natgillin/translations-raw huggingface dataset:
169 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Izsledki številnih raziskav kažejo, da sproži interferon po vezavi na celično membrano zapleteno kaskado znotrajceličnih procesov, med drugim indukcijo nekaterih encimov.
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Menijo, da je ta proces vsaj deloma odgovoren za različne celične odzive na interferon, vključno z zavoro replikacije virusov v celicah 178 okuženih z virusi, supresijo celične proliferacije in različnimi oblikami imunomodulacijskega delovanja, kot je npr. okrepitev fagocitne aktivnosti makrofagov in povečanje specifične citotoksičnosti limfocitov za tarčne celice.
Response rates in these trials were increased with compliance.
179 Pogostnosti odziva v teh raziskavah so se povečevale z boljšim sodelovanje bolnika.
dic
180
171 All Genotype 1, 4
Genotipa 1,
multicentre trials and received Viraferon 3 MIU/ m2 3 times a week plus ribavirin 15 mg/ kg per day for 1 year followed by 6 months follow-up after-treatment.
Otroci in mladostniki, stari od 3 do 16 let in s kompenziranim kroničnim hepatitisom C in merljivimi količinami HCV RNA (kar je ocenil osrednji laboratorij z uporabo raziskovalnega testa RT- PCR), so bili vključeni v dve multicentrični preskušanji in so zdravilo Viraferon prejemali v odmerku 3 mio i. e. / m2 trikrat na teden skupaj z ribavirinom v odmerku 15 mg/ kg na dan v času enega leta, čemur je sledilo 6 - 181 mesečno spremljanje po zdravljenju.
(n = 17)
182 (n = 17)
uth monkeys.
Raziskave mutagenosti interferona alfa- 2b niso pokazale nobenih neželenih dogodkov
ra No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa- 2b on growth, development, sexual maturation, and behaviour ((see section 4.4 and Rebetol SPC if Viraferon
Lie
Disodium phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, Edetate disodium, Sodium chloride, t uc
183 Natrijev dihidrogen fosfat monohidrat Natrijev edetat Natrijev klorid M- krezol Polisorbat 80
2 years i dic
eg 2 leti
2ºC – 8ºC.
ur temperaturi od 2 do 8 ºC.
6.4 Special precautions for storage
sťo 6. 4 Posebna navodila za shranjevanje
Do not freeze.
Shranjujte v hladilniku (2 °C - 8 °C). no Ne zamrzujte.
Viraferon can be put back in the refrigerator at any time during this seven-day period.
Če zdravila ne lat
174 If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
porabite v 7 dneh, ga ne smete dati nazaj v hladilnik za naslednje obobje shranjevanja, ampak ga morate zavreči. up
2.5 ml of solution (corresponding to 25 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
2, 5 ml raztopine (kar ustreza 25 milijonom i. e.) v viali (iz stekla tipa I), z zamaškom (iz halobutilne gume) no
ed Pack sizes of 1, 2 or 12
1 komplet, 2 kompleta ali 12 kompletov. če
s ori 2.5 ml of solution (corresponding to 25 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) with 6 injection syringes, 6 injection needles and 12 cleansing swabs.
2, 5 ml raztopine (kar ustreza 25 milijonom i. e.) v viali (iz stekla tipa I), z zamaškom (iz halobutilne gume) on
ra 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje ks
ge appropriate dosage form and strength.
Lie
Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “ How to self inject Viraferon”). t uc
184 Natančna navodila za subkutano uporabo zdravila so opisana v navodilu za uporabo (nanaša se na "Kako si sami injicirate zdravilo Viraferon").
SP Europe 73, rue de Stalle B-1180 Bruxelles lp
ác SP Europe 73, rue de Stalle
Belgium na
r B- 1180 Bruxelles
8.
eg 8.
EU/ 1/ 99/ 128/ 026 EU/ 1/ 99/ 128/ 027 EU/ 1/ 99/ 128/ 028 Me
ur EU/ 1/ 99/ 128/ 026 EU/ 1/ 99/ 128/ 027 EU/ 1/ 99/ 128/ 028
9.
sťo 9.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRVEGA DOVOLJENJA OZ.
Date of first authorisation:
PODALJŠANJA DOVOLJENJA no Datum pridobitve dovoljenja za promet:
23 May 2005
23. maja 2005 lat
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA up
175 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /. no če on uk ks Lie
176 1.
185 1.
Viraferon 18 million IU solution for injection, multidose pen
Viraferon 18 milijonov i. e., raztopina za injiciranje, večodmerni peresnik
ed One cartridge contains 18 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1.2 ml.
ác En vložek vsebuje 18 milijonov i. e. rekombinantnega interferona alfa- 2b pridobljenega iz E. coli s tehnikami rekombinantne DNA tehnologije v 1, 2 ml.
s One ml contains 15 million IU of interferon alfa-2b.
r ist En ml vsebuje 15 milijonov i. e. interferona alfa- 2b.
ori The pen is designed to deliver its contents of 18 million IU in doses ranging from 1.5 to 6 million IU.
Presnikje oblikovan tako, da njegovo vsebino 18 milijonov i. e., lahko odmerjamo v razponu od 1, 5 do 6
uth For a full list of excipients, see section 6.1.
ur Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
ra 3.
sťo 3.
4.
Raztopina je bistra in brezbarvna. no 4.
CLINICAL PARTICULARS
KLINIČNI PODATKI lat
4.1 Therapeutic indications
4. 1 Terapevtske indikacije up
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and t
Zdravljenje odraslih bolnikov s kroničnim hepatitisom B, ki imajo znake replikacije virusa hepatitisa B (prisotnost HBV- DNA in HBeAg), povečano vrednost alanin- aminotransferaze (ALT) in histološko dokazano aktivno vnetje in/ ali fibrozo jeter. no
Adult patients: rod
Odrasli bolniki: če
Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4). lp
Viraferon je indiciran za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki imajo povečane vrednosti transaminaz brez dekompenzacije jeter in pozitivne izvide za serumsko HCV- RNA ali anti- HCV (glejte poglavje 4. 4). on
The best way to use Viraferon in this indication is in combination with ribavirin. na
Pri tej indikaciji je zdravilo Viraferon najbolje uporabljati v kombinaciji z ribavirinom. uk
Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver i dic
Zdravilo Viraferon je namenjeno uporabi v kombinirani terapiji z ribavirinom za zdravljenje otrok, starih 3 leta ali več, ki imajo predhodno nezdravljen kronični hepatitis C brez jetrne dekompenzacije in pozitiven ks
The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials Me
Pri tem morate pretehtati pričakovano korist Lie
(see sections 4.4, 4.8 and 5.1).
zdravljenja v primerjavi z izsledki o varnosti zdravila pri pediatričnih bolnikih v kliničnih preskušanjih (glejte poglavja 4. 4, 4. 8 in 5. 1).
Multidose presentations must be for individual patient use only.
186 Večodmerna pakiranja so namenjena le za posamezne bolnike.
177 Not all dosage forms and strengths are appropriate for some indications.
Vse farmacevtske oblike in koncentracije niso primerne za vse indikacije.
Please make sure to select an appropriate dosage form and strength.
ie primerno obliko in koncentracijo.
If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
Če
If persistent or recurrent intolerance develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon.
r po ustrezni prilagoditvi odmerka ugotavljate trdovratno ali ponavljajočo intoleranco za zdravilo ali če
ed administered subcutaneously.
ist bolezen napreduje, ukinite terapijo z zdravilom Viraferon.
Chronic Hepatitis B:
eg Kronični hepatitis B:
s subcutaneously three times a week (every other day) for a period of 4 to 6 months.
Priporočeni odmerek je v razponu od 5 do 10 milijonov i. e., injiciran subkutano trikrat na teden (vsak drugi dan) v času 4 do 6 mesecev.
Treatment should be
ur Če se pojavijo hematološke motnje (število levkocitov < 1. 500/ mm3, število granulocitov < 1. 000/ mm3, število trombocitov < 100. 000/ mm3), odmerek zmanjšajte za 50%.
uth discontinued in case of severe leukopaenia (< 1,200/ mm3), severe neutropaenia (< 750/ mm3) or severe thrombocytopaenia (< 70,000/ mm3).
Zdravljenje ukinite v primeru hude levkopenije (< 1. 200/ mm3), hude nevtropenije (< 750/ mm3) ali hude trombocitopenije (< 70. 000/ mm3).
ra For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue Viraferon therapy.
sťo Pri vseh bolnikih velja, da če po 3 do 4 mesecih zdravljenja ne ugotavljate nobenega izboljšanja serumske vrednosti HBV- DNA (ob največjem odmerku, ki ga bolnik še prenaša), morate terapijo z zdravilom Viraferon ukiniti. no Kronični hepatitis C:
ge Chronic Hepatitis C:
kombinirani terapiji z ribavirinom. up
Viraferon is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin. lon Children 3 years of age or older and adolescents:
Interferon alfa – 2b 3 milijoni i. e. / m2 dajemo subkutano trikrat na teden (vsak drugi dan), v kombinaciji s kapsulami ali peroralno raztopino (zjutraj in zvečer).
Interferon alfa-2b 3 MIU/ m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening). no
(Glede odmerjanja kapsul ribavirina in smernic za prilagoditev odmerka pri kombinirani terapiji glejte v no
(See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
povzetek glavnih značilnosti zdravila (SPC) za ribavirin.
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC). t uc
Za bolnike, ki tehtajo < 47 kg ali ne morejo pogoltniti kapsul, glejte SPC za peroralno raztopino. če
Viraferon is given in combination with ribavirin. rod
Viraferon se uporablja v kombinaciji z ribavirinom. on
Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for 6 months.
Na podlagi poročil iz kliničnih raziskav, v katerih so navedeni podatki za 6- mesečno zdravljenje, priporočamo, da te bolnike zdravite 6 mesecev z zdravilom Viraferon v kombinaciji z ribavirinom. uk
Naïve patients: lp
Bolniki, ki še niso bili zdravljeni s tem zdravilom:
Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin. na
Zdravilo Viraferon uporabljajte samostojno predvsem v primeru intolerance ali kontraindikacij za ribavirin. ks
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is i
Na podlagi poročil iz kliničnih raziskav, v katerih so navedeni podatki za 12- mesečno zdravljenje, Lie
recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months. dic
priporočamo, da te bolnike zdravite najmanj 6 mesecev z zdravilom Viraferon v kombinaciji z ribavirinom.
Treatment should be continued for another 6-month period (i. e., a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and Me
Pri bolnikih z negativnim izvidom HCV- RNA po 6 mesecih, virusnim genotipom 1 (kar se določi na vzorcu, odvzetem pred terapijo) ter veliko virusno obremenitvijo pred začetkom zdravljenja le- tega podaljšajte še za 6 mesecev (t. j. skupaj 12 mesecev).
high pre-treatment viral load.
187 Pri odločitvi o podaljšanju terapije na 12 mesecev upoštevajte tudi druge negativne prognostične dejavnike (starost > 40 let, moški spol, premostitvena fibroza).
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.
V kliničnih raziskavah tisti bolniki, ki po 6 mesecih zdravljenja niso pokazali virološkega odziva (HCV -
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- RNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
ie RNA pod spodnjo mejo detekcije), tudi kasneje niso postali virološko odzivni (HCV- RNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
178 Viraferon alone:
ác Viraferon v monoterapiji:
The optimal duration of therapy with Viraferon alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
ist svetujemo, naj zdravljenje traja od 12 do 18 mesecev.
It is recommended that patients be treated with Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Priporočamo, da bolnike zdravite z zdravilom Viraferon v monoterapiji najmanj 3 do 4 mesece, potem pa
ed HCV-RNA.
eg opravite preiskave na HCV- RNA.
The efficacy and safety of Viraferon in combination with ribavirin has been
Pri tistih bolnikih, ki imajo negativen izvid na HCV- RNA, nadaljujte z zdravljenjem.
s studied in children and adolescents who have not been previously treated for chronic hepatitis C.
Varnost in učinkovitost zdravljenja s kombinacijo zdravila Viraferon in ribavirina so ocenjevali pri otrocih in mladostnikih, ki jih predhodno še niso zdravili za hepatitis C.
ori Genotype 1:
sťo Genotip 1:
Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive
Pri bolnikih, ki niso dosegli virološkega odziva do 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
Treatment should be discontinued in these patients.
Pri teh bolnikih je treba zdravljenje prekiniti. no Genotip 2 or 3:
Genotype 2/ 3:
4. 3 Kontraindikacije
ra Virological responses after 1 year of treatment and 6 months of follow-up were 36% for genotype 1 and 81% for genotype 2/ 3/ 4.
- Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov,
- A history of severe pre-existing cardiac disease, e. g., uncontrolled congestive heart failure, recent
no
agents excluding short term corticosteroid withdrawal. uc
kratkotrajne ukinitve kortikosteroidov, on
ideation or suicide attempt. lp
samomorilne misli ali poskus samomora.
Combination therapy with ribavirin:
Glejte tudi SPC za ribavirin, če uporabljate interferon alfa- 2b v Lie
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C. na
kombinaciji z ribavirinom pri bolnikih s kroničnim hepatitisom C.
Psychiatric and central nervous system (CNS):
188 Psihiatrične motnje in centralni živčni sistem (CŽS):
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after Me
Med terapijo z zdravilom Viraferon so pri nekaterih bolnikih opažali hude učinke na CŽS, še posebej depresijo, samomorilne misli in tudi poskus samomora, celo po ukinitvi zdravljenja, predvsem v 6- mesečnem obdobju spremljanja.
Among children and adolescents treated with Viraferon in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6-month follow-up after treatment.
Tako kot pri odraslih
As in adult patients, children and adolescents experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence).
ie bolnikih so tudi pri otroci in mladostniki opazili druge psihiatrične neželene dogodke (npr. depresijo, čustveno labilnost in zaspanost).
Other CNS effects including aggressive behaviour (sometimes directed against others), confusion and alterations of mental status have been observed with alpha interferons.
Opažali so tudi druge učinke interferona alfa na CŽS, vključno z
Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
ác agresivnostjo (ki je včasih usmerjena proti drugim), zmedenostjo in spremembami duševnega statusa.
If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Bolnike skrbno spremljajte, da ugotovite morebitne znake ali simptome psihiatričnih motenj.
If psychiatric
Če se pojavijo
179 symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
r takšni simptomi, mora zdravnik, ki predpiše zdravilo, upoštevati potencialno resnost teh neželenih
Patients with existence of or history of severe psychiatric conditions:
ist učinkov in mora po potrebi uvesti ustrezno terapijo.
The use of interferon alfa-2b in children and adolescents
Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z zdravilom Viraferon in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
ed with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
eg Bolniki s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi:
s medication and institute appropriate medical therapy.
ur motnjami v sedanji ali pretekli anamnezi, ga smete uvesti šele potem, ko ste zagotovili ustrezno individualno diagnostično in terapevtsko obravnavo psihiatrične motnje.
ori treatment.
sťo poglavje 4. 3).
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon
Redko so med terapijo z zdravilom Viraferon opažali akutne preobčutljivostne reakcije na interferon alfa - no 2b (npr. urtikarijo, angioedem, bronhokonstrikcijo, anafilaktične reakcije).
Transient rashes do not necessitate interruption of treatment.
Pri prehodnem izpuščaju ni potrebna prekinitev zdravljenja. lat
Any patient developing liver function abnormalities during treatment
Vse bolnike, pri katerih se med zdravljenjem z up
ge with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
zdravilom Viraferon pojavijo motnje delovanja jeter, morate natančno spremljati in zdravljenje prekiniti, če se znaki in simptomi slabšajo.
Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive lon treatment.
Med terapijo z zdravilom Viraferon ali do dva dni po prenehanju terapije lahko nastopi hipotenzija, zaradi no
Adequate hydration must be maintained in patients undergoing Viraferon therapy since hypotension related to fluid depletion has been seen in some patients.
Pri bolnikih na terapiji z zdravilom Viraferon morate vzdrževati ustrezno hidracijo, saj so pri nekaterih če
Fluid replacement may be necessary. no
V tem primeru je lahko potrebno nadomeščanje tekočine. on
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out. t uc
Četudi je zvišana telesna temperatura lahko povezana z gripoznim sindromom, ki je pogost med zdravljenjem z interferonom, morate najprej izključiti druge vzroke za trdovratno zvišanje telesne uk
Viraferon must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e. g., chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis.
Zdravilo Viraferon morate uporabljati previdno pri bolnikih z izčrpujočimi boleznimi in motnjami, npr. pri tistih s pljučno boleznijo v anamnezi (npr. kronična obstruktivna pljučna bolezen) ali sladkorna bolezen z ks
pulmonary embolism) or severe myelosuppression.
nagnjenostjo h ketoacidozi.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed lp
Lie
If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
Če rentgenogram pokaže pljučne infiltrate ali znake motenosti pljučne funkcije, morate 189 bolnika skrbno nadzorovati in po potrebi ukiniti interferon alfa.
Ocular adverse events (see section 4.8) including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instance after treatment with alpha interferons.
ie V redkih primerih so po zdravljenju z alfa interferoni poročali o očesnih neželenih dogodkih (glejte poglavje 4. 8), npr. krvavitvah v mrežnico, bombažu podobnih lisah in zamašitvi mrežnične arterije ali
Periodic visual examinations during Viraferon therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
ist zdravilom Viraferon priporočamo redne preglede vida, še posebej pri tistih z boleznimi, ki so lahko povezane z retinopatijo, npr. sladkorna bolezen ali hipertenzija.
180 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
eg Pri nekaterih bolnikih so ugotavljali močnejšo otopelost in komo, vključno s primeri encefalopatije, običajno pri starostnikih, zdravljenih z večjimi odmerki.
While these effects are generally reversible, in a few patients full resolution took up to three weeks.
Ti učinki so na splošno reverzibilni, vendar pa so
It is recommended that
sťo Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v pretekli anamnezi in/ ali s predhodnimi ali obstoječimi aritmijami, ki potrebujejo terapijo z zdravilom Viraferon, morate skrbno spremljati.
ed those patients who have pre-existing cardiac abnormalities and/ or are in advanced stages of cancer have electrocardiograms taken prior to and during the course of treatment.
Priporočamo, da pri bolnikih z obstoječimi srčnimi motnjami in/ ali tistih, ki so v napredovalih stadijih maligne bolezni, posnamete EKG pred in po terapiji.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of Viraferon
Srčne aritmije (predvsem no supraventrikularne) se običajno odzovejo na konvencionalno terapijo, vendar je pri njih lahko potrebna ukinitev terapije z zdravilom Viraferon.
There are no data in children or adolescents with a history of cardiac disease.
Ni podatkov otrocih in mladostnikih s srčno boleznijo v anamnezi. lat
Monitoring of lipid levels is, therefore, recommended.
Opisali so hipertrigliceridemijo in poslabšanje hipertrigliceridemije, ki je bilo včasih hudo, zato priporočamo spremljanje lipidov v krvi. up