natgillin/translations-raw huggingface dataset:
hovedsageligt gives alene i tilfælde af intolerance eller kontraindikation for ribavirin.
Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin. lp
3 Viraferon i kombination med ribavirin:
Viraferon in combination with 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.
recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months.
alg 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
Treatment should be continued for another 6-month period (i. e., a total of 12 months) in patients who exhibit i
s prøve før behandling) og høj virusmængde før behandling.
negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and dic
til Andre negative prognostiske faktorer (alder > 40 år, hankøn, bridging fibrose) bør tages i betragtning ved fortsat behandling til 12 måneder.
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into Me
t ere I kliniske undersøgelser blev patienter, som ikke udviste virologisk respons efter 6 måneders behandling (HCV- RNA under nedre detektionsgrænse), ikke vedvarende virologiske respondere (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).
is Viraferon alene:
Viraferon alone:
tor behandling på mellem 12 og 18 måneder anbefales.
3 The optimal duration of therapy with Viraferon alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
Det anbefales, at patienter behandles med Viraferon alene i mindst 3 til 4 måneder, hvorefter HCV -
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.
Børn og unge:
ed Children and adolescents:
Effekt og sikkerhed ved Viraferon i kombination med ribavirin er blevet undersøgt hos ere børn og unge, der ikke tidligere har været behandlet for kronisk hepatitis C.
The efficacy and safety of Viraferon in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C.
Genotype 1:
s Genotype 1:
Patienter, der ikke opnår virologisk respons efter 12 uger, har meget lille sandsynlighed for at blive vedvarende virologiske responders (negativ ng
Patients who fail to achieve virological
prædiktiv værdi 96%).
ori response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
Genotype 2/ 3:
uth Genotype 2/ 3:
Den anbefalede behandlingsvarighed er 24 uger. læ
The recommended duration of treatment is 24 weeks.
Virologisk respons efter 1 års behandling og 6 måneders opfølgning var 36% for genotype 1 og 81% for genotype 2/ 3/ 4. ke
Virological responses after 1 year of treatment and 6 months of follow-up were 36% for genotype 1 and
Viraferon kan indgives ved brug af enten glas - eller plastik- éngangsinjektionssprøjter. r ik
Viraferon may be administered using either glass or plastic disposable injection syringes.
4. 3 Kontraindikationer
ge 4.3 Contraindications lon
- Anamnese med alvorlig tidligere hjertesygdom, såsom ukontrolleret hjerteinsufficiens, nylig
- A history of severe pre-existing cardiac disease, e. g., uncontrolled congestive heart failure, recent
myokardieinfarkt, svære arytmilidelser.
myocardial infarction, severe arrhythmic disorders.
- Kronisk hepatitis hos patienter, som bliver eller for nylig er blevet behandlet med
- Chronic hepatitis in patients who are being or have been treated recently with immunosuppressive
Immunsupprimerede
agents excluding short term corticosteroid withdrawal. t uc
transplantationsrecipienter. ge
- Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant recipients.
Læ
Children and adolescents:
eller selvmordsforsøg.
ideation or suicide attempt. lp
Se tillige ribavirin produktresume hvis interferon alfa- 2b skal indgives i kombination med ribavirin hos patienter med kronisk hepatitis C.
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C. na
4 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use i dic
alg Psykiatri og centralnervesystem (CNS):
Psychiatric and central nervous system (CNS):
Alvorlig CNS- påvirkning, særlig depression, selvmordstanker og selvmordsforsøg er set hos nogle patienter under Viraferon- behandling, og selv efter behandlingsophør især under 6- måneders opfølgningsperioden.
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after Me
Som hos voksne patienter
Among children and adolescents treated with Viraferon in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6-month follow-up after treatment.
til oplevede børn og unge andre psykiatriske bivirkninger (såsom depression, emotionel labilitet og døsighed).
As in adult patients, children and adolescents experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence).
Patienter bør følges nøje for eventuelle tegn
Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Hvis psykiatriske symptomer vedvarer eller forværres, eller selvmordstanker identificeres, anbefales det, at behandling med Viraferon afbrydes, og patienten
If psychiatric
is følges med passende psykiatrisk intervention.
4 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.
tor Patienter med eksisterende eller tidligere alvorlig psykiatriske lidelser:
Patients with existence of or history of severe psychiatric conditions:
Hvis behandling med interferon alfa- 2b vurderes nødvendig hos voksne patienter med eksisterende eller tidligere alvorlige psykiatriske lidelser, bør denne kun initieres efter en passende individualiseret diagnosticering og
The use of interferon alfa-2b in children and adolescents
Brugen af interferon alfa- 2b hos børn og unge med eksisterende eller tidligere alvorlige psykiatriske lidelser er kontraindiceret (se pkt.
ed with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
4. 3). ere Akutte overfølsomhedsreaktioner (såsom urticaria, angioødem, bronkokonstriktion, anafylaksi) over for interferon alfa- 2b har sjældent været observeret under Viraferon behandling.
If such a reaction develops, discontinue the
Hvis en sådan reaktion opstår, skal behandlingen afbrydes og nødvendig medicinsk behandling påbegyndes.
s medication and institute appropriate medical therapy.
Forbigående udslæt ng
Transient rashes do not necessitate interruption of
nødvendiggør ikke afbrydelse af behandlingen. læ
Transient rashes do not necessitate interruption of treatment.
Moderate til alvorlige bivirkninger kan nødvendiggøre justering af patientens dosering eller i nogle tilfælde afbrydelse af Viraferon- behandling.
ra Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of Viraferon therapy.
Enhver patient, der viser unormal leverfunktion under Viraferon - behandlingen, skal følges tæt og behandlingen skal afbrydes, hvis der er tegn og symptomer på forværring. ke
Any patient developing liver function abnormalities during treatment
Hypotension kan opstå under eller op til to dage efter Viraferon- behandling og kan kræve understøttende behandling. r ik
Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive lon treatment.
Tilstrækkelig hydreringstilstand skal opretholdes hos patienter, der gennemgår Viraferon- behandling, idet hypotension på grund af væskemangel er set hos nogle patienter.
Adequate hydration must be maintained in patients undergoing Viraferon therapy since hypotension related to fluid depletion has been seen in some patients.
Væsketilskud kan blive nødvendig. te
Fluid replacement may be necessary. no
Da feber kan ses sammen med de influenzalignende reaktioner, der sædvanligvis rapporteres under interferonbehandling, bør andre årsager til vedvarende feber udelukkes. dle
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out. t uc
Viraferon skal anvendes med forsigtighed hos patienter med invaliderende sygdom, som for eksempel patienter med tidligere lungesygdom (såsom kronisk obstruktiv lungesygdom) eller diabetes mellitus med tendens til ketoacidosis.
Viraferon must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e. g., chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis.
Varsomhed skal ligeledes iagttages hos patienter med koagulationsforstyrrelser mi
Caution must be observed also in patients with coagulation disorders (e. g., thrombophlebitis, rod
(såsom thrombophlebitis, lungeemboli) eller alvorlig myelosuppression.
pulmonary embolism) or severe myelosuppression.
Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet ge
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed lp
observeret hos interferon- alfa behandlede patienter, inklusive de, som er behandlet med Viraferon.
rarely in interferon alpha treated patients, including those treated with Viraferon.
Disse symptomer er blevet rapporteret oftere, når shosaikoto, en kinesisk Læ
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.5).
4. 5).
dyspnea or other respiratory symptoms must have a chest X-ray taken.
Mens dette er rapporteret oftere hos patienter med kronisk hepatitis C behandlet med interferon- alfa, er det også rapporteret hos patienter med
While this has been reported more often in patients with chronic i dic
5 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.
Hurtig afbrydelse af interferon- alfa indgift og behandling med kortikosteroider synes at være forbundet med ophør af pulmonale bivirkninger.
Me
alg 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.
s 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.
Regelmæssige synsundersøgelser under Viraferon behandling anbefales især hos patienter med sygdomme, der kan
Periodic visual examinations during Viraferon therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
t ere Mere signifikant omtågethed samt coma, inklusive tilfælde af encefalopati, er set hos nogle patienter, sædvanligvis hos ældre patienter behandlet med højere doser.
5 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
is Voksne patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/ eller tidligere eller eksisterende
It is recommended that
De patienter, som har haft hjerteanomalier og/ eller er i fremskreden cancerstadie, skal have taget elektrokardiogram før og under behandling.
ed those patients who have pre-existing cardiac abnormalities and/ or are in advanced stages of cancer have electrocardiograms taken prior to and during the course of treatment.
Hjertearytmier (især supraventrikulære) responderer normalt på sædvanlig behandling, men
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of Viraferon
au seponering af Viraferon- behandling kan være nødvendig.
s therapy.
Der er set hypertriglyceridæmi og forværring af hypertriglyceridæmi, undertiden alvorlig.
ori Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
På grund af rapporter med interferon alfa og akut forværring af tidligere psoriasislidelse og 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
sarcoidosis, anbefales brug af Viraferon hos patienter med psoriasis eller sarcoidosis kun, hvis den forventede gavnlige effekt opvejer den mulige risiko. læ
ra potential risk.
Tidlige resultater indikerer, at interferon alfa behandling kan forbindes med en øget incidens af frastødning efter nyretransplantation.
Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney
Frastødning efter levertransplantation er også rapporteret. ke
Liver graft rejection has also been reported.
Udvikling af auto- antistoffer og autoimmune lidelser er blevet rapporteret under behandling med alfa interferoner.
The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha lon interferons.
Tilfælde af Vogt- Koyanagi- Harada (VKH) syndrom har været rapporteret hos patienter med kronisk te
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). no
hepatitis C, der blev behandlet med interferon.
Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C treated with interferon.
4. 8). dle
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 koagulationsmarkører, der kan være tegn på leverinsufficiens. mi
Discontinue treatment with Viraferon in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation. rod
Passende vaccination (hepatitis A og B) bør overvejes hos patienter, der regelmæssigt/ gentagne gange får humant albumin udvundet fra plasma. ge
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/ repeated receipt of human plasma-derived albumin. lp
Standardmetoder til forebyggelse af infektioner, der stammer fra anvendelse af lægemidler fremstillet Læ
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific na
fra humant blod eller plasma, omfatter udvælgelse af donorer, screening af individuelle donationer og plasmapools for specifikke markører for infektion og inklusion af effektive fremstillingstrin for inaktivering/ fjernelse af vira.
markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Dette gælder også for ukendte eller nye opstående vira og andre patogener.
This also applies to unknown or i dic
6 Der er ingen rapporter om virusoverførsler med albumin fremstillet efter European Pharmacopoeia specifikationer med fastlagte procedurer.
emerging viruses and other pathogens.
Det anbefales kraftigt hver gang Viraferon anvendes til en patient, at navn og batchnummer for
Me
alg præparatet registreres for at bevare en forbindelse mellem patienten og batchen af præparatet.
It is strongly recommended that every time that Viraferon is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
s Kombinationsbehandling med med ribavirin:
Combination therapy with ribavirin:
Se tillige ribavirin produktresume hvis Viraferon skal indgives i kombination med ribavirin hos patienter med kronisk hepatitis C.
Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C.
til Alle patienter i de kliniske undersøgelser af kronisk hepatitis C fik foretaget leverbiopsi før inklusion, men i visse tilfælde (for eksempel patienter med genotype 2 og 3), kan behandling være mulig uden histologisk
6 All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i. e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Voksne patienter, som var i behandling med Viraferon for kronisk hepatitis C, viste med
Infrequently, adult patients treated for chronic hepatitis C with Viraferon developed thyroid
is mindre hyppighed unormal thyreoideafunktion, enten hypothyreoidisme eller hyperthyreoidisme.
ed abnormalities, either hypothyroidism or hyperthyroidism.
I kliniske undersøgelser med Viraferon- behandling udviklede 2, 8% af patienterne unormal
In clinical trials using Viraferon therapy, 2.8% patients overall developed thyroid abnormalities.
Mekanismen med hvilken Viraferon kan ændre thyreoideafunktionen er ukendt.
Prior to
Før påbegyndelse med Viraferon- behandling af kronisk hepatitis C, bør thyroidstimulerende hormon
s initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating
au (TSH) koncentrationen måles.
ori hormone (TSH) levels.
Viraferon- behandling kan påbegyndes, hvis TSH- koncentrationen kan holdes på normalt niveau med behandling.
Viraferon treatment may be initiated if TSH levels can be maintained in the normal range by medication.
Hvis en patient under Viraferon- behandling udvikler symptomer, der ere tyder på thyreoideadysfunktion, skal man undersøge TSH- koncentrationen.
Determine TSH levels if, during the course of Viraferon therapy, a patient develops symptoms
I tilfælde af 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.
Seponering af Viraferon- behandling har ikke ændret thyreoideadysfunktion opstået under behandlingen (se også børn og unge, thyreoidea monitorering). ng
Discontinuation of Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and
Supplerende monitorering specifikt for børn og unge Thyreoidea monitorering:
ra adolescents, Thyroid monitoring).
Omtrent 12% af børn behandlet med interferon alfa- 2b og ribavirin læ
Supplemental monitoring specific for children and adolescents
udviklede en forøgning af TSH.
Approximately 12% of children treated with interferon alfa-2b and ribavirin developed increase in TSH.
Inden initiering af Viraferon behandling, skal TSH niveauet evalueres og mulige thyreoideaabnormaliteter detekteret på dette tidspunkt, skal behandles med konventionel behandling. ke
Prior to initiation of Viraferon therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be lon treated with conventional therapy.
Hvis thyreoideaabnormaliteter detekteres, bør patientens thyreoideastatus r ik
If thyroid abnormalities are detected, the patient’ s thyroid status should be evaluated and treated as clinically appropriate.
evalueres og behandles klinisk passende.
of thyroid dysfunction (e. g.
TSH). te
TSH).
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 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 t uc
efter behandling.
A general reversal of these trends was noted during the 6 months follow-up post treatment.
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. mi
However, based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6%) children had a > 30 percentile decrease despite being off rod
Det ge
Therefore, the risk/ benefit of the combined use of interferon alfa-2b and ribavirin should be assessed in young children prior lp
anbefales at læger monitorerer væksten af børn, der tager ribavirin i kombination med interferon alfa - 2b.
Physicians are advised to monitor the growth of children taking ribavirin in combination with interferon alfa-2b.
Læ
There are no data on long term effects on growth and development and on sexual maturation. na
7 Samtidig infektion med HCV/ HIV:
HCV/ HIV Coinfection:
Forsigtighed bør udvises, når Viraferon og ribavirin adderes til HAART terapi (se ribavirin produktresume).
Caution should be used when adding Viraferon i dic
alg 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.
Supplerende behandling med alfa interferoner alene eller i kombination med
Adding treatment with alfa interferons alone or in combination with ribavirin may Me
s ribavirin kan medføre øget risiko for denne undergruppe af patienter.
increase the risk in this patient subset.
til Dentale og parodontale lidelser:
Dental and periodontal disorders:
Dentale og parodontale lidelser, som kan føre til tab af tænder, er blevet rapporteret hos patienter, der fik Viraferon og ribavirin kombinationsbehandling.
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Viraferon and ribavirin combination therapy.
Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Viraferon and ribavirin.
is Laboratorieundersøgelser:
7 Laboratory Tests:
Standard hæmatologiske prøver og klinisk- kemiske blodundersøgelser (komplet blodtælling og
Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, 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.
tor 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.
During treatment for hepatitis B or C the recommended testing schedule is at weeks 1, 2, 4, 8, 12, 16, and