FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Slovenian: Irbesartan z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, zavira delovanje tega hormona, kar omogoči razširitev krvnih žil.
English: For the full description of all side effects reported with Irbesartan Zentiva, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Irbesartan Zentiva, glejte navodilo za uporabo.
English: The most common side effect with Irbesartan Zentiva (seen in more than 1 patient in 10) is dizziness, hyperkalaemia (high blood potassium levels).
Slovenian: Najpogostejša neželena učinka zdravila Irbesartan Zentiva (opažena pri več kot 1 bolniku od 10) sta omotica in hiperkaliemija (visoka raven kalija v krvi).
English: One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine.
Slovenian: V prvi študiji so proučevali označevalce poškodb ledvic, in sicer na podlagi merjenja, ali ledvice v urin izločajo beljakovino albumin.
English: In the blood pressure studies, Irbesartan Zentiva was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Slovenian: V študijah krvnega tlaka je bilo zdravilo Irbesartan Zentiva pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje visokega krvnega tlaka.
English: The second study looked at whether Irbesartan Zentiva increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
Slovenian: V drugi študiji so proučevali, ali zdravilo Irbesartan Zentiva podaljša čas, v katerem se raven kreatinina (označevalca ledvičnega obolenja) v krvi bolnikov podvoji, čas do pojava potrebe po presaditvi ledvic ali dializi oziroma čas do nastopa smrti.
English: What is the risk associated with Irbesartan Zentiva?
Slovenian: Kakšna tveganja so povezana z zdravilom Irbesartan Zentiva?
English: In the first kidney disease study, Irbesartan Zentiva was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Slovenian: V prvi študiji ledvičnega obolenja je bilo zdravilo Irbesartan Zentiva učinkovitejše od placeba pri zmanjševanju tveganja za pojav poškodbe ledvic, merjene na podlagi izločanja beljakovin.
English: A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Slovenian: Pri bolnikih na hemodializi (postopku čiščenja krvi) ali pri bolnikih, starejših od 75 let, lahko začetni odmerek znaša 75 mg.
English: Irbesartan Zentiva was originally studied in 11 trials for its effects on blood pressure.
Slovenian: Učinke zdravila Irbesartan Zentiva na krvni tlak so prvotno proučevali v 11 preskušanjih.
English: In the second kidney disease study, Irbesartan Zentiva reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Slovenian: V drugi študiji ledvičnega obolenja je zdravilo Irbesartan Zentiva v primerjavi s placebom za 20 % zmanjšalo relativno tveganje za podvojitev ravni kreatinina v krvi, za pojav potrebe po presaditvi ledvic ali dializi ali za nastop smrti med študijo.
English: Irbesartan Zentiva is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Slovenian: Zdravilo Irbesartan Zentiva se uporablja tudi za zdravljenje ledvičnega obolenja pri odraslih z visokim krvnim tlakom in sladkorno boleznijo tipa 2.
English: Why has Irbesartan Zentiva been approved?
Slovenian: Zakaj je bilo zdravilo Irbesartan Zentiva odobreno?
English: How has Irbesartan Zentiva been studied?
Slovenian: Kako je bilo zdravilo Irbesartan Zentiva raziskano?
English: What is Irbesartan Zentiva?
Slovenian: Kaj je zdravilo Irbesartan Zentiva?
English: How is Irbesartan Zentiva used?
Slovenian: Kako se zdravilo Irbesartan Zentiva uporablja?
English: What is Irbesartan Zentiva used for?
Slovenian: Za kaj se zdravilo Irbesartan Zentiva uporablja?
English: How does Irbesartan Zentiva work?
Slovenian: Kako zdravilo Irbesartan Zentiva deluje?
English: Date of first authorisation: 08 January 2014 Date of latest renewal: 20 November 2018
Slovenian: Datum prve odobritve: 08. januar 2014 Datum zadnjega podaljšanja: 20. november 2018
English: 10 DATE OF REVISION OF THE TEXT
Slovenian: 10 DATUM ZADNJE REVIZIJE BESEDILA
English: A risk of birth defects for your unborn child cannot be completely excluded.
Slovenian: Tveganja za prirojene napake pri vašem nerojenem otroku ni mogoče popolnoma izključiti.
English: Elderly (65 years and older)
Slovenian: Starejši (65 let in starejši)
English: Children (4 to 12 years)
Slovenian: Otroci (od 4 do 12 let)
English: You should not stop your treatment without discussing this with your doctor.
Slovenian: Zdravljenja ne smete prekiniti, ne da bi se o tem pogovorili z zdravnikom.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno dostopni podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil za določanje odmerjanja ni mogoče izdelati.
English: Height (cm) x ks
Slovenian: Višina (cm) x ks
English: The elimination half-life was approximately 5 hours.
Slovenian: Razpolovni čas izločanja je bil približno 5 ur.
English: The mechanism of action of levetiracetam still remains to be fully elucidated.
Slovenian: Mehanizem delovanja levetiracetama še vedno ni popolnoma pojasnjen.
English: These effects should however decrease over time.
Slovenian: Vendar se jakost teh učinkov s časom zmanjša.
English: The lowest effective dose should be used.
Slovenian: Uporabiti je treba najmanjši učinkovit odmerek.
English: • infection;
Slovenian: • okužba;
English: Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.
Slovenian: Ne jemljite makrogola (učinkovina, ki se uporablja kot laksativ) eno uro pred in eno uro po jemanju levetiracetama, ker lahko zmanjša učinek levetiracetama.
English: Other unidentified components accounted only for 0.6% of the dose.
Slovenian: Druge, neidentificirane sestavine predstavljajo le 0,6 % odmerka.
English: Total Daily Dose
Slovenian: Celokupni dnevni odmerek
English: If not used immediately, in-use storage time and conditions are the responsibility of the user.
Slovenian: V primeru, da se ga ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren uporabnik.
English: • encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
Slovenian: • encefalopatija (glejte podpoglavje “Takoj obvestite zdravnika” za podroben opis simptomov)
English: Available data in children did not suggest impact on growth and puberty.
Slovenian: Podatki, ki so na razpolago pri otrocih, ne kažejo na vpliv na rast in puberteto.
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.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti cepiva za to cepivo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Dose adjustment is not required.
Slovenian: Prilagoditev odmerjanja ni potrebna.
English: The mechanism of this risk is not known.
Slovenian: Mehanizem tveganja še ni znan.
English: No impact on fertility was detected in animal studies (see section 5.3).
Slovenian: V študijah na živalih vpliva na plodnost niso odkrili (glejte poglavje 5.3).
English: * Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Slovenian: * Prevalenca je bistveno večja pri japonskih bolnikih v primerjavi z ne-japonskimi bolniki.
English: Physiological changes during pregnancy may affect levetiracetam concentration.
Slovenian: Fiziološke spremembe med nosečnostjo lahko vplivajo na koncentracijo levetiracetama.
English: Cases of encephalopathy generally occurred at the beginning of the treatment (few days to a few months) and were reversible after treatment discontinuation.
Slovenian: Primeri encefalopatije so se običajno pojavili na začetku zdravljenja (od nekaj dni do nekaj mesecev) in so bili reverzibilni, ko se je zdravljenje prekinilo.
English: Dose in adults and adolescents (from 16 years of age):
Slovenian: Odmerjanje pri odraslih in mladostnikih (od 16. leta starosti):
English: He/she may decide if your dose should be adjusted.
Slovenian: Odločil se bo, ali je vaš odmerek potrebno prilagoditi.
English: This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy).
Slovenian: To zmanjšanje koncentracije je bolj izrazito v tretjem trimesečju (do 60 % glede na običajno koncentracijo pred nosečnostjo).
English: Then CLcr is adjusted for body surface area (BSA) as follows:
Slovenian: CLcr je prilagojen na telesno površino (BSA, body surface area) na naslednji način:
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: Hydrolysis of the acetamide group was measurable in a large number of tissues including blood cells.
Slovenian: Hidrolizo acetamidne skupine so izmerili v številnih tkivih vključno s krvnimi celicami.
English: The pharmacokinetic and safety profiles did not identify any safety concerns.
Slovenian: Farmakokinetični in varnostni profil nista pokazala nobenih vplivov na varnost.
English: Levetiracetam Hospira must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Slovenian: Zdravilo Levetiracetam Hospira morate prejeti dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.
English: EXP Use immediately after dilution.
Slovenian: EXP: Uporabite takoj po redčenju.
English: • limp or difficulty walking.
Slovenian: • šepanje ali težave pri hoji.
English: Tell your doctor immediately, or go to your nearest emergency department, if you experience:
Slovenian: Nemudoma obvestite zdravnika ali obiščite oddelek za nujno medicinsko pomoč, če opazite:
English: This leaflet was last revised in month/YYYY.
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec LLLL}.
English: Chemical and physical in-use stability of the diluted product stored in PVC bags has been demonstrated for 24 hours at 30 °C and at 2-8 °C.
Slovenian: Kemična in fizikalna stabilnost razredčenega zdravila med uporabo, shranjenega v PVC vrečkah, sta bili dokazani za obdobje 24 ur pri temperaturi 30 °C in pri od 2 do 8 °C.
English: Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.
Slovenian: Zagotoviti je treba ustrezno klinično spremljanje nosečnic, ki se zdravijo z levetiracetamom.
English: However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
Slovenian: Vendar pa dolgoročni učinki na učenje, inteligenco, rast, delovanje žlez, puberteto in rodnost pri otrocih ostajajo neznani.
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.
Slovenian: • 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: ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Slovenian: ks = 0,55 pri otrocih, mlajših od 13 let in pri mladostnicah; ks = 0,7 pri mladostnikih moškega spola
English: • elevated/abnormal values in a liver function test;
Slovenian: • povišane/nenormalne vrednosti testov jetrnih funkcij;
English: Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients;
Slovenian: Pogostnost je bistveno večja pri japonskih bolnikih v primerjavi z ne-japonskimi bolniki;
English: The major route of excretion was via urine, accounting for a mean 95% of the dose (approximately 93% of the dose was excreted within 48 hours).
Slovenian: Glavna pot izločanja je z urinom, s katerim se izloči povprečno 95 % odmerka (približno 93 % odmerka se izloči v 48 urah).
English: This recommendation is based on a study in adult renally impaired patients.
Slovenian: To priporočilo temelji na študiji pri odraslih bolnikih z ledvično okvaro.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: 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) and very rare (<1/10,000).
Slovenian: Neželeni učinki so navedeni po padajoči resnosti in njihova pogostnost je opredeljena takole: 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: Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila vi ali vaš otrok natančno preberite navodilo, ker vsebuje za vaju pomembne podatke!
English: The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Slovenian: Bolniki so morali imeti neizzvane parcialne napade ali samo generalizirane tonično-klonične napade.
English: Your total daily dose and frequency of administration remain identical.
Slovenian: Vaš celokupni dnevni odmerek in pogostost uporabe ostaneta enaki.
English: There is no modification of the clearance after repeated administration.
Slovenian: Očistek se po ponavljajočem dajanju ne spremeni.
English: One was obtained by hydroxylation of the pyrrolidone ring (1.6 % of the dose) and the other one by opening of the pyrrolidone ring (0.9% of the dose).
Slovenian: Eden nastane s hidroksilacijo pirolidonskega obroča (1,6 % odmerka), drugi z odprtjem pirolidonskega obroča (0,9 % odmerka).
English: Oral contraceptives and other pharmacokinetics interactions
Slovenian: Peroralni kontraceptivi in druge farmakokinetične interakcije
English: Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery.
Slovenian: Ti bolniki morajo biti zato previdni pri izvajanju zahtevnih opravil, npr. pri vožnji vozil ali upravljanju strojev.
English: Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Slovenian: Bolnikom svetujemo, naj ne vozijo ali upravljajo s stroji, dokler ni potrjeno, da ni vpliva na njihovo sposobnost izvajanja teh dejavnosti.
English: Levetiracetam caused mild induction of CYP2B6 and CYP3A4.
Slovenian: Levetiracetam je povzročil blago indukcijo CYP2B6 in CYP3A4.
English: There was no effect on embryomortality and no increased incidence of malformations.
Slovenian: Umrljivosti zarodka in povečanje pojava malformacij ni bilo.
English: The apparent body weight adjusted clearance was approximately 30% higher than in epileptic adults.
Slovenian: Navidezni telesni očistek je bil približno 30 % večji kot pri odraslih z epilepsijo.
English: The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/kg, a value close to the total body water volume.
Slovenian: Volumen porazdelitve levetiracetama je približno 0,5 do 0,7 l/kg, kar je blizu vrednosti celotnega volumna vode v telesu.
English: • a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
Slovenian: • hujšo obliko izpuščaja, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza)
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14.
Slovenian: Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX14.
English: Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders (section 4.8).
Slovenian: Priporoča se določitev celotne krvne slike pri bolnikih, ki imajo močno slabost, pireksijo, ponavljajoče okužbe ali motnje v koagulaciji (poglavje 4.8)
English: Levetiracetam has minor or moderate influence on the ability to drive and use machines.
Slovenian: Levetiracetam ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding.
Slovenian: Če je zdravljenje z levetiracetamom v obdobju dojenja potrebno, se mora pretehtati razmerje med koristjo in tveganjem zdravljenja glede na pomembnost dojenja.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo znaki depresije in/ali samomorilnega razmišljanja in vedenja.
English: • decreased number of all blood cell types;
Slovenian: • zmanjšano število vseh vrst krvnih celic;
English: The metabolite ucb L057 is pharmacologically inactive.
Slovenian: Presnovek ucb L057 ni farmakološko aktiven.
English: When you first start taking Levetiracetam Hospira, your doctor will prescribe you a lower dose for 2 weeks before giving you the lowest general dose.
Slovenian: Na začetku jemanja zdravila Levetiracetam Hospira vam bo zdravnik, preden vam bo predpisal najnižji običajni odmerek, za dva tedna predpisal nižji odmerek.
English: The use of levetiracetam has been very rarely associated with acute kidney injury with a time to onset ranging from a few days to several months.
Slovenian: Uporaba levetiracetama je bila zelo redko povezana z akutno poškodbo ledvic, ki se lahko pojavi v razponu od nekaj dni do nekaj mesecev od uporabe.
English: You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Slovenian: Ne smete voziti ali upravljati strojev, dokler ni potrjeno, da zdravilo ne vpliva na vašo sposobnost izvajanja teh dejavnosti.
English: • severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
Slovenian: • hude alergijske reakcije (DRESS, anafilaktična reakcija [huda in pomembna alergijska reakcija], Quinckejev edem [otekanje obraza, ustnic, jezika in žrela]);
English: nasopharyngitis (infection of the nose or throat); somnolence (sleepiness), headache.
Slovenian: nazofaringitis (okužba nosu ali žrela); somnolenca (zaspanost), glavobol.
English: Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered.
Slovenian: Zato je treba bolnike med zdravljenjem nadzirati glede znakov depresije in/ali samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
English: Infusion Time Frequency of administration
Slovenian: Čas infuzije Pogostost uporabe
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: Conversion to or from oral to intravenous administration can be done directly without titration.
Slovenian: Prehod na ali od peroralne k intravenski uporabi je lahko neposreden brez titracije.
English: What Levetiracetam Hospira is and what it is used for What you need to know before you are given Levetiracetam Hospira How Levetiracetam Hospira is given Possible side effects
Slovenian: Kaj je zdravilo Levetiracetam Hospira in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Levetiracetam Hospira Kako se daje zdravilo Levetiracetam Hospira Možni neželeni učinki
English: However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behaviour were not worse than baseline.
Slovenian: Kljub temu pa se osebam, ki so jemale levetiracetam med dolgotrajno, odprto, sledilno študijo, v povprečju niso poslabšale njihove vedenjske in emocionalne funkcije; natančneje, rezultati meritev agresivnega obnašanja niso bili slabši od začetnih vrednosti.
English: • signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
Slovenian: • znaki resnih duševnih sprememb ali če kdo okoli vas opazi znake zmedenosti, somnolence (zaspanost), amnezije (izguba spomina), oslabljen spomin (pozabljivost), neobičajno vedenje ali druge nevrološke znake, vključno z nehotenim ali nenadzorovanim gibanjem.
English: A large amount of post-marketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations.
Slovenian: Veliko podatkov, pridobljenih v obdobju trženja, o nosečnicah, ki so bile izpostavljene samostojnemu zdravljenju z levetiracetamom (več kot 1800, od katerih jih je bilo več kot 1500 izpostavljenih med prvim trimesečjem), ne kažejo na povečanje tveganja za večje prirojene malformacije.
English: In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1.
Slovenian: V kulturi človeških hepatocitov je imel levetiracetam majhen učinek ali pa ni imel učinka na CYP1A2, SULT1E1 ali UGT1A1.
English: At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Slovenian: Na začetku zdravljenja ali po povečanju odmerka lahko neželeni učinki, kot so na primer zaspanost, utrujenost in omotica, postanejo pogostejši.
English: Nevertheless, the concentration of this metabolite remains low.
Slovenian: Kljub temu ostane koncentracija primarnega presnovka nizka.
English: This medicinal product is for single use only, any unused solution should be discarded.
Slovenian: Zdravilo je samo za enkratno uporabo, neuporabljeno raztopino je treba zavreči.
English: A doctor or a nurse will administer you Levetiracetam Hospira as an intravenous infusion.
Slovenian: Zdravnik ali medicinska sestra vam bo zdravilo Levetiracetam Hospira dal kot intravensko infuzijo.
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali druge pirolidonske derivate ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: • delirium;
Slovenian: • delirij;