natgillin/translations-raw huggingface dataset:
Concomitant use with precautions - Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4 inhibitors (e.g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 70 bpm, with monitoring of heart rate.
- Zmerni zaviralci citokroma P450 3A4: o sočasnem jemanju ivabradina z drugimi zmernimi zaviralci citokroma P450 3A4 (na primer flukonazolom) se lahko odločate ob začetnem odmerku 2,5 mg dvakrat na dan in če je srčna frekvenca med mirovanjem nad 70 utripov na minuto, ob spremljanju srčne frekvence.
What Procoralan looks like and contents of the pack Procoralan 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other.
Izgled zdravila Procoralan in vsebina pakiranja Tablete zdravila Procoralan 5 mg so lososove barve, podolgovate in filmsko obložene, z zarezo na obeh straneh in vrezano oznako “5” na eni ter na drugi strani.
The European Medicines Agency has waived the obligation to submit the results of studies with Procoralan in children aged 0 to less than 6 months for the treatment of chronic heart failure.
Procoralan za otroke od 0 do manj kot 6 mesecev starosti za zdravljenje kroničnega srčnega popuščanja.
In a 1277-patients randomised placebo-controlled study, ivabradine demonstrated a statistically significant additional efficacy on response to treatment (defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill ETT) on top of amlodipine 5 mg o.d. or nifedipine GITS 30 mg o.d. at the trough of drug activity (12 hours after oral ivabradine intake) over a 6-week treatment period (OR = 1.3, 95% CI [1.0-1.7]; p=0.012).
V randomizirani, s placebom nadzorovani študiji pri 1.277 bolnikih je ivabradin kot dodatek amlodipinu 5 mg enkrat na dan ali nifedipinu GITS (gastrointestinalni terapevtski sistem) 30 mg enkrat na dan v času najmanjšega učinka (12 ur po peroralnem jemanju) med 6-tedenskim zdravljenjem (razmerje obetov = 1,3; 95% interval zaupanja [1,0-1,7]; p = 0,012) dokazal statistično značilno dodatno učinkovitost pri odzivu na zdravljenje (definiranem kot zmanjšanje za najmanj 3 napade angine pektoris na teden in/ali podaljšanje časa do 1-mm depresije segmenta ST za najmanj 60 s med obremenitvenim testiranjem (ETT) hoje po tekočem traku).
Ivabradine has low affinity for CYP3A4, shows no clinically relevant CYP3A4 induction or inhibition and is therefore unlikely to modify CYP3A4 substrate metabolism or plasma concentrations.
Ivabradin ima majhno afiniteto za citokrom P450 3A4, ki ga ne spodbuja ali zavira klinično pomembno, zato ni verjetno, da bi vplival na presnovo substratov citokroma P450 3A4
Talk to your doctor if you are breast-feeding or intending to breast-feed as breast-feeding should be discontinued if you take Procoralan.
Če dojite ali nameravate dojiti se posvetujte z zdravnikom, ker morate z dojenjem prekiniti, če jemljete zdravilo Procoralan.
The usual recommended starting dose is one tablet of Procoralan 5 mg twice daily increasing if necessary to one tablet of Procoralan 7.5 mg twice daily.
Če se zdravite zaradi kroničnega srčnega popuščanja Običajen priporočljiv začetni odmerek je ena tableta zdravila Procoralan 5 mg dvakrat na dan, kar lahko povečate na eno tableto zdravila Procoralan 7,5 mg dvakrat na dan, če je potrebno.
Procoralan 7.5 mg film-coated tablets
Procoralan 7,5 mg filmsko obložene tablete
Talk to your doctor or pharmacist before taking Procoralan - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Pred začetkom jemanja zdravila Procoralan se posvetujte z zdravnikom ali farmacevtom: - če imate motnje srčnega ritma (kot so nepravilen srčni utrip, palpitacije, povečana bolečina v prsih), vztrajno atrijsko fibrilacijo (vrsto nerednega srčnega utripa) ali nepravilnost v elektrokardiogramu (EKG), ki se imenuje 'podaljšan interval QT'; - če opažate simptome, kot so utrujenost, vrtoglavost ali zasoplost (to bi lahko pomenilo, da se vaše srce preveč upočasnjuje); - če imate simptome atrijske fibrilacije (nenavadno visok srčni utrip v mirovanju (nad 110
Procoralan 5 mg film-coated tablets
Procoralan 5 mg filmsko obložene tablete
Package leaflet: information for the patient Procoralan 5 mg film-coated tablets Procoralan 7.5 mg film-coated tablets ivabradine
Navodilo za uporabo Procoralan 5 mg filmsko obložene tablete Procoralan 7,5 mg filmsko obložene tablete ivabradin
Ivabradine is indicated : - in adults unable to tolerate or with a contraindication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
Ivabradin je indiciran: - pri odraslih, pri katerih so antagonisti adrenergičnih receptorjev beta kontraindicirani ali jih ne prenašajo,
Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.
Bolnike s kroničnim srčnim popuščanjem z motnjami intraventrikularne prevodnosti (levokračni blok,
Specific drug-drug interaction studies have shown no clinically significant effect of the following medicinal products on pharmacokinetics and pharmacodynamics of ivabradine: proton pump inhibitors (omeprazole, lansoprazole), sildenafil, HMG CoA reductase inhibitors (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin and warfarin.
(omeprazola, lansoprazola), sildenafila, zaviralcev hidroksimetilglutaril koencim A (HMG CoA) reduktaze (simvastatina), dihidropiridinskih kalcijevih antagonistov (amlodipina, lacidipina),
Excipient with known effect: 63.91 mg lactose monohydrate Procoralan 7.5 mg film-coated tablets
Pomožna snov z znanim učinkom: 63,91 mg laktoze monohidrata.
NAME OF THE MEDICINAL PRODUCT Procoralan 7.5 mg film-coated tablets ivabradine
Procoralan 7,5 mg filmsko obložene tablete ivabradin
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.
Po dveh tednih zdravljenja lahko odmerek povečate na 7,5 mg dvakrat na dan, če srčna frekvenca med mirovanjem vztraja nad 60
mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
kinidin, dizopiramid, ibutilid, sotalol, amjodaron (proti motnjam srčnega ritma) bepridil (proti angini pektoris)
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).
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.
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).
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)
The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
slabotnost, utrujenost in otekanje gležnjev.
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).
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,
• Certain laboratory tests may change.
• Določeni laboratorijski testi se lahko spremenijo.
These are natural substances that transmit messages between cells.
To so naravne snovi, ki prenašajo sporočila med celicami.
Do not put your fingers in the safety guard.
Ne vtikajte svojih prstov v varovalo.
At the present time, it is not known for how long patients should be treated.
Zaenkrat ni znano, kako dolgo bi se bolniki morali zdraviti.
• if you are severely depressed at present.
• če imate trenutno hudo depresijo.
No specific risk factors have been identified.
Specifičnih dejavnikov tveganja niso identificirali.
• Alcohol wipes or similar.
• alkoholne krpice ali podobno
Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Glede na podatke pri živalih (glejte poglavje 5.3) morda obstaja povečano tveganje za spontani splav.
Parameter Statistics
Parameter Statistika
• Visually check that there is no liquid left.
• Vizualno preverite, če je ostalo kaj tekočine.
KM Estimate
Ocena KM
For example, your muscles may feel very tense or very weak, preventing you from moving as you want.
Na primer, vaše mišice bodo lahko zelo napete ali zelo šibke, kar vam bo onemogočalo gibanje po vaši želji.
• at the same time of day (preferably in the evening).
• vedno ob istem času dneva (najbolje zvečer).
Let the skin dry.
Pustite, da se koža osuši.
Push the pen against your skin until you feel resistance.
Peresnik potisnite na vašo kožo, dokler ne začutite odpora.
• Increased sweating
• večje znojenje
Rebif should be administered three times per week, and if possible:
Zdravilo Rebif se mora dajati trikrat na teden in, če je mogoče:
Cox's Proportional Hazard Ratio [95% CI]
Sorazmerno razmerje tveganja po Coxu [95% IZ]
• on the same three days every week (at least 48 hours apart, e.g. Monday, Wednesday, Friday)
• na iste tri dni vsak teden (z razmakom najmanj 48 ur, npr. v ponedeljek, sredo, petek)
• Use each RebiDose only once.
• Uporabite vsak peresnik RebiDose samo enkrat.
In some markets only one of these devices may be available.
Na nekaterih trgih je na voljo le en od teh pripomočkov za injiciranje.
Please follow these carefully.
Dosledno jih upoštevajte.
• Loss of appetite
• izgubi apetita
• Serious skin reactions - some with mucosal lesions
• resne kožne reakcije - nekatere z mukoznimi lezijami
The majority of the cases of severe liver injury occurred within the first six months of treatment.
Večina primerov hudih jetrnih poškodb se je pojavila v prvih šestih mesecih zdravljenja.
• Wait until the green light switches off.
•Počakajte, da zelena lučka ugasne.
In any case, treatment should only be considered for patients classified as high risk.
V vsakem primeru je treba zdraviti samo bolnike, razvrščene med tiste z visokim tveganjem.
In particular you should tell your doctor if you are using antiepileptics or antidepressants.
Zdravnika še zlasti obvestite, če jemljete antiepileptike ali antidepresive.
Succursale d'Aubonne Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Switzerland
Succursale d'Aubonne Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Švica
You will hear a click which indicates the start of the injection and the plunger will start moving.
Zaslišali boste klik, ki označuje začetek injiciranja in bat se bo začel premikati.
Inform your doctor if you have a disease of
Obvestite zdravnika, če imate bolezen
• Current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
• Trenutna huda depresija in/ali samomorilne misli (glejte poglavji 4.4 in 4.8).
• Serious allergic (hypersensitivity) reactions.
• Resne alergijske (preobčutljivostne) reakcije.
Usually symptoms disappear within one or two weeks after treatment is stopped.
Simptomi običajno izzvenijo v enem ali dveh tednih po koncu zdravljenja.
These changes are generally not noticed by the patient (no symptoms), are usually reversible and mild, and most often do not require particular treatment.
Teh sprememb bolnik na splošno ne opazi (ni znakov) in so običajno reverzibilne in blage ter najpogosteje ne zahtevajo posebnega zdravljenja.
Interferons are produced by the body and play an essential role in the immune system.
Interferone proizvaja telo in igrajo bistveno vlogo v imunskem sistemu.
Otherwise go to the section “If you use RebiSlide”.
Sicer pojdite na poglavje »Če uporabljate pripomoček RebiSlide«.
After first injection use within 28 days.
Po prvem injiciranju uporabite v 28 dneh.
Depression and suicidal ideation
Depresija in samomorilne misli
If a bit of alcohol is left on the skin, you may get a stinging sensation.
Če na koži ostane le kanec alkohola, vam lahko povzroči pekoč občutek.
Tell your doctor as they may be signs of a possible kidney problem.
To povejte zdravniku, saj so lahko to znaki možnih težav z ledvicami.
Therefore you should not stop using Rebif but continue to use it regularly to achieve the desired result.
Zato ne prenehajte uporabljati zdravila Rebif, temveč nadaljujte z redno uporabo za doseganje želenih rezultatov.
• RebiDose is for single use only and should never be reused.
• Peresnik RebiDose je namenjen samo za enkratno uporabo, zato ga ne smete nikoli ponovno uporabiti.
The number of red blood cells, white blood cells or platelets may decrease either individually (very common) or all at one time (rare).
Število rdečih krvnih celic, belih krvnih celic ali trombocitov se lahko zmanjša bodisi posamezno (zelo pogosto) ali pa pri vseh hkrati (redko).
This is to minimise the risk of skin damage (necrosis).
Tako zmanjšate tveganje za poškodbo kože (nekrozo).
The estimated apparent half-life is 50 to 60 hours, which is in line with the accumulation observed after multiple dosing.
Ocenjen navidezni razpolovni čas je 50 do 60 ur, kar je v skladu s kopičenjem, opaženim po večkratnem odmerjanju.
Not all injection devices may be available.
Na voljo ni vseh pripomočkov za injiciranje.
• This section tells you how to use RebiDose.
• To poglavje vam pove kako uporabljati peresnik RebiDose.
However, a paediatric retrospective cohort study collected safety data with Rebif from medical records in children (n=52) and adolescents (n=255).
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).
• Insomnia (sleeping difficulty)
• nespečnost (težave s spanjem)
(To prevent accidental freezing, avoid placing near the freezer compartment).
(Za preprečitev naključnega zamrzovanja se izogibajte shranjevanju zdravila v bližini zamrzovalnega predela).
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Znano je, da se depresija in samomorilske misli bolj pogosto pojavljajo pri populaciji z multiplo sklerozo in v povezavi z uporabo interferonov.
The interaction of Rebif with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Medsebojno delovanje zdravila Rebif s kortikosteroidi ali adrenokortikotropnim hormonom (ACTH) še ni sistematično raziskano.
It is produced in mammalian cells (Chinese hamster ovary) and is therefore glycosylated like the natural protein.
Tvori se v celicah sesalcev (ovarijih kitajskega hrčka) in je zato glikoziliran kot naravna beljakovina.
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.
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.
This tells you that the injection is completed.
To pomeni, da je injiciranje končano.
EXP After first injection use within 28 days.
EXP Po prvem injiciranju uporabite v 28 dneh.
The occurrence of injection site reactions usually decreases over time.
Pojav reakcij na mestu injiciranja se običajno sčasoma zmanjšuje.
• Nervousness
• nervoznosti
Through mechanisms that are not totally understood, interferons help to limit the damage of the central nervous system associated with multiple sclerosis.
S pomočjo mehanizmov, ki jih v celoti še ne razumemo, interferoni pomagajo omejiti škodo v osrednjem živčnem sistemu, ki jo povzroča multipla skleroza.
CDMS Conversion
Konverzija CDMS
This “Instructions for use” was last revised in
»Navodilo za uporabo» je bilo nazadnje revidirano dne
• or if you have any history of epileptic seizures, so that he/she can closely monitor your treatment and any worsening of these conditions.
• ali ste imeli/imate epileptične napade, tako da bo lahko skrbno spremljal vaše zdravljenje in kakršno koli poslabšanje teh bolezni.
Log-Rank p-value
Log-Rank vrednost p
Hepatitis with or without icterus*
hepatitis z ali brez zlatenice*
Recommended Titration (% of final dose)
Priporočeno postopno povečevanje odmerka (% končnega odmerka)
CH-1804 Corsier-sur-Vevey Switzerland or
CH-1804 Corsier-sur-Vevey Švica ali
Myalgia, arthralgia
mialgia, artralgija
No harmful effects on the breastfed newborn/infant are anticipated.
Škodljivih učinkov na dojene novorojenčke/dojenčke ni pričakovati.
Discuss with your doctor which device is the most suitable for you.
Z zdravnikom se pogovorite o tem, kateri pripomoček je za vas najbolj primeren.
Ask your pharmacist how to safely dispose of RebiDose.
Vprašajte farmacevta kako varno zavreči peresnik RebiDose.
Rebif should not be used in this age group.
Zdravila Rebif ne smete uporabljati v tej starostni skupini.
• 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'.
• 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".
• Do not remove the cap until you are ready to administer the injection.
• Ne odstranite zaporke, dokler niste pripravljeni na dajanje injekcije.
It is also approved for use in patients who have experienced a single clinical event likely to be a first sign of multiple sclerosis.
Odobreno je tudi za uporabo pri bolnikih, ki so imeli en klinični dogodek, ki bi lahko bil prvi znak multiple skleroze.
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.
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.
Keep RebiDose pressed against the skin for at least 10 seconds in order to inject all of the medicine.
Peresnik RebiDose pritiskajte na kožo vsaj 10 sekund, da se vbrizga celotna količina zdravila.
Other medicines and Rebif
Druga zdravila in zdravilo Rebif
Initiating treatment
Začetek zdravljenja
No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Formalnih kliničnih preskušanj ali farmakokinetičnih študij pri otrocih ali mladostnikih niso izvedli.
A study on embryo/foetal toxicity in monkeys showed no evidence of reproductive disturbances.
Študija embrio/fetalne toksičnosti pri opicah ni pokazala znakov reproduktivnih motenj.
For single dose only.
Samo za enkratni odmerek.
• Rebif should only be used under the supervision of your doctor.
• Zdravilo Rebif se sme uporabljati samo pod nadzorom zdravnika.
Children and teenagers Side effects in children and teenagers are similar to those observed in adults.
Otroci in mladostniki Neželeni učinki pri otrocih in mladostnikih so podobni kot pri odraslih.
Depression, insomnia
depresija, nespečnost
McDonald (2005) Conversion
Konverzija McDonald (2005) Število dogodkov Ocena KM
The mechanism for the rare symptomatic hepatic dysfunction is not known.
Mehanizem redkih simptomatskih jetrnih disfunkcij ni znan.
• Look through the transparent window to make sure that the plunger has moved to the bottom as indicated in the figure.
• Poglejte skozi prozorno okence in se prepričajte, da se je bat premaknil do dna, kot prikazuje slika.
• Check the expiry date on the RebiDose label or on the outer box (as indicated as “EXP”).
• Preverite datum izteka roka uporabnosti na nalepki peresnika RebiDose ali na zunanji škatli (označenega kot "EXP").
In case of overdose, patients should be hospitalised for observation and appropriate supportive treatment should be given.
V primeru prevelikega odmerjanja je treba bolnika sprejeti v bolnišnico na opazovanje in mu dati primerno podporno terapijo.
• 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)
• 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)
From the fifth week onwards, RebiSmart will automatically switch to the usual dose regimen.
Od petega tedna naprej pripomoček RebiSmart samodejno preklopi na običajni režim odmerjanja.
What Rebif is and what it is used for
Kaj je zdravilo Rebif in za kaj ga uporabljamo
It may also be administered with a suitable auto-injector.
Lahko se jo uporabi tudi s primernim avtoinjektorjem.
The effects of Rebif may not be noticed immediately.
Učinkov zdravila Rebif morda ne boste opazili takoj.