natgillin/translations-raw huggingface dataset:
Standardmetoder til forebyggelse af infektioner, der stammer fra anvendelse af lægemidler fremstillet fra humant blod eller plasma, omfatter udvælgelse af donorer, screening af individuelle donationer og 7 plasmapools for specifikke markører for infektion og inklusion af effektive fremstillingstrin for inaktivering/ fjernelse af vira.
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 markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Det anbefales kraftigt hver gang IntronA anvendes til en patient, at navn og batchnummer for præparatet registreres for at bevare en forbindelse mellem patienten og batchen af præparatet.
It is strongly recommended that every time that IntronA 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.
Kombinationsbehandling med med ribavirin:
Combination therapy with ribavirin:
Se tillige ribavirin produktresume hvis IntronA skal indgives i kombination med ribavirin hos patienter med kronisk hepatitis C.
Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C.
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. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Voksne patienter, som var i behandling med IntronA for kronisk hepatitis C, viste med mindre hyppighed unormal thyreoideafunktion, enten hypothyreoidisme eller hyperthyreoidisme.
Infrequently, adult patients treated for chronic hepatitis C with IntronA developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
I kliniske undersøgelser med IntronA- behandling udviklede 2, 8% af patienterne unormal thyreoideafunktion.
In clinical trials using IntronA therapy, 2.8% patients overall developed thyroid abnormalities.
Mekanismen med hvilken IntronA kan ændre thyreoideafunktionen er ukendt.
The mechanism by which IntronA may alter thyroid status is unknown.
Før påbegyndelse med IntronA- behandling af kronisk hepatitis C, bør thyroidstimulerende hormon (TSH) koncentrationen måles.
Prior to initiation of IntronA therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
IntronA- behandling kan påbegyndes, hvis TSH- koncentrationen kan holdes på normalt niveau med behandling.
IntronA treatment may be initiated if TSH levels can be maintained in the normal range by medication.
Hvis en patient under IntronA- behandling udvikler symptomer, der tyder på thyreoideadysfunktion, skal man undersøge TSH- koncentrationen.
Determine TSH levels if, during the course of IntronA therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
I tilfælde af thyreoideadysfunktion kan IntronA- behandling fortsættes, hvis TSH- koncentrationen kan holdes i normalområdet ved relevant behandling.
In the presence of thyroid dysfunction, IntronA treatment may be continued if TSH levels can be maintained in the normal range by medication.
Seponering af IntronA- behandling har ikke ændret thyreoideadysfunktion opstået under behandlingen (se også børn og unge, thyreoidea monitorering).
Discontinuation of IntronA therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
Supplerende monitorering specifikt for børn og unge Thyreoidea monitorering:
Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
Omtrent 12% af børn behandlet med interferon alfa- 2b og ribavirin udviklede en forøgning af TSH.
Approximately 12% of children treated with interferon alfa-2b and ribavirin developed increase in TSH.
Andre 4% havde et forbigående fald under den nedre normalgrænse.
Another 4% had a transient decrease below the lower limit of normal.
Inden initiering af IntronA behandling, skal TSH niveauet evalueres og mulige thyreoideaabnormaliteter detekteret på dette tidspunkt, skal behandles med konventionel behandling.
Prior to initiation of IntronA therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
IntronA behandling kan initieres, hvis TSH niveauet kan fastholdes indenfor normalområdet ved medicinsk behandling.
IntronA therapy may be initiated if TSH levels can be maintained in the normal range by medication.
Thyreoideadysfunktion under behandling med interferon alfa- 2b og ribavirin har været observeret.
Thyroid dysfunction during treatment with interferon alfa-2b and ribavirin has been observed.
Hvis thyreoideaabnormaliteter detekteres, bør patientens thyreoideastatus evalueres og behandles klinisk passende.
If thyroid abnormalities are detected, the patient’ s thyroid status should be evaluated and treated as clinically appropriate.
Børn og unge patienter bør monitoreres hver 3. måned for tegn på thyreoideadysfunktion (f. eks.
Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e. g.
Vækst og udvikling:
Growth and Development:
Under et 1- årigt behandlingsforløb var der et fald i hastigheden for lineær vækst (gennemsnitlig procentvist fald på 9%) og et fald i hastigheden for vægtøgning (gennemsnitlig procentvist fald på 13%).
During a 1-year course of therapy there was a decrease in the rate of linear growth (mean percentile decrease of 9%) and a decrease in the rate of weight gain (mean percentile decrease of 13%).
En generel reversering af disse tendenser sås under 6 måneders opfølgning efter behandling.
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.
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 treatment for more than 1 year.
5. 3).
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).
Risk/ benefit af den kombinerede anvendelse af interferon alfa- 2b og ribavirin bør derfor vurderes hos små børn før initiering af behandling.
Therefore, the risk/ benefit of the combined use of  8 interferon alfa-2b and ribavirin should be assessed in young children prior to the initiation of therapy.
Det 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.
8 Samtidig infektion med HCV/ HIV:
HCV/ HIV Coinfection:
Patienter, der samtidig er inficeret med HIV og modtager høj- aktiv anti- retroviral terapi (HAART), kan have øget risiko for at udvikle mælkesyreacidose.
Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Forsigtighed bør udvises, når IntronA og ribavirin adderes til HAART terapi (se ribavirin produktresume).
Caution should be used when adding IntronA and ribavirin to HAART therapy (see ribavirin SPC).
Co- inficerede patienter med fremskreden cirrhose, der får HAART, kan have øget risiko for nedsat leverfunktion og død.
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
Samtidig kemoterapi:
Concomitant chemotherapy:
Indgift af IntronA i kombination med andre kemoterapeutika (såsom Ara- C, cyclophosphamid, doxorubicin, teniposid) kan føre til forøget risiko for toksicitet (sværhedsgrad og varighed), som kan være livstruende eller fatal som et resultat af det samtidigt indgivne lægemiddel.
Administration of IntronA in combination with other chemotherapeutic agents (e. g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a result of the concomitantly administered medicinal product.
4. 5).
Because of the risk of increased toxicity, careful adjustments of doses are required for IntronA and for the concomitant chemotherapeutic agents (see section 4.5).
Dentale og parodontale lidelser:
Dental and periodontal disorders:
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 IntronA- 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 patients prior to and periodically during systemic treatment with IntronA.
Hvis ALAT blusser op under IntronA- behandling til større end eller lig med 2 gange basisniveau, kan man fortsætte IntronA - behandling med mindre der er tegn og symptomer på leversvigt.
If ALT flares during IntronA therapy to greater than or equal to 2 times baseline, IntronA therapy may be continued unless signs and symptoms of liver failure are observed.
Under ALAT opblussen skal man foretage leverfunktionsundersøgelser:
During ALT flare, liver function tests:
ALAT, protrombintid, basisk fosfatase, albumin og bilirubin med to ugers interval.
ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin must be monitored at two-week intervals.
Effekt på fertilitet:
Effect on fertility:
5. 3).
Interferon may impair fertility (see section 4.6 and section 5.3).
9 Interferoner kan påvirke den oksidative metaboliske proces.
 9 Interferons may affect the oxidative metabolic process.
Dette skal tages i betragtning ved samtidig behandling med præparater, der metaboliseres på denne måde, såsom xanthin- derivaterne theophyllin eller aminophyllin.
This must be considered during concomitant therapy with medicinal products metabolised by this route, such as the xanthine derivatives theophylline or aminophylline.
Ved samtidig behandling med xanthin- præparater bør serum- theophyllin- niveau monitoreres og dosis om nødvendigt justeres.
During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dosage adjusted if necessary.
Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet observeret hos interferon- alfa behandlede patienter, inklusive de, som er behandlet med IntronA.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
4. 4).
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.4).
4. 4).
Administration of IntronA in combination with other chemotherapeutic agents (e. g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration) (see section 4.4).
(Se tillige ribavirin produktresume hvis IntronA skal indgives i kombination med ribavirin hos patienter med kronisk hepatitis C).
(Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C).
Nedsatte serum østradiol og progesteron koncentrationer har været rapporteret hos kvinder behandlet med human leukocyt- interferon.
Decreased serum estradiol and progesterone concentrations have been reported in women treated with human leukocyte interferon.
Der foreligger 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.
Se ribavirin produktresume vedrørende ribavirinrelaterede bivirkninger, hvis IntronA skal indgives sammen med ribavirin til patienter med kronisk hepatitis C.
See ribavirin SPC for ribavirin-related undesirable effects if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C.
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 rapporterede bivirkninger feber, træthed, hovedpine og myalgi.
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.
I Tabel 1 er hyppigheden af patienter, der rapporterede 10 (behandlingsrelaterede) bivirkninger, vist.
In Table 1 the frequency of patients reporting (treatment related) undesirable effects is
Dette bygger på kliniske undersøgelser af naive patienter, der blev behandlet i et år.
 10 presented from clinical trials in naïve patients treated for one year.
De bivirkninger, der er listet i Tabel 1, er baseret på erfaringer fra kliniske undersøgelser og post- marketing.
The adverse reactions listed in Table 1 are based on experience from clinical trials and post- marketing.
Indenfor systemorganklasserne, er bivirkningerne listet under overskrifter efter hyppighed under anvendelse af følgende kategorier: meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); ikke almindelig (≥1/ 1. 000, < 1/ 100); sjælden (≥1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000); ikke kendt.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rarely (≥ 1/ 10,000, < 1/ 1,000); very rarely (< 1/ 10,000); not known.
Bivirkninger rapporteret ved kliniske undersøgelser eller efter markedsføring af IntronA alene eller i kombination med ribavirin Systemorganklasser Infektioner og parasitære sygdomme
Adverse reactions reported during clinical trials or following the marketing use of IntronA alone or in combination with ribavirin System Organ Class Infections and infestations
Pharyngitis *, viral infektion * Bronkitis, sinuitis, herpes simplex (resistent), rhinitis Bakterieinfektion Lungebetændelse§, sepsis
Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Bacterial infection Pneumonia§, sepsis
Leukopeni Thrombocytopeni, lymphadenopati, lymphopeni Aplastisk anæmi Pure red cell aplasi, idiopatisk thrombocytopenisk purpura, thrombotisk thrombocytopenisk purpura
Leukopaenia Thrombocytopaenia, lymphadenopathy, lymphopenia Aplastic anaemia Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Sarcoidose, forværring af sarcoidose Systemisk lupus erythematose, vaskulitis, reumatoid arthritis (ny eller forværret), Vogt- Koyanagi- Harada syndrom, akutte overfølsomhedsreaktioner inklusive nældefeber, angioødem, bronkokonstriktion, anafylakse§
Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid arthritis (new or aggravated), Vogt-Koyanagi-Harada syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis§
Psykiske forstyrrelser§
Very rarely: § Psychiatric disorders
Anoreksi Hypokalcæmi, dehydrering, hyperuricæmi, tørst Hyperglykæmi, hypertriglyceridæmi§, øget appetit
Anorexia Hypocalcaemia, dehydration, hyperuricemia, thirst Hyperglycaemia, hypertriglyceridaemia§, increased appetite
Depression, søvnløshed, angst, følelsesmæssig ustabilitet *, agitation, nervøsitet
Depression, insomnia, anxiety, emotional lability*, agitation, nervousness
Forvirring, søvnforstyrrelser, nedsat libido Selvmordstanker Selvmord, selvmordsforsøg, aggressiv adfærd (nogle gange rettet mod andre), psykose inklusive hallucinationer
Confusion, sleep disorder, libido decreased Suicide ideation Suicide, suicide attempts, aggressive behaviour (sometimes directed against others), psychosis including hallucinations
Ikke kendt: § Nervesystemet
Nervous system disorders§
Morderiske tanker, ændring af mental tilstand§, mani, bipolare lidelser
Homicidal ideation, mental status change§, mania, bipolar disorders
Svimmelhed, hovedpine, koncentrationsbesvær, mundtørhed Tremor, paresthesi, hypoesthesi, migræne, rødmen, søvnighed, smagsforstyrrelser
Dizziness, headache, concentration impaired, mouth dry Tremor, paresthesia, hypoesthesia, migraine, flushing, somnolence, taste perversion
Perifer neuropati Cerebrovaskulær blødning, cerebrovaskulær iskæmi, kramper, bevidsthedsforstyrrelse, encephalopati
Peripheral neuropathy Cerebrovascular haemorrhage, cerbrovascular ischaemia, seizure, impaired consciousness, encephalopathy
11 Øjne Meget almindelig:
Very common:
Sløret syn Konjunktivitis, unormalt syn, forstyrrelse af tårekanalen, øjensmerte
Vision blurred Conjunctivitis, vision abnormal, lacrimal gland disorder, eye pain
Retinal blødning§, retinopatier (inklusive makulært ødem), retinal arterie - eller veneobstruktion§, optisk neuritis, papilødem, tab af synsskarphed eller synsfelt, slørede pletter§
Retinal haemorrhages§, retinopathies (including macular
Almindelig:

Palpitation, tachycardi Cardiomyopati Myocardieinfarkt, hjerteiskæmi Arytmi
Palpitation, tachycardia Cardiomyopathy Myocardial infarction, cardiac ischaemia Arrhythmia
Hypertension Perifer iskæmi, hypotension§
Hypertension Peripheral ischaemia, hypotension§
Dyspnø *, hoste * Epistaxis, respiratorisk forstyrrelse, forstoppet næse, rhinorrhea, hoste uden slim
Dyspnoea*, coughing* Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive
Lungeinfiltrationer§, lungebetændelse§
Pulmonary infiltrates§, pneumonitis§
Kvalme/ opkastning, mavesmerte, diarré, stomatitis, dyspepsi Ulcerativ stomatitis, smerte i øvre højre kvadrant, glossitis, tandkødsbetændelse, forstoppelse, løs afføring
Stomatitis ulcerative, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools
Pancreatitis, iskæmisk colitis, ulcerativ colitis, blødning af tandkød
Pancreatitis, ischaemic colitis, ulcerative colitis, gingival bleeding
Alopeci, pruritus *, tør hud *, udslæt *, øget svedtendens Psoriasis (ny eller forværret) §, maculopapulært udslæt, erytematøst udslæt, eksem, erytem, hudlidelser
Alopecia, pruritus*, skin dry*, rash*, sweating increased Psoriasis (new or aggravated)§, rash maculopapular, rash erythematous, eczema, erythema, skin disorder
Stevens Johnson syndrom, toksisk epidermal nekrolyse, erytem multiforme
Stevens Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
Myalgi, arthralgi, smerter i bevægeapparatet Arthritis Rhabdomyolyse, myositis, benkramper, rygsmerte
Myalgia, arthralgia, musculoskeletal pain Arthritis Rhabdomyolysis, myositis, leg cramps, back pain
12 Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
Very common:
Inflammation på injektionsstedet, reaktion på injektionsstedet *, træthed, stivhed, feber§, influenzalignende symptomer§, asteni, irritabilitet, brystsmerte, utilpashed
Injection site inflammation, injection site reaction*, fatigue, rigors, fever§, flu-like symptoms§, asthenia, irritability, chest pain, malaise
Smerte på injektionsstedet Nekrose på injektionsstedet, ansigtsødem
Injection site pain Injection site necrosis, face oedema
4. 4
* These events were only common with IntronA alone § See section 4.4
For eksempel var incidensen af træthed, feber, myalgi, neutropeni/ anæmi, anoreksi, kvalme og opkastning, diarré, kulderystelser, influenzalignende symptomer, depression, alopeci, smagsforstyrrelser og svimmelhed i en undersøgelse af højdosis adjuverende IntronA behandling hos patienter med melanom større end i hepatitis C undersøgelserne.
For example, in a trial of high-dose adjuvant IntronA treatment in patients with melanoma, incidences of fatigue, fever, myalgia, neutropaenia/anaemia, anorexia, nausea and vomiting, diarrhoea, chills, flu- like symptoms, depression, alopecia, altered taste, and dizziness were greater than in the hepatitis C trials.
Sværhedgraden steg også med højdosis behandling (WHO Grad 3 og 4, i henholdsvis 66% og 14% af patienterne) sammenlignet med den lette til moderate sværhedsgrad, der sædvanligvis var forbundet med lavere doser.
Severity also increased with high dose therapy (WHO Grade 3 and 4, in 66% and 14% of patients, respectively), in comparison with the mild to moderate severity usually associated with lower doses.
4. 4).
Cardiomyopathy, that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4).
4. 4).
A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies (see also section 4.4).
Klinisk signifikante laboratorieafvigelser er hyppigst set med doser større end 10 millioner IE dagligt og omfatter reduktion i antal af granulocytter og hvide blodlegemer, nedsat hæmoglobinniveau og trombocyttal, øgning i basisk fosfatase, LDH, serum- kreatinin og serum- urinstof.
Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
Forøgelse i serum ALAT/ ASAT (SGPT/ SGOT) - koncentrationer er blevet observeret som en abnormitet hos nogle non- hepatitis personer samt hos nogle patienter med kronisk hepatitis B samtidig med udskillelse af viral DNAp.
Increase in serum ALT/AST (SGPT/SGOT) levels have been noted as an abnormality in some non-hepatitis subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp.
4. 4.
For safety with respect to transmissible agents, see section 4.4.
Børn
Paediatric population
Børn og unge - kronisk hepatitis C I kliniske undersøgelser med 118 børn og unge i alderen 3 til 16 år afbrød 6% behandling på grund af bivirkninger.
Children and adolescents – Chronic Hepatitis C In clinical trials of 118 children or adolescents 3 to 16 years of age, 6% discontinued therapy due to adverse events.
4. 4).
In general, the adverse event profile in the limited paediatric population studied was similar to that observed in adults, although there is a paediatric specific concern regarding growth inhibition as decrease in height (mean percentile decrease of growth velocity of 9%) and weight (mean percentile decrease of 13%) percentile were observed during treatment (see section 4.4).
Derudover blev selvmordstanker eller - forsøg rapporteret hyppigere sammenlignet med voksne patienter (2, 4% mod 1%) under behandling og i den 6 måneder lange opfølgningsperiode efter behandling.
Furthermore, 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.
4. 4).
As in adult patients, children and adolescents also experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence) (see section 4.4).