natgillin/translations-raw huggingface dataset:
• 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.
• 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.
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.
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.
For these reasons, N-nitrosamine impurities in pharmaceuticals such as sartans intended for long-term use should be reduced as much as possible.
Zato je treba vsebnost N-nitrozaminskih nečistot v zdravilih, kot so sartani, namenjenih dolgotrajni uporabi, čim bolj zmanjšati.
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.
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.
Electrolyte imbalance
Elektrolitsko neravnovesje
Implement a control strategy to detect and control N-nitrosamine impurities in the API (or intermediate, if justified).
3. uvedba strategije nadzora za odkrivanje in nadzor N-nitrozaminskih nečistot v učinkovini (ali intermediatu, če je to utemeljeno).
Appropriate regulatory actions (such as quarantine or batch recalls) have been taken where relevant.
Kjer je bilo primerno, so bili izvedeni ustrezni regulativni ukrepi (kot so karantena in odpoklici serij).
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.
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.
Sartan-containing medicinal products are important treatment options of serious or potentially serious conditions such as hypertension or certain heart or kidney diseases.
Zdravila, ki vsebujejo sartan, so pomembna možnost za zdravljenje resnih in morebitno resnih stanj, kot so hipertenzija in določene bolezni srca ali ledvic.
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.
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.
Risks resulting from multiple exposures are considered to add up in patients as mutagenic carcinogens are currently considered as summation toxins.
Tveganja, ki izhajajo iz večkratne izpostavljenosti, naj bi se pri bolnikih seštevala, saj se mutagene karcinogene snovi trenutno obravnavajo kot strupi, ki se seštevajo.
Grounds for CHMP opinion
Razlogi za mnenje odbora CHMP
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.
Meja 0,03 ppm za NDMA in NDEA se bo začela uporabljati po dveletnem prehodnem obdobju po uradnem obvestilu o sprejetju sklepa Komisije.
• 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.
• 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;
Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.
Simptomi vključujejo akuten pojav zmanjšane ostrine vida ali bolečine v očesu in se običajno pojavijo v nekaj urah ali tednih po začetku zdravljenja.
The mean age of patients was 52.5 years, 13 % were ≥ 65 years of age, and just 2 % were ≥ 75 years of age.
Srednja starost bolnikov je bila 52,5 let, 13 % bolnikov je bilo starih 65 let ali starejših.
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.
Čeprav ni na voljo kontrolnih epidemioloških podatkov glede tveganja pri uporabi antagonistov angiotenzina II, lahko podobno tveganje obstaja tudi za to skupino zdravil.
The study recruited 58 % males.
V študijo je bilo vključenih 58 % bolnikov moškega spola.
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.
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.
• 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)
• 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);
Studies have not been performed in patients with severe hepatic impairment.
Študij pri bolnikih s hudo jetrno okvaro niso izvedli.
All of these changes were considered to be caused by the pharmacological action of irbesartan.
Vse te spremembe so bile verjetno posledica farmakološke aktivnosti irbesartana.
If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Če se takšna reakcija pojavi, je zdravljenje priporočljivo prekiniti.
Plasma protein binding of irbesartan is approximately 96%, with negligible binding to cellular blood components.
Na plazemske beljakovine se veže približno 96 % irbesartana, na celične sestavine krvi pa zanemarljivo malo.
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.
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.
Film-coated tablets
filmsko obložene tablete
Frequency ‘not known': Skin and lip cancer (Non-melanoma skin cancer)
Pogostnost „neznana“: Kožni rak in rak ustnice (nemelanomski kožni rak)
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.
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.
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.
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.
Irbesartan is excreted in the milk of lactating rats.
Irbesartan se izloča v mleko doječih podgan.
Irbesartan/Hydrochlorothiazide Teva should be taken at least one hour before or four hours after these medications;
Irbesartan/hidroklorotiazid Teva je treba jemati vsaj eno uro pred ali štiri ure po jemanju teh zdravil.
The combination should be administered with caution, especially in the elderly.
Pri sočasnem zdravljenju je potrebna previdnost, še posebej pri starostnikih.
• 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.
• 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.
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.
Primarni cilj te študije je bil primerjati odstotek bolnikov z nadzorovano vrednostjo diastoličnega tlaka v sedečem položaju (SeDBP < 90 mmHg) v 5. tednu zdravljenja.
Modifying manufacturing processes, where necessary, to minimise contamination as much as possible.
2. po potrebi prilagoditev postopkov proizvodnje, da se onesnaženje čim bolj zmanjša;
Serum electrolytes and creatinine should be monitored frequently.
Pogosto je treba preverjati serumske vrednosti elektrolitov in kreatinina.
In addition to NDMA and NDEA, other N-nitrosamines have been detected in a few sartan-containing medicinal products.
Poleg NDMA in NDEA so v nekaterih zdravilih, ki vsebujejo sartan, odkrili tudi drugeN-nitrozamine.
The mechanism of antihypertensive effect of thiazide diuretics is not fully known.
Antihipertenzijski mehanizem delovanja tiazidnih diuretikov ni natančno znan.
There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Dokazov o mutagenosti, klastogenosti ali karcinogenosti ni.
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.
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.
Peak effects occurred at 3-6 hours.
Največji učinek je bil dosežen po 3-6 urah.
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.
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;
• 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
• 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;
The major circulating metabolite is irbesartan glucuronide (approximately 6 %).
Glavni presnovek v obtoku je irbesartanov glukuronid (približno 6 %).
In long-term follow-up studies, the effect of irbesartan/hydrochlorothiazide was maintained for over one year.
V študijah, ki so trajale dolgo časa, so ugotovili, da je učinek irbesartana/hidroklorotiazida trajal še več kot eno leto.
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.
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.
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.
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).
If you accidentally take too many tablets, contact your doctor immediately.
Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
In patients with creatinine clearance < 20 ml/min, the elimination half-life of hydrochlorothiazide was reported to increase to 21 hours.
Pri bolnikih z ledvičnim očistkom < 20 ml/min se razpolovni čas izločanja hidroklorotiazida podaljša na 21 ur.
Hydrochlorothiazide is 68% proteinbound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Na plazemske beljakovine se veže približno 68 % hidroklorotiazida; njegov porazdelitveni volumen je 0,83 do 1,14 l/kg.
In rabbits, abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Pri kuncih je prišlo do abortusa ali zgodnje absorpcije pri odmerkih, ki so povzročili pomembno toksičnost pri samici, vključno s smrtjo.
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
- zaviralec ACE (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne težave z ledvicami, ki so povezane s sladkorno boleznijo
Thiazides in high doses causing intense diuresis can inhibit the milk production.
Tiazidi v velikih odmerkih, ki povzročijo močno diurezo, lahko zmanjšajo nastajanje mleka.
Activated charcoal may be useful in the treatment of overdose.
Pri zdravljenju prevelikega odmerjanja je lahko koristna tudi uporaba aktivnega oglja.
Max. daily dose (mg)
Učinkovina Največji dnevni odmerek (mg)
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Omejeno kopičenje irbesartana v plazmi (< 20 %) se pojavi po več dneh jemanja irbesartana enkrat na dan.
There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Dokazov o nenormalni sistemski toksičnosti ali toksičnosti za ciljni organ pri klinično primernih odmerkih ni.
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.
Kot pri vseh antihipertenzivih lahko preveliko znižanje krvnega tlaka pri bolnikih z ishemično kardiopatijo ali ishemično kardiovaskularno boleznijo povzroči miokardni infarkt ali kap.
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.
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.
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).
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 %).
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.
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.
Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten.
Angiotenzin II je snov, ki nastaja v telesu in se veže na receptorje v krvnih žilah, kar povzroči njihovo zoženje.
It is unknown whether irbesartan or its metabolites are excreted in human milk.
Ni znano, ali se irbesartan ali njegovi presnovki izločajo v materino mleko.
Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see 5.3).
Razpoložljivi farmakodinamični/toksikološki podatki pri podganah kažejo na izločanje irbesartana ali njegovih presnovkov v mleko (za podrobnosti glejte poglavje 5.3).
Hydrochlorothiazide is excreted in human milk in small amounts.
Hidroklorotiazid se v majhnih količinah izloča v materino mleko.
This includes any possible side effects not listed in this leaflet.
če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.
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.
Zavira vse učinke angiotenzina II, ki jih posredujejo receptorji AT1, ne glede na izvor in pot nastanka angiotenzina II.
When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Pri vožnji motornih vozil in delu s stroji pa je treba upoštevati, da se med zdravljenjem hipertenzije občasno lahko pojavita omotičnost in utrujenost.
You must tell your doctor if you think you are (or might become) pregnant.
Zdravniku morate povedati, če mislite, da ste noseči (ali bi lahko zanosili).
If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.
Če se pojavi hipotenzija, je treba bolnika namestiti v ležeči položaj in mu hitro začeti nadomeščati sol in tekočino.
Epidemiological studies have shown that long term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
V epidemioloških študijah so ugotovili, da se zaradi dolgotrajnega zdravljenja s hidroklorotiazidom zmanjša nevarnost pojava bolezni srca in ožilja in umrljivosti zaradi njih.
Irbesartan and hydrochlorothiazide are orally active agents and do not require biotransformation for their activity.
Irbesartan in hidroklorotiazid sta peroralno aktivni učinkovini, ki za aktivnost ne potrebujeta biotransformacije.
Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.3).
Irbesartan ni vplival na plodnost podgan in njihovih potomcev v odmerkih, ki so povzročili prve znake toksičnih učinkov pri starših (glejte poglavje 5.3).
A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Razmerje med kumulativnim odmerkom in odzivom so dokazali s tem, da se je prilagojeni OR z 2,1 (95-odstotni IZ: 1,7-2,6), zvišal na 3,9 (3,0-4,9) pri velikih odmerkih (~ 25.000 mg) in celo na 7,7 (5,7-10,5) pri največjih kumulativnih odmerkih (~ 100.000 mg) (glejte tudi poglavje 4.4).
Irbesartan/Hydrochlorothiazide Teva should not be given to children and adolescents (under 18 years).
Zdravila Irbesartan/hidroklorotiazid Teva otroci in mladostniki (mlajši od 18 let) ne smejo jemati.
Hypotension - Volume-depleted patients
Hipotenzija - zmanjšan intravaskularni volumen
Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Presnova irbesartana večinoma poteka preko CYP2C9 in v manjšem obsegu z glukuronidacijo.
Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Posledica hipokaliemije so mišični krči in/ali povdarjene srčne aritmije, povezane s sočasno uporabo digitalisovih glikozidov in nekaterih antiaritmikov.
• kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system;
• ledvične spremembe so se kazale kot blago zvečanje sečnine in kreatinina v serumu ter hiperplazija/hipertrofija jukstaglomerulnega aparata, kar je neposredna posledica interakcije med irbesartanom in sistemom renin-angiotenzin
As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Kot pri vseh bolnikih, ki dobivajo diuretike, je treba periodično preverjati serumsko vrednost elektrolitov, v primernih časovnih intervalih.
No dosage adjustment is necessary in female patients.
Prilagoditev odmerka pri ženskah ni potrebna.
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Zdravljenje je simptomatsko in podporno.
N-nitrosamines belong to a “cohort of concern” compounds in this guideline.
N-nitrozamini v navedenih smernicah spadajo med spojine iz „kohorte, ki vzbuja zaskrbljenost“.
At least 61 % of the oral dose is eliminated unchanged within 24 hours.
V 24 urah se v nespremenjeni obliki izloči najmanj 61 % peroralnega odmerka hidroklorotiazida.
The CHMP, as a consequence, considers that the benefit-risk balance of products containing candesartan, irbesartan, losartan, olmesartan, valsartan remains favourable subject to the conditions described above.
Odbor CHMP je posledično menil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo kandesartan, irbesartan, losartan, olmesartan ali valsartan, še naprej ugodno, če se upoštevajo zgoraj opisani pogoji.
In case of identification of other nitrosamines, this should be forthwith reported to the competent authorities, together with a toxicology assessment of the impurity, a clinical assessment for the exposed patients, a root cause analysis and a corrective action plan (e.g. changes to the manufacturing process).
Če se ugotovi prisotnost drugih nitrozaminov, je treba o tem takoj poročati pristojnim organom, skupaj s toksikološko oceno nečistote, klinično oceno pri izpostavljenih bolnikih, analizo osnovnih vzrokov in načrtom korektivnih ukrepov (npr. sprememb postopka proizvodnje).
Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidneys.
Hidroklorotiazid se ne presnavlja, temveč se hitro izloči skozi ledvice.