FrancophonIA/ELRC3.0 huggingface dataset:
English: • PRAC recommended monitoring of the liver function at least monthly of patients under treatment as well as up to four weeks after the discontinuation of the treatment.
Slovenian: • Odbor PRAC je priporočil, da se pri bolnikih, ki se zdravijo s tem zdravilom, delovanje jeter preverja vsaj enkrat na mesec in še do štiri tedne po prenehanju zdravljenja.
English: The possible causal relationship between Esmya and acute liver failure of those three cases prompted an in-depth investigation of this risk and its impact on the benefit risk balance of Esmya is warranted.
Slovenian: Možna vzročna zveza med zdravilom Esmya in akutno odpovedjo jeter v teh treh primerih je sprožila poglobljeno raziskavo tega tveganja in njegovega vpliva na razmerje med tveganji in koristmi.
English: The PRAC considered the potential risk of hepatotoxicity of the product, together with the fact that Esmya is a symptomatic treatment and not curative, that has the potential to reduce the need for surgical intervention.
Slovenian: Odbor PRAC je upošteval možno tveganje za hepatotoksičnost zdravila in dejstvo, da se zdravilo Esmya uporablja za simptomatsko in ne kurativno zdravljenje, ki lahko zmanjša potrebo za kirurški poseg.
English: These investigations should occur immediately in case a patient shows signs or symptoms compatible with liver injury.
Slovenian: Te preiskave je treba v primeru, če bolnik kaže znake ali simptome, ki nakazujejo na poškodbo jeter, opraviti nemudoma.
English: Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Slovenian: Zdravilo Esmya (ulipristalacetat, 5 mg) je odobreno po centraliziranem postopku in je indicirano za predoperacijsko in intermitentno zdravljenje zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v rodni dobi.
English: • During the ongoing review of safety and efficacy data in relation to the overall risk of liver injury with Esmya, the PRAC reviewed all data currently available from post-marketing settings and from clinical trials as well as the responses provided by the marketing authorisation holder on cases of serious liver injury reported with Esmya.
Slovenian: • Med potekajočim pregledom podatkov o varnosti in učinkovitosti v povezavi s splošnim tveganjem zdravila Esmya za poškodbo jeter je odbor PRAC pregledal vse trenutno dostopne podatke iz obdobja trženja in iz kliničnih preskušanj ter odgovore, ki jih je o primerih resne poškodbe jeter, o kateri so poročali v povezavi z zdravilom Esmya, predložil imetnik dovoljenja za promet z zdravilom.
English: The therapeutic indication for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on results from another study providing data for up to 4 intermittent treatment courses of 3 months each with ulipristal acetate along with data for repeated treatment courses from the previous studies.
Slovenian: Terapevtska indikacija za intermitentno zdravljenje zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v rodni dobi je temeljila na rezultatih druge študije, kjer so zbrali podatke za do štiri trimesečna intermitentna zdravljenja z ulipristalacetatom ter podatke o ponovljenih zdravljenjih iz prejšnjih študij.
English: Given the estimated exposure to Esmya of approximately 175,000 patient years, the number of cases of subacute severe liver impairment leading to liver transplantation with Esmya appears higher than expected, although background incidence on drug induced liver injury is uncertain.
Slovenian: Glede na ocenjeno izpostavljenost zdravilu Esmya približno 175.000 bolnik-let se zdi število primerov subakutne hude okvare jeter, ki je privedla do presaditve jeter, pri zdravilu Esmya višje od pričakovanega, čeprav je osnovna incidenca z zdravili povzročene poškodbe jeter nejasna.
English: Considering all these factors, in order to recommend the measure that would be the most proportionate, the PRAC concluded to provisionally limit the use of the medicinal product to patients that are currently under therapeutic treatment.
Slovenian: Da bi priporočil ukrep, ki bi bil najbolj sorazmeren, je odbor PRAC ob upoštevanju vseh teh dejavnikov sklenil, da porabo zdravila začasno omeji na bolnike, ki se z njim trenutno zdravijo terapevtsko.
English: The impact of the new safety findings in the currently authorised indications of Esmya cannot be evaluated with certainty at present in view of the limited data available.
Slovenian: Ker so na voljo samo omejeni podatki, vpliva novih izsledkov o varnosti pri trenutno odobrenih indikacijah za zdravilo Esmya trenutno ni mogoče z gotovostjo ovrednotiti.
English: In patients suffering from heavy menstrual bleeding associated with uterine fibroids, repeated 3-month treatment courses with ulipristal acetate provide a medical alternative to surgery and have the potential to reduce the need for surgical intervention.
Slovenian: Pri bolnicah, ki so imele močno menstruacijsko krvavitev, povezano z materničnimi fibroidi, je večkratno trimesečno zdravljenje z ulipristalacetatom pomenilo alternativo kirurškemu zdravljenju in možnost za zmanjšanje potrebe po kirurškem posegu.
English: In view of the above, the Committee considers that the benefit-risk balance of Esmya remains favourable subject to the agreed provisional measures.
Slovenian: Odbor je glede na zgoraj navedeno menil, da je razmerje med tveganji in koristmi zdravila Esmya še naprej ugodno, če se upoštevajo dogovorjene začasne spremembe informacij o zdravilu.
English: The clinical efficacy of ulipristal acetate in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on short-term studies demonstrating the ability of the active substance to reduce fibroid-related bleeding, anaemia and fibroid size if administered in a daily dose of 5 mg for up to three months.
Slovenian: Klinična učinkovitost ulipristalacetata pri predoperacijskem zdravljenju zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v rodni dobi temelji na kratkotrajnih študijah, ki so pokazale zmožnost zdravilne učinkovine za zmanjševanje s fibroidi povezanih krvavitev, anemije in velikosti fibroidov ob trimesečnem vsakodnevnem dajanju 5-miligramskega odmerka.
English: The above provisional measures should be reflected in the terms of the marketing authorisation, including the product information of Esmya, and communicated to HCPs via a DHPC.
Slovenian: Navedeni začasni ukrepi se morajo odražati v pogojih dovoljenja za promet z zdravilom, vključno z informacijami o zdravilu Esmya, in morajo biti z neposrednimi sporočili za zdravstvene delavce sporočeni zdravstvenim delavcem.
English: PRAC reviewed all data currently available from post-marketing settings and from clinical trials as well as the responses provided by the marketing authorisation holder on cases of serious liver injury reported with Esmya.
Slovenian: Odbor PRAC je pregledal vse trenutno razpoložljive podatke iz obdobja trženja in iz kliničnih preskušanj ter odgovore, ki jih je glede primerov resne poškodbe jeter, o kateri so poročali v povezavi z zdravilom Esmya, predložil imetnik dovoljenja za promet z zdravilom.
English: With regards to patients under intermittent treatment, the use of the medicinal product should not be repeated in patients who have finalised a previous treatment course.
Slovenian: Kar zadeva bolnike, ki se zdravijo intermitentno, se zdravilo pri bolnikih, ki so končali prejšnje zdravljenje, ne sme ponovno uporabiti.
English: No signal of hepatic toxicity was identified during the review of non-clinical or clinical trials of Esmya inducing hepatic toxicity.
Slovenian: Pri pregledu nekliničnih ali kliničnih preskušanj zdravila Esmya, ki je učinkovalo hepatotoksično, ni bil prepoznan noben znak hepatotoksičnosti.
English: With regards to patients under intermittent treatment, the use of the medicinal product should be discontinued in patients who have finalised a previous treatment course.
Slovenian: Kar zadeva bolnike, ki se zdravijo intermitentno, je treba uporabo zdravila pri bolnikih, ki so končali prejšnje zdravljenje z njim, ustaviti.
English: Patients who develop transaminase levels > 2 times the upper level of normal during Esmya treatment should stop treatment and be closely monitored.
Slovenian: Če se pri bolniku koncentracija transaminaz pri zdravljenju z zdravilom Esmya za več kot dvakrat zviša nad zgornjo normalno, je treba zdravljenje z zdravilom Esmya ustaviti in bolnika natančno spremljati.
English: Healthcare Professionals (HCPs) should be informed of the cases of liver injury and hepatic failure reported with the use of Esmya in post-marketing experience.
Slovenian: Zdravstveni delavci morajo biti obveščeni o primerih poškodbe jeter in odpovedi jeter, o katerih so v povezavi z uporabo zdravila Esmya poročali v obdobju trženja.
English: No information on hepatic events is currently included in the Product Information of Esmya.
Slovenian: V informacije o zdravilu Esmya trenutno niso vključene nobene informacije o neželenih učinkih, povezanih z jetri.
English: In addition, several cases of hepatic injury in patients using Esmya were reported.
Slovenian: Poleg tega so pri bolnikih, ki so uporabljali zdravilo Esmya, poročali o več primerih poškodbe jeter.
English: • The PRAC noted that four cases of acute liver failure leading to liver transplantation including one with fatal outcome have been reported with Esmya.
Slovenian: • Odbor PRAC je ugotovil, da so v obdobju trženja pri bolnikih, izpostavljenih zdravilu Esmya, poročali o skupno štirih primerih akutne odpovedi jeter, ki je privedla do transplantacije, vključno z enim primerom s smrtnim izidom.
English: In post-marketing settings, a total of four cases of acute liver failure leading to liver transplantation including one with fatal outcome have been reported in patients exposed to Esmya.
Slovenian: V obdobju trženja so pri bolnikih, izpostavljenih zdravilu Esmya, poročali o skupno štirih primerih akutne odpovedi jeter, ki je privedla do transplantacije, vključno z enim primerom s smrtnim izidom.
English: While the magnitude and nature (e.g. pattern of hepatotoxicity and possible mechanism of action) of the risk are being reviewed in depth, having considered the seriousness of the risk, the PRAC considered that the above raised a reasonable doubt that justifies adopting provisional measures in the meantime.
Slovenian: Odbor PRAC je ob upoštevanju resnosti tveganja menil, da obstaja razumno tveganje, zaradi katerega so med poglobljenim pregledom velikosti in narave (npr. vzorca hepatotoksičnosti in možnih mehanizmov delovanja) tveganja upravičeni začasni ukrepi.
English: Four cases of serious liver injury leading to a hepatic transplantation were reported since the marketing authorisation of Esmya.
Slovenian: Od izdaje dovoljenja za promet z zdravilom Esmya so poročali o štirih primerih resnih poškodb jeter, ki so privedle do presaditve jeter.
English: Among those, there are positive de-challenge cases.
Slovenian: Med temi so primeri izboljšanja po prekinitvi zdravljenja.
English: In view of the seriousness of the cases, the PRAC considered that provisional measures are now needed to minimise this risk and protect patients, while the review is ongoing and a thorough assessment of all available data related to the benefit-risk of Esmya is performed.
Slovenian: Medtem ko potekata pregled in izčrpna ocena vseh razpoložljivih podatkov, povezanih z razmerjem med tveganji in koristmi zdravila Esmya, je odbor PRAC glede na resnost primerov menil, da so potrebni začasni ukrepi za zmanjšanje tveganja in zaščito bolnikov,.
English: • if you are more than 3 months pregnant.
Slovenian: • če ste noseči več kot 3 mesece.
English: • A heart attack within the last four weeks.
Slovenian: • srčni napad v preteklih štirih tednih.
English: You may notice this as dizziness when standing up.
Slovenian: Ta učinek lahko opazite kot omotico, ko vstajate.
English: Treatment of essential hypertension in adults:
Slovenian: Zdravljenje esencialne hipertenzije pri odraslih:
English: Supportive treatment should be instituted.
Slovenian: Uvesti je treba podporno zdravljenje.
English: The tablets should be swallowed with some water or other non-alcoholic drink.
Slovenian: Tablete morate vzeti z nekaj vode ali druge brezalkoholne pijače.
English: Do not take a double dose to make up for forgotten individual doses.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadomestili pozabljenega.
English: See section 3.
Slovenian: Glejte poglavje 3.
English: However, no adverse events attributable to such interaction have been reported.
Slovenian: Kljub temu pa ni poročil o neželenih dogodkih, ki bi jih lahko pripisali takšni interakciji.
English: It is important that you take Onduarp every day until your doctor tells you otherwise.
Slovenian: Pomembno je, da jemljete zdravilo Onduarp vsak dan, dokler vam zdravnik ne naroči drugače.
English: • if you suffer from severe low blood pressure (including shock).
Slovenian: • če imate zelo nizek krvni tlak (tudi šok);
English: No new or more severe adverse reactions were observed.
Slovenian: Novih ali hujših neželenih učinkov niso zasledili.
English: Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Slovenian: Krvni tlak je treba redno meriti in preverjati, ali je znotraj normalnih vrednosti.
English: The volume of distribution of amlodipine is approximately 21 l/kg.
Slovenian: Porazdelitveni volumen amlodipina je približno 21 l/kg.
English: • Erythromycin (antibiotic).
Slovenian: • eritromicin (antibiotik),
English: Little information is available in the very elderly patients.
Slovenian: Za zelo stare bolnike je na voljo malo podatkov.
English: Children and adolescents The use of Onduarp in children and adolescents up to the age of 18 years is not recommended.
Slovenian: Otroci in mladostniki Uporabe zdravila Onduarp pri otrocih in mladostnikih do 18. leta ne priporočamo.
English: The pharmacokinetics of telmisartan do not differ in young and elderly patients.
Slovenian: Farmakokinetika telmisartana se med mladimi in starejšimi bolniki ne razlikuje.
English: Paediatric population (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Slovenian: Pediatrična populacija (mlajši od 18 let) Za pediatrično populacijo ni na voljo podatkov o farmakokinetiki.
English: • Shock (including cardiogenic shock)
Slovenian: • šok (tudi kardiogeni šok),
English: Dyspnoea, rhinitis
Slovenian: dispneja, rinitis
English: It is recommended to take Onduarp with some liquid.
Slovenian: Priporočeno ga je jemati z nekaj tekočine.
English: Signs and symptoms of overdose are expected to be in line with exaggerated pharmacological effects.
Slovenian: Znaki in simptomi po prevelikem odmerku se predvidoma ujemajo s prekomernimi farmakološkimi učinki.
English: If you forget to take a dose, take it as soon as you remember and then carry on as before.
Slovenian: Če ste odmerek zdravila pozabili vzeti, ga vzemite takoj, ko se spomnite in nadaljujte z jemanjem kot običajno.
English: Additional information on individual components
Slovenian: Dodatne informacije o posameznih učinkovinah
English: Serious syncope may occur rarely (less than 1 case per 1,000 patients).
Slovenian: Redko se lahko pojavi resna sinkopa (manj kot 1 primer na 1000 bolnikov).
English: • Diltiazem (cardiac medicine).
Slovenian: • diltiazem (zdravilo za srce),
English: Onduarp should therefore be used with caution in these patients.
Slovenian: Zdravilo Onduarp je treba pri teh bolnikih previdno uporabljati.
English: Onduarp with food and drink
Slovenian: Zdravilo Onduarp skupaj s hrano in pijačo
English: Your doctor will normally advise you to stop taking Onduarp before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Onduarp.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravilo Onduarp prenehate jemati, preden boste zanosili ali takoj ko boste vedeli, da ste noseči, in vam svetoval, da namesto zdravila Onduarp jemljete drugo zdravilo.
English: Telmisartan has been studied in a large outcome study in 25,620 patients with high cardiovascular risk (ONTARGET).
Slovenian: Telmisartan so preskušali v obsežni študiji o izidih zdravljenja, ki je zajela 25.620 bolnikov z velikim srčnožilnim tveganjem (ONTARGET).
English: If you experience these side effects, do not drive or use machines.
Slovenian: Če opazite naštete neželene učinke, ne vozite ali upravljajte strojev.
English: The safety and efficacy of Onduarp in children aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Onduarp pri otrocih, ki so mlajši od 18 let, še nista dokazani.
English: • Raised aldosterone levels (which lead to water and salt retention in the body along with imbalance of various blood minerals).
Slovenian: • zvišano raven aldosterona (ki povzroči zadrževanje vode in soli v telesu ter neravnovesje različnih mineralov v krvi),
English: The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.
Slovenian: Varnost in prenašanje zdravila Onduarp so ocenili v petih nadzorovanih kliničnih študijah pri več kot 3500 bolnikih, od katerih jih je več kot 2500 jemalo telmisartan v kombinaciji z amlodipinom.
English: Onduarp is indicated for long term treatment.
Slovenian: Zdravilo Onduarp je indicirano za dolgotrajno zdravljenje.
English: If you do not take your tablet on one day, take your normal dose on the next day.
Slovenian: Če en dan na tableto pozabite, vzemite naslednji dan običajen odmerek.
English: What Onduarp is and what it is used for
Slovenian: Kaj je zdravilo Onduarp in za kaj ga uporabljamo
English: The majority of the antihypertensive effect was attained within 2 weeks after initiation of therapy.
Slovenian: Večji del antihipertenzivnega učinka se je razvil v dveh tednih po začetku zdravljenja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Onduarp in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila se je odrekla zahtevi po predložitvi izsledkov preskušanj zdravila Onduarp pri hipertenziji pri vseh podskupinah pediatrične populacije (glejte informacijo o uporabi pri pediatrični populaciji v poglavju 4.2).
English: • if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker).
Slovenian: • če ste alergični na druga zdravila dihidropiridinskega tipa (vrsta zaviralcev kalcijevih kanalov);
English: Corticosteroids (systemic route) Reduction of the antihypertensive effect.
Slovenian: Kortikosteroidi (sistemski) Zmanjšajo antihipertenzivni učinek.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Slovenian: Bolnika je treba natančno spremljati ter uvesti simptomatsko in podporno zdravljenje.
English: Absolute bioavailability has been estimated to be between 64 and 80%.
Slovenian: Ocenjena absolutna biološka uporabnost je med 64 in 80 %.
English: In vitro studies have shown that approximately 97.5 % of circulating amlodipine is bound to plasma proteins in hypertensive patients.
Slovenian: In vitro študije kažejo, da je približno 97,5 % amlodipina v obtoku pri bolnikih s hipertenzijo vezanega na beljakovine v plazmi.
English: Onduarp is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Slovenian: Zdravila Onduarp v zgodnji nosečnosti ne priporočajo; ne smete pa ga jemati, ko boste noseči več kot 3 mesece, ker lahko po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdraviloneželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Serum electrolytes and creatinine should be monitored frequently.
Slovenian: Pogosto je treba preveriti elektrolite v serumu in kreatinin.
English: The most common adverse reactions were peripheral oedema and dizziness, see also section 4.8.
Slovenian: Najpogostejša neželena učinka sta bila periferni edem in omotica; glejte tudi poglavje 4.8.
English: Talk to your doctor before taking Onduarp:
Slovenian: Posvetujte se z zdravnikom, preden boste vzeli zdravilo Onduarp:
English: Onduarp has moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo Onduarp zmerno vpliva na sposobnost voznje in upravljanja strojev.
English: This applies especially to the medicines listed below taken at the same time with Onduarp:
Slovenian: To velja zlasti za spodaj našteta zdravila, kadar jih jemljete hkrati z zdravilomOnduarp:
English: If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Slovenian: Če pomotoma vzamete preveč tablet, morate nemudoma poklicati svojega zdravnika, farmacevta ali oddelek za nujno pomoč v najbližji bolnišnici.
English: (It is also better to avoid Onduarp in early pregnancysee Warnings and precautions and Pregnancy section.)
Slovenian: (Bolje je, da zdravila Onduarp tudi v zgodnji nosečnosti ne uporabljate - glejte odstavek Opozorila in previdnostni ukrepi in odstavek Nosečnost);
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Slovenian: Čeprav ni na voljo kontroliranih epidemioloških podatkov glede tveganja pri uporabi antagonistov angiotenzina II, lahko podobno tveganje obstaja tudi za to skupino zdravil.
English: Interactions linked to telmisartan
Slovenian: Interakcije, ki so povezane s telmisartanom
English: Similarly, no effects on male and female fertility were reported for amlodipine (see section 5.3).
Slovenian: Tudi za amlodipin niso poročali o učinkih na plodnost pri moških in ženskah (glejte poglavje 5.3).
English: Onduarp contains sorbitol.
Slovenian: Zdravilo Onduarp vsebuje sorbitol.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 November 2011
Slovenian: Datum prve odobritve: 24. november 2011 Datum tadnjega podaljšanja:
English: Furthermore low blood pressure may be aggravated by alcohol.
Slovenian: Stanje z nizkim krvnim tlakom lahko poslabša alkohol.
English: • Simvastatin to treat elevated levels of cholesterol.
Slovenian: • simvastatin, za zdravljenje zvišanih ravni holesterola,
English: The small reduction in AUC for telmisartan is not expected to cause a reduction in the therapeutic efficacy.
Slovenian: Nekoliko zmanjšana površina pod krivuljo (AUC) za telmisartan predvidoma ne zmanjša terapevtske učinkovitosti.
English: Such conditions should be corrected before the administration of telmisartan.
Slovenian: Tovrstna stanja moramo uravnati pred zdravljenjem s telmisartanom.
English: Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Slovenian: Poročali so še o izraziti in verjetno podaljšani sistemski hipotenziji, ki se je stopnjevala do šoka, tudi s smrtnim izidom.
English: For telmisartan the posology should not exceed 40 mg once daily (see section 4.4).
Slovenian: Odmerek telmisartana ne sme prekoračiti 40 mg enkrat na dan (glejte poglavje 4.4).
English: After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Slovenian: Telmisartan se po peroralnem (in intravenskem) dajanju skoraj izključno izloča z blatom, pretežno kot nespremenjena spojina.
English: Hepatitis, jaundice, hepatic enzyme elevations (mostly consistent with cholestasis
Slovenian: hepatitis, zlatenica, povečanje jetrnih encimov (večinoma se ujema s holestazo)
English: Other medicines and Onduarp
Slovenian: Druga zdravila in zdravilo Onduarp