natgillin/translations-raw huggingface dataset:
Thrombocytopeni er rapporteret med store fald i blodpladetal.
There have been reports of thrombocytopenia, with profound decreases in platelet count.
Som ved andre beta- interferoner er der i sjældne tilfælde indberettet alvorlige leverskader, herunder tilfælde med leversvigt, hos patienter under behandling med Betaferon.
As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking Betaferon.
De alvorligste tilfælde forekom ofte hos patienter, under behandling med andre lægemidler eller stoffer, der er kendt for at være forbundet med levertoksicitet eller ved andre samtidige medicinske tilstande (f. eks. metastaserende ondartet sygdom, alvorlig infektion og sepsis, alkoholmisbrug).
The most serious events often occurred in patients exposed to other drugs or substances known to be associated with hepatotoxicity or in the presence of comorbid medical conditions (e. g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Inddragelse af Betaferon bør overvejes, hvis koncentrationerne stiger signifikant, eller hvis der er kliniske symptomer på f. eks. gulsot.
Withdrawal of Betaferon should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundices.
Der bør udvises forsigtighed, og nøje monitorering bør overvejes, når Interferon beta gives til patienter med svært nedsat nyrefunktion.
Caution should be used and close monitoring considered when administering Interferon beta to patients with severe renal failure.
Hjertesygdomme
4 Cardiac disorders
Det skal også anvendes med forsigtighed til patienter som lider af tidligere eksisterende hjertesygdomme, Patienter med tidligere eksisterende signifikant hjertesygdom, som for eksempel kongestiv hjertesvigt, lidelser i kranspulsåren eller arytmi, bør monitoreres for forværring af den kardiologiske tilstand, især under den indledende behandling med Betaferon.
It should also be used with caution in patients who suffer from pre-existing cardiac disorders, 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 Betaferon.
I perioden efter markedsføringen er der modtaget
While Betaferon 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.
4 meget sjældne rapporter om forværret hjertetilstand hos patienter med tidligere eksisterende signifikant hjertesygdom, som midlertidigt blev forbundet med den indledende Betaferon- behandling.
During the postmarketing 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 Betaferon therapy.
Hvis reaktionerne er svære, bør Betaferon- behandlingen seponeres, og passende medicinsk behandling indledes.
If reactions are severe, Betaferon should be discontinued and appropriate medical intervention instituted.
Der er rapporteret om nekrose på injektionsstedet hos patienter, som bruger Betaferon (se afsnit 4. 8).
Injection site necrosis has been reported in patients using Betaferon (see section 4.8).
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 Betaferon 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 Betaferon.
− anvende en aseptisk injektionsteknik − skifte injektionssted med hver dosis.
− use an aseptic injection technique − rotate the injection sites with each dose.
Patientens selv- injektionsprocedure bør gennemgås regelmæssigt, især hvis der er opstået reaktioner på injektionsstedet.
The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
I de forskellige, kontrollerede kliniske undersøgelser udviklede mellem 23% og 41% af patienterne neutraliserende aktivitet mod interferon beta- 1b i serum, bekræftet ved mindst 2 efterfølgende positive titreringer; Af disse patienter gik mellem 43% og 55% over til en stabil, antistof- negativ status (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.
Udvikling af neutraliserende aktivitet er associeret med en reduktion i den kliniske effekt, men kun hvad angår relapsaktivitet.
5 The development of neutralising activity is associated with a reduction in clinical efficacy only with regard to relapse activity.
Inden for
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 Betaferon; of these, 47% (41) returned to negative status over a 3 year period.
5 denne periode blev udviklingen af neutraliserende aktivitet ikke forbundet med en reduktion i den kliniske effekt (med hensyn til tid til klinisk definitiv dissemineret sklerose (CDMS), og tid til 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).
Det er blevet bevist in vitro, at Betaferon krydsreagerer med naturligt interferon beta.
It has been demonstrated in vitro that Betaferon cross reacts with natural interferon beta.
Der er sparsomme og inkonklusive data fra patienter, som har udviklet neutraliserende aktivitet og har afsluttet Betaferon- behandlingen.
There are sparse and inconclusive data on patients who have developed neutralising activity and have completed Betaferon therapy.
IE) Betaferon - 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 Betaferon 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 Betaferon.
Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Betaferon.
Det er blevet rapporteret, at interferoner reducerer aktiviteten af hepatisk cytokrom P450- afhængige enzymer hos mennesker og dyr.
Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Der bør udvises forsigtighed, når Betaferon anvendes samtidig med medikamenter, der har et smalt terapeutisk indeks, og som hovedsagelig er afhængig af cytokrom P450- systemet til clearance. f. eks. antiepileptika.
Caution should be exercised when Betaferon 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.
Erfaringsgrundlaget for anvendelse af Betaferon til gravide er utilstrækkeligt.
There is limited information on the use of Betaferon in pregnancy.
Tilgængelige data indikerer at der kan være en øget risiko for spontan abort.
Available data indicates that there may be an increased risk of spontaneous abortion.
Betaferon er kontraindiceret under graviditet (se sektion 4. 3).
Initiation of treatment is contraindicated during pregnancy (see section 4.3).
• Kvinder i den fertile alder
• Women of child-bearing potential
Kvinder i den fertile alder bør anvende sikker kontraception under behandlingen.
Women of child-bearing potential should take appropriate contraceptive measures.
Hvis patienten bliver gravid eller planlægger at blive gravid, mens hun tager Betaferon, skal hun informeres om de potentielle risici, og seponering af behandlingen skal overvejes (se sektion 5. 3).
If the patient becomes pregnant or plans to become pregnant while taking Betaferon, she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Hos patienter med høj relapsfrekvens før behandlingsstart, bør risikoen for alvorlig relaps efter seponering af Betaferon i tilfælde af graviditet 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 Betaferon in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
• Amning
6 • Lactation
Det vides ikke, om interferon beta- 1b udskilles i modermælken.
It is not known whether interferon beta-1b is excreted in human milk.
På grund af muligheden for alvorlige bivirkninger hos det diende barn, skal det besluttes, om enten amningen eller Betaferon- behandlingen skal ophøre.
Because of the potential for serious adverse reactions in nursing infants a decision should be made whether to discontinue breast- feeding or Betaferon therapy.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre bil eller betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
6 Påvirkning af centralnervesystemet som følge af brugen af Betaferon kan hos modtagelige patienter nedsætte evnen til at føre bil eller betjene maskiner.
Central nervous system-related adverse events associated with the use of Betaferon might influence the ability to drive and use machines in susceptible patients.
a) Ved starten af behandlingen er bivirkninger almindelige, men generelt aftager de med yderligere behandling.
a) At the beginning of treatment adverse reactions are common but in general they subside with further treatment.
De oftest rapporterede bivirkninger er et kompleks af influenzalignende symptomer (feber, kuldegysninger, ledsmerter, ubehag, perspiration, hovedpine eller muskelsmerter) samt reaktioner ved injektionsstedet, som hovedsagelig skyldes lægemidlets farmakologiske effekt samt reaktioner ved injektionsstedet.
The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia) and injection site reactions, which is mainly due to the pharmacological effects of the medicinal product and injection site reactions.
Rødme, hævelse, misfarvning, inflammation, smerte, overfølsomhed, nekrose og uspecifikke reaktioner var signifikant forbundet med 250 mikrogram (8 millioner IE) Betaferon- behandling.
Redness, swelling, discoloration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8 million IU) Betaferon treatment.
Generelt anbefales dosistitrering ved behandlingsstart for at øge tolerabiliteten over for Betaferon (se sektion 4. 2).
Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Betaferon (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 drugs.
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 (tabel 2, rapporteringshyppighed baseret på rapporter om spontane 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) af Betaferon.
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 Betaferon use.
Erfaringer med Betaferon hos patienter med DS er begrænset, og derfor er bivirkninger, som opstår meget sjældent, muligvis endnu ikke observeret:
Experience with Betaferon in patients with MS is limited, consequently those adverse events which occur very rarely may not yet have been observed.
Tabel 1 (bivirkninger og uregelmæssigheder i laboratorieresultater med hyppigheder ≥ 10% og de respektive procentdele under placebo; signifikant associerede bivirkninger < 10%).
7 Table 1 (adverse events and laboratory abnormalities with incidence rates ≥ 10% and the respective percentages under placebo; significantly associated side effects < 10%).
Systemorganklasse
SystemOrganClass
Sekundær Sekundær
Single Event suggestive of
Recidiverende -
Secondary Secondary Progressive Progressive
hændelse som
Relapsing Remitting
progressiv progressiv
Adverse Event and Laboratory Abnormalities
remitterende
Multiple Sclerosis (BENEFIT) #
Bivirkninger og
Multiple Multiple Sclerosis Sclerosis (European (North Study) American Study)
tyder på
Multiple Sclerosis
dissemineret dissemineret
Betaferon Betaferon 250 250
uregelmæssigheder i
Betaferon 250 microgram
dissemineret
Betaferon 250
sklerose sklerose
microgram microgram
sklerose
(Placebo)
laboratorieresultater
microgram
sklerose
(Placebo) (Placebo)
(Europæisk
n=317 (n=308)
(Nord -
(Placebo)
(BENEFIT) #
Infections and infestations
undersøgelse)
n=292 (n=176)
amerikansk
n=360 (n=358)
undersøgelse)
n=124 (n=123)
Betaferon Betaferon Betaferon
Infection Abscess
250
6% (3%) 0% (1%)
mikrogram 250 mikrogram 250 mikrogram (Placebo) (Placebo) (Placebo)
13% (11%) 4% (2%)
250 mikrogram (Placebo)
11% (10%) 4% (5%)
n=292 (n=176)
14% (13%) 1% (6%)
Infektioner og parasitære sygdomme Infektion Absces Blod - og lymfesystem
Blood and lymphatic system disorders Lymphocyte count decreased (< 1500/ mm³) Λ °
6% (3%) 0% (1%)
×
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 *°
13% (4%)
11% (2%)
16% (4%)
13% (4%)
undersøgelse)
13% (4%)
undersøgelse)
16% (4)%
Betaferon
Lymphadenopathy
250 mikrogram (Placebo) n=292 (n=176)
1% (1%)
Metabolisme og ernæring Reduceret blodglukose (< 55 mg/ dl) x Psykiske forstyrrelser
Metabolism and nutrition disorders Blood glucose decreased (< 55 mg/ dl) × Psychiatric disorders
Depression Angst Nervesystemet
Depression Anxiety Nervous system disorders
HovedpineΛ Svimmelhed Søvnløshed Migræne Paræstesi Øjne
Headache Λ Dizziness Insomnia Migraine Paresthesia Eye disorders
Conjunctivitis Unormalt synΛ Øre og labyrint
Conjunctivitis Abnormal vision Λ Ear and labyrinth disorders
Ørepine Hjerte
Ear pain Cardiac disorders
Palpitation * Vaskulære sygdomme
Palpitation * Vascular disorders
Vasodilatation Hypertension °
Vasodilatation Hypertension °
Sinuitis Forøget hoste Dyspnø * Mave- tarm- kanalen
Sinusitis
Diaré
8
4% (2%)
SystemOrganClass
7% (10%)
Single Event suggestive of
35% (29%)
Secondary Progressive
Forstoppelse Kvalme
Relapsing Remitting
1% (1%) 3% (4%)
Adverse Event and Laboratory Abnormalities
12% (12%) 13% (13%)
Multiple Sclerosis (BENEFIT) #
22% (24%) 32% (30%)
Multiple Sclerosis (European Study)
24% (18%) 48% (49%)
Multiple Sclerosis (North American Study)
Opkastning Mavesmerter
Multiple Sclerosis
5% (1%) 5% (3%)
Betaferon 250
4% (6%) 11% (6%)
Betaferon 250
10% (12%) 18% (16%)
Betaferon 250 microgram
21% (19%) 32% (24%)
Betaferon 250
18% (5%)
microgram microgram
14% (5%)
(Placebo)
4% (2%)
microgram
19% (6%)
(Placebo) (Placebo)
8 Systemorganklasse
n=317 (n=308)
Enkelt
(Placebo)
Sekundær Sekundær
n=292 (n=176)
Recidiverende -
n=360 (n=358)
hændelse som
n=124 (n=123)
progressiv progressiv
Cough increased Dyspnea * Gastrointestinal disorders
remitterende
2% (2%) 0% (0%)
Bivirkninger og
5% (10%) 3% (2%)
tyder på
11% (15%) 8% (6%)
dissemineret dissemineret
31% (23%) 8% (2%)
dissemineret
Diarrhoea Constipation Nausea Vomiting Λ Abdominal pain ° Hepatobiliary disorders
uregelmæssigheder i
4% (2%) 1% (1%) 3% (4%) 5% (1%) 5% (3%)
dissemineret
7% (10%) 12% (12%) 13% (13%) 4% (6%) 11% (6%)
sklerose sklerose
21% (19%) 22% (24%) 32% (30%) 10% (12%) 18% (16%)
laboratorieresultater
35% (29%) 24% (18%) 48% (49%) 21% (19%) 32% (24%)
sklerose
Alanine aminotransferase increased (SGPT > 5 times baseline) × Λ * °
(Nord -
18% (5%)
undersøgelse)
14% (5%)
amerikansk
4% (2%)
undersøgelse)
19% (6%)
Betaferon Betaferon Betaferon
Aspartate aminotransferase increased (SGOT > 5 times baseline) × Λ * °
Betaferon
6% (1%)
250 mikrogram (Placebo) n=292 (n=176)
4% (1%)
250 mikrogram (Placebo) n=317 (n=308)
2% (1%)
250 mikrogram (Placebo) n=124 (n=123)
4% (0%)
Øget aspartataminotransfera se (SGOT > 5 gange baseline) × Λ * ° Hud og subkutane væv
Skin and subcutaneous tissue disorders Skin disorder Λ
6% (1%)
1% (0%)
4% (1%)
4% (4%)
2% (1%)
19% (17%)
4% (0%)
6% (8%)
Hudlidelse Udslæt Λ °
Rash °
1% (0%) 11% (3%)
11% (3%)
4% (4%) 20% (12%)
20% (12%)
19% (17%) 26% (20%)
26% (20%)
6% (8%) 27% (32%)
27% (32%)
Knogler, led, muskler og bindevæv Hypertoni° Myalgi * ° Myasteni
Musculoskeletal and connective tissue disorders Hypertonia° Myalgia * ° Myasthenia
Rygsmerter Smerter i ekstremiteter Nyrer og urinveje
Back pain Pain in extremity Renal and urinary disorders
(37%) (0%)
36% (37%) 0% (0%)
15% (13)
15% (13%)
Positiv urinprotein (> 1+) x
Urinary protein positive (> 1+)×
Urininkontinens Imperiøs vandladning
Urinary incontinence Urinary urgency
Det reproduktive system og mammae Dysmenoré
Reproductive system and breast disorders Dysmenorrhea Menstrual disorder *
18% (11%)
6% (5%) 10% (8%)
17% (8%)
18% (11%) 17% (8%)
Metrorrhagia Impotens
Metrorrhagia Impotence
Almene symptomer og reaktioner på administrationsstedet Reaktion ved injektionssted (forskellige typer) Λ * °§
General disorders and administration site conditions Injection site reaction Λ § (various kinds) * °
Nekrose ved injektionssted * °
Injection site necrosis * ° & Λ
Influenzalign. symptomer & Λ * °
Flu-like symptoms *° Fever Λ * °
59% (41%) 52% (48%) 15% (15%) 7% (8%) 49% (35%)
52% (48%) 59% (41%)
9 Systemorganklasse
9 SystemOrganClass
Bivirkninger og
Multiple Sclerosis (BENEFIT) #
dissemineret dissemineret
Multiple Multiple Sclerosis Sclerosis (European (North Study) American Study)
dissemineret
Multiple Sclerosis
uregelmæssigheder i
Betaferon Betaferon 250 250
sklerose sklerose
Betaferon 250 microgram
sklerose
Betaferon 250
laboratorieresultater
microgram microgram
(Europæisk
microgram
(BENEFIT) #
(Placebo) (Placebo)
undersøgelse)
n=317 (n=308)
amerikansk
(Placebo)
Betaferon Betaferon Betaferon
n=360 (n=358)
Betaferon
n=124 (n=123)
x Laboratorieanormalitet Λ
Pain Chest pain ° Peripheral edema Asthenia * Chills Λ * ° Sweating * Malaise * × Laboratory abnormality Λ
250 mikrogram (Placebo) n=292 (n=176)
4% (4%) 1% (0%) 0% (0%) 22% (17%) 5% (1%) 2% (1%) 0% (1%)
250 mikrogram (Placebo) n=360 (n=358)
31% (25%) 5% (4%) 7% (7%) 63% (58%) 23% (7%) 6% (6%) 8% (5%)
250 mikrogram (Placebo) n=317 (n=308)
59% (59%) 15% (8%) 21% (18%) 64% (58%) 22% (12%) 10% (10%) 6% (2%)
250 mikrogram (Placebo) n=124 (n=123)
52% (48%) 15% (15%) 7% (8%) 49% (35%) 46% (19%) 23% (11%) 15% (3%)
Signifikant associeret med Betaferon- behandling hos patienter med første hændelse, som tyder på dissemineret sklerose, p < 0, 05 * Signifikant associeret med Betaferon- behandling for RRDS, p < 0, 05 ° Signifikant associeret med Betaferon- behandling for SPDS, p < 0, 05 § Reaktioner på injektionsstedet (forskellige typer) omfatter alle uønskede bivirkninger, som forekommer på injektionsstedet, dvs. følgende termer: blødning på injektionsstedet, overfølsomhed på injektionsstedet, inflammation på injektionsstedet, absces på injektionsstedet, nekrose på injektionsstedet, smerte på injektionsstedet, reaktion på injektionsstedet, ødem på injektionsstedet og atrofi på injektionsstedet & ” Influenzalignende systemkompleks ” omfatter influenzasyndrom og/ eller en kombination af mindst to bivirkninger af feber, kulderystelser, myalgi, utilpashed, perspiration. # Der blev ikke observeret nogen ændring i den kendte risikoprofil for Betaferon under det tredje BENEFIT- studieår.
Significantly associated with Betaferon treatment for patients with first event suggestive of MS, p < 0.05 * Significantly associated with Betaferon treatment for RRMS, p < 0.05 ° Significantly associated with Betaferon 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 hemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site edema, and injection site atrophy & “ Flu-like symptom complex ” denotes flu syndrome and/ or a combination of at least two AEs from fever, chills, myalgia, malaise, sweating. # During the third year of the BENEFIT study, no change of the known risk profile of Betaferon was observed.
Den mest relevante MedDRA- term er anvendt til at beskrive en vis reaktion og dens synonymer og relaterede tilstande.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Tabel 2 (Rapporteringshyppigheder (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), baseret på spontane rapporter om bivirkninger)
10 Table 2 (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).
Meget almindelig ≥ 1/ 10
Very common ≥ 1/ 10
Almindelig ≥ 1/ 100 til < 1/ 10
Common ≥ 1/ 100 to < 1/ 10
Ikke almindelig ≥ 1/ 1, 000 to < 1/ 100
Uncommon ≥ 1/ 1,000 to < 1/ 100
Sjælden ≥ 1/ 10, 000 til < 1/ 1000
Rare ≥ 1/ 10,000 to < 1/ 1,000
Anæmi, thrombocytopeni, leukopeni
Anemia, Thrombocyto- penia, Leukopenia
Det endokrine system
Immune system disorders Endocrine disorders
Hyper - thyroidisme, hypo- thyroidisme, thyroid funktionssvigt
Anaphylactic reactions Hyperthyroidism, Hypothyroidism, Thyroid disorder
Øget blod - triglycerider, anoreksi
Blood triglycerides increased Anorexia
Depression (se også sektion 4. 4)
Depression (see also section 4.4)
Forvirring, angst, stemnings - labilitet, selvmords- forsøg (se også sektion 4. 4)
Confusion, Anxiety, Emotional lability, Suicide attempt (see also section 4.4)
Kardiomyopati, takykardi, palpitation
Cardiomyopathy, Tachycardia, Palpitation
Luftveje, thorax og mediastinum
Respiratrory, thoracic and mediastinal disorders
Bronkospasme, dyspnø
Bronchospasm, Dyspnea
Opkastning, kvalme
Vomiting, Nausea
Pancreatitis
Pancreatitis
Øget alanin - amino- transferase, øget aspartat - amino- transferase
Alanine amino- transferase increased, Aspartate amino- transferase increased
Øget blod - bilirubin, øget gamma - glutamyl - transferase, hepatitis
Blood bilirubin increased, Gamma-glutamyl- transferase increased, Hepatitis
Urticaria, udslæt, pruritus, alopeci
Urticaria, Rash, Pruritus, Alopecia
Misfarvning af hud
Myalgia, Hypertonia
Knogler, led, muskler og bindevæv Det reproduktive system og mammae
Reproductive system and breast disorders
Myalgi, hypertoni
Very common ≥ 1/ 10
Menstruations - forstyrrelse
Uncommon ≥ 1/ 1,000 to < 1/ 100