natgillin/translations-raw huggingface dataset:
til med ribavirin blev selvmordstanker eller - forsøg rapporteret oftere end hos voksne patienter (2, 4% mod 1%) under behandling og under den 6- måneders opfølgning efter behandling.
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.
Hvis sådanne symptomer forekommer, skal den foreskrivende læge være opmærksom på den potentielle alvor af disse bivirkninger, og behovet for
If psychiatric
Hvis psykiatriske symptomer vedvarer eller forværres, eller selvmordstanker identificeres, anbefales det, at behandling med Viraferon afbrydes, og patienten
179 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 følges med passende psykiatrisk intervention.
Patients with existence of or history of severe psychiatric conditions:
Patienter med eksisterende eller tidligere alvorlig psykiatriske lidelser:
If a treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Hvis behandling med
The use of interferon alfa-2b in children and adolescents
au 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 terapeutisk håndtering af den psykiatriske lidelse er blevet sikret.
ed with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Brugen af interferon alfa- 2b hos ere børn og unge med eksisterende eller tidligere alvorlige psykiatriske lidelser er kontraindiceret (se pkt.
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during Viraferon therapy.
4. 3).
ori treatment.
Akutte overfølsomhedsreaktioner (såsom urticaria, angioødem, bronkokonstriktion, anafylaksi) over for ng
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon
interferon alfa- 2b har sjældent været observeret under Viraferon behandling.
uth alfa-2b have been observed rarely during Viraferon therapy.
nødvendiggør ikke afbrydelse af behandlingen.
Transient rashes do not necessitate interruption of treatment.
Enhver patient, der viser unormal leverfunktion under Viraferon - ke
Any patient developing liver function abnormalities during treatment
behandlingen, skal følges tæt og behandlingen skal afbrydes, hvis der er tegn og symptomer på forværring. r ik
ge with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
Hypotension kan opstå under eller op til to dage efter Viraferon- behandling og kan kræve understøttende behandling.
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 te
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.
Fluid replacement may be necessary. no
Da feber kan ses sammen med de influenzalignende reaktioner, der sædvanligvis rapporteres under 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
interferonbehandling, bør andre årsager til vedvarende feber udelukkes.
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.
Viraferon skal anvendes med forsigtighed hos patienter med invaliderende sygdom, som for eksempel mi
Caution must be observed also in patients with coagulation disorders (e. g., thrombophlebitis, rod
Varsomhed skal ligeledes iagttages hos patienter med koagulationsforstyrrelser (såsom thrombophlebitis, lungeemboli) eller alvorlig myelosuppression. ge
pulmonary embolism) or severe myelosuppression.
Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet Læ
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed lp
Disse symptomer er blevet rapporteret oftere, når shosaikoto, en kinesisk urtemedicin, gives samtidig med interferon- alfa (se pkt.
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.5).
Enhver patient, som udvikler feber, hoste, kortåndethed eller andre åndedrætssymptomer, bør have taget røntgen af thorax.
dyspnea or other respiratory symptoms must have a chest X-ray taken.
Hvis røntgen af thorax viser lungeinfiltrat eller der er tegn på lungefunktionsnedsættelse, skal patienten følges nøje, og hvis det skønnes nødvendigt, skal interferon- alfa behandlingen afbrydes.
While this has been reported more often in patients with chronic i dic
Mens dette er rapporteret oftere hos 176 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.
Regelmæssige
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.
til synsundersøgelser under Viraferon behandling anbefales især hos patienter med sygdomme, der kan være forbundet med retinopati, såsom diabetes mellitus eller hypertension.
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.
180 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
Meget sjældent er der set kramper ved
Very rarely, seizures have occurred with high doses of Viraferon.
is høje doser af Viraferon.
It is recommended that
tor Voksne patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/ eller tidligere eller eksisterende arytmisygdomme, som kræver Viraferon- behandling, skal følges tæt.
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.
De patienter, som har haft hjerteanomalier og/ eller er i fremskreden cancerstadie, skal have taget elektrokardiogram før og under
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of Viraferon
au behandling.
s therapy.
Hjertearytmier (især supraventrikulære) responderer normalt på sædvanlig behandling, men seponering af Viraferon- behandling kan være nødvendig.
There are no data in children or adolescents with a history of cardiac disease.
Der er ingen resultater hos børn eller unge med tidligere hjertesygdom. ere Der er set hypertriglyceridæmi og forværring af hypertriglyceridæmi, undertiden alvorlig.
ori Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
Derfor anbefales overvågning af lipidniveauer. ng
Monitoring of lipid levels is, therefore, recommended.
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. læ
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
Patienter, der er prædisponerede for udviklingen af autoimmune lidelser, kan have øget r ik
Patients predisposed to the development of autoimmune disorders may be at increased risk.
4. 8). 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
Behandling med Viraferon bør afbrydes hos patienter med kronisk hepatitis, som udvikler forlængelse af mi
Discontinue treatment with Viraferon in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation. rod
Kronisk hepatitis C: ge
Chronic Hepatitis C:
Læ
Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C. lp
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 verifikation.
All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i. e. na
Gældende behandlingsvejledninger bør overvejes med hensyn til, om en leverbiopsi er nødvendig før behandling initieres.
Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment. i dic
177 Monoterapi:
Monotherapy:
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 abnormalities, either hypothyroidism or hyperthyroidism.
I kliniske undersøgelser med Viraferon- behandling udviklede 2, 8% af patienterne unormal thyreoideafunktion.
In clinical trials using Viraferon therapy, 2.8% patients overall developed thyroid abnormalities.
Forandringerne kunne kontrolleres med konventionel behandling for
The abnormalities were controlled by conventional therapy Me
alg thyreoideadysfunktion.
for thyroid dysfunction.
Før påbegyndelse med Viraferon- behandling af kronisk hepatitis C, bør thyroidstimulerende hormon (TSH) koncentrationen måles.
Prior to initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
s konventionel behandling.
Any thyroid abnormality detected at that time must be treated with conventional therapy.
til tyder på thyreoideadysfunktion, skal man undersøge TSH- koncentrationen.
Determine TSH levels if, during the course of Viraferon therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
Seponering af Viraferon- behandling har ikke ændret
Discontinuation of
t ere thyreoideadysfunktion opstået under behandlingen (se også børn og unge, thyreoidea monitorering).
181 Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
is 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
Prior to initiation of Viraferon therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be
tor thyreoideaabnormaliteter detekteret på dette tidspunkt, skal behandles med konventionel behandling.
ed treated with conventional therapy.
Thyreoideadysfunktion under behandling med interferon alfa- 2b og ribavirin
Thyroid dysfunction during treatment with interferon alfa-2b and ribavirin has been observed.
au har været observeret.
s treated as clinically appropriate.
Hvis thyreoideaabnormaliteter detekteres, bør patientens thyreoideastatus evalueres og behandles klinisk passende.
Children and adolescents should be monitored every 3 months for evidence
Børn og unge patienter bør monitoreres hver 3. måned for tegn på thyreoideadysfunktion (f. eks.
TSH).
TSH). ere Vækst og udvikling:
Growth and Development:
En generel reversering af disse tendenser sås under 6 måneders opfølgning ng
During a 1-year course of therapy there was a decrease in the rate of linear growth
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. læ
However, based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile
Prækliniske toksicitetsresultater hos unge har endvidere vist et mindre dosisrelateret fald i samlet vækst hos neonatale rotter, der fik ribavirin (se pkt.
ra decrease in rate of linear growth, of whom 5 (6%) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Risk/ benefit af den kombinerede anvendelse af interferon alfa- 2b og ribavirin bør derfor vurderes hos små børn før initiering af behandling.
In addition, preclicinal juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3).
Det ke
Therefore, the
Der foreligger ingen data på langtidseffekten på vækst og udvikling samt seksuel modning. r ik
There are no data on long term effects on growth and development and lon on sexual maturation.
Forsigtighed bør udvises, når Viraferon og te
Caution should be used when adding Viraferon no
ribavirin adderes til HAART terapi (se ribavirin produktresume).
and ribavirin to HAART therapy (see ribavirin SPC).
Co- inficerede patienter med fremskreden cirrhose, der får HAART, kan have øget risiko for nedsat dle
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic t
leverfunktion og død.
decompensation and death.
Supplerende behandling med alfa interferoner alene eller i kombination med ribavirin kan medføre øget risiko for denne undergruppe af patienter. mi
Adding treatment with alfa interferons alone or in combination with ribavirin may uc
Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling ge
Dental and periodontal disorders, which may lead to loss of teeth, have rod
med kombinationen af Viraferon og ribavirin.
been reported in patients receiving Viraferon and ribavirin combination therapy.
Patienter bør børste deres tænder omhyggeligt to gange daglig og have regelmæssige tandeftersyn.
Patients should brush their teeth thoroughly twice daily and have lp
Læ
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards. na
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.
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 i dic
178 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.
Hvis ALAT blusser op under Viraferon- behandling til større end eller lig med 2 gange basisniveau, kan man fortsætte Viraferon -
If ALT flares during Viraferon therapy to greater than or Me
alg behandling med mindre der er tegn og symptomer på leversvigt.
equal to 2 times baseline, Viraferon therapy may be continued unless signs and symptoms of liver failure are observed.
s Effekt på fertilitet:
Effect on fertility:
til 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
t ere Narkotika, hypnotika og sedativa skal indgives med forsigtighed samtidig med Viraferon.
182 Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with Viraferon.
is Interferoner kan påvirke den oksidative metaboliske proces.
Interferons may affect the oxidative metabolic process.
Dette skal tages i betragtning ved samtidig
This must be considered during concomitant therapy
tor behandling med præparater, der metaboliseres på denne måde, såsom xanthin- derivaterne theophyllin eller aminophyllin.
ed with medicinal products metabolised by this route, such as the xanthine derivatives theophylline or aminophylline.
au Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet observeret hos interferon- alfa behandlede patienter, inklusive de, som er behandlet med Viraferon. ere Ætiologien er ikke fastlagt.
s ori Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with Viraferon.
Disse symptomer er blevet rapporteret oftere, når shosaikoto, en kinesisk urtemedicin, gives samtidig med interferon- alfa (se pkt.
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is
4. 4).
uth administered concomitantly with interferon alpha (see section 4.4).
(Se tillige ribavirin produktresume hvis Viraferon skal indgives i kombination med ribavirin hos ng
(Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with
patienter med kronisk hepatitis C).
ra chronic hepatitis C).
4. 6 Graviditet og amning læ
4.6 Pregnancy and lactation
Kvinder i den fødedygtige alder skal anvende effektiv antikonception under behandlingen.
ge Women of childbearing potential have to use effective contraception during treatment.
koncentrationer har været rapporteret hos kvinder behandlet med human leukocyt- interferon.
Decreased serum estradiol and progesterone concentrations have been lon reported in women treated with human leukocyte interferon.
Der foreligger ikke tilstrækkelige data om brugen af interferon alfa- 2b hos gravide kvinder. r ik
There are no adequate data from the use of interferon alfa-2b in pregnant women.
Den potentielle risiko for mennesker er ukendt.
Viraferon is to be no
Viraferon må kun anvendes under graviditet, hvis den mulige gavn berettiger den potentielle risiko for fosteret. te
used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Af hensyn til muligheden for bivirkninger hos de ammede børn, bør amning afbrydes før påbegyndelse af behandling. dle
Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of t uc
Ribavirin forårsager alvorlige fosterskader ved anvendelse under graviditet.
Ribavirin causes serious birth defects when administered during rod
Den yderste mi
Ribavirin therapy is contraindicated in women who are pregnant.
forsigtighed skal udvises for at undgå graviditet hos kvindelige patienter eller hos partnere af mandlige patienter, der får Viraferon i kombination med ribavirin.
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Viraferon in combination with ribavirin.
Fertile kvinder og deres partnere skal begge anvende en effektiv antikonception under behandling og i 4 måneder efter behandlingen er afsluttet. ge
Females of childbearing potential and their partners must each use an effective contraceptive during lp
Læ
Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC). na
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines i dic
179 4. 8 Bivirkninger
4.8 Undesirable effects Me
alg I kliniske undersøgelser foretaget i en lang række indikationer og i et bredt dosisområde (fra 6 MIE/ m2/ uge ved hårcelleleukæmi op til 100 MIE/ m2/ uge ved melanom) var de mest almindeligt
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.
til I kliniske undersøgelser udført hos patienter med hepatitis C, blev forsøgspersonerne behandlet med Viraferon alene eller i kombination med ribavirin i et år.
183 In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
Indenfor
The adverse reactions listed in Table 1 are based on experience from clinical trials and post-marketing.
is systemorganklasserne, er bivirkningerne listet under overskrifter efter hyppighed under anvendelse af følgende kategorier: meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); sjælden
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very
tor (≥1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000); ikke kendt.
ed common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); rarely (≥ 1/ 10,000, < 1/ 1,000); very rarely (< 1/ 10,000); not known.
au Tabel 1.
s Table 1.
Bivirkninger rapporteret ved kliniske undersøgelser eller efter markedsføring af Viraferon alene eller i kombination med ribavirin Systemorganklasser Infektioner og parasitære sygdomme
ori alone or in combination with ribavirin System Organ Class Infections and infestations
Bivirkninger ere
Adverse Reactions
Meget almindelig:
uth Very common:
Blod og lymfesystem
ra Blood and lymphatic system disorders Very common:
læ
Leukopaenia Thrombocytopaenia, lymphadenopathy, lymphopenia
Leukopeni
ge Very rarely:
Almindelig:
Not known:
Thrombocytopeni, lymphadenopati, lymphopeni Aplastisk anæmi Pure red cell aplasi, idiopatisk thrombocytopenisk purpura, thrombotisk thrombocytopenisk purpura
Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid arthritis (new or aggravated), Vogt-Koyanagi-Harada no
Immunsystemet§ Meget sjælden:
Endocrine disorders
r ik
t
Sarcoidose, forværring af sarcoidose Systemisk lupus erythematose, vaskulitis, reumatoid arthritis
syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis§
(ny eller forværret), Vogt- Koyanagi- Harada syndrom, akutte overfølsomhedsreaktioner inklusive nældefeber, angioødem, bronkokonstriktion, anafylakse§ te
uc
Det endokrine system Almindelig:
Hypothyroidism§, hyperthyroidism§
Hypothyroidisme§, hyperthyroidisme§ Diabetes, forværret diabetes
Diabetes, aggravated diabetes
Metabolisme og ernæring Meget almindelig:
Very common:
Almindelig: mi
Common:
Psykiske forstyrrelser ge
Psychiatric disorders
Hyperglykæmi, hypertriglyceridæmi§, øget appetit
Anorexia Hypocalcaemia, dehydration, hyperuricemia, thirst Hyperglycaemia, hypertriglyceridaemia§, increased appetite
Selvmordstanker Selvmord, selvmordsforsøg, aggressiv adfærd (nogle gange rettet mod andre), psykose inklusive hallucinationer
Suicide ideation Suicide, suicide attempts, aggressive behaviour (sometimes
180
Me
Meget almindelig:
Dizziness, headache, concentration impaired, mouth dry