natgillin/translations-raw huggingface dataset:
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN mi
MARKETING AUTHORISATION HOLDER lp
SP Europe 73, rue de Stalle B- 1180 Bruxelles ge
SP Europe 73, rue de Stalle na
Belgien Læ
B-1180 Bruxelles Belgium i dic
190 8.
8.
EU/ 1/ 99/ 128/ 029 EU/ 1/ 99/ 128/ 030
EU/ 1/ 99/ 128/ 029 Me
alg EU/ 1/ 99/ 128/ 031
EU/ 1/ 99/ 128/ 030 EU/ 1/ 99/ 128/ 031
s 9.
9.
til Dato for første tilladelse:
Date of first authorisation:
t ere 10.
194 10.
is Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
tor au ere ng læ ke r ik te dle mi ge Læ
lp i na dic Me
191 1.
195 1.
s En cylinderampul indeholder 30 millioner IE rekombinant interferon alfa- 2b, produceret i E. coli ved rekombinant DNA- teknologi i 1, 2 ml.
ed One cartridge contains 30 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1.2 ml.
til En ml indeholder 25 millioner IE interferon alfa- 2b.
s One ml contains 25 million IU of interferon alfa-2b.
t ere Pennen er designet til at afgive sit indhold af 30 millioner IE i doser fra 2, 5 til 10 millioner IE.
ori The pen is designed to deliver its contents of 30 million IU in doses ranging from 2.5 to 10 million IU.
192 Ikke alle formuleringer og styrker er hensigtsmæssige for visse indikationer.
196 Not all dosage forms and strengths are appropriate for some indications.
193 Naive patienter:
Naïve patients: lp
Viraferon alene:
197 Viraferon alone:
194 Kombinationsbehandling med ribavirin:
Combination therapy with ribavirin:
Hvis psykiatriske symptomer vedvarer eller forværres, eller selvmordstanker identificeres, anbefales det, at behandling med Viraferon afbrydes, og patienten
198 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.
Mens dette er rapporteret oftere hos 195 patienter med kronisk hepatitis C behandlet med interferon- alfa, er det også rapporteret hos patienter med onkologiske sygdomme behandlet med interferon- alfa.
hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
t ere Mere signifikant omtågethed samt coma, inklusive tilfælde af encefalopati, er set hos nogle patienter, sædvanligvis hos ældre patienter behandlet med højere doser.
199 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
196 Monoterapi:
Monotherapy:
t ere thyreoideadysfunktion opstået under behandlingen (se også børn og unge, thyreoidea monitorering).
200 Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
197 Under behandling af hepatitis B eller C, anbefales det at udføre disse kontroller ved uge 1, 2, 4, 8, 12 og 16 samt hver anden måned derefter under hele behandlingen.
During treatment for hepatitis B or C the recommended testing schedule is at weeks 1, 2, 4, 8, 12, 16, and every other month, thereafter, throughout treatment.
t ere Narkotika, hypnotika og sedativa skal indgives med forsigtighed samtidig med Viraferon.
201 Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with Viraferon.
198 4. 8 Bivirkninger
4.8 Undesirable effects Me
til I kliniske undersøgelser udført hos patienter med hepatitis C, blev forsøgspersonerne behandlet med Viraferon alene eller i kombination med ribavirin i et år.
202 In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
au Tabel 1.
s ori Table 1.
Bivirkninger rapporteret ved kliniske undersøgelser eller efter markedsføring af Viraferon alene eller i kombination med ribavirin Systemorganklasser Infektioner og parasitære sygdomme
Adverse reactions reported during clinical trials or following the marketing use of Viraferon alone or in combination with ribavirin System Organ Class
Meget almindelig:
uth Infections and infestations Very common:
Pharyngitis *, viral infektion * Bronkitis, sinuitis, herpes simplex (resistent), rhinitis Lungebetændelse§
Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis
Meget almindelig:
Pneumonia§
læ
Very common:
Thrombocytopeni, lymphadenopati, lymphopeni Aplastisk anæmi Pure red cell aplasi, idiopatisk thrombocytopenisk purpura, thrombotisk thrombocytopenisk purpura
Thrombocytopaenia, lymphadenopathy, lymphopenia Aplastic anaemia Pure red cell aplasia, idiopathic thrombocytopenic purpura, lon thrombotic thrombocytopenic purpura
Immunsystemet§ Meget sjælden:
Not known:
Sarcoidose, forværring af sarcoidose Systemisk lupus erythematose, vaskulitis, reumatoid arthritis
arthritis (new or aggravated), Vogt-Koyanagi-Harada syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis§
Ikke kendt:
Endocrine disorders uc
Det endokrine system Almindelig:
Common:
Meget almindelig:
§ Psychiatric disorders Very common:
Almindelig:
Rarely:
Læ
i
Forvirring, søvnforstyrrelser, nedsat libido
Confusion, sleep disorder, libido decreased Suicide ideation
Selvmordstanker Selvmord, selvmordsforsøg, aggressiv adfærd (nogle gange rettet mod andre), psykose inklusive hallucinationer
Suicide, suicide attempts, aggressive behaviour (sometimes
Ikke kendt:
directed against others), psychosis including hallucinations Not known:
Nervesystemet§
Nervous system disorders Me
s Øjne Meget almindelig:
203 Very common:
til Almindelig:
Common:
Konjunktivitis, unormalt syn, forstyrrelse af tårekanalen, øjensmerte
Vision blurred Conjunctivitis, vision abnormal, lacrimal gland disorder, eye pain
Retinal blødning§, retinopatier (inklusive makulært ødem),
Retinal haemorrhages§, retinopathies (including macular oedema), retinal artery or vein obstruction§, optic neuritis, papilloedema, loss of visual acuity or visual field, cotton- wool spots§
is Almindelig:
ed Ear and labyrinth Common:
tor Hjerte Almindelig:
ori Common:
Palpitation, tachycardi Cardiomyopati
Palpitation, tachycardia Cardiomyopathy Myocardial infarction, cardiac ischaemia
Myocardieinfarkt, hjerteiskæmi Arytmi ere
Arrhythmia
Meget sjælden:
ra Very rarely:
Hypertension Perifer iskæmi, hypotension§
Peripheral ischaemia, hypotension§
Meget almindelig:
ge Very common:
Epistaxis, respiratorisk forstyrrelse, forstoppet næse, rhinorrhea, hoste uden slim Lungeinfiltrationer§, lungebetændelse§
Dyspnoea*, coughing* Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive lon
Mave- tarmkanalen Meget almindelig:
Gastrointestinal disorders
Kvalme/ opkastning, mavesmerte, diarré, stomatitis, dyspepsi Ulcerativ stomatitis, smerte i øvre højre kvadrant, glossitis,
Stomatitis ulcerative, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools
Hepatotoksicitet, (inklusive dødsfald)
Hepatomegaly Hepatotoxicity, (including fatality)
Meget almindelig: dle
Very common: lp
Alopeci, pruritus *, tør hud *, udslæt *, øget svedtendens
Alopecia, pruritus*, skin dry*, rash*, sweating increased
Psoriasis (ny eller forværret) §, maculopapulært udslæt, erytematøst udslæt, eksem, erytem, hudlidelser
Psoriasis (new or aggravated)§, rash maculopapular, rash erythematous, eczema, erythema, skin disorder
Meget sjælden: mi
Very rarely:
erytem multiforme Knogler, led, muskler og bindevæv Myalgi, arthralgi, smerter i bevægeapparatet ge
erythema multiforme Musculoskeletal and connective tissue i
Arthritis Rhabdomyolyse, myositis, benkramper, rygsmerte
Myalgia, arthralgia, musculoskeletal pain Arthritis Rhabdomyolysis, myositis, leg cramps, back pain
Amenorré, brystsmerte, dysmenore, menoragi,
General disorders and administration
200 menstruationsforstyrrelser, vaginale lidelser
Amenorrhea, breast pain, dysmenorrhea, menorrhagia, menstrual disorder, vaginal disorder
Meget almindelig:
204 site conditions Very common:
til Meget almindelig:
ed Very common:
4. 4
*These events were only common with Viraferon alone § See section 4.4
t ere Disse bivirkninger er også rapporteret med Viraferon alene.
s ori These undesirable effects have also been reported with Viraferon alone.
Kardiovaskulære (CV) bivirkninger, specielt arytmi, syntes for det meste at være indbyrdes forbundet med
Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-
is tidligere CV sygdom og tidligere behandling med kardiotoksiske stoffer (se pkt.
uth existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Kardiomyopati, som kan være reversibel efter seponering af interferon alfa, er blevet rapporteret sjældent hos patienter uden
Cardiomyopathy, that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4).
4. 4).
ra A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated),
Mange forskellige autoimmune og immunmedierede sygdomme er blevet rapporteret med alfa -
ge idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies (see also section 4.4).
Forøgelse i serum ng
Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
ALAT/ ASAT (SGPT/ SGOT) - koncentrationer er blevet observeret som en abnormitet hos nogle non - hepatitis personer samt hos nogle patienter med kronisk hepatitis B samtidig med udskillelse af viral læ
Increase in serum ALT/ AST (SGPT/ SGOT) levels have been noted as an abnormality in some non-hepatitis no
4. 4. ke
subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp.
Børn r ik
Paediatric population t uc
Generelt svarede bivirkningsprofilen i den begrænsede undersøgte pædiatriske population til den profil, der er observeret hos voksne, selvom der er en specifik pædiatrisk bekymring te
In general, the adverse event profile in the limited paediatric population studied was similar to that rod
4. 4).
observed in adults, although there is a paediatric specific concern regarding growth inhibition as decrease in height (mean percentile decrease of growth velocity of 9%) and weight (mean percentile decrease of 13%) percentile were observed during treatment (see section 4.4).
Derudover blev selvmordstanker eller - forsøg rapporteret hyppigere dle
Furthermore, suicidal ideation or attempts were lp
sammenlignet med voksne patienter (2, 4% mod 1%) under behandling og i den 6 måneder lange opfølgningsperiode efter behandling.
reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month follow-up after treatment.
Som hos voksne patienter oplevede børn og unge også andre psykiatriske bivirkninger (såsom depression, emotionel labilitet og søvnighed) (se pkt.
As in adult patients, children and adolescents also experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence) (see section 4.4).
Derudover mi
In addition, injection na
forekom lidelser på injektionsstedet, feber, anoreksi, opkastning og emotionel labilitet hyppigere hos børn og unge sammenlignet med voksne patienter.
site disorders, fever, anorexia, vomiting, and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Dosisjusteringer var nødvendige hos 30% af patienterne, mest almindeligt for anæmi og neutropeni. ge
Dose modifications were required in 30% of patients, most commonly for anaemia and neutropaenia. i dic
Læ
The adverse reactions listed in Table 2 are based on experience from paediatric clinical trials.
Bivirkningerne er listet efter hyppighed under overskrifterne indenfor systemorganklasserne.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following Me
Følgende kategorier er anvendt: meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10).
categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10).
s Almindelig:
205 Common:
Svampeinfektion, bakteriel infektion, pulmonal infektion, otitis media, tand absces, herpes simplex, urinvejsinfektion, vaginitis,
Neoplasms benign, malignant and unspecified (including cysts and polyps)
til gastroenteritis Benigne, maligne og uspecificerede tumorer (inkl.
Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
t ere cyster og polypper) Almindelig:
Common:
Meget almindelig:
ed Blood and lymphatic system disorders Very common:
Anæmi, neutropeni
Anaemia, neutropaenia
is Almindelig:
s Common:
Thrombocytopeni, lymphadenopati
Thrombocytopaenia, lymphadenopathy
tor Meget almindelig:
ori Endocrine disorders Very common:
Psykiske forstyrrelser
Psychiatric disorders§
Anoreksi Hypertriglyceridæmi§, hyperurikæmi, øget appetit ere
Hypertriglyceridemia§, hyperuricemia, increased appetite
Depression, emotionel ustabilitet, søvnløshed Selvmordstanker, aggressiv reaktion, forvirring, adfærdsforstyrrelser, agitation, søvngængeri, angst, nervøsitet, søvnforstyrrelser, unormale drømme, apati ng
Depression, emotional lability, insomnia
Konjunktivitis, øjensmerte, unormalt syn, tårekirtelproblemer
Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder t
Raynauds syndrome, rødmen, bleghed
Raynaud’ s disease, flushing, pallor uc
Luftveje, thorax og mediastinum Almindelig:
Respiratory, thoracic and mediastinal disorders rod
te
Common:
Mave- tarmkanalen Meget almindelig: dle
Very common: lp
Mundsår, ulcerativ stomatitis, stomatitis, smerte i øvre højre kvadrant, dyspepsi, glossitis, gastroøsofageal refluks, rektale forstyrrelser, gastrointestinale forstyrrelser, forstoppelse, løs afføring, tandpine, tandproblemer
disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder Hepatobiliary disorders i
Lever og galdeveje Almindelig: ge
Common:
Hud og subkutane væv Meget almindelig:
Skin and subcutaneous tissue disorders Very
Almindelig:
common:
Alopeci, udslæt Fotosensitivitets reaktioner, makulopapulært udslæt, eksem, akne,
Alopecia, rash
hudlidelse, neglelidelse, pigmentforandringer, pruritus, tør hud, erythem, blå mærker, øget svedtendens Knogler, led, muskler og bindevæv Meget almindelig:
Musculoskeletal and connective tissue disorders
Artralgi, myalgi, smerte i bevægeapparatet
Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased
202
Arthralgia, myalgia, musculoskeletal pain
alg Almindelig:
206 Reproductive system and breast disorders Common:
til administartionsstedet Meget almindelig:
ed conditions Very common:
t ere irritabilitet Almindelig:
s Common:
Meget almindelig:
ori Investigations Very common:
4. 4
uth Common: § See section 4.4
au 4. 9 Overdosering
ra 4.9 Overdose
Der er ingen meddelelser om tilfælde af overdosering, der har medført akutte kliniske symptomer. ere Som for ethvert farmakologisk aktivt stof er symptomatisk behandling med hyppig monitorering af vitale tegn og tæt observation af patienten dog indiceret. ng
However, as for any
L03A B05 ke
L03A B05 t uc
Viraferon er en steril, stabil, formulering af højt oprenset interferon alfa- 2b produceret ved rekombinant r ik
Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
Det fås fra en klon af E. coli, som huser et genetisk fremstillet plasmid, hybridiseret med et interferon alfa- 2b gen fra humane leukocytter. te
It is obtained from a clone of E. coli, which harbours a genetically engineered rod
Aktiviteten af Viraferon udtrykkes i IE, med 1 mg af rekombinant interferon alfa- 2b protein svarende til 2, 6 x 108 IE.
plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Internationale enheder fastsættes ved at sammenligne aktiviteten af rekombinant interferon alfa- 2b med aktiviteten af den internationale referencestandard af human leukocyt interferon fastsat af dle
The activity of Viraferon is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein lp
verdenssundhedsorganisationen WHO.
corresponding to 2.6 x l08 IU.
produceres og udskilles af celler som respons på virale infektioner eller forskellige syntetiske og biologiske substanser.
They are produced and secreted by cells in response to viral infections or various synthetic i dic
Tre væsentlige klasser af interferon er blevet identificeret:
and biological inducers.
Disse tre ge
Three major classes of interferons have been identified: alpha, beta and gamma.
Mere end 14 genetisk forskellige humane alfa interferoner er blevet identificeret.
Me
Læ
Viraferon has been classified as recombinant interferon alfa-2b.
203 visse abearter, såsom rhesus aber, modtagelige for farmakodynamisk stimulation ved udsættelse for human type 1 interferoner.
However, certain monkey species, eg, rhesus monkeys, are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Resultaterne af adskillige undersøgelser antyder, at når interferon er bundet til cellemembranen starter en
207 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.
Rekombinant interferon alfa- 2b har vist antiproliferative effekter i undersøgelser under anvendelse af både
It has demonstrated significant
Det har vist signifikant immunmodulerende aktivitet in vitro.
s immunomodulatory activity in vitro.
Skønt den nøjagtige
ori Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
tor dannede virioner ude af stand til at forlade cellen.
uth This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.
au Nuværende kliniske erfaringer med patienter, som forbliver i interferon alfa- 2b behandling i 4 til 6 måneder, viser, at behandlingen kan give elimination af serum HBV- DNA.
ra Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that therapy can produce clearance of serum HBV-DNA.
Hos voksne patienter med nedsættelse af HbeAg og HBV- DNA er set en ere signifikant reduktion i morbiditet og mortalitet.
In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has
Interferon alfa- 2b (6 MIE/ m2 3 gange om ugen i 6 måneder) er blevet givet til børn med kronisk aktiv hepatitis B.
Interferon alfa-2b (6 MIU/ m2 3 times a week for 6 months) has been given to children with chronic active lon hepatitis B.
med interferon alfa- 2b en nedsat væksthastighed og nogle tilfælde af depression sås.
Moreover children treated with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed.
Kronisk hepatitis C: læ
Chronic hepatitis C: no
Viraferon alene eller i kombination med ribavirin er blevet undersøgt r ik
The trials compared the efficacy of rod
Undersøgelserne sammenlignede effekten af Viraferon anvendt alene eller i kombination med ribavirin.
Viraferon used alone or in combination with ribavirin.
Effekt blev defineret som vedvarende virologisk respons 6 måneder efter afsluttet te
Efficacy was defined as sustained virologic response, 6 months after the end of treatment.
Patienter, der kunne indgå i disse undersøgelser, havde kronisk hepatitis C bekræftet ved en positiv HCV- RNA polymerasekædereaktions assay (PCR) (> 100 kopier/ ml), en leverbiopsi i overensstemmelse med en histologisk diagnose med kronisk hepatitis uden anden årsag til den dle
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/ ml), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum lp
kroniske hepatitis, og abnorm serum ALAT.
ALT. na
Viraferon blev indgivet i en dosis på 3 MIE 3 gange om ugen som monoterapi eller i kombination med mi
Viraferon was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with ribavirin.
Alle patienter blev fulgt i yderligere 6 måneder efter afsluttet behandling for bestemmelse af vedvarende virologisk respons.
All patients were followed for an additional 6 months after the end of treatment for the determination of sustained virologic response. i
Vedvarende virologiske responsrater for behandlingsgrupper behandlet i et år med Viraferon ge
Sustained virologic response rates for treatment groups treated for one year with Viraferon alone or in dic
Samtidig indgift af Viraferon med ribavirin øgede effekten af Viraferon til mindst det dobbelte ved Læ
Co-administration of Viraferon with ribavirin increased the efficacy of Viraferon by at least two fold for the Me
behandling af kronisk heptatitis C hos naive patienter.
treatment of chronic heptatitis C in naïve patients.
205 Tabel 4
dic
0, 017
209 All Genotype 1, 4
Grundet manglende resultater fra 206 børn med alvorlig sygdomsprogression, samt muligheden for bivirkninger, bør forholdet mellem fordele og ulemper af kombinationen ribavirin og interferon alfa- 2b overvejes nøje i denne population (se pkt.
the potential for undesirable effects, the benefit/ risk of the combination of ribavirin and interferon alfa-2b dic
ere Genotype 1 (n=92)
210 Genotype 1 (n=92)
208 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
t ere Ikke alle pakningsstørrelser er nødvendigvis markedsført.
212 1.2 ml of solution (corresponding to 30 MIU) in a pen made of a cartridge (type I glass) sealed at one end with an cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber) with 12 injection needles and12 cleansing swabs Pack sizes of 1, 2 or 8 Not all pack sizes may be marketed.
Pennen er designet til at afgive sit indhold af 30 millioner IE i doser fra 2, 5 til 10 millioner IE.
ed The pen is designed to deliver its contents of 30 million IU in doses ranging from 2.5 to 10 million IU.
Detaljerede instruktioner til brug af præparatet følger med indlægsseddelen (se ” Hvordan injicerer De selv Viraferon ”). læ
ra Remove the pen from the refrigerator approximately 30 minutes before administration to allow the injectable solution to reach room temperature (not more than 25°C).
209 8.
8.
EU/ 1/ 99/ 128/ 032 EU/ 1/ 99/ 128/ 033
EU/ 1/ 99/ 128/ 032 Me
alg EU/ 1/ 99/ 128/ 034
EU/ 1/ 99/ 128/ 033 EU/ 1/ 99/ 128/ 034
t ere 10.
213 10.
210 1.
214 1.
s En cylinderampul indeholder 60 millioner IE rekombinant interferon alfa- 2b, produceret i E. coli ved rekombinant DNA- teknologi i 1, 2 ml.
ed One cartridge contains 60 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1.2 ml.
til En ml indeholder 50 millioner IE interferon alfa- 2b.
s One ml contains 50 million IU of interferon alfa-2b.
t ere Pennen er designet til at afgive sit indhold af 60 millioner IE i doser fra 5 til 20 millioner IE.
ori The pen is designed to deliver its contents of 60 million IU in doses ranging from 5 to 20 million IU.
211 Ikke alle formuleringer og styrker er hensigtsmæssige for visse indikationer.
215 Not all dosage forms and strengths are appropriate for some indications.
212 Naive patienter:
Naïve patients: lp
Viraferon alene:
216 Viraferon alone:
213 Kombinationsbehandling med ribavirin:
Combination therapy with ribavirin:
s selvmordsforsøg er set hos nogle patienter under Viraferon- behandling og i opfølgningsperioden.
treatment discontinuation mainly during the 6-month follow-up periodand in the follow-up period.