natgillin/translations-raw huggingface dataset:
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).
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).
The effects of Rebif on fertility have not been investigated.
Učinkov zdravila Rebif na plodnost niso preučili.
• 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.
• 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.
• Suicide attempt
• poskus samomora
If you feel depressed or develop thoughts of suicide, report it immediately to your doctor.
Če se počutite potrto ali so se pri vas pojavile misli na samomor, o tem takoj obvestite svojega zdravnika.
To give yourself an injection you will need:
Če si želite zdravilo injicirati sami, potrebujete:
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.
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.
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.
Čeprav klinična pomembnost nastanka protiteles še ni popolnoma pojasnjena, je razvoj nevtralizirajočih protiteles povezan z zmanjšano učinkovitostjo na klinične in magnetno resonančne spremenljivke.
If clinically needed, the use of Rebif may be considered during pregnancy
Če je klinično potrebno, se zdravilo Rebif lahko uporablja med nosečnostjo.
For storage of the device with the cartridge, see section 6.4.
Za shranjevanje pripomočka z vložkom glejte poglavje 6.4.
The physician should discuss with the patient which device is the most appropriate.
Zdravnik se mora z bolnikom pogovoriti o tem, kateri pripomoček je zanj najbolj primeren.
Tell your doctor immediately and stop using Rebif if you experience any of the following serious side effects:
Takoj obvestite svojega zdravnika in prenehajte z jemanjem zdravila Rebif, če opazite katerega od sledečih resnih neželenih učinkov:
Rebif 44 mcg tiw* (n=171)
Rebif 44 µg tiw* (n = 171)
• Depression is common (may affect up to 1 in 10 people) in treated patients with multiple sclerosis.
• Depresija je pogosta (pojavi se lahko pri največ 1 od 10 bolnikov) pri zdravljenih bolnikih z multiplo sklerozo.
The following side effects were reported for interferon beta (frequency not known)
Poročali so tudi o sledečih neželenih učinkih interferona beta (pogostnost ni znana):
It is intended for single use and should only be used following adequate training of the patient and/or carer.
Namenjen je za enkratno uporabo po ustreznem izobraževanju bolnika in/ali negovalca.
• if you are allergic to natural or recombinant interferon beta or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na naravni ali rekombinantni interferon beta ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Asymptomatic increases in laboratory parameters of hepatic function and decreases in white blood cells are also common.
Asimptomatsko povečanje laboratorijskih vrednosti parametrov jetrne funkcije in zmanjšanje števila belih krvnih celic sta tudi pogosta.
What you need to know before you use Rebif
Kaj morate vedeti, preden boste uporabili zdravilo Rebif
• Keep enough pressure on the skin and press the button with your thumb.
• Dovolj čvrsto pritiskajte na kožo in s palcem pritisnite gumb.
After repeated subcutaneous administration every 48 hours for 4 doses, these biological responses remain elevated, with no signs of tolerance development.
Po ponavljajoči subkutani aplikaciji vsakih 48 ur, 4 odmerke zapored, ostanejo ti biološki odzivi povišani, brez znakov razvoja tolerance.
Effects of the disease itself or of its treatment might influence your ability to drive or to use machines.
Vpliv na sposobnost upravljanja vozil in strojev Vplivi same bolezni ali zdravljenja bolezni lahko vplivajo na vašo sposobnost upravljanja vozil ali uporabe strojev.
The adverse reactions presented have been identified from clinical studies as well as from postmarketing reports (an asterisk [*] indicates adverse reactions identified during post-marketing surveillance).
Predstavljeni neželeni učinki so bili opredeljeni v kliničnih študijah in poročilih iz obdobja trženja zdravila (zvezdica [*] pomeni neželene učinke, opredeljene med spremljanjem v obdobju trženja).
• Dispose of all used items: once you have finished your injection, immediately discard the syringe in an appropriate disposal unit.
• Odstranite vse uporabljene predmete: ko ste zaključili z injiciranjem, takoj zavrzite brizgo v ustrezno posodo za odlaganje.
An increased risk of abortions has been reported in animal studies of other alpha and beta interferons.
O povečanem tveganju za spontani splav so poročali v študijah na živalih z drugimi alfa in beta interferoni.
Use in children (below 2 years of age) Rebif is not recommended for use in children below 2 years of age.
Uporaba pri otrocih (starih manj kot 2 leti) Zdravilo Rebif se ne priporoča pri otrocih, starih manj kot 2 leti.
See recommendations in section “Warnings and precautions” to minimise the risk of injection site reactions.
Glejte tudi priporočila v poglavju »Opozorila in previdnostni ukrepi«, za zmanjšanje tveganja za nastanek reakcij na mestu injiciranja.
Rebif belongs to a class of medicines known as interferons.
Zdravilo Rebif spada v razred zdravil, znanih kot interferoni.
Do not use this medicine if you notice any visible signs of deterioration such as if the solution is no longer clear or if it contains particles.
Ne uporabljajte tega zdravila, če opazite vidne znake kvarjenja, če na primer raztopina ni več bistra ali če vsebuje delce.
Suicide attempt*
poskus samomora*
For administration of Rebif, please read the following instructions carefully: This medicine is for single use.
Za uporabo zdravila Rebif pozorno preberite naslednja navodila: Zdravilo je za enkratno uporabo.
Liver function tests may be disturbed (very common).
Jetrni testi so lahko moteni (zelo pogosto).
After repeated subcutaneous doses in healthy volunteers, the main PK parameters (AUCtau and Cmax) increased proportional to the increased in dose from 22 micrograms to 44 micrograms.
Po dajanju ponavljajočih subkutanih odmerkov zdravim prostovoljcem sta se glavna FK parametra (AUCtau in Cmax) zvečala sorazmerno z večanjem odmerka od 22 mikrogramov do 44 mikrogramov.
Interferons are a group of endogenous glycoproteins endowed with immunomodulatory, antiviral and antiproliferative properties.
Interferoni so skupina endogenih glikoproteinov z imunomodulatornimi, antivirusnimi in antiproliferativnimi lastnostmi.
(LOWER FLAP)
(SPODNJI POKLOPEC)
• Your doctor may have prescribed you RebiSmart or RebiSlide device.
• Vaš zdravnik vam je morda predpisal pripomoček RebiSmart ali RebiSlide.
• Breathing difficulties
• težave z dihanjem
If you have been prescribed RebiSmart please go to the section “If you use RebiSmart”.
Če vam je predpisal pripomoček RebiSmart, pojdite na poglavje »Če uporabljate pripomoček RebiSmart«.
Please read also the instructions in the manual provided with your device.
Preberite tudi navodila v priročniku, priloženem vašemu pripomočku.
• Press the injection button.
• Pritisnite injekcijski gumb.
• The initiation pack contains two identical cartridges of Rebif and you may initiate treatment with either cartridge.
• Začetno pakiranje vsebuje dva identična vložka zdravila Rebif in zdravljenje lahko začnete z enim ali drugim vložkom.
First demyelinating event
Prvi dogodek demielinizacije
G. Safety guard H. Needle
G. varovalo H. igla
Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Poročali so, da interferoni zmanjšajo aktivnost od jetrnega citokroma P450 odvisnih encimov pri človeku in živalih.
The precise mechanism of action of Rebif in multiple sclerosis is still under investigation.
Natančni mehanizem delovanja zdravila Rebif pri multipli sklerozi še vedno proučujejo.
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Zdravljenje se mora začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem te bolezni.
Pharmacotherapeutic group: Immunostimulants, Interferons, ATC code: L03AB07
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, interferoni, oznaka ATC: L03AB07
• Short instructions on how to use Rebif cartridges with each device are given below.
• Kratka navodila o uporabi vložkov zdravila Rebif s posamezno napravo so navedena spodaj.
This lower dose is recommended for patients who cannot tolerate the higher dose.
Ta nižji odmerek se priporoča za bolnike, ki ne morejo prenašati višjih odmerkov.
• Check (just after removing from the refrigerator) that the cartridge is not accidentally frozen in the pack or inside the device.
• Preverite, da vložek (ko ga odstranite iz hladilnika) ni po nesreči zamrznil v škatli ali znotraj pripomočka.
• use an aseptic injection technique,
• uporabljajo aseptično tehniko injiciranja
If you use RebiSmart • RebiSmart is programmed to guide you through the entire initiation process and automatically increases the dose during the initiation period.
• Pripomoček RebiSmart je programiran tako, da vas vodi skozi celotni začetni postopek in samodejno povečuje odmerek v začetnem obdobju.
It is recommended that patients should be evaluated at least every second year in the 4-year period after initiation of treatment with Rebif and a decision for longer term treatment should then be made on an individual basis by the treating physician.
Zato se priporoča, da lečeči zdravnik bolnika pregleda najmanj vsako drugo leto v 4-letnem obdobju od začetka zdravljenja z zdravilom Rebif in na individualni osnovi sprejme odločitev o dolgoročnem zdravljenju.
It has been shown to reduce the number and the severity of relapses and to slow the progression of disability.
Dokazano je, da zmanjšuje število in jakost zagonov te bolezni ter upočasnjuje napredovanje nesposobnosti.
• Blood clots such as deep venous thrombosis
• krvni strdki, kot je globoka venska tromboza
The injection site can become infected (uncommon); the skin may become swollen tender and hard and the whole area could be very painful.
Mesto injiciranja se lahko okuži (občasno); koža lahko postane otekla, občutljiva in trda, celotni predel je lahko zelo boleč.
Patients with single lesions may continue provided that the necrosis is not too extensive.
Bolniki, ki imajo eno samo lezijo, lahko z zdravljenjem nadaljujejo pod pogojem, da nekroza ni preobširna.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC , ODGOVOREN ZA SPROŠČANJE SERIJ
• Insert the needle into the skin as you have been told by your doctor.
•Zabodite iglo v kožo, kot vas je poučil vaš zdravnik.
In some cases such symptoms are associated with fever or flu-like symptoms described above.
V nekaterih primerih se takšni znaki lahko pojavijo v povezavi z zvišano telesno temperaturo ali gripi podobnimi znaki, ki so opisani zgoraj.
For multidose use.
Za večkratno uporabo.
These results obtained in a subgroup of patients a posteriori should be interpreted cautiously.
Pri interpretaciji rezultatov iz podskupine bolnikov a posteriori je potrebna previdnost.
* Million International Units, measured by cytopathic effect (CPE) bioassay against the in-house interferon beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531).
* milijon mednarodnih enot, merjeno z biološkim testom s citopatskim učinkom (CPE) po standardu proizvajalca za interferon beta-1a, ki je kalibriran po trenutnem mednarodnem NIH standardu (GB-23-902-531).
The safety and efficacy of Rebif in children below 2 years of age have not yet been established.
Varnost in učinkovitost zdravila Rebif pri otrocih, starih manj kot 2 leti, še nista bili dokazani.
You should not discontinue the treatment without first contacting your doctor.
Zdravljenja ne smete prekiniti, ne da bi se predhodno posvetovali z zdravnikom.
Therefore, in addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, liver enzyme monitoring and complete and differential blood cell counts and platelet counts are recommended at regular intervals (1, 3 and 6 months) following introduction of Rebif therapy and then periodically thereafter in the absence of clinical symptoms.
Zato se poleg tistih laboratorijskih testov, ki so normalno potrebni za spremljanje bolnikov z multiplo sklerozo, priporoča spremljanje testov jetrne funkcije in spremljanje celotne in diferencialne krvne slike ter števila trombocitov v rednih časovnih razmakih (1, 3 in 6 mesecev) po začetku zdravljenja z zdravilom Rebif in nato periodično, če ni kliničnih znakov.
• Full instructions for use are provided with your device.
• Izčrpna navodila za uporabo so priložena vašemu pripomočku.
Rebif has not been investigated for carcinogenicity.
Zdravila Rebif niso preizkušali na kancerogenost.
The use of various assays to detect serum antibodies and differing definitions of antibody positivity limits the ability to compare antigenicity among different products.
Uporaba različnih testov za dokazovanje serumskih protiteles in različne definicije mej za pozitivnost protiteles omejujejo možnost primerjave antigenskih lastnosti med različnimi zdravili.
If you experience symptoms suggesting a liver disorder, such as loss of appetite accompanied by other symptoms such as nausea, vomiting, jaundice, please contact your doctor immediately (see above “Tell your doctor immediately...”).
Če imate znake, ki kažejo na motnje v delovanju jeter, kot so izguba apetita, ki ga spremljajo drugi znaki, kot so siljenje na bruhanje, bruhanje, zlatenica, se prosimo takoj posvetujte s svojim zdravnikom (glejte zgoraj »Takoj obvestite svojega zdravnika...«).
Below is a picture showing what RebiDose looks like.
Spodnja slikakaže kako izgleda peresnik RebiDose.
Very common (may affect more than 1 in 10 people): • Headache
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): • glavobol
Severe liver problems can be associated with additional signs, e.g. difficulty concentrating, sleepiness and confusion.
Hude težave z jetri lahko spremljajo dodatni znaki kot so težave s koncentracijo, zaspanost in zmedenost.
Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (see section 5.1).
Učinkovitost ni bila ugotovljena pri bolnikih s sekundarno progresivno multiplo sklerozo, ki nimajo aktivnih zagonov (glejte poglavje 5.1).
If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Rebif is recommended.
Če je TMA diagnosticirana, je potrebno takojšnje zdravljenje (razmisliti o izmenjavi plazme), priporoča pa se tudi takojšnje prenehanje zdravljenja z zdravilom Rebif.
If you miss a dose, continue to inject from the day of the next scheduled dose.
Če ste izpustili odmerek, nadaljujte z injekcijami z dnevom, predvidenim za naslednji odmerek.
The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Periodično moramo preverjati postopek samoinjiciranja, še posebej pri bolnikih, pri katerih so se pojavile reakcije na mestu injiciranja.
Efficacy results of Rebif 44 micrograms given three times per week compared to placebo from this study are as follows:
Rezultati učinkovitosti zdravila Rebif 44 mikrogramov, dajanega trikrat na teden v primerjavi s placebom v tej študiji so:
• or if you have experienced depression,
• ste bili v depresiji,
The devices are provided separately.
Pripomočka sta na voljo posebej.
• MS pseudo-relapse (frequency not known): There is a possibility that at the beginning of your treatment with Rebif you may experience symptoms that resemble those of a multiple sclerosis relapse.
• Navidezni ponovni zagon MS (pogostnost ni znana): Obstaja možnost, da boste na začetku zdravljenja z zdravilom Rebif opazili znake, ki so podobni znakom ponovnega zagona multiple skleroze.
Limited information available on the transfer of interferon beta-1a into breast milk, together with the chemical/physiological characteristics of interferon beta, suggests that levels of interferon beta-1a excreted in human milk are negligible.
Omejeni podatki o prehajanju interferona beta-1a v materino mleko, skupaj s kemičnimi/fiziloškimi značilnostmi interferona beta kažejo, da so ravni interferona beta-1a, ki se izločijo v materino mleko, zanemarljive.
• Inform your doctor immediately if you experience any of the following possible symptoms of a liver problem: jaundice (yellowing of the skin or of the whites of the eyes), widespread itching, loss of appetite accompanied by nausea and vomiting and easy bruising of the skin.
• Takoj obvestite svojega zdravnika, če ste opazili katerega od sledečih možnih znakov, ki kažejo na težave z jetri: zlatenica (porumenelost kože ali beločnic), splošno srbenje, izguba apetita, ki jo spremljajo siljenje na bruhanje in bruhanje ter pojav manjših podplutb na koži.
• Gently pinch the skin together around the site (to lift it up a bit).
• Nežno stisnite kožo okoli mesta (da jo malce dvignete).
Patients treated with Rebif should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Bolnike, ki se zdravijo z zdravilom Rebif, moramo opozoriti, da o morebitnih znakih depresije in/ali samomorilskih mislih takoj poročajo svojemu zdravniku.
The carton contains a package leaflet with full instructions for use and handling.
V škatli je navodilo za uporabo s popolnimi navodili za uporabo in ravnanje z zdravilom.
From the fifth week onwards, after you have completed your initiation period, you will follow the usual dose regimen prescribed by your doctor.
Od petega tedna naprej, ko boste zaključili uvajalno obdobje, boste sledili običajnemu režimu odmerjanja, ki vam ga je predpisal vaš zdravnik.
• Check the appearance of Rebif through the transparent window.
• Preverite videz zdravila Rebif skozi prozorno okence.
Following repeated subcutaneous injections of 22 and 44 micrograms doses of Rebif maximum concentrations were typically observed after 8 hours, but this was highly variable.
Po ponavljajočih subkutanih injekcijah odmerkov z 22 in 44 mikrogrami zdravila Rebif so največje koncentracije običajno opazili po 8 urah, vendar se je to med bolniki močno razlikovalo.
The majority of adverse reactions observed with interferon beta-1a are usually mild and reversible, and respond well to dose reductions.
Večina neželenih učinkov, opaženih pri interferonu beta-1a, je običajno blagih in reverzibilnih in se dobro odzivajo na zmanjšanje odmerka.
Dose reduction of Rebif should be considered if ALT rises above 5 times the ULN, and gradually re-escalated when enzyme levels have normalized.
Pretehtati moramo potrebo po zmanjšanju odmerka zdravila Rebif, če ALT naraste čez 5-kratno ULN in nato odmerek postopoma povečevati, ko se raven encimov normalizira.
If tests are normal at baseline, routine testing is not needed but should be performed if clinical findings of thyroid dysfunction appear (see section 4.8).
Če so vrednosti testov ob pričetku normalne, rutinske preiskave niso potrebne, vendar se morajo izvajati, če se pojavijo klinični znaki motenj delovanja ščitnice (glejte poglavje 4.8).
• You will need to select the dose prescribed by your doctor via the RebiSmart menu to ensure the correct recording of your dose.
• Na meniju pripomočka RebiSmart boste morali izbrati odmerek, ki vam ga je predpisal zdravnik, s čimer zagotovite pravilno zapisovanje vašega odmerka.
The thyroid gland may function either excessively, or insufficiently.
Delovanje ščitnice je lahko preveliko ali premajhno.
Quincke's oedema (angio-oedema)*, erythema multiforme*, erythema multiforme-like skin reactions*, Stevens Johnson syndrome* Musculoskeletal and connective disorders Common:
Quinckejev edem (angioedem)*, multiformni eritem*, multiformnemu eritemu podobne kožne reakcije*, Stevens-Johnsonov sindrom* Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti:
• Dilatation of the blood vessels and palpitation
• dilataciji krvnih žil in palpitaciji
In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
V kliničnih študijah z zdravilom Rebif je bilo pogosto asimptomatsko zvišanje jetrnih transaminaz (zlasti alanin-aminotransferaze (ALT)) in 1-3 % bolnikov je razvilo povečanje jetrnih transaminaz, ki je preseglo 5-kratne vrednosti zgornje meje normalne ravni (ULN).
If you have poor vision you should not use RebiSlide unless someone with good eyesight can provide support.
Če slabo vidite, ne smete uporabljati pripomočka RebiSlide, razen če vam pomaga oseba, ki nima težav z vidom.
** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.
** pridobljen s tehnologijo rekombinantne DNK na ovarijskih celicah kitajskega hrčka (CHO-K1).
It is recommended that you keep track of and rotate your injection sites, so that one area is not injected too frequently in order to minimise the risk of injection site necrosis.
Priporočljivo je, da si beležite mesta injiciranja in jih izmenjujete tako, da ne zabadate prepogosto v eno in isto mesto, da zmanjšate tveganje za nekrozo na mestu injiciranja.
Approximately 70% of patients treated with Rebif can expect to experience the typical interferon flu-like syndrome within the first six months after starting treatment.
Približno 70 % bolnikov zdravljenih z zdravilom Rebif lahko pričakuje pojav za interferon značilnega gripi podobnega sindroma v prvih šestih mesecih po začetku zdravljenja.
Approximately 30% of patients will also experience reactions at the injection site, predominantly mild inflammation or erythema.
Približno 30 % bolnikov bo izkusilo tudi reakcije na mestu injiciranja, pretežno blago vnetje ali eritem.
Hepatic failure* (see section 4.4), autoimmune hepatitis*
jetrna odpoved* (glejte poglavje 4.4), avtoimuni hepatitis*
Do not use Rebif
Ne uporabljajte zdravila Rebif
For the time being there is no well established definition of a high risk patient, although a more conservative approach is to accept at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan taken at least 1 month after the initial scan.
Trenutno ni uveljavljene definicije bolnikov z visokim tveganjem, čeprav se po bolj konzervativnem pristopu sprejme vsaj devet hiperintenzivnih T2-lezij na začetnem posnetku in vsaj ena nova T2 ali ena nova z gadolinijem vidna lezija na naslednjem posnetku, ki je narejen vsaj 1 mesec po začetnem posnetku.
In the absence of clinical symptoms, serum ALT levels should be monitored prior to the start of therapy, at months 1, 3 and 6 on therapy and periodically thereafter.
Če ni kliničnih znakov, moramo nadzirati serumsko raven ALT pred začetkom zdravljenja, po 1, 3 in 6 mesecih zdravljenja in nato periodično.