FrancophonIA/ELRC3.0 huggingface dataset:
English: After two weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension.
Slovenian: Po dveh tednih zdravljenja lahko odmerek povečate na 7,5 mg dvakrat na dan, če srčna frekvenca med mirovanjem vztraja nad 60
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Slovenian: kinidin, dizopiramid, ibutilid, sotalol, amjodaron (proti motnjam srčnega ritma) bepridil (proti angini pektoris)
English: In a 725-patients randomised placebo-controlled study, ivabradine did not show additional efficacy on top of amlodipine 10 mg o.d. at the trough of drug activity (12 hours after oral intake) while an additional efficacy was shown at peak (3-4 hours after oral intake).
Slovenian: 10 mg enkrat na dan ni pokazal dodatne učinkovitosti v času najmanjšega učinka (12 ur po peroralnem jemanju), medtem ko so v času največjega učinka (3 do 4 ure po peroralnem jemanju) dodatno učinkovitost zasledili.
English: Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Procoralan or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Slovenian: določene vrste zdravil proti tesnobnosti, shizofreniji ali drugim psihozam (kot so pimozid, ziprazidon, sertindol) zdravila proti malariji (na primer meflokin ali halofantrin) eritromicin v žilo (antibiotik) pentamidin (zdravilo proti parazitom) cisaprid (proti gastroezofagealnemu refluksu)
English: The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
Slovenian: slabotnost, utrujenost in otekanje gležnjev.
English: If, during treatment, resting heart rate decreases persistently below 50 bpm or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.2).
Slovenian: Če se med zdravljenjem srčna frekvenca vztrajno znižuje pod 50 utripov na minuto med mirovanjem ali če imajo bolniki simptome, povezane z bradikardijo, kot so omotica, utrujenost ali hipotenzija,
English: • Certain laboratory tests may change.
Slovenian: • Določeni laboratorijski testi se lahko spremenijo.
English: These are natural substances that transmit messages between cells.
Slovenian: To so naravne snovi, ki prenašajo sporočila med celicami.
English: Do not put your fingers in the safety guard.
Slovenian: Ne vtikajte svojih prstov v varovalo.
English: At the present time, it is not known for how long patients should be treated.
Slovenian: Zaenkrat ni znano, kako dolgo bi se bolniki morali zdraviti.
English: • if you are severely depressed at present.
Slovenian: • če imate trenutno hudo depresijo.
English: No specific risk factors have been identified.
Slovenian: Specifičnih dejavnikov tveganja niso identificirali.
English: • Alcohol wipes or similar.
Slovenian: • alkoholne krpice ali podobno
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Slovenian: Glede na podatke pri živalih (glejte poglavje 5.3) morda obstaja povečano tveganje za spontani splav.
English: Parameter Statistics
Slovenian: Parameter Statistika
English: • Visually check that there is no liquid left.
Slovenian: • Vizualno preverite, če je ostalo kaj tekočine.
English: KM Estimate
Slovenian: Ocena KM
English: For example, your muscles may feel very tense or very weak, preventing you from moving as you want.
Slovenian: Na primer, vaše mišice bodo lahko zelo napete ali zelo šibke, kar vam bo onemogočalo gibanje po vaši želji.
English: • at the same time of day (preferably in the evening).
Slovenian: • vedno ob istem času dneva (najbolje zvečer).
English: Let the skin dry.
Slovenian: Pustite, da se koža osuši.
English: Push the pen against your skin until you feel resistance.
Slovenian: Peresnik potisnite na vašo kožo, dokler ne začutite odpora.
English: • Increased sweating
Slovenian: • večje znojenje
English: Rebif should be administered three times per week, and if possible:
Slovenian: Zdravilo Rebif se mora dajati trikrat na teden in, če je mogoče:
English: Cox's Proportional Hazard Ratio [95% CI]
Slovenian: Sorazmerno razmerje tveganja po Coxu [95% IZ]
English: • on the same three days every week (at least 48 hours apart, e.g. Monday, Wednesday, Friday)
Slovenian: • na iste tri dni vsak teden (z razmakom najmanj 48 ur, npr. v ponedeljek, sredo, petek)
English: • Use each RebiDose only once.
Slovenian: • Uporabite vsak peresnik RebiDose samo enkrat.
English: In some markets only one of these devices may be available.
Slovenian: Na nekaterih trgih je na voljo le en od teh pripomočkov za injiciranje.
English: Please follow these carefully.
Slovenian: Dosledno jih upoštevajte.
English: • Loss of appetite
Slovenian: • izgubi apetita
English: • Serious skin reactions - some with mucosal lesions
Slovenian: • resne kožne reakcije - nekatere z mukoznimi lezijami
English: The majority of the cases of severe liver injury occurred within the first six months of treatment.
Slovenian: Večina primerov hudih jetrnih poškodb se je pojavila v prvih šestih mesecih zdravljenja.
English: • Wait until the green light switches off.
Slovenian: •Počakajte, da zelena lučka ugasne.
English: In any case, treatment should only be considered for patients classified as high risk.
Slovenian: V vsakem primeru je treba zdraviti samo bolnike, razvrščene med tiste z visokim tveganjem.
English: In particular you should tell your doctor if you are using antiepileptics or antidepressants.
Slovenian: Zdravnika še zlasti obvestite, če jemljete antiepileptike ali antidepresive.
English: Succursale d'Aubonne Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Switzerland
Slovenian: Succursale d'Aubonne Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Švica
English: You will hear a click which indicates the start of the injection and the plunger will start moving.
Slovenian: Zaslišali boste klik, ki označuje začetek injiciranja in bat se bo začel premikati.
English: Inform your doctor if you have a disease of
Slovenian: Obvestite zdravnika, če imate bolezen
English: • Current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Slovenian: • Trenutna huda depresija in/ali samomorilne misli (glejte poglavji 4.4 in 4.8).
English: • Serious allergic (hypersensitivity) reactions.
Slovenian: • Resne alergijske (preobčutljivostne) reakcije.
English: Usually symptoms disappear within one or two weeks after treatment is stopped.
Slovenian: Simptomi običajno izzvenijo v enem ali dveh tednih po koncu zdravljenja.
English: These changes are generally not noticed by the patient (no symptoms), are usually reversible and mild, and most often do not require particular treatment.
Slovenian: Teh sprememb bolnik na splošno ne opazi (ni znakov) in so običajno reverzibilne in blage ter najpogosteje ne zahtevajo posebnega zdravljenja.
English: Interferons are produced by the body and play an essential role in the immune system.
Slovenian: Interferone proizvaja telo in igrajo bistveno vlogo v imunskem sistemu.
English: Otherwise go to the section “If you use RebiSlide”.
Slovenian: Sicer pojdite na poglavje »Če uporabljate pripomoček RebiSlide«.
English: After first injection use within 28 days.
Slovenian: Po prvem injiciranju uporabite v 28 dneh.
English: Depression and suicidal ideation
Slovenian: Depresija in samomorilne misli
English: If a bit of alcohol is left on the skin, you may get a stinging sensation.
Slovenian: Če na koži ostane le kanec alkohola, vam lahko povzroči pekoč občutek.
English: Tell your doctor as they may be signs of a possible kidney problem.
Slovenian: To povejte zdravniku, saj so lahko to znaki možnih težav z ledvicami.
English: Therefore you should not stop using Rebif but continue to use it regularly to achieve the desired result.
Slovenian: Zato ne prenehajte uporabljati zdravila Rebif, temveč nadaljujte z redno uporabo za doseganje želenih rezultatov.
English: • RebiDose is for single use only and should never be reused.
Slovenian: • Peresnik RebiDose je namenjen samo za enkratno uporabo, zato ga ne smete nikoli ponovno uporabiti.
English: The number of red blood cells, white blood cells or platelets may decrease either individually (very common) or all at one time (rare).
Slovenian: Število rdečih krvnih celic, belih krvnih celic ali trombocitov se lahko zmanjša bodisi posamezno (zelo pogosto) ali pa pri vseh hkrati (redko).
English: This is to minimise the risk of skin damage (necrosis).
Slovenian: Tako zmanjšate tveganje za poškodbo kože (nekrozo).
English: The estimated apparent half-life is 50 to 60 hours, which is in line with the accumulation observed after multiple dosing.
Slovenian: Ocenjen navidezni razpolovni čas je 50 do 60 ur, kar je v skladu s kopičenjem, opaženim po večkratnem odmerjanju.
English: Not all injection devices may be available.
Slovenian: Na voljo ni vseh pripomočkov za injiciranje.
English: • This section tells you how to use RebiDose.
Slovenian: • To poglavje vam pove kako uporabljati peresnik RebiDose.
English: However, a paediatric retrospective cohort study collected safety data with Rebif from medical records in children (n=52) and adolescents (n=255).
Slovenian: Vendar pa so v pediatrični retrospektivni kohortni študiji zbirali podatke o varnosti z zdravilom Rebif iz zdravniških kartotek pri otrocih (n = 52) in mladostnikih (n = 255).
English: • Insomnia (sleeping difficulty)
Slovenian: • nespečnost (težave s spanjem)
English: (To prevent accidental freezing, avoid placing near the freezer compartment).
Slovenian: (Za preprečitev naključnega zamrzovanja se izogibajte shranjevanju zdravila v bližini zamrzovalnega predela).
English: Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Slovenian: Znano je, da se depresija in samomorilske misli bolj pogosto pojavljajo pri populaciji z multiplo sklerozo in v povezavi z uporabo interferonov.
English: The interaction of Rebif with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Slovenian: Medsebojno delovanje zdravila Rebif s kortikosteroidi ali adrenokortikotropnim hormonom (ACTH) še ni sistematično raziskano.
English: It is produced in mammalian cells (Chinese hamster ovary) and is therefore glycosylated like the natural protein.
Slovenian: Tvori se v celicah sesalcev (ovarijih kitajskega hrčka) in je zato glikoziliran kot naravna beljakovina.
English: However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when the pregnancy was detected and/or confirmed.
Slovenian: Vendar pa je trajanje izpostavljenosti v prvem trimesečju negotovo, ker so bili podatki zbrani, ko je bila uporaba interferona beta med nosečnostjo kontraindicirana in je bilo zdravljenje verjetno prekinjeno, ko je bila nosečnost ugotovljena in/ali potrjena.
English: This tells you that the injection is completed.
Slovenian: To pomeni, da je injiciranje končano.
English: EXP After first injection use within 28 days.
Slovenian: EXP Po prvem injiciranju uporabite v 28 dneh.
English: The occurrence of injection site reactions usually decreases over time.
Slovenian: Pojav reakcij na mestu injiciranja se običajno sčasoma zmanjšuje.
English: • Nervousness
Slovenian: • nervoznosti
English: Through mechanisms that are not totally understood, interferons help to limit the damage of the central nervous system associated with multiple sclerosis.
Slovenian: S pomočjo mehanizmov, ki jih v celoti še ne razumemo, interferoni pomagajo omejiti škodo v osrednjem živčnem sistemu, ki jo povzroča multipla skleroza.
English: CDMS Conversion
Slovenian: Konverzija CDMS
English: This “Instructions for use” was last revised in
Slovenian: »Navodilo za uporabo» je bilo nazadnje revidirano dne
English: • or if you have any history of epileptic seizures, so that he/she can closely monitor your treatment and any worsening of these conditions.
Slovenian: • ali ste imeli/imate epileptične napade, tako da bo lahko skrbno spremljal vaše zdravljenje in kakršno koli poslabšanje teh bolezni.
English: Log-Rank p-value
Slovenian: Log-Rank vrednost p
English: Hepatitis with or without icterus*
Slovenian: hepatitis z ali brez zlatenice*
English: Recommended Titration (% of final dose)
Slovenian: Priporočeno postopno povečevanje odmerka (% končnega odmerka)
English: CH-1804 Corsier-sur-Vevey Switzerland or
Slovenian: CH-1804 Corsier-sur-Vevey Švica ali
English: Myalgia, arthralgia
Slovenian: mialgia, artralgija
English: No harmful effects on the breastfed newborn/infant are anticipated.
Slovenian: Škodljivih učinkov na dojene novorojenčke/dojenčke ni pričakovati.
English: Discuss with your doctor which device is the most suitable for you.
Slovenian: Z zdravnikom se pogovorite o tem, kateri pripomoček je za vas najbolj primeren.
English: Ask your pharmacist how to safely dispose of RebiDose.
Slovenian: Vprašajte farmacevta kako varno zavreči peresnik RebiDose.
English: Rebif should not be used in this age group.
Slovenian: Zdravila Rebif ne smete uporabljati v tej starostni skupini.
English: • To activate the “initiation/titration” menu you need to first select 44 micrograms, then ‘initiation/titration', press ‘change', select ‘on', press ‘ok' and confirm ‘initiation/titration on' by pressing ‘ok'.
Slovenian: • Za aktiviranje menija "začetek/titriranje" morate najprej izbrati 44 mikrogramov, nato "začetek/titriranje", nato pritisnite "spremeni", izberite "vklop", pritisnite "ok" in potrdite "začetek/vklop titriranja" s pritiskom na "ok".
English: • Do not remove the cap until you are ready to administer the injection.
Slovenian: • Ne odstranite zaporke, dokler niste pripravljeni na dajanje injekcije.
English: It is also approved for use in patients who have experienced a single clinical event likely to be a first sign of multiple sclerosis.
Slovenian: Odobreno je tudi za uporabo pri bolnikih, ki so imeli en klinični dogodek, ki bi lahko bil prvi znak multiple skleroze.
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Slovenian: Tveganja za spontane splave pri nosečnicah, izpostavljenih interferonu beta, na osnovi trenutno razpoložljivih podatkov ni mogoče zadovoljivo oceniti, vendar pa podatki zaenkrat ne kažejo na povečano tveganje.
English: Keep RebiDose pressed against the skin for at least 10 seconds in order to inject all of the medicine.
Slovenian: Peresnik RebiDose pritiskajte na kožo vsaj 10 sekund, da se vbrizga celotna količina zdravila.
English: Other medicines and Rebif
Slovenian: Druga zdravila in zdravilo Rebif
English: Initiating treatment
Slovenian: Začetek zdravljenja
English: No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Slovenian: Formalnih kliničnih preskušanj ali farmakokinetičnih študij pri otrocih ali mladostnikih niso izvedli.
English: A study on embryo/foetal toxicity in monkeys showed no evidence of reproductive disturbances.
Slovenian: Študija embrio/fetalne toksičnosti pri opicah ni pokazala znakov reproduktivnih motenj.
English: For single dose only.
Slovenian: Samo za enkratni odmerek.
English: • Rebif should only be used under the supervision of your doctor.
Slovenian: • Zdravilo Rebif se sme uporabljati samo pod nadzorom zdravnika.
English: Children and teenagers Side effects in children and teenagers are similar to those observed in adults.
Slovenian: Otroci in mladostniki Neželeni učinki pri otrocih in mladostnikih so podobni kot pri odraslih.
English: Depression, insomnia
Slovenian: depresija, nespečnost
English: McDonald (2005) Conversion
Slovenian: Konverzija McDonald (2005) Število dogodkov Ocena KM
English: The mechanism for the rare symptomatic hepatic dysfunction is not known.
Slovenian: Mehanizem redkih simptomatskih jetrnih disfunkcij ni znan.
English: • Look through the transparent window to make sure that the plunger has moved to the bottom as indicated in the figure.
Slovenian: • Poglejte skozi prozorno okence in se prepričajte, da se je bat premaknil do dna, kot prikazuje slika.
English: • Check the expiry date on the RebiDose label or on the outer box (as indicated as “EXP”).
Slovenian: • Preverite datum izteka roka uporabnosti na nalepki peresnika RebiDose ali na zunanji škatli (označenega kot "EXP").
English: In case of overdose, patients should be hospitalised for observation and appropriate supportive treatment should be given.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika sprejeti v bolnišnico na opazovanje in mu dati primerno podporno terapijo.
English: • patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1)
Slovenian: • bolnikov z enim dogodkom demielinizacije z aktivnim vnetnim procesom, če so bile alternativne diagnoze izključene in če je bilo ugotovljeno, da so izpostavljeni visokemu tveganju za razvoj klinično dokončne multiple skleroze (glejte poglavje 5.1)
English: From the fifth week onwards, RebiSmart will automatically switch to the usual dose regimen.
Slovenian: Od petega tedna naprej pripomoček RebiSmart samodejno preklopi na običajni režim odmerjanja.
English: What Rebif is and what it is used for
Slovenian: Kaj je zdravilo Rebif in za kaj ga uporabljamo
English: It may also be administered with a suitable auto-injector.
Slovenian: Lahko se jo uporabi tudi s primernim avtoinjektorjem.
English: The effects of Rebif may not be noticed immediately.
Slovenian: Učinkov zdravila Rebif morda ne boste opazili takoj.
English: The following definitions apply to the frequency terminology used hereafter: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).
Slovenian: V nadaljevanju se uporabljajo naslednje navedbe pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (< 1/10.000), pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The effects of Rebif on fertility have not been investigated.
Slovenian: Učinkov zdravila Rebif na plodnost niso preučili.
English: • Pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Slovenian: • pljučna arterijska hipertenzija - bolezen, ki povzroči hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerih kri teče iz srca v pljuča.
English: • Suicide attempt
Slovenian: • poskus samomora
English: If you feel depressed or develop thoughts of suicide, report it immediately to your doctor.
Slovenian: Če se počutite potrto ali so se pri vas pojavile misli na samomor, o tem takoj obvestite svojega zdravnika.
English: To give yourself an injection you will need:
Slovenian: Če si želite zdravilo injicirati sami, potrebujete:
English: A large amount of data (more than 1,000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy.
Slovenian: Veliko število podatkov (več kot 1.000 izpostavljenih nosečnosti) iz registrov in izkušnje iz obdobja trženja zdravila ne kaže povečanega tveganja za večje prirojene okvare po izpostavljenosti interferonu beta pred zanositvijo ali takšni izpostavljenosti v prvem trimesečju nosečnosti.
English: Although the clinical significance of the induction of antibodies has not been fully elucidated, the development of neutralising antibodies is associated with reduced efficacy on clinical and MRI variables.
Slovenian: Čeprav klinična pomembnost nastanka protiteles še ni popolnoma pojasnjena, je razvoj nevtralizirajočih protiteles povezan z zmanjšano učinkovitostjo na klinične in magnetno resonančne spremenljivke.
English: If clinically needed, the use of Rebif may be considered during pregnancy
Slovenian: Če je klinično potrebno, se zdravilo Rebif lahko uporablja med nosečnostjo.
English: For storage of the device with the cartridge, see section 6.4.
Slovenian: Za shranjevanje pripomočka z vložkom glejte poglavje 6.4.
English: The physician should discuss with the patient which device is the most appropriate.
Slovenian: Zdravnik se mora z bolnikom pogovoriti o tem, kateri pripomoček je zanj najbolj primeren.
English: Tell your doctor immediately and stop using Rebif if you experience any of the following serious side effects:
Slovenian: Takoj obvestite svojega zdravnika in prenehajte z jemanjem zdravila Rebif, če opazite katerega od sledečih resnih neželenih učinkov:
English: Rebif 44 mcg tiw* (n=171)
Slovenian: Rebif 44 µg tiw* (n = 171)
English: • Depression is common (may affect up to 1 in 10 people) in treated patients with multiple sclerosis.
Slovenian: • Depresija je pogosta (pojavi se lahko pri največ 1 od 10 bolnikov) pri zdravljenih bolnikih z multiplo sklerozo.
English: The following side effects were reported for interferon beta (frequency not known)
Slovenian: Poročali so tudi o sledečih neželenih učinkih interferona beta (pogostnost ni znana):
English: It is intended for single use and should only be used following adequate training of the patient and/or carer.
Slovenian: Namenjen je za enkratno uporabo po ustreznem izobraževanju bolnika in/ali negovalca.
English: • if you are allergic to natural or recombinant interferon beta or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na naravni ali rekombinantni interferon beta ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Asymptomatic increases in laboratory parameters of hepatic function and decreases in white blood cells are also common.
Slovenian: Asimptomatsko povečanje laboratorijskih vrednosti parametrov jetrne funkcije in zmanjšanje števila belih krvnih celic sta tudi pogosta.
English: What you need to know before you use Rebif
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Rebif
English: • Keep enough pressure on the skin and press the button with your thumb.
Slovenian: • Dovolj čvrsto pritiskajte na kožo in s palcem pritisnite gumb.
English: After repeated subcutaneous administration every 48 hours for 4 doses, these biological responses remain elevated, with no signs of tolerance development.
Slovenian: Po ponavljajoči subkutani aplikaciji vsakih 48 ur, 4 odmerke zapored, ostanejo ti biološki odzivi povišani, brez znakov razvoja tolerance.