natgillin/translations-raw huggingface dataset:
Patienterne i forsøg I, II og III blev testet på forskellige tidspunkter for antistoffer mod adalimumab fra te
ris Patients in Studies I, II and III were tested at multiple timepoints for antibodies to adalimumab during the 6 to 12 month period.
Hos patienter, som ikke fik methotrexat samtidig, var incidensen 12, 4% dle
In patients not given
sammenlignet med 0, 6%, når adalimumab blev givet i kombination med methotrexat.
tho concomitant methotrexate, the incidence was 12.4%, compared to 0.6% when adalimumab was used as add-on to methotrexate.
Hos patienter med psoriasis artrit blev der påvist adalimumab antistoffer hos 38/ 376 patienter (10%) mi
In patients with psoriatic arthritis, adalimumab antibodies were identified in 38/ 376 subjects (10%)
behandlet med adalimumab.
au treated with adalimumab.
Hos patienter, der ikke samtidig fik methotrexat, var forekomsten 13, 5% (24/ 178 patienter), sammenlignet med 7% (14 ud af 198 patienter), når adalimumab blev anvendt som tillæg til methotrexat. ge
In patients not given concomitant methotrexate, the incidence was 13.5% (24/ 178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate.
Hos patienter med ankyloserende spondylitis blev der påvist antistoffer hos 17/ 204 patienter (8, 3%) behandlet med adalimumab.
r ge In patients with ankylosing spondylitis antibodies were identified in 17/ 204 subjects (8.3%) treated with adalimumab.
(8, 6%), sammnelignet med 1/ 19 (5, 3%), når adalimumab blev anvendt som tillæg til methotrexat.
In patients not given concomitant methotrexate, the incidence was 16/ 185 (8.6%), compared to 1/ 19 (5.3%) when adalimumab was used as add-on to methotrexate. lon In patients with Crohn’ s disease, adalimumab antibodies were identified in 7/ 269 subjects (2.6%) treated with adalimumab.
42 Hos patienter med Crohns sygdom, blev der identificeret adalimumab- antistoffer hos 7/ 269 individer (2, 6%) behandlet med adalimumab.
Because immunogenicity analyses are product-specific, comparison of antibody rates with those from no
sa sammenligne antistofhyppigheden med andre produkter.
other products is not appropriate.
5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties t
ret gennemsnitlige absolutte biotilgængelighed af adalimumab, estimeret ud fra tre forsøg efter en enkelt 40 mg subkutan dosis, var 64%.
The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg rod
ise fordelingsvolumen (Vss) var mellem 5 og 6 liter, og den gennemsnitlige terminale halveringstid var cirka to uger.
Adalimumab concentrations in the synovial fluid from several lP
Koncentrationen af adalimumab i synovialvæsken fra adskillige reumatoid artrit - patienter målt i serum var 31– 96%.
rheumatoid arthritis patients ranged from 31-96% of those in serum.
Adalimumab- niveauet i serum ved
Following subcutaneous administration of 40 mg of Trudexa every other week in rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg/ ml (without na
au steady- state- lavpunktet blev forøget omtrent proportionalt med doser på 20, 40 og 80 mg hver anden uge og hver uge ved subkutan dosering.
The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg every other week and every week subcutaneous dosing. i dic
Ved et induktionsregime på 160 mg Trudexa i uge 0 fulgt af 80 mg Trudexa i uge 2 blev ge
A loading dose of 160 mg Trudexa on week 0 followed by 80 mg Me
12 µg/ ml i induktions- perioden.
Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ ml during the induction period.
Gennemsnitlige steady- state laveste niveauer på omtrent 7 µg/ ml blev set hos patienter med Crohns sygdom, som modtog vedligeholdelsesdosis på 40 mg Trudexa hver anden uge. æn
Mean steady-state trough levels of approximately 7 µg/ ml were observed in Crohn’ s disease patients who received a maintenance dose of 40 mg Trudexa every other week.
Serumniveauet i frit adalimumab (dvs. ikke bundet til anti- adalimumab- antistoffer, AAA) blev målt til l
The serum
Trudexa er ikke undersøgt hos ke
41 levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
5. 3 Prækliniske sikkerhedsdata r ik
5.3 Preclinical safety data
De prækliniske data viser ingen særlig fare for mennesker på basis af forsøg af toksicitet efter enkeltdosering, gentagen dosistoksicitet og genotoksicitet. te
ed Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Karcinogenicitetsforsøg og standardvurdering af fertilitet og postnatal toksicitet blev ikke udført med dle
Carcinogenicity studies, and standard assessment of
adalimumab, da der ikke findes passende modeller for et antistof med begrænset krydsreaktivitet over for gnaver- TNF og udviklingen af neutraliserende antistoffer hos gnavere. mi
tho fertility and postnatal toxicity, were not performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and the development of neutralizing antibodies in rodents.
6. 1 Fortegnelse over hjælpestoffer ge
6.1 List of excipients
Mannitol Citronsyremonohydrat Læ
r ge Mannitol Citric acid monohydrate Sodium citrate lon Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Polysorbate 80 no
43 Natriumchlorid Polysorbat 80
Sodium hydroxide Water for injections
sa 6. 2 Uforligeligheder
6.2 Incompatibilities t uc
til Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. rod
ret 6. 3 Opbevaringstid
6.3 Shelf life
ise 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Må ikke nedfryses.
Do not freeze. na
tor 6. 5 Emballage (art og indhold)
6.5 Nature and contents of container i
au Trudexa, 40 mg injektionsvæske, opløsning i fyldt engangssprøjte (type 1- glas) til patientbrug:
Trudexa 40 mg solution for injection in single-use pre-filled syringe (type I glass) for patient use: dic
Pakninger af: • 1 fyldt injektionssprøjte (0, 8 ml steril opløsning) med 1 alkoholserviet i en blisterpakning. re • 2 fyldte injektionssprøjter (0, 8 ml steril opløsning) med 2 alkoholservietter i en blisterpakning. • 4 fyldte injektionssprøjter (0, 8 ml steril opløsning) med 4 alkoholservietter i en blisterpakning. ge
Me
• 6 fyldte injektionssprøjter (0, 8 ml steril opløsning) med 6 alkoholservietter i en blisterpakning.
• 2 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. • 4 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. • 6 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
Ikke alle pakningsstørrelser markedsføres alle steder. æn
Not all pack sizes may be marketed.
Ikke anvendt lægemiddel eller affald heraf bør bortskaffes i overensstemmelse med lokale l
42 Any unused product or waste material should be disposed of in accordance with local requirements.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN r ik
MARKETING AUTHORISATION HOLDER
Queenborough Kent ME11 5EL England te
ed Queenborough Kent ME11 5EL United Kingdom
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) dle
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 03/ 257/ 002 EU/ 1/ 03/ 257/ 003 mi
tho EU/ 1/ 03/ 257/ 002 EU/ 1/ 03/ 257/ 003 EU/ 1/ 03/ 257/ 004
EU/ 1/ 03/ 257/ 004 EU/ 1/ 03/ 257/ 005 ge
au EU/ 1/ 03/ 257/ 005
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN Læ
DATE OF FIRST AU`THORISATION/ RENEWAL OF THE AUTHORISATION
1 september 2003
r ge 1 September 2003 10.
DATO FOR ÆNDRING AF TEKSTEN 44 Læ ge {MM/ ÅÅÅÅ}
{MM/ YYYY}
mi dle te r ik ke l
uc rod lP i na dic Me
45 æn ge re au tor ise ret til sa lg 1.
43 1.
lg Trudexa, 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte med beskyttelseshætte.
Trudexa 40 mg solution for injection in pre-filled syringe with needleguard
tor Injektionsvæske, opløsning i fyldt injektionssprøjte med beskyttelseshætte.
au Solution for injection in pre-filled syringe with needleguard.
au 4.
4.
Terapeutiske indikationer
r ge 4.1 Therapeutic indications
Trudexa i kombination med methotrexat er indiceret til: ge
Rheumatoid arthritis lon Trudexa in combination with methotrexate, is indicated for:
• behandling af moderat til alvorlig aktiv reumatoid artrit hos voksne patienter, hvor responsen på sygdomsmodificerende antireumatiske lægemidler, herunder methotrexat, har været utilstrækkelig. æn
the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the no
• behandling af alvorlig, aktiv og progressiv reumatoid artrit hos voksne patienter, som ikke tidligere er blevet behandlet med methotrexat. l
response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. t uc
Trudexa kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat ke
Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. rod
forbedre den fysiske funktion, når det gives i kombination med methotrexat.
Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Ankyloserende spondylitis mi
Ankylosing spondylitis i
Trudexa er indiceret til behandling af voksne med alvorlig aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på konventionel behandling. ge
Trudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have dic
Crohns sygdom
had an inadequate response to conventional therapy.
Trudexa kan gives
For induction treatment, Trudexa should be given in combination with corticosteroids.
sa 4. 2 Dosering og indgivelsesmåde
44 4.2 Posology and method of administration
Der er begrænset erfaring med gentagen administration efter mere end 8 uger efter den foregående dosis. ge
There is little experience from re administration after more than 8 weeks since the previous dose.
47 Nogle patienter, som ikke har responderet ved uge 4, kan have fordel af fortsat
Some patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg Trudexa every week.
lg vedligeholdelsesbehandling i 12 uger.
45 Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
Denne undersøgelse bør omfatte en detaljeret sygdomshistorie med personlig tuberkuloseanamnese eller eventuel tidligere eksponering for patienter med aktiv
46 Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
49 Kanylens beskyttelseshætte indeholder naturgummi (latex).
47 The needle cover of the syringe contains natural rubber (latex).
50 alvorlig hjerteinsufficiens (se punkt 4. 3).
Trudexa is contraindicated in moderate to severe heart failure (see section 4.3).
lg Autoimmune processer
48 Autoimmune processes
lg fem måneder efter den sidste Trudexa- behandling.
49 However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Trudexa treatment.
ise Trudexa blev undersøgt hos 5293 patienter i kontrolleredeog åbne forsøg i op til 60 måneder.
These
Sygdomme i blod - og lymfesystem
50 Blood and the lymphatic system disorders
tor
51
54
connective tissue and bone disorders
ved injektionsstedet (erythem og/ eller kløe, blødning, smerter eller hævelse) sammenlignet med 10% af de patienter, som fik placebo eller aktiv kontrol. Reaktioner ved injektionsstedet gjorde det normalt ke
52 In the twelve controlled trials, 16% of patients treated with Trudexa developed injection site reactions (erythema and/ or itching, haemorrhage, pain or swelling), compared to 10% of patients receiving placebo or active control.
55 I de kontrollerede dele af ti Trudexa- forsøg af mindst 12 ugers varighed (I- IX og CHARM) hos patienter med moderat til svær aktiv reumatoid artrit, psoriasis artrit, ankyloserende spondylitis og
Malignancies and lymphoproliferative disorders lon During the controlled portions of ten Trudexa trials at least 12 weeks in duration (I-IX and CHARM) in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’ s disease, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 5.7 (3.3, 10.1) per 1000 patient-years among no
56 Tabel 2 Uønskede virkninger iovervågning efter markedsføring og kliniske fase IV- forsøg
ge The additional adverse reactions in Table 2 have been reported from postmarketing surveillance or Phase IV clinical trials: lon Table 2 Undesirable Effects in Postmarketing Surveillance and Phase IV Clinical Studies no
Farmakodynamiske virkninger r ik
54 Pharmacodynamic effects
57 Forsøg I evaluerede 271 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel, hvor
Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18
røntgenresultater).
55 additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
58 Tabel 3:
Table 3:
Der blev observeret en significant mindre radiografisk progression hos Trudexa - / methotrexat - re patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 5.
Trudexa/ methotrexate patients demonstrated significantly less radiographic progression than no
ødelæggelse opretholdes i 60 måneder i en delmængde af patienterne.
Data from the open-label extension phase indicate that the reduction in rate of progression of structural damage is maintained for 60 months in a subset of patients.
Blandt disse viste 66 patienter ingen af progression af strukturel ødelæggelse defineret som ændring af æn
Among those, 66 patients showed no uc
TSS på nul eller mindre.
progression of structural damage defined by a change in the TSS of zero or less..
Læ
58
58% 61 ***
58% ***
Forsøgspersoner (n=215, 54, 7%), som ikke opnåede ASAS 20 ved uge 12, eller 16 eller 20 fik tidligere adgang til åben adalimumab 40 mg subkutant hver anden uge og blev ge
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses. t uc
62 a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
ed b Bath Ankylosing Spondylitis Disease Activity Index
Table 9:
60 Table 9:
Infliximab Naive Patienter Placebo Trudexa Trudexa N=74 80/ 40 mg 160/ 80 mg
Infliximab Naive Patients
63 Lignende remissions- rater sås for 160/ 80 mg og 80/ 40 mg induktionsregimerne ved uge 8, mens bivirkninger oftere sås i gruppen med 160/ 80 mg.
Similar remission rates were observed for the 160/ 80 mg and 80/ 40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/ 80 mg group.
3% (2/ 66)
(2/ 66)
15% (11/ 74) **
(11/ 58)**
Uge 56
15%
5% (3/ 66) re
(3/ 66)
blandt den adalimumab- behandlede- grupper sammenlignet med placebo- gruppen.
61 Trudexa 80/ 40 mg and 160/ 80 mg compared to placebo and was seen at weeks 26 and 56 in CHARM as well among the adalimumab treatment groups compared to the placebo group.
64 (24/ 178 patienter), sammenlignet med 7% (14 ud af 198 patienter), når adalimumab blev anvendt som tillæg til methotrexat.
In patients not given concomitant methotrexate, the incidence was 13.5% (24/ 178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate.
Trudexa er ikke undersøgt hos te
62 levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
ise Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. rod
Må ikke nedfryses. re 6. 5 Emballage (art og indhold) ge
Do not freeze. na
Trudexa, 40 mg injektionsvæske, opløsning i fyldt engangssprøjte (type 1- glas) med beskyttelseshætte til hospitals - og plejepersonalebrug: æn
Trudexa 40 mg solution for injection in single-use pre-filled syringe (type I glass) with needleguard dic
1 fyldt injektionssprøjte med beskyttelseshætte (0, 8 ml steril opløsning) i en blisterpakning samt en alkoholserviet. l ke
1 pre-filled syringe with needleguard (0.8 ml sterile solution) in a blister, and 1 alcohol pad.
Queenborough dle
MARKETING AUTHORISATION HOLDER 63 Abbott Laboratories Ltd.
EU/ 1/ 03/ 257/ 006 ge
EU/ 1/ 03/ 257/ 006
1 September 2003
tho 1 September 2003
mi dle te r ik ke l DATO FOR ÆNDRING AF TEKSTEN
r ge lon not uc rod lP i na dic Me
67 æn ge re au tor ise ret til sa lg 1.
64 1.
lg Trudexa, 40 mg injektionsvæske, opløsning i fyldt pen
Trudexa 40 mg solution for injection in pre-filled pen
Hver fyldte 0, 8 ml enkeltdosis pen indeholder 40 mg adalimumab.
ed Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
tor Injektionsvæske, opløsning i fyldt pen.
au Solution for injection in pre-filled pen.
• behandling af alvorlig, aktiv og progressiv reumatoid artrit hos voksne patienter, som ikke tidligere er blevet behandlet med methotrexat. l
response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Trudexa kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat ke
the treatment of severe, active and progressive rheumatoid arthritis in adults not previously t
behandling med methotrexat er uhensigtsmæssig.
treated with methotrexate. uc
Trudexa har vist sig at hæmme udviklingen af leddestruktion bedømt ved måling med røntgen og at r ik
Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. rod
forbedre den fysiske funktion, når det gives i kombination med methotrexat.
Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. lP
Psoriasisartrit te
Psoriatic arthritis
Trudexa er indiceret til behandling af aktiv og progressiv psoriasisartrit hos voksne patienter, hvor responset på forudgående behandling med sygdomsmodificerende antireumatiske lægemidler har været utilstrækkelig. dle
response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Ankyloserende spondylitis mi
Ankylosing spondylitis i dic
Trudexa er indiceret til behandling af voksne med alvorlig aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på konventionel behandling. ge
Me
Trudexa kan gives
65 For induction treatment, Trudexa should be given in combination with corticosteroids.
sa 4. 2 Dosering og indgivelsesmåde
4.2 Posology and method of administration
til Behandling med Trudexa bør initieres og overvåges af speciallæger med erfaring i diagnosticering og behandling af reumatoid artrit, psoriasisartrit, ankolyserende spondylitis eller Crohns sygdom.
ed Trudexa treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or Crohn’ s disease.
ret Efter passende oplæring i injektionsteknik kan patienter selv injicere Trudexa, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
ris After proper training in injection technique, patients may self-inject with Trudexa if their physician determines that it is appropriate and with medical follow-up as necessary.
ise immunmodulerende midler) optimeres.
tho During treatment with Trudexa, other concomitant therapies (e. g., corticosteroids and/ or immunomodulatory agents) should be optimised.
Voksne
au Adults
Den anbefalede dosis af Trudexa til voksne patienter med reumatoid artrit er 40 mg adalimumab givet
r The recommended dose of Trudexa for adult patients with rheumatoid arthritis is 40 mg adalimumab
Der fortsættes med methotrexat under behandling med Trudexa.
ge administered every other week as a single dose via subcutaneous injection.
Der kan fortsættes med glukokortikoider, salicylater, non- steroide antiinflammatoriske eller re analgetiske lægemidler under behandling med Trudexa.
Methotrexate should be continued during treatment with Trudexa. lon Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Trudexa.
Se punkt 4. 4 og 5. 1 vedrørende kombination med andre sygdomsmodificerende antireumatiske lægemidler end methotrexat. ge
Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1. no
Ved behandling med Trudexa alene kan det være en fordel for visse patienter, der oplever faldende respons, at øge dosis til 40 mg adalimumab hver uge. æn
In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week.
Psoriasisartrit og ankyloserende spondylitis
Psoriatic arthritis and ankylosing spondylitis t uc
Den anbefalede dosis af Trudexa til patienter med psoriaris artrit er 40 mg adalimumab givet som enkeltdosis subkutan injektion hver anden uge. l ke
The recommended dose of Trudexa for patients with psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. rod
Fortsat behandling bør overvejes nøje, hvis patienten ikke responderer inden for denne periode. r ik
Continued therapy should be carefully reconsidered in a patient not responding within this time period. lP
Det anbefalede Trudexa induktions- dosis- regime til voksne patienter med svær Crohns sygdom er 80 mg i uge 0 efterfulgt af 40 mg i uge 2.
The recommended Trudexa induction dose regimen for adult patients with severe Crohn’ s disease is na
I tilfælde, hvor der er brug for et hurtigere respons af behandlingen, kan regimet 160 mg i uge 0 (dosis kan administreres som fire injektioner på en dag eller dle
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness i dic
som to injektioner pr. dag i to på hinanden følgende dage), 80 mg i uge 2, anvendes med erkendelse af, at risikoen for bivirkninger er højere under induktionen.
that the risk for adverse events is higher during induction.
Læ
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Nogle patienter, som oplever en nedgang i deres respons, kan have fordel af en stigning i dosis til 40 mg Trudexa hver uge.
66 Some patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg Trudexa every week.
69 Nogle patienter, som ikke har responderet ved uge 4, kan have fordel af fortsat
Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
sa Ældre patienter
ed Elderly patients
til Dosisjustering er ikke nødvendig.
ris No dose adjustment is required.
ret Der er ingen erfaring med børn.
tho There is no experience in children.
tor 4. 3 Kontraindikationer
4.3 Contraindications
Overfølsomhed over for den aktive substans eller over for ét eller flere af hjælpestofferne.
r ge Hypersensitivity to the active substance or to any of the excipients.