natgillin/translations-raw huggingface dataset:
ret Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i den modificerede totale Sharp score ≤ 0, 5) signifikant højere med Trudexa/ methotrexat- kombinationsterapi (henholdsvis 63, 8% og 61, 2%) sammenlignet med
tho Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified total Sharp score ≤ 0.5) was significantly higher with Trudexa/ methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate
ise methotrexat- monoterapi (henholdsvis 37, 4% og 33, 5%, p < 0, 001) og Trudexa monoterapi (henholdsvis 50, 7%, p < 0, 002 og 44, 5%, p < 0, 001).
au monotherapy (37.4% and 33.5% respectively, p < 0.001) and Trudexa monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
tor Helbredsrelateret livskvalitet og fysisk funktion blev evalueret ud fra et fysisk funktionsevneindeks fra Health Assessment Questionnaire (HAQ) i de fire originale adækvate og velkontrollerede forsøg, som
r ge Health-related quality of life and physical function was assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in Study III.
Alle doser/ skemaer for Trudexa i alle fire forsøg viste statistisk signifikant større forbedring ifølge HAQ’ s fysiske funktionsevneindeks fra baseline til 6. måned sammenlignet med placebo, og i forsøg III blev det samme set efter 52 uger.
All doses/ schedules of Trudexa lon in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in Study III the same was seen at week 52.
Resultater fra Short Form Health Survey (SF 36) for alle doser/ skemaer for Trudexa i alle fire forsøg re understøtter disse resultater med statistisk signifikant værdi for physical component summary (PCS) såvel som med statistisk signifikant værdi for smerte - og vitalitetsområde for 40 mg dosering hver ge
Results from the Short Form Health Survey (SF 36) for all doses/ schedules of Trudexa in all four studies support these findings, with statistically significant physical component summary (PCS) no
anden uge.
scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Et statistisk signifikant fald i værdierne for træthed, målt ved funktionel vurdering af kronisk sygdomsbehandling (FACIT), blev set i alle tre forsøg (forsøg I, III, IV). æn
A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (Studies I, III, IV). t uc
Forbedring af livskvalitet blev målt op til uge 156 (36 måneder) og forbedringen blev opretholdt gennem hele denne tidsperiode. l
improvement was maintained through that time.
I forsøg V var forbedringen i HAQ funktionsevneindeks og den fysiske komponent fra SF 36 større ke
In Study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Trudexa/ methotrexate combination therapy versus lP
(p < 0, 001) for Trudexa/ methotrexat- kombinationsterapi end for methotrexat- monoterapi og Trudexa - monoterapi efter 52 uger.
methotrexate monotherapy and Trudexa monotherapy at week 52, which was maintained through week 104.
Psoriasisartrit
Psoriatic arthritis na
I forsøg VI blev 313 voksne te
Study VI with 24 week duration, i dic
50% methorexate.
treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
I forsøg VII blev 100 patienter, som havde utilstrækkelig respons over for DMARD- terapi, behandlet i 12 uger. dle
Me
Der foreligger ikke tilstrækkelig dokumentation for virkningen af Trudexa hos patienter med ankyloserende spondyltitis- lignende psoriasis arthropati, da kun få patienter er blevet undersøgt (se tabel 7). mi
There is insufficient evidence of the efficacy of Trudexa in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied (see Table 7).
ACR respons i placebokontrollerede psoriasisartrit forsøg (Procentdel af patienter) ge
ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Læ
16
Placebo
Response
Trudexa Placebo
Placebo
Respons
Placebo
ACR
Trudexa
20
ACR 20
58% 17 ***
58% ***
Uge 24
Week 24 ACR 50
lg ACR 50
ed
til *** p < 0, 001 for alle sammenligninger mellem Trudexa og placebo
tho *** p < 0.001 for all comparisons between Trudexa and placebo
p < 0, 05 for alle sammenligninger mellem Trudexa og placebo
p < 0.05 for all comparisons between Trudexa and placebo
ret ACR respons i forsøg VI var det samme med og uden methotrexat- kombinationsbehandling.
au ACR responses in Study VI were similar with and without concomitant methotrexate therapy.
ise funktionsevneindeks og Short Form Health Survey (SF 36) fra baseline til uge 24.
Trudexa treated patients demonstrated improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36), from base-line to week 24.
Ankyloserende spondylitis
r Ankylosing spondylitis
tor Trudexa 40 mg hver anden uge blev undersøgt i to randomiserede, 24 ugers dobbelt- blinde placebo - kontrollerede forsøg med 393 patienter med aktiv ankyloserende spondylitis (gennemsnits score ved baseline for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var
ge Trudexa 40 mg every other week was assessed in 393 patients in two randomised, 24 week double− blind, placebo− controlled studies in patients with active ankylosing spondylitis (mean lon baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Nioghalvfjerds (20, 1%) af patienterne blev samtidigt behandlet med sygdomsmodificerende antireumatiske lægemidler, og 37 (9, 4%) af patienterne med glukokortikoider.
The blinded period was followed by an open− label period no
Den blindede periode re blev efterfulgt af en åben periode, hvor patienterne modtog Trudexa 40 mg hver anden uge subkutant i op til yderligere 28 uger.
during which patients received Trudexa 40 mg every other week subcutaneously for up to an additional 28 weeks.
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
I det største forsøg (VIII) med 315 patienter, viste resultaterne statistisk signifikant forbedring af tegn og symptomer på ankyloserende spondylitis hos patienter behandlet med Trudexa sammenlignet med æn
In the larger study (VIII) with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Trudexa compared to placebo.
Første signifikante respons blev observeret ved uge 2 og blev opretholdt frem til uge 24 (Tabel 8).
Significant response was first observed at Week 2 and maintained through 24 weeks (Table 8). rod
Tabel 8 - Effekt respons i placebo- kontrolleret AS forsøg – forsøg VIII l
Table 8 - Efficacy Responses in Placebo-Controlled AS Study – Study VIII Reduction of Signs and Symptoms lP
Respons
Response ASASa 20 na
16% 21%
dic
te
i
Uge 24
Week 2 Week 12 Week 24
Uge 24
Week 12 Week 24
***, ** Statistisk signifikant på < 0, 001, < 0, 01 for alle sammenligning mellem Trudexa og placebo ved uge 2, 12 og 24
***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between Trudexa and placebo at Weeks 2, 12 and 24 a ASsessments in Ankylosing Spondylitis
18 a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
ed b Bath Ankylosing Spondylitis Disease Activity Index
lg sa Patienter i behandling med Trudexa havde signifikant større forbedringer ved uge 12, som blev opretholdt frem til uge 24, i både SF36 og ankyloserende spondylitis livskvalitetsspørgeskema (ASQoL).
Trudexa treated patients had significantly greater improvement at Week 12 which was maintained through Week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire
til Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbelt - blindede, placebokontrollerede forsøg (IX) på 82 voksne patienter med aktiv ankyloserende spondylitis.
Similar trends (not all statistically significant) were seen in the smaller randomised, double− blind,
ret Crohns sygdom
Crohn’ s Disease
ise Sikkerhed og effekt af Trudexa er undersøgt i randomiserede, dobbelt- blinde, placebo- kontrollerede forsøg i over 1400 patienter med moderat til svær aktiv Crohns sygdom (Crohns sygdoms - aktivitetsindeks (CDAI) ≥ 220 og ≤ 450).
au The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn’ s disease (Crohn’ s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Af de tilmeldte patienter blev 478 (32%) defineret som
478 of the enrolled patients (32%) were defined as having a
4. 1).
r severe disease (CDAI score > 300 and concomitant corticosteroid and/ or immunosuppressants)
au patienterne fortsatte med at modtage mindst et af disse lægemidler.
ge corresponding to the population defined in the indication (see section 4.1).
Induktion af klinisk remission (defineret som CDAI < 150) blev undersøgt i to forsøg, CLASSIC I og GAIN.
Concomitant stable doses of aminosalicylates, corticosteroids, and/ or immunomodulatory agents were permitted and 79% of patients continued to receive at least one of these medications. lon Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CLASSIC I and GAIN.
In CLASSIC I, blev 299 TNF- antagonist- naive patienter randomiseret til en af fire re behandlingsgrupper; placebo i uge 0 og 2, 160 mg Trudexa i uge 0 og 80 mg i uge 2, 80 mg i uge 0 og 40 mg i uge 2, og 40 mg i uge 0 og 20 mg i uge 2.
In CLASSIC I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg Trudexa at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
I GAIN, blev 325 patienter, der ikke længere ge
In GAIN, 325 patients who had lost no
responderede eller var intolerante over for infliximab, randomiseret til at modtage enten 160 mg Trudexa i uge 0 og 80 mg i uge 2 eller placebo i uge 0 og 2.
response or were intolerant to infliximab were randomised to receive either 160 mg Trudexa at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
De oprindelige non- responders blev ekskluderet fra forsøgene, og derfor blev disse patienter ikke yderligere undersøgt. æn
The primary non-responders were excluded from the studies and therefore these patients were not further evaluated. t uc
I CHARM modtog 854 patienter open- label 80 mg i uge 0 og 40 mg i uge 2.
In CHARM, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Patienter i klinisk l
Patients in clinical rod
respons (nedgang i CDAI ≥ 70) i uge 4 blev stratificeret og analyseret adskilt fra dem, som ikke havde ke
response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Tabel 9 viser rater for induktion af remission og respons i CLASSIC I og GAIN. r ik
CLASSIC I and GAIN induction of remission and response rates are presented in Table 9. lP Me
Table 9:
18 Table 9:
Induktion af Klinisk Remission og Respons (Procent af Patienterne) te
Induction of Clinical Remission and Response (Percent of Patients)
dle
CLASSIC I:
Infliximab Naive Patienter Placebo Trudexa Trudexa N=74 80/ 40 mg 160/ 80 mg
Naive Patients
Infliximab Erfarne Patienter Placebo Trudexa N=166 160/ 80 mg
Infliximab Experienced Patients
Uge 4
ed Week 4
Klinisk remission mi
ris Clinical remission
Klinisk respons (CR- 100)
Clinical response (CR-
Alle p- værdier er parvise sammenligninger af forholdet for Trudexa vs. placebo ge
tho 100) All p-values are pairwise comparisons of proportions for Trudexa versus placebo * p < 0.001 **
* p < 0, 001 ** p < 0, 01 Læ
au p < 0.01
19 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.
lg I CHARM var 58% (499/ 854) af patienterne i klinisk respons i uge 4 og blev vurderet i den primære
r ge In CHARM, at week 4, 58% (499/ 854) of patients were in clinical response and were assessed in the primary analysis.
Vedligeholdelse af remission - og respons- raterne er vist i Tabel 10.
Maintenance of remission and response rates are presented in Table 10.
Raterne for klinisk remission forblev forholdvis konstante uanset tidligere TNF- antagonist- eksposition.
Clinical lon remission results remained relatively constant irrespective of previous TNF antagonist exposure.
til Tabel 10:
Table 10:
Vedligeholdelse af Klinisk Remission og Respons (Procent af Patienter)
Maintenance of Clinical Remission and Response (Percent of Patients) no
ret
Placebo
Placebo
40 mg Trudexa
40 mg Trudexa hver anden uge
40 mg Trudexa
40
every other week
mg Trudexa hver uge
every week
ise Uge 26 Klinisk remission Klinisk respons (CR- 100)
Week 26
N=170 17% 27%
N=170
N=172 40% * 52% *
N=172
N=157 47% * 52% *
N=157
tor
27%
Patienter i steroid- fri remission i > =90 dagea
Patients in steroid-free remission rod
Uge 56
lP
au Klinisk remission Klinisk respons (CR- 100)
Clinical response (CR-100)
Patienter i steroid- fri remission i > =90 dagea
Patients in steroid-free remission for > =90 daysa na
5% (3/ 66) re
5% (3/ 66)
* p < 0, 001 for Trudexa vs. placebo parvise sammenligninger af forholdet ge
* p < 0.001 for Trudexa versus placebo pairwise comparisons of proportions ** p < 0.02 for Trudexa versus placebo pairwise comparisons of proportions a i
** p < 0, 02 for Trudexa vs. placebo parvise sammenligninger af forholdet a Af dem som modtog kortikosteroider ved baseline æn
Of those receiving corticosteroids at baseline dic
Blandt de patienter, som ikke havde respons i uge 4, responderede 43% af patienterne i Trudexa vedligeholdelsesbehandling ved uge 12 sammenlignet med 30% af patienter i placebogruppen.
Among patients who were not in response at week 4, 43% of Trudexa maintenance patients responded by week 12 compared to 30% of placebo maintenance patients.
Disse resultater tyder på, at nogle patienter, som ikke har responderet ved uge 4, har fordel af fortsat l
These results suggest that some patients who have not responded by week 4 benefit from continued maintenance therapy through week Me
vedligeholdelsesbehandling til og med uge 12.
12.
4. 2). ke
Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2).
Livskvalitet r ik
Quality of Life
I CLASSIC I og GAIN, blev der opnået statistisk signifikante forbedringer i total score i det sygdoms - specifikke tarm- sygdoms- spørgeskema (IBDQ) ved uge 4 for patienter randomiseret til Trudexa 80/ 40 mg og 160/ 80 mg sammenlignet med placebo, og i CHARM blev det set ved uge 26 og 56, såvel som te
In CLASSIC I and GAIN, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to
blandt den adalimumab- behandlede- grupper sammenlignet med placebo- gruppen.
19 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.
Immunogenicitet dle
Immunogenicity
Dannelse af adalimumab- antistoffer er forbundet med øget clearence og reduceret effekt af adalimumab.
Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy
Der er ikke nogen tydelig sammenhæng mellem tilstedeværelse af antistoffer og bivirkninger. mi
There is no apparent correlation between the presence of anti-adalimumab antibodies and adverse events.
Patienterne i forsøg I, II og III blev testet på forskellige tidspunkter for antistoffer mod adalimumab fra 6. til 12. måned.
ris Patients in Studies I, II and III were tested at multiple timepoints for antibodies to adalimumab during the 6 to 12 month period.
I de pivotale forsøg blev der identificeret anti- adalimumab- antistoffer hos 58/ 1. 053 ge
In patients not given
Læ
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%) behandlet med adalimumab.
In patients with psoriatic arthritis, adalimumab antibodies were identified in 38/ 376 subjects (10%)
20 (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.
lg Hos patienter med ankyloserende spondylitis blev der påvist antistoffer hos 17/ 204 patienter (8, 3%)
r ge In patients with ankylosing spondylitis antibodies were identified in 17/ 204 subjects (8.3%) treated with adalimumab.
Hos patienter, der ikke samtidig fik methotrexat, var forekomsten 16/ 185 (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.
til 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
ret Eftersom immunogenicitetsanalyser er produktspecifikke, giver det ikke nogen mening at sammenligne antistofhyppigheden med andre produkter.
other products is not appropriate.
ise 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties t
Den
After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab uc
tor 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
Efter doser på 0, 5 mg/ kg (~ 40 mg) var clearance 11- 15 ml/ time,
After doses of 0.5 mg/ kg (~40 mg), clearances ranged from 11 to 15 ml/ hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half- life was approximately two weeks.
au fordelingsvolumen (Vss) var mellem 5 og 6 liter, og den gennemsnitlige terminale halveringstid var cirka to uger.
rheumatoid arthritis patients ranged from 31-96% of those in serum.
Koncentrationen af adalimumab i synovialvæsken fra adskillige reumatoid artrit - patienter målt i serum var 31– 96%. re Efter subkutan administration af 40 mg Trudexa hver anden uge hos patienter med rheumatoid artrit (RA) var middel steady- state- koncentrationerne på henholdsvis cirka 5 µg/ ml (uden kombination med ge
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
methotrexat) og 8- 9 µg/ ml (i kombination med methotrexat).
concomitant methotrexate) and 8 to 9 µg/ ml (with concomitant methotrexate), respectively.
Adalimumab- niveauet i serum ved steady- state- lavpunktet blev forøget omtrent proportionalt med doser på 20, 40 og 80 mg hver anden uge og hver uge ved subkutan dosering. æn
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
5, µg/ ml.
In patients with Crohn’ s disease, the loading dose of 80 mg Trudexa on week 0 followed by 40 mg Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg/ ml during the induction period.
Ved et induktionsregime på 160 mg Trudexa i uge 0 fulgt af 80 mg Trudexa i uge 2 blev l
A loading dose of 160 mg Trudexa on week 0 followed by 80 mg Me
12 µg/ ml i induktions- perioden. ke
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.
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.
Farmakokinetiske populationsanalyser med data fra flere end 1300 RA patienter viste en tendens til en r ik
Population pharmacokinetic analyses with data from over 1300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Efter justering for vægtforskelle viste køn og alder sig kun at have minimal effekt på clearance af adalimumab.
The serum
Trudexa er ikke undersøgt hos te
20 levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
børn eller hos patienter med nedsat lever - eller nyrefunktion.
Trudexa has not been studied in children or in patients with hepatic or renal impairment.
5. 3 Prækliniske sikkerhedsdata dle
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. mi
ed Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Et embryoføtalt udviklingstoksicitet - / perinatalt udviklingsforsøg foretaget på cynomolgusaber med 0, 30 og 100 mg/ kg (9- 17 aber/ gruppe) viste ingen tegn på fosterskader på grund af adalimumab.
ris An embryo-foetal developmental toxicity/ perinatal developmental study has been performed in cynomologous monkeys at 0, 30 and 100 mg/ kg (9-17 monkeys/ group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Karcinogenicitetsforsøg og standardvurdering af fertilitet og postnatal toksicitet blev ikke udført med ge
Carcinogenicity studies, and standard assessment of
Læ
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.
lg Mannitol Citronsyremonohydrat
6.1 List of excipients
sa Natriumcitrat Natriumdihydrogenfosfatdihydrat Dinatriumfosfatdihydrat
r ge Mannitol Citric acid monohydrate Sodium citrate lon Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Polysorbate 80 no
ret Vand til injektionsvæske.
Sodium hydroxide Water for injections.
6. 2 Uforligeligheder
6.2 Incompatibilities t uc
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
tor 6. 3 Opbevaringstid
6.3 Shelf life
18 måneder
18 months lP
au 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Hætteglasset opbevares i den ydre karton. Må ikke nedfryses re 6. 5 Emballage (art og indhold) ge
Do not freeze. na