FrancophonIA/ELRC3.0 huggingface dataset:
English: Dafiro HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Dafiro HCT.
Slovenian: Zdravila Dafiro HCT ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilne učinkovine zdravila, druge sulfonamide, derivate dihidropiridina ali katero koli drugo sestavino zdravila
English: What is the risk associated with Dafiro HCT?
Slovenian: Kakšna tveganja so povezana z zdravilom Dafiro HCT?
English: Finally, Dafiro HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Slovenian: Zdravila Dafiro HCT poleg tega ne smejo uporabljati bolniki s hipokaliemijo (nizko ravnjo kalija v krvi), hiponatriemijo (nizko ravnjo natrija v krvi) in hiperkalciemijo (visoko ravnjo kalcija v krvi), ki se ne odzivajo na zdravljenje, ter bolniki s simptomatsko hiperurikemijo (visoko koncentracijo sečne kisline v krvi).
English: Other information about Dafiro HCT
Slovenian: Druge informacije o zdravilu Dafiro HCT
English: Dafiro HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Slovenian: Prav tako se ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), pri bolnikih s sladkorno boleznijo tipa 2 ali zmerno do hudo ledvično okvaro.
English: Why has Dafiro HCT been approved?
Slovenian: Zakaj je bilo zdravilo Dafiro HCT odobreno?
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Dafiro HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Slovenian: Poleg tega je bila izvedena glavna študija, v kateri so proučevali 2 271 bolnikov z zmerno do hudo hipertenzijo, ki so prejemali največji odmerek zdravila Dafiro HCT (320 mg valsartana, 10 mg amlodipina in 25 mg hidroklorotiazida) Bolniki so osem tednov prejemali bodisi zdravilo Dafiro HCT bodisi eno od treh kombinacij, ki so vsebovale le dve zdravilni učinkovini.
English: The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Dafiro HCT which combines the three substances in a single tablet.
Slovenian: CHMP je menil, da bi uporaba zdravila Dafiro HCT, pri katerem so tri zdravilne učinkovine prisotne v eni tableti, bolnikom, ki tri zdravilne učinkovine že prejemajo ločeno, omogočila doslednejše jemanje zdravila.
English: How has Dafiro HCT been studied?
Slovenian: Kako je bilo zdravilo Dafiro HCT raziskano?
English: What is Dafiro HCT?
Slovenian: Kaj je zdravilo Dafiro HCT?
English: How is Dafiro HCT used?
Slovenian: Kako se zdravilo Dafiro HCT uporablja?
English: How does Dafiro HCT work?
Slovenian: Kako zdravilo Dafiro HCT deluje?
English: • The role and use of the Patient Alert Card
Slovenian: Vloga in uporaba Opozorilne kartice za bolnika.
English: • Who have a history of Torsades de Pointes unless all risk factors that contributed to Torsades have been corrected.
Slovenian: ki imajo Torsades de pointes v anamnezi, razen če so bili vsi dejavniki tveganja, ki so prispevali k Torsades, odpravljeni.
English: • The need to counsel patients about the risk of prolonged QTc and PRES and inform them of what symptoms and signs to be aware of and the actions to take
Slovenian: Potreba po svetovanju bolnikom glede tveganj za podaljšanje intervala QTc in PRES ter seznanitev bolnikov o simptomih in znakih na katere morajo biti pozorni ter kako je treba ukrepati.
English: • That vandetanib may cause Posterior reversible encephalopathy syndrome (PRES) also known as Reversible posterior leukoencephalopathy syndrome (RPLS)
Slovenian: Da lahko vandetanib povzroči sindrom posteriorne reverzibilne encefalopatije (PRES), znan tudi kot sindrom reverzibilne posteriorne levkoencefalopatije (RPLS).
English: • PRES should be considered in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function.
Slovenian: PRES je treba upoštevati pri katerem koli bolniku, ki se mu pojavijo krči, glavobol, motnje vida, zmedenost ali motnje zavesti.
English: • If QTc increases markedly but stays below 500 msec, the advice of a cardiologist should be sought.
Slovenian: Če se interval QTc znatno podaljša, vendar ostane krajši od 500 ms, je treba poiskati nasvet kardiologa.
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch and thereafter, all Healthcare Professionals who are expected to use and/or prescribe Caprelsa are provided with an Educational pack.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da bo po prihodu zdravila na tržišče in zatem, zdravstvenemu osebju, za katere bo pričakovati, da bo uporabljalo in/ali predpisovalo zdravilo Caprelsa, priskrbel paket izobraževalnega gradiva.
English: Dosing can be resumed at a reduced dose after return of the ECG QTc interval to pretreatment status has been confirmed and correction of possible electrolyte imbalance has been made.
Slovenian: Odmerjanje je mogoče znova uvesti v manjšem odmerku, ko je potrjeno, da je interval QTc spet takšen kot pred zdravljenjem in, da je morebitno elektrolitsko neravnovesje popravljeno.
English: • Patients who develop a single value of corrected ECG QTc interval of at least 500 msec should stop taking vandetanib.
Slovenian: Bolniki, ki se jim na EKG pojavi ena sama vrednost korigiranega intervala QTc v vrednosti vsaj 500 ms, morajo prenehati z jemanjem vandetaniba.
English: • The need for an ECG, and serum levels of potassium, calcium and magnesium and thyroid stimulating hormone (TSH) and the times and situations when it should be performed
Slovenian: Trenutki in okoliščine kadar je treba izvesti preiskavo EKG, določitev serumskih ravni kalija, kalcija in magnezija ter tiroideo-stimulirajočega hormona.
English: • Details of medicinal products where the co-administration of vandetanib is either contraindicated or not recommended.
Slovenian: Podrobnosti glede zdravil s katerimi je sočasno dajanje ali kontraindicirano ali pa ni priporočljivo.
English: • Vandetanib prolongs the QTc interval and can cause Torsades de Pointes and sudden death
Slovenian: Izobraževalno gradivo za zdravstveno osebje mora vsebovati naslednje ključne elemente: Vandetanib podaljša interval QTc in lahko sproži Torsades de pointes in nenadno smrt.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Pogoji in omejitve glede varne in učinkovite uporabe zdravila, ki jih bodo uveljavile države članice Države članice morajo zagotoviti, da bodo vsi pogoji ali omejitve glede varne in učinkovite uporabe zdravila, kot je opisano spodaj, uveljavljene: Pred prihodom zdravila na tržišče v vsaki državi članici se bo imetnik dovoljenja za promet dogovoril glede vsebine in oblike izobraževalnega gradiva z nacionalnim organom, pristojnim za zdravila.
English: • Whose ECG QTc interval is greater than 480 msec
Slovenian: Zdravljenja z vandetanibom se ne sme uvesti pri bolnikih: pri katerih je interval QTc daljši od 480 ms, ki imajo sindrom prirojenega podaljšanja intervala QTc.
English: The educational material for Healthcare Professionals should contain the following key elements:
Slovenian: Paket izobraževalnega gradiva bi naj vseboval naslednje: Povzetek glavnih značilnosti zdravila in Navodilo za uporabo, Izobraževalno gradivo za zdravstveno osebje, Opozorilno kartico za bolnika (besedilo usklajeno s CHMP).
English: Restrictions on the use of methysergide-containing medicines
Slovenian: Omejitev uporabe zdravil, ki vsebujejo metizergid
English: The pharmaceutical forms and the approved indications, strengths and doses vary in different EU countries.
Slovenian: Farmacevtske oblike ter odobrene indikacije, jakosti in odmerki se v posameznih državah EU razlikujejo.
English: This examination should include a re-assessment of the benefit-risk balance in the individual patient.
Slovenian: Pregled mora vključevati ponovno oceno razmerja med tveganji in koristmi pri posameznem bolniku.
English: In the EU, medicines containing methysergide have been authorised by national procedures and have been marketed under various trade names.
Slovenian: Zdravila, ki vsebujejo metizergid, so bila v EU odobrena po nacionalnih postopkih in se tržijo pod različnimi tržnimi imeni.
English: The review of methysergide was initiated on 24 May 2012 at the request of the French medicines agency ANSM under Article 31 of Directive 2001/83/EC following concerns about serious cases of fibrosis identified by the French agency.
Slovenian: Pregled metizergida je bil sprožen 24. maja 2012 na zahtevo francoske agencije za zdravila (ANSM) v skladu s členom 31 Direktive 2001/83/ES, potem ko so se pojavili pomisleki zaradi resnih primerov fibroze, ki jih je odkrila francoska agencija.
English: The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 28 April 2014.
Slovenian: Odbor CHMP je mnenje predložil Evropski komisiji, ki ga je potrdila in 28. aprila 2014 izdala končni pravno zavezujoči sklep.
English: The Agency's recommendations are based on available data on the benefits and risks of methysergide, from clinical studies, post-marketing safety reports and the scientific literature.
Slovenian: Priporočila agencije temeljijo na razpoložljivih podatkih o koristih in tveganjih, povezanih z metizergidom, iz kliničnih študij, poročil o varnosti zdravila iz obdobja trženja in znanstvene literature.
English: • Following the review of methysergide-containing medicines, methysergide should now only be used for:
Slovenian: • V skladu z izidom pregleda zdravil, ki vsebujejo metizergid, se lahko metizergid odslej uporablja samo za:
English: If you are being treated for this purpose, please contact your doctor to discuss alternative treatment.
Slovenian: Če zdravilo uporabljate za ta namen, se posvetujte z zdravnikom o drugih možnostih zdravljenja.
English: The symptoms of fibrosis often take some time to appear and without screening the diagnosis may come too late to prevent severe (and potentially life-threatening) damage to organs .
Slovenian: Simptomi fibroze se pogosto pojavijo šele čez nekaj časa, zato se lahko brez presejalnih preiskav diagnoza postavi prepozno, da bi lahko preprečili hude (in morda smrtno nevarne) poškodbe organov.
English: The CHMP recommendations were sent to the European Commission, which has endorsed them and issued a final legally-binding decision that is valid throughout the EU.
Slovenian: Odbor CHMP je priporočila predložil Evropski komisiji, ki jih je potrdila in izdala končni pravno zavezujoči sklep, ki velja za celotno EU.
English: However, there were no data to support this use and Methysergide should therefore no longer be used in carcinoid disease.
Slovenian: Vendar tovrstne uporabe ne podpirajo nobeni podatki, zato se metizergid pri karcinoidni bolezni ne sme več uporabljati.
English: Based on these data a potential causal association between methysergide and fibrosis seems likely.
Slovenian: Glede na te podatke se morebitna vzročna povezava med metizergidom in fibrozo zdi verjetna.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP), which conducted the review, noted that these recommendations were necessary due to the reports of fibrosis seen with methysergide and other medicines of the same class (ergot derivatives).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji, ki je opravil pregled, je izpostavil, da so bila ta priporočila nujno potrebna zaradi poročil o fibrozi, ki so jo opažali pri uporabi metizergida in drugih zdravil iz iste skupine (derivati ergot alkaloidov).
English: The prescribing information for physicians and information in the patients' information leaflet has been updated.
Slovenian: Navodila za zdravnike glede predpisovanja zdravil in informacije v navodilu za uporabo so bile posodobljene.
English: • Your doctor will also regularly re-assess the need for you to continue treatment with methysergide by seeing if your symptoms return after periodic breaks in treatment.
Slovenian: • Zdravnik bo prav tako redno ocenjeval, ali pri vas še obstaja potreba po nadaljnjem zdravljenju z metizergidom, tako da bo preveril, ali se vaši simptomi po občasnih prekinitvah zdravljenja ponovno pojavijo.
English: • If you are using methysergide to prevent migraines and cluster headaches, your doctor will check on a regular basis whether you are developing any signs or symptoms of fibrosis.
Slovenian: • Če metizergid uporabljate za preprečevanje migren in glavobolov v rafalih, bo zdravnik redno preverjal, ali so se pri vas morda pojavili kateri koli znaki ali simptomi fibroze.
English: The mechanism by which methysergide could cause fibrosis through serotoninergic-receptor activation is widely described in the literature.
Slovenian: Mehanizem, prek katerega bi metizergid z aktivacijo serotoninergičnih receptorjev lahko povzročil fibrozo, je obsežno opisan v literaturi.
English: Methysergide is a medicine that belongs to the class ‘ergot alkaloids' that has been used in the EU for preventing migraines (with or without aura) and other types of throbbing headaches.
Slovenian: Metizergid je zdravilo, ki spada v skupino „ergot alkaloidov“, ki se v EU uporabljajo za preprečevanje migren (z avro ali brez nje) ter drugih vrst utripajočih glavobolov.
English: On 20 February 2014, the European Medicines Agency recommended restricting the use of methysergide due to concerns that it could cause fibrosis, a condition in which fibrous (scar) tissue accumulates in the body's organs potentially damaging them.
Slovenian: Evropska agencija za zdravila je 20. februarja 2014 priporočila omejitev uporabe metizergida zaradi skrbi, da bi lahko povzročal fibrozo, tj. bolezen, pri kateri se v telesnih organih nabira fibrozno (brazgotinsko) tkivo, ki jih lahko poškoduje.
English: Regarding the benefits, the Committee noted that there is some evidence of a clinically relevant effect of methysergide when used for prevention in patients who regularly get migraines and cluster headaches and for whom treatment options are limited.
Slovenian: Kar zadeva koristi, je odbor menil, da obstaja nekaj dokazov o klinično pomembnem učinku metizergida, kadar se uporablja za preprečevanje migren in glavobolov v rafalih pri bolnikih, pri katerih se ti redno pojavljajo in ki imajo omejene možnosti zdravljenja.
English: Screening investigations may include heart ultrasound, abdominal MRI and lung function tests.
Slovenian: Presejalne preiskave lahko vključujejo ultrazvok srca, MRS trebuha in preiskave delovanja pljuč.
English: Previous treatment must have included treatment with medicines of other classes for at least 4 months at the maximum tolerated dose;
Slovenian: Predhodno zdravljenje je moralo vključevati zdravljenje z zdravili iz drugih skupin, ki je trajalo najmanj 4 mesece pri največjem tolerančnem odmerku;
English: • Methysergide-containing medicines may cause a potentially serious condition known as fibrosis, in which scar tissue accumulates in some of the body's organs.
Slovenian: • Zdravila, ki vsebujejo metizergid, lahko povzročijo možno resno bolezen, imenovano fibroza, pri kateri se v nekaterih telesnih organih nabira brazgotinsko tkivo.
English: • During treatment with methysergide, a treatment-free period of at least 4 weeks must be allowed between treatment courses at least every 6 months.
Slovenian: • Med zdravljenjem z metizergidom je treba med ciklusi zdravljenja najmanj vsakih šest mesecev zagotoviti vsaj štiritedensko obdobje brez zdravljenja.
English: Previous treatment must have included treatment with medicines of at least 2 classes for a minimum of 2 months.
Slovenian: Predhodno zdravljenje je moralo vključevati zdravljenje z zdravili iz najmanj dveh skupin, ki je trajalo vsaj dva meseca.
English: It was also used to treat diarrhoea caused by carcinoid disease.
Slovenian: Poleg tega se je uporabljal tudi za zdravljenje driske, ki jo povzroča karcinoidna bolezen.
English: • Treatment must not begin until after the patient has been examined for any pre-existing fibrotic conditions.
Slovenian: • Zdravljenje se ne sme začeti, dokler se pri bolniku ne opravi pregled za ugotavljanje morebitnih že obstoječih fibroznih bolezni.
English: • Treatment with methysergide should only be started and supervised by specialised physicians with experience in treating migraine and cluster headaches.
Slovenian: • Zdravljenje z metizergidom smejo uvesti in nadzorovati samo zdravniki specialisti, ki imajo izkušnje z zdravljenjem migrene in glavobolov v rafalih.
English: In addition, treatment should only be started and supervised by a specialist doctor with experience in treating migraine and cluster headaches.
Slovenian: Poleg tega sme zdravljenje uvesti in nadzorovati samo zdravnik specialist, ki ima izkušnje z zdravljenjem migrene in glavobolov v rafalih.
English: • Methysergide should no longer be used for treating diarrhoea caused by carcinoid disease.
Slovenian: • Metizergid se ne sme več uporabljati za zdravljenje driske, ki jo povzroča karcinoidna bolezen.
English: Methysergide medicines are now only to be used for preventing severe intractable migraines and cluster headaches (a type of severe, recurring headache on one side of the head, usually around the eye) when standard medicines have failed.
Slovenian: Zdravila, ki vsebujejo metizergid, se lahko odslej uporabljajo samo za preprečevanje hudih trdovratnih migren in glavobolov v rafalih (vrste hudega ponavljajočega se glavobola, ki se pojavi na eni strani glave, običajno okoli očesa), potem ko je bilo zdravljenje s standardnimi zdravili neuspešno.
English: • Methysergide should no longer be used for treating diarrhoea caused by carcinoid disease (a type of slow-growing tumour).
Slovenian: • Metizergid se ne sme več uporabljati za zdravljenje driske, ki jo povzroča karcinoidna bolezen (vrsta počasi rastočega tumorja).
English: Methysergide has also been used for treating diarrhoea caused by carcinoid disease (a slow-growing tumour that commonly affects the gut).
Slovenian: Metizergid se je uporabljal tudi za zdravljenje driske, ki jo povzroča karcinoidna bolezen (počasi rastoč tumor, ki običajno prizadene črevesje).
English: − Prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults, when treatment with standard medicines has failed.
Slovenian: − profilaktično zdravljenje hude trdovratne migrene (z avro ali brez nje) s funkcionalno nezmožnostjo pri odraslih, potem ko je bilo zdravljenje s standardnimi zdravili neuspešno.
English: As a result of this, the use of these medicines is being restricted to the prevention of severe intractable migraines and cluster headaches when standard medicines have failed.
Slovenian: Zato je bila uporaba teh zdravil omejena na uporabo za preprečevanje hudih trdovratnih migren in glavobolov v rafalih, potem ko je bilo zdravljenje s standardnimi zdravili neuspešno.
English: Treatment must be stopped if a patient develops symptoms suggestive of fibrosis unless an alternative cause is confirmed.
Slovenian: Če se pri bolniku pojavijo simptomi, ki kažejo na fibrozo, je treba zdravljenje prekiniti, razen če se potrdi drug vzrok.
English: Once treatment is started the patient must be examined for occurrence of fibrosis at 6monthly intervals.
Slovenian: Po začetku zdravljenja je treba bolnika na vsakih šest mesecev pregledati glede pojava fibroze.
English: − Prophylactic treatment of episodic and chronic cluster headache in adults when treatment with standard medicines has failed.
Slovenian: − profilaktično zdravljenje epizodnega in kroničnega glavobola v rafalih pri odraslih, potem ko je bilo zdravljenje s standardnimi zdravili neuspešno.
English: • Patients should be screened for fibrosis at baseline and at least every 6 months thereafter.
Slovenian: • Pri bolnikih je treba opraviti presejalne preiskave za odkrivanje fibroze ob začetku zdravljenja in nato še najmanj vsakih šest mesecev.
English: Patients should also be screened for fibrosis at the start of treatment and should have additional screenings every 6 months.
Slovenian: Prav tako je treba pri bolnikih ob začetku zdravljenja opraviti presejalne preiskave za odkrivanje fibroze, ki jih je nato treba ponoviti vsakih šest mesecev.
English: Treatment must be discontinued if symptoms of fibrosis occur.
Slovenian: Če se pojavijo simptomi fibroze, je treba zdravljenje prekiniti.
English: Your doctor will stop your treatment if fibrosis is suspected.
Slovenian: Ob sumu na fibrozo bo zdravnik zdravljenje prekinil.
English: Adopted at the 8-11 February 2016 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 8. in 11. februarjem 2016
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni: prizadenejo lahko največ 1 osebo od 100
English: EMA/PRAC/87260/2016
Slovenian: EMA/PRAC/137773/2016 Corr1
English: What you need to know before you take Lysodren Warnings and precautions
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Lysodren Opozorila in previdnostni ukrepi
English: Abdominal pain may be a symptom of the above listed complications.
Slovenian: Abdominalna bolečina je lahko simptom zgoraj naštetih zapletov.
English: Patients should be advised to notify their physician if they experience any of the symptoms associated with the above events.
Slovenian: Bolnikom je treba svetovati, naj obvestijo svojega zdravnika, če opazijo kateri koli simptom, ki je povezan z zgornjimi dogodki.
English: Some events may result in serious outcomes, such as surgery and/or death.
Slovenian: Nekateri dogodki lahko privedejo do resnih končnih izidov, kot je operacija in/ali smrt.
English: (Applicable to bosutinib and ponatinib)
Slovenian: (Velja za bosutinib in ponatinib)
English: You should tell your doctor if any of the following applies to you:
Slovenian: Zdravniku povejte, če za vas velja kar koli izmed spodaj navedenega:
English: (Applicable to imatinib, dasatinib and nilotinib)
Slovenian: (Velja za imatinib, dasatinib in nilotinib)
English: Most bezoars reside in the stomach but bezoars may be encountered elsewhere in the intestinal tract.
Slovenian: Večina bezoarjev se zadržuje v želodcu, lahko pa se pojavijo kjer koli v prebavnem traktu.
English: Possible side effects - Recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Slovenian: Možni neželeni učinki - Ponovitev (reaktivacija) okužbe s hepatitisom B, če ste imeli hepatitis B v preteklosti (okužba jeter).
English: Frequency ‘not known': Hepatitis B reactivation
Slovenian: Pogostost „neznana“: reaktivacija hepatitisa B
English: • Pocket of infection (abscess) - this could happen after the tube is placed in your stomach
Slovenian: • Okužba v žepu (absces) - do tega lahko pride po vstavitvi cevke v želodec.
English: • Blockage (obstruction), bleeding or ulcer in the gut.
Slovenian: • Zapora (obstrukcija), krvavitev ali razjeda v črevesu.
English: Bezoars are retained concretions of undigested food indigestible material (such as vegetable or fruit non-digestible fibers) in the intestinal tract.
Slovenian: Bezoarji so preostanki nepresnovljene hrane neprebavljivih snovi (kot so neprebavljiva vlakna v zelenjavi in sadju) v prebavnem traktu.
English: DUODOPA (levodopa/carbidopa - intestinal gel)Intussusception (EPITT no 18424)
Slovenian: DUODOPA (levodopa/karbidopa - intestinalni gel)invaginacija (št. EPITT 18424)
English: - If you have gynaecological problems such as bleeding and/or pelvic pain.
Slovenian: - Če imate ginekološke težave, kot je krvavitev in/ali bolečina v predelu medenice.