natgillin/translations-raw huggingface dataset:
Injektion af opløsningen Vælg injektionsstedet.
Select the injection site.
ydersiden af overarmen (De skal eventuelt have hjælp af en anden person for at bruge dette sted), underlivet (undtagen navlen og taljen).
The best sites for injection are tissues with a layer of fat between skin and muscle: thigh, outer surface of the upper arm (you may need the assistance of another person to use this site), abdomen (except the navel or waistline).
Varier Deres injektionssted hver gang. te
Change your injection site each time. lp
Vent til området er tørt.
Wait for the area to dry. na
Med den ene hånd klemmes en fold af løs hud.
With one hand, pinch a fold of loo se skin.
Med Deres anden hånd tages sprøjten op og holdes, dle
With your other hand, pick up the pen and hold it as you would a pencil.
Stik kanylen ind i den sammenklemte hud med en vinkel på cirka 45°.
Insert the needle into the pinched skin at an angle of approximately 45°. i
Trykknappen presses herefter fuldstændigt i bund (se Diagram P). mi ge Læ
Then press the push button down fully (see Diagram P). dic Me
404 Lad kanylen sidde i nogle få sekunder med trykknappen presset i bund for at Viraferon, injektionsvæske, opløsning kan fordeles under huden, hvorefter den fjernes.
412 Keeping the push button down, leave the injection needle in place for a few seconds to allow the Viraferon, solution for injection, to distribute under the skin, then remove.
til
rod
Diagram Q
lp
tor
dic
is
i
ere
na
au Skru kanyledelen fuldstændig af ved at dreje mod uret som vist i Diagram R.
Me
Sæt igen penhætten på med trekanten over for doseringsviseren som vist i Diagram T.
413 Replace the pen cap with the triangle once again opposite the dosage indicator as shown in Diagram T.
405
414
ViraferonPeg er et lægemiddel, der indeholder det aktive stof peginterferon alfa- 2b.
ViraferonPeg is a medicine containing the active substance peginterferon alfa-2b.
ViraferonPeg anvendes til behandling af voksne patienter med kronisk hepatitis C (langvarig leverbetændelse forårsaget af hepatitis C- virus).
ViraferonPeg is used to treat adult patients with chronic (long-term) hepatitis C (a disease of the liver due to infection with the hepatitis C virus).
ViraferonPeg anvendes hos patienter, hvis lever stadig fungerer, men som har tegn på sygdommen (forhøjede transaminaser (leverenzymer) og infektionsmarkører i blodet, f. eks. viralt RNA eller antistoffer mod viruset).
ViraferonPeg is used in patients whose liver is still functioning but who have signs of the disease (raised transaminases [liver enzymes] and markers of infection in the blood, such as viral RNA or antibodies against the virus).
Den bedste måde at anvende ViraferonPeg på er sammen med ribavirin (et antiviralt lægemiddel).
The best way to use ViraferonPeg is with ribavirin (an antiviral medicine).
Denne kombination er både egnet til ikke tidligere behandlede patienter og til patienter, hvor tidligere behandling med enhver type interferon alfa, med eller uden ribavirin, ikke har virket.
This combination is suitable for treatment-naïve patients (who have not been treated before) and for patients in whom previous treatment including any type of interferon alfa, with or without ribavirin, did not work.
ViraferonPeg kan anvendes alene, hvis patienten ikke tåler ribavirin eller ikke bør have det.
ViraferonPeg can be used alone if the patient does not tolerate or should not take ribavirin.
Behandlingen med ViraferonPeg bør iværksættes og overvåges af en læge med erfaring i behandling af patienter med hepatitis C.
ViraferonPeg treatment should be initiated and supervised by a doctor who has experience in the management of patients with hepatitis C.
ViraferonPeg gives en gang om ugen ved subkutan injektion (indsprøjtning under huden).
ViraferonPeg is given once a week as a subcutaneous injection (under the skin).
Det anvendes alene i en dosis på 0, 5 eller 1 mikrogram pr. kg legemsvægt pr. uge, eller i en dosis på 1, 5 mikrogram/ kg/ uge sammen med ribavirin.
It used on its own at a dose of 0.5 or 1 microgram per kilogram body weight per week, or at a dose of 1.5 micrograms/ kg/ week when used with ribavirin.
Behandlingens varighed afhænger af patientens tilstand og reaktion på behandlingen og er på mellem 24 uger og ét år.
The duration of treatment depends on the patient’ s condition and response to treatment, and ranges from 24 weeks to a year.
ViraferonPeg skal opbevares i køleskab (2° C til 8° C).
ViraferonPeg has to be stored in a refrigerator (2°C - 8°C).
Det aktive stof i ViraferonPeg, peginterferon alfa- 2b, tilhører gruppen af ‘ interferoner ’.
The active substance in ViraferonPeg, peginterferon alfa-2b, belongs to the group ‘ interferons’.
Interferoner er naturlige stoffer, der produceres af kroppen som forsvar mod f. eks. virusinfektioner.
The exact way alpha interferons work in viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the
Det vides ikke nøjagtigt, hvordan alfa- interferoner virker ved virussygdomme, men de menes at virke 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
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(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged immune system, the body’ s defence system, works).
Alfa- interferoner blokerer desuden muligvis formeringen af virus.
Alpha interferons may also block the multiplication of viruses.
Peginterferon alfa- 2b ligner interferon alfa- 2b, der allerede markedsføres i Den Europæiske Union (EU) under navnet IntronA.
Peginterferon alfa-2b is similar to interferon alfa-2b, which is already available in the European Union (EU) as IntronA.
I ViraferonPeg er interferon alfa- 2b blevet "pegyleret" (dvs. overtrukket med det kemiske stof polyethylenglycol).
In ViraferonPeg, the interferon alfa-2b has been ‘ pegylated’ (coated with a chemical called polyethylene glycol).
Interferon alfa- 2b produceres af en bakterie, der har fået indsat et gen (dna), som sætter den i stand til at producere stoffet.
The interferon alfa-2b in ViraferonPeg is produced by a method known as ‘ recombinant DNA technology’: the interferon alfa-2b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
ViraferonPeg blev uden tillægsbehandling anvendt i en undersøgelse med deltagelse af 1 224 ikke tidligere behandlede voksne patienter med kronisk hepatitis C.
The use of ViraferonPeg alone in chronic hepatitis C has been studied in one study in 1,224 treatment- naïve adult patients.
ViraferonPeg, anvendt én gang om ugen i 48 uger (i en dosis på 0, 5, 1 eller 1, 5 mikrogram/ kg), blev i undersøgelsen sammenlignet med interferon alfa- 2b, anvendt i en dosis på 3 millioner internationale enheder (IE) tre gange ugentligt.
ViraferonPeg used once a week for 48 weeks (at 0.5, 1 or 1.5 micrograms/ kg) was compared with interferon alfa-2b used at 3 million international units (IU) three times a week.
Her blev ViraferonPeg anvendt efter to forskellige doseringsskemaer i kombination med ribavirin.
The use of ViraferonPeg with ribavirin has been studied over 48 weeks in 1,580 treatment-naïve patients.
Sammenligningsbehandlingen var en kombination af interferon alfa- 2b og ribavirin.
This study compared two schedules of ViraferonPeg used with ribavirin with the combination of interferon alfa-2b and ribavirin.
I to andre undersøgelser blev ViraferonPeg anvendt i kombination med ribavirin hos 565 patienter, der desuden var smittet med hiv, og i yderligere en undersøgelse blev der set nærmere på anvendelsen af denne kombination hos 1 354 patienter, hvis tidligere behandling med interferon alfa (pegyleret eller ikke- pegyleret) ikke havde virket, eller hvis sygdom var vendt tilbage efter tidligere behandling.
An additional two studies have looked at the use of ViraferonPeg in combination with ribavirin in 565 patients also infected with HIV, and a further study looked at the use of this combination in 1,354 patients whose previous treatment including interferon alfa (pegylated or non-pegylated) did not work or whose disease had come back after previous treatment.
I den første undersøgelse var ViraferonPeg mere effektivt end interferon alfa- 2b.
In the first study, ViraferonPeg was more effective than interferon alfa-2b.
Efter 24 ugers behandling var der flere patienter uden viralt RNA i blodet efter behandling med ViraferonPeg end efter behandling med interferon alfa- 2b:
More patients had no circulating viral RNA after 24 weeks of treatment with ViraferonPeg than with interferon alfa-2b:
Det var således tilfældet hos 46% af dem, der havde fået ViraferonPeg, 1, 5 mikrogram/ kg/ uge, men kun hos 24% af dem, der havde fået interferon alfa- 2b.
46% with ViraferonPeg 1.5 microgram/ kg/ week compared with 24% with the comparator.
Ved undersøgelsens slutning havde kombinationen med ViraferonPeg virket hos 65% af patienterne (mod 54% i kombinationen med interferon alfa- 2b).
Combining ribavirin and ViraferonPeg (as a once-weekly injection of 1.5 micrograms/ kg) was more effective than the combination with interferon alfa-2b (3 million IU three times a week): more patients had responded to treatment at the end of the study (65% compared with 54%).
Kombinationen af ViraferonPeg med ribavirin var også effektiv til behandling af hepatitis C hos patienter, der desuden var smittet med hiv.
The combination of ViraferonPeg with ribavirin was also effective for the treatment of hepatitis C in patients also infected with HIV.
I undersøgelsen af patienter, hvis tidligere behandling ikke havde virket, responderede ca. en femtedel af patienterne på behandlingen med ViraferonPeg og ribavirin.
In the study of patients whose previous treatment did not work, around a fifth of the patients responded to treatment with ViraferonPeg and ribavirin.
De hyppigst forekommende bivirkninger ved ViraferonPeg (der ses hos flere end 1 ud af hver 10 patienter) er virusinfektion, vægttab, depression, irritabilitet, søvnbesvær, angst, nedsat koncentrationsevne, emotionel labilitet (humørsvingninger), hovedpine, mundtørhed, dyspnø (åndenød), pharyngitis (ondt i halsen), hoste, opkastning, kvalme, mavesmerter, diarré, anoreksi (appetitløshed), hårtab, kløe, tør hud, udslæt, myalgi (muskelsmerter), ledsmerter, smerter i muskler og knogler, inflammation på injektionsstedet, reaktioner på injektionsstedet (smerte og rødmen), svimmelhed, træthed, kulderystelser, feber, influenzalignende symptomer og asteni (kraftesløshed).
The most common side effects with ViraferonPeg (seen in more than 1 patient in 10) are viral infection, weight loss, depression, irritability, insomnia (difficulty sleeping), anxiety, impaired concentration, emotional lability (mood swings), headache, dry mouth, dyspnoea (difficulty breathing), pharyngitis (sore throat), coughing, vomiting, nausea (feeling sick), abdominal (tummy) pain, diarrhoea, anorexia (loss of appetite), alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), inflammation at the site of the injection, injection site reaction (pain and redness), dizziness, fatigue (tiredness), rigors (shaking chills), fever, flu-like symptoms and asthenia (weakness).
Den fuldstændige liste over de indberettede bivirkninger ved ViraferonPeg fremgår af indlægssedlen.
For the full list of all side effects reported with ViraferonPeg, see the Package Leaflet.
ViraferonPeg bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for interferon eller andre af indholdsstofferne.
ViraferonPeg should not be used in people who may be hypersensitive (allergic) to any interferon or any of the other ingredients.
ViraferonPeg bør ikke anvendes hos: • patienter med tidligere svær hjertesygdom, • patienter med svære sygdomme, • patienter med autoimmune sygdomme (sygdomme, der medfører allergi over stoffer i egen krop), • patienter med svær leversygdom, • patienter med sygdomme i skjoldbruskkirtlen, medmindre sygdommen er velkontrolleret,
For a list of all restrictions with ViraferonPeg, see the Package Leaflet.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved ViraferonPeg opvejer risiciene ved behandling af voksne patienter, der har kronisk hepatitis C, har forhøjede transaminaser uden leverdekompensation og er serumpositive for RNA fra hepatitis C- virus (HCV) eller for anti- HCV, herunder ikke tidligere behandlede patienter med samtidig klinisk stabil hiv - infektion.
The Committee for Medicinal Products for Human Use (CHMP) decided that ViraferonPeg’ s benefits are greater than its risks for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum hepatitis C virus (HCV) RNA or anti-HCV including naïve patients with clinically stable HIV co-infection.
Udvalget anbefalede udstedelse af markedsføringstilladelse for ViraferonPeg.
The Committee recommended that ViraferonPeg be given marketing authorisation.
Andre oplysninger om ViraferonPeg:
Other information about ViraferonPeg:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ViraferonPeg til SP Europe den 29. maj 2000.
The European Commission granted a marketing authorisation valid throughout the European Union for ViraferonPeg to SP Europe on 29 May 2000.
Markedsføringstilladelsen blev fornyet den 29. maj 2005.
The marketing authorisation was renewed on 29 May 2005.
Den fuldstændige EPAR om ViraferonPeg findes her.
The full EPAR for ViraferonPeg is available here.
Indhold (koncentration)
Content (concentration
Subkutan Pulver: hætteglas
powder: vial (glass); solvent: ampoule (glass)
1 hætteglas + 1
1 vial + 1 ampoule
1 hætteglas + 1 ampul + injektionssæti
1 vial + 1 ampoule + 1 injection set1
1 hætteglas + 1 ampul + injektionssæt1
1 vial + 1 ampoule + 1 injection set1
1/ 5 EU/ 1/ 00/ 132/ 012
EU/ 1/ 00/ 132/ 012
4 hætteglas + 4 ampuller + 4 injektionssæt 1
4 vials + 4 ampoules + 4 injection sets1
2/ 5 EU/ 1/ 00/ 132/ 024
EU/ 1/ 00/ 132/ 024
4 hætteglas + 4 ampuller + injektionssæt1
4 vials + 4 ampoules + 4 injection sets1
12 hætteglas + 12 ampuller + 12 injektionssæt1
12 vials + 12 ampoules + 12 injection sets1
3/ 5 EU/ 1/ 00/ 132/ 035
EU/ 1/ 00/ 132/ 035
4/ 5 EU/ 1/ 00/ 132/ 046
EU/ 1/ 00/ 132/ 046
i Injektionssæt = injektionssprøjte + 2 kanyler + renseserviet.
5/ 6 1 Injection set = injection syringe + 2 injection needles + cleansing swab.
Hvert hætteglas ViraferonPeg, pulver til injektionsvæske, opløsning, indeholder 50 mikrogram peginterferon alfa- 2b målt på proteinbasis.
Each vial of ViraferonPeg, powder for solution for injection contains 50 micrograms of peginterferon alfa- 2b as measured on a protein basis.
ViraferonPeg indeholder 40 mg sucrose per 0, 5 ml.
ViraferonPeg contains 40 mg of sucrose per 0.5 ml.
4. 4).
ViraferonPeg 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, including naïve patients with clinically stable HIV co-infection (see section 4.4).
Den bedste måde at anvende ViraferonPeg ved denne indikation er i kombination med ribavirin.
The best way to use ViraferonPeg in this indication is in combination with ribavirin.
Se venligst også produktresume (SPC) for ribavirin, når ViraferonPeg skal anvendes i kombination med ribavirin.
Please refer also to the ribavirin Summary of Product Characteristics (SPC) when ViraferonPeg is to be used in combination with ribavirin.
Dosis, der skal indgives ViraferonPeg bør indgives som en ugentlig subkutan injektion.
Dose to be administered ViraferonPeg should be administered as a once weekly subcutaneous injection.
2 Kombinationsbehandling ViraferonPeg 1, 5 mikrogram/ kg/ uge i kombination med ribavirin kapsler.
2 Combination therapy ViraferonPeg 1.5 micrograms/ kg/ week in combination with ribavirin capsules.
Den foreskrevne dosis ViraferonPeg 1, 5 μg/ kg til anvendelse i kombination med ribavirin kan indgives ifølge kategorier efter patientens vægt og styrken af pen/ hætteglas, som anført i Tabel 1.
The intended dose of 1.5 μ g/ kg of ViraferonPeg to be used in combination with ribavirin may be delivered in weight categories with the pen/ vial strengths according to Table 1.
En
The negative predictive value for sustained response in HCV/ HIV co-infected patients treated with ViraferonPeg in combination with ribavirin was 99% (67/ 68; Study 1) (see section 5.1).
3 positiv forudsigelig værdi på 50% (52/ 104; Undersøgelse 1) blev observeret for HCV/ HIV co - inficerede patienter, der modtog kombinationsbehandling.
A positive predictive value of 50% (52/ 104; Study 1) was observed for HCV/ HIV co-infected patients receiving combination therapy.
ViraferonPeg monoterapi Ved monoterapi er ViraferonPeg regimen 0, 5 eller 1, 0 mikrogram/ kg/ uge.
ViraferonPeg monotherapy As monotherapy the ViraferonPeg regimen is 0.5 or 1.0 microgram/ kg/ week.
ViraferonPeg monoterapi blev ikke undersøgt i HCV/ HIV co- inficerede patienter.
ViraferonPeg monotherapy was not studied in HCV/ HIV co-infected patients.
Dosisjustering for alle patienter Hvis der udvikles alvorlige bivirkninger eller unormale laboratorieværdier under behandling med ViraferonPeg monoterapi eller ViraferonPeg i kombination med ribavirin, justeres doserne af hvert lægemiddel efter behov, indtil bivirkningerne aftager.
Dose modification for all patients If severe adverse reactions or laboratory abnormalities develop during treatment with ViraferonPeg monotherapy or ViraferonPeg in combination with ribavirin, modify the dosages of each product as appropriate, until the adverse reactions abate.
Reducer kun Reducer kun
Reduce only Reduce only
ribavirin dosis til
ribavirin dose to
ViraferonPeg dosis til
ViraferonPeg
Kombinations -
combination
600 mg/ dag * hvis:
Haemoglobin Haemoglobin in:
halv dosis, hvis:
600 mg/ day* if: < 10 g/ dl
behandling, hvis:
dose
Hæmoglobin Hæmoglobin hos
to one-half dose if: -
< 4
≥ 2
Dosisreduktion af ViraferonPeg kan ske ved enten at reducere det foreskrevne volumen med halvdelen eller ved at bruge en lavere styrke, som anført i Tabel 2b.
Dose reduction of ViraferonPeg may be accomplished by either reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 2b.
Tabel 2b – Reduceret ViraferonPeg dosering ved kombinationsbehandling
Table 2b – Reduced ViraferonPeg Dosing for Combination Therapy
ViraferonPeg monoterapi - vejledninger for dosisreduktion
ViraferonPeg Monotherapy Dose Reduction Guidelines
Vejledninger for dosisjustering hos patienter, som anvender ViraferonPeg monoterapi, fremgår af Tabel 3a.
Dose modification guidelines for patients who use ViraferonPeg monotherapy are shown in Table 3a.
5 Tabel 3a Dosisjusteringsvejledninger for ViraferonPeg monoterapi Laboratorieværdier
Table 3a Dose modification guidelines for ViraferonPeg monotherapy
Afbryd ViraferonPeg, hvis:
Discontinue ViraferonPeg if:
Dosisreduktion hos patienter, som anvender ViraferonPeg 0, 5 μg/ kg som monoterapi, skal ske ved at reducere det foreskrevne volumen med halvdelen.
5 Dose reduction for patients who use 0.5 μ g/ kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Hos patienter, som anvender ViraferonPeg 1, 0 μg/ kg som monoterapi, kan dosisreduktion ske ved at reducere det foreskrevne volumen med halvdelen eller ved at bruge en lavere styrke, som vist i Tabel 3b.
For patients who use 1.0 μ g/ kg ViraferonPeg monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 3b.
Tabel 3b – Reduceret ViraferonPeg dosis for 1, 0 μg/ kg monoterapiregimen
Table 3b – Reduced ViraferonPeg Dose for the 1.0 μ g/ kg Monotherapy Regimen
Hos patienter med moderat nedsat nyrefunktion (creatinin clearance 30- 50 ml/ minut) bør initialdosis af ViraferonPeg reduceres med 25%.
In patients with moderate renal dysfunction (creatinine clearance 30-50 ml/ minute), the starting dose of ViraferonPeg should be reduced by 25%.
Patienter med kraftigt nedsat nyrefunktion (creatinin clearance 15- 29 ml/ minut) bør have initialdosis af ViraferonPeg reduceret med 50%.
Patients with severe renal dysfunction (creatinine clearance 15-29 ml/ minute) should have the starting dose of ViraferonPeg reduced by 50%.
5. 2).
Data are not available for the use of ViraferonPeg in patients with creatinine clearance < 15 ml/ minute (see section 5.2).
Hvis nyrefunktionen nedsættes under behandling, bør ViraferonPeg behandlingen afbrydes.
If renal function decreases during treatment, ViraferonPeg therapy should be discontinued.
Patienter med creatinin clearance < 50 ml/ minut må ikke behandles med ViraferonPeg i kombination med ribavirin (se ribavirin SPC).
Patients with creatinine clearance < 50 ml/ minute must not be treated with ViraferonPeg in combination with ribavirin (see ribavirin SPC).
Sikkerhed og effekt ved ViraferonPeg behandling er ikke blevet vurderet hos patienter med alvorlig leverfunktionsforringelse, derfor må ViraferonPeg ikke anvendes til disse patienter.
The safety and efficacy of ViraferonPeg therapy has not been evaluated in patients with severe hepatic dysfunction, therefore ViraferonPeg must not be used for these patients.
5. 2).
Data from elderly patients treated with a single dose of ViraferonPeg suggest no alteration in ViraferonPeg dose is necessary based on age (see section 5.2).
- Initiering af ViraferonPeg er kontraindiceret i HCV/ HIV patienter med cirrhose og en Child -
- Initiation of ViraferonPeg is contraindicated in HCV/ HIV patients with cirrhosis and a Child-Pugh
Pugh score ≥ 6.
score ≥ 6.
Se også produktresumeet (SPC) for ribavirin hvis ViraferonPeg skal gives i kombination med ribavirin hos patienter med kronisk hepatitis C.
Also see ribavirin Summary of the Product Characteristics (SPC) if ViraferonPeg is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Alvorlig CNS- påvirkning, særlig depression, selvmordstanker og selvmordsforsøg, er set hos nogle patienter under ViraferonPeg behandling, og selv efter behandlingsophør især under 6- måneders opfølgningsperioden.
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during ViraferonPeg therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Hvis psykiatriske symptomer vedvarer eller forværres, eller selvmordstanker identificeres, anbefales det, at behandling med ViraferonPeg afbrydes, og at patienten følges med passende psykiatrisk intervention.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with ViraferonPeg be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Hvis en sådan reaktion udvikles 7 under behandling med ViraferonPeg, seponer behandlingen og indsæt omgående passende medicinsk behandling.
If such a reaction develops during treatment with ViraferonPeg, discontinue treatment and institute appropriate medical therapy immediately.
Som med interferon alfa- 2b kræver patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/ eller tidligere eller nuværende arytmilidelser, der får ViraferonPeg behandling, tæt monitoring.
As with interferon alfa-2b, patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders, receiving ViraferonPeg therapy require close monitoring.