natgillin/translations-raw huggingface dataset:
Patients with renal impairment receiving a single dose of 1.0 micrograms/kg pegylated interferon alfa-2b showed an increased relation of Cmax, AUC, and half-life to the degree of renal impairment.
Bolniki z okvaro ledvic, ki so prejeli enkraten odmerek 1,0 mikrograma/kg pegiliranega interferona alfa-2b, so imeli Cmax, AUC in razpolovni čas povečan skladno s stopnjo ledvične okvare.
The Besremi 250 micrograms pre-filled pen can be used to inject doses of 50, 100, 150, 200 and 250 micrograms.
Zdravilo Besremi 250 mikrogramov napolnjen injekcijski peresnik lahko uporabite za injiciranje odmerkov po 50, 100, 150, 200 in 250 mikrogramov.
Let the area dry before you inject the medicine.
Preden zdravilo injicirate, počakajte, da se področje posuši.
• Do not use the pen if the solution is cloudy, has particles or flakes, or is any colour other than colourless to slightly yellow.
• Ne uporabite peresnika, če je raztopina motna, so v njej vidni delci ali kosmiči ali če ni brezbarvna ali rahlo rumena.
• If you are using your pen for the first time, prepare the pen for injection by turning the dose knob until you see the symbol of a “drop”.
• Če vaš peresnik uporabljate prvič, peresnik za injiciranje pripravite z vrtenjem odmernega gumba, dokler v okencu ni viden simbol »kaplje«.
The recommended posology for the titration phase of ropeginterferon alfa-2b (see section 4.2) results in a prolonged time to reach the individual optimal dose compared to hydroxycarbamide.
Faza titracije odmerka Priporočeno odmerjanje v fazi titracije ropeginterferona alfa-2b (glejte poglavje 4.2) v primerjavi s hidroksikarbamidom povzroči podaljšanje časa za doseganje individualnega optimalnega odmerka.
Regardless of the starting dose or degree of renal impairment, patients should be monitored.
Bolnike je treba spremljati ne glede na začetni odmerek ali stopnjo ledvične okvare.
Also contains sodium chloride, polysorbate 80, anhydrous sodium acetate, glacial acetic acid, water for injections, and benzyl alcohol.
Vsebuje tudi natrijev klorid, polisorbat 80, brezvodni natrijev acetat, koncentrirano ocetno kislino, vodo za injekcije in benzilalkohol.
• Hold the pen with the needle pointing upwards.
• Peresnik držite tako, da je igla obrnjena navzgor.
*No CTCAE grade 4 (life-threating or disabling) or grade 5 (death) adverse reactions have been reported.
*O neželenih učinkih stopnje 4 (ogrožajo življenje ali povzročijo hudo prizadetost) ali stopnje 5 (smrtni izid) po
- The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, anhydrous sodium acetate, glacial acetic acid, and water for injections.
- Druge sestavine so natrijev klorid, polisorbat 80, benzilalkohol, brezvodni natrijev acetat, koncentrirana ocetna kislina in voda za injekcije.
No recommendation on dose adjustment for ropeginterferon alfa-2b can be given for these patients.
Priporočila glede prilagajanja odmerka ropeginterferona alfa-2b pri teh bolnikih ni mogoče dati.
Ropeginterferon alfa-2b is a covalent conjugate of the protein interferon alpha-2b, produced in Escherichia coli cells by recombinant DNA technology, with a methoxypolyethylene glycol (mPEG) moiety.
Ropeginterferon alfa-2b je kovalentni konjugat beljakovine interferon alfa-2b, pridobljene s tehnologijo rekombinantne DNK v celicah Escherichia coli, z metoksipolietilenglikolskim (mPEG) delom.
Before ropeginterferon alfa-2b therapy, any pre-existing thyroid disease needs to be treated and controlled with conventional therapy (see section 4.3).
Pred zdravljenjem z ropeginterferonom alfa-2b je treba s konvencionalnim zdravljenjem zdraviti in nadzorovati kakršno koli obstoječo bolezen ščitnice (glejte poglavje 4.3).
Following treatment-related adverse reactions were reported with ropeginterferon alfa-2b in clinical studies in 178 polycythaemia vera adult patients.
O naslednjih z zdravljenjem povezanih neželenih učinkih so poročali v kliničnih študijah z ropeginterferonom alfa-2b, ki so jih opravili pri 178 odraslih bolnikih s pravo policitemijo.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
• Press the push button all the way down until the “0” mark is aligned with the dot in the display window.
• Pritisnite potisni gumb popolnoma navzdol, dokler oznaka »0« ni poravnana s piko v okencu.
- if you are allergic to ropeginterferon alfa-2b or any of the other ingredients of this medicine
- če ste alergični na ropeginterferon alfa-2b ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6);
- if you have a liver or kidney disease.
- če ste noseči ali dojite, - če imate bolezen jeter ali ledvic.
Following multiple dosing of pegylated interferon alfa-2b (1.0 micrograms/kg subcutaneously administered every week for four weeks), the clearance of pegylated interferon alfa-2b was reduced by a mean of 17% and 44% in patients with moderate or severe renal impairment, respectively, compared to subjects with normal renal function.
Po večkratnem odmerjanju pegiliranega interferona alfa-2b (1,0 mikrograma/kg subkutano enkrat na teden štiri tedne) se je očistek pegiliranega interferona alfa-2b pri bolnikih z zmerno ledvično okvaro in hudo ledvično okvaro zmanjšal za povprečno 17 % in povprečno 44 % v primerjavi s preskušanci z normalnim delovanjem jeter.
Ropeginterferon alfa-2b clinical studies ADR >10%
Klinične študije ropeginterferona alfa-2b NU > 10 %
• History or presence of autoimmune disease
• prisotnost avtoimune bolezni ali avtoimuna bolezen v anamnezi,
The absolute bioavailability of subcutaneous administered ropeginterferon alfa-2b was not investigated in humans.
Absolutna biološka uporabnost subkutano danega ropeginterferona alfa-2b pri ljudeh ni bila preiskovana.
Endocrine disorders common hypothyroidism, hyperthyroidism, thyroiditis uncommon diabetes mellitus#
Bolezni endokrinega sistema pogosti hipotiroidizem, hipertiroidizem, tiroiditis občasni sladkorna bolezen#
Ropeginterferon alfa-2b is a recombinant interferon alfa-2b conjugated with a two-arm methoxypolyethylene glycol (mPEG) at a degree of substitution of 1 mole of polymer/mole of protein.
Ropeginterferon alfa-2b je rekombinantni interferon alfa-2b, konjugiran na dvoverižni metoksipolietilenglikol (mPEG) s stopnjo substitucije 1 mol polimera na 1 mol beljakovine.
Abbreviations: CTCAE, common terminology criteria for adverse events; n.r., not reported; ADR, adverse drug reaction; PT, preferred term; IR, incidence rate of mean adverse events per 100 patients per year; N: number of patients.
NU, neželeni učinek; PI, priporočeni izraz; SI, povprečna stopnja incidence neželenih učinkov na 100 bolnikov na leto; n: število bolnikov.
Blood and lymphatic system disorders very common leukopenia, thrombocytopenia common pancytopenia, neutropenia, anaemia
Bolezni krvi in limfatičnega sistema zelo pogosti levkopenija, trombocitopenija pogosti pancitopenija, nevtropenija, anemija
Each pack contains 1 pre-filled pen and 2 injection needles.
Eno pakiranje vsebuje 1 napolnjen injekcijski peresnik in 2 injekcijski igli.
The most common adverse reactions are leukopenia (19.1%), thrombocytopenia (18.5%), arthralgia (12.9%), fatigue (12.4%), increased gamma-glutamyltransferase (11.2%), influenza like illness (10.7%), myalgia (10.7%), pyrexia (8.4%), pruritus (8.4%), increased alanine aminotransferase (8.4%), anaemia (7.9%), pain in extremity (6.7%), alopecia (6.7%), neutropenia (6.7%), increased aspartate aminotransferase (6.2%), headache (6.2%), diarrhoea (5.6%), chills (5.1%), dizziness (5.1%) and injection site reaction (5.1%).
(10,7 %), mialgija (10,7 %), pireksija (8,4 %), pruritus (8,4 %), zvečana vrednost alaninaminotransferaze (8,4 %), anemija (7,9 %), bolečina v okončinah (6,7 %), alopecija (6,7 %),
A combination therapy with telbivudine and ropeginterferon alfa-2b is contraindicated (see section 4.3).
Kombinirano zdravljenje s telbivudinom in ropeginterferonom alfa-2b je kontraindicirano (glejte poglavje 4.3).
Pharmacokinetics were not evaluated in patients with increased severity of hepatic impairment.
Pri bolnikih z okvaro jeter hujše jakosti farmakokinetike niso ovrednotili.
• Do not lift or move the pen during injection.
• Peresnika med injiciranjem ne dvigajte ali premikajte.
• Remove the outer needle cap from the needle.
• Odstranite zunanji pokrovček igle z igle.
Nervous system disorders common headache, dizziness, hypoesthesia, somnolence, paraesthesia uncommon polyneuropathy, peripheral motor neuropathy, radiculopathy, migraine, mental impairment, tremor, aura
Bolezni živčevja pogosti glavobol, omotica, hipestezija, somnolenca, parestezija občasni polinevropatija, periferna motorična nevropatija, radikulopatija, migrena, poslabšanje mentalnih sposobnosti, tremor, avra
- The active substance is ropeginterferon alfa-2b.
- Učinkovina je ropeginterferon alfa-2b.
The pre-filled pen label must always be checked before each injection to avoid medication errors between Besremi 250 micrograms/0.5 mL solution for injection and Besremi 500 micrograms/0.5 mL solution for injection.
Pred vsakim injiciranjem je treba preveriti nalepko napolnjenega injekcijskega peresnika, da se izognemo nenamerni zamenjavi zdravil Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje in Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje.
A new, sterile needle as provided with the pre-filled pen must be carefully attached onto the pre-filled pen before each injection.
Pred vsakim injiciranjem je treba na napolnjen injekcijski peresnik skrbno namestiti novo, sterilno iglo, ki je priložena napolnjenem injekcijskem peresniku.
The use of interferon alfa has not been evaluated in patients with decompensated cirrhosis (i.e. ChildPugh B or C) and is contraindicated in these patients (see section 4.3).
Pri bolnikih z dekompenzirano cirozo (npr. Child-Pugh B ali C) uporabe interferona alfa niso ovrednotili, zato je pri teh bolnikih uporaba kontraindicirana (glejte poglavje 4.3).
If this occurs, ropeginterferon alfa-2b therapy must be discontinued and appropriate medical therapy instituted immediately.
Če se pojavi preobčutljivostna reakcija, je treba zdravljenje z ropeginterferonom alfa-2b prekiniti in nemudoma uvesti ustrezno zdravljenje.
Solution for injection in pre-filled pen 1 pre-filled pen + 2 injection needles 0.5 mL solution
raztopina za injiciranje v napolnjenem injekcijskem peresniku 1 napolnjen injekcijski peresnik + 2 injekcijski igli 0,5 ml raztopine
• Severe pre-existing cardiovascular disease, (i.e. uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis,
• obstoječa huda psihiatrična bolezen ali huda psihiatrična bolezen v anamnezi, še zlasti huda depresija, samomorilne misli ali poskus samomora • huda obstoječa srčno-žilna bolezen (npr. nenadzorovana hipertenzija, kongestivno srčno popuščanje (≥ NYHA razred 2), resna srčna aritmija, pomembna stenoza koronarnih arterij,
The mean dose after 36 months of treatment (12-month treatment duration in the PROUD-PV Study and 24month treatment duration in the extension study) was 363 (±149) micrograms for ropeginterferon alfa2b.
PROUD-PV in 24-mesečno trajanje zdravljenja v podaljšani študiji) je znašal 363 (±149) mikrogramov ropeginterferona alfa-2b.
Very rare side effects (may affect up to 1 in 10,000 people): - blindness - breathing problems including shortness of breath, cough and chest pain which may be caused by lung infiltration, pneumonia (lung infection), pulmonary arterial hypertension (high blood pressure in the blood vessels bringing blood from the heart to the lungs) and pulmonary fibrosis (a lung disease where scars are formed in the lung tissue)
- težave z dihanjem, vključno s kratko sapo, kašljem in bolečino v prsnem košu, ki jih lahko povzroči infiltracija pljuč, pljučnica (okužba pljuč), pljučna arterijska hipertenzija (visok krvni tlak v krvnih žilah, ki dovajajo kri iz srca v pljuča) in pljučna fibroza (bolezen pljuč, pri kateri v pljučnem tkivu nastajajo brazgotine).
What Besremi looks like and contents of the pack
Izgled zdravila Besremi in vsebina pakiranja
Hepatobiliary very common gamma-glutamyltransferase increased disorders common liver disorder, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased uncommon hepatotoxicity, hepatitis toxic, hepatomegaly rare hepatic failure#
žolčnika in žolčevodov zelo pogosti zvečana vrednost gama-glutamiltransferaze pogosti bolezen jeter, zvečana vrednost alanin-aminotransferaze, zvečana vrednost aspartat-aminotransferaze, zvečana vrednost alkalne fosfataze v krvi občasni hepatotoksičnost, toksični hepatitis, hepatomegalija redki odpoved jeter#
This leaflet was last revised in .
Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
The European Medicines Agency has waived the obligation to submit the results of studies with Besremi in all subsets of the paediatric population in the treatment of polycythaemia vera (see section 4.2 for information on paediatric use).
Besremi za vse podskupine pediatrične populacije za zdravljenje prave policitemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Musculoskeletal and connective tissue disorders very common arthralgia, myalgia common
Bolezni mišično skeletnega sistema in vezivnega tkiva zelo pogosti artralgija, mialgija pogosti
If psychiatric symptoms worsen, it is recommended to discontinue ropeginterferon alfa-2b therapy.
Če se psihiatrični simptomi poslabšajo, je priporočljivo zdravljenje z ropeginterferonom alfa-2b prekiniti.
• Raise a fold of skin between the thumb and forefinger.
• S palcem in kazalcem napravite kožno gubo.
In addition, dry mouth could damage teeth and the lining of the mouth during long-term treatment with Besremi.
Poleg tega lahko med dolgotrajnim zdravljenjem z zdravilom Besremi zaradi suhih ust pride do poškodb zob in ustne sluznice.
It is not known if Besremi is present in breast milk.
Ni znano, ali se zdravilo Besremi izloča v materino mleko.
• Needle
• iglo,
Patients with this condition who cannot be effectively controlled by medicinal products should not begin ropeginterferon alfa-2b therapy.
Bolniki s sladkorno boleznijo, ki je ni mogoče učinkovito nadzorovati z zdravili, ne smejo začeti zdravljenja z ropeginterferonom alfa-2b.
The use of Besremi is not recommended during pregnancy.
Uporaba zdravila Besremi med nosečnostjo ni priporočljiva.
How to store Besremi 6.
Shranjevanje zdravila Besremi 6.
CNS effects, in particular depression, have been observed in some patients treated with ropeginterferon alfa-2b during the clinical development program (see section 4.8).
Centralni živčni sistem (CŽS) V programu kliničnega razvoja zdravila so pri nekaterih bolnikih, zdravljenih z ropeginterferonom alfa-2b, opazili učinke na CŽS, še zlasti depresijo (glejte poglavje 4.8).
Sjogren's syndrome, arthritis, pain in extremity, musculoskeletal pain, bone pain, muscle spasms uncommon muscular weakness, neck pain, groin pain
Sjögrenov sindrom, artritis, bolečina v okončinah, mišično-skeletna bolečina, bolečina v kosteh, mišični krči občasni mišična šibkost, bolečina v vratu, bolečina v dimljah
CNS effects including suicide attempt, suicidal ideation, aggression, bipolar disorder, mania and confusion have been reported with interferon alfa (see section 4.4).
Pri interferonu alfa so poročali o učinkih na CŽS, vključno s poskusom samomora, samomorilnimi mislimi, agresijo, bipolarno motnjo, manijo in zmedenostjo (glejte poglavje 4.4).
During the clinical study program, one accidental case of overdose has been reported with ropeginterferon alfa-2b.
V programu kliničnih študij so poročali o enemu primeru nenamernega prevelikega odmerjanja z ropeginterferonom alfa-2b.
• Check the solution through the inspection windows along the sides of the cartridge holder.
• Skozi kontrolna okenca, ki potekajo vzdolž držala vložka, preverite raztopino.
It should not be injected into an area of the body where the skin is irritated, reddened, bruised, infected or scarred.
Ne sme se ga injicirati v predele telesa, kjer je koža razdražena, pordela, podpluta, okužena ali brazgotinasta.
Interaction studies of other pegylated interferon alfa medicinal products Co-administration of pegylated interferon alfa-2a with telbivudine in patients with hepatitis B increased the risk of developing peripheral neuropathy.
Pri bolnikih s hepatitisom B je sočasna uporaba pegiliranega interferona alfa-2a s telbivudinom povečala tveganje za nastanek periferne nevropatije.
Reproductive system and breast disorders uncommon erectile dysfunction, haematospermia
Motnje reprodukcije in dojk občasni erektilna disfunkcija, hemospermija
Wilhelminenstrasse 91/IIf
AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/IIf 1160 Dunaj
Besremi contains benzyl alcohol.
Pomožne snovi Zdravilo Besremi vsebuje benzilalkohol.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with ropeginterferon alfa-2b.
Poleg tega imajo lahko suha usta med dolgotrajnim zdravljenjem z ropeginterferonom alfa-2b škodljive učinke na zobe in sluznice v ustni votlini.
Cardiac disorders common atrial fibrillation uncommon myocardial infarction#, atrioventricular block, intracardiac thrombus, aortic valve incompetence, cardiovascular disorder rare cardiomyopathy#, angina pectoris#
Srčne bolezni pogosti atrijska fibrilacija občasni miokardni infarkt#, atrioventrikularni blok, intrakardialni krvni strdek, insuficienca aortne zaklopke, srčno-žilna bolezen redki kardiomiopatija#, angina pektoris#
Psychiatric disorders common depression, aggression#, insomnia, anxiety, mood altered, mood swings, listless uncommon suicide attempt#, suicidal ideation#, confusional state#, acute stress disorder, hallucination, emotional distress, nervousness, apathy, nightmare, irritability rare bipolar disorder#, mania#
Psihiatrične motnje pogosti depresija, agresija#, nespečnost, anksioznost, spremembe razpoloženja, nihanje razpoloženja, ravnodušnost občasni poskus samomora#, samomorilne misli#, zmedenost#, akutna stresna reakcija, halucinacije, čustvena stiska,
Fertility There are no data on the effect of ropeginterferon alfa-2b therapy on the fertility of females or males.
Podatkov o vplivu ropeginterferona alfa-2b na plodnost pri ženskah ali moških ni na voljo.
The patient recovered completely after paracetamol administration and temporary discontinuation of ropeginterferon alfa-2b therapy.
Bolnik je po zdravljenju s paracetamolom in začasni prekinitvi zdravljenja z ropeginterferonom alfa-2b popolnoma okreval.
Shelf life after first use: may be stored for a maximum of 30 days in the refrigerator (2 °C - 8 °C) when stored with the pen cap on and kept in the outer carton in order to protect from light.
EXP Rok uporabnosti po prvi uporabi: shranjuje se lahko v hladilniku (2 °C - 8 °C) največ 30 dni, če je shranjeno z nameščenim pokrovčkom peresnika in v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Reproductive and developmental studies were not performed with ropeginterferon alfa-2b.
Študij vpliva na razmnoževanje in razvoj z ropeginterferonom alfa-2b niso opravili.
White n (%)
Bela n (%)
Patients with pre-existing or a history of cardiovascular disorders should be closely monitored during ropeginterferon alfa-2b therapy.
Bolnike z obstoječimi srčno-žilnimi boleznimi ali anamnezo le-teh je treba med zdravljenjem z ropeginterferonom alfa-2b skrbno spremljati.
Do not drive or use machines if you feel dizzy, sleepy or confused while using Besremi.
Če se med uporabo zdravila Besremi počutite omotično, zaspano ali zmedeno, ne vozite in ne upravljajte strojev.
Complete haematological responsea Complete haematological responsea and improvement in disease burdenb a defined as haematocrit <45% without phlebotomy (at least 3 months since last phlebotomy), platelets <400 x 109/L and leukocytes <10 x 109/L.
Popoln hematološki odziva Popoln hematološki odziva in izboljšanje bremena boleznib a Določeno kot hematokrit < 45 % brez flebotomije (najmanj 3 mesece od zadnje flebotomije), trombociti
JAK2V617F allele burden JAK2V617F changes from baseline
Breme alela JAK2V617F
Thus, other products (e.g. hydroxycarbamide) may be preferred in patients for whom an early reduction in elevated blood counts is necessary to prevent thrombosis and bleeding.
Zato so pri bolnikih, pri katerih je nujno zgodnje zmanjšanje zvišanega števila krvnih celic za preprečevanje tromboze in krvavitev, morda ustreznejša druga zdravila (npr. hidroksikarbamid).
Rare side effects (may affect up to 1 in 1,000 people): - loss of vision which may be caused by damage to the retina (such as obstruction of the blood vessels in the eye) or the optic nerve
- izguba vida, ki jo lahko povzroči poškodba mrežnice (kot je oviranje pretoka v krvnih žilah v očesu) ali vidnega živca.
In 13 patients with ESRD requiring chronic haemodialysis, administration of 135 micrograms pegylated interferon alfa-2a once weekly resulted in a 34% lower drug exposure than in patients with normal renal function.
135 mikrogramov pegiliranega interferona alfa-2a enkrat na teden povzročilo 34 % manjšo izpostavljenost kot pri bolnikih z normalnim delovanjem ledvic.
Patients who develop respiratory symptoms should be monitored closely and if necessary, ropeginterferon alfa-2b therapy should be discontinued.
Bolnike, pri katerih se pojavijo simptomi na dihalih, je treba skrbno spremljati in njihovo zdravljenje z ropeginterferonom alfa-2b prekiniti, če je to potrebno.
112-month treatment duration in the PROUD-PV Study and 12-month treatment duration in the extension study 212-month treatment duration in the PROUD-PV Study and 24-month treatment duration in the extension study
1 12-mesečno trajanje zdravljenja v študiji PROUD-PV in 12-mesečno trajanje zdravljenja v podaljšani študiji.
Diabetes mellitus have been observed with other interferon alfa medicinal products (see section 4.8).
Pri drugih zdravilih z interferonom alfa so opazili sladkorno bolezen (glejte poglavje 4.8).
Over a dose range of 24 to 270 micrograms, ropeginterferon alfa-2b Cmax increased proportionally with dose in a pharmacokinetic study with healthy subjects.
V farmakokinetični študiji zdravih preskušancev se je pri razponu odmerkov od 24 do 270 mikrogramov Cmax ropeginterferona alfa-2b zvečevala sorazmerno z odmerkom.
Co-administration of pegylated interferon alfa-2b showed no significant interaction with tolbutamide (CYP2C9 substrate), midazolam (CYP3A4 substrate), dapsone (N-acetyltransferase substrate) and modestly increased the exposure of caffeine (CYP1A2 substrate) and desipramine (CYP2D6 substrate).
Sočasna uporaba pegiliranega interferona alfa-2b ni pokazala pomembnih medsebojnih delovanj s tolbutamidom (substrat CYP2C9), midazolamom (substrat CYP3A4) in dapsonom (substrat
You should see a droplet of liquid appearing at the needle tip.
Na konici igle se mora pojaviti kaplja tekočine.
• Put the cap back on the pen securely.
• Pokrovček namestite nazaj na peresnik.
Respiratory, thoracic and mediastinal disorders common dyspnoea uncommon pneumonitis, cough, epistaxis, throat irritation very rare lung infiltration#
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti dispneja občasni pnevmonitis, kašelj, epistaksa, draženje žrela zelo redki infiltracija pljuč#
Likewise, caution is recommended with CYP2D6 substrates (e.g. vortioxetine, risperidone) combined with ropeginterferon alfa-2b.
Prav tako je priporočljiva previdnost pri kombinaciji ropeginterferona alfa-2b s substrati CYP2D6 (npr. vortioksetinom, risperidonom).
The elimination of ropeginterferon alfa-2b is not fully characterised.
Izločanje ropeginterferona alfa-2b ni popolnoma opredeljeno.
The dose is titrated individually with a recommended starting dose of 100 micrograms (or 50 micrograms in patients under another cytoreductive therapy).
Odmerek se titrira individualno, priporočeni začetni odmerek je 100 mikrogramov (oziroma
Ropeginterferon alfa-2b treatment arm1 (n=94)
Skupina, zdravljenja z ropeginterferonom alfa-2b1 (n = 94)