natgillin/translations-raw huggingface dataset:
Ninety-five patients continued to receive ropeginterferon alfa-2b (from 50 to 500 micrograms administered subcutaneously every two, three or four weeks).
Devedeset i pet posto bolesnika nastavilo je primati ropeginterferon alfa-2b (od 50 do 500 mikrograma primijenjeno supkutano svaka 2, 3 ili 4 tjedna).
At doses up to 100 micrograms, the same pen can be used twice.
Pri dozama do 100 mikrograma ista brizgalica može se koristiti dva puta.
Solution for injection in pre-filled pen (injection).
Otopina za injekciju u napunjenoj brizgalici (injekcija).
Female n (%) Male n (%)
Žene n (%) Muškarci n (%)
Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with ropeginterferon alfa-2b.
Narkotike, hipnotike ili sedative treba primjenjivati s oprezom kada se primjenjuju istodobno s ropeginterferonom alfa-2b.
Treatment should be initiated under supervision of a physician experienced in the management of the disease.
4.2 Doziranje i način primjene Liječenje treba započeti pod nadzorom liječnika iskusnog u liječenju bolesti.
At doses up to 250 micrograms, the same pen can be used twice.
Pri dozama do 250 mikrograma ista brizgalica može se koristiti dva puta.
Inter-subject variability was observed with 25% and 35% for AUC and Cmax, respectively, in healthy volunteers.
Kod zdravih dobrovojaca je između ispitanika uočena varijabilnost od 25% i 35% za AUC odnosno za Cmax.
How to use Besremi
Kako primjenjivati Besremi
Besremi 500 micrograms/0.5 mL
Besremi 500 mikrograma/0,5 ml
In a clinical study in polycythaemia vera, the end of the mean individual titration phase for ropeginterferon alfa-2b was reached after approximately 3.7 months, for hydroxycarbamide after approximately 2.6 months of treatment.
U kliničkom ispitivanju policitemije vere, trajanje prosječne faze individualne titracije ropeginterferona alfa-2b iznosilo je približno 3,7 mjeseci, a za hidroksikarbamid približno 2,6 mjeseci liječenja.
19 (10.7) 6.3 n.r.
19 (10,7) 6,3 n.z.
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.
Iz masene ravnoteže, distribucije u tkiva i ispitivanja autoradioluminografije cijelog tijela u ispitivanjima na štakorima dokazano je da se lijek koji sadrži interferon alfa (pegilirani inteferon alfa2a) distribuirao u jetru, bubrege i koštanu srž pored njegove visoke koncentracije u krvi.
Metabolism and nutrition disorders common hypertriglyceridaemia, decreased appetite
Poremećaji metabolizma i prehrane često hipertrigliceridemija, smanjeni apetit
Dental and gum disorders, which may lead to loss of teeth, can occur with interferon medicines.
Poremećaji zubi i desni, koji mogu uzrokovati gubitak zubi, mogu se javiti kod primjene lijekova koji sadrže interferon.
Each pack contains 1 pre-filled pen and 2 injection needles.
Jedno pakiranje sadrži 1 napunjenu brizgalicu i 2 igle za injekcije.
Store the pen in the outer carton in the refrigerator.
Čuvajte brizgalicu u vanjskoj kutiji u hladnjaku.
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.
Besremi 500 mikrograma napunjena brizgalica može se upotrijebiti za ubrizgavanje doza od 50, 100, 150, 200, 250, 300, 350, 400, 450 i 500 mikrograma.
Dental and periodontal disorders, which may lead to loss of teeth, have been reported with other interferon alfa medicinal products (see section 4.8).
Zubni i parodontni poremećaji, koji mogu dovesti do gubitka zubi, prijavljeni su kod drugih lijekova koji sadrže interferon alfa (vidjeti dio 4.8).
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).
Učinci na SŽS, posebice depresija, bili su opaženi u nekih bolesnika liječenih ropeginterferonom alfa2b tijekom programa kliničkog razvoja (vidjeti dio 4.8).
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.
uočen je porast od 25% u AUC-u teofilina (supstrat CYP1A2) pokazujući da je pegilirani interferon alfa-2a inhibitor aktivnosti CYP1A2.
- if you have kidney problems.
- ako imate problema s bubrezima.
Studies in rats with a similar interferon alfa medicinal product (pegylated interferon alfa-2a) showed a primarily elimination via hepatic metabolism.
Ispitivanja na štakorima sa sličnim lijekovima koji sadrže interferon alfa (pegilirani interferon alfa-2a) pokazala su primarnu eliminaciju metabolizmom kroz jetru.
22 (12.4) 10.1 n.r.
22 (12,4) 10,1 n.z.
*No CTCAE grade 4 (life-threating or disabling) or grade 5 (death) adverse reactions have been reported.
n.z. *Nisu zabilježene nuspojave prema CTCAE stupnja 4 (po život opasne) ili stupnja 5 (smrt).
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.
Tijekom terapije ropeginterferonom alfa-2b dogodila su se tri slučaja atrijske fibrilacije (1,1%; stopa incidencije: 0,5 događaja/100 bolesnika na godinu) sa stupnjem intenziteta 1 do 3 u dva bolesnika.
Besremi contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-free'.
Besremi sadrži manje od 1 mmol natrija (23 mg) po ml, tj. zanemarive količine natrija.
Mean % (± SD)
Srednja vrijednost % (±SD)
Basedow's disease, sarcoidosis very rare idiopathic or thrombotic thrombocytopenic purpura#
Basedowljeva bolest, sarkoidoza imunološkog sustava vrlo rijetko idiopatska ili trombotička trombocitopenična purpura#
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.
Srednja vrijednost veličine doze nakon 36 mjeseci terapije (12-mjesečno trajanje terapije u ispitivanju PROUD-PV te 24-mjesečno trajanje terapije u produžetku ispitivanja) iznosila je 363 (±149) mikrograma za ropeginterferon alfa-2b.
Sodium chloride Sodium acetate, anhydrous Acetic acid, glacial Benzyl alcohol Polysorbate 80
Natrijev klorid Natrijev acetat, bezvodni Acetatna kiselina, ledena Benzilni alkohol Polisorbat 80
A reduced starting dose for ropeginterferon alfa-2b of 50 micrograms is recommended for patients with severe (GFR 1529 mL/min) renal impairment.
Reducirana početna doza ropeginterferona alfa-2b od 50 mikrograma preporučuje se u bolesnika s teškim (GFR 15-29 ml/min) oštećenjem bubrega.
Recovered
Oporavak
Besremi contains the active substance ropeginterferon alfa-2b, which belongs to the class of medicinal products called interferons.
Besremi sadrži djelatnu tvar ropeginterferon alfa-2b, koji pripada skupini lijekova koji se zovu interferoni.
Please read this leaflet carefully before using the Besremi 250 micrograms pre-filled pen.
Pažljivo pročitajte ovu uputu prije nego počnete koristiti Besremi 250 mikrograma napunjenu brizgalicu.
Patients who develop symptoms indicative of a thyroid dysfunction during ropeginterferon alfa-2b therapy, should evaluate their thyroid stimulating hormone (TSH) levels.
Bolesnicima koji razviju simptome koji ukazuju na difunkciju štitnjače tijekom terapije ropeginterferonom alfa-2b, treba procijeniti njihove razine hormona koji stimulira štitnjaču (TSH).
(listed in section 6).
(vidjeti dio 4.6).
The involvement of transport proteins in absorption, distribution and elimination of ropeginterferon alfa-2b is not known.
Uključenost transportnih proteina u apsorpciju, distribuciju i eliminaciju ropeginterferona alfa-2b nije poznata.
It is unknown whether the active substance of the medicinal product is excreted in human milk.
Nije poznato izlučuje li se djelatna tvar lijeka u majčino mlijeko.
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.
Ovaj lijek se ne smije upotrijebiti ako primijetite da se brizgalica čini oštećena, otopina zamućena, sadrži čestice ili pahuljice ili joj je boja različita od bezbojne do svijetložute.
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).
Ispitivanja farmakokinetičkih interakcija u ljudi s pegiliranim interferonom alfa-2a ukazala su na umjereni inhbitorni učinak na supstrate koje metaboliziraju CYP1A2 i CYP2D6 (vidjeti dio 4.5).
• Do not use the pen if the solution is cloudy, has particles or flakes, or is any colour other than colourless to slightly yellow.
• Nemojte koristiti brizgalicu ako je otopina zamućena, ima čestice ili pahuljice ili joj je boja različita od bezbojne do svijetložute.
Patient characteristics at screening in the PROUD-PV Study.
Tablica 2. Karakteristike bolesnika pri probiru u ispitivanju PROUD-PV
• Optional: adhesive plaster
• nije obavezno: flaster
250 μg, 300 μg, 350 μg, 400 μg, 450 μg and 500 μg.
50 μg, 100 μg, 150 μg, 200 μg, 250 μg, 300 μg, 350 μg, 400 μg, 450 μg i 500 μg.
• Needle
• iglu
Discontinuation of ropeginterferon alfa-2b should be considered in patients who develop new or worsening eye disorders.
Prekid terapije ropeginterferonom alfa-2b treba uzeti u obzir kod bolesnika u kojih dođe do pojave novog ili pogoršanje postojećeg poremećaja oka.
The pharmacokinetic profile in patients with moderate or severe renal impairment and in patients with end stage renal disease (ESRD) has been evaluated only for other pegylated interferon alfa medicinal products.
Oštećenje bubrega Farmakokinetički profil u bolesnika s umjerenim ili teškim oštećenjem bubrega sa završnim stadijem bolesti bubrega (engl. end stage renal disease, ESRD) procijenjen je samo za druge pegilirane interferone alfa.
Besremi is used as monotherapy for the treatment of polycythaemia vera in adults.
Besremi se koristi kao monoterapija (samo jedan lijek u terapiji) za liječenje policitemije vere u odraslih.
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.
Nakon višekratnog doziranja pegiliranog interferona alfa-2b (1,0 mikrograma/kg supkutano primijenjeno svaki tjedan tijekom 4 tjedna), klirens pegiliranog interferona alfa-2b smanjen je za prosječno 17% te 44% u bolesnika s umjerenim ili teškim oštećenjem jetre u usporedbi s ispitanicima s normalnom bubrežnom funkcijom.
The response to ropeginterferon alfa-2b treatment is presented in Table 3 and Table 4.
Odgovor na liječenje ropeginterferonom alfa-2b prikazan je u tablicama 3 i 4.
Uncommon side effects (may affect up to 1 in 100 people): - attempted suicide, thoughts about killing yourself - loss of vision which may be caused by bleeding in the retina (the retina is the light-sensitive layer in the eye), or by build-up of fat in or under the retina
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): - pokušaj samoubojstva, misli o samoubojstvu - gubitak vida koji može biti uzrokovan krvarenjem u mrežnici (mrežnica je sloj u oku osjetljiv na svjetlost) ili nakupljanjem masnoća u ili ispod mrežnice
Enzymes of the protein catabolism are considered to be involved in the metabolism of ropeginterferon alfa-2b.
Smatra se da su enzimi koji sudjeluju u katabolizmu proteina uključeni u metabolizam ropeginterferona alfa-2b.
Respiratory disorders such as lung infiltration, pneumonitis, pneumonia or pulmonary arterial hypertension have been observed rarely in patients treated with interferon alfa (see section 4.8).
Respiratorni poremećaji poput infiltracije pluća, pneumonitisa, pneumonije ili hipertenzije plućne arterije rijetko su zabilježeni u bolesnika liječenih interferonom alfa (vidjeti dio 4.8).
• Press the push button all the way down until the “0” mark is aligned with the dot in the display window.
• Pritisnite potisni gumb do kraja, dok se oznaka „0“ ne poravna s točkom na prozorčiću za prikaz.
If psychiatric symptoms worsen, it is recommended to discontinue ropeginterferon alfa-2b therapy.
Ako se psihijatrijski simptomi pogoršaju, preporučuje se prekinuti terapiju ropeginterferonom 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.
Naljepnicu na napunjenoj brizgalici treba uvijek provjeriti prije svake primjene injekcije kako bi se izbjegle medikacijske pogreške između Besremi 250 mikrograma/0,5 ml otopine za injekciju i
No recommendation on dose adjustment for ropeginterferon alfa-2b can be given for these patients.
Ne može se dati preporuka za prilagodbu doze ropeginterferona alfa-2b u tih bolesnika.
Severe eye problems may occur during Besremi therapy.
Tijekom terapije lijekom Besremi mogu se pojaviti teški očni problemi.
- if you have liver problems − you will have blood tests regularly to check how your liver is working if you are on a long-term Besremi therapy.
- ako imate problema s jetrom - redovito ćete obavljati krvne pretrage za provjeru rada
Fertility There are no data on the effect of ropeginterferon alfa-2b therapy on the fertility of females or males.
Nema podataka o učinku terapije ropeginterferonom alfa-2b na plodnost žena ili muškaraca.
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.
U 13 bolesnika sa završnim stadijem bolesti bubrega, koji su zahtijevali kroničnu hemodijalizu, primjena 135 mikrograma pegiliranog interferona alfa-2a jedanput na tjedan rezultirala je u 34% nižoj izloženosti lijeku nego u bolesnika s normalnom funkcijom bubrega.
The pharmacokinetic profile of other interferon alfa medicinal products (pegylated interferon alfa-2a and pegylated interferon alfa-2b) was evaluated in renal impaired patients (see section 5.2).
Farmakokinetički profil drugih lijekova koji sadrže interferon alfa (pegilirani interferon alfa-2a te pegilirani interferon alfa-2b) procijenjen je u bolesnika s oštećenjem bubrega (vidjeti dio 5.2).
Cardiac events including cardiomyopathy, myocardial infarction, atrial fibrillation and ischaemic coronary artery disorders have been associated with interferon alfa treatment (see section 4.8).
Srčani događaji, uključujući kardiomiopatiju, infarkt miokarda, fibrilaciju atrija i koronarne ishemijske poremećaje povezani su s liječenjem interferonom alfa (vidjeti dio 4.8).
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).
Primjena interferona alfa nije procijenjena u bolesnika s dekompenziranom cirozom jetre (tj. ChildPugh stadij B ili C) te je kontraindicirana u tih bolesnika (vidjeti dio 4.3).
The Besremi 250 micrograms pre-filled pen can be used to inject doses of 50, 100, 150, 200 and 250 micrograms.
Besremi 250 mikrograma napunjena brizgalica može se upotrijebiti za ubrizgavanje doza od 50, 100, 150, 200, i 250 mikrograma.
Inter-subject variability for ropeginterferon alfa-2b was 35% (Cmax) and 25% (AUC).
Varijabilnost između ispitanika za ropeginterferon alfa-2b iznosila je 35% (Cmax) i
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.
U bolesnika s kompenziranom cirozom (tj. Child-Pugh stadij A), drugi lijek s pegiliranim interferonom alfa (pegilirani interferon alfa-2a) pokazao se sigurnim.
GGT (≥3 times the upper limit of normal) and bilirubin (>2 times the upper limit of normal) levels have been observed in patients treated with ropeginterferon alfa-2b.
Porasti u razinama ALT (≥3 puta veći od gornje granice normale), AST (≥3 puta veći od gornje granice normael), GGT (≥3 puta veći od gornje granice normale) te bilirubin (>2 puta veći od gornje granice normale) uočeni su kod bolesnika liječenih ropeginterferonom alfa-2b.
- The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, anhydrous sodium acetate, glacial acetic acid, and water for injections.
- Drugi sastojci su natrijev klorid, polisorbat 80, benzilni alkohol, bezvodni natrijev acetat, ledena acetatna kiselina i voda za injekcije.
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.
Bolesnici s umjerenim ili teškim oštećenjem bubrega, koji primaju 180 mikrograma pegiliranog interferona alfa-2a jedanput na tjedan, pokazali su usporedivu odnosno za 60% višu izloženost lijeku u plazmi, u usporedbi s ispitanicima s normalnom funkcijom bubrega.
• Do not touch the needle tip at any time.
• Nemojte nikada dodirivati vrh igle.
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 Bolesnici s 36 mjeseci liječenja ropeginterferonom alfa-2b (12-mjesečno trajanje liječenja u ispitivanju PROUD-PV i 24-mjesečnom trajanju liječenja u produžetku ispitivanja).
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 proteina interferon alfa-2b, proizvedenog u stanicama bakterije Escherichia coli tehnologijom rekombinantne DNK, i metoksipolietilenglikola (mPEG).
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.
Bolesnici s oštećenjem bubrega koji su primili jednokratnu dozu od 1,0 mikrograma/kg pegiliranog interferona alfa-2a pokazali su povećanu povezanost između Cmax, AUC te poluvijeka sa stupnjem oštećenja bubrega.
Solution for injection in pre-filled pen 1 pre-filled pen + 2 injection needles 0.5 mL solution
Otopina za injekciju u napunjenoj brizgalici 1 napunjena brizgalica + 2 igle za injekciju 0,5 ml otopine
The strength indicates the quantity of the interferon alpha-2b moiety of ropeginterferon alfa-2b without consideration of the pegylation.
Jačina se odnosi na kvantitativni sadržaj interferon alfa-2b dijela ropeginterferona alfa-2b, dakle bez pegilacije.
including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa medicinal products.
Drugi učinci na SŽS uključujući suicidalnu ideaciju, pokušaj suicida, agresiju, bipolarni poremećaj, maniju i konfuznost uočeni su kod primjene drugih lijekova koji sadrže interferon alfa.
• Remove the outer needle cap from the needle.
• Skinite vanjsku kapicu s igle.
Before ropeginterferon alfa-2b therapy, any pre-existing thyroid disease needs to be treated and controlled with conventional therapy (see section 4.3).
Prije terapije ropeginterferonom alfa-2b, potrebno je svaku postojeću bolest štitnjače liječiti i kontrolirati standardnom terapijom (vidjeti dio 4.3).
- if you develop symptoms of a cold or other respiratory infection (such as difficulty in breathing, cough, fever and chest pain).
- ako razvijete simptome prehlade ili drugih respiratornih infekcija (poput otežanog disanja,
Blood and lymphatic system disorders very common leukopenia, thrombocytopenia common pancytopenia, neutropenia, anaemia
Poremećaji krvi i limfnog sustava vrlo često leukopenija, trombocitopenija često pancitopenija, neutropenija, anemija
- The active substance is ropeginterferon alfa-2b.
- Djelatna tvar je ropeginterferon alfa-2b.
Tell your doctor especially if you are taking any of the following medicines: - theophylline (a medicine used to treat respiratory diseases such as asthma) - methadone (a medicine used to treat pain or opioid dependence) - vortioxetine or risperidone (medicines used to treat mental disorders) - anti-cancer medicines such as those stopping or slowing the growth of blood-forming cells in the bone marrow (e.g. hydroxycarbamide) - medicines that work on the central nervous system to relieve pain, help you sleep, or have a calming effect (e.g. morphine, midazolam)
Recite svom liječniku posebno ako uzimate bilo koje od sljedećih lijekova: - teofilin (lijek koji se koristi za liječenje bolesti dišnog sustava poput astme) - metadon (lijek koji se koristi za liječenje boli ili ovisnosti o opioidima) - vortioksetin ili risperidon (lijekovi koji se koriste za liječenje psihičkih poremećaja)
A combination therapy with telbivudine and ropeginterferon alfa-2b is contraindicated (see section 4.3).
Kombinirana terapija s telbivudinom i ropeginterferonom alfa-2b je kontraindicirana (vidjeti dio 4.3).
Sjogren's syndrome, arthritis, pain in extremity, musculoskeletal pain, bone pain, muscle spasms uncommon muscular weakness, neck pain, groin pain
Sjogrenov sindrom, artritis, bol u ekstremitetima, bol u mišićno-koštanom sustavu, bol u kostima, grčevi u mišićima manje često slabost mišića, bol u vratu, bol u preponama
Following treatment-related adverse reactions were reported with ropeginterferon alfa-2b in clinical studies in 178 polycythaemia vera adult patients.
Tablični popis nuspojava Sljedeće nuspojave povezane s liječenjem prijavljene su s ropeginterferonom alfa-2b u kliničkim ispitivanjima u 178 odraslih bolesnika s policitemijom verom.
Endocrine disorders common hypothyroidism, hyperthyroidism, thyroiditis uncommon diabetes mellitus#
Endokrini poremećaji često hipotiroidizam, hipertiroidizam, tiroiditis manje često dijabetes melitus#
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.
Poremećaji probavnog sustava prijavljeni su kod drugih lijekova koji sadrže interferon alfa te su zabilježeni u 15,2% bolesnika koji se liječe ropeginterferonom alfa-2b.
Common side effects (may affect up to 1 in 10 people): - changes in your heart beat (when the heart beats very fast and uneven)
- promjene u srčanom ritmu (kada srce kuca vrlo brzo i neujednačeno)
The patient recovered completely after paracetamol administration and temporary discontinuation of ropeginterferon alfa-2b therapy.
Bolesnik se u potpunosti oporavio nakon primjene paracetamola te privremenog prekida terapije ropeginterferonom alfa-2b.
Rare side effects (may affect up to 1 in 1,000 people): - bipolar disorders (mood disorders with episodes of sadness and excitement), mania (extreme excitement or unreasonable enthusiasm) - cardiomyopathy (diseases that affect the heart muscle), angina pectoris (a severe chest pain as a result of blockage of the heart vessels) - liver failure
- bipolarni poremećaji (promjene raspoloženja s epizodama tuge i uzbuđenja), manija (pretjerano uzbuđenje ili nerazumni entuzijazam) - kardiomiopatija (bolesti koje zahvaćaju srčani mišić), angina pektoris (teška bol u prsištu kao rezultat začepljenja krvnih žila srca) - zatajenje jetre
The 500 micrograms/0.5 mL pre-filled pen has a blue push button.
Napunjena brizgalica 500 mikrograma/0,5 ml ima plavi potisni gumb.
Ropeginterferon alfa-2b treatment arm1 (n=94)
Skupina koja je primala ropeginterferon alfa-2b1 (n=94)
The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweighted patients.
Farmakokinetički profil ropeginterferona alfa-2b nije utvrđen u pretilih i pothranjenih bolesnika.
If this occurs, ropeginterferon alfa-2b therapy must be discontinued and appropriate medical therapy instituted immediately.
U tom slučaju, terapiju ropeginterferonom alfa-2b treba prekinuti te odmah započeti s odgovarajućim liječenjem.