natgillin/translations-raw huggingface dataset:
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 September 2014.
Po preučitvi podlage za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in 22. septembra 2014 potrdil zavrnitev vloge za spremembo dovoljenja za promet z zdravilom.
During the re-examination, the CHMP looked again at the data from the company and confirmed its opinion that the benefits of Avastin had not been sufficiently demonstrated in newly diagnosed glioblastoma.
Pri ponovnem pregledu je odbor CHMP znova pregledal podatke, ki jih je predložila družba, in potrdil svoje mnenje, da koristi zdravila Avastin niso bile zadostno dokazane pri novo postavljeni diagnozi glioblastoma.
Refusal of a change to the marketing authorisation for Avastin (bevacizumab)
Zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Avastin (bevacizumab)
The active substance in Avastin, bevacizumab, is a monoclonal antibody (a type of protein), that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that
Zdravilna učinkovina v zdravilu Avastin, bevacizumab, je monoklonsko protitelo (vrsta beljakovine), ki deluje tako, da prepozna žilni endotelijski rastni faktor (VEGF), tj. beljakovino, ki kroži v krvi in
What is happening with Avastin for treatment of other cancers?
Kakšne so posledice za zdravilo Avastin, indicirano za zdravljenje drugih vrst raka?
Avastin is a cancer medicine that contains the active substance bevacizumab.
Avastin je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino bevacizumab.
By attaching to VEGF, Avastin stops cancer cells from developing their own blood supply and starves them of oxygen and nutrients, helping to slow down the growth of the cancer.
Zdravilo Avastin tako z vezanjem na ta faktor povzroči, da se rakave celice ne morejo oskrbovati s krvjo in dobivajo premalo kisika ter hranil, kar pripomore k upočasnitvi rasti raka.
What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisation?
Kateri so bili glavni zadržki, zaradi katerih je odbor CHMP predlagal zavrnitev vloge za spremembo dovoljenja za promet z zdravilom?
Avastin was also expected to be used to treat adult patients with newly diagnosed glioblastoma in combination with radiotherapy (treatment with radiation) and temozolomide (another cancer medicine).
Zdravilo Avastin naj bi se prav tako uporabljalo v kombinaciji z radioterapijo (zdravljenjem z obsevanjem) in temozolomidom (drugim zdravilom za zdravljenje raka) za zdravljenje odraslih bolnikov z novo postavljeno diagnozo glioblastoma.
What was Avastin expected to be used for?
Za kaj naj bi se zdravilo Avastin uporabljalo?
In the study, patients received Avastin or placebo (a dummy treatment) in addition to treatment with radiotherapy and temozolomide.
V študiji so bolniki poleg zdravljenja z radioterapijo in temozolomidom prejemali zdravilo Avastin ali placebo (zdravilo brez zdravilne učinkovine).
circulates in the blood and makes blood vessels grow.
povzroča rast krvnih žil, in se veže nanj.
How is Avastin expected to work?
Kako naj bi zdravilo Avastin delovalo?
The company informed the CHMP that there are no consequences for patients with glioblastoma receiving Avastin in clinical trials: patients will continue to receive Avastin in the on-going and future clinical trials.
Družba je obvestila odbor CHMP, da zavrnitev nima nobenih posledic za bolnike z glioblastomom, ki prejemajo zdravilo Avastin v kliničnih preskušanjih.
Therefore, the CHMP maintained its previous recommendation that the change to the marketing authorisation be refused.
Zato je ostal pri svojem prejšnjem priporočilu, da zavrne vlogo za spremembo dovoljenja za promet z zdravilom.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Avastin in the treatment of newly diagnosed glioblastoma did not outweigh its risks.
Posledično je odbor CHMP tedaj menil, da koristi zdravila Avastin pri zdravljenju novo postavljene diagnoze glioblastoma ne odtehtajo z njim povezanih tveganj, zato je priporočil zavrnitev vloge za spremembo dovoljenja za promet z zdravilom.
--1 Porcine circovirus type 2 ORF2 subunit antigen ≥4.5 log2 ELISA units* * Antibody titre obtained according to the in vivo potency test in chickens
--1 Cirkovirus prašičev, tip 2, antigenska podenota ORF2: ≥ 4,5 log2 enot ELISA* * Titer protiteles je določen z in vivo preskusom učinkovitosti pri piščancih.
MA (EU) number
MA (EU) številka
Packaging Content Package size
Velikost pakiranj a
Many may feel quite normal.
Veliko se jih lahko po uti povsem normalno.
“Recent” here means between 12 hours and 10 days.
"Nedavni" pri tem pomeni pred 12 urami do 10 dnevi.
• Medicines should not be disposed of via wastewater or household waste.
• Zdravila ne smete odvre i v odpadne vode ali med gospodinjske odpadke.
Take Diovan at about the same time each day.
Zdravilo Diovan vzemite vsak dan ob približno istem asu.
The average accumulation factor is about 1.7.
Povpre ni akumulacijski faktor je okrog 1,7.
It may harm them, even if their symptoms are the same as yours.
Njim bi lahko celo škodovalo, eprav imajo znake bolezni, podobne vašim.
People with high blood pressure often do not notice any signs of this problem.
Ljudje z visokim krvnim tlakom pogosto ne utijo nobenih težav, povezanih s tem.
• lithium, a medicine used to treat some types of psychiatric illness.
• litij, zdravilo za zdravljenje nekaterih vrst psihiatri nih bolezni.
Member State EU/EEA
EU/EGP
Do not stop taking your medicine unless your doctor tells you to.
Ne prenehajte jemati zdravila, razen e vam je tako naro il zdravnik.
It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body.
Do tega pride takrat, ko sr na rpalka ne more rpati dovolj krvi, da bi s krvjo oskrbela celotno telo.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, e jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi e ste ga dobili brez recepta.
The half-life of valsartan is 6 hours.
Razpolovni as valsartana je približno 6 ur.
• Submit a Risk Management Plan (or its update) for Diovan at National level, taking into account the new paediatric data and the CHMP recommendations.
• predložil na rt za obvladovanje tveganja (ali njegovo posodobitev) za zdravilo Diovan na nacionalni ravni ob upoštevanju novih pediatri nih podatkov in priporo il CHMP.
Valsartan shows multiexponential decay kinetics (t½ <1 h and t½ß about 9 h).
Valsartan kaže multieksponentno kinetiko upadanja (t½ <1 ura in t½ß približno 9 ur).
Lowering your blood pressure to normal reduces the risk of developing these disorders.
Z znižanjem krvnega tlaka na normalne vrednosti, se zmanjša tveganje za razvoj teh bolezni.
The mean treatment duration was two years.
Zdravljenje je trajalo povpre no dve leti.
This period coincides with 36 weeks of gestation in humans, which could occasionally extend up to 44 weeks after conception in humans.
To obdobje se ujema s 36 tedni nose nosti pri ljudeh, kar bi v asih lahko podaljšali tudi do 44. tedna po spo etju pri ljudeh.
• difficulty in breathing or swallowing
• težave z dihanjem ali s požiranjem
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH LANICAH
Valsartan is highly bound to serum proteins (94-97%), mainly serum albumin.
Valsartan je mo no vezan na beljakovine v serumu (94-97 %), predvsem na albumin v serumu.
Like many other medicines used to treat high blood pressure, Diovan may in rare cases cause dizziness and affect the ability to concentrate.
Kot številna druga zdravila za zdravljenje visokega krvnega tlaka lahko zdravilo Diovan v redkih primerih povzro i omoti nost in vpliva na sposobnost koncentracije.
Stopping your treatment with Diovan may cause your disease to get worse.
Prenehanje zdravljenja z zdravilom Diovan lahko povzro i poslabšanje vaše bolezni.
Valsartan is not known to bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Ni znano, da bi valsartan vezal ali zaviral druge receptorje hormonov ali ionske kanal ke, ki so pomembni za kardiovaskularno regulacijo.
When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.
Pri vožnji ali upravljanju s stroji je treba upoštevati, da se lahko ob asno pojavi omoti nost ali ob utek utrujenosti.
The protocol of the study will be submitted by the applicant in the second quarter of 2010 for agreement with the CHMP with input from the PDCO.
Protokol študije bo predlagatelj predložil v drugem etrtletju leta 2010 za pridobitev soglasja odbora CHMP ob upoštevanju mnenja Odbora za pediatrijo (PDCO).
Overall, the dosedependent antihypertensive effect of valsartan was consistent across all the demographic subgroups.
V celoti je bilo od odmerka odvisno antihipertenzivno delovanje valsartana skladno po vseh demografskih podskupinah.
Overdose with Diovan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock.
Preveliko odmerjanje zdravila Diovan lahko povzro i izrazito hipotenzijo, ki lahko vodi v motnje zavesti, cirkulacijski kolaps in/ali šok.
These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Neželeni u inki se pojavljajo s pogostnostjo, ki je opredeljena spodaj: zelo pogosti: prizadenejo ve kot 1 od 10 uporabnikov pogosti: prizadenejo 1 do 10 od 100 uporabnikov ob asni: prizadenejo 1 do 10 od 1.000 uporabnikov redki: prizadenejo 1 do 10 od 10.000 uporabnikov zelo redki: prizadenejo manj kot 1 od 10.000 uporabnikov neznana: pogostnosti ni mogo e oceniti iz razpoložljivih podatkov
Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Diovan affects you.
Vpliv na sposobnost upravljanja vozil in strojev Preden za nete voziti, uporabljati orodje, upravljati stroje ali izvajati druge dejavnosti, ki zahtevajo zbranost, morate zagotovo vedeti, kako zdravilo Diovan deluje na vas.
Side effects in children and adolescents are similar to those seen in adults.
Pri otrocih in mladostnikih so neželeni u inki podobni kot pri odraslih.
• if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Diovan listed at the end of this leaflet.
• e ste alergi ni (preob utljivi) na valsartan ali katerekoli sestavine zdravila Diovan, ki so navedene na koncu tega navodila,
• if you suffer from aldosteronism.
• e imate aldosteronizem.
Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000 fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Valsartan nima delnega agonisti nega u inka na receptorje AT1 in ima veliko (približno 20.000-kratno) ve jo afiniteto za receptorje AT1 kot za receptorje AT2.
All changes were considered to be caused by the pharmacological action of valsartan which produces prolonged hypotension, particularly in marmosets.
Vse spremembe so pripisali farmakološkemu u inku valsartana, ki povzro a podaljšano hipotenzijo, še zlasti pri marmozetkah.
• Do not use Diovan if you notice that the pack is damaged or shows signs of tampering.
• Ne uporabljajte zdravila Diovan, e opazite, da je ovojnina poškodovana ali opazite, da je bila že odprta.
If any of these apply to you, tell your doctor before you take Diovan.
e karkoli od naštetega velja za vas, obvestite svojega zdravnika, preden uporabite zdravilo Diovan.
The addition of a diuretic such as hydrochlorothiazide will decrease blood pressure even further in these patients.
Dodajanje diuretika, kot je hidroklorotiazid, pri teh bolnikih še bolj zniža krvni tlak.
This is a disease in which your adrenal glands make too much of the hormone aldosterone.
To je bolezen, pri kateri vaše nadledvi ne žleze tvorijo preve hormona aldosterona.
If you forget to take a dose, take it as soon as you remember.
e ste pozabili vzeti zdravilo Diovan e pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
It may be necessary to check the amount of potassium in your blood at regular intervals.
Morda bo treba v rednih intervalih preverjati koli ino kalija v vaši krvi,
Taking Diovan with food and drink You can take Diovan with or without food.
Jemanje zdravila Diovan skupaj s hrano in pijao Zdravilo Diovan je mogoe jemati s hrano ali brez nje.
If hypotension occurs, the patient should be placed in a supine position and blood volume correction should be undertaken.
e pride do hipotenzije, je treba bolnika položiti vznak in ustrezno popraviti volumen krvi.
This medicinal product is authorised in the Member States of the EEA under the following names: [To be completed nationally]
Zdravilo je v državah lanicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: [Izpolni država lanica]
Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase.
Angiotenzin II je snov v telesu, ki povzro i, da se krvne žile stisnejo, kar povzro i zvišanje krvnega tlaka.
Adverse reactions are ranked by frequency, the most frequent first, 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), including isolated reports.
V razvrstitvah pogostnosti so neželeni u inki navedeni po pogostnosti, najbolj pogosti najprej, in sicer po naslednjem dogovoru: zelo pogosti ( 1/10); pogosti ( 1/100 do < 1/10); ob asni ( 1/1.000 do < 1/100); redki ( 1/10.000 do < 1/1.000); zelo redki (<1/10.000), vklju no s posami nimi poro ili.
4.8 Undesirable effects
4.8 Neželeni u inki
• muscle pain (myalgia)
• bole ine v mišicah (mialgija)
[To be completed nationally]
[Izpolni država lanica]
What Diovan looks like and contents of the pack [To be completed nationally]
Izgled zdravila Diovan in vsebina pakiranja [Izpolni država lanica]
Swallow Diovan with a glass of water.
Tablete zdravila Diovan vzemite s kozarcem vode
If symptomatic hypotension or renal dysfunction occur, consideration should be given to a dose reduction.
e pride do simptomatske hipotenzije ali ledvi ne disfunkcije, je treba razmisliti o zmanjšanju odmerka.
It acts selectively on the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Deluje selektivno na receptorje podvrste AT1, ki so odgovorni za znane u inke angiotenzina II.
The therapeutic measures depend on the time of ingestion and the type and severity of the symptoms; stabilisation of the circulatory condition is of prime importance.
Ukrepi zdravljenja so odvisni od asa zaužitja in vrste ter izraženosti simptomov; pri tem je najbolj pomembno stabilizirati stanje krvnega obtoka.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KAKOVOSTNA IN KOLI INSKA SESTAVA
Valsartan is not biotransformed to a high extent as only about 20% of dose is recovered as metabolites.
Valsartan se biološko ne transformira v veliki meri, saj je le približno 20 % odmerka mogo e prestre i v obliki metabolitov.
Approximately 70% of the dose absorbed is eliminated in the bile, essentially in the unchanged form.
Okrog 70 % absorbiranega odmerka se izlo i z žol em, ve inoma v obliki nespremenjene spojine.
Combining valsartan with captopril did not add further benefit over captopril alone.
Kombinacija valsartana s kaptoprilom ni prinesla dodatnih koristi v primerjavi z uporabo le kaptoprila.
Elderly No dose adjustment is required in elderly patients.
Starejši bolniki Pri starejših bolnikih ni treba prilagajati odmerka.
In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan or any of the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Pri študijah medsebojnega delovanja zdravil z valsartanom niso opazili klini no pomembnih interakcij z valsartanom ali katero koli od naslednjih u inkovin: cimetidin, varfarin, furosemid, digoksin, atenolol, indometacin, hidroklorotiazid, amlodipin in glibenklamid.
• to treat adult patients after a recent heart attack (myocardial infarction).
• Za zdravljenje odraslih bolnikov po nedavnem sr nem infarktu (miokardni infarkt).
Do not take a double dose to make up for a forgotten dose.
Ne vzemite dvojnega odmerka, e ste pozabili vzeti prejšnji odmerek.
The safety profile seen in controlled-clinical studies in adult patients with post-myocardial infarction and/or heart failure varies from the overall safety profile seen in hypertensive patients.
Varnostni profil iz kontroliranih klini nih študij pri odraslih bolnikih po miokardnem infarktu in/ali s sr nim popuš anjem se razlikuje od splošnega profila varnosti pri hipertenzivnih bolnikih.
As expected for a compound where renal clearance accounts for only 30% of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
V skladu s pri akovanji za spojino, katere ledvi ni o istek predstavlja samo 30 % celotnega o istka plazme, niso našli nikakršne korelacije med delovanjem ledvic in sistemsko izpostavljenostjo valsartanu.
• [Storage conditions statements - To be completed nationally]
• [Pogoji shranjevanja - izpolni država lanica]
• if you have recently undergone kidney transplantation (received a new kidney).
• e so vam pred kratkim presadili ledvico (dobili ste novo ledvico),
The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Volumen porazdelitve valsartana v stanju dinami nega ravnovesja je po intravenskem vnosu okrog 17 litrov, kar kaže, da se valsartan v tkiva ne porazdeli v veliki meri.
The European Medicines Agency has waived the obligation to submit the results of studies with Diovan in all subsets of the paediatric population in heart failure and heart failure after recent myocardial infarction.
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Diovan za vse skupine pediatri ne populacije za sr no popuš anje in za sr no popuš anje po nedavnem miokardnem infarktu.
• if you are below 18 years of age and you take Diovan in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and the amount of potassium in your blood at regular intervals.
• e ste stari manj kot 18 let in jemljete zdravilo Diovan v kombinaciji z drugimi zdravili, ki zavirajo sistem renin-angiotenzin-aldosteron (zdravila, ki znižujejo krvni tlak), vam bo morda zdravnik v rednih intervalih preverjal delovanje vaših ledvic in koli ino kalija v vaši krvi,
Diovan belongs to a class of medicines known as angiotensin II receptor antagonist, which help to control high blood pressure.
Zdravilo Diovan sodi v skupino zdravil, znano pod imenom antagonisti receptorjev angiotenzina II, ki pomagajo uravnavati visok krvni tlak.
A somewhat higher systemic exposure to valsartan was observed in some elderly subjects than in young subjects; however, this has not been shown to have any clinical significance.
Pri nekaterih starejših bolnikih so opazili nekoliko ve jo sistemsko izpostavljenost valsartanu v primerjavi z mladimi osebami; vendar se ni pokazalo, da bi imelo to kakšen klini en pomen.
The applicant will initiate a scientific dialogue via the CHMP's Scientific Advice with the involvement of the PDCO for protocol assistance with the aim of gaining further insight on a hypertensive clinical trial in younger children with valsartan and to define objectives and design parameters in investigating the efficacy in this population.
Predlagatelj bo za el strokovni dialog s pomo jo strokovnih nasvetov odbora CHMP ob vklju itvi odbora PDCO za pomo pri protokolu, katerega cilj je pridobiti nadaljnji vpogled v klini no preskušanje hipertenzije pri majhnih otrocih, ki prejemajo valsartan, ter dolo iti cilje in oblikovati parametre za prou evanje u inkovitosti zdravila v tej populaciji.
High blood pressure increases the workload on the heart and arteries.
Visok krvni tlak poveuje obremenitev srca in arterij.
The rats in the juvenile valsartan study were dosed up to day 70, and effects on renal maturation (postnatal 4-6 weeks) cannot be excluded.
V študiji valsartana pri mladih živalih so podgane prejemale valsartan tudi do 70. dne in vpliva na dozorevanje ledvic (v 4. do 6. tednu po rojstvu) ni mogo e izklju iti.
Valsartan is primarily eliminated by biliary excretion in faeces (about 83% of dose) and renally in urine (about 13% of dose), mainly as unchanged drug.
Valsartan se izlo a predvsem z blatom (približno 83 % odmerka) in preko ledvic z urinom (približno 13 % odmerka), ve inoma v obliki nespremenjenega zdravila.
DATE OF REVISION OF THE TEXT [To be completed nationally]
DATUM ZADNJE REVIZIJE BESEDILA [Izpolni država lanica]
• certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
• nekatere vrste zdravil za lajšanje bole in, ki se imenujejo nesteroidna protivnetna zdravila
Sodium and/or volume depletion should be corrected before starting treatment with Diovan, for example by reducing the diuretic dose.
Pomanjkanje natrija in hipovolemijo je treba pred za etkom zdravljenja z zdravilom Diovan odpraviti, na primer z zmanjšanjem odmerka diuretika.
Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni u inki navedeni po padajo i resnosti.
Due to the lack of experience with concomitant use of valsartan and lithium, this combination is not recommended.
Zaradi pomanjkanja izkušenj o so asni uporabi valsartana in litija ta kombinacija ni priporo ena.
The primary endpoint was time to all-cause mortality.
Primarni cilj opazovanja je bil as do smrti (umrljivost iz vseh vzrokov).
Irrespective of treatment, mortality was lower in the group of patients treated with a beta blocker, suggesting that the known beta blocker benefit in this population was maintained in this trial.
Ne glede na vrsto zdravljenja je bila umrljivost manjša v skupini bolnikov, ki so se zdravili z antagonistom adrenergi nih receptorjev beta, kar kaže, da so se znane koristi antagonistov adrenergi nih receptorjev beta v tej skupini bolnikov v tem preskušanju ohranile.
The apparent clearance of valsartan following oral administration is approximately 4.5 l/h.
Navidezni o istek valsartana po peroralni aplikaciji je približno 4,5 l/h.
Valsartan is highly bound to plasma protein and is unlikely to be removed by dialysis.
Valsartan je v veliki meri vezan na beljakovine v plazmi, zato ni verjetno, da bi se izlo al med dializo.
In marmosets at similar doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy which included raised urea and creatinine.
Pri marmozetkah so bile pri podobnih odmerkih spremembe podobne, vendar bolj resne, še zlasti v ledvicah, kjer so se pojavile spremembe, podobne nefropatiji, ki so vklju evale zvišanje ravni se nine in kreatinina.
• if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics).
• e izgubite veliko teko ine (dehidracija) zaradi driske, bruhanja ali velikih odmerkov tablet za odvajanje vode (diuretikov),
The antihypertensive effect persists over 24 hours after dosing.
Antihipertenzivni u inek traja 24 ur po odmerjanju.
4.6 Fertility, pregnancy and lactation
4.6 Plodnost, nose nost in dojenje