FrancophonIA/ELRC3.0 huggingface dataset:
English: If your vision worsens, your doctor may decide to discontinue your treatment.
Slovenian: Če se vaš vid poslabša, se zdravnik lahko odloči za prekinitev zdravljenja.
English: • You have to inject the medicine subcutaneously (under the skin).
Slovenian: • Zdravilo si morate injicirati subkutano (pod kožo).
English: Vogt-Koyanagi-Harada disease#, acute hypersensitivity reactions#**
Slovenian: Vogt-Koyanagi-Haradova bolezen#, akutne preobčutljivostne reakcije#**
English: What Besremi is and what it is used for 2.
Slovenian: Kaj je zdravilo Besremi in za kaj ga uporabljamo 2.
English: The dose at which stabilisation of the haematological parameters is achieved should be maintained in a two week administration interval for at least 1.5 years.
Slovenian: Odmerek, pri katerem pride do stabilizacije hematoloških parametrov, je treba vzdrževati z intervalom odmerjanja na vsaka dva tedna za obdobje najmanj 1,5 leta.
English: Your doctor will then increase your dose stepwise and may adjust your dose during treatment.
Slovenian: Zdravnik bo odmerek nato postopoma zvečeval in lahko med zdravljenjem vaš odmerek prilagodi.
English: Remove the pen from the refrigerator 15 minutes before the injection to let it reach room temperature.
Slovenian: Peresnik vzemite iz hladilnika 15 minut pred injiciranjem in ga pustite, da doseže sobno temperaturo.
English: This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Slovenian: To storite zato, ker se lahko velike količine benzilalkohola nakopičijo v vašem telesu in povzročijo neželene učinke (imenovane »presnovna acidoza«).
English: The average molecular mass is approximately 60 kDa, of which the PEG moiety constitutes approximately 40 kDa .
Slovenian: Povprečna molekulska masa je približno 60 kDa, od tega predstavlja del PEG približno 40 kDa.
English: • Combination with telbivudine (see section 4.5)
Slovenian: • kombinacija s telbivudinom (glejte poglavje 4.5),
English: Your doctor will help you decide if you have to stop breast-feeding when you are using this medicine.
Slovenian: Zdravnik se vam bo pomagal odločiti, ali morate med uporabo tega zdravila prenehati z dojenjem.
English: • Take a new needle and remove the protective foil.
Slovenian: • Vzemite novo iglo in odstranite zaščitno folijo.
English: Endocrine system
Slovenian: Endokrini sistem
English: What you need to know before you use Besremi 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Besremi 3.
English: Adverse reactions are listed by system organ class and frequency (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) or not known (cannot be estimated from available data).
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in 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) oziroma neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Nuclear translocation of STAT proteins controls distinct gene-expression programs and exhibit various cellular effects.
Slovenian: STAT v jedru nadzira ekspresijo določenih programov izražanja genov in zavira različne celične učinke.
English: The potency of this medicinal product should not be compared to that of another pegylated or nonpegylated protein of the same therapeutic class (see section 5.1).
Slovenian: Jakosti tega zdravila se ne sme primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin iz istega terapevtskega razreda (glejte poglavje 5.1).
English: Any medicine remaining in the pre-filled pen after the second use and/or after 30 days must be discarded.
Slovenian: Zdravilo, ki je preostalo v peresniku po drugi uporabi in/ali 30 dneh, je treba zavreči.
English: There is no antidote for the medicinal product available.
Slovenian: Za to zdravilo antidota ni na voljo.
English: Get a new pen and start afresh.
Slovenian: Priskrbite si nov peresnik in začnite znova.
English: You should brush your teeth thoroughly twice daily and have regular dental checks.
Slovenian: Zobe si morate temeljito umiti dvakrat na dan in hoditi na redne zobozdravstvene kontrolne preglede.
English: • Keep the injection site clean until the small injection wound has closed.
Slovenian: • Mesto injiciranja ohranite čisto, dokler se majhna injekcijska rana ne zapre.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,
English: The patients recovered completely after permanent medicinal product discontinuation.
Slovenian: Bolniki so po trajni ukinitvi zdravljenja popolnoma okrevali.
English: Transient rashes do not necessitate interruption of treatment.
Slovenian: Zaradi prehodnih izpuščajev prekinitev zdravljenja ni potrebna.
English: Insert the needle at a 90 degrees angle until the blue protective sleeve on the needle is no longer visible.
Slovenian: Iglo vstavite pod kotom 90 stopinj, dokler moder zaščitni tulec ni več viden.
English: The pre-filled pen may be used up to two times within these 30 days.
Slovenian: Napolnjen injekcijski peresnik lahko znotraj teh 30 dni uporabite do dvakrat.
English: The patient received a 10-time higher starting dose as recommended and developed flu-like symptoms for three days which were rated as non-serious.
Slovenian: Bolnik je prejel 10-krat večji začetni odmerek od priporočenega in razvil gripi podobne simptome, ki so trajali tri dni in jih niso ocenili kot resne.
English: Serious adverse reactions are depression (1.1%), atrial fibrillation (1.1%) and acute stress disorder
Slovenian: Resni neželeni učinki so depresija (1,1 %), atrijska fibrilacija (1,1 %) in akutna stresna reakcija
English: In case of appearance or worsening of this skin disorders, the stop of the treatment must be envisaged.
Slovenian: V primeru pojava ali poslabšanja teh kožnih bolezni je treba zdravljenje predvidoma ustaviti.
English: However, if more than 2 days have passed since you missed the dose, leave out the dose and inject the next dose when it is due.
Slovenian: Če pa je od izpuščenega odmerka minilo več kot 2 dneva, odmerek izpustite in si injicirajte naslednjega, ko je čas zanj.
English: - if you had an organ transplantation and you take medicines which suppress your immune system.
Slovenian: - če so vam opravili presaditev organa in jemljete zdravila za zaviranje vašega imunskega sistema;
English: b defined as the improvement of disease-related signs (clinically significant splenomegaly) and disease-related symptoms (microvascular disturbances, pruritus, headache).
Slovenian: b Določeno kot izboljšanje z boleznijo povezanih znakov (klinično pomembna splenomegalija) in z boleznijo povezanih simptomov (mikrovaskularne motnje, pruritus, glavobol).
English: Events were reported at various time points typically several months after starting treatment with interferon alfa.
Slovenian: O tem so poročali v različnih časovnih točkah, običajno več mesecev po začetku zdravljenja z interferonom alfa.
English: This medicine is for subcutaneous use which means that it is injected in the tissue under your skin.
Slovenian: To zdravilo je za subkutano uporabo, kar pomeni, da se injicira v podkožno tkivo.
English: Please note down your injection dates and dose as instructed by your doctor.
Slovenian: Zabeležite si datume injiciranja in odmerek, kot vam bo naročil zdravnik.
English: • If you do not see a droplet at the needle tip, repeat steps 5 and 6 up to six times until a droplet emerges.
Slovenian: • Če na konici igle ni videti kaplje, ponovite koraka 5 in 6 do šestkrat, dokler se kaplja ne pokaže.
English: The usual starting dose of Besremi is 100 microgram every 2 weeks.
Slovenian: Običajni začetni odmerek zdravila Besremi je 100 mikrogramov vsaka 2 tedna.
English: Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Slovenian: Bolniki si morajo dvakrat na dan temeljito umiti zobe in hoditi na redne zobozdravstvene kontrolne preglede.
English: You will see the figures in the window change, and you will hear clicks when the button moves.
Slovenian: Oznake v okencu se bodo spremenile, ko se gumb premika, pa boste zaslišali klikajoče zvoke.
English: Titration phase
Slovenian: Obdobje titracije
English: The needle should be inserted into the skin.
Slovenian: Iglo morate vstaviti v kožo.
English: • Carefully remove the needle from the skin.
Slovenian: • Iglo pazljivo izvlecite iz kože.
English: The safety and efficacy of Besremi in children and adolescents has not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Besremi pri otrocih in mladostnikih nista bili dokazani.
English: If adverse events develop during therapy, the administered dose should be reduced or treatment discontinued temporarily until adverse events abate; further, treatment should be re-initiated with a lower dose than the dose that caused adverse events.
Slovenian: Če se med zdravljenjem pojavijo neželeni učinki, je treba dani odmerek zmanjšati oziroma začasno prekiniti zdravljenje, dokler neželeni učinki ne izzvenijo; nato je treba zdravljenje ponovno uvesti z manjšim odmerkom od tistega, ki je povzročil neželene učinke.
English: Do not use Besremi if you are taking telbivudine (for treating hepatitis B) since the combination of these medicines increases the risk of peripheral neuropathy (numbness, tingling, or burning sensations in the arms and legs).
Slovenian: Ne uporabljajte zdravila Besremi, če jemljete telbivudin (za zdravljenje hepatitisa B), saj kombinacija teh zdravil povečuje tveganje za periferno nevropatijo (odrevenelost, mravljinčenje ali pekoč občutek v rokah in nogah).
English: You will need the following supplies for your injection:
Slovenian: Za injiciranje boste potrebovali naslednje pripomočke:
English: High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
Slovenian: Velike volumne je treba uporabljati previdno in le, če je to nujno potrebno, še zlasti pri bolnikih z okvaro jeter ali ledvic, saj obstaja tveganje za akumulacijo in toksičnost (presnovna acidoza).
English: The medicinal product is intended for long-term treatment and can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections with the pre-filled pen.
Slovenian: Zdravilo je namenjeno dolgoročnemu zdravljenju in ga lahko bolniku da zdravnik, medicinska sestra, družinski član ali pa si ga bolnik da sam, če je bil poučen o dajanju subkutanih injekcij z napolnjenim injekcijskim peresnikom.
English: When the increase in liver enzyme levels is progressive and persistent, the dose should be reduced.
Slovenian: Kadar je zvišanje jetrnih encimov napredujoče in vztrajno, je treba odmerek zmanjšati.
English: Besremi has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Besremi ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Details on how to prepare and inject Besremi are given in the Instructions for Use.
Slovenian: Podrobnosti glede priprave in injiciranja zdravila Besremi so navedene v Navodilu za uporabo.
English: Apply an adhesive plaster if needed.
Slovenian: Če je treba, namestite samolepilni obliž.
English: • If you need two pens, use a different injection site for each pen (e. g., right and left side of belly or right and left thigh).
Slovenian: • Če potrebujete dva peresnika, za vsakega od njiju uporabite drugo mesto injiciranja (npr. leva in desna stran popka ali levo in desno stegno).
English: - if you have changes in your vision − you must tell your doctor and have an immediate eye examination.
Slovenian: - če se vam pojavijo spremembe vida - posvetujte se z zdravnikom in nemudoma pojdite na očesni pregled.
English: If you have health problems which may lead to eye problems such as diabetes or high blood pressure, you doctor should check your vision also during treatment.
Slovenian: Če imate zdravstvene težave, ki lahko vodijo do težav z očmi, kot sta sladkorna bolezen in visok krvni tlak, vam mora zdravnik vid pregledovati tudi med zdravljenjem.
English: Your doctor or pharmacist will show you how to use the pen.
Slovenian: Zdravnik ali farmacevt vam bo pokazal, kako uporabljati peresnik.
English: If an increase of haematological parameters (haematocrit, platelets, leukocytes) is observed, the dose and/or dosing interval needs to be adapted individually.
Slovenian: Če se pojavi zvečanje hematoloških parametrov (hematokrit, trombociti, levkociti), je treba odmerek in/ali interval odmerjanja individualno prilagoditi.
English: If a certain dose cannot be set, an insufficient quantity of medicinal product may be left in the pen and a new pen must be used.
Slovenian: Če določenega odmerka ne morete nastaviti, je lahko v peresniku ostala nezadostna količina zdravila in uporabiti je treba nov peresnik.
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC code: L03AB15
Slovenian: Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, interferoni, oznaka ATC: L03AB15
English: Tell your doctor if you are being treated with telbivudine.
Slovenian: Obvestite zdravnika, če se zdravite s telbivudinom.
English: Binding to IFNAR initiates a downstream signalling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and activator of transcription (STAT) proteins.
Slovenian: Vezava na IFNAR sproži kaskado potovanja signalov navzdol prek aktivacije kinaz, še zlasti Janusove kinaze 1 (JAK1) in tirozin kinaze 2 (TYK2), ter beljakovin, ki aktivirajo transkripcije (STAT).
English: very rare myocardial ischemia#
Slovenian: zelo redki miokardna ishemija#
English: In case of an overdose, close monitoring of the patient and symptomatic treatment, if necessary, are recommended.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo bolnika skrbno spremljati in uvesti simptomatsko zdravljenje, če je to potrebno.
English: In this case, place the pen back into the outer carton and store it in the refrigerator for the next use.
Slovenian: V tem primeru peresnik shranite nazaj v zunanjo ovojnino in ga do naslednje uporabe shranjujte v hladilniku.
English: Any patient reporting a decrease or loss of vision or reporting other eye symptoms should have an immediate eye examination.
Slovenian: ki navaja zmanjšanje ali izgubo vida ali druge očesne simptome, je treba nemudoma pregledati oči.
English: Patients were stratified by previous exposure to hydroxycarbamide, age at screening (≤60 or >60 years) and presence of thromboembolic events in the past.
Slovenian: Bolnike so stratificirali glede na predhodno izpostavljenost hidroksikarbamidu, starost ob presejanju (≤ 60 ali > 60 let) in prisotnost trombemboličnih dogodkov v anamnezi.
English: Your doctor or pharmacist will explain to you how to use the two pens.
Slovenian: Zdravnik ali farmacevt vam bo pojasnil, kako uporabiti dva peresnika.
English: It is unknown if the active substance of the medicinal product is excreted into experimental animal or human milk (see section 4.6).
Slovenian: Ni znano, ali se učinkovina v tem zdravilu izloča v mleko pri eksperimentalnih živalih ali materino mleko pri človeku (glejte poglavje 4.6).
English: If the increase in liver enzymes is progressive and clinically significant despite dose reduction, or if there is evidence of hepatic decompensation, therapy should be discontinued (see section 4.4).
Slovenian: Če je zvišanje jetrnih encimov kljub zmanjšanju odmerka napredujoče in klinično pomembno ali so prisotni dokazi dekompenzacije jeter, je treba zdravljenje prekiniti (glejte poglavje 4.4).
English: The pre-filled pen may not be used more than twice, and must be discarded 30 days after the first use, regardless of any medicinal product remaining in the pre-filled pen.
Slovenian: Napolnjenega injekcijskega peresnika se ne sme uporabiti več kot dvakrat in ga je treba 30 dni po prvi uporabi zavreči, ne glede na to, ali je v napolnjenem injekcijskem peresniku ostalo še kaj zdravila.
English: • Click the needle onto the pen and make sure that it is firmly attached.
Slovenian: • Iglo namestite na peresnik in se prepričajte, da je dobro pritrjena.
English: It may only be used if the solution is clear, colourless to pale yellow, with no particles visible.
Slovenian: Uporabiti se sme le, če je raztopina bistra, brezbarvna do bledo rumena in brez vidnih delcev.
English: If at any time during the use of the pen, you feel you may have damaged it (e. g. by dropping it or using excessive force), do not use the pen further.
Slovenian: Če imate med uporabo peresnika kadar koli občutek, da ste ga poškodovali (npr. da vam je padel ali ste uporabili pretirano silo), ga prenehajte uporabljati.
English: • Decompensated cirrhosis of the liver (Child-Pugh B or C)
Slovenian: • dekompenzirana ciroza jeter (Child-Pugh B ali C),
English: AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/II f 1160 Vienna
Slovenian: AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/II f 1160 Dunaj
English: • Hold the push button down and wait for at least 10 seconds before removing the needle.
Slovenian: • Potisni gumb držite pritisnjen navzdol in počakajte najmanj 10 sekund, preden umaknete iglo.
English: The most common adverse reactions (including number of patients, incidence rate, severity grade, necessity for dose adaptation and outcome) reported during the ropeginterferon alfa-2b clinical development program are summarised in Table 1.
Slovenian: Najpogostejši neželeni učinki (vključno s številom bolnikov, stopnjo incidence, stopnjo resnosti, potrebo po prilagajanju odmerka in izidu), o katerih so poročali v programu kliničnega razvoja ropeginterferona alfa-2b, so povzeti v Preglednici 1.
English: As ropeginterferon alfa-2b may have the same effect, this medicinal product is not recommended during pregnancy.
Slovenian: Ker ima lahko ropeginterferon alfa-2b enak učinek, tega zdravila ni priporočljivo uporabljati med nosečnostjo.
English: To prevent possible transmission of disease or any kind of contamination, the use of Besremi pre-filled pen should remain strictly for a single patient, even when the needle is changed.
Slovenian: Za preprečevanje morebitnega prenosa bolezni ali kakršne koli kontaminacije mora biti uporaba napolnjenega injekcijskega peresnika zdravila Besremi strogo omejena na enega bolnika, tudi če je igla zamenjana.
English: What you need to know before you use Besremi Do not use Besremi:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Besremi Ne uporabljajte zdravila Besremi:
English: The maximum recommended single dose is 500 micrograms injected every two weeks.
Slovenian: Največji priporočeni posamični odmerek je 500 mikrogramov, injiciran vsaka dva tedna.
English: • End stage renal disease (GFR <15 mL/min)
Slovenian: • končna ledvična odpoved (GFR < 15 ml/min).
English: The effect of Besremi during pregnancy is not known.
Slovenian: Učinek zdravila Besremi med nosečnostjo ni znan.
English: Years*
Slovenian: Leta*
English: Complete haematological responsea Complete haematological responsea and improvement in disease burdenb
Slovenian: Popoln hematološki odziva Popoln hematološki odziva in izboljšanje bremena boleznib
English: - if you have psoriasis or other skin problems because they may get worse during treatment with Besremi.
Slovenian: - če imate luskavico ali druge težave s kožo, ker se lahko med zdravljenjem z zdravilom Besremi poslabšajo.
English: Polycythaemia vera is a type of cancer in which the bone marrow produces too many red blood cells, white blood cells and platelets (cells that help the blood to clot).
Slovenian: Prava policitemija je vrsta raka, pri katerem kostni mozeg izdeluje preveč rdečih krvnih celic, belih krvnih celic in trombocitov (celic, ki pomagajo pri strjevanju krvi).
English: Once you have started Besremi treatment, talk to your doctor: - if you develop symptoms of depression (such as feelings of sadness, dejection, and suicidal thoughts).
Slovenian: Po začetku zdravljenja z zdravilom Besremi se posvetujte z zdravnikom: - če se vam pojavijo simptomi depresije (kot so občutek žalosti, potrtost in samomorilne misli);
English: Do not stop using Besremi before you have talked to your doctor.
Slovenian: Ne prenehajte uporabljati zdravila Besremi, ne da bi se prej pogovorili z zdravnikom.
English: Inter-subject variability for ropeginterferon alfa-2b was 35% (Cmax) and 25% (AUC).
Slovenian: Razlike med preskušanci za ropeginterferon alfa-2b so bile 35 % (Cmax) in 25 % (AUC).
English: Phlebotomy as rescue treatment to normalise blood hyperviscosity may be necessary.
Slovenian: Morda bo kot rešilno zdravljenje za normalizacijo hiperviskoznosti krvi potrebna flebotomija.
English: For benzyl alcohol and sodium, see section 2 “Besremi contains benzyl alcohol” and “Besremi contains sodium”.
Slovenian: Za benzialkohol in natrij glejte poglavje 2 »Zdravilo Besremi vsebuje benzilalkohol« in »Zdravilo Besremi vsebuje natrij«.
English: Other medicines and Besremi
Slovenian: Druga zdravila in zdravilo Besremi
English: Do not use the pen later than 30 days.
Slovenian: Po preteku 30 dni peresnika ne uporabljajte več.
English: Note: You may see a small droplet of liquid sitting on your skin after you remove the needle.
Slovenian: Opomba: na koži lahko po odstranitvi igle opazite majhno kapljo tekočine.
English: JAK2V617F allele burden (%)* 41.9±23.49
Slovenian: Breme alela JAK2V617F (%)* 41,9±23,49
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na ml, kar v bistvu pomeni »brez natrija«.
English: • Optional: adhesive plaster
Slovenian: • izbirno: samolepilni obliž.
English: Responder % (n/N)
Slovenian: Odzivni % (n/N)
English: CTCAE intensity grade ≥3 N (%)
Slovenian: Stopnja jakosti po CTCAE ≥ 3 n (%)
English: • Alcohol wipe
Slovenian: • alkoholni zloženec,
English: The dose will be set individually for you by your doctor for your condition.
Slovenian: Zdravnik vam bo odmerek določil individualno glede na vašo bolezen.
English: A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from ropeginterferon alfa-2b therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba ali prenehati z dojenjem ali prenehati oz. vzdržati se zdravljenja z ropeginterferonom alfa-2b, pri čemer je treba upoštevati koristi dojenja za otroka in koristi zdravljenja za mater.
English: Side effects with frequency not known (cannot be estimated from the available data): - detachment of the retina (you may experience eye problems including changes in vision)
Slovenian: Neželeni učinki neznane pogostnosti (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): - odstop mrežnice (pojavijo se vam lahko težave z očmi, vključno s spremembami vida).
English: If you are a woman of childbearing potential, your doctor will discuss with you if effective birth control should be used during your treatment with Besremi.
Slovenian: Če ste ženska v rodni dobi, se bo zdravnik z vami pogovoril glede uporabe učinkovite metode kontracepcije med zdravljenjem z zdravilom Besremi.
English: Interferons are produced by your immune system to block the growth of cancer cells.
Slovenian: Interferone izdeluje vaš imunski sistem za onemogočanje rasti rakavih celic.
English: The dose should be gradually increased by 50 micrograms every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilisation of the haematological parameters is achieved (haematocrit <45%, platelets <400 x 109/L and leukocytes <10 x 109/L).
Slovenian: Odmerek je treba postopno zvečevati po 50 mikrogramov vsaka dva tedna (vzporedno je treba postopno zmanjševati drugo citoreduktivno zdravljenje, če je to primerno), dokler ni dosežena stabilizacija hematoloških parametrov (hematokrit < 45 %, trombociti < 400 x 109/l in levkociti < 10 x 109/l).