natgillin/translations-raw huggingface dataset:
Forstyrrelser i immunsystemet Administration af cytokiner til patienter, der lider af monoklonal gammopati, er blevet forbundet med udvikling af systemisk kapillær lækage- syndrom med choklignende symptomer og dødelig udgang.
Immune system disorders The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Gastrointestinale sygdomme I sjældne tilfælde sås pancreatitis ved brug af Extavia, ofte i forbindelse med hypertriglyceridæmi.
Gastrointestinal disorders In rare cases, pancreatitis was observed with Extavia use, often associated with hypertriglyceridaemia.
4. 3).
3 Nervous system disorders Extavia should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
Det er kendt, at depression og selvmordstanker kan opstå med øget frekvens hos patienter med dissemineret sklerose og i forbindelse med brug af interferon.
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Patienter, der behandles med Extavia, skal rådes til straks at meddele symptomer på depression og/ eller selvmordstanker til deres læge.
Patients treated with Extavia should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
4. 3 og 4. 8).
Cessation of therapy with Extavia should be considered (see also sections 4.3 and 4.8).
4. 5 og 4. 8).
Extavia should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti- epileptics (see sections 4.5 and 4.8).
Dette produkt indeholder humant albumin og har dermed en potentiel risiko for at overføre virale sygdomme.
This product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Risiko for overførsel af Creutzfeld- Jacobs sygdom kan ikke udelukkes.
A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.
Laboratorietests Regelmæssige thyroideafunktionsprøver anbefales til patienter med thyroideaforstyrrelser i anamnesen eller efter klinisk indikation.
Laboratory tests Thyroid function tests are recommended regularly in patients with a history of thyroid dysfunction or as clinically indicated.
Ud over de laboratorietests, som normalt er nødvendige til monitorering af patienter med dissemineret sklerose, anbefales fuldstændig blodtælling og differentialtælling af hvide blodceller og blodpladetal samt blodkemi, herunder leverfunktionstests (f. eks. aspartat aminotransferase serum glutamin - oksalsyre transaminase (SGOT), alanin aminotransferase serum glutamat pyruvat transaminase (SGPT) og gamma- glutamyltransferase) før behandlingen indledes med regelmæssige intervaller efter Extavia- behandlingen og med mellemrum derefter, hvis der ikke foreligger nogen kliniske symptomer.
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e. g. aspartate aminotransferase serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase serum glutamate pyruvate transaminase (SGPT) and gamma glutamyltransferase), are recommended prior to initiation and at regular intervals following introduction of Extavia therapy, and then periodically thereafter in the absence of clinical symptoms.
Det kan blive nødvendigt at intensivere monitoreringen af det totale blodcelletal med differential - og blodpladetal hos patienter, der lider af anæmi, thrombocytopeni og/ eller leukopeni.
Patients with anaemia, thrombocytopenia or leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Sygdomme i lever og galdeveje Asymptomatiske stigninger i serumtransaminaser, der i de fleste tilfælde var milde og forbigående, forekom under kliniske studier hyppigt hos patienter, der blev behandlet med Extavia.
Hepatobiliary disorders Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Extavia during clinical trials.
Som ved andre beta- interferoner er der i sjældne tilfælde indberettet alvorlige leverskader, herunder tilfælde af leversvigt, hos patienter i behandling med Extavia.
As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking Extavia.
De alvorligste tilfælde forekom ofte hos patienter, i behandling med andre lægemidler eller stoffer, der er kendt for at være forbundet med levertoksicitet eller ved andre samtidige medicinske tilstande (f. eks. metastaserende malignitet, alvorlig infektion og sepsis eller alkoholmisbrug).
The most serious events often occurred in patients exposed to other medicinal products or substances known to be associated with hepatotoxicity or in the presence of co-morbid medical conditions (e. g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Det bør overvejes at stoppe behandlingen med Extavia, hvis koncentrationerne stiger signifikant, eller hvis der er kliniske symptomer på f. eks. gulsot.
Withdrawal of Extavia should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundices.
Sygdomme i nyre og urinveje Når patienter med svært nedsat nyrefunktion behandles med interferon beta, bør der udvises forsigtighed og en nøje monitorering bør overvejes.
Renal and urinary disorders Caution should be used and close monitoring considered when administering interferon beta to patients with severe renal failure.
Hjertesygdomme Extavia skal også anvendes med forsigtighed til patienter, som lider af hjertesygdomme, Patienter med tidligere alvorlig hjertesygdom, som for eksempel kongestivt hjertesvigt, lidelser i kranspulsåren eller arytmi, bør monitoreres for forværring af den kardiologiske tilstand, især under den indledende behandling med Extavia.
Patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia, should be monitored for worsening of their cardiac condition, particularly during initiation of treatment with Extavia.
4 Extavia ikke har nogen direkte kardiologisk toksicitet, men symptomer på det influenzalignende syndrom, som forbindes med beta- interferoner, kan vise sig at belaste patienter med tidligere alvorlige hjertesygdomme.
4 While Extavia does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
I perioden efter markedsføringen er der modtaget meget sjældne rapporter om forværret hjertetilstand hos patienter med tidligere hjertesygdom, som midlertidigt blev forbundet med den indledende behandling med Extavia.
During the post-marketing period very rare reports have been received of worsening of cardiac status in patients with pre-existing significant cardiac disease temporarily associated with the initiation of Extavia therapy.
Almene lidelser og reaktioner på indgivelsesstedet Der kan forekomme alvorlige overfølsomhedsreaktioner (sjældne, men svære akutte reaktioner som bronkospasmer, anafylakse og urticaria).
General disorders and administration site conditions Serious hypersensitivity reactions (rare but severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Hvis reaktionerne er svære, bør Extavia- behandlingen seponeres, og passende medicinsk behandling indledes.
If reactions are severe, Extavia should be discontinued and appropriate medical intervention instituted.
Af og til kan debridering og mindre hyppigt hudtransplantation blive nødvendig, og heling kan tage op til 6 måneder.
Occasionally debridement and, less often, skin grafting are required and healing may take up to 6 months.
Hvis patienten oplever bristning af huden, som kan være forbundet med opsvulmen eller drænage af væske fra injektionsstedet, bør patienten rådgives til at søge læge, før injektionerne med Extavia fortsættes.
If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with his/ her physician before continuing injections with Extavia.
For at minimere risikoen for nekrose på injektionsstedet, bør patienten anbefales at: − anvende en aseptisk injektionsteknik − skifte injektionssted for hver dosis.
To minimise the risk of injection site necrosis patients should be advised to: − use an aseptic injection technique, − rotate the injection sites with each dose.
I pivotalforsøget med patienter med en enkelt klinisk hændelse, der tyder på dissemineret sklerose, anvendte størstedelen af patienterne en autoinjektor.
In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an auto-injector was used in the majority of patients.
Patientens selv- injektionsprocedure bør gennemgås regelmæssigt, især hvis der er opstået reaktioner på injektionsstedet.
The procedure for self-administration by the patient should be reviewed periodically, especially if injection site reactions have occurred.
Immunogenicitet Som med alle terapeutiske proteiner er der en mulighed for immunogenicitet.
Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity.
Der blev indsamlet serumprøver i kontrollerede kliniske undersøgelser hver 3. måned for at monitorere udviklingen af antistoffer mod Extavia.
Serum samples in controlled clinical trials were collected every 3 months for monitoring of development of antibodies to Extavia.
Af disse patienter gik mellem 43% og 55% over til en stabil, negativ antistofstatus (baseret på to negative titreringer i træk) i løbet af det respektive studies efterfølgende observationsperiode.
In the different controlled clinical trials, between 23% and 41% of the patients developed serum interferon beta-1b neutralising activity confirmed by at least two consecutive positive titres; of these patients, between 43% and 55% converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the respective study.
Nogle analyser antyder, at denne virkning kan være større hos patienter med højere titreringsniveauer af neutraliserende aktivitet.
Some analyses suggest that this effect might be larger in patients with higher titre levels of neutralising activity.
I denne periode blev
In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (88) of the patients treated immediately with Extavia; of these, 47% (41) returned to negative status over a 3-year period.
5 udviklingen af neutraliserende aktivitet ikke forbundet med en reduktion i den kliniske effekt (med hensyn til tidsrummet før klinisk definitiv dissemineret sklerose (CDMS), samt tid for bekræftet EDSS- progression).
Within this period, the development of neutralising activity was not associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), and time to confirmed EDSS progression).
Nye bivirkninger er ikke blevet relateret til udviklingen af neutraliserende aktivitet.
5 New adverse events have not been associated with the development of neutralising activity.
Det er blevet bevist in vitro, at Extavia krydsreagerer med naturlig interferon beta.
It has been demonstrated in vitro that Extavia cross-reacts with natural interferon beta.
IE) Extavia - givet hver anden dag til patienter med dissemineret sklerose - er ukendt.
The effect of alternate-day administration of 250 microgram (8.0 million IU) of Extavia on drug metabolism in multiple sclerosis patients is unknown.
Kortikosteroid - eller ACTH- behandling af relapser i perioder på op til 28 dage har været vel tolereret hos patienter, der fik Extavia.
Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Extavia.
Der bør udvises forsigtighed, når Extavia anvendes samtidig med medikamenter, der har et smalt terapeutisk indeks, og som hovedsageligt er afhængige af cytokrom P450- systemet til clearance. f. eks. antiepileptika.
Caution should be exercised when Extavia is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e. g. anti-epileptics.
Graviditet Der er begrænset information om anvendelsen af Extavia under graviditet.
Pregnancy There is limited information on the use of Extavia in pregnancy.
Kvinder i den fødedygtige alder Kvinder i den fødedygtige alder bør anvende prævention.
Women of child-bearing potential Women of child-bearing potential should take appropriate contraceptive measures.
5. 3).
If the patient becomes pregnant or plans to become pregnant while taking Extavia, she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Risikoen for alvorlige relapser efter seponering af Extavia bør i tilfælde af graviditet hos patienter med hyppige relapser før behandlingsstart vægtes mod den mulige øgede risiko for spontan abort.
In patients with a high relapse rate before treatment started, the risk of a severe relapse following discontinuation of Extavia in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
Amning Det vides ikke, om interferon beta- 1b udskilles i modermælken.
Lactation It is not known whether interferon beta-1b is excreted in human milk.
6 Hos modtagelige patienter kan brugen af Extavia påvirke centralnervesystemet og nedsætte evnen til at føre bil eller betjene maskiner.
Central nervous system-related adverse events associated with the use of Extavia might influence the ability to drive and use machines in susceptible patients.
a) Bivirkninger er almindelige ved behandlingsstart, men de aftager generelt ved fortsat behandling.
a) At the beginning of treatment adverse reactions are common but in general they subside with further treatment.
Rødme, hævelse, misfarvning, inflammation, smerte, overfølsomhed, nekrose og uspecifikke reaktioner var signifikant forbundet med Extaviadosen 250 mikrogram (8 millioner IE).
Redness, swelling, discoloration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8 million IU) Extavia treatment.
4. 2).
Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Extavia (see section 4.2).
Influenzalignende symptomer kan også reduceres ved administrering af ikke - steroide antiinflammatoriske lægemidler.
Flu-like symptoms may also be reduced by administration of non- steroidal anti-inflammatory medicinal products.
b) Følgende liste over bivirkninger er baseret på rapporter fra kliniske forsøg (Tabel 1, bivirkninger og uregelmæssigheder i laboratorieresultater) og fra overvågning foretaget efter markedsføringen af Extavia (Tabel 2, hyppighed baseret på uopfordrede rapporter om bivirkninger, klassificeret som 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 og meget sjælden < 1/ 10. 000).
b) The following adverse event listing is based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from the post-marketing surveillance (Table 2, reporting rates based on spontaneous adverse drug reaction reports classified as 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) of Extavia use.
Erfaringer med Extavia hos patienter med dissemineret sklerose (DS) er begrænset, og derfor er bivirkninger, som opstår meget sjældent, muligvis endnu ikke observeret:
Experience with Extavia in patients with multiple sclerosis (MS) is limited, consequently those adverse events which occur very rarely may not yet have been observed.
Bivirkninger og uregelmæssigheder i laboratorieresultater med hyppigheder ≥10% og de respektive procentdele under placebo; signifikant associerede bivirkninger < 10%
Adverse events and laboratory abnormalities with incidence rates ≥ 10% and the respective percentages under placebo; significantly associated side effects < 10%
hændelse som
System Organ
progressiv progressiv
Class Single Event Secondary Secondary suggestive of Progressive Progressive
remitterende
Relapsing- Remitting
Bivirkninger og
Adverse Event and
dissemineret dissemineret
Multiple Multiple Multiple Sclerosis Sclerosis Sclerosis
uregelmæssigheder i
Laboratory Abnormalities
dissemineret
(BENEFIT)
sklerose sklerose
(European
sklerose
(North
sklerose
Study)
(Europæisk
American Study)
(Nord -
Extavia
(BENEFIT)
Extavia
amerikansk
Extavia
undersøgelse)
Extavia
Extavia Extavia Extavia
Infections and infestations
250
250 microgram (Placebo) n=292 (n=176)
mikrogram 250 mikrogram 250 mikrogram (Placebo) (Placebo) (Placebo)
250 microgram (Placebo) n=360 (n=358)
250 mikrogram (Placebo)
250 microgram (Placebo) n=317 (n=308)
n=124 (n=123)
250 microgram (Placebo) n=124 (n=123)
Infektiøse og parasitære sygdomme Infektion Absces
Infection Abscess
Sygdomme i blod - og lymfesystem Reduceret lymfocyttælling (< 1500/ mm3°) × Λ °
Blood and lymphatic system disorders Lymphocyte count decreased (< 1500/ mm³) × Λ °
53
53% (28%)
Reduceret absolut neutrofiltælling (< 1500/ mm3) × Λ * °
Absolute neutrophil count decreased (< 1500/ mm³) × Λ *°
Reduceret antal hvide blodceller (< 3000/ mm3) × Λ * °
White blood cell count decreased (< 3000/ mm³) × Λ *°
7 Systemorganklasse
Lymphadenopathy
Enkelt
1% (1%)
Sekundær Sekundær
3% (1%)
Recidiverende -
11% (5%)
hændelse som
14% (11%)
progressiv progressiv
Metabolism and nutrition disorders Blood glucose decreased (< 55 mg/ dl) ×
remitterende
3% (5%)
Bivirkninger og
27% (27%)
tyder på
5% (3%)
dissemineret dissemineret
15% (13%)
dissemineret
7 System Organ Class
uregelmæssigheder i
Single Event suggestive of
dissemineret
Secondary Secondary Progressive Progressive
sklerose sklerose
Relapsing- Remitting
sklerose
Adverse Event and Laboratory Abnormalities
laboratorieresultater
Multiple Sclerosis (BENEFIT)
sklerose
Multiple Multiple Sclerosis Sclerosis (European (North Study) American Study)
(Europæisk
Multiple Sclerosis
undersøgelse)
Extavia Extavia
Extavia Extavia Extavia
Psychiatric disorders
Depression Angst Sygdomme i nervesystemet
Depression Anxiety Nervous system disorders
HovedpineΛ Svimmelhed Søvnløshed Migræne Paræstesi Øjensygdomme
Headache Λ Dizziness Insomnia Migraine Paraesthesia Eye disorders
Conjunctivitis Λ
Conjunctivitis Λ
Synsforstyrrelser Sygdomme i det ydre og det indre øre
Abnormal vision
Ørepine Hjertesygdomme
Ear and labyrinth disorders Ear pain Cardiac disorders
Palpitation * Karsygdomme
Palpitation * Vascular disorders
Sygdomme i åndedrætsorganer, brysthule og mediastinum Infektion i de øvre luftveje
Respiratory, thoracic and mediastinal disorders Upper respiratory infection
Sinuitis Forøget hoste Dyspnø * Gastrointestinale sygdomme
Sinusitis Cough increased Dyspnoea * Gastrointestinal disorders
Forstoppelse Kvalme OpkastningΛ Mavesmerter Sygdomme i lever og galdeveje
Constipation Nausea Vomiting Λ Abdominal pain ° Hepatobiliary disorders
Øget alaninaminotransferase (SGPT > 5 gange baseline) ×Λ * °
Alanine aminotransferase increased (SGPT > 5 times baseline) × Λ * °
8 Systemorganklasse
Aspartate aminotransferase increased (SGOT > 5 times baseline) × Λ * °
Enkelt
6% (1%)
Sekundær Sekundær
4% (1%)
Recidiverende -
2% (1%)
hændelse som
4% (0%)
progressiv progressiv
Skin and subcutaneous tissue
remitterende
disorders
Bivirkninger og
Skin disorder Λ
tyder på
1% (0%)
dissemineret dissemineret
4% (4%)
dissemineret
19% (17%)
uregelmæssigheder i
6% (8%)
dissemineret
Rash °
sklerose sklerose
11% (3%)
sklerose
20% (12%)
laboratorieresultater
26% (20%)
sklerose
27% (32%)
(Europæisk
8 System Organ Class
(Nord -
Single Event suggestive of
(BENEFIT)
Relapsing- Remitting
undersøgelse)
Adverse Event and Laboratory Abnormalities
amerikansk
Multiple Sclerosis (BENEFIT)
undersøgelse)
Multiple Sclerosis
Extavia Extavia Extavia
Extavia Extavia Extavia
250
250 microgram 250 microgram (Placebo) (Placebo) n=292 (n=176) n=360 (n=358)
mikrogram 250 mikrogram 250 mikrogram
250 microgram (Placebo) n=317 (n=308)
250
250 microgram (Placebo) n=124 (n=123)
Sygdomme i bevægeapparatet og bindevæv Hypertoni° Myalgi * ° Myasteni
Musculoskeletal and connective tissue disorders Hypertonia° Myalgia * ° Myasthenia
10% (7%)
10% (7%)
26% (24%)
26% (24%)
36% (37%)
36% (37%)
Smerter i ekstremiteter Sygdomme i nyre og urinveje
Pain in extremity Renal and urinary disorders
6% (3%)
6% (3%)
14% (12%)
14% (12%)
(0%)
0% (0%)
Urinretention x
Urinary retention
Positiv urinprotein (> 1+)
Urinary protein positive (> 1+)×
Lidelser i det reproduktive system og brystsygdomme Dysmenoré
Reproductive system and breast disorders Dysmenorrhoea
Menstruationsforstyrrelse *
Menstrual disorder *
Almene lidelser og reaktioner på indgivelsesstedet Reaktion ved injektionssted (forskellige typer) Λ * ° §
General disorders and administration site conditions Injection site reaction (various kinds) Λ * ° §
Nekrose ved injektionssted * °
Injection site necrosis & Λ
Influenzalign. symptomer & Λ * °
* °
44% (18%)
1% (0%)
61% (40%)
5% (0%)
43% (33%)
6% (0%)
52% (28%)
5% (0%)
Feber Λ * ° Smerte Smerte i brystet Perifert ødem Asteni * Kuldegysninger Λ * ° *
Flu-like symptoms Fever Λ * ° Pain Chest pain ° Peripheral oedema Asthenia * Λ
Perspiration Ubehag *
Chills * ° Sweating * Malaise * ×
9 Systemorganklasse
Laboratory abnormality Λ Significantly associated with Extavia treatment for patients with first event suggestive of MS, p < 0.05 * Significantly associated with Extavia treatment for RRMS, p < 0.05 ° Significantly associated with Extavia treatment for SPMS, p < 0.05 § Injection site reaction (various kinds) comprises all adverse events occurring at the injection site, i. e. the following terms: injection site haemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site oedema, and injection site atrophy & “ Flu-like symptom complex” denotes flu syndrome and/ or a combination of at least two adverse events from fever, chills, myalgia, malaise, sweating.
Enkelt
9 The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
hændelse som
Table 2
progressiv progressiv
Reporting rates (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) based on spontaneous adverse drug reaction reports
remitterende
System Organ Class
Bivirkninger og
Very common Common Uncommon Rare ≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000
tyder på
Blood and
dissemineret dissemineret
Anemia, Lymphadenopathy
uregelmæssigheder i
lymphatic system disorders Immune system disorders Endocrine disorders
sklerose sklerose
Thrombocytopenia, Leukopenia
laboratorieresultater
Anaphylactic reactions Hyperthyroidism, Hypothyroidism, Thyroid disorder
undersøgelse)
Metabolism and nutrition disorders
Extavia Extavia Extavia
Blood triglycerides increased, Anorexia
mikrogram 250 mikrogram 250 mikrogram
Psychiatric disorders
mikrogram
Depression (see also section 4.4)
(Placebo) (Placebo) (Placebo)
Confusion, Anxiety, Emotional lability, Suicide attempt (see also section 4.4)
Laboratorieanormalitet
Nervous system disorders
n=317 (n=308)
Convulsion
n=124 (n=123)
Cardiac disorders
Den mest relevante MedDRA- term er anvendt til at beskrive en vis reaktion og dens synonymer og relaterede tilstande.
Cardiomyopathy, Tachycardia, Palpitation