FrancophonIA/ELRC3.0 huggingface dataset:
English: However the terminal half-life was not significantly altered.
Slovenian: Končna razpolovna časa pa se bistveno ne razlikujeta.
English: The terminal elimination half-life of irbesartan is 11-15 hours.
Slovenian: Končni razpolovni čas izločanja irbesartana je 11 do 15 ur.
English: During the 8-week treatment period, there were no reported cases of syncope in either treatment group.
Slovenian: Med 8-tedenskim zdravljenjem niso v nobeni skupini poročali o pojavu sinkope.
English: Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
Slovenian: Hidroklorotiazida se ne sme uporabljati za zdravljenje esencialne hipertenzije pri nosečnicah, razen v redkih primerih, ko ni možno uporabiti nobenega drugega zdravljenja.
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.
Slovenian: • dveletno prehodno obdobje je sprejemljivo za spremembo postopkov proizvodnje, da se vzpostavijo sinteze, v katerih N-nitrozamini ne nastajajo, za uvedbo analitskih metod za strategijo nadzora ter za preprečitev pomanjkanja zdravil;
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).
Slovenian: Pogostnost neželenih učinkov je v nadaljevanju navedena v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
English: Chloride deficit is generally mild and usually does not require treatment.
Slovenian: Pomanjkanje klorida je običajno blago in ga običajno ni treba zdraviti.
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.
Slovenian: • odbor CHMP je pregledal podatke o kakovosti v zvezi s postopki proizvodnje sartanov s tetrazolno skupino, analitske podatke, vključno z rezultati testov in razpoložljivimi metodami, ter razpoložljive toksikološke podatke za N-nitrozamine, prisotne v nekaterih od teh zdravil.
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.
Slovenian: Takoj ko je problematika onesnaženja z nitrozamini postala znana, so pristojni organi v EU uvedli takojšnje previdnostne ukrepe, kot so odpoklici zadevnih serij iz lekarn.
English: For these reasons, N-nitrosamine impurities in pharmaceuticals such as sartans intended for long-term use should be reduced as much as possible.
Slovenian: Zato je treba vsebnost N-nitrozaminskih nečistot v zdravilih, kot so sartani, namenjenih dolgotrajni uporabi, čim bolj zmanjšati.
English: During this time period, MAHs and manufacturers are requested to introduce relevant changes to the manufacturing processes of the drug substances, as well as develop appropriate analytical methods while ensuring adequate supply of the market for these essential medicinal products.
Slovenian: V tem času bodo morali imetniki dovoljenj za promet z zdravili in proizvajalci uvesti potrebne spremembe postopkov proizvodnje učinkovin in razviti ustrezne analitske metode, hkrati pa zagotoviti ustrezno oskrbo trga s temi pomembnimi zdravili.
English: Electrolyte imbalance
Slovenian: Elektrolitsko neravnovesje
English: Implement a control strategy to detect and control N-nitrosamine impurities in the API (or intermediate, if justified).
Slovenian: 3. uvedba strategije nadzora za odkrivanje in nadzor N-nitrozaminskih nečistot v učinkovini (ali intermediatu, če je to utemeljeno).
English: Appropriate regulatory actions (such as quarantine or batch recalls) have been taken where relevant.
Slovenian: Kjer je bilo primerno, so bili izvedeni ustrezni regulativni ukrepi (kot so karantena in odpoklici serij).
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.
Slovenian: Zgoraj navedeno zelo majhno teoretično tveganje je treba pretehtati glede na tveganja morebitnih ukrepov za spremljanje bolnikov, kot sta kolonoskopija in gastroskopija, ki lahko presegajo teoretično čezmerno tveganje za raka.
English: Sartan-containing medicinal products are important treatment options of serious or potentially serious conditions such as hypertension or certain heart or kidney diseases.
Slovenian: Zdravila, ki vsebujejo sartan, so pomembna možnost za zdravljenje resnih in morebitno resnih stanj, kot so hipertenzija in določene bolezni srca ali ledvic.
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.
Slovenian: Nitrozamini so kemijsko preproste molekule in lahko nastajajo med farmacevtsko proizvodnjo, kadar koli so prisotni sekundarni (ali terciarni) amini in nitriti, običajno v kislih pogojih.
English: Risks resulting from multiple exposures are considered to add up in patients as mutagenic carcinogens are currently considered as summation toxins.
Slovenian: Tveganja, ki izhajajo iz večkratne izpostavljenosti, naj bi se pri bolnikih seštevala, saj se mutagene karcinogene snovi trenutno obravnavajo kot strupi, ki se seštevajo.
English: Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.
Slovenian: Sumljive kožne spremembe je treba čim prej pregledati, po možnosti naj se opravi tudi histološki pregled biopsij.
English: Grounds for CHMP opinion
Slovenian: Razlogi za mnenje odbora CHMP
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.
Slovenian: Meja 0,03 ppm za NDMA in NDEA se bo začela uporabljati po dveletnem prehodnem obdobju po uradnem obvestilu o sprejetju sklepa Komisije.
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.
Slovenian: • po prehodnem obdobju je treba za NDMA in NDEA uvesti mejo največ 0,03 ppm, ki odraža najnižjo določljivo raven na podlagi zmogljivosti razpoložljivih analitskih metod;
English: Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.
Slovenian: Simptomi vključujejo akuten pojav zmanjšane ostrine vida ali bolečine v očesu in se običajno pojavijo v nekaj urah ali tednih po začetku zdravljenja.
English: The mean age of patients was 52.5 years, 13 % were ≥ 65 years of age, and just 2 % were ≥ 75 years of age.
Slovenian: Srednja starost bolnikov je bila 52,5 let, 13 % bolnikov je bilo starih 65 let ali starejših.
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.
Slovenian: Čeprav ni na voljo kontrolnih epidemioloških podatkov glede tveganja pri uporabi antagonistov angiotenzina II, lahko podobno tveganje obstaja tudi za to skupino zdravil.
English: The study recruited 58 % males.
Slovenian: V študijo je bilo vključenih 58 % bolnikov moškega spola.
English: A full risk assessment for patients previously exposed to NDMA and/or NDEA impurities in sartans, especially valsartan which was found to contain the highest nitrosamine contamination, is not possible as the real extent of exposure of patients is unknown.
Slovenian: Celovita ocena tveganja pri bolnikih, predhodno izpostavljenih nečistotam NDMA in/ali NDEA v sartanih, zlasti valsartanu, v katerem so našli najvišje vrednosti onesnaženja z nitrozamini, ni mogoča, saj je dejanski obseg izpostavljenosti bolnikov neznan.
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)
Slovenian: • odbor CHMP je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo sartane s tetrazolnim obročem (kandesartan, irbesartan, losartan, olmesartan, valsartan);
English: Studies have not been performed in patients with severe hepatic impairment.
Slovenian: Študij pri bolnikih s hudo jetrno okvaro niso izvedli.
English: All of these changes were considered to be caused by the pharmacological action of irbesartan.
Slovenian: Vse te spremembe so bile verjetno posledica farmakološke aktivnosti irbesartana.
English: If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Slovenian: Če se takšna reakcija pojavi, je zdravljenje priporočljivo prekiniti.
English: Plasma protein binding of irbesartan is approximately 96%, with negligible binding to cellular blood components.
Slovenian: Na plazemske beljakovine se veže približno 96 % irbesartana, na celične sestavine krvi pa zanemarljivo malo.
English: The key issue of this referral concerns the detection of N-nitrosamine (esp. NDMA and/or NDEA) contaminations in sartans, the resulting potential long-term risk to patients and measures to minimise as much as possible these contaminations.
Slovenian: Ključno vprašanje v tej napotitvi zadeva odkrivanje onesnaženja z N-nitrozaminom (zlasti NDMA in/ali NDEA) v sartanih, posledično dolgoročno tveganje za bolnike in ukrepe za čim večje zmanjšanje tovrstnega onesnaženja.
English: Film-coated tablets
Slovenian: filmsko obložene tablete
English: Teva Pharmaceutical Works Private Limited Company Pallagi út 13
Slovenian: Teva Pharmaceutical Works Private Limited Company
English: Frequency ‘not known': Skin and lip cancer (Non-melanoma skin cancer)
Slovenian: Pogostnost „neznana“: Kožni rak in rak ustnice (nemelanomski kožni rak)
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.
Slovenian: Ukrepi se sicer osredotočajo na NDMA in NDEA, vendar je treba načela, uporabljena v tem postopku v smislu toksikološke ocene, strategije nadzora in sprememb postopkov proizvodnje učinkovin, smiselno uporabiti tudi za druge nitrozamine.
English: In comparison to the daily intake levels calculated based on ICH M7(R1) using non-clinical toxicology, it is possible to generate additional safety factors ranging from 2.73 - 27.3 for NDMA and 10.0 - 100 for NDEA, by defining 0.03 ppm as the common technical target limit for NDEA and NDMA in tetrazole sartan APIs.
Slovenian: V primerjavi z ravnmi dnevnega vnosa, izračunanimi na podlagi smernic ICH M7(R1) z uporabo neklinične toksikologije, je mogoče ustvariti dodatne varnostne dejavnike v razponu od 2,73 do 27,3 za NDMA in od 10,0 do 100 za NDEA, pri čemer je raven 0,03 ppm opredeljena kot skupna tehnična ciljna meja za NDEA in NDMA v sartanskih učinkovinah s tetrazolom.
English: Irbesartan is excreted in the milk of lactating rats.
Slovenian: Irbesartan se izloča v mleko doječih podgan.
English: Irbesartan/Hydrochlorothiazide Teva should be taken at least one hour before or four hours after these medications;
Slovenian: Irbesartan/hidroklorotiazid Teva je treba jemati vsaj eno uro pred ali štiri ure po jemanju teh zdravil.
English: The combination should be administered with caution, especially in the elderly.
Slovenian: Pri sočasnem zdravljenju je potrebna previdnost, še posebej pri starostnikih.
English: • CHMP could not identify cancer screening methods that patients would benefit from, considering the uncertainty of the target organ(s) of NDMA/NDEA toxicity in humans and the risks of measures to monitor patients such as colonoscopy or gastroscopy which may exceed the theoretical excess cancer risk.
Slovenian: • odbor CHMP ni mogel prepoznati metod za presejanje raka, ki bi bolnikom koristile, in sicer z upoštevanjem negotovosti tarčnih organov toksičnosti NDMA/NDEA pri človeku in tveganja ukrepov za spremljanje bolnikov, kot sta kolonoskopija in gastroskopija, ki lahko presegajo teoretično čezmerno tveganje za raka.
English: The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
Slovenian: Primarni cilj te študije je bil primerjati odstotek bolnikov z nadzorovano vrednostjo diastoličnega tlaka v sedečem položaju (SeDBP < 90 mmHg) v 5. tednu zdravljenja.
English: Modifying manufacturing processes, where necessary, to minimise contamination as much as possible.
Slovenian: 2. po potrebi prilagoditev postopkov proizvodnje, da se onesnaženje čim bolj zmanjša;
English: Serum electrolytes and creatinine should be monitored frequently.
Slovenian: Pogosto je treba preverjati serumske vrednosti elektrolitov in kreatinina.
English: 2031GA Haarlem The Netherlands
Slovenian: 2031GA Haarlem Nizozemska
English: In addition to NDMA and NDEA, other N-nitrosamines have been detected in a few sartan-containing medicinal products.
Slovenian: Poleg NDMA in NDEA so v nekaterih zdravilih, ki vsebujejo sartan, odkrili tudi drugeN-nitrozamine.
English: The mechanism of antihypertensive effect of thiazide diuretics is not fully known.
Slovenian: Antihipertenzijski mehanizem delovanja tiazidnih diuretikov ni natančno znan.
English: There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Slovenian: Dokazov o mutagenosti, klastogenosti ali karcinogenosti ni.
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.
Slovenian: Epidemiološki podatki niso pokazali teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju nosečnosti izpostavljene zaviralcem ACE, vendar pa majhnega povečanja tveganja ni možno izključiti.
English: Peak effects occurred at 3-6 hours.
Slovenian: Največji učinek je bil dosežen po 3-6 urah.
English: The CHMP also carried out a risk assessment for patients previously exposed to NDMA and NDEA in sartans and calculated daily intake levels based on the principles of ICH M7(R1) which are associated with an additional lifetime risk of 1 in 100,000 patients.
Slovenian: Odbor CHMP je opravil tudi oceno tveganja za bolnike, predhodno izpostavljene NDMA in NDEA v sartanih, in po načelih iz smernic ICH M7(R1) izračunal ravni dnevnega vnosa, ki so povezane z dodatnim doživljenjskim tveganjem enega bolnika na 100 000;
English: • During this period, NDMA and NDEA impurities in the API should be controlled for a transition period at limits calculated based on the principles of ICH M7(R1) using validated assays
Slovenian: • v tem času je treba nečistoti NDMA in NDEA v učinkovini v sklopu prehodnega obdobja ohranjati v okviru mej, izračunanih na podlagi načel iz smernic ICH M7(R1) z validiranimi testi;
English: The major circulating metabolite is irbesartan glucuronide (approximately 6 %).
Slovenian: Glavni presnovek v obtoku je irbesartanov glukuronid (približno 6 %).
English: In long-term follow-up studies, the effect of irbesartan/hydrochlorothiazide was maintained for over one year.
Slovenian: V študijah, ki so trajale dolgo časa, so ugotovili, da je učinek irbesartana/hidroklorotiazida trajal še več kot eno leto.
English: Should NDMA and NDEA be detected in parallel in an API batch, this should lead to rejection of the respective batch, considering that a combined contamination would translate into a combined risk, which may be higher than one additional case of cancer in 100.000 individuals.
Slovenian: Če se v določeni seriji učinkovine hkrati odkrijeta NDMA in NDEA, je treba zadevno serijo zavrniti, in sicer ob upoštevanju, da kombinirano onesnaženje pomeni kombinirano tveganje, ki je lahko večje od enega dodatnega primera raka na 100 000 posameznikov.
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.
Slovenian: V nedavnem pregledu so na primer ocenili, da je med presejalno kolonoskopijo tveganje za predrtje 4 na 10 000 (95-odstotni interval zaupanja, 2-5), za večjo krvavitev pa 8 na 10 000 (95-odstotni interval zaupanja, 5-14).
English: If you accidentally take too many tablets, contact your doctor immediately.
Slovenian: Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
English: In patients with creatinine clearance < 20 ml/min, the elimination half-life of hydrochlorothiazide was reported to increase to 21 hours.
Slovenian: Pri bolnikih z ledvičnim očistkom < 20 ml/min se razpolovni čas izločanja hidroklorotiazida podaljša na 21 ur.
English: Hydrochlorothiazide is 68% proteinbound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Slovenian: Na plazemske beljakovine se veže približno 68 % hidroklorotiazida; njegov porazdelitveni volumen je 0,83 do 1,14 l/kg.
English: In rabbits, abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Slovenian: Pri kuncih je prišlo do abortusa ali zgodnje absorpcije pri odmerkih, ki so povzročili pomembno toksičnost pri samici, vključno s smrtjo.
English: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Slovenian: - zaviralec ACE (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne težave z ledvicami, ki so povezane s sladkorno boleznijo
English: Thiazides in high doses causing intense diuresis can inhibit the milk production.
Slovenian: Tiazidi v velikih odmerkih, ki povzročijo močno diurezo, lahko zmanjšajo nastajanje mleka.
English: Activated charcoal may be useful in the treatment of overdose.
Slovenian: Pri zdravljenju prevelikega odmerjanja je lahko koristna tudi uporaba aktivnega oglja.
English: Max. daily dose (mg)
Slovenian: Učinkovina Največji dnevni odmerek (mg)
English: Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Slovenian: Omejeno kopičenje irbesartana v plazmi (< 20 %) se pojavi po več dneh jemanja irbesartana enkrat na dan.
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).
Slovenian: Zdravljenje s hidroklorotiazidom, še posebej na dolgi rok z velikimi odmerki, lahko poveča tveganje za razvoj nekaterih vrst kožnega raka ali raka ustnice (nemelanomski kožni rak).
English: There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Slovenian: Dokazov o nenormalni sistemski toksičnosti ali toksičnosti za ciljni organ pri klinično primernih odmerkih ni.
English: As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischemic cardiopathy or ischemic cardiovascular disease could result in a myocardial infarction or stroke.
Slovenian: Kot pri vseh antihipertenzivih lahko preveliko znižanje krvnega tlaka pri bolnikih z ishemično kardiopatijo ali ishemično kardiovaskularno boleznijo povzroči miokardni infarkt ali kap.
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.
Slovenian: Določanje dopustnega vnosa temelji na ekstrapolaciji tveganja za karcinogenost na podlagi podatkov o karcinogenosti pri glodavcih, in sicer kot odmerek, ki privede do enega primera raka pri 100 000 posameznikih, ki so celo življenje izpostavljeni nečistoti.
English: Thus, the risk assessment is based on a potential worst case scenario, which would be a partially combined exposure to the highest levels of NDEA for 4 years (2011 - 2015) and to NDMA for 6 years (2012 - 2018) reported from a sartan, resulting in a cumulative theoretical excess cancer risk of 29.5:100,000 or 1:3390 (0.029%) when extrapolated from the available rat studies according to ICH M7(R1).
Slovenian: Zato ocena tveganja temelji na morebitnem najslabšem možnem scenariju, kar je delno kombinirana izpostavljenost najvišjim ravnem NDEA v obdobju štirih let (2011-2015) in najvišjim ravnem NDMA v obdobju šestih let (2012-2018), o katerih so poročali za sartan; to ob ekstrapolaciji iz razpoložljivih študij pri podganah v skladu s smernicami ICH M7(R1) kumulativno privede do teoretičnega čezmernega tveganja za raka 29,5 : 100 000 ali 1 : 3 390 (0,029 %).
English: An interim limit based on daily intakes according to principles in ICH M7(R1) using toxicology data are set in order to control these impurities in the meantime at an acceptable level.
Slovenian: Na podlagi dnevnih vnosov po načelih iz smernic ICH M7(R1) so bile z uporabo toksikoloških podatkov določene začasne meje, da bi v vmesnem času te nečistote zadrževali na sprejemljivi ravni.
English: Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten.
Slovenian: Angiotenzin II je snov, ki nastaja v telesu in se veže na receptorje v krvnih žilah, kar povzroči njihovo zoženje.
English: It is unknown whether irbesartan or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se irbesartan ali njegovi presnovki izločajo v materino mleko.
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Slovenian: Izkušnje z jemanjem hidroklorotiazida med nosečnostjo, zlasti v prvem trimesečju, so omejene.
English: Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri podganah kažejo na izločanje irbesartana ali njegovih presnovkov v mleko (za podrobnosti glejte poglavje 5.3).
English: Hydrochlorothiazide is excreted in human milk in small amounts.
Slovenian: Hidroklorotiazid se v majhnih količinah izloča v materino mleko.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.
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.
Slovenian: Zavira vse učinke angiotenzina II, ki jih posredujejo receptorji AT1, ne glede na izvor in pot nastanka angiotenzina II.
English: When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Slovenian: Pri vožnji motornih vozil in delu s stroji pa je treba upoštevati, da se med zdravljenjem hipertenzije občasno lahko pojavita omotičnost in utrujenost.
English: Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Slovenian: Izrazita hiperkalciemija je lahko znak prikritega hiperparatiroidizma.
English: You must tell your doctor if you think you are (or might become) pregnant.
Slovenian: Zdravniku morate povedati, če mislite, da ste noseči (ali bi lahko zanosili).
English: If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.
Slovenian: Če se pojavi hipotenzija, je treba bolnika namestiti v ležeči položaj in mu hitro začeti nadomeščati sol in tekočino.