natgillin/translations-raw huggingface dataset:
An open-label, phase IIIb extension study (CONTINUATION-PV) enrolled 171 adult polycythaemia vera patients who previously completed the PROUD-PV Study to evaluate the long-term efficacy and safety of ropeginterferon alfa-2b.
Odprta podaljšana študija faze IIIb (CONTINUATION-PV) je vključevala 171 odraslih bolnikov s pravo policitemijo, ki so pred tem zaključili študijo PROUD-PV, in je ocenjevala dolgoročno učinkovitost in varnost ropeginterferona alfa-2b.
From mass balance, tissue distribution and whole body autoradioluminography studies performed in rats, it was shown that a similar interferon alfa medicinal product (pegylated interferon alfa-2a) was distributed to the liver, kidney and bone marrow in addition to being highly concentrated in the blood.
Raziskave masnega ravnovesja, porazdelitve v tkiva in raziskave avtoradioluminografije celega telesa pri podganah so pokazale, da se podobno zdravilo z interferonom alfa (pegiliran interferon alfa-2a) porazdeli v jetra, ledvice in kostni mozeg poleg tega, da je visoko koncentriran v krvi.
Ninety-five patients continued to receive ropeginterferon alfa-2b (from 50 to 500 micrograms administered subcutaneously every two, three or four weeks).
Petindevetdeset bolnikov je nadaljevalo s prejemanjem ropeginterferona alfa-2b (od 50 do 500 mikrogramov subkutano, danih vsaka dva, tri ali štiri tedne).
Patients showed a statistically significant difference in the JAK2V617F allele burden (19.7%) and JAK2V617F allele change from baseline (-22.9%).
Bolniki so imeli statistično pomembno razliko v bremenu alela JAK2V617F (19,7 %) in spremembi od izhodišča alela JAK2V617F (−22,9 %).
The selected dose must align with the dot and dose display window.
Izbrani odmerek mora biti poravnan s piko v odmernem okencu.
unstable angina) or recent stroke or myocardial infarction
nestabilna angina pektoris) ali nedavna možganska kap ali miokardni infarkt,
Interferon alfa was shown to have an inhibitory effect on the proliferation of hematopoietic and bone marrow fibroblast progenitor cells and antagonised the action of growth factors and other cytokines that have a role in the development of myelofibrosis.
Pokazali so, da ima interferon alfa zaviralni učinek na proliferacijo fibroblastnih hematopoetskih matičnih celic in fibroblastnih matičnih celic v kostnem mozgu ter preprečuje delovanje rastnih dejavnikov in drugih citokinov, ki imajo vlogo v razvoju mielofibroze.
Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Zdravilo Besremi je indicirano kot monoterapija pri odraslih za zdravljenje prave policitemije brez simptomatske splenomegalije.
not known
neznana
• If you have used your Besremi 500 microgram pre-filled pen once before, continue directly with step 7.
• Če ste vaš napolnjen injekcijski peresnik zdravila Besremi 500 mikrogramov pred tem že enkrat uporabili, nadaljujte neposredno s korakom 7.
Do not use this medicine after the expiry date which is stated on the label and the outer carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Do not use this medicine if you notice that the pre-filled pen appears damaged, the solution is cloudy, has particles or flakes, or has any colour other than colourless to slightly yellow.
Ne uporabljajte tega zdravila, če je peresnik videti poškodovan ali je raztopina motna ali so v njej vidni delci ali kosmiči ali je katere koli druge barve kot brezbarvna ali rahlo rumena.
The most common gastrointestinal disorders reported in these studies were diarrhoea (5.1%; incidence rate: 2.8 [events/100 patients per year]) and nausea (4.5%; incidence rate: 1.6 events/100 patients per year]).
V teh študijah so bile najpogostejše bolezni prebavil diareja (5,1 %; stopnja incidence: 2,8 dogodkov/100 bolnikov na leto) in navzea (4,5 %; stopnja incidence: 1,6 dogodkov/100 bolnikov na leto).
Based on single dose data, clearance was similar in patients with severe renal impairment not on haemodialysis and in patients who received haemodialysis.
Glede na podatke za enkratni odmerek je bil očistek pri bolnikih s hudo ledvično okvaro, ki niso na hemodializi, podoben kot pri tistih na hemodializi.
There are no or limited amount of data from the use of interferon alfa in pregnant women.
Podatkov o uporabi interferona alfa pri nosečih ženskah ni oziroma so omejeni.
In the same study, a 25% increase in the AUC of theophylline (CYP1A2 substrate) was observed, demonstrating that pegylated interferon alfa-2a is an inhibitor of CYP1A2 activity.
V isti študiji so opazili tudi 25-odstotno zvečanje AUC teofilina (substrat CYP1A2), kar dokazuje, da je pegiliran interferon alfa-2a zaviralec aktivnosti CYP1A2.
If TSH levels can be controlled within the normal range, the therapy can be continued.
Z zdravljenjem se lahko nadaljuje, če je mogoče ravni TSH ohranjati v normalnem območju.
Further, it was demonstrated that interferon alfa is able to decrease the mutated JAK2V617F allele burden in patients with polycythaemia vera (a V617F point mutation in the JAK2 kinase is a hallmark of polycythaemia vera and is present in approximately 95% of patients).
Nadalje so dokazali, da je interferon alfa pri bolnikih s pravo policitemijo zmožen zmanjšati breme mutiranega alela JAK2V617F (točkovna mutacija V617F v kinazi JAK2, ki je znak prave policitemije in je prisotna pri približno 95 % bolnikov).
The mean dose after 12 months of treatment was 382 (±141) micrograms for ropeginterferon alfa-2b.
Povprečni odmerek po 12 mesecih zdravljenja je znašal 382 (±141) mikrogramov ropeginterferona alfa-2b.
If you need a dose of more than 250 micrograms, you require two Besremi 250 microgram pre-filled pens.
Če potrebujete odmerek, ki je večji od 250 mikrogramov, boste potrebovali dva napolnjena injekcijska peresnika zdravila Besremi 250 mikrogramov.
The use of ropeginterferon alfa-2b is associated with skin disorders (pruritus, alopecia, rash, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhydrosis).
Uporaba ropeginterferona alfa-2b je povezana z boleznimi kože (pruritus, alopecija, izpuščaj, eritem, psoriaza, kseroderma, akneiformni dermatitis, hiperkeratoza, hiperhidroza).
• Disinfect your skin in the injection area using an alcohol swab before the injection.
• Kožo na mestu injiciranja pred injiciranjem razkužite z alkoholnim zložencem.
Caution must be exercised when administering ropeginterferon alfa-2b in combination with other potentially myelosuppressive/chemotherapeutic agents.
Previdnost je potrebna pri dajanju ropeginterferona alfa-2b v kombinaciji z drugimi morebitno mielosupresivnimi/kemoterapevtskimi učinkovinami.
Besremi is presented as a solution for injection (injection) in a pre-filled pen.
Zdravilo Besremi je raztopina za injiciranje (injekcija) v napolnjenem injekcijskem peresniku.
Talk to your doctor before using Besremi: - if you have thyroid disease.
Pred začetkom uporabe zdravila Besremi se posvetujte z zdravnikom: - če imate bolezen ščitnice;
After subcutaneous multiple dose administration (dose range 50 - 450 micrograms), the terminal halflife of ropeginterferon alfa-2b in patients is approximately 6 to 10 days and the clearance of ropeginterferon alfa-2b is 0.023 to 0.061 L/h.
Po večkratnem subkutanem odmerjanju (razpon odmerkov 50-450 mikrogramov) je končni razpolovni čas ropeginterferona alfa-2b pri bolnikih znašal približno 6 do 10 dni, očistek ropeginterferona alfa-2b pa je znašal od 0,023 do 0,061 l/h.
Women of childbearing potential/Contraception in females Women of childbearing potential have to use effective contraception during the treatment with ropeginterferon alfa-2b, unless otherwise discussed with the physician.
Ženske v rodni dobi/kontracepcija pri ženskah Ženske v rodni dobi morajo med zdravljenjem z ropeginterferonom alfa-2b uporabljati učinkovito metodo kontracepcije, razen če jim je zdravnik svetoval drugače.
Interferon alfa was shown to be abortifacient in primates and ropeginterferon alfa-2b is expected to have a similar effect.
Ugotovili so, da interferon alfa deluje abortivno pri primatih in pričakujejo, da ima ropeginterferon alfa-2b podoben učinek.
**e.g. urticaria, angioedema, bronchoconstriction or anaphylaxis.
**Npr. koprivnica, angioedem, bronhokonstrikcija ali anafilaksija.
• Discard the pen after use as instructed by your doctor or pharmacist.
• Po uporabi peresnik odstranite, kot vam je naročil zdravnik ali farmacevt.
Contents of the pack and other information What Besremi contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Besremi
Ropeginterferon alfa-2b is found mainly in the bloodstream and extracellular fluid as seen by the volume of distribution at steady-state (Vd) of 6.6 to 17 litres in patients after subcutaneous administration (dose range 50 - 450 micrograms).
Porazdelitev Ropeginterferon alfa-2b najdemo predvsem v krvnem obtoku in zunajcelični tekočini, kar je razvidno tudi iz volumna porazdelitve, ki v stanju dinamičnega ravnovesja (Vd) pri bolnikih po subkutanem dajanju znaša 6,6 do 17 litrov (razpon odmerka 50-450 mikrogramov).
The Besremi 500 micrograms pre-filled pen can be used to inject doses of 50, 100, 150, 200, 250, 300, 350, 400, 450 and 500 micrograms.
Zdravilo Besremi 500 mikrogramov napolnjen injekcijski peresnik lahko uporabite za injiciranje odmerkov po 50, 100, 150, 200, 250, 300, 350, 400, 450 in 500 mikrogramov.
Reuse of the pen:
Ponovna uporaba peresnika:
Ropeginterferon alfa-2b must not be administered in patients with existence of or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt (see section 4.3).
Ropeginterferona alfa-2b se ne sme dati bolnikom z obstoječimi hudimi psihiatričnimi boleznimi ali anamnezo takih bolezni, še zlasti hude depresije, samomorilnih misli ali poskusa samomora (glejte poglavje 4.3).
- if you develop symptoms of a cold or other respiratory infection (such as difficulty in breathing, cough, fever and chest pain).
- če se vam pojavijo simptomi prehlada ali druge okužbe dihal (kot so oteženo dihanje, kašelj,
An open label, randomised phase III study (PROUD-PV) evaluated the efficacy and safety of ropeginterferon alfa-2b in comparison to hydroxycarbamide in 254 adult polycythaemia vera patients (randomisation 1:1).
V odprti, randomizirani študiji III. faze (PROUD-PV) so ovrednotili učinkovitost in varnost ropeginterferona alfa-2b v primerjavi s hidroksikarbamidom pri 254 odraslih bolnikih s pravo policitemijo (randomizacija 1:1).
Inter-subject variability was observed with 25% and 35% for AUC and Cmax, respectively, in healthy volunteers.
Pri zdravih prostovoljcih so bile razlike med preskušanci opažene pri 25 % in 35 % za AUC in Cmax.
The absorption of ropeginterferon alfa-2b is sustained in patients with peak serum concentrations reached after 3 to 6 days.
Absorpcija ropeginterferona alfa-2b pri bolnikih je trajna, največje serumske koncentracije pa so dosežene po 3 do 6 dneh.
Find a well-lit area without significant distraction for the injection.
Za injiciranje poiščite dobro osvetljen prostor, kjer ne boste deležni pretiranega odvračanja pozornosti.
Dental and periodontal disorders
Bolezni zobnih in obzobnih tkiv
• If you have used your Besremi 250 microgram pre filled pen once before, continue directly with step 7.
• Če ste vaš napolnjen injekcijski peresnik zdravila Besremi 250 mikrogramov pred tem že enkrat uporabili, nadaljujte neposredno s korakom 7.
Besremi is used as monotherapy for the treatment of polycythaemia vera in adults.
Zdravilo Besremi se uporablja kot monoterapija za zdravljenje prave policitemije pri odraslih.
Severe eye problems may occur during Besremi therapy.
Med zdravljenjem z zdravilom Besremi lahko pride do hudih težav z očmi.
Besremi contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-free'.
Zdravilo Besremi vsebuje manj kot 1 mmol natrija (23 mg) na ml, kar v bistvu pomeni »brez natrija«.
No dose adjustment for ropeginterferon alfa-2b is required for adult patients with mild (GFR 6089 mL/min) or moderate (GFR 30-59 mL/min) renal impairment.
Prilagajanje odmerka ropeginterferona alfa-2b pri odraslih bolnikih z blago (GFR 60-89 ml/min) ali zmerno (GFR 30-59 ml/min) okvaro ledvic ni potrebno.
Studies with a similar interferon alfa medicinal product (pegylated interferon alfa-2a) indicated that the kidney is a major organ for excretion of radiolabelled metabolic products (study in rats) and that the systemic clearance of pegylated interferon alfa-2a in humans is about 100-fold lower compared to the native, unpegylated interferon alfa-2a.
Študije s podobnim zdravilom z interferonom alfa (pegiliran interferon alfa-2a) so pokazale, da so ledvice glavni organ za izločanje radioaktivno označenih presnovkov (študija na podganah) in da je sistemski očistek pegiliranega interferona alfa-2a pri ljudeh približno 100-krat manjši v primerjavi z nespremenjenim, nepegiliranem interferonom alfa-2a.
Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with ropeginterferon alfa-2b.
Narkotike, hipnotike ali sedative je treba pri sočasni uporabi z ropeginterferonom alfa-2b uporabljati previdno.
• If you do not see the droplet after the seventh time, ask your doctor or pharmacist for advice.
• Če po sedmem poskusu kaplje še vedno ni videti, se posvetujte z zdravnikom ali farmacevtom.
19 (10.7) 6.0 n.r.
19 (10,7) 6,0 n.p.
Mean Cmax was 2.4 ng/mL (with a dose of 5080 micrograms) to 49 ng/mL (with a dose of 450 micrograms) and AUC0-t ranged from 28.5 ng.h/mL (with a dose of 50 - 80 micrograms) to 552.6 ng.h/mL (with a dose of 450 micrograms) in patients after subcutaneous multiple dose administration.
Pri bolnikih je po večkratnem subkutanem odmerjanju povprečni Cmax znašal 2,4 ng/ml (pri odmerku 50-80 mikrogramov) do 49 ng/ml (pri odmerku 450 mikrogramov), AUC0-t pa je znašal od 28,5 ng*h/ml (pri odmerku 5080 mikrogramov) do 552,6 ng*h/ml (pri odmerku 450 mikrogramov).
Mean % (± SD)
Povprečje % (±SD)
Patients should be closely monitored, in particular during the titration phase; complete blood counts including determination of haematocrit level, leukocyte and platelet counts should be performed regularly also after the individual optimal dose has been established.
redno je treba opravljati pregled celotne krvne slike, vključno z določanjem ravni hematokrita, številom levkocitov in trombocitov, tudi po tem, ko je bil individualni optimalni odmerek že določen.
Besremi contains benzyl alcohol
Zdravilo Besremi vsebuje benzilalkohol
The instructions for use in the package leaflet should be followed.
Slediti je treba navodilom za dajanje zdravila v navodilu za uporabo.
Then, tap the pen (cartridge holder) gently with your fingers to allow any air bubbles to rise to the top of the cartridge holder.
Nato s prsti narahlo potrkajte po peresniku (držalu vložka), da se morebitni zračni mehurčki dvignejo na vrh držala vložka.
You have to use a different injection site for each of the two pens.
Za vsakega od peresnikov morate uporabiti drugo mesto injiciranja.
1 Patients with 36 months of ropeginterferon alfa-2b treatment (12-month treatment duration in the PROUD-PV Study and 24-month treatment duration in the extension study).
1 Bolniki s 36 meseci zdravljenja z ropeginterferonom alfa-2b (12-mesečno trajanje zdravljenja v študiji PROUD-PV in 24-mesečno trajanje zdravljenja v podaljšani študiji).
Your doctor will tell you where you have to inject it. Possible injection sites are the belly (more than five centimeters away from the belly button) or the thigh.
Možna mesta injiciranja so področje popka (več kot pet centimetrov stran od popka) ali stegno.
If the pre-filled pen is used for the first time, the pen is prepared for injection by turning the dose knob until the symbol of a “drop” in the display window is seen.
Če napolnjen injekcijski peresnik uporabljate prvič, peresnik za injiciranje pripravite z vrtenjem odmernega gumba, dokler v okencu ni viden simbol »kaplje«.
The involvement of transport proteins in absorption, distribution and elimination of ropeginterferon alfa-2b is not known.
Vpletenost prenašalnih beljakovin v absorpcijo, distribucijo in izločanje ropeginterferona alfa-2b ni znana.
It is unknown whether the active substance of the medicinal product is excreted in human milk.
Ni znano, ali se učinkovina v tem zdravilu izloča v materino mleko.
The push button should be pressed in completely and held down for at least 10 seconds before removing the needle.
Potisni gumb je treba pritisniti do konca in pred umikom igle peresnik tiščati ob kožo vsaj 10 sekund.
Metabolism and nutrition disorders common hypertriglyceridaemia, decreased appetite
Presnovne in prehranske motnje pogosti hipertrigliceridemija, zmanjšan apetit
This medicine contains 5 mg benzyl alcohol in each 0.5 mL.
To zdravilo vsebuje 5 mg benzilalkohola na vsakih 0,5 ml. Benzilalkohol lahko povzroči alergijske reakcije.
Gastrointestinal disorders have been reported with other interferon alfa medicinal products and have been reported in 15.2% of patients with ropeginterferon alfa-2b treatment.
Pri drugih zdravilih z interferonom alfa so poročali o boleznih prebavil, prav tako pa so o njih poročali pri 15,2 % bolnikov, ki so se zdravili z ropeginterferonom alfa-2b.
Patients should have eye examinations before and during ropeginterferon alfa-2b therapy, specifically in those patients with retinopathy associated disease such as diabetes mellitus or hypertension.
Bolnikom je treba pred začetkom zdravljenja z ropeginterferonom alfa-2b in med zdravljenjem z njim pregledovati oči, še zlasti bolnikom z boleznimi, ki so povezane z retinopatijo, kot sta sladkorna bolezen ali hipertenzija.
While holding the pre-filled pen with the needle pointing upwards, tap the pre-filled pen gently with the fingers so that any air bubbles rise up towards the needle.
Med tem, ko napolnjen injekcijski peresnik držite tako, da je igla obrnjena navzgor, narahlo potrkajte po njem s prsti, da se zračni mehurčki dvignejo navzgor proti igli.
It is available in packs containing 1 pre-filled pen and 2 injection needles.
Na voljo je v pakiranju z 1 napolnjenim injekcijskim peresnikom in 2 injekcijskima iglama.
At doses up to 100 micrograms, the same pen can be used twice.
Pri odmerkih do 100 mikrogramov lahko peresnik uporabite dvakrat.
Interferon alfa has shown to influence the activity of cytochrome P450 (CYP) isozymes CYP1A2 and CYP2D6.
Pokazali so, da interferon alfa vpliva na aktivnost izoencimov citokroma P450 (CYP) CYP1A2 in CYP2D6.
The pen can be adjusted to administer doses in 50 microgram intervals in the range of 50 to 250 micrograms or 50 to 500 micrograms.
Peresnik lahko nastavite v intervalih po 50 mikrogramov za dajanje odmerkov od 50 do 250 mikrogramov ali od 50 do 500 mikrogramov.
The strength indicates the quantity of the interferon alpha-2b moiety of ropeginterferon alfa-2b without consideration of the pegylation.
Jakost izraža količino dela interferona alfa-2b v ropeginterferonu alfa-2b, brez upoštevanja pegilacije.
During ropeginterferon alfa-2b therapy, three cases of atrial fibrillation (1.1%; incidence rate: 0.5 events/100 patients per year) with intensity grade 1 to 3 occurred in two patients.
Med zdravljenjem z ropeginterferonom alfa-2b je pri dveh bolnikih prišlo do treh primerov atrijske fibrilacije (1,1 %; stopnja incidence: 0,5 dogodka/100 bolnikov na leto) stopnje 1 do 3.
Correct the dose if necessary by turning the dose knob.
odmerek popravite z vrtenjem gumba.
19 (10.7) 6.3 n.r.
19 (10,7) 6,3 n.p.
Female n (%) Male n (%)
Ženski n (%) Moški n (%)
- if you have or had severe mental disorders (such as depression or suicidal thoughts or if you tried to kill yourself).
- če imate bolezen ščitnice, ki ni nadzorovana z zdravili; - če imate ali ste imeli hudo duševno motnjo (kot je depresija ali samomorilne misli ali če ste poskušali napraviti samomor);
IR
SI
- if you have kidney problems.
- težave s spolnostjo,
Disposal of the pen:
Odstranjevanje peresnika:
The attachment of interferon alfa-2b to a high molecular weight (40 kDa) branched polyethylene glycol moiety is considered as the main reason for the differences in the elimination compared to unpegylated interferons.
Menijo, da je vezava interferona alfa-2b na razvejan polietilenglikol z visoko molekulsko maso (40 kDa) glavni razlog za razlike v izločanju v primerjavi z nepegiliranimi interferoni.
- if you take telbivudine (a medicine used to treat hepatitis B infection).
- če jemljete telbivudin (zdravilo, ki se uporablja za zdravljenje okužbe z virusom hepatitisa B); - če imate napredovalo, nenadzorovano bolezen jeter;
Besremi contains the active substance ropeginterferon alfa-2b, which belongs to the class of medicinal products called interferons.
Zdravilo Besremi vsebuje učinkovino ropeginterferon alfa-2b, ki spada v skupino zdravil, imenovanih interferoni.
Patients with moderate or severe renal impairment receiving 180 micrograms of pegylated interferon alfa-2a once weekly showed a comparable or 60% higher drug plasma exposure, respectively, compared to subjects with normal renal function.
Bolniki z zmerno ali hudo okvaro ledvic, ki so prejemali 180 mikrogramov pegiliranega interferona alfa-2a enkrat na teden, so imeli primerljivo ali 60 % večjo izpostavljenost zdravilu v plazmi v primerjavi s preskušanci z normalnim delovanjem ledvic.
Hydroxycarbamide treatment-naïve (n=160) or hydroxycarbamide treated (n=94) patients were randomised to receive ropeginterferon alfa-2b or hydroxycarbamide.
Bolnike, ki predhodno niso prejeli zdravljenja s hidroksikarbamidom (n = 160) ali pa so zdravljenje s hidroksikarbamidom prejeli (n = 94), so randomizirali, da so prejeli ropeginterferon alfa-2b ali hidroksikarbamid.
JAK2V617F allele burden and changes from baseline in the CONTINUATION-PV extension study.
Breme alela JAK2V617F in spremembe od izhodišča v podaljšani študiji
Then press the push button until the display window shows “0”.
Nato pritisnite potisni gumb, dokler v okencu ni vidna »0«.
Most common adverse reactions
Najpogostejši neželeni učinki
Pharmacokinetic interaction studies in humans with pegylated interferon alfa-2a indicated a moderate inhibitory effect on substrates metabolised by CYP1A2 and CYP2D6 (see section 4.5).
Študije farmakokinetičnih medsebojnih delovanj s pegiliranim interferonom alfa-2a pri ljudeh so pokazale zmeren zaviralni učinek na substrate, ki se presnavljajo preko CYP1A2 in CYP2D6 (glejte poglavje 4.5).
The cartridge is sealed in a pen injector.
Vložek je zaprt v injekcijski peresnik.
(N=178) Leukopenia 34 (19.1) 27.2 3 (8.8)* 23 (67.6) 7 (20.6)
34 (19,1) 27,2 3 (8,8)* 23 (67,6) 7 (20,6) n.p. Trombocitopenija 33 (18,5) 15,0 4 (12,1)* 13 (39,4) 3 (9,1)
Dental and gum disorders, which may lead to loss of teeth, can occur with interferon medicines.
Pri zdravilih z interferoni lahko pride do bolezni zob in dlesni, ki lahko vodijo do izgube zob.
In patients with compensated cirrhosis (i.e. Child-Pugh A), another pegylated interferon alfa medicinal product (pegylated interferon alfa-2a) has been shown to be safe.
Pri bolnikih s kompenzirano cirozo (npr. Child-Pugh A) so pokazali, da je varno drugo zdravilo s pegiliranim interferonom alfa (pegiliran interferon alfa-2a).
At doses up to 250 micrograms, the same pen can be used twice.
Pri odmerkih do 250 mikrogramov lahko peresnik uporabite dvakrat.
22 (12.4) 10.1 n.r.
22 (12,4) 10,1 n.p.
Therefore, care should be taken when ropeginterferon alfa-2b is co-administered with CYP1A2 substrates notably those having a narrow therapeutic margin such as theophylline or methadone.
Zato je potrebna previdnost pri sočasni uporabi ropeginterferona alfa-2b s substrati CYP1A2, še zlasti tistimi z ozkim terapevtskim oknom, kot sta teofilin ali metadon.
Inspect the solution before use.
Raztopino je treba pred uporabo pregledati.
CNS
CŽS
The response to ropeginterferon alfa-2b treatment is presented in Table 3 and Table 4.
Odziv na zdravljenje z ropeginterferonom alfa-2b je predstavljen v Preglednici 3 in Preglednici 4.
• Do not put the outer needle cap back on the needle until after you have injected the medicine.
• Zunanjega pokrovčka igle ne nameščajte nazaj na iglo,