FrancophonIA/ELRC3.0 huggingface dataset:
English: Heart valve fibrosis may cause increased heart rate, swelling in the hands and feet and can be identified by clinical examination.
Slovenian: Fibroza srčne zaklopke lahko povzroči povišan srčni utrip ter zatekanje dlani in stopal, ugotoviti pa jo je mogoče s kliničnim pregledom.
English: - For prophylactic treatment of severe intractable migraine a number of other classes of treatment may be considered (e.g. beta-blockers, anticonvulsivants, calcium channel blocker or tricyclic antidepressants).
Slovenian: - Pri profilaktičnem zdravljenju hude neobvladljive migrene lahko pridejo v poštev številni drugi razredi zdravil (npr. zaviralci beta receptorjev, antikonvulzivi, zaviralci kalcijevih kanalov ali triciklični antidepresivi).
English: Once treatment is commenced the patient must be examined for occurrence of fibrosis at 6-monthly intervals, this examination should include a reassessment of the benefit: risk balance in the individual patient.
Slovenian: Po začetku zdravljenja je treba bolnika zaradi možnosti pojava fibroze pregledovati v 6-mesečnih intervalih, ti pregledi pa morajo vključevati ponovno oceno razmerja med koristmi in tveganji pri posameznem bolniku.
English: • Prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Slovenian: • Profilaktično zdravljenje hude neobvladljive migrene (z avro ali brez nje) s funkcionalno nezmožnostjo pri odraslih.
English: Fibrotic reactions have been reported, especially of the pleura and retro-peritoneum, and also of the pericardium and cardiac valves.
Slovenian: Poročali so o fibrotičnih reakcijah, še posebej plevre in retroperitoneja ter tudi perikardija in srčnih zaklopk.
English: However, it should only be used after at least two other types of medication for treating this type of headache have been tried for at least 2 months and failed to adequately treat the cluster headaches.
Slovenian: Vendar pa ga smejo uporabiti šele potem, ko so jemali vsaj dve drugi vrsti zdravil za zdravljenje te vrste glavobola, in sicer vsaj 2 meseca, a ta zdravila niso v zadovoljivi meri ozdravila glavobolov v rafalih.
English: - For prophylactic treatment of episodic and chronic cluster headache at least two other classes of treatment should be considered first (e.g. verapamil, topiramate or lithium).
Slovenian: - Pri profilaktičnem zdravljenju epizodnega in kroničnega glavobola v rafalih je treba prej razmisliti o uporabi vsaj dveh drugih razredov zdravil (npr. verapamil, topiramat ali litij).
English: If symptoms suggestive of a fibrosis occur, treatment with methysergide should be discontinued unless an alternative aetiology is confirmed.
Slovenian: Če nastopijo simptomi, ki kažejo na fibrozo, je treba zdravljenje z metizergidom prekiniti, razen če je potrjena druga etiologija.
English: Nausea and vomiting, particularly if [Invented name] is taken outside meals.
Slovenian: Siljenje na bruhanje in bruhanje, še posebej, če zdravila [izmišljeno ime] ne jemljete z obroki.
English: It is taken regularly as a preventative measure to reduce how often they get the migraines.
Slovenian: To zdravilo se jemlje redno kot preventivni ukrep za zmanjšanje pogostosti migren.
English: [Invented name] should not be used to stop a headache once it has started.
Slovenian: Zdravila [izmišljeno ime] ne smete uporabiti zato, da bi ustavili glavobol, ki se je že začel.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Slovenian: Dopolnitev ustreznih poglavij v povzetkih glavnih značilnosti zdravil in navodilih za uporabo
English: Patients should have failed at least 2 classes of drugs before starting methysergide (see section 4.4).
Slovenian: Pred začetkom zdravljenja z metizergidom mora pri bolnikih priti do neuspeha z najmanj 2 razredoma zdravil (glejte poglavje 4.4.).
English: Cardiac and vascular disorders
Slovenian: Srčne in žilne bolezni
English: Valvular fibrosis (see General disorders).
Slovenian: Valvularna fibroza (glejte Splošne težave).
English: Section 4.8 Undesirable effects [This section should be amended to reflect the following wording]
Slovenian: Poglavje 4.8 Neželeni učinki [To poglavje je treba spremeniti tako, da vsebuje naslednje besedilo.]
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 ni bila pri bolniku s pregledom ovržena možnost že obstoječih fibrotičnih stanj.
English: Section 4.1 Therapeutic indications [The wording of this section should be read as below]
Slovenian: Poglavje 4.1 Terapevtske indikacije [Besedilo tega poglavja mora biti naslednje.]
English: However, it should only be used after other standard treatments have failed, those treatments should have been tried for at least 4 months at the maximum dose without success before [Invented name] is started.
Slovenian: Vendar pa smete to zdravilo vzeti šele potem, ko druga standardna zdravljenja niso bila uspešna; ta zdravljenja z največjim odmerkom morajo trajati vsaj 4 mesece brez uspeha, preden vzamete zdravilo [izmišljeno ime].
English: The following investigations should be performed prior to initiation of treatment with methysergide and at 6-monthly intervals thereafter: cardiac ultrasound, pulmonary function tests, abdominal MRI.
Slovenian: Pred začetkom zdravljenja z metizergidom in ob 6-mesečnih intervalih po njem je treba opraviti naslednje preiskave: ultrazvok srca, teste pljučne funkcije, MRI trebuha.
English: Treatment duration should not exceed 6 months.
Slovenian: Trajanje zdravljenja ne sme preseči 6 mesecev.
English: For chronic cluster headaches, treatment duration should not exceed 6 months.
Slovenian: Pri kroničnih glavobolih v rafalih trajanje zdravljenja ne sme preseči 6 mesecev.
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Slovenian: Ta povzetek glavnih značilnosti zdravila in navodilo za uporabo sta bila dogovorjena v postopku napotitve.
English: Insomnia, somnolence, dizziness, minor mood changes (nervousness, restlessness, depression and confusion in rare cases).
Slovenian: Nespečnost, zaspanost, omotičnost, manjše spremembe razpoloženja (živčnost, nemirnost, depresija in zmedenost v redkih primerih).
English: Insomnia, drowsiness, dizziness, minor psychological changes of a temporary nature (nervousness, restlessness, depression and confusion in rare cases).
Slovenian: Nespečnost, somnolenca, omotica, manjše psihološke spremembe začasnega značaja (nervoza, nemirnost, depresija in zmedenost v redkih primerih).
English: [Invented name] is also taken by people who have episodes or regular ‘cluster' headaches.
Slovenian: Zdravilo [izmišljeno ime] jemljejo tudi ljudje, ki redno ali epizodično dobivajo »glavobol v rafalih«.
English: For episodic cluster headache, the treatment duration should be adjusted according to the usual duration of the episodes, which would normally be no longer than 2 or 3 months.
Slovenian: Pri epizodnem glavobolu v rafalih bo trajanje zdravljenja prilagojeno glede na običajno trajanje epizod, in sicer ponavadi ne bo daljše od 2 ali 3 mesecev.
English: Retro-peritoneal fibrosis (see General disorders).
Slovenian: Retroperitonealna fibroza (glejte Splošne težave).
English: Migraine prophylaxis
Slovenian: Profilaksa migrene
English: [The wording of this section should be read as below]
Slovenian: [Besedilo tega poglavja mora biti naslednje.]
English: A treatment-free interval of at least 4 weeks must be allowed between courses.
Slovenian: Med posameznimi cikli zdravljenja mora biti interval brez zdravljenja v dolžini najmanj 4 tednov.
English: Section 4.2 Posology and method of administration [This section should be amended to reflect the following wording]
Slovenian: Poglavje 4.2 Odmerjanje in način uporabe [To poglavje je treba spremeniti tako, da vsebuje naslednje besedilo.]
English: This may be observed as heart or vascular murmurs, tachycardia, peripheral oedema, raised JVP or palpitations.
Slovenian: Te so lahko opazne kot srčni ali žilni šumi, tahikardija, periferni edem, povečan tlak v jugularni veni ali palpitacije.
English: If you notice any of the following symptoms you must immediately inform your doctor: pain in your chest or abdomen, awareness of your heart beat, difficulty in breathing, dry cough, nausea, general weakness, fatigue, loss of appetite/weight loss, urinary symptoms, pain/coldness/numbness in limbs.
Slovenian: Če opazite katerega koli od naslednjih simptomov, morate o tem takoj obvestiti svojega zdravnika: bolečina v prsih ali trebuhu, zavedanje svojega srčnega utripa, težave z dihanjem, suh kašelj, siljenje na bruhanje, splošna slabotnost, utrujenost, izguba apetita/izguba telesne mase, težave s sečili, občutek bolečine, hladu ali omrtvičenosti v udih.
English: Depending on the location of the affected blood vessel, this complication may be expressed as precordial (angina) or abdominal pain, as cold, dull, and painful sensations in the extremities, with or without paresthesia, as reduced or absence of a pulse, and theoretically, through arterial hypertension.
Slovenian: Glede na lokacijo prizadete krvne žile se ta zaplet lahko izrazi kot prekordialna (angina pektoris) ali abdominalna bolečina; kot hladni, topi in boleči občutki v okončinah s parestezijo ali brez nje; kot zmanjšan pulz ali njegova odsotnost in teoretično kot arterijska hipertenzija.
English: Skin reactions (e.g. rash, urticaria)
Slovenian: Kožne reakcije (npr. izpuščaj, urtikarija)
English: Depending on the location of the affected blood vessel, this complication may be expressed as chest pain or abdominal pain, as cold, dull, and painful sensations in the extremities, with or without numbness, as reduced or absence of a pulse, and theoretically, through arterial tension increase.
Slovenian: Glede na mesto prizadete krvne žile se ta zaplet lahko izrazi kot bolečina v prsih ali trebuhu; kot hladni, topi in boleči občutki v okončinah z omrtvičenostjo ali brez nje; kot zmanjšan pulz ali njegova odsotnost in teoretično kot povečanje arterijskega tlaka.
English: [This section should be amended to reflect the following wording] Like all medicines, [Invented name] can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo [izmišljeno ime] neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: If [Invented name] is taken uninterruptedly for a long time, fibrosis (accumulation of scarring in the body organs) was seen at the pleural site (membrane covering the lungs), the peritoneum (membrane covering the abdominal cavity as well as the abdominal organs) and the heart valves.
Slovenian: Ob dolgem in neprekinjenem jemanju zdravila [izmišljeno ime] so opazili fibrozo (brazgotinjenje v telesnih organih) pri pljučni mreni (membrani, ki obdaja pljuča), trebušni mreni (membrani, ki obdaja trebušno votlino in organe trebušne votline) in srčnih zaklopkah.
English: Retroperitoneal fibrosis may cause obstruction of the urinary tract with symptoms such as general asthenia, back pain, lumbar pain, dysuria, oliguria, raised blood nitrogen, nausea, anorexia, and vascular insufficiency, weak pulse and skin discolouration in the lower limbs.
Slovenian: Retroperitonealna fibroza lahko povzroči obstrukcijo sečil s simptomi, kot so splošna astenija, bolečina v hrbtu, bolečina v lumbalnem predelu, disurija, oligurija, povečana vrednost dušika v krvi, navzea, anoreksija, vaskularna insuficienca, slaboten pulz in razbarvanje kože na nogah.
English: Patients should be examined regularly for the presence of: peripheral oedema, leg discolouration, digital clubbing, weak/irregular pulse(s), tachycardia, cardiac murmur, vascular bruits, raised jugular vein pressure, lung basal crepitations, pleural/pericardial friction rubs, abdominal/flank masses/tenderness.
Slovenian: Bolnike je treba redno pregledovati glede prisotnosti: perifernega edema, razbarvanja kože na nogah, betičastih prstov, slabotnega/nerednega pulza oz. pulzov, tahikardije, srčnega šuma, žilnih hropcev, povečanega tlaka v jugularni veni, pljučnih bazalnih krepitacij, plevralnega/perikardnega trenja, abdominalnih/ledvenih zatrdlin/občutljivosti.
English: Skin reactions (e.g. rash, urticaria).
Slovenian: Kožne reakcije (npr. izpuščaj, koprivnica).
English: Section 4.4 Special warnings and precautions for use [This section should be amended to reflect the following wording] Because of the potential serious safety concerns (in particular fibrotic reactions), methysergide should only be used after other treatment have failed.
Slovenian: Zaradi možnosti resnih pomislekov glede varnosti (še posebej fibrotičnih reakcij) se sme metizergid uporabljati šele po neuspehu drugih zdravljenj.
English: During clinical assessment of the patient, particular attention should be paid to complaints of: abdominal, loin or chest pain, palpitations, dyspnoea, dry cough, nausea, malaise, fatigue, anorexia/weight loss, urinary symptoms, pain/coldness/numbness in limbs.
Slovenian: Med klinično oceno bolnika je treba posvetiti posebno pozornost poročilom o: bolečini v trebuhu, ledjih ali prsih, palpitacijah, dispneji, suhem kašlju, navzei, slabem počutju, utrujenosti, anoreksiji/izgubi telesne mase, urinarnih simptomih, bolečini/hladnosti/omrtvičenosti v udih.
English: Retroperitoneal Fibrosis may occur.
Slovenian: Lahko pride do retroperitonealne fibroze.
English: Fibrotic symptoms of the pleura are: chest pain and shortness of breath, dry cough and weight loss.
Slovenian: Simptomi fibroze pljučne mrene so: bolečina v prsih in zasoplost, suh kašelj in izguba telesne mase.
English: Fibrosis of the retroperitoneum can cause symtpoms such general discomfort, back pain, waist- or rib pain, pain during urination, reduced urine production, loss of appetite and skin discolouration in the legs.
Slovenian: Fibroza trebušne mrene lahko povzroči simptome, kot so splošno nelagodje, bolečina v hrbtu, bolečina v pasu ali rebrih, bolečina med uriniranjem, zmanjšana količina urina, izguba apetita in razbarvanje kože na nogah.
English: The duration of continuous administration must not exceed six months.
Slovenian: Trajanje neprekinjene uporabe naj ne preseže šestih mesecev.
English: Pleuro-pulmonary fibrosis presents as precordial pains, dyspnoea, pleural frictional noise, lung basal crepitations or pleural effusion, digital clubbing, dry cough, anorexia and weight loss.
Slovenian: Plevropulmonalna fibroza se kaže kot prekordialne bolečine, dispneja, zvoki plevralnega trenja, pljučne bazalne krepitacije ali plevralni izliv, betičasti prsti, suh kašelj, anoreksija in izguba telesne mase.
English: Pleuro-pulmonary fibrosis (see General disorders), dyspnoea, pleurisy, pleural effusion.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Plevropulmonalna fibroza (glejte Splošne težave), dispneja, plevritis, plevralni izliv.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.> <Or> <[Invented name] contains lactose and sucrose.
Slovenian: Bolniki z redkimi dednimi težavami intolerance za galaktozo, laponske oblike pomanjkanja laktaze ali malabsorpcije glukoze/galaktoze tega zdravila ne smejo jemati.> <ali> <Zdravilo [izmišljeno ime] vsebuje laktozo in sukrozo.
English: Pleuro-pulmonary fibrosis (see General disorders), difficulty of breath, pleura inflammation, presence of fluid in the pleura.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Plevropulmonalna fibroza (glejte Splošne težave), oteženo dihanje, vnetje pljučne mrene, tekočina v pljučni mreni.
English: Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.>
Slovenian: Bolniki z redkimi dednimi težavami intolerance za galaktozo ali fruktozo, laponske oblike pomanjkanja laktaze ali malabsorpcije glukoze/galaktoze ali insuficience sukraze/izomaltaze tega zdravila ne smejo jemati.>
English: <Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take [Invented name].>
Slovenian: <Bolniki z redkimi dednimi težavami intolerance za galaktozo, laponske oblike pomanjkanja laktaze ali malabsorpcije glukoze/galaktoze ne smejo jemati zdravila [izmišljeno ime].>
English: Always take [Invented name] exactly as your doctor has told you to.
Slovenian: Pri jemanju zdravila [izmišljeno ime] natančno upoštevajte navodila zdravnika.
English: <Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take [Invented name].>
Slovenian: <Bolniki z redkimi dednimi težavami intolerance za galaktozo ali fruktozo, laponske oblike pomanjkanja laktaze ali malabsorpcije glukoze/galaktoze ali insuficience sukraze/izomaltaze ne smejo jemati zdravila [izmišljeno ime].>
English: How to take [Invented name] [This section should be amended to reflect the following wording] You should only get your medication initiated and supervised by a doctor who specialises in the treatment of migraine and cluster headache (neurologist).
Slovenian: To zdravilo smete začeti jemati le na podlagi odločitve zdravnika, ki je specializiran za zdravljenje migrene in glavobola v rafalih (nevrologa), in ta mora vaše zdravljenje tudi nadzorovati.
English: Cluster headache
Slovenian: Glavoboli v rafalih
English: Package Leaflet
Slovenian: Bolezni prebavil
English: 6 August 2014
Slovenian: 6. avgust 2014
English: Consequently, newborns should be monitored carefully.
Slovenian: Novorojenčke je zato treba skrbno spremljati.
English: The European Commission issued a decision on 6 August 2014.
Slovenian: Evropska komisija je sklep izdala 6. avgusta 2014.
English: • treatment of schizophrenia;
Slovenian: • zdravljenje shizofrenije;
English: Therefore, quetiapine should only be used during pregnancy if the benefits justify the potential risks.
Slovenian: Kvetiapin se zato lahko uporablja med nosečnostjo samo, če koristi upravičujejo možna tveganja.
English: Seroquel is available as tablets (25, 100, 150, 200 and 300 mg) while Seroquel XR is available as prolonged-release tablets (50, 150, 200, 300 and 400 mg).
Slovenian: Zdravilo Seroquel je na voljo v obliki tablet (25, 100, 150, 200 in 300 mg), zdravilo Seroquel XR pa v obliki tablet s podaljšanim sproščanjem (50, 150, 200, 300 in 400 mg).
English: Prolonged-release means that the active substance is released slowly from the tablet over a few hours.
Slovenian: Podaljšano sproščanje pomeni, da se zdravilna učinkovina počasi sprošča iz tablete nekaj ur.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for these medicines in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je potrebna uskladitev informacij o predpisovanju teh zdravil v Evropski uniji (EU).
English: As neurotransmitters are chemicals that allow nerve cells to communicate with each other, this affects signals transmitted between brain cells.
Slovenian: Ker so živčni prenašalci kemične snovi, ki omogočajo medsebojno sporazumevanje živčnih celic, to vpliva na signale, ki se prenašajo med možganskimi celicami.
English: The exact mechanism of action of quetiapine is unknown, but it attaches to several receptors on the surface of nerve cells in the brain, including the receptors for the neurotransmitters dopamine and serotonin.
Slovenian: Natančen mehanizem delovanja kvetiapina ni znan, se pa veže na več receptorjev na površini živčnih celic v možganih, med katerimi so tudi receptorji za živčna prenašalca dopamin in serotonin.
English: The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use) and 4.8 (undesirable effects).
Slovenian: Odbor CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjema 4.4 (Posebna opozorila in previdnostni ukrepi) in 4.8 (Neželeni učinki).
English: This has led to divergences across Member States in the way the medicines can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
Slovenian: To je povzročilo razlike med državami članicami glede tega, kako se zdravili lahko uporabljata, kar se odraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, v katerih se zdravili tržita.
English: Having reviewed the data available on the use of quetiapine during pregnancy, the CHMP concluded that no definite conclusion can be drawn on the risk of malformations in the unborn child when the medicine is used during early pregnancy (first trimester).
Slovenian: Potem ko je odbor CHMP pregledal razpoložljive podatke o uporabi kvetiapina med nosečnostjo, je zaključil, da ni mogoče podati dokončnega zaključka o tveganju za malformacije pri nerojenem otroku, kadar se zdravilo uporablja v zgodnji nosečnosti (v prvem trimesečju).
English: The company that markets these medicines is Astra Zeneca.
Slovenian: Zdravili trži farmacevtska družba Astra Zeneca.
English: The CHMP also harmonised the dosing recommendations, particularly how to increase the dose and the recommended daily dose.
Slovenian: Odbor CHMP je uskladil tudi priporočila za odmerjanje, zlasti v zvezi s povečevanjem odmerka in priporočenim dnevnim odmerkom.
English: After reviewing the available data supporting the use of the medicines, the CHMP agreed that Seroquel and Seroquel XR can continue to be used for the treatment of schizophrenia and treatment and prevention of bipolar disorder, but recommended harmonised wordings for these indications as follows:
Slovenian: Potem ko je odbor CHMP pregledal razpoložljive podatke v podporo uporabi teh zdravil, se je strinjal, da se lahko zdravili Seroquel in Seroquel XR še naprej uporabljata za zdravljenje shizofrenije ter zdravljenje in preprečevanje bipolarne motnje, vendar je za te indikacije priporočil naslednja usklajena besedila:
English: They are used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Slovenian: Uporabljata se pri bolnikih s shizofrenijo, tj. duševno boleznijo, ki ima vrsto simptomov, med katerimi so nepovezano razmišljanje in govorjenje, halucinacije (bolnik sliši ali vidi stvari, ki jih ni), sumničavost ter blodnje (zmotna prepričanja).
English: Since these neurotransmitters are involved in schizophrenia, bipolar disorder and major depression, quetiapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Slovenian: Ker omenjena živčna prenašalca sodelujeta pri shizofreniji, bipolarni motnji in hudi depresiji, kvetiapin pomaga normalizirati dejavnost možganov in s tem zmanjša simptome teh bolezni.
English: They are also used for the prevention and treatment of bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression.
Slovenian: Prav tako se uporabljata za preprečevanje in zdravljenje bipolarne motnje, tj. duševne bolezni, pri kateri imajo bolniki manične epizode (obdobja nenormalno privzdignjenega razpoloženja), ki se izmenjujejo z obdobji normalnega razpoloženja, ter depresivne epizode.
English: Additionally, the data available show that newborns who were exposed to antipsychotics (including quetiapine) during late pregnancy (third trimester) are at risk of side effects including agitation, somnolence, breathing and feeding problems.
Slovenian: Poleg tega razpoložljivi podatki kažejo, da pri novorojenčkih, ki so izpostavljeni antipsihotikom (vključno s kvetiapinom) med pozno nosečnostjo (v tretjem trimesečju), obstaja tveganje za neželene učinke, kot so agitacija, somnolenca, težave z dihanjem in težave pri hranjenju.