natgillin/translations-raw huggingface dataset:
Stor tumorbyrde (> 7 cm), involvering af mindst tre nodale områder (hver > 3 cm), systemiske symptomer (vægttab > 10%, feber > 38C i mere end 8 dage, eller natlige svedeture), splenomegali til under navlen, obstruktion af større organ eller kompressionssyndrom, orbital eller epidural involvering, serøs ekssudation eller leukæmi.
High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10%, fever > 38°C for more than 8 days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.
Carcinoid tumor:
Carcinoid Tumour:
Malignt melanom:
Malignant Melanoma:
Supplerende behandling hos patienter, som er sygdomsfri efter operation, men har høj risiko for tilbagefald, for eksempel patienter med primær eller recidiverende (klinisk eller patologisk) lymfeknudepåvirkning.
As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e. g., patients with primary or recurrent (clinical or pathological) lymph node involvement.
Den anbefalede dosering er fra 5 til 10 millioner IE, givet subkutant tre gange om ugen (hver anden dag) i en periode på 4- 6 måneder.
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 blodlegemer < 1. 500/ mm3, granulocytter < 1. 000/ mm3, thrombocytter < 100. 000/ mm3).
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 thrombocytopeni (< 70. 000/ mm3).
Treatment should be discontinued in case of severe leukopaenia (< 1,200/ mm3), severe neutropaenia (< 750/ mm3) or severe thrombocytopaenia (< 70,000/ mm3).
For alle patienter gælder, at hvis der ikke ses nogen forbedring i serum HBV- DNA efter 3 til 4 måneders behandling (ved den højeste tolererede dosis), skal IntronA behandlingen afbrydes.
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 IntronA therapy.
Børn i alderen 3 år eller derover og unge:
Children 3 years of age or older and adolescents:
Interferon alfa- 2b 3 millioner IE/ m2 indgives subkutant 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).
Interferon alfa-2b 3 MIU/ m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening).
3 (Se produktresume for ribavirin kapsler med henblik på dosis af ribavirin kapsler og retningslinierne for dosisindstilling ved kombinationsbehandling.
 3 (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
Effekten af IntronA er øget ved indgift i kombination med ribavirin.
The efficacy of IntronA is enhanced when given in combination with ribavirin.
IntronA i kombination med ribavirin:
IntronA in combination with ribavirin:
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.
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 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).
IntronA alene:
IntronA alone:
Det anbefales, at patienter behandles med IntronA alene i mindst 3 til 4 måneder, hvorefter HCV- RNA status bør bestemmes.
It is recommended that patients be treated with IntronA alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Behandling bør fortsættes hos patienter, der udviser negativ HCV- RNA.
Treatment should be continued in patients who exhibit negative HCV-RNA.
Genotype 1:
Genotype 1:
Den anbefalede behandlingsvarighed er et år.
The recommended duration of treatment is one year.
Patienter, der ikke opnår virologisk respons efter 12 uger, har meget lille sandsynlighed for at blive vedvarende virologiske responders (negativ prædiktiv værdi 96%).
Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
Virologisk respons er defineret som fravær af påviselig HCV- RNA i uge 12.
Virological response is defined as absence of detectable HCV-RNA at Week 12.
Genotype 2/ 3:
Genotype 2/ 3:
Den anbefalede behandlingsvarighed er 24 uger.
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.
Virological responses after 1 year of treatment and 6 months of follow-up were 36% for genotype 1 and 81% for genotype 2/ 3/ 4.
Den anbefalede dosering er 2 millioner IE/ m2 givet subkutant tre gange om ugen (hver anden dag) for både splenektomerede og ikke splenektomerede patienter.
The recommended dosage is 2 million IU/ m2 administered subcutaneously three times a week (every other day) for both splenectomised and non-splenectomised patients.
For de fleste patienter med hårcelleleukæmi kan ses normalisering af en eller flere hæmatologiske variable inden for en til to måneders IntronA behandling.
For most patients with Hairy Cell Leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
4 Kronisk myeloid leukæmi:
 4 Chronic Myelogenous Leukaemia:
Den anbefalede dosering af IntronA er 4 til 5 millioner IE/ m2 givet dagligt subkutant.
The recommended dosage of IntronA is 4 to 5 million IU/ m2 administered daily subcutaneously.
Nogle patienter har vist at have gavn af IntronA 5 millioner IE/ m2 indgivet dagligt subkutant i forbindelse med cytarabin (Ara- C) 20 mg/ m2 indgivet dagligt subkutant i 10 dage per måned (op til en maksimal daglig dosis på 40 mg).
Some patients have been shown to benefit from IntronA 5 million IU/ m2 administered daily subcutaneously in association with cytarabine (Ara-C) 20 mg/ m2 administered daily subcutaneously for 10 days per month (up to a maximum daily dose of 40 mg).
Når leucocyttallet er under kontrol, bør den maksimalt tolererede dosis IntronA (4 til 5 millioner IE/ m2 daglig) indgives for at vedligeholde den hæmatologiske remission.
When the white blood cell count is controlled, administer the maximum tolerated dose of IntronA (4 to 5 million IU/ m2 daily) to maintain haematological remission.
IntronA- behandling bør afbrydes efter 8 til 12 ugers behandling, hvis ikke mindst en partiel hæmatologisk remission eller en klinisk betydningsfuld cytoreduktion er opnået.
IntronA treatment must be discontinued after 8 to 12 weeks of treatment if at least a partial haematological remission or a clinically meaningful cytoreduction has not been achieved.
Hos patienter, som er i plateaufase (mere end 50% reduktion af myelom- protein) efter initial induktionskemoterapi, kan interferon alfa- 2b gives som monoterapi, subkutant i en dosering på 3 millioner IE/ m2 tre gange om ugen (hver anden dag).
In patients who are in the plateau phase (more than 50% reduction of myeloma protein) following initial induction chemotherapy, interferon alfa-2b may be administered as monotherapy, subcutaneously, at a dose of 3 million IU/ m2 three times a week (every other day).
Supplerende til kemoterapi kan interferon alfa- 2b gives subkutant i en dosis på 5 millioner IE tre gange ugentlig (hver anden dag) i en periode på 18 måneder.
Adjunctively with chemotherapy, interferon alfa-2b may be administered subcutaneously, at a dose of 5 million IU three times a week (every other day) for a duration of 18 months.
CHOP- lignende regimer anbefales, men klinisk erfaring findes kun med CHVP (kombination af cyclophosphamid, doxorubicin, teniposid og prednisolon).
CHOP-like regimens are advised, but clinical experience is available only with CHVP (combination of cyclophosphamide, doxorubicin, teniposide and prednisolone).
Behandlingen bør fortsætte, så længe patienten responderer på interferon alfa- 2b behandling.
Therapy may continue for as long as the patient responds to interferon alfa-2b treatment.
6. 6).
As induction therapy, interferon alfa-2b is administered intravenously at a dose of 20 million IU/ m2 daily for five days a week for a four-week period; the calculated interferon alfa-2b dose is added to sodium chloride 9 mg/ ml (0.9%) solution for injection and administered as a 20- minute infusion (see section 6.6).
Som vedligeholdelsesbehandling er den anbefalede dosis 10 millioner IE/ m2 indgivet subkutant tre gange om ugen (hver anden dag) i 48 uger.
As maintenance treatment, the recommended dose is 10 million IU/ m2 administered subcutaneously three days a week (every other day) for 48 weeks.
Hvis der udvikles alvorlige bivirkninger under interferon alfa- 2b behandlingen, især hvis granulocyttallet falder til < 500/ mm3 eller alaninaminotransferase/ aspartataminotransferase (ALAT/ ASAT) stiger til > 5 gange den øvre normalgrænse, skal behandlingen midlertidigt afbrydes, indtil bivirkningen aftager.
If severe adverse events develop during interferon alfa-2b treatment, particularly if granulocytes decrease to< 500/mm3 or alanine aminotransferase/aspartate aminotransferase (ALT/AST) rises to> 5 x upper limit of normal, discontinue treatment temporarily until the adverse event abates.
Interferon alfa- 2b behandlingen bør genstartes med 50% af den tidligere dosis.
Interferon alfa-2b treatment is to be restarted at 50% of the previous dose.
Hvis intolerance vedvarer efter dosisjustering, eller hvis granulocyttallet falder til < 250/ mm3 eller ALAT/ ASAT stiger til > 10 gange den øvre normalgrænse, skal interferon alfa- 2b behandling afbrydes.
If intolerance persists after dose adjustment or if granulocytes decrease to< 250/mm3 or ALT/AST rises to> 10 x upper limit of normal, discontinue interferon alfa-2b therapy.
Skønt den optimale (minimale) dosis for opnåelse af den fulde kliniske effekt er ukendt, skal patienterne behandles med de anbefalede doser, dog med dosisreduktion ved toxicitet som angivet.
Although the optimal (minimum) dose for full clinical benefit is unknown, patients must be treated at the recommended dose, with dose reduction for toxicity as described.
IntronA kan indgives ved brug af enten glas - eller plastik- éngangsinjektionssprøjter.
IntronA may be administered using either glass or plastic disposable injection syringes.
- Overfølsomhed over for det (de) aktive stof( fer) eller over for et eller flere af hjælpestofferne.
- Hypersensitivity to the active substance or to any of the excipients.
- Anamnese med alvorlig tidligere hjertesygdom, såsom ukontrolleret hjerteinsufficiens, nylig
- A history of severe pre-existing cardiac disease, e. g., uncontrolled congestive heart failure,
myokardieinfarkt, svære arytmilidelser.
recent myocardial infarction, severe arrhythmic disorders.
- Alvorlig nyre - eller leverlidelse, inklusive lidelser forårsaget af metastaser.
- Severe renal or hepatic dysfunction; including that caused by metastases.
4. 4).
- Epilepsy and/ or compromised central nervous system (CNS) function (see section 4.4).
- 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
immunsuppressive stoffer, bortset fra korttids korticosteroid afbrydelse.
immunosuppressive agents excluding short term corticosteroid withdrawal.
Immunsupprimerede
- Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant
transplantationsrecipienter.
recipients.
- Tidligere thyreoideasygdom, medmindre den er velkontrolleret med konventionel behandling.
- Pre-existing thyroid disease unless it can be controlled with conventional treatment.
5 Børn og unge:
 5 Children and adolescents:
- Nuværende eller tidligere alvorlig psykiatrisk lidelse, især alvorlig depression, selvmordstanker
- Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal
eller selvmordsforsøg.
ideation or suicide attempt.
Kombinationsbehandling med ribavirin:
Combination therapy with ribavirin:
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.
Psykiatri og centralnervesystem (CNS):
Psychiatric and central nervous system (CNS):
Alvorlig CNS- påvirkning, særlig depression, selvmordstanker og selvmordsforsøg er set hos nogle patienter under IntronA- 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 IntronA therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Blandt børn og unge behandlet med IntronA i kombination 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 IntronA 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.
Som hos voksne patienter 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).
Andre CNS virkninger inklusive aggressiv opførsel (sommetider rettet mod andre), bipolare lidelser, mani, forvirring og ændret mental tilstand, er blevet set med alfa interferoner.
Other CNS effects including aggressive behaviour (sometimes directed against others), bipolar disorders, mania, confusion and alterations of mental status have been observed with alpha interferons.
Hvis psykiatriske symptomer vedvarer eller forværres, eller selvmordstanker identificeres, anbefales det, at behandling med IntronA afbrydes, og patienten følges med passende psykiatrisk intervention
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with IntronA be discontinued, and the patient followed, with psychiatric intervention as appropriate.
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 terapeutisk håndtering af den psykiatriske lidelse er blevet sikret.
If 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.
4. 3).
The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Akutte overfølsomhedsreaktioner (såsom urticaria, angioødem, bronkokonstriktion, anafylaksi) over for interferon alfa- 2b har sjældent været observeret under IntronA behandling.
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during IntronA therapy.
Moderate til alvorlige bivirkninger kan nødvendiggøre justering af patientens dosering eller i nogle tilfælde afbrydelse af IntronA- behandling.
Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of IntronA therapy.
Enhver patient, der viser unormal leverfunktion under IntronA - behandlingen, skal følges tæt og behandlingen skal afbrydes, hvis der er tegn og symptomer på forværring.
Any patient developing liver function abnormalities during treatment with IntronA must be monitored closely and treatment discontinued if signs and symptoms progress.
Hypotension kan opstå under eller op til to dage efter IntronA- behandling og kan kræve understøttende behandling.
Hypotension may occur during IntronA therapy or up to two days post-therapy and may require supportive treatment.
Tilstrækkelig hydreringstilstand skal opretholdes hos patienter, der gennemgår IntronA- behandling, idet hypotension på grund af væskemangel er set hos nogle patienter.
Adequate hydration must be maintained in patients undergoing IntronA therapy since hypotension related to fluid depletion has been seen in some patients.
IntronA 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.
IntronA 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 (såsom thrombophlebitis, lungeemboli) eller alvorlig myelosuppression.
Caution must be observed also in patients with coagulation disorders (e. g., thrombophlebitis, pulmonary embolism) or severe myelosuppression.
Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet observeret hos interferon- alfa behandlede patienter, inklusive de, som er behandlet med IntronA.
 6 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
4. 5).
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.5).
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.
If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
Mens dette er rapporteret oftere hos patienter med kronisk hepatitis C behandlet med interferon- alfa, er det også rapporteret hos patienter med onkologiske sygdomme behandlet med interferon- alfa.
While this has been reported more often in patients with chronic 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.
Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events.
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 instances after treatment with alpha interferons.
Regelmæssige synsundersøgelser under IntronA behandling anbefales især hos patienter med sygdomme, der kan være forbundet med retinopati, såsom diabetes mellitus eller hypertension.
Periodic visual examinations during IntronA therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Voksne patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/ eller tidligere eller eksisterende arytmisygdomme, som kræver IntronA- behandling, skal følges tæt.
Adult patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders, who require IntronA therapy, must be closely monitored.
De patienter, som har haft hjerteanomalier og/ eller er i fremskreden cancerstadie, skal have taget elektrokardiogram før og under behandling.
It is recommended that 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 seponering af IntronA- behandling kan være nødvendig.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of IntronA therapy.
På grund af rapporter med interferon alfa og akut forværring af tidligere psoriasislidelse og sarcoidosis, anbefales brug af IntronA hos patienter med psoriasis eller sarcoidosis kun, hvis den forventede gavnlige effekt opvejer den mulige risiko.
Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of IntronA in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
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 interferons.
4. 8).
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).
Tilfælde af Vogt- Koyanagi- Harada (VKH) syndrom har været rapporteret hos patienter med kronisk 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).
If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8).
Behandling med IntronA bør afbrydes hos patienter med kronisk hepatitis, som udvikler forlængelse af koagulationsmarkører, der kan være tegn på leverinsufficiens.
Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation.
Passende vaccination (hepatitis A og B) bør overvejes hos patienter, der regelmæssigt/ gentagne gange får humant albumin udvundet fra plasma.
 7 Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/ repeated receipt of human plasma-derived albumin.