natgillin/translations-raw huggingface dataset:
Hvis behandling med peginterferon alfa- 2b bedømmes som værende nødvendig hos patienter med eksisterende eller tidligere alvorlige psykiatriske lidelser, bør dette kun initieres efter sikring af en passende individuel diagnostisk og terapeutisk behandling af den psykiatriske lidelse.
If treatment with peginterferon alfa-2b is judged necessary in 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.
Akut overfølsomhed:
Acute hypersensitivity:
Akutte overfølsomhedsreaktioner (såsom urticaria, angioødem, bronkokonstriktion, anafylaksi) har været set sjældent under interferon alfa- 2b behandling.
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely during interferon alfa-2b therapy.
Hvis en sådan reaktion udvikles 7 under behandling med PegIntron, seponer behandlingen og indsæt omgående passende medicinsk behandling.
If such a reaction develops during treatment with PegIntron, discontinue treatment and institute appropriate medical therapy immediately.
Kardiovaskulære system:
Cardiovascular system:
Som med interferon alfa- 2b kræver patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/ eller tidligere eller nuværende arytmilidelser, der får PegIntron behandling, tæt monitoring.
As with interferon alfa-2b, patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders, receiving PegIntron therapy require close monitoring.
Det anbefales, at patienter, der har forud eksisterende hjerteanomalier, får taget elektrocardiogrammer før og under behandlingsforløbet.
It is recommended that patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Hjertearytmier (primært supraventrikulære) responderer sædvanligvis på konventionel behandling, men kan kræve afbrydelse af PegIntron behandling.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of PegIntron therapy.
Som ved alle interferoner, afbryd behandling med PegIntron hos patienter, der udvikler forlængede koagulationsmarkører, hvilket kan være tegn på leversvigt.
As with all interferons, discontinue treatment with PegIntron in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Feber:
Fever:
Hydrering:
7 Hydration:
Tilstrækkelig hydrering skal opretholdes hos patienter, der får PegIntron behandling, da hypotension relateret til væskemangel har været set hos nogle patienter behandlet med alfa interferoner.
Adequate hydration must be maintained in patients undergoing PegIntron therapy since hypotension related to fluid depletion has been seen in some patients treated with alpha interferons.
Lungeforandringer:
Pulmonary changes:
Lungeinfiltrater, pneumonitis og pneumoni, i visse tilfælde dødeligt forløbende, er i sjældne tilfælde blevet set hos interferon alfa behandlede patienter.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients.
Enhver patient, der får feber, hoste, dyspnø eller andre luftvejssymptomer skal have taget et røntgen af thorax.
Any patient developing fever, cough, dyspnea or other respiratory symptoms must have a chest X-ray taken.
Hvis dette røntgen af thorax viser lungeinfiltrater, eller der er tegn på forringet lungefunktion, skal patienten følges nøje, og om nødvendigt ophøre med interferon alfa.
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.
Øjeblikkelig afbrydelse af interferon alfa indgift og behandling med korticosteroider synes at være forbundet med helbredelse af lungebivirkningerne.
Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events.
Autoimmun sygdom:
Autoimmune disease:
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 Thyroid changes and 4.8).
Øjenforandringer:
Ocular changes:
4. 8).
Ophthalmologic disorders, including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instances after treatment with alpha interferons (see section 4.8).
Alle patienter bør have foretaget en øjenundersøgelse ved start af behandlingen.
All patients should have a baseline eye examination.
Enhver patient, som klager over øjensymptomer, inklusive nedsat visuel skarphed eller synsfelt skal straks have foretaget en fuldstændig øjenundersøgelse.
Any patient complaining of ocular symptoms, including loss of visual acuity or visual field must have a prompt and complete eye examination.
Regelmæssige synsundersøgelser anbefales under PegIntron behandling, især hos patienter med sygdomme, der kan være forbundet med retinopati, såsom diabetes mellitus eller hypertension.
Periodic visual examinations are recommended during PegIntron therapy, particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Seponering af PegIntron bør overvejes hos patienter, som udvikler nye eller forværrede oftalmologiske lidelser.
Discontinuation of PegIntron should be considered in patients who develop new or worsening ophthalmological disorders.
Thyreoideaændringer:
Thyroid changes:
I sjældne tilfælde har patienter behandlet for kronisk hepatitis C med interferon alfa udviklet thyreoideaabnormaliteter, enten hypothyreoidisme eller hyperthyreoidisme.
Infrequently, patients treated for chronic hepatitis C with interferon alpha have developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
Thyreoidea stimulerende hormon (TSH) værdier bør bestemmes, hvis en patient under behandlingsforløbet udvikler symptomer i overensstemmelse med mulig nedsat thyreoideafunktion.
Determine thyroid stimulating hormone (TSH) levels if, during the course of therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
Ved tilstedeværelse af nedsat thyreoideafunktion kan PegIntron behandling fortsættes, hvis TSH værdier kan bibeholdes i normalområdet med medicinsk behandling.
In the presence of thyroid dysfunction, PegIntron treatment may be continued if TSH levels can be maintained in the normal range by medication.
Metaboliske forstyrrelser:
Metabolic disturbances:
8 Mitokondriel toksicitet og mælkesyre acidose:
HCV/ HIV Co-infection Mitochondrial toxicity and lactic acidosis:
Forsigtighed bør udvises, når PegIntron og ribavirin adderes til HAART terapi (se ribavirin SPC).
Caution should be used when adding PegIntron and ribavirin to HAART therapy (see ribavirin SPC).
Hepatisk dekompensering hos HCV/ HIV co- inficerede patienter med fremskreden cirrose:
Hepatic decompensation in HCV/ HIV co-infected patients with advanced cirrhosis:
Andre baseline- faktorer hos co - inficerede patienter, som kan associeres med en højere risiko for hepatisk dekompensering, inkluderer behandling med didanosin og forhøjet bilirubin serumkoncentration.
Other baseline factors in co-infected patients that may be associated with a higher risk of hepatic decompensation include treatment with didanosine and elevated bilirubin serum concentration.
Deres Child- Pugh- score bør vurderes under behandling.
Co-infected patients receiving both antiretroviral (ARV) and anti-hepatitis treatment should be closely monitored, assessing their Child-Pugh score during treatment.
Patienter som udvikler hepatisk inkompensation, bør have deres antihepatiske behandling seponeret øjeblikkeligt, og ARV - behandling skal revurderes.
Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Hæmatologiske anomalier hos HCV/ HIV co- inficerede patienter:
8 Haematological abnormalities in HCV/ HIV co-infected patients:
Patienter, der samtidig er inficeret med HCV/ HIV, og som modtager peginterferon alfa- 2b/ ribavirin - behandling og HAART, kan have øget risiko for at udvikle hæmatologiske anomalier (som neutropeni, thrombocytopeni og anæmi) sammenlignet med HCV mono- inficerede patienter.
HCV/ HIV co-infected patients receiving peginterferon alfa-2b/ ribavirin treatment and HAART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
4. 2 og under ” Laboratorieanalyser ” og pkt.
Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “ Laboratory tests” and section 4.8).
4. 5)
Patients treated with PegIntron and ribavirin combination therapy and zidovudine are at increased risk of developing anaemia and therefore the concomitant use of this combination with zidovudine is not recommended (see section 4.5).
Patienter med lave CD4- tællinger:
Patients with low CD4 counts:
Blandt patienter, der er co- inficeret med HCV/ HIV, er der, for patienter med CD4- tællinger mindre end 200 celler/ μl, begrænsede effekt - og sikkerhedsdata (N = 25) tilgængelige.
In patients co-infected with HCV/ HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/ µl.
Forsigtighed anbefales derfor i behandlingen af patienter med lave CD4- tællinger.
Caution is therefore warranted in the treatment of patients with low CD4 counts.
For de antiretrovirale lægemidler, der skal tages samtidig med HCV- behandling, henvises der til disses respektive produktresuméer for kendskab og håndtering af toksicitet, der er specifik for det enkelte produkt samt potentialet for overlappende toksiciteter med PegIntron og ribavirin.
Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with PegIntron and ribavirin.
Organtransplantatmodtagere:
Organ transplant recipients:
Sikkerheden og effekten af PegIntron alene eller i kombination med ribavirin ved behandling af hepatitis C hos lever - eller andre organtransplantatmodtagere har ikke været undersøgt.
The safety and efficacy of PegIntron alone or in combination with ribavirin for the treatment of hepatitis C in liver or other organ transplant recipients have not been studied.
Præliminære resultater tyder på, at behandling med interferon alfa kan være forbundet med en øget frekvens af nyretransplantatafstødning.
Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
På grund af meddelelser om at interferon alfa kan forværre tilstedeværende psoriasissygdom og sarcoidosis, kan brug af PegIntron til patienter med psoriasis eller sarcoidosis kun anbefales, hvis den potentielle gavnlige effekt retfærdiggør den mulige risiko.
Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of PegIntron in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Laboratorieundersøgelser:
Laboratory tests:
Hæmatologiske, klinisk- kemiske standardparametre og en prøve for at undersøge thyreoideafunktionen skal udføres hos alle patienter før påbegyndt behandling.
Standard haematologic tests, blood chemistry and a test of thyroid function must be conducted in all patients prior to initiating therapy.
Acceptable udgangsværdier, som kan anvendes som retningslinie før påbegyndelse af PegIntron behandling, er:
Acceptable baseline values that may be considered as a guideline prior to initiation of PegIntron therapy are:
9 • • •
• • •
Blodplader Neutrofile TSH niveau
Platelets Neutrophil count TSH level
≥ 100. 000/ mm3 ≥ 1. 500/ mm3 skal være inden for normalområdet
≥ 100,000/mm3 ≥ 1,500/mm3 must be within normal limits
Vigtige oplysninger om visse af indholdsstofferne i PegIntron:
Important information about some of the ingredients of PegIntron:
Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per 0, 7 ml, det vil sige er praktisk taget "natriumfrit".
This medicinal product contains less than 1 mmol sodium (23 mg) per 0.7 ml, i.e., essentially "sodium-free".
Patienter med sjældne arvelige lidelser som fruktoseintolerans, glukose- galaktose malabsorption eller manglende sucrase- isomaltase bør ikke tage dette lægemiddel.
Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine.
Resultater fra en multidosis undersøgelse, som vurderede P450 substrater hos kroniske hepatitis C patienter, som modtog PegIntron (1, 5 µg/ kg) en gang ugentligt i 4 uger, viste en øgning i aktiviteten af CYP2D6 og CYP2C8/ 9.
Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly PegIntron (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of
Der blev ikke observeret ændringer i aktiviteten af CYP1A2, CYP3A4, eller N- acetyltransferase.
No change in activity of CYP1A2, CYP3A4, or N-acetyltransferase was observed.
Forsigtighed bør udvises ved administration af peginterferon alfa- 2b med lægemidler, som metaboliseres af CYP2D6 og CYP2C8/ 9, specielt dem med snævert terapeutisk vindue, såsom warfarin og phenytoin (CYP2C9) og flecainid (CYP2D6).
Caution should be used when administering peginterferon alfa-2b with medicines metabolised by CYP2D6 and CYP2C8/9, especially those with narrow therapeutic window, such as warfarin and phenytoin (CYP2C9) and flecainide (CYP2D6).
Disse fund kan delvist være relaterede til forbedret metabolisk kapacitet, som følge af reduceret hepatisk inflammation hos patienter i behandling med PegIntron.
These findings may partly relate to improved metabolic capacity due to reduced hepatic inflammation in patients undergoing treatment with PegIntron.
Forsigtighed tilrådes derfor, når PegIntron behandling mod kronisk hepatitis initieres hos patienter der behandles med lægemidler med et snævert terapeutisk vindue og følsomhed for mild metabolisk svækkelse af leveren.
Caution is therefore advised when PegIntron treatment is initiated for chronic hepatitis in patients treated with medication with a narrow therapeutic window and sensitive to mild metabolic impairment of the liver.
15% (95% Cl for AUC ratio estimat 103 – 128%).
In patients with chronic hepatitis C that were on stable methadone maintenance therapy and naïve to peginterferon alfa-2b, addition of 1.5 microgram/kg/week of PegIntron subcutaneously for 4 weeks increased R-methadone AUC by approximately 15% (95% Cl for AUC ratio estimate 103 – 128%).
Den kliniske signifikans af denne observation er ukendt; patienter bør imidlertid monitoreres for tegn og symptomer på øget sedativ effekt, såvel som respiratorisk depression.
The clinical significance of this finding is unknown; however, patients should be monitored for signs and symptoms of increased sedative effect, as well as respiratory depression.
Særligt hos patienter på en høj dosis metadon, bør risikoen for forlængelse af QTc overvejes.
Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
Samtidig infektion med HCV/ HIV Nukleosidanaloger:
HCV/HIV Co-infection Nucleoside analogs:
Anvendelse af nukleosid- analoger, alene eller i kombination med andre nukleosider, har resulteret i lactacidose.
Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.
Denne virkning kunne øge den risiko for lactacidose, der er forårsaget af purinnukleosid- analoger (såsom didanosin eller abacavir).
This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Tilfælde af mitokondrietoksicitet, særligt mælkesyreacidose og pancreatitis, nogle fatale, har været rapporteret (se ribavirin SPC).
Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see ribavirin SPC).
Til trods for at den nøjagtige mekanisme stadig mangler at blive belyst, er der set forværring af anæmi som følge af ribavirin, når zidovudin er en del af de lægemidler, der anvendes til behandling af HIV.
Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV, although the exact mechanism remains to be elucidated.
4. 4).
The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Det bør overvejes, hvorvidt zidovudin kan erstattes i en kombinationsbehandling med anti- retrovirale (ART) lægemidler, hvis en sådan allerede er etableret.
Consideration should be given to replacing zidovudine in a combination anti-retroviral treatment (ART) regimen if this is already established.
10 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
PegIntron anbefales kun til brug hos fertile kvinder, når de anvender effektiv antikonception under behandlingen.
PegIntron is recommended for use in fertile women only when they are using effective contraception during the treatment.
Der forligger ikke tilstrækkelige data om brugen af interferon alfa- 2b hos gravide kvinder.
There are no adequate data from the use of interferon alfa-2b in pregnant women.
Interferon alfa- 2b har vist sig at være abortfremkaldende hos primater.
Interferon alfa-2b has been shown to be abortifacient in primates.
Det vides ikke om indholdsstofferne i dette lægemiddel udskilles i modermælk.
It is not known whether the components of this medicinal product are excreted in human milk.
På grund af muligheden for bivirkninger hos det ammede barn, bør amning afbrydes før behandlingsstart.
Because of the potential for adverse reactions in breast-fed infants, breast-feeding should be discontinued prior to initiation of treatment.
Kombinationsterapi med ribavirin:
Combination therapy with ribavirin:
Ribavirin forårsager alvorlige medfødte misdannelser ved indgivelse under graviditet.
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 patienter, der får PegIntron i kombination med ribavirin.
Females of
Fertile kvinder og deres partnere skal begge anvende en effektiv antikonception under behandling og i 4 måneder efter behandlingen er afsluttet.
10 childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
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 Ribavirin SPC).
Patienter, der udvikler træthed, søvnighed eller forvirring under behandling med PegIntron advares mod at køre bil og betjene maskiner.
Patients who develop fatigue, somnolence or confusion during treatment with PegIntron are cautioned to avoid driving or operating machinery.
De hyppigste behandlingsrelaterede bivirkninger, der er rapporteret under kliniske undersøgelser med PegIntron i kombination med ribavirin, og som er set hos mere end halvdelen af forsøgspersonerne, var hovedpine, træthed og reaktion på injektionsstedet.
The most common treatment-related adverse reactions reported during clinical trials with PegIntron in combination with ribavirin, seen in more than half of the study subjects, were headache, fatigue, and injection site reaction.
Yderligere væsentlige bivirkninger, der er rapporteret hos mere end 25% af personerne omfattede myalgi, feber, asteni, alopeci, kvalme, anoreksi, vægttab, depression, irritabilitet og søvnløshed.
Additional important adverse reactions reported in more than 25% of subjects included myalgia, fever, asthenia, alopecia, nausea, anorexia, weight decrease, depression, irritability and insomnia.
Træthed, alopeci, kløe, kvalme, anoreksi, vægttab, irritabilitet og søvnløshed forekommer i en bemærkelsesværdig lavere frekvens hos patienter behandlet med PegIntron monoterapi sammenlignet med dem, der behandledes med kombinationsbehandling (se Tabel 4).
Fatigue, alopecia, pruritus, nausea, anorexia, weight decrease, irritability and insomnia occur at a notably lower rate in patients treated with PegIntron monotherapy compared to those treated with combination therapy (see Table 4).
Følgende behandlingsrelaterede bivirkninger blev rapporteret under behandling med PegIntron.
The following treatment-related adverse reactions were reported during therapy with PegIntron.
Reaktionerne er anført i tabel 4 efter systemorganklasse og hyppighed (meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100 til < 1/ 10), ikke almindelig (≥ 1/ 1. 000 til < 1/ 100), sjælden (≥ 1/ 10. 000 til < 1/ 1. 000), meget sjælden (< 1/ 10. 000) eller ikke kendt.
These reactions are listed in table 4 by system organ class and frequency (very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known.
11 Tabel 4
Table 4
Bivirkninger, der er rapporteret i kliniske undersøgelser eller efter markedsføring hos patienter behandlet med interferon alfa- 2b, inklusive PegIntron monoterapi eller PegIntron + ribavirin.
Adverse reactions reported in clinical trials or through post-marketing surveillance in patients treated with interferon alfa-2b, including PegIntron monotherapy or PegIntron + ribavirin.
Infektioner og parasitære sygdomme Meget almindelig:
Infection s and infestations Very common:
Virusinfektion *
Infection viral*
Svampeinfektion, bakterieinfektion inklusive sepsis, herpes simplex, otitis media
Fungal infection, bacterial infection including sepsis, herpes simplex, otitis media
Anæmi, leukopeni, trombocytopeni, lymfadenopati
Anaemia, leukopaenia, thrombocytopaenia, lymphadenopathy
Pure red cell aplasi
Pure red cell aplasia
Sarcoidose eller forværring af sarcoidose
Sarcoidosis or exacerbation of sarcoidosis
Akutte allergiske reaktioner inklusive angioødem, anafylaksi og anafylaktiske reaktioner inklusive anafylaktisk chok, idiopatisk trombocytopenisk purpura, trombotisk trombocytopenisk purpura, systemisk lupus erythematosus, vaskulitis, reumatoid arthritis og forværret reumatoid arthritis
Acute hypersensitivity reactions including angioedema, anaphylaxis and anaphylactic reactions including anaphylactic shock, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, systemic lupus erythematosus, vasculitis, arthritis rheumatoid and arthritis rheumatoid aggravated
Meget almindelig:
11 Metabolism and nutrition disorders Very common:
Hypokalcæmi, hyperurikæmi, tørst
Hypocalcemia, hyperuricemia, thirst
Depression, irritabilitet, søvnløshed, angst *, nedsat koncentration, emotionel labilitet *
Depression, irritability, insomnia, anxiety*, concentration impaired, emotional lability*
Aggressiv opførsel, adfærdsforstyrrelser, uro, nervøsitet, døsighed, søvnforstyrrelser, unormale drømme, nedsat libido, apati, øget appetit
Aggressive behaviour, behaviour disorder, agitation, nervousness, somnolence, sleep disorder, dreaming abnormal, decreased libido, apathy, appetite increased
Selvmordsforsøg, selvmordstanker
Attempted suicide, suicidal ideation
Psykose, hallucinationer
Psychosis, hallucination
Mani, bipolare lidelser
Mania, bipolar disorders
Hovedpine, mundtørhed *
Headache, mouth dry*