natgillin/translations-raw huggingface dataset:
Hurtig afbrydelse af interferon- alfa indgift og behandling med kortikosteroider synes at være forbundet med ophør af pulmonale bivirkninger.
Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events. i dic
4. 8) inklusive nethindehæmoragi, "uldtotter", og arterie - eller veneokklusion i nethinden er blevet rapporteret i sjældne tilfælde efter behandling med alfa interferoner.
Ocular adverse events (see section 4.8) including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instance after treatment with alpha interferons.
Alle patienter bør have foretaget en baseline øjenundersøgelse.
All patients Me
alg visuelle skarphed eller synsfeltet, eller rapporterer om andre oftalmologiske symptomer under behandling med Viraferon, skal straks have foretaget en fuldstændig øjenundersøgelse.
Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with Viraferon, must have a prompt and complete eye examination.
Selv om disse effekter sædvanligvis er
85 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
t ere reversible, tog fuld restitution op til 3 uger hos nogle få patienter.
While these effects are generally reversible, in a few patients full resolution took up to three weeks.
Voksne patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/ eller tidligere eller eksisterende
Adult patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders, who require Viraferon therapy, must be closely monitored.
De patienter, som har haft hjerteanomalier og/ eller er i fremskreden cancerstadie, skal have taget elektrokardiogram før og under
ed electrocardiograms taken prior to and during the course of treatment.
Hjertearytmier (især supraventrikulære) responderer normalt på sædvanlig behandling, men seponering af Viraferon- behandling kan være nødvendig.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of Viraferon therapy.
au Der er set hypertriglyceridæmi og forværring af hypertriglyceridæmi, undertiden alvorlig.
s ori Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
Derfor anbefales overvågning af lipidniveauer. ere På grund af rapporter med interferon alfa og akut forværring af tidligere psoriasislidelse og sarcoidosis, anbefales brug af Viraferon hos patienter med psoriasis eller sarcoidosis kun, hvis den forventede gavnlige effekt opvejer den mulige risiko. ng
uth Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of Viraferon in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Tidlige resultater indikerer, at interferon alfa behandling kan forbindes med en øget incidens af frastødning efter nyretransplantation.
ra Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Frastødning efter levertransplantation er også rapporteret. læ
Liver graft rejection has also been reported.
Udvikling af auto- antistoffer og autoimmune lidelser er blevet rapporteret under behandling med alfa interferoner.
ge The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
Patienter med sygdomstegn eller symptomer, der er forenelige med autoimmune lidelser, bør evalueres nøje, og fordel versus risici ved fortsat interferonbehandling bør revurderes (se også pkt.
Patients predisposed to the development of autoimmune disorders may be at increased risk. lon Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Chronic hepatitis C, Monotherapy (thyroid abnormalities) and section 4.8).
4. 8). r ik
Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C no
Tilfælde af Vogt- Koyanagi- Harada (VKH) syndrom har været rapporteret hos patienter med kronisk hepatitis C, der blev behandlet med interferon.
treated with interferon.
4. 8).
If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8). t uc
Behandling med Viraferon bør afbrydes hos patienter med kronisk hepatitis, som udvikler forlængelse af dle
Discontinue treatment with Viraferon in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation. rod
Kronisk hepatitis C: mi
Chronic Hepatitis C:
Se tillige ribavirin produktresume hvis Viraferon skal indgives i kombination med ribavirin hos patienter med kronisk hepatitis C. ge
Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C. lp
Gældende behandlingsvejledninger bør overvejes med hensyn til, om en leverbiopsi er Læ
Current na
nødvendig før behandling initieres.
treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment. i
Voksne patienter, som var i behandling med Viraferon for kronisk hepatitis C, viste med mindre hyppighed unormal thyreoideafunktion, enten hypothyreoidisme eller hyperthyreoidisme.
Infrequently, adult patients treated for chronic hepatitis C with Viraferon developed thyroid dic
I kliniske undersøgelser med Viraferon- behandling udviklede 2, 8% af patienterne unormal 82 thyreoideafunktion.
In clinical trials using Viraferon therapy, 2.8% patients overall developed thyroid abnormalities.
Mekanismen med hvilken Viraferon kan ændre thyreoideafunktionen er ukendt.
Prior to Me
Før påbegyndelse med Viraferon- behandling af kronisk hepatitis C, bør thyroidstimulerende hormon (TSH) koncentrationen måles.
initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
alg konventionel behandling.
Any thyroid abnormality detected at that time must be treated with conventional therapy.
I tilfælde af
Determine TSH levels if, during the course of Viraferon therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
s thyreoideadysfunktion kan Viraferon- behandling fortsættes, hvis TSH- koncentrationen kan holdes i normalområdet ved relevant behandling.
In the presence of thyroid dysfunction, Viraferon treatment may be continued if TSH levels can be maintained in the normal range by medication.
til thyreoideadysfunktion opstået under behandlingen (se også børn og unge, thyreoidea monitorering).
Discontinuation of Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
Supplerende monitorering specifikt for børn og unge
86 Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
is Viraferon behandling kan initieres, hvis TSH niveauet kan fastholdes indenfor normalområdet ved medicinsk behandling.
Viraferon therapy may be initiated if TSH levels can be maintained in the normal range by medication.
Thyreoideadysfunktion under behandling med interferon alfa- 2b og ribavirin
Thyroid dysfunction during treatment with interferon alfa-2b and ribavirin has
tor har været observeret.
ed been observed.
au Vækst og udvikling:
s ori Growth and Development:
Under et 1- årigt behandlingsforløb var der et fald i hastigheden for lineær vækst (gennemsnitlig procentvist fald på 9%) og et fald i hastigheden for vægtøgning (gennemsnitlig ere procentvist fald på 13%).
During a 1-year course of therapy there was a decrease in the rate of linear growth (mean percentile decrease of 9%) and a decrease in the rate of weight gain (mean percentile decrease of 13%).
En generel reversering af disse tendenser sås under 6 måneders opfølgning efter behandling.
However,
Baseret på foreløbige data fra en langsigtet opfølgningsundersøgelse, havde 12 (14%) af 84 børn dog en > 15 procent nedgang i hastigheden af linear vækst, af hvilke 5 (6%) børn havde en > 30 procent nedgang på trods af, at behandlingen havde været afbrudt i mere end et år. ng
In addition, preclicinal juvenile toxicity results have demonstrated a minor,
Prækliniske toksicitetsresultater hos unge har endvidere vist et mindre dosisrelateret fald i samlet vækst hos neonatale rotter, der fik ribavirin (se pkt.
ra dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3).
Risk/ benefit af den kombinerede anvendelse af interferon alfa- 2b og ribavirin bør derfor vurderes hos små børn før initiering af behandling.
Therefore, the risk/ benefit of the combined use of interferon alfa-2b and ribavirin should be assessed in young children prior to the initiation of therapy.
Det læ
Physicians are advised to monitor the growth of children taking ribavirin in
anbefales at læger monitorerer væksten af børn, der tager ribavirin i kombination med interferon alfa - 2b.
ge combination with interferon alfa-2b.
Der foreligger ingen data på langtidseffekten på vækst og udvikling samt seksuel modning. ke
There are no data on long term effects on growth and development and on sexual maturation.
Samtidig infektion med HCV/ HIV:
HCV/ HIV Coinfection:
Patienter, der samtidig er inficeret med HIV og modtager høj- aktiv anti- retroviral terapi (HAART), kan have øget risiko for at udvikle mælkesyreacidose.
Patients co-infected with HIV and
Forsigtighed bør udvises, når Viraferon og r ik
lon receiving Highly Active Anti-Retroviral Therapy
ribavirin adderes til HAART terapi (se ribavirin produktresume).
Caution should be used when adding Viraferon and ribavirin to HAART therapy (see ribavirin SPC).
Patienter behandlet med Viraferon og ribavirin kombinationsbehandling og zidovudin kan have øget risiko for at udvikle anæmi.
Patients treated with Viraferon and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia. no
leverfunktion og død.
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
Supplerende behandling med alfa interferoner alene eller i kombination med ribavirin kan medføre øget risiko for denne undergruppe af patienter. dle
Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset. t uc
Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling mi
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the rod
med kombinationen af Viraferon og ribavirin.
combination of Viraferon and ribavirin.
Hvis denne reaktion forekommer, bør de anbefales at skylle deres mund omhyggeligt bagefter. ge Læ
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards. lp
83 Laboratorieundersøgelser:
Laboratory Tests:
Standard hæmatologiske prøver og klinisk- kemiske blodundersøgelser (komplet blodtælling og differentialtælling, trombocyttal, elektrolytter, leverenzymer, serum- protein, serum- bilirubin og serum - kreatinin) bør udføres hos alle patienter før og med faste intervaller under systemisk Viraferon- behandling.
electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with Viraferon. i dic
Hvis ALAT blusser op
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.
s under Viraferon- behandling til større end eller lig med 2 gange basisniveau, kan man fortsætte Viraferon - behandling med mindre der er tegn og symptomer på leversvigt.
If ALT flares during Viraferon therapy to greater than or equal to 2 times baseline, Viraferon therapy may be continued unless signs and symptoms of liver failure are observed.
Under ALAT opblussen skal man
During ALT flare, liver function tests:
ALAT, protrombintid, basisk fosfatase, albumin og bilirubin med to ugers interval.
bilirubin must be monitored at two-week intervals.
t ere Effekt på fertilitet:
Effect on fertility:
is Narkotika, hypnotika og sedativa skal indgives med forsigtighed samtidig med Viraferon.
Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with Viraferon.
tor Interaktioner mellem Viraferon og andre lægemidler er ikke fuldt vurderet.
87 Interactions between Viraferon and other medicinal products have not been fully evaluated.
au Interferoner kan påvirke den oksidative metaboliske proces.
Interferons may affect the oxidative metabolic process.
Ved samtidig behandling med xanthin- præparater bør serum- theophyllin- niveau ere monitoreres og dosis om nødvendigt justeres.
During concomitant therapy with xanthine agents, serum theophylline levels must be
Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet observeret hos interferon- alfa behandlede patienter, inklusive de, som er behandlet med Viraferon. ng
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed
Ætiologien er ikke fastlagt.
ori defined.
4. 4). læ
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.4).
(Se tillige ribavirin produktresume hvis Viraferon skal indgives i kombination med ribavirin hos patienter med kronisk hepatitis C). ke
uth (Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C).
4. 6 Graviditet og amning
ra 4.6 Pregnancy and lactation
Viraferon r ik
Viraferon must be
skal anvendes med forsigtighed hos fertile mænd.
ge used with caution in fertile men.
Nedsatte serum østradiol og progesteron koncentrationer har været rapporteret hos kvinder behandlet med human leukocyt- interferon. te
Decreased serum estradiol and progesterone concentrations have been reported in women treated with human leukocyte interferon. lon There are no adequate data from the use of interferon alfa-2b in pregnant women.
Viraferon må kun anvendes under graviditet, hvis den mulige gavn berettiger den potentielle dle
Viraferon is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. no
Af hensyn til muligheden for mi
It is not known whether the components of this medicinal product are excreted in human milk.
bivirkninger hos de ammede børn, bør amning afbrydes før påbegyndelse af behandling.
Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of treatment. t uc
Ribavirin forårsager alvorlige fosterskader ved anvendelse ge
Ribavirin causes serious birth defects when administered during pregnancy.
Den yderste forsigtighed skal udvises for at undgå graviditet hos kvindelige patienter eller hos partnere af mandlige Læ
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Viraferon in combination with rod
patienter, der får Viraferon i kombination med ribavirin.
ribavirin.
Mandlige patienter og deres kvindelige partnere skal begge anvende en effektiv antikonception under behandling og i 7 måneder efter behandlingen er afsluttet (Se Ribavirin SPC).
Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see lp
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner 84 Patienter bør informeres om, at de kan udvikle træthed, døsighed eller konfusion under behandling med Viraferon, og derfor anbefales det, at de undgår at føre bil og betjene maskiner.
Patients are to be advised that they may develop fatigue, somnolence, or confusion during treatment with Viraferon, and therefore it is recommended that they avoid driving or operating machinery. i dic
alg 4. 8 Bivirkninger
4.8 Undesirable effects
Se ribavirin produktresume vedrørende ribavirinrelaterede bivirkninger, hvis Viraferon skal indgives
See ribavirin SPC for ribavirin-related undesirable effects if Viraferon is to be administered in combination Me
s sammen med ribavirin til patienter med kronisk hepatitis C.
with ribavirin in patients with chronic hepatitis C.
Feber og træthed var ofte reversible
In clinical trials conducted in a broad range of indications and at a wide range of doses (from 6 MIU/ m2/ week in hairy cell leukaemia up to 100 MIU/ m2/ week in melanoma), the most commonly reported undesirable effects were fever, fatigue, headache and myalgia.
t ere inden for 72 timer efter afbrydelse eller ophør af behandlingen.
Fever and fatigue were often reversible within 72 hours of interruption or cessation of treatment.
I kliniske undersøgelser udført hos patienter med hepatitis C, blev forsøgspersonerne behandlet med Viraferon alene eller i kombination med ribavirin i et år.
88 In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
Alle patienter i disse undersøgelser fik 3 MIE
All patients in these trials received 3 MIU of Viraferon three times a week.
Dette bygger på kliniske undersøgelser af naive patienter,
In Table 1 the frequency of patients reporting (treatment related) undesirable effects is presented from clinical trials in naïve patients treated for one year.
De bivirkninger, der er listet i Tabel 1, er baseret på erfaringer fra kliniske undersøgelser og post- marketing.
The adverse reactions listed in Table 1 are based on experience from clinical trials and post-marketing.
Indenfor systemorganklasserne, er bivirkningerne listet under overskrifter efter hyppighed under anvendelse af
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); rarely (≥ 1/ 10,000, < 1/ 1,000); very rarely (< 1/ 10,000); not
au følgende kategorier: meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); sjælden (≥1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000); ikke kendt.
ed known.
Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed. ere Tabel 1.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Bivirkninger rapporteret ved kliniske undersøgelser eller efter markedsføring af Viraferon alene eller i kombination med ribavirin Systemorganklasser
Adverse reactions reported during clinical trials or following the marketing use of Viraferon
ng
s alone or in combination with ribavirin
Bivirkninger
ori System Organ Class Infections and infestations
Infektioner og parasitære sygdomme
Adverse Reactions
Pharyngitis *, viral infektion *
Pharyngitis*, infection viral*
Almindelig:
uth Common:
r ik
ge Not known:
Thrombocytopeni, lymphadenopati, lymphopeni Aplastisk anæmi Pure red cell aplasi, idiopatisk thrombocytopenisk purpura,
Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura lon
Ikke kendt: thrombotisk thrombocytopenisk purpura Immunsystemet§ Meget sjælden:
Not known:
te
Endocrine disorders
Sarcoidose, forværring af sarcoidose
urticaria, angioedema, bronchoconstriction, anaphylaxis§
dle
t
Hypothyroidisme§, hyperthyroidisme§
Hypothyroidism§, hyperthyroidism§
Metabolisme og ernæring ge
uc
Diabetes, forværret diabetes
Diabetes, aggravated diabetes
Meget almindelig:
Metabolism and nutrition disorders Very common:
Læ
§
Anoreksi Hypokalcæmi, dehydrering, hyperuricæmi, tørst Hyperglykæmi, hypertriglyceridæmi§, øget appetit
Hypocalcaemia, dehydration, hyperuricemia, thirst Hyperglycaemia, hypertriglyceridaemia§, increased appetite
§ Psykiske forstyrrelser Meget almindelig:
Very common:
Depression, søvnløshed, angst, følelsesmæssig ustabilitet *, agitation, nervøsitet
Depression, insomnia, anxiety, emotional lability*,
Almindelig:
agitation, nervousness Common:
Selvmord, selvmordsforsøg, aggressiv adfærd (nogle gange rettet mod andre), psykose inklusive hallucinationer
Suicide, suicide attempts, aggressive behaviour (sometimes directed against others), psychosis including hallucinations
Nervesystemet§
dic
alg Meget almindelig:
§ Nervous system disorders Very common:
Almindelig:
Me
Svimmelhed, hovedpine, koncentrationsbesvær, mundtørhed Tremor, paresthesi, hypoesthesi, migræne, rødmen, søvnighed, smagsforstyrrelser
Dizziness, headache, concentration impaired, mouth dry Tremor, paresthesia, hypoesthesia, migraine, flushing,
s Meget sjælden:
somnolence, taste perversion Very rarely:
Cerebrovaskulær blødning, cerebrovaskulær iskæmi, kramper, bevidsthedsforstyrrelse, encephalopati, neuropati,
Cerebrovascular haemorrhage, cerbrovascular ischaemia, seizure, impaired consciousness, encephalopathy, neuropathy, polyneuropathy
til polyneuropati Ikke kendt:
Not known:
t ere Meget almindelig:
Very common:
Sløret syn Konjunktivitis, unormalt syn, forstyrrelse af tårekanalen, øjensmerte
Vision blurred Conjunctivitis, vision abnormal, lacrimal gland disorder, eye
Sjælden:
89 pain Rarely:
Retinal blødning§, retinopatier (inklusive makulært ødem),
Ear and labyrinth
is retinal arterie - eller veneobstruktion§, optisk neuritis, papilødem, tab af synsskarphed eller synsfelt, slørede
Retinal haemorrhages§, retinopathies (including macular oedema), retinal artery or vein obstruction§, optic neuritis, papilloedema, loss of visual acuity or visual field, cotton- wool spots§
tor pletter§ Øre og labyrint Almindelig:
Common:
Vertigo, tinnitus
Vertigo, tinnitus
au Meget sjælden:
ed Very rarely:
Palpitation, tachycardi ere
Palpitation, tachycardia
Sjælden:
s Rarely:
Cardiomyopati Myocardieinfarkt, hjerteiskæmi Arytmi
Myocardial infarction, cardiac ischaemia Arrhythmia
Luftveje, thorax og mediastinum Meget almindelig:
ra disorders Very common:
Meget sjælden:
ge cough nonproductive Very rarely:
Lungeinfiltrationer§, lungebetændelse§
Pulmonary infiltrates§, pneumonitis§ lon
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, gingivitis, constipation, loose stools no
Pancreatitis, iskæmisk colitis, ulcerativ colitis, blødning af
Pancreatitis, ischaemic colitis, ulcerative colitis, gingival bleeding
tandkød Ikke kendt:
Not known:
Lever og galdeveje dle
t
Hud og subkutane væv mi
rod
Alopeci, pruritus *, tør hud *, udslæt *, øget svedtendens Psoriasis (ny eller forværret) §, maculopapulært udslæt,
Alopecia, pruritus*, skin dry*, rash*, sweating increased Psoriasis (new or aggravated)§, rash maculopapular, rash erythematous, eczema, erythema, skin disorder
Læ
Musculoskeletal and connective tissue na
Knogler, led, muskler og bindevæv Meget almindelig:
disorders Very common:
86
Me
Almindelig:
Micturition frequency
Hyppig vandladning Nyresvigt, nyreinsufficiens, nefrotisk syndrom
Renal failure, renal insufficiency, nephrotic syndrome
Amenorré, brystsmerte, dysmenore, menoragi,
General disorders and administration site conditions
alg menstruationsforstyrrelser, vaginale lidelser Almene symptomer og reaktioner på administrationsstedet
Amenorrhea, breast pain, dysmenorrhea, menorrhagia, menstrual disorder, vaginal disorder
Inflammation på injektionsstedet, reaktion på injektionsstedet *, træthed, stivhed, feber§, influenzalignende
Injection site inflammation, injection site reaction*, fatigue,
til symptomer§, asteni, irritabilitet, brystsmerte, utilpashed Almindelig:
90 rigors, fever§, flu-like symptoms§, asthenia, irritability, chest pain, malaise Common:
t ere Undersøgelser Meget almindelig:
Very common:
* Disse hændelser var kun almindelige med Viraferon alene § Se pkt.
*These events were only common with Viraferon alone
4. 4
ed § See section 4.4