natgillin/translations-raw huggingface dataset:
Du kan finde yderligere information om VIRACEPT på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
alg EMEA/ H/ C/ 282
EMEA/ H/ C/ 282
s EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR)
d se EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
til VIRAFERON
VIRAFERON
EPAR - sammendrag for offentligheden
ori EPAR summary for the public
ret ise Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR).
uth This document is a summary of the European Public Assessment Report (EPAR).
tor Hvis du ønsker yderligere oplysninger om din sygdomstilstand eller behandling, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
ra If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
au drøftelser (også en del af denne EPAR). re Hvad er Viraferon?
ge of the EPAR).
Viraferon er et lægemiddel, der indeholder det aktive stof interferon alfa- 2b.
What is Viraferon? lon Viraferon is a medicine containing the active substance interferon alfa-2b.
Det leveres som pulver og solvens, der skal blandes til en injektionsvæske eller infusionsvæske, opløsning, som en brugsklar ge
It is available as a powder and solvent to be made up into a solution for injection or infusion, as a ready-to-use solution for injection and as a multidose pen for injection.
Disse indeholder fra 1 til 50 mio.
These contain from 1 to 50 million IU (international units) per millilitre. no
Viraferon anvendes til behandling af: • kronisk (langvarig) hepatitis B (en leversygdom, der skyldes en infektion med hepatitis B- virus) l
Viraferon is used for the treatment of: • chronic (long-term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus) t
Hos voksne ke
in adults; uc
kan Viraferon anvendes alene, men det er bedst at anvende det i kombination med ribavirin (et antiviralt lægemiddel) Hos børn anvendes det sammen med ribavirin. r ik
In children it is used with ribavirin. rod
Behandlingen med Viraferon bør varetages af en læge med erfaring i behandling af den sygdom, te
Treatment with Viraferon should be initiated by a doctor who has experience in the management of lp
lægemidlet anvendes til.
the disease it is being used for.
Det gives almindeligvis som en subkutan injektion (under huden).
Viraferon is given three times per week (every other day) by subcutaneous injection (under the skin).
Yderligere oplysninger fremgår af indlægssedlen.
For more information, see the Package Leaflet. ina
Viraferon skal opbevares i køleskab (2°C - 8°C). mi
Viraferon has to be stored in a refrigerator (2°C-8°C).
Det aktive stof i Viraferon, interferon alfa- 2b, hører til gruppen af ‘ interferoner ’.
The active substance in Viraferon, interferon alfa-2b, belongs to the group ‘ interferons’.
Interferoner er ge
Interferons dic
naturlige stoffer, der produceres af kroppen, og som hjælper med til at bekæmpe angreb mod kroppen såsom infektioner, der skyldes vira.
are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Den nøjagtige måde, hvorpå alfa- interferoner virker mod kræft - og virussygdomme kendes endnu ikke fuldt ud, men man mener, at de virker som immunmodulatorer Læ
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 immune system, the Me
(stoffer der ændrer den måde, hvorpå immunsystemet (kroppens forsvarssystem) fungerer).
Alpha interferons may also block the multiplication of viruses.
Alfa - interferoner kan ligeledes blokere formeringen af vira.
The interferon alfa-2b in Viraferon 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
Erstatningsinterferon alfa- 2b virker på samme måde som naturligt
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
alg produceret interferon alfa.
The replacement interferon alfa-2b acts in same way as naturally produced interferon alpha.
s Da interferon alfa- 2b tidligere er blevet anvendt til behandling af en række sygdomme i EU, har firmaet, der fremstiller Viraferon, fremlagt data fra den videnskabelige litteratur og fra undersøgelser
d Because interferon alfa-2b has been used to treat a number of diseases in the European Union (EU) before, the company that makes Viraferon supplied data from the scientific literature and from studies
til af brugen af interferon alfa- 2b til børn med kronisk hepatitis B.
se of its use in children with chronic hepatitis B.
Virksomheden fremlagde ligeledes resultater fra en række undersøgelser, hvor Viraferon blev anvendt alene eller sammen med ribavirin til behandling af kronisk hepatitis C.
The company also supplied information from a number of studies of Viraferon used alone or with ribavirin for the treatment of chronic hepatitis C.
Disse undersøgelser omfattede i alt 2 552 behandlingsnaive
These included a total of 2,552 treatment-naïve patients (who had not been treated before) and a total of 345
ret patienter (som ikke var blevet behandlet tidligere) og i alt 345 patienter, hvis sygdom var vendt tilbage efter tidligere behandling med interferon.
ori patients whose disease had relapsed (returned) after previous treatment with interferon.
Brugen af Viraferon i kombination med ribavirin er endvidere blevet undersøgt hos 118 behandlingsnaive børn med hepatitis C i alderen 3– 16 år.
The use of Viraferon in combination with ribavirin has also been studied in 118 hepatitis C treatment-naïve children aged between three and 16 years.
ise Virkningen blev hovedsagelig bedømt på responsraten.
The main measure of effectiveness was response rates.
Hvilken fordel viser undersøgelserne, at der er ved Viraferon?
uth What benefit has Viraferon shown during the studies?
tor Undersøgelserne viste, at Viraferon er effektivt til behandling af de sygdomme, til hvilke det er indikeret.
The studies showed that Viraferon is effective in the diseases for which it can be used.
Viraferon har også vist sig at være fordelagtig til børn med kronisk hepatitis B.
Viraferon was also shown to have a benefit in children with chronic hepatitis B.
Viraferon, sammen med eller uden ribavirin, viste sig at være effektiv til behandling af hepatitis C hos både
Viraferon, with or without ribavirin,
au behandlingsnaive voksne og hos voksne, hvis sygdom var vendt tilbage.
ra was shown to be effective in treating hepatitis C in both treatment-naïve and relapsed adults.
Det var ligeledes effektivt til børn, når det blev anvendt sammen med ribavirin, idet 46% af børnene havde reageret positivt på behandlingen ved det 6- måneders kontrolbesøg, der fulgte efter 1 års behandling. re Hvilken risiko er der forbundet med Viraferon?
It was also effective in children when used with ribavirin, with 46% of the children having responded to treatment at the six-month follow up visit following a year’ s treatment.
er leukopeni (lavt antal hvide blodlegemer), appetitløshed, depression, søvnløshed, angst, ophidselse, nervøsitet, svimmelhed, hovedpine, nedsat koncentrationsevne, mundtørhed, sløret syn, kvalme eller opkastning mavesmerter, diarré, betændelse i mundslimhinden (stomatitis), dyspepsi æn
The most common side effects with Viraferon in adults (seen in more than 1 patient in 10) are leucopenia (low white blood cell counts), anorexia (loss of appetite), depression, insomnia (difficulty lon sleeping), anxiety, agitation, nervousness, dizziness, headache, impaired concentration, dry mouth, blurred vision, nausea (feeling sick) or vomiting, abdominal (tummy) pain, diarrhoea, stomatitis (inflammation of the lining of the mouth), dyspepsia (indigestion), alopecia (hair loss), increased sweating, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), inflammation at the site of the injection, fatigue (tiredness), rigors (shaking chills), fever, flu- no
(fordøjelsesbesvær), hårtab, øget svedafsondring, muskelsmerter, ledsmerter, smerter i muskler og knogler, betændelse på indstiksstedet, træthed, kulderystelser, feber, influenzalignende symptomer, slaphed, irritabilitet, brystsmerter, ubehag og vægttab.
like symptoms, asthenia (weakness), irritability, chest pain, malaise (feeling unwell) and weight loss.
Der kunne iagttages tilsvarende bivirkninger hos børn, der fik Viraferon, samt hæmning af vækst.
Similar side effects have been seen in children receiving Viraferon, as well as inhibition of growth.
Den fuldstændige liste over de indberettede l
For the full list of all side effects reported with Viraferon, see the Package Leaflet.
bivirkninger ved Viraferon fremgår af indlægssedlen. ke
Viraferon should not be used in people who may be hypersensitive (allergic) to interferon alfa-2b or t
Viraferon bør ikke anvendes af personer, som kan være overfølsomme (allergiske) over for interferon alfa- 2b eller et af de øvrige indholdsstoffer.
any of the other ingredients.
Viraferon bør ikke anvendes af: • Patienter med alvorlig hjertesygdom, r ik
Viraferon should not be used in: uc
• Patienter med alvorlig nyre - eller leversygdom, herunder en sådan, der er forårsaget af kræft, • Patienter med epilepsi eller andre problemer i centralnervesystemet, • Patienter med skjoldbrusksygdom, medmindre den er under kontrol, • Hepatitis- patienter med levercirrose eller som for nylig er blevet behandlet med lægemidler, der te
• patients with a history of severe heart disease, • patients with severe kidney or liver disease including that caused by cancer, • patients with epilepsy or other central nervous system problems, rod
påvirker immunsystemet, • Patienter med en sygehistorie med visse forstyrrelser i immunsystemet, eller som har gennemgået dle
• patients with thyroid disease unless it is controlled, • hepatitis patients who have liver cirrhosis (scarring) that is causing symptoms or who have recently received medicines that affect the immune system, • patients with a history of certain disorders of the immune system, or who have had an organ lp
organtransplantation, og som tager medicin, der svækker immunsystemet, • Børn og unge med en sygehistorie, der omfatter alvorlig mental sygdom, især svær depression, selvmordstanker eller selvmordsforsøg.
transplant and are taking medicines that suppress the immune system, • children and adolescents with a history of severe mental illness, particularly severe depression, suicidal thoughts or suicide attempts. ina
Da Viraferon kan forbindes med bivirkninger såsom depression, skal patienterne overvåges nøje under behandlingen. ge
Because Viraferon can be associated with side effects such as depression, patients must be closely monitored during treatment. dic
Udvalget for Humanmedicinske Lægemidler (CHMP) var af den opfattelse, at fordelene ved Viraferon Læ
The Committee for Medicinal Products for Human Use (CHMP) decided that Viraferon’ s benefits are greater than its risks for the treatment of chronic hepatitis B and C.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Viraferon.
Me
2/ 3 Andre oplysninger om Viraferon:
Other information about Viraferon:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Viraferon til SP Europe den 9. marts 2000.
The European Commission granted a marketing authorisation valid throughout the EU for Viraferon to SP Europe on 9 March 2000.
Markedsføringstilladelsen blev fornyet den 9.
The marketing authorisation was renewed on 9 March 2005.
s Dette sammendrag blev sidst ajourført i 02- 2008.
2/ 3 This summary was last updated in 02-2008.
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a lg ti ls EU- nummer
ed EU Number
et EU/ 1/ 99/ 128/ 001
EU/ 1/ 99/ 128/ 001
1 million
1 million IU/ ml
pulver: hætteglas (glas);
Powder: vial (glass) Solvent: ampoule (glass)
1, 0 ml (1 million
1.0 ml (1 million
IU/ ml)
IU/ ml)
injektionssæt1
1 vial + 1 ampoule + 1 injection set1
EU/ 1/ 99/ 128/ 002
th EU/ 1/ 99/ 128/ 002
3 millioner
3 million IU/ ml
1, 0 ml (3 millioner
1.0 ml (3 million IU/ ml)
1 hætteglas + 1 ampul +1
1 vial + 1 ampoule + 1 injection set1
o EU/ 1/ 99/ 128/ 003
au EU/ 1/ 99/ 128/ 003
5 millioner
5 million IU/ ml
1, 0 ml (5 millioner
1.0 ml (5 million IU/ ml)
re EU/ 1/ 99/ 128/ 005
g on EU/ 1/ 99/ 128/ 005
5 millioner IU/ ml
5 million IU/ ml
pulver: hætteglas (glas); solvens: ampul (glas)
Powder: vial (glass) Solvent: ampoule (glass)
1, 0 ml (5 millioner IU/ ml)
1.0 ml (5 million IU/ ml)
e ng EU/ 1/ 99/ 128/ 006
l EU/ 1/ 99/ 128/ 006
10 millioner IU/ ml
10 million
Pulver og solvens til injektionsvæske
Powder and solvent for
pulver: hætteglas (glas); solvens: ampul (glas)
Powder: vial (glass)
1, 0 ml (10 millioner IU/ ml)
1.0 ml (10 million IU/ ml)
EU/ 1/ 99/ 128/ 007
EU/ 1/ 99/ 128/ 007
10 millioner
10 million
læ
t
IU/ ml
IU/ ml
injektionsvæske
solution for injection
solvens: ampul (glas)
Solvent: ampoule (glass)
e EU/ 1/ 99/ 128/ 008
uc EU/ 1/ 99/ 128/ 008
10 millioner
10 million IU/ ml
10 hætteglas + 10 ampuller
10 vials + 10 ampoules + 10 injection sets1
i EU/ 1/ 99/ 128/ 009
d EU/ 1/ 99/ 128/ 009
3 millioner
3 million
0, 5 ml (6 millioner
0.5 ml (6 million IU/ ml)
IU/ 0, 5 ml
ro IU/ 0.5ml
1 hætteglas + 1
1 vial + 1 injection set2
le EU/ 1/ 99/ 128/ 011
al IU/ 0.5ml EU/ 1/ 99/ 128/ 011
6 hætteglas + 6
6 vials + 6 injection sets2
EU/ 1/ 99/ 128/ 012
ic EU/ 1/ 99/ 128/ 012
3 millioner
3 million IU/ 0.5ml
12 hætteglas + 12
12 vials + 12 injection sets2
ge EU/ 1/ 99/ 128/ 013
ed EU/ 1/ 99/ 128/ 013
5 millioner IU/ 0, 5 ml
5 million IU/ 0.5ml
0, 5 ml (10 millioner IU/ ml)
0.5 ml (10 million IU/ ml)
ti (Koncentration) EU/ 1/ 99/ 128/ 014
M EU/ 1/ 99/ 128/ 014
5 millioner
5 million IU/ 0.5ml
r EU/ 1/ 99/ 128/ 015
EU/ 1/ 99/ 128/ 015
5 millioner
5 million
millioner IU/ ml)
1/ 3 IU/ 0.5ml
i EU/ 1/ 99/ 128/ 016
ed EU/ 1/ 99/ 128/ 016
IU/ 0, 5 ml
is
ut EU/ 1/ 99/ 128/ 017
EU/ 1/ 99/ 128/ 017
10 millioner IU/ ml
10 million IU/ ml
a EU/ 1/ 99/ 128/ 018
th EU/ 1/ 99/ 128/ 018
ng EU/ 1/ 99/ 128/ 020
er EU/ 1/ 99/ 128/ 020
l æ EU/ 1/ 99/ 128/ 021
EU/ 1/ 99/ 128/ 021
18 millioner IU/ 3 ml
18 million
3, 0 ml (6 millioner IU/ ml)
3.0 ml (6 million IU/ ml)
e kk EU/ 1/ 99/ 128/ 022
l EU/ 1/ 99/ 128/ 022
i er EU/ 1/ 99/ 128/ 023
no IU/ 3ml EU/ 1/ 99/ 128/ 023
2 hætteglas
t IU/ 3ml
t EU/ 1/ 99/ 128/ 024
uc EU/ 1/ 99/ 128/ 024
18 millioner
18 million IU/ 3ml
3, 0 ml (6 millioner
3.0 ml (6 million IU/ ml)
id EU/ 1/ 99/ 128/ 025
d EU/ 1/ 99/ 128/ 025
25 millioner IU/ 2, 5 ml
25 million
2, 5 ml (10 millioner IU/ ml)
2.5 ml (10 million IU/ ml)
m EU/ 1/ 99/ 128/ 026
p EU/ 1/ 99/ 128/ 026
1 hætteglas + 6
1 vial + 6 injection sets4
Styrke
2 vials
Emballage
in IU/ 2.5ml
ti (Koncentration) EU/ 1/ 99/ 128/ 028
ic EU/ 1/ 99/ 128/ 028
25 millioner
25 million IU/ 2.5ml
r EU/ 1/ 99/ 128/ 029
ed EU/ 1/ 99/ 128/ 029
Subkutan anvendelse
Solution for injection in a Subcutaneous use multidose pen
cylinderampul (glas) i
Cartridge (glass) in multidose pen
ri flerdosispen EU/ 1/ 99/ 128/ 030
M EU/ 1/ 99/ 128/ 030
2 penne + 24
2 pens + 24 injection sets3
au flerdosispen EU/ 1/ 99/ 128/ 031
EU/ 1/ 99/ 128/ 031
18 millioner IU
18 million
Subkutan anvendelse
Solution for injection in a Subcutaneous use
1, 2 ml (15 millioner IU/ ml)
1.2 ml (15 million IU/ ml)
re flerdosispen
multidose pen
e EU/ 1/ 99/ 128/ 032
ed EU/ 1/ 99/ 128/ 032
30 millioner
30 million IU
1 pen + 12 injektionssæt3
1 pen +12 injection sets3
ng
or
EU/ 1/ 99/ 128/ 033
EU/ 1/ 99/ 128/ 033
e kk EU/ 1/ 99/ 128/ 034
th EU/ 1/ 99/ 128/ 034
30 millioner IU
30 million IU
cylinderampul (glas) i flerdosispen
Cartridge (glass) in multidose pen
1, 2 ml (25 millioner IU/ ml)
1.2 ml (25 million IU/ ml)
er EU/ 1/ 99/ 128/ 035
u EU/ 1/ 99/ 128/ 035
60 millioner IU
60 million
1, 2 ml (50 millioner IU/ ml)
1.2 ml (50 million IU/ ml)
t flerdosispen
multidose pen
le EU/ 1/ 99/ 128/ 036
er EU/ 1/ 99/ 128/ 036
60 millioner
60 million IU
m EU/ 1/ 99/ 128/ 037
EU/ 1/ 99/ 128/ 037
60 millioner
60 million
Injektionsvæske,
Solution for injection in a Subcutaneous use
Subkutan anvendelse
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8 penne + 96
8 pens + 96 injection sets3
ge
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multidose pen
flerdosispen
multidose pen
Læ 3/ 4 a lg ls 1 injektionssæt = injektionssprøjte + 2 kanyler + renseserviet
l no 1 injection set = injection syringe + 2 injection needles + cleansing swab 2 injection set = injection syringe + injection needle + cleansing swab
ti 2 injektionssæt = injektionssprøjte + kanyle + renseserviet
t uc 3 injection set = injection needle + cleansing swab 4 injection set = injection syringe + injection needle + 2 cleansing swabs
et 3 injektionssæt = kanyle + renseserviet
3/ 3
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s
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til
ori uth ra ge lon ANNEX I
salg
SUMMARY OF PRODUCT CHARACTERISTICS t no uc rod lp nai dic Me
Viraferon 1 million IE/ ml pulver og solvens til injektionsvæske, opløsning
Viraferon 1 million IU/ ml powder and solvent for solution for injection
alg 2.
2.
s Et hætteglas med pulver indeholder 1 Million IE interferon alfa- 2b produceret i E. coli ved rekombinant DNA- teknologi.
ed One vial of powder contains 1 million IU of interferon alfa-2b produced in E. coli by recombinant DNA technology.
til Efter rekonstitution, 1 ml indeholder 1 million IE interferon alfa- 2b.
After reconstitution, 1 ml contains 1 million IU of interferon alfa-2b.
6. 1.
s ori For a full list of excipients, see section 6.1.
t ere 3.
uth 3.
is Pulver og solvens til injektionsvæske, opløsning.
Powder and solvent for solution for injection
tor Hvidt til cremefarvet pulver.
ra White to cream coloured powder.
au 4.
ge 4.
KLINISKE OPLYSNINGER Terapeutiske indikationer
CLINICAL PARTICULARS lon 4.1 Therapeutic indications
Behandling af voksne patienter med kronisk hepatitis B forbundet med tegn på hepatitis B virusreplikation (tilstedeværelse af HBV- DNA og HBeAg), forhøjet alaninaminotransferase ng
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B no
(ALAT) og histologisk påvist aktiv leverinflammation og/ eller fibrose.
viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/ or fibrosis. t
Kronisk hepatitis C: læ
Chronic Hepatitis C: uc
Viraferon er beregnet til behandling af voksne patienter med kronisk hepatitis C, som har forhøjede transaminaser uden leverdekompensation, og som er positive med hensyn til HCV- RNA eller anti- HCV ke
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 rod
Den bedste måde at anvende Viraferon ved denne indikation er i kombination med ribavirin. r ik
The best way to use Viraferon in this indication is in combination with ribavirin. lp
Viraferon er beregnet til anvendelse, i kombination med ribavirin, til behandling af børn og unge i te
Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and na
alderen 3 år eller ældre, som lider af tidligere ubehandlet kronisk hepatitis C uden leverdekompensation, og som er positive med hensyn til serum HCV- RNA.
adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Beslutningen om at behandle bør tages individuelt fra patient til patient, under hensyntagen til tegn på dle
The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and i dic
sygdomsprogression såsom leverinflammation og fibrose, såvel som prognostiske faktorer for respons, HCV genotype og virusmængde.
fibrosis, as well as prognostic factors for response, HCV genotype and viral load.
4. 4, 4. 8 og mi
The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).
5. 1).
Me
4. 2 Dosering og indgivelsesmåde ge
4.2 Posology and method of administration
Læ
Treatment must be initiated by a physician experienced in the management of the disease.
Hvis der opstår bivirkninger under behandling med Viraferon uanset indikation skal dosis justeres eller behandlingen afbrydes midlertidigt, indtil bivirkningerne aftager.
2 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.
Hvis der opstår vedvarende eller 2 tilbagevendende intolerance til trods for tilstrækkelig dosisjustering, eller hvis sygdommen progredierer, skal behandling med Viraferon afbrydes.
If persistent or recurrent intolerance develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon.
alg Kronisk hepatitis B:
Chronic Hepatitis B:
Den anbefalede dosering er fra 5 til 10 millioner IE, givet subkutant tre gange om ugen (hver anden dag) i en periode på 4- 6 måneder.
The recommended dosage is in the range 5 to 10 million IU administered
til skal seponeres i tilfælde af svær leukopeni (< 1. 200/ mm3), svær neutropeni (< 750/ mm3) eller svær thrombocytopeni (< 70. 000/ mm3).
ed subcutaneously three times a week (every other day) for a period of 4 to 6 months.
Passende vaccination (hepatitis A og B) bør overvejes hos patienter, der regelmæssigt/ gentagne gange
The administered dose should be reduced by 50% in case of occurrence of haematological disorders (white
is får humant albumin udvundet fra plasma.
s blood cells < 1,500/ mm3, granulocytes < 1,000/ mm3, thrombocytes < 100,000/ mm3).
På trods af dette kan muligheden for overførsel af infektioner ikke helt udelukkes, når lægemidler fremstillet på basis af humant blod eller plasma anvendes.
ori discontinued in case of severe leukopaenia (< 1,200/ mm3), severe neutropaenia (< 750/ mm3) or severe thrombocytopaenia (< 70,000/ mm3).
Det anbefales kraftigt hver gang Viraferon anvendes til en patient, at navn og batchnummer for præparatet registreres for at bevare en forbindelse mellem patienten og batchen af præparatet. læ
uth 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.
Kronisk hepatitis C:
ra Chronic Hepatitis C:
Viraferon indgives subkutant i en dosis på 3 millioner IE tre gange om ugen (hver anden dag) til voksne patienter, både anvendt som monoterapi og i kombination med ribavirin. ke
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.
Børn i alderen 3 år eller derover og unge:
ge Children 3 years of age or older and adolescents:
(Se produktresume for ribavirin kapsler med henblik på dosis af ribavirin kapsler og retningslinierne for dosisindstilling ved kombinationsbehandling.
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). lon (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
For pædiatriske patienter, der vejer < 47 kg eller ikke te
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC). no
Relaps patienter (voksne): dle
Relapse patients (adults):
Viraferon anvendes i kombination med ribavirin.
Viraferon is given in combination with ribavirin. t uc
behandling, anbefales det, at patienter behandles med Viraferon i kombination med ribavirin i 6 måneder. ge
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. rod
Viraferon bør Læ
The efficacy of Viraferon is enhanced when given in combination with ribavirin.