FrancophonIA/ELRC3.0 huggingface dataset:
English: How has Clopidogrel Qualimed been studied?
Slovenian: Kako je bilo zdravilo Clopidogrel Qualimed raziskano?
English: Clopidogrel Qualimed clopidogrel
Slovenian: Clopidogrel Qualimed klopidogrel Povzetek EPAR za javnost
English: Your doctor will be able to decide what is suitable for you.
Slovenian: Vaš zdravnik se bo odločil, kaj je za vas najboljše.
English: • if you are pregnant
Slovenian: • če ste noseči
English: Date of first authorisation: 03 August 2009 Date of latest renewal: 19 June 2014
Slovenian: Datum prve odobritve: 03. avgust 2009 Datum zadnjega podaljšanja: 19. junij 2014
English: • allergic reactions (see above)
Slovenian: • alergijske reakcije (glejte zgoraj)
English: • macrolide antibiotics,
Slovenian: • makrolidni antibiotiki,
English: • Take the tablets once a day preferably in the morning with or without food.
Slovenian: • Tablete vzemite enkrat na dan, najbolje zjutraj, s hrano ali brez nje.
English: That can lead to difficulties in concentration and memory, or in keeping your balance.
Slovenian: To lahko povzroči težave s koncentracijo in spominom ali ohranjanjem ravnotežja.
English: To monitor the effects of Samsca your doctor will do regular blood tests.
Slovenian: Za nadziranje učinkov zdravila Samsca bo zdravnik opravljal redne krvne teste.
English: • if you do not realise when you are thirsty
Slovenian: • če ne morete zaznati, da ste žejni
English: • Patients who cannot perceive thirst
Slovenian: • bolniki, ki ne zaznavajo žeje
English: • low blood pressure when standing up
Slovenian: • nizek krvni tlak ob vstajanju
English: Consequently, the frequency of these adverse reactions is qualified as "not known".
Slovenian: Zato je pogostnost teh neželenih učinkov opredeljena kot „neznana“.
English: This includes all medicines obtained without a prescription.
Slovenian: To vključuje vsa zdravila, ki ste jih dobili brez recepta.
English: Therefore, patients must have access to water and be able to drink sufficient amounts of water.
Slovenian: Zato morajo imeti bolniki dostop do vode in biti sposobni spiti zadostne količine vode.
English: The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
Slovenian: Pogostnosti neželenih učinkov, o katerih so poročali med uporabo v obdobju trženja, ni mogoče določiti, saj so pridobljeni iz spontanih poročil.
English: The safety and efficacy of tolvaptan in children and adolescents under the age of 18 years have not yet been established.
Slovenian: Varnost in učinkovitost tolvaptana pri otrocih in mladostnikih pod 18 let še nista bili dokazani.
English: These responses were seen in patients independent of the underlying disease.
Slovenian: Te odzive so opazili pri bolnikih neodvisno od osnovne bolezni.
English: Appropriate replacement of water and/or electrolytes must continue until aquaresis abates.
Slovenian: Ustrezno nadomeščanje vode in/ali elektrolitov se mora nadaljevati, dokler se akvareza ne ublaži.
English: If you forget to take your medicine you have to take the dose as soon as you remember on the same day.
Slovenian: Če ste pozabili vzeti zdravilo, morate vzeti enak odmerek takoj, ko se to tega dne spomnite.
English: Less than 1 % of intact active substance is excreted unchanged in the urine.
Slovenian: Manj kot 1 % snovi se nespremenjene izloča v urinu.
English: Most of the liver enzyme abnormalities were observed during the first 18 months of treatment.
Slovenian: Večino nenormalnostih jetrnih encimov so opazili prvih 18 mesecev zdravljenja.
English: If you do not take your tablet on one day, take your normal dose on the next day.
Slovenian: Če en dan ne vzamete svoje tablete, vzemite naslednji dan običajni odmerek.
English: It is therefore important that you have access to water and that you are able to drink sufficient amounts when you feel thirsty.
Slovenian: Zato je pomembno, da imate dostop do vode in da ste sposobni spiti zadostne količine vode, ko začutite žejo.
English: Do not take this medicine if you are pregnant or breast-feeding.
Slovenian: Tega zdravila ne jemljite, če ste noseči ali dojite.
English: Drinking enough water
Slovenian: Pitje zadostne količine vode
English: • if you cannot drink enough water or if you are fluid restricted
Slovenian: • če ne morete spiti dovolj vode ali so vam omejili količino tekočine
English: • Treatment with Samsca will be initiated in hospital.
Slovenian: • Zdravljenje z zdravilom Samsca se začne v bolnici.
English: However, you may occasionally feel dizzy or weak or you may faint for a short period.
Slovenian: Vendar pa lahko občasno povzroči občutek omotičnosti ali šibkosti, lahko pa za kratek čas tudi omedlite.
English: If you have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately.
Slovenian: Če ste vzeli več tablet, kot je predpisan odmerek, spijte veliko količino vode in takoj pojdite k svojemu zdravniku ali v lokalno bolnišnico.
English: To achieve the desired level of serum sodium your doctor can give in some instances a lower dose of 7.5 mg.
Slovenian: Za doseganje želene ravni natrija v serumu vam lahko zdravnik v nekaterih primerih da nižji odmerek 7,5 mg.
English: Adequate contraceptive measures must be used during use of this medicine.
Slovenian: Med uporabo tega zdravila je treba uporabljati ustrezno kontracepcijo.
English: The efficacy and safety of tolvaptan in those with a creatinine clearance < 10 mL/min has not been evaluated and is therefore unknown.
Slovenian: Učinkovitost in varnosti tolvaptana pri bolnikih z očistkom kreatinina < 10 ml/min nista bili ovrednoteni in zato nista znani.
English: • increased need to urinate, or to urinate more frequently
Slovenian: • večja potreba po odvajanju urina ali bolj pogostemu uriniranju
English: The elevations gradually improved after discontinuation of tolvaptan.
Slovenian: Povečanje se je po prekinitvi uporabe tolvaptana postopoma izboljšalo.
English: Tolvaptan has to be initiated at a dose of 15 mg once daily.
Slovenian: Uporabo tolvaptana je treba začeti pri odmerku 15 mg enkrat dnevno.
English: • if you have a condition which increases the salt in your blood (“hypernatremia”)
Slovenian: • če imate bolezen, zaradi katere se viša raven soli v vaši krvi („hipernatriemija“)
English: The pharmaco-dynamically predictable and most commonly reported adverse reactions are thirst, dry mouth and pollakiuria occurring in approximately 18 %, 9 % and 6 % of patients.
Slovenian: Farmakodinamično predvidljivi in najbolj pogosto poročani neželeni učinki so bili žeja, suha usta in polakiurija, ki se pojavijo pri približno 18 %, 9 % in 6 % bolnikov.
English: Fluid and electrolyte balance
Slovenian: Ravnovesje tekočine in elektrolitov
English: A total of 111 patients started tolvaptan treatment in an open-label, extension trial, regardless of their previous randomisation.
Slovenian: Skupaj 111 bolnikov je začelo zdravljenje s tolvaptanom v odprtem podaljšanju preskušanja, ne glede na njihovo prejšnjo naključno razvrstitev v skupine.
English: Vasopressin is a hormone that helps prevent the loss of water from the body by reducing urine output.
Slovenian: Vazopresin je hormon, ki pomaga preprečiti izgubo vode iz telesa tako, da zmanjša izločanje urina.
English: Samsca is not suitable for children and adolescents (under age 18).
Slovenian: Zdravilo Samsca ni primerno za otroke ali mladostnike (stare manj kot 18 let).
English: • decrease in level of blood sugar
Slovenian: • znižanje ravni sladkorja v krvi
English: This leads to a reduction in the amount of water in the body by increasing urine production and as a result it increases the level or concentration of sodium in your blood.
Slovenian: S tem se zmanjša količina vode v telesu zaradi pogostejšega odvajanja urina in posledično zviša raven ali koncentracija natrija v vaši krvi.
English: The following medicines may lower the effect of this medicine:
Slovenian: Naslednja zdravila lahko zmanjšajo učinek tega zdravila:
English: This medicine may increase the effect of the following medicines: • digoxin (used for treatment of irregularities of heart beat and heart failure).
Slovenian: To zdravilo lahko poveča učinek naslednjih zdravil: • digoksin (uporablja se za zdravljenje nepravilnosti srčnega utripa in srčnega popuščanja).
English: Samsca with food and drink
Slovenian: Zdravilo Samsca skupaj s hrano in pijačo
English: Improvements in serum sodium levels were observed as early as the first day after dosing and continued for on-treatment assessments up to Week 106.
Slovenian: Izboljšanje ravni natrija v serumu so opazili že prvi dan po uporabi, in se je nadaljevalo v ocenjevanju med zdravljenjem do 106. tedna.
English: Results were highly variable with large overlap between dose groups; changes were not significantly correlated with tolvaptan exposure.
Slovenian: Rezultati so bili zelo različni, z velikim prekrivanjem med skupinami odmerkov; spremembe niso pomembno korelirale z izpostavljenostjo tolvaptanu.
English: Therefore, you should only stop taking Samsca if you notice side effects requiring urgent medical attention (see section 4) or if your doctor tells you to.
Slovenian: Zato zdravilo Samsca prenehajte jemati le, če opazite neželene učinke, zaradi katerega potrebujete nujno medicinsko pomoč (glejte poglavje 4) ali če vam to naroči zdravnik.
English: Antagonist means that it prevents vasopressin having its effect on water retention.
Slovenian: Antagonist pomeni, da preprečujejo učinek vazopresina na zadrževanje vode.
English: Radio labelled tolvaptan experiments showed that 40 % of the radioactivity was recovered in the urine and 59 % was recovered in the faeces where unchanged tolvaptan accounted for 32 % of radioactivity.
Slovenian: Poskusi z radiološko označenim tolvaptanom so pokazali, da je bilo 40 % radioaktivnosti najdene v urinu in 59 % v blatu, medtem ko je nespremenjen tolvaptan predstavljal 32 % radioaktivnosti.
English: Data on the long-term safety and efficacy of tolvaptan were assessed for up to 106 weeks in a clinical trial in patients (any aetiology) who had previously completed one of the pivotal hyponatremia trials.
Slovenian: Podatke o dolgoročni varnosti in učinkovitosti tolvaptana so ocenjevali do 106 tednov v kliničnih preskušanjih pri bolnikih (vse etiologije), ki so pred tem končali enega od osrednjih preskušanj o hiponatriemiji.
English: These findings may suggest that tolvaptan has the potential to cause irreversible and potentially fatal liver injury.
Slovenian: Ti izsledki kažejo, da lahko tolvaptan povzroči nepopravljivo in potencialno smrtno poškodbo jeter.
English: Stop taking Samsca and immediately contact a doctor or go to the nearest hospital if you:
Slovenian: Takoj prenehajte jemati zdravilo Samsca in pojdite k svojemu zdravniku ali v najbližjo bolnišnico, če:
English: Tolvaptan is only a minor component in plasma (3 %).
Slovenian: Tolvaptan je le manjša sestavina v plazmi (3 %).
English: • For treatment of your low sodium (hyponatremia), your doctor will start with a dose of 15 mg and may then increase it to a maximum of 60 mg to achieve the desired level of serum sodium.
Slovenian: • Pri zdravljenju nizke ravni natrija (hiponatriemija) bo zdravnik začel z odmerkom 15 mg in ga bo nato lahko povečal do največ 60 mg za dosego želene ravni natrija v serumu.
English: These patients may be at higher risk for developing rapid correction of serum sodium during the first 1-2 days of treatment due to potential additive effects.
Slovenian: Pri teh bolnikih je lahko tveganje za razvoj naglega porasta popravka natrija v serumu v 1-2 dneh zdravljenja večje zaradi možni aditivnih učinkov.
English: For such patients, alternative treatment has to be considered.
Slovenian: Pri teh bolnikih je treba razmisliti o drugem zdravljenju.
English: • if you have a condition which is associated with a very low blood volume
Slovenian: • če imate bolezen, povezano z zelo nizkim volumnom krvi
English: • high levels of sodium, potassium, creatinine, uric acid and blood sugar
Slovenian: • visoke ravni natrija, kalija, kreatinina, sečne kisline in sladkorja v krvi
English: It may still be alright for you to take these medicines and Samsca together.
Slovenian: Kljub temu lahko morda uporabljate ta zdravila skupaj z zdravilom Samsca.
English: It is unknown whether tolvaptan is excreted in human milk.
Slovenian: Ni znano, ali se tolvaptan izloča v materino mleko.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: In the setting of hyponatremia, the treatment duration is determined by the underlying disease and its treatment.
Slovenian: Pri hiponatriemiji se trajanje zdravljenja ugotavlja glede na osnovno bolezen in njeno zdravljenje.
English: The mean serum sodium concentration at trial entry was 129 mEq/L (range 114-136).
Slovenian: Povprečna koncentracija natrija v serumu ob začetku preskušanja je bila 129 mEq/l (razpon 114-136).
English: Tolvaptan treatment is expected to last until the underlying disease is adequately treated or until such time that hyponatremia is no longer a clinical issue.
Slovenian: Pričakovati je, da traja zdravljenje s tolvaptanom, dokler osnovna bolezen ni ustrezno zdravljena ali dokler hiponatriemija ni več klinični problem.
English: During the first 1-2 days and until the tolvaptan dose is stabilised serum sodium and volume status must be monitored at least every 6 hours.
Slovenian: Med prvima 1 - 2 dnevoma in do stabilizacije odmerka tolvaptana je treba natrij v serumu in stanje volumna nadzirati vsakih 6 ur.
English: There are no or limited amount of data from the use of tolvaptan in pregnant women.
Slovenian: Podatkov o uporabi tolvaptana pri nosečnicah ni oziroma jih je malo.
English: The primary endpoint for these trials was the average daily AUC for change in serum sodium from baseline to Day 4 and baseline to Day 30.
Slovenian: Primarna končna točka za ta preskušanja je bil povprečni dnevni AUC za spremembo natrija v serumu od izhodiščne točke do 4. dneva in od izhodiščne točke do 30. dneva.
English: • find a swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).
Slovenian: • se pojavi oteklost obraza, ustnic ali jezika, srbenje, splošni izpuščaj ali hudo sopenje ali kratka sapa (simptomi alergijske reakcije).
English: Women of childbearing potential have to use effective contraception during tolvaptan treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem s tolvaptanom.
English: Markedly higher doses of tolvaptan produce more sustained responses without affecting the magnitude of excretion, as active concentrations of tolvaptan are present for longer periods of time.
Slovenian: Izrazito višji odmerki tolvaptana povzročijo bolj podaljšan odziv, ne da bi to vplivalo na obseg izločanja, saj so aktivne koncentracije tolvaptana prisotne dalj časa.
English: • if you have difficulties in urination or have an enlarged prostate
Slovenian: • če imate težave z uriniranjem ali povečano prostato
English: In order to minimise the risk of too rapid correction of hyponatremia the increase of serum sodium should be less than 10-12 mmol/L/24 hours and less than 18 mmol/L/48 hours.
Slovenian: Za zmanjšanje tveganja prehitrega popravka hiponatriemije mora biti povečanje natrija v serumu manj kot 10-12 mmol/l/24 ur in manj kot 18 mmol/l/48 ur.
English: Elderly No dose adjustment is needed in elderly patients.
Slovenian: Pri starejših bolnikih ni treba prilagajati odmerka.
English: The primary objective of the study was to compare the effects of tolvaptan + SC with placebo + SC on the time to all-cause mortality and on the time to first occurrence of cardiovascular (CV) mortality or hospitalisation for HF. Tolvaptan treatment had no statistically significant favourable or unfavourable effects on overall survival or the combined endpoint of CV mortality or HF hospitalisation, and did not provide convincing evidence for clinically relevant benefit.
Slovenian: Primarni cilj študije je bil primerjati učinke tolvaptana + SO s placebom + SO časa do umrljivosti zaradi vseh vzrokov in časa do prvega pojava kardiovaskularne (KV) umrljivosti ali hospitalizacije zaradi SP. Zdravljenje s tolvaptanom ni imelo ugodnih ali neugodnih statistično značilnih učinkov na splošno preživetje ali kombinirano končno točko KV smrtnosti ali hospitalizacije zaradi SP, in ni prineslo prepričljivih dokazov o klinično pomembnih koristih.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Samsca in one or more subsets of the paediatric population in treatment of dilutional hyponatremia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Samsca za eno ali več podskupin pediatrične populacije za zdravljenje dilucijske hiponatriemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The efficacy and safety in this population is not well established.
Slovenian: Učinkovitosti in varnosti pri tej skupini bolnikov niso ugotavljali.
English: When treatment was discontinued, serum sodium concentrations decreased to approximately baseline values, despite the reinstatement of standard care therapy.
Slovenian: Po prekinitvi zdravljenja so se koncentracije natrija v serumu znižale na približne vrednosti ob izhodišču, kljub ponovni uvedbi standardne oskrbe.
English: Samsca is used to treat low serum sodium levels in adults.
Slovenian: Zdravilo Samsca se uporablja za zdravljenje nizkih ravni natrija v serumu pri odraslih.
English: In a peri-and post-natal study in rats, delayed ossification and reduced pup bodyweight were seen at the high dose of 1,000 mg/kg/day.
Slovenian: V perinatalnih in postnatalnih študijah na podganah so opazili zapoznelo osifikacijo in zmanjšano telesno maso mladičev pri visokih odmerkih 1.000 mg/kg/dan.
English: For all doses, urine excretion rates returned to baseline levels after 24 hours.
Slovenian: Pri vseh odmerkih se je izločanje urina vrnilo na izhodiščno raven po 24 urah.
English: No clinically significant changes have been seen in clearance for doses ranging from 5 to 60 mg.
Slovenian: Klinično pomembnih sprememb pri očistku za odmerke od 5 do 60 mg niso opazili.
English: Tolvaptan affinity for the human V2-receptor is 1.8 times that of native AVP.
Slovenian: Afiniteta tolvaptana za humani receptor V2 je 1,8-krat večja od nativnega AVP.
English: Samsca, which contains the active substance tolvaptan, belongs to a group of medicines called vasopressin antagonists.
Slovenian: Zdravilo Samsca, ki vsebuje učinkovino tolvaptan, sodi v skupino zdravil, imenovanih antagonisti vazopresina.
English: Patients taking tolvaptan should avoid ingesting grapefruit juice.
Slovenian: Bolniki, ki uporabljajo tolvaptan, se morajo izogibati uživanju soka grenivke.
English: Individual maximal increases in serum sodium were negatively correlated with fluid balance; mean change in fluid balance showed a dose dependent decrease.
Slovenian: Posamezna največja zvečanja vrednosti serumske koncentracije natrija so negativno korelirala s tekočinskim ravnovesjem; povprečna sprememba v tekočinskem ravnovesju je pokazala od odmerka odvisno zmanjšanje vrednosti.
English: Mean maximal changes in serum sodium were highest following the 15 mg dose (7.9 mmol/L) but median maximal changes were highest for the 7.5 mg dose (6.0 mmol/L).
Slovenian: Povprečne najvišje spremembe v serumski koncentraciji natrija so bile najvišje po odmerku 15 mg (7,9 mmol/l), vendar je bila mediana največjih sprememb najvišja pri odmerku 7,5 mg (6,0 mmol/l).
English: In case of inadequate improvement in serum sodium levels, other treatment options have to be considered, either in place of or in addition to tolvaptan.
Slovenian: V primeru, da se ravni natrija v serumu ne popravijo ustrezno, je treba razmisliti o drugih načinih zdravljenja, bodisi namesto tolvaptana ali poleg njega.
English: Fluid and electrolyte status has to be monitored in all patients and particularly in those with renal and hepatic impairment.
Slovenian: Stanje tekočine in elektrolitov je treba nadzirati pri vseh bolnikih, zlasti pri tistih z okvari ledvic in jeter.
English: Tolvaptan plasma concentrations have been decreased by up to 87 % (AUC) after the administration of CYP3A4 inducers.
Slovenian: Koncentracije tolvaptana v plazmi so se znižale za do 87 % (AUC) po uporabo induktorjev CYP3A4.
English: Elevation (>3 × ULN) of serum aspartate aminotransferase (AST) was observed in 3.1 % (30/958) of patients on tolvaptan and 0.8 % (4/484) patients on placebo.
Slovenian: Povečanje (> 3 × ULN) serumske aspartat aminotransferaze (AST) so opazili pri 3,1 % (30/958) bolnikov, ki so uporabljali tolvaptan, in pri 0,8 % (4/484) bolnikov na placebu.
English: conivaptan, fenoldopam mesylate or mirtazapine)
Slovenian: fenoldopamijev mesilat ali mirtazapin)
English: However, when driving or using machines it should be taken into account that occasionally dizziness, asthenia or syncope may occur.
Slovenian: Vendar je pri vožnji ali upravljanju strojev treba upoštevati, da se lahko občasno pojavi omotičnost,
English: Contents of the pack and other information What Samsca contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Samsca
English: What you need to know before you take Samsca Do not take Samsca
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Samsca Ne jemljite zdravila Samsca
English: The results of self-assessed health status using the SF-12 Health Survey for the mental scores showed statistically significant and clinically relevant improvements for tolvaptan treatment compared to placebo.
Slovenian: Rezultati stanja zdravja, kot so ga ocenili bolniki sami s vprašalnikom o zdravju SF-12 za mentalno oceno, so pokazali statistično značilno in klinično pomembno izboljšanje zdravljenja s tolvaptanom v primerjavi s placebom.
English: 10 × 1 tablet 30 × 1 tablet
Slovenian: 10 × 1 tableta 30 × 1 tableta
English: In healthy subjects, tolvaptan, a CYP3A4 substrate, had no effect on the plasma concentrations of some other CYP3A4 substrates (e.g. warfarin or amiodarone).
Slovenian: Pri zdravih prostovoljcih ni imel tolvaptan, substrat CYP3A4, nobenega učinka na koncentracije nekaterih drugih substratov CYP3A4 v plazmi (npr. varfarina ali amiodarona).
English: Samsca is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Slovenian: Zdravilo Samsca je indicirano pri odraslih za zdravljenje hiponatriemije, sekundarne k sindromu neustreznega izločanja antidiuretičnega hormona (syndrome of inappropriate antidiuretic hormone secretion - SIADH).
English: Samsca has no or negligible influence on the ability to drive or use machines.
Slovenian: Zdravilo Samsca nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Therefore, the effect of vasopressin analogues such as desmopressin may be attenuated in patients using such analogues to prevent or control bleeding when co-administered with tolvaptan.
Slovenian: Zato se lahko učinki analogov vazopresina, kot je dezmopresin, pri bolnikih, ki uporabljajo te analoge za preprečevanje ali nadzor krvavitev, pri sočasni uporabi s tolvaptanom zmanjšajo.
English: Administration preferably in the morning, without regard to meals.
Slovenian: Najbolj primerna je uporaba zdravila zjutraj, ne glede na hrano.
English: Diabetic patients with an elevated glucose concentration (e.g. in excess of 300 mg/dL) may present with pseudo-hyponatremia.
Slovenian: Pri bolnikih s sladkorno boleznijo, ki imajo zvišano koncentracijo glukoze (npr. več kot 300 mg/dl), se lahko pojavi psevdohiponatriemija.