FrancophonIA/ELRC3.0 huggingface dataset:
English: Some side effects can be serious and need immediate medical attention:
Slovak: Nekateri neželeni učinki so lahko resni in zahtevajo takojšnjo zdravstveno oskrbo:
English: If you forget to take a dose, do not worry.
Slovak: Če pozabite vzeti odmerek zdravila, naj vas ne skrbi.
English: Children and adolescents
Slovak: Otroci in mladostniki
English: (See section 5.3).
Slovak: (glejte poglavje 5.3).
English: Clinical efficacy and safety
Slovak: Klinična učinkovitost in varnost
English: NN: {number} {national reimbursement number or other national number identifying the medicinal product}
Slovak: NN: {številka} [nacionalna številka povračila stroškov za zdravilo ali druga nacionalna številka za identifikacijo zdravila]
English: The binding is long-lasting.
Slovak: Vezava je dolgotrajna.
English: The mean duration of follow up was 4 years and 8 months.
Slovak: Srednje trajanje sledenja je bilo 4 leta in 8 mesecev.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Slovak: Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji zdravila.
English: About 60 % of the oral dose is eliminated within 48 hours.
Slovak: Približno 60 % peroralnega odmerka se izloči v 48 urah.
English: See section 4.
Slovak: Glejte poglavje 4.
English: In some cases you may have to stop taking one of the medicines.
Slovak: V nekaterih primerih boste morali katero od teh zdravil prenehati jemati.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovak: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Summary of the safety profile
Slovak: Povzetek varnostnega profila
English: Therefore the combination should be administered with caution, especially in the elderly.
Slovak: Zato je treba kombinacijo previdno dajati zlasti starejšim bolnikom.
English: PC: {number} {product code}
Slovak: PC: {številka} [koda zdravila]
English: Other sources of information
Slovak: Drugi viri informacij
English: The expiry date refers to the last day of that month.
Slovak: Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovak: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: Your doctor may need to change the dose of these other medications or take other precautions.
Slovak: Zdravnik bo morda moral spremeniti odmerek teh zdravil ali uvesti druge previdnostne ukrepe.
English: Contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Slovak: Nemudoma morate poklicati svojega zdravnika, farmacevta ali oddelek za nujno pomoč v najbližji bolnišnici.
English: Biotransformation
Slovak: Biotransformacija
English: Sepsis including fatal outcome
Slovak: sepsa, tudi z usodnim izidom
English: Elderly Pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Slovak: Starejši Farmakokinetika telmisartana se med starejšimi bolniki in bolniki, mlajšimi od 65 let, ne razlikuje.
English: Aluminium/aluminium blisters (PA/Al/PVC/Al or PA/PA/Al/PVC/Al).
Slovak: Pretisni omoti iz aluminija/aluminija (PA/Al/PVC/Al ali PA/PA/Al/PVC/Al).
English: Terminal elimination half-life was >20 hours.
Slovak: Končna razpolovna doba izločanja je bila > 20 ur.
English: The tablets should be swallowed with some water or other non-alcoholic drink.
Slovak: Tablete morate pogoltniti z nekaj vode ali brezalkoholne pijače.
English: You may notice this as dizziness when standing up.
Slovak: Ta učinek boste opazili kot omotico med vstajanjem.
English: • if you are taking digoxin.
Slovak: • če jemljete digoksin.
English: even if their signs of illness are the same as yours.
Slovak: čeprav imajo znake bolezni, podobne vašim.
English: Take it as soon as you remember then carry on as before.
Slovak: Vzemite ga takoj, ko se spomnite, in z jemanjem nadaljujte kot običajno.
English: One blister contains 7 or 10 tablets.
Slovak: En pretisni omot vsebuje 7 ali 10 tablet.
English: If a photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Slovak: Če se med zdravljenjem pojavi fotosenzibilna reakcija, ga je priporočljivo prekiniti.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovak: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Slovak: Bolnika je treba skrbno spremljati, zdravimo pa simptomatsko in podporno.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Slovak: Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
English: Primary aldosteronism
Slovak: Primarni aldosteronizem
English: If you do not take your tablet on one day, take your normal dose on the next day.
Slovak: Če tablete ves dan ne vzamete, vzemite naslednji dan običajni odmerek.
English: See also information under the heading “Do not take Kinzalkomb”.
Slovak: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Kinzalkomb”.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovak: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Paediatric population
Slovak: Pediatrična populacija
English: Kaiser-Wilhelm-Allee 51368 Leverkusen Germany
Slovak: Kaiser-Wilhelm-Allee 51368 Leverkusen Nemčija
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovak: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovak: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: For more detailed information see above under the heading “Cardiovascular prevention”.
Slovak: Za podrobnejše informacije glejte zgoraj pod naslovom "Preprečevanje srčnožilnih bolezni".
English: • Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Slovak: • drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6),
English: Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Slovak: Torej je potrebno krvni tlak meriti redno, da bi preverili, ali je v normalnem območju.
English: SN: {number} {serial number}
Slovak: SN: {številka} [serijska številka]
English: Not all pack sizes may be available in your country.
Slovak: Vsa navedena pakiranja v vaši državi morda niso na voljo.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovak: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Renal clearance is about 250 - 300 ml/min.
Slovak: Ledvični očistek je približno 250 do 300 ml/min.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Slovak: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP.
English: It may harm them,
Slovak: Njim bi lahko celo škodovalo,
English: The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Slovak: Primarno zdravljenje je čim hitrejša prekinitev uporabe hidroklorotiazida.
English: This leaflet was last revised in
Slovak: Navodilo je bilo nazadnje revidirano
English: The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Slovak: Nekoliko zmanjšano območje pod krivuljo (AUC) predvidoma ne zmanjša terapevtske učinkovitosti.
English: This is not considered to be of clinical relevance.
Slovak: Ta pojav ne velja za klinično pomembnega.
English: Activated charcoal may be useful in the treatment of overdose.
Slovak: Aktivno oglje je lahko koristno pri zdravljenju po prevelikem odmerku.
English: You do not need to take any action if this happens.
Slovak: Če se to zgodi, ni treba storiti ničesar.
English: Mechanism of action
Slovak: Mehanizem delovanja
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovak: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovak: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: The clinical relevance of this observation is not known.
Slovak: Klinični pomen tega pojava ni znan.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovak: UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
English: Warnings and precautions
Slovak: Opozorila in previdnostni ukrepi
English: • if you have severe kidney disease.
Slovak: • če imate hudo ledvično bolezen,
English: Plasma concentrations of telmisartan are generally 2 - 3 times higher in females than in males.
Slovak: Koncentracije telmisartana v plazmi so pri ženskah večinoma 2- do 3-krat večje kot pri moških.
English: The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan.
Slovak: Funkcija teh receptorjev ni znana, kakor tudi ne posledice njihovega prevelikega spodbujanja z angiotenzinom II, katerega raven telmisartan poveča.
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Slovak: Čeprav ni na voljo kontroliranih epidemioloških podatkov glede tveganja pri uporabi antagonistov angiotenzina II, lahko podobno tveganje obstaja tudi za to skupino zdravil.
English: 4.6 Fertility, pregnancy and lactation
Slovak: 4.6 Plodnost, nosečnost in dojenje
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovak: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Slovak: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: The apparent volume of distribution for telmisartan is approximately 500 litres indicating additional tissue binding.
Slovak: Povprečen navidezen volumen porazdelitve je približno 500 l, kar kaže na dodatno tkivno vezavo.
English: Do not throw away any medicines via wastewater or household waste.
Slovak: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: For the full list of excipients, see section 6.1.
Slovak: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Chloride deficit is generally mild and usually does not require treatment.
Slovak: Pomanjkanje klorida je običajno blago in ga ni potrebno zdraviti.
English: Try to take the tablet at the same time each day.
Slovak: Poskusite tablete jemati vsak dan ob isti uri.
English: The most common signs and symptoms of overdose are nausea and somnolence.
Slovak: Najpogostejša znaka in simptoma prevelikega odmerka sta slabost in zaspanost.
English: Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.
Slovak: Alkohol vam lahko dodatno zniža krvni tlak ali poveča verjetnost, da boste omotični ali se počutili slabotno.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Slovak: Dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS)
English: There are no adequate data from the use of Kinzalkomb in pregnant women.
Slovak: Ni zadostnih podatkov o uporabi zdravila Kinzalkomb pri nosečnicah.
English: Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
Slovak: Hidroklorotiazida ne smemo uporabljati za zdravljenje esencialne hipertenzije pri nosečnicah, razen v redkih primerih, kadar ni možno drugo zdravljenje.
English: In functionally anephric patients the elimination half-life is about 34 hours.
Slovak: Pri bolnikih brez ledvične funkcije je razpolovna doba izločanja približno 34 ur.
English: Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.
Slovak: Sumljive kožne spremembe je treba čim prej pregledati, po možnosti naj se opravi tudi histološki pregled biopsij.
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Slovak: Izkušnje z jemanjem hidroklorotiazida med nosečnostjo, zlasti v prvem trimesečju, so omejene.
English: If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Slovak: Če je zdravljenje z dvojno blokado res nujno, sme potekati le pod nadzorom specialista in s pogostimi natančnimi kontrolami delovanja ledvic, elektrolitov in krvnega tlaka.
English: Serum electrolytes and creatinine should be monitored frequently.
Slovak: Potrebna je pogosta kontrola serumskih elektrolitov in kreatinina.
English: Contents of the pack and other information
Slovak: Vsebina pakiranja in dodatne informacije
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovak: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Erectile dysfunction
Slovak: erektilna disfunkcija
English: Linearity/non-linearity
Slovak: Linearnost/nelinearnost
English: Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body.
Slovak: Zdravljenje s hidroklorotiazidom lahko povzroči neravnovesje elektrolitov v telesu.
English: After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Slovak: Po prvem odmerku telmisartana postane antihipertenzivni učinek postopno zaznaven v 3 urah.
English: These findings are considered to be due to the pharmacological activity of telmisartan.
Slovak: Menijo, da so našteti pojavi posledica farmakološkega delovanja telmisartana.
English: Both substances help to control high blood pressure.
Slovak: Obe učinkovini pomagata uravnavati visok krvni tlak.
English: Read the package leaflet before use.
Slovak: Pred uporabo preberite priloženo navodilo!
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovak: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
Slovak: • če vaš zdravnik odkrije, da imate nizko raven kalija ali visoko raven kalcija v krvi in da tega stanja zdravljenje ne izboljša,
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Slovak: Hidroklorotiazid sproži diurezo v 2 urah, doseže največji učinek približno po 4 urah, njegovo delovanje pa traja približno 6 do 12 ur.
English: Absorption
Slovak: Absorpcija
English: Name and address of the manufacturer responsible for batch release
Slovak: Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: • if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
Slovak: • če ste alergični na telmisartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: There are usually no symptoms of high blood pressure before damage occurs.
Slovak: Visok krvni tlak običajno ne povzroča simptomov, dokler se ne pojavijo okvare.
English: • Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product).
Slovak: • preobčutljivost na druge sulfonamidne derivate (ker je hidroklorotiazid sulfonamidni derivat),
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Slovak: KAKOVOSTNA IN KOLIČINSKA
English: • if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines.
Slovak: • če ste alergični na hidroklorotiazid ali katerokoli drugo sulfonamidno zdravilo,
English: Your doctor will normally advise you to stop taking Kinzalkomb before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kinzalkomb.
Slovak: Zdravnik vam bo praviloma svetoval, da zdravilo Kinzalkomb prenehate jemati, preden boste zanosili ali takoj, ko boste vedeli, da ste noseči, in vam svetoval, da namesto zdravila Kinzalkomb jemljete drugo zdravilo.
English: Chest pain Influenza-like illness, pain
Slovak: gripi podobna bolezen, bolečina
English: Additional information on individual components
Slovak: Dodatni podatki o posameznih sestavinah zdravila
English: The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements.
Slovak: Antihipertenzivni učinek ostaja enakomeren 24 ur po zaužitju zdravila, tudi zadnje 4 ure pred naslednjim odmerkom, kar so pokazala ambulantna merjenja krvnega tlaka.
English: Ask your pharmacist how to throw away medicines you no longer use.
Slovak: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: Do not take a double dose to make up for forgotten individual doses.
Slovak: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnje odmerke.
English: Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Slovak: Epidemiološke raziskave so pokazale, da dolgotrajno zdravljenje s hidroklorotiazidom zmanjša tveganje obolevnosti in umrljivost zaradi srčnožilnih bolezni.
English: The safety and efficacy of Kinzalkomb in children and adolescents aged below 18 have not been established.
Slovak: Varnost in učinkovitost zdravila Kinzalkomb pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: * The event may have happened by chance or could be related to a mechanism currently not known.
Slovak: * Morebiti gre za naključje ali pa je pojav povezan z mehanizmom, ki še ni znan.
English: The mechanism of the antihypertensive effect of thiazide diuretics is not fully known.
Slovak: Mehanizem antihipertenzivnega delovanja tiazidnih diuretikov še ni povsem jasen.
English: 4.7 Effects on ability to drive and use machines
Slovak: Vpliv na sposobnost vožnje in upravljanja strojev
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovak: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovak: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: Some people feel dizzy or tired when taking Kinzalkomb.
Slovak: Nekateri ljudje so med zdravljenjem z zdravilom Kinzalkomb omotični ali utrujeni.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Kinzalkomb in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Slovak: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Kinzalkorb za vse podskupine pediatrične populacije s hipertenzijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In clinical trials however, no significant increases in blood pressure response or in the incidence of orthostatic hypotension were found in women.
Slovak: Vendar v kliničnih preskušanjih pri ženskah niso zasledili pomembno večjega odziva krvnega tlaka niti večje pogostnosti ortostatske hipotenzije.
English: In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
Slovak: Telmisartan pri hipertenzivnih bolnikih znižuje sistolični in diastolični krvni tlak, ne da bi vplival na hitrost pulza.
English: The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Slovak: Kombinacija obeh sestavin ima aditiven antihipertenzivni učinek, zato učinkoviteje znižuje krvni tlak kot posamični sestavini.
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Slovak: dihalna stiska (tudi pnevmonitis in pljučni edem)
English: If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat.
Slovak: Če ste vzeli večji odmerek zdravila Kinzalkomb, kot bi smeli Če pomotoma vzamete preveč tablet, se lahko pojavijo simptomi, kot so nizek krvni tlak in pospešen srčni utrip.
English: Symptoms
Slovak: Simptomi
English: The following adverse reactions listed below have been accumulated from all clinical trials in patients treated with telmisartan for hypertension or in patients 50 years or older at high risk of cardiovascular events.
Slovak: Našteti neželeni učinki zdravila so zbrani iz vseh kliničnih preskušanj pri bolnikih, ki so se s telmisartanom zdravili zaradi hipertenzije, ali pri bolnikih starih 50 let ali starejših, z velikim tveganjem za srčnožilne dogodke.
English: Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
Slovak: Po nenadni ukinitvi zdravljenja s telmisartanom se krvni tlak v nekaj dneh postopno zviša na vrednosti pred zdravljenjem, ne da bi prišlo do povratne hipertenzije.
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.
Slovak: Epidemiološki podatki niso pokazali teratogenega učinka pri nosečnicah, ki so bile v prvem trimesečju izpostavljene zaviralcem ACE, vendar pa majhnega povečanega tveganja ni možno izključiti.
English: Telmisartan may increase the hypotensive effect of other antihypertensive agents.
Slovak: Telmisartan lahko poveča hipotenzivni učinek drugih antihipertenzivov.
English: EXPIRY DATE
Slovak: DATUM IZTEKA