is defined 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).
Croatian: Učestalost dolje navedenih nuspojava definirana je na sljedeći način: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000).
English: - aliskiren if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Croatian: - aliskiren ako ste imali rak kože ili ako Vam se pojavi neočekivana lezija (promjena) na koži tijekom liječenja.
English: A clear cumulative dose response relationship was observed for both BCC and SCC.
Croatian: Primijećena je jasna povezanost odgovora i kumulativne doze i za BCC i za SCC.
English: Activated charcoal may be useful in the treatment of overdose.
Croatian: Aktivni ugljen može biti koristan u liječenju predoziranja.
English: There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Croatian: Nije bilo dokaza mutagenosti, klastogenosti ili karcinogenosti.
English: For an individual risk assessment, data on the exact drug products and batches used by each individual patient would be necessary.
Croatian: Za pojedinačnu procjenu rizika potrebni su podatci o konkretnim lijekovima i serijama lijekova koje upotrebljava svaki pojedinačni pacijent.
English: Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.
Croatian: Sumnjive lezije na koži potrebno je hitno pregledati, potencijalno uključujući histološke preglede uzorka dobivenog biopsijom.
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Croatian: Respiratorni distres (uključujući pneumonitis i plućni edem)
English: Hydrochlorothiazide is excreted in human milk in small amounts.
Croatian: Hidroklorotiazid Hidroklorotiazid se izlučuje u ljudskom mlijeku u manjim količinama.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti od svakoga.
English: UAB Sicor Biotech filiāle Latvijā
Croatian: Latvija UAB Sicor Biotech filiāle Latvijā
English: However, as the DNA damage mechanisms documented in these studies are also relevant in humans and in vitro data in human cells are not significantly different from those in animal cells, it is prudent to assume that effects seen in animals may also occur in humans after exposure to sufficiently large amounts of these nitrosamines.
Croatian: Međutim, budući da su mehanizmi oštećenja DNK koji su dokumentirani u tim ispitivanjima relevantni i za ljude, a podatci dobiveni in vitro ispitivanjem staničnih linija ljudi nisu značajno različiti od onih dobivenih ispitivanjem staničnih linija životinja, razumno je pretpostaviti da se učinci zabilježeni u životinja mogu pojaviti i u ljudi nakon izlaganja dostatno velikim količinama tih nitrozamina.
English: Initially, this was only necessary for valsartan containing APIs from few manufacturers but later also for some other sartans with a tetrazole ring.
Croatian: To je prvotno bilo nužno samo u slučaju aktivnih farmaceutskih sastojaka koji sadržavaju valsartan koje je proizveo malen broj proizvođača, no poslije i u slučaju nekih drugih sartana s tetrazolnim prstenom.
English: During the 8-week treatment period, there were no reported cases of syncope in either treatment group.
Croatian: Tijekom osmotjednog liječenja nije bilo prijavljenih slučajeva sinkope niti u jednoj od skupina.
English: Epidemiological studies have shown that long term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Croatian: Epidemiološke su studije pokazale da dugoročno liječenje hidroklorotiazidom smanjuje rizik od kardiovaskularnog morbiditeta i mortaliteta.
English: Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
Croatian: Hidroklorotiazid se ne smije koristiti za liječenje esencijalne hipertenzije u trudnica osim u rijetkim slučajevima kada se ne može primijeniti nijedna druga terapija.
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 ne reagiraju na antihipertenzivne lijekove koji djeluju putem inhibicije renin-angiotenzinskog sustava.
English: In long-term follow-up studies, the effect of irbesartan/hydrochlorothiazide was maintained for over one year.
Croatian: U dugoročnim studijama praćenja, učinak kombinacije irbesartan/hidroklorotiazid održao se kroz više od godinu dana.
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 angiotenzin II receptora.
English: The underlying concept of the proposed approach is to keep the amount of N-nitrosamine impurities as low as possible, irrespective of the type of sartan or dose.
Croatian: Temeljni je koncept predloženog pristupa održati što nižu razinu N-nitrozaminskih nečistoća, neovisno o vrsti sartana ili dozi.
English: Irbesartan did not affect survival, development, or reproduction of offspring.
Croatian: Irbesartan nije utjecao na preživljenje, razvoj ni reprodukciju okota.
English: Hydrochlorothiazide is 68% proteinbound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Croatian: Za proteine u plazmi veže se 68% hidroklorotiazida, a njegov prividni volumen distribucije iznosi 0,83-1,14 l/kg.
English: Modifying manufacturing processes, where necessary, to minimise contamination as much as possible.
Croatian: Izmjena proizvodnih procesa gdje je to potrebno kako bi se kontaminacija svela na najmanju moguću mjeru.
English: Overall, taking into account the available data assessed in this procedure, the benefit risk balance of medicines containing a sartan with a tetrazole ring remains positive subject to the conditions imposed.
Croatian: Općenito, uzimajući u obzir dostupne podatke procijenjene u ovom postupku, omjer koristi i rizika lijekova koji sadržavaju sartan s tetrazolnim prstenom i dalje je pozitivan, što je podložno uvjetima koji su određeni.
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Croatian: Iako ne postoje kontrolirani epidemiološki podaci o riziku kod primjene antagonista receptora angiotenzina II, slični rizici mogli bi postojati za ovu skupinu lijekova.
English: Whilst the measures are focused on NDMA and NDEA, the principles used in this procedure in terms of toxicology assessment, control strategy and changes to the manufacturing processes for drug substances should be applied by analogy to other nitrosamines.
Croatian: Iako su mjere usmjerene na tvari NDMA i NDEA, načela koja se primjenjuju u ovom postupku u pogledu toksikološke procjene, kontrolne strategije i promjena proizvodnih procesa djelatnih tvari lijekova potrebno je analogno primijeniti na druge nitrozamine.
English: Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions.
Croatian: Bolesnike koji uzimaju hidroklorotiazid potrebno je informirati o riziku od NMSC-a i savjetovati da redovito provjeravaju svoju kožu kako bi se uočila pojava svake nove lezije te da hitno prijave svaku sumnjivu leziju na koži.
English: However, there was no difference in the half-life and accumulation of irbesartan.
Croatian: Nije, međutim, bilo razlika glede poluvijeka i akumulacije irbesartana.
English: Sartan-containing medicinal products are important treatment options of serious or potentially serious conditions such as hypertension or certain heart or kidney diseases.
Croatian: Lijekovi koji sadržavaju sartan važne su mogućnosti liječenja ozbiljnih ili potencijalno ozbiljnih stanja kao što su hipertenzija ili određene bolesti srca ili bubrega.
English: • The CHMP reviewed data on quality regarding the manufacturing processes of sartans with a tetrazole group, analytical data including test results and available methods, and toxicological data available for the N-nitrosamines found in some of these products.
Croatian: • CHMP je pregledao podatke o kvaliteti u vezi s proizvodnim procesima sartana s tetrazolnom skupinom, analitičke podatke, uključujući rezultate ispitivanja i dostupne metode, te toksikološke podatke dostupne za N-nitrozamine pronađene u nekim od tih lijekova.
English: • A two-year transition period) is considered acceptable to change production processes to achieve syntheses in which N-nitrosamines are not formed, to adopt analytical methods for the control strategy and in order to avoid product shortages.
Croatian: • Smatra se da je za promjenu proizvodnih procesa prihvatljivo dvogodišnje prijelazno razdoblje kako bi se postigle sinteze pri kojima ne dolazi do nastanka N-nitrozamina, donijele analitičke metode za kontrolnu strategiju i izbjegao nedostatak lijekova.
English: If you accidentally take too many tablets, contact your doctor immediately.
Croatian: Ako slučajno uzmete previše tableta, odmah se obratite svom liječniku.
English: As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Croatian: Kao i kod bilo koje kombinacije dviju djelatnih tvari, ne mogu se isključiti nuspojave povezane s jednom od djelatnih tvari.
English: The above stated very small theoretical risk has to be balanced against the risks of potential measures to monitor patients such as colonoscopy or gastroscopy which may exceed the theoretical excess cancer risk.
Croatian: Prethodno naveden vrlo mali teoretski rizik mora se odvagnuti u odnosu na rizike povezane s potencijalnim mjerama za praćenje pacijenata kao što su kolonoskopija ili gastroskopija koji mogu premašiti teoretski prekomjerni rizik od razvoja raka.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Croatian: Epidemiološki podaci koji se odnose na rizik od teratogenog učinka nakon primjene ACE inhibitora tijekom prvog tromjesečja nisu bili dostatni za donošenje zaključaka; međutim manji porast rizika ne može se isključiti.
English: There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Croatian: Nije bilo znakova abnormalne sistemske toksičnosti ili toksičnosti za ciljni organ pri klinički relevantnim dozama.
English: Furthermore, the target organ(s) of NDMA/NDEA toxicity in humans are still not sufficiently clear.
Croatian: Nadalje, toksičnost tvari NDMA/NDEA za ciljane organe u ljudi još nije dovoljno jasna.
English: Less than 2 % of the dose is excreted in the urine as unchanged irbesartan.
Croatian: Manje od 2% doze izlučuje se u obliku nepromijenjenog irbesartana.
English: Teva Pharmaceutical Works Private Limited Company Pallagi út 13
Croatian: Teva Pharmaceutical Works Private Limited Company
English: It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Croatian: Očekuje se da blokira sve aktivnosti angiotenzina II posredovane AT1 receptorom, bez obzira na izvor ili način sinteze angiotenzina II.
English: • After the transition period, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented, which reflects the lowest quantifiable level based on capability of the available analytical methods.
Croatian: • Nakon prijelaznog razdoblja potrebno je primijeniti graničnu vrijednost za NDMA i NDEA od najviše 0,03 ppm, što odražava najnižu mjerljivu razinu na temelju mogućnosti dostupnih analitičkih metoda.
English: Nitrosamines are chemically simple molecules and can be formed in pharmaceutical manufacturing steps whenever there is a presence of a secondary (or tertiary) amines and nitrites, usually in acidic conditions.
Croatian: Nitrozamini su kemijski jednostavne molekule koje mogu nastati u fazama farmaceutske proizvodnje u prisutnosti sekundarnih (ili tercijarnih) amina i nitrita, obično u kiselim uvjetima.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove (EMAe): http://www.ema.europa.eu/.
English: Additional information on irbesartan interactions
Croatian: Dodatne informacije o interakcijama irbesartana
English: The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
Croatian: Vrste i incidencije nuspojava prijavljenih za bolesnike liječene kombinacijom bile su slične profilu nuspojava u bolesnika na monoterapiji.
English: These 24-hour effects were observed without excessive blood pressure lowering at peak and are consistent with safe and effective blood-pressure lowering over the once-daily dosing interval.
Croatian: Ti su učinci zabilježeni tijekom 24 sata bez prekomjernog sniženja krvnog tlaka pri vršnoj koncentraciji i sukladni su sa sigurnim i učinkovitim sniženjem krvnog tlaka u intervalu jednokratne dnevne primjene.
English: 2031GA Haarlem The Netherlands
Croatian: 2031GA Haarlem Nizozemska
English: For example, a recent review has estimated risks of perforation of 4 per 10,000 (95% confidence interval, 2-5) and major haemorrhage of 8 per 10,000 (95% confidence interval, 5-14) with screening colonoscopy.
Croatian: Na primjer, u nedavnom pregledu procijenjen je rizik od perforacije od 4 na 10 000 (interval pouzdanosti od 95 %, 2 - 5) i rizik od velikih krvarenja od 8 na 10 000 (interval pouzdanosti od 95 %, 5 - 14) pri probirnoj kolonoskopiji.
English: Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC.
Croatian: Fotosenzibilizirajući učinci hidroklorotiazida mogli bi predstavljati mogući mehanizam za NMSC.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for products containing sartans with a tetrazole group (candesartan, irbesartan, losartan, olmesartan, valsartan)
Croatian: • CHMP je razmotrio postupak koji se provodi u skladu s člankom 31. Direktive 2001/83/EZ za lijekove koji sadrže sartane s tetrazolnom skupinom (kandesartan, irbesartan, losartan, olmesartan, valsartan).
English: No significant effects on the number of corpora lutea, implants, or live foetuses were observed.
Croatian: Nije zabilježen značajan utjecaj na broj žutih tijela, broj implantacija ili živih fetusa.
English: The determination of an acceptable intake (AI) is based on extrapolation of carcinogenic risk from rodent carcinogenicity data, as the dose resulting in one cancer case among 100,000 individuals exposed for a life-time to the impurity.
Croatian: Određivanje prihvatljivog unosa temelji se na ekstrapolaciji rizika od kancerogenosti iz podataka o kancerogenosti u glodavaca kao doze koja rezultira jednim slučajem raka na 100 000 pojedinaca doživotno izloženih nečistoći.
English: All of these changes were considered to be caused by the pharmacological action of irbesartan.
Croatian: Sve te navedene promjene smatraju se uzrokovanim farmakološkim djelovanjem irbesartana.
English: Alcohol Potentiation of orthostatic hypotension may occur;
Croatian: Alkohol: Može se pojaviti ortostatska hipotenzija;
English: In addition, advancing age, comorbidity and use of anticoagulants were found to be strongly associated with both gastrointestinal and non-gastrointestinal complications.
Croatian: Osim toga, utvrđeno je da su starija dob, komorbiditet i primjena antikoagulansa snažno povezani s gastrointestinalnim i negastrointestinalnim komplikacijama.
English: The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%).
Croatian: Najčešće prijavljene nuspojave bile su omaglica (5,6%), umor (4,9%), mučnina/povraćanje (1,8%) i abnormalno mokrenje (1,4%).
English: Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/
English: if you have severe liver or kidney problems.
Croatian: ako imate teških problema s jetrom ili bubrezima.
English: The limit of 0.03 ppm for NDMA and NDEA will be enforceable after a transitional period of 2 years from the notification of the Commission Decision.
Croatian: Granična vrijednost od 0,03 ppm za tvari NDMA i NDEA bit će provediva nakon prijelaznog razdoblja od dvije godine od obavijesti o odluci Komisije.
English: Jaundice Hepatitis, abnormal liver function
Croatian: Hepatitis, abnormalna funkcija jetre
English: The most likely manifestations of irbesartan overdose are expected to be hypotension and tachycardia; bradycardia might also occur.
Croatian: Najčešće očekivane manifestacije predoziranja irbesartanom su hipotenzija i tahikardija; također se može pojaviti bradikardija.
English: Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer).
Croatian: Liječenje hidroklorotiazidom, naročito dugotrajna primjena uz visoke doze, može povećati rizik od nekih vrsta raka kože ili usana (nemelanomski rak kože).
English: As soon as the problem of nitrosamine-contamination became known, immediate, precautionary measures were taken by competent authorities across the EU such as recalls of affected batches from pharmacies.
Croatian: Čim se doznalo za problem kontaminacije nitrozaminom, nadležna tijela diljem EU-a odmah su poduzela mjere opreza kao što je povlačenje zahvaćenih serija lijekova iz ljekarni.
English: Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy (see section 4.8).
Croatian: Faktori rizika za razvoj akutnog glaukoma zatvorenog kuta mogu uključivati alergiju na sulfonamid ili penicilin u povijesti bolesti (vidjeti dio 4.8).
English: Latent diabetes mellitus may become manifest during thiazide therapy.
Croatian: Latentni diabetes mellitus može postati izražen za vrijeme terapije tiazidima.
English: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Croatian: - ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću.
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist.
Croatian: Irbesartan je snažan, oralno djelotvoran, selektivni antagonist receptora angiotenzina II (podtip AT1).