natgillin/translations-raw huggingface dataset:
Sjælden:
Not known:
Thrombocytopeni, lymphadenopati, lymphopeni Aplastisk anæmi Pure red cell aplasi, idiopatisk thrombocytopenisk purpura,
Aplastic anaemia Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura lon
Sarcoidose, forværring af sarcoidose
Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid arthritis (new or aggravated), Vogt-Koyanagi-Harada no
Ikke kendt:
Endocrine disorders
Systemisk lupus erythematose, vaskulitis, reumatoid arthritis (ny eller forværret), Vogt- Koyanagi- Harada syndrom, akutte overfølsomhedsreaktioner inklusive nældefeber, angioødem,
syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis§
bronkokonstriktion, anafylakse§ Det endokrine system Almindelig: mi
Common:
Metabolisme og ernæring ge
Metabolism and nutrition disorders rod
Sjælden:
na
Forvirring, søvnforstyrrelser, nedsat libido Selvmordstanker
Confusion, sleep disorder, libido decreased
123
Rarely:
Selvmord, selvmordsforsøg, aggressiv adfærd (nogle gange rettet mod andre), psykose inklusive hallucinationer
Suicide ideation Suicide, suicide attempts, aggressive behaviour (sometimes
Nervesystemet§
Nervous system disorders
alg Meget almindelig:
Me
Svimmelhed, hovedpine, koncentrationsbesvær, mundtørhed Tremor, paresthesi, hypoesthesi, migræne, rødmen, søvnighed, smagsforstyrrelser
Tremor, paresthesia, hypoesthesia, migraine, flushing, somnolence, taste perversion
Almindelig:
127 Common:
Sløret syn Konjunktivitis, unormalt syn, forstyrrelse af tårekanalen, øjensmerte
Conjunctivitis, vision abnormal, lacrimal gland disorder, eye pain
tor pletter§ Øre og labyrint Almindelig:
ed Common:
au Meget sjælden:
Very rarely:
Sjælden:
ori Rarely:
Cardiomyopati Myocardieinfarkt, hjerteiskæmi Arytmi
Cardiomyopathy Myocardial infarction, cardiac ischaemia Arrhythmia
Almindelig:
uth Vascular disorders Common:
Luftveje, thorax og mediastinum Meget almindelig:
ra Respiratory, thoracic and mediastinal disorders Very common:
Kvalme/ opkastning, mavesmerte, diarré, stomatitis, dyspepsi Ulcerativ stomatitis, smerte i øvre højre kvadrant, glossitis, tandkødsbetændelse, forstoppelse, løs afføring
Stomatitis ulcerative, right upper quadrant pain, glossitis, no
te
t
Lever og galdeveje dle
uc
Hud og subkutane væv mi
Skin and subcutaneous tissue disorders
Hepatomegali Hepatotoksicitet, (inklusive dødsfald)
Hepatotoxicity, (including fatality)
Almindelig: ge
Common: lp
erytematøst udslæt, eksem, erytem, hudlidelser Meget sjælden:
erythematous, eczema, erythema, skin disorder Very rarely:
Læ
na
Knogler, led, muskler og bindevæv Meget almindelig:
Musculoskeletal and connective tissue disorders i
Nyrer og urinveje
Renal and urinary disorders Me
Myalgi, arthralgi, smerter i bevægeapparatet Arthritis Rhabdomyolyse, myositis, benkramper, rygsmerte
Arthritis Rhabdomyolysis, myositis, leg cramps, back pain
s Meget almindelig:
128 Very common:
til symptomer§, asteni, irritabilitet, brystsmerte, utilpashed Almindelig:
Common:
4. 4
ed *These events were only common with Viraferon alone § See section 4.4
is Disse bivirkninger er også rapporteret med Viraferon alene.
s These undesirable effects have also been reported with Viraferon alone.
tor Kardiovaskulære (CV) bivirkninger, specielt arytmi, syntes for det meste at være indbyrdes forbundet med tidligere CV sygdom og tidligere behandling med kardiotoksiske stoffer (se pkt.
ori Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre- existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Kardiomyopati, som
Cardiomyopathy, that may
4. 4).
uth 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). ng
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), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies
Klinisk signifikante laboratorieafvigelser er hyppigst set med doser større end 10 millioner IE dagligt og læ
ge (see also section 4.4).
omfatter reduktion i antal af granulocytter og hvide blodlegemer, nedsat hæmoglobinniveau og trombocyttal, øgning i basisk fosfatase, LDH, serum- kreatinin og serum- urinstof.
Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU lon 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.
DNAp.
Paediatric population t
4. 4. r ik
Children and adolescents – Chronic Hepatitis C uc
Børn og unge - kronisk hepatitis C I kliniske undersøgelser med 118 børn og unge i alderen 3 til 16 år afbrød 6% behandling på grund af bivirkninger.
In clinical trials of 118 children or adolescents 3 to 16 years of age, 6% discontinued therapy due to adverse events.
Generelt svarede bivirkningsprofilen i den begrænsede undersøgte pædiatriske dle
In general, the adverse event profile in the limited paediatric population studied was similar to that observed in adults, although there is a paediatric specific concern regarding growth inhibition as decrease in rod
population til den profil, der er observeret hos voksne, selvom der er en specifik pædiatrisk bekymring vedrørende væksthæmning, da en procentvis formindsket højde (gennemsnitlig procentvis nedgang i væksthastighed på 9%) og vægt (gennemsnitlig procentvis nedgang på 13%) blev observeret under mi
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 sammenlignet med voksne patienter (2, 4% mod 1%) under behandling og i den 6 måneder lange opfølgningsperiode efter behandling.
Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month lp
Derudover forekom lidelser på injektionsstedet, feber, anoreksi, opkastning og emotionel labilitet hyppigere hos Læ
In addition, injection site disorders, fever, anorexia, vomiting, and emotional lability occurred more frequently in children and na
børn og unge sammenlignet med voksne patienter.
adolescents compared to adult patients.
Dosisjusteringer var nødvendige hos 30% af patienterne, mest almindeligt for anæmi og neutropeni.
Dose modifications were required in 30% of patients, most commonly for anaemia and neutropaenia. i dic
Virusinfektion, pharyngitis Svampeinfektion, bakteriel infektion, pulmonal infektion, otitis
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection, otitis
t ere media, tand absces, herpes simplex, urinvejsinfektion, vaginitis, gastroenteritis Benigne, maligne og uspecificerede tumorer (inkl.
129 media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
is cyster og polypper) Almindelig:
Blood and lymphatic system
tor Blod og lymfesystem Meget almindelig:
ed disorders Very common:
au Det endokrine system Meget almindelig:
ori Very common:
Hypothyroidisme§, Hyperthyroidisme§, virilisering ere
Hypothyroidism§, Hyperthyroidism§, virilism
Meget almindelig:
uth Metabolism and nutrition disorders Very common:
Meget almindelig:
ra Psychiatric disorders§ Very common:
Depression, emotionel ustabilitet, søvnløshed Selvmordstanker, aggressiv reaktion, forvirring, læ
Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour
adfærdsforstyrrelser, agitation, søvngængeri, angst, nervøsitet, søvnforstyrrelser, unormale drømme, apati Nervesystemet§ Meget almindelig:
ge disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy Nervous system disorders§ lon Very common:
Hyperkinesi, tremor, dysfoni, parestesi, hypoestesi, hyperestesi, koncentrationsbesvær, søvnighed
Headache, dizziness Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence no
Luftveje, thorax og mediastinum dle
Respiratory, thoracic and uc
Almindelig:
mediastinal disorders Common:
Dyspnø, takypnø, epistaxis, hoste, næseforstoppelse, næseirritation, næseflåd, nysen
Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal
Meget almindelig: mi
irritation, rhinorrhea, sneezing Gastrointestinal disorders Very common:
Mundsår, ulcerativ stomatitis, stomatitis, smerte i øvre højre kvadrant, dyspepsi, glossitis, gastroøsofageal refluks, rektale
Diarrhoea, vomiting, nausea, abdominal pain Mouth ulceration, stomatitis ulcerative, stomatitis, right upper
forstyrrelser, gastrointestinale forstyrrelser, forstoppelse, løs afføring, tandpine, tandproblemer Lever og galdeveje Læ
quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, na
Almindelig:
toothache, tooth disorder Hepatobiliary disorders Common:
Hud og subkutane væv
Hepatic function abnormal
Unormal hepatisk funktion
Skin and subcutaneous tissue dic
Alopeci, udslæt Fotosensitivitets reaktioner, makulopapulært udslæt, eksem, akne, hudlidelse, neglelidelse, pigmentforandringer, pruritus, tør hud,
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin
126 erythem, blå mærker, øget svedtendens
disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased Musculoskeletal and connective tissue disorders Very common:
Det reproduktive system og
Reproductive system and
s mammae Almindelig:
130 breast disorders Common:
ere reaktioner på administartionsstedet Meget almindelig:
ed Very common:
Inflammation på injektionsstedet, reaktion på injektionsstedet, træthed, stivhed, feber§, influenzalignende symptomer§, utilpashed,
Injection site inflammation, injection site reaction, fatigue, rigors, fever§, influenza-like symptoms§, malaise, irritability
is irritabilitet Almindelig:
Common:
tor Undersøgelser Meget almindelig:
Injury and poisoning
au Traumer, forgiftninger og behandlingskomplikationer Almindelig: § Se pkt.
Common:
ng
uth § See section 4.4
Som for ethvert farmakologisk aktivt stof er symptomatisk behandling med hyppig monitorering af vitale tegn og tæt observation af patienten dog indiceret. læ
However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close
FARMAKOLOGISKE EGENSKABER ke
PHARMACOLOGICAL PROPERTIES
5. 1 Farmakodynamiske egenskaber r ik
5.1 Pharmacodynamic properties no
Viraferon er en steril, stabil, formulering af højt oprenset interferon alfa- 2b produceret ved rekombinant te
Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA uc
Internationale enheder fastsættes ved at sammenligne aktiviteten af rekombinant interferon mi
International Units are determined by comparison of the activity of the lp
alfa- 2b med aktiviteten af den internationale referencestandard af human leukocyt interferon fastsat af verdenssundhedsorganisationen WHO. ge
recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte interferon established by the World Health Organisation. na
De produceres og udskilles af celler som respons på virale infektioner eller forskellige syntetiske og biologiske Læ
They are produced and secreted by cells in response to viral infections or various synthetic and biological inducers.
Alfa, beta og gamma.
Three major classes of interferons have been identified: alpha, beta and gamma. i dic
127 Interferoner udøver deres cellulære aktiviteter ved at binde sig til specifikke membranreceptorer på celleoverfladen.
Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
Det formodes, at
131 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.
HCV genotype og baseline virusmængde er 128 prognostiske faktorer, som er kendt for at kunne påvirke responsrater.
HCV genotype and baseline virus load are prognostic Me
s fik Viraferon i kombination med ribavirin og fik ≥ 80% af deres behandling, et højere vedvarende respons 6 måneder efter 1 års behandling end dem, der anvendte < 80% af deres behandling (56%
132 response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
129 Tabel 4
dic
0, 017
133 All Genotype 1, 4
Grundet manglende resultater fra 130 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)
134 Genotype 1 (n=92)
132 Inden for holdbarhedsperioden kan opløsningen under transport opbevares ved eller under 25°C i op til syv dage inden anvendelse.
Within its shelf-life, for the purpose of transport, the solution can be kept at or below 25ºC for a period up to seven days before use.
s 1 ml opløsning (svarende til 10 MIE) i et hætteglas (type I glas), med en prop (halobutylgummi) i et aftageligt segl (aluminium) med en hætte (polypropylen).
136 1 ml of solution (corresponding to 10 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip- off seal (aluminium) with a bonnet (polypropylene) Pack sizes of 1
t ere 1 ml opløsning (svarende til 10 MIE) i et hætteglas (type I glas), med en prop (halobutylgummi) i et aftageligt segl (aluminium) med en hætte (polypropylen) med 1 injektionssprøjte, 1 kanyle og 1 renseserviet.
1 ml of solution (corresponding to 10 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-
is Pakningsstørrelse á 1, 6 eller 12.
Packs sizes of 1, 6 or 12
EU/ 1/ 99/ 128/ 017 EU/ 1/ 99/ 128/ 018 EU/ 1/ 99/ 128/ 019 ge
EU/ 1/ 99/ 128/ 017 na
EU/ 1/ 99/ 128/ 020 Læ
EU/ 1/ 99/ 128/ 018 EU/ 1/ 99/ 128/ 019 EU/ 1/ 99/ 128/ 020 i dic
133 9.
9.
til Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
137 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
134 1.
138 1.
Viraferon 18 millioner IE/ 3 ml injektionsvæske, opløsning
Viraferon 18 million IU/ 3 ml solution for injection
s Et hætteglas Viraferon injektionsvæske, opløsning flerdosis hætteglas indeholder 18 millioner IE interferon alfa- 2b, produceret i E. coli ved rekombinant DNA- teknologi i 3 ml opløsning.
ed One vial of Viraferon solution for injection, multiple dose vial, contains 18 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 3 ml of solution.
til En ml opløsning indeholder 6 millioner IE interferon alfa- 2b.
s One ml of solution contains 6 million IU of interferon alfa-2b.
6. 1.
ori For a full list of excipients, see section 6.1.
3.
uth 3.
is Injektionsvæske, opløsning
ra Solution for injection Solution is clear and colourless.
KLINISKE OPLYSNINGER
CLINICAL PARTICULARS Therapeutic indications
4. 1 Terapeutiske indikationer ere Kronisk hepatitis B:
Chronic Hepatitis B:
Behandling af voksne patienter med kronisk hepatitis B forbundet med tegn på hepatitis B virusreplikation (tilstedeværelse af HBV- DNA og HBeAg), forhøjet alaninaminotransferase (ALAT) og histologisk påvist aktiv leverinflammation og/ eller fibrose. ng
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 no
Kronisk hepatitis C: læ
Chronic Hepatitis C: t
Voksne patienter:
Adult patients: uc
4. 4). 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 section 4.4). rod
Viraferon er beregnet til anvendelse, i kombination med ribavirin, til behandling af børn og unge i alderen 3 år eller ældre, som lider af tidligere ubehandlet kronisk hepatitis C uden te
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 na
leverdekompensation, og som er positive med hensyn til serum HCV- RNA.
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 sygdomsprogression såsom leverinflammation og fibrose, såvel som prognostiske faktorer for respons, dle
The expected benefit of i dic
4. 4, 4. 8 og 5. 1). mi
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).
4. 2 Dosering og indgivelsesmåde ge
4.2 Posology and method of administration Me
Hvis der opstår bivirkninger under behandling med Viraferon uanset indikation skal dosis justeres eller behandlingen afbrydes midlertidigt, indtil bivirkningerne aftager.
If persistent or recurrent intolerance
Hvis der opstår vedvarende eller tilbagevendende intolerance til trods for tilstrækkelig dosisjustering, eller hvis sygdommen progredierer, 135 skal behandling med Viraferon afbrydes.
139 develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon.
Den anbefalede dosering er fra 5 til 10 millioner IE, givet subkutant tre gange om
The recommended dosage is in the range 5 to 10 million IU administered subcutaneously three times a week (every other day) for a period of 4 to 6 months.
Den givne dosis skal reduceres med 50% i tilfælde af forekomst af hæmatologiske lidelser (hvide
ed The administered dose should be reduced by 50% in case of occurrence of haematological disorders (white blood cells < 1,500/ mm3, granulocytes < 1,000/ mm3, thrombocytes < 100,000/ mm3).
Behandlingen skal seponeres i tilfælde af svær leukopeni (< 1. 200/ mm3), svær neutropeni (< 750/ mm3) eller svær
Treatment should be discontinued in case of severe leukopaenia (< 1,200/ mm3), severe neutropaenia (< 750/ mm3) or severe
til thrombocytopeni (< 70. 000/ mm3).
s thrombocytopaenia (< 70,000/ mm3).
t ere behandling (ved den højeste tolererede dosis), skal Viraferon behandlingen afbrydes.
ori 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.
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.
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.
Interferon alfa- 2b 3 millioner IE/ m2 indgives subkutant ke
Interferon alfa-2b 3 MIU/ m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution
3 gange om ugen (hver anden dag) i kombination med ribavirin kapsler eller oral opløsning indgivet oralt fordelt på to daglige doser til et måltid (morgen og aften). r ik
ge administered orally in two divided doses daily with food (morning and evening).
(Se produktresume for ribavirin kapsler med henblik på dosis af ribavirin kapsler og retningslinierne for dosisindstilling ved kombinationsbehandling.
(See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination lon therapy.
For pædiatriske patienter, der vejer < 47 kg eller ikke kan synke kapsler, se produktresume for ribavirin oral opløsning). te
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC).
Relaps patienter (voksne):
Relapse patients (adults): no
Viraferon anvendes i kombination med ribavirin. dle
Viraferon is given in combination with ribavirin.
På baggrund af resultater fra kliniske undersøgelser, i hvilke data er til rådighed for 6 måneders behandling, anbefales det, at patienter behandles med Viraferon i kombination med ribavirin mi
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. t uc
Naive patienter: ge
Naïve patients:
Læ
given alone mainly in case of intolerance or contraindication to ribavirin.
På baggrund af resultater fra kliniske undersøgelser, i hvilke data er til rådighed for 12 måneders behandling, anbefales det, at patienter behandles med Viraferon i kombination med ribavirin i mindst 6 måneder.
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is lp
136 Behandling bør fortsættes i yderligere en 6- måneders periode (det vil sige i alt 12 måneder) hos patienter, der udviser negativ HCV- RNA ved 6 måneder, og ved viral genotype 1 (bestemt ved en prøve før behandling) og høj virusmængde før behandling.
recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months. na
alg Andre negative prognostiske faktorer (alder > 40 år, hankøn, bridging fibrose) bør tages i betragtning ved fortsat behandling til 12 måneder.
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 high pre-treatment viral load. i dic
s I kliniske undersøgelser blev patienter, som ikke udviste virologisk respons efter 6 måneders behandling (HCV- RNA under nedre detektionsgrænse), ikke vedvarende virologiske respondere
Me
til (HCV- RNA under nedre detektionsgrænse 6 måneder efter ophørt behandling).
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).
Det anbefales, at patienter behandles med Viraferon alene i mindst 3 til 4 måneder, hvorefter HCV -
140 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.
137 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use na
is Patienter med eksisterende eller tidligere alvorlig psykiatriske lidelser:
141 Patients with existence of or history of severe psychiatric conditions:
Selv om disse effekter sædvanligvis er
142 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
I kliniske undersøgelser med Viraferon- behandling udviklede 2, 8% af patienterne unormal 139 thyreoideafunktion.
In clinical trials using Viraferon therapy, 2.8% patients overall developed thyroid abnormalities.
Supplerende monitorering specifikt for børn og unge
143 Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
140 Laboratorieundersøgelser:
Laboratory Tests:
tor Interaktioner mellem Viraferon og andre lægemidler er ikke fuldt vurderet.
144 Interactions between Viraferon and other medicinal products have not been fully evaluated.