natgillin/translations-raw huggingface dataset:
Inden for systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til &lt; 1/10); ikke almindelig (≥ 1/1.000 til &lt; 1/100); sjælden (≥ 1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Infliximab passerer placenta og er blevet sporet i serum hos spÃ¦dbÃ¸rn op til 6 mÃ¥neder efter fÃ¸dslen.
Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
** PASI 75 respons for IMPACT ikke inkluderet som følge af lav N; p &lt; 0.001 for infliximab vs. placebo i uge 24 for IMPACT 2.
** PASI 75 response for IMPACT not included due to low N; p &lt; 0.001 for infliximab vs. placebo at week 24 for IMPACT 2.
Der blev registreret signifikante forbedringer fra baseline i DLQI (p &lt; 0,001) og de fysiske og mentale del-scorer af SF 36 (p &lt; 0,001 for hver enkelt delsammenligning).
Significant improvements from baseline were demonstrated in DLQI (p &lt; 0.001) and the physical and mental component scores of the SF 36 (p &lt; 0.001 for each component comparison).
Baseret på patienter med PASI &gt; 2.5 ved baseline for IMPACT, og patienter med &gt; 3 % BSA psoriasis hud påvirkning ved baseline af IMPACT 2.
Based on patients with PASI ≥ 2.5 at baseline for IMPACT, and patients with ≥ 3% BSA psoriasis skin involvement at baseline in IMPACT 2.
Der forekom én alvorlig infusionsrelateret reaktion ( &lt; 1 %) hos en patient på infliximab monoterapi.
One serious infusion reaction ( &lt; 1%) occurred in a patient on infliximab monotherapy.
Kortere infusionstid ved doser &gt; 6 mg/kg er ikke blevet undersøgt (se pkt.
Shortened infusions at doses &gt; 6 mg/kg have not been studied (see section 4.8).
178 af de 580 inkluderede patienter (30,7 %) blev defineret som havende svær sygdom (CDAI score &gt; 300 og samtidig kortikoid og/eller immunsupprimerende behandling) svarende til populationen defineret i indikationen (se pkt.
178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score &gt; 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Infliximab hÃ¦mmer den funktionelle aktivitet af TNFï¡ i en lang rÃ¦kke forskellige in vitro bioassays.
Infliximab inhibits the functional activity of TNFï¡ in a wide variety of in vitro bioassays.
p = 0,030 og &lt; 0,001 for henholdsvis 3 mg/kg og 6 mg/kg behandlingsgruppen mod placebo + MTX.
p = 0.030 and &lt; 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Infliximab krydsreagerer ikke med TNFï¡ fra andre arter end mennesker og chimpanser.
Infliximab does not cross react with TNFï¡ from species other than human and chimpanzees.
Infliximab-behandling af patienter med Crohns sygdom var ogsÃ¥ forbundet med en betydelig reduktion af den ofte forhÃ¸jede serum betÃ¦ndelsesmarkÃ¸r, CRP.
Infliximab treatment of Crohn's disease patients was also associated with a substantial reduction of the commonly elevated serum inflammatory marker, CRP.
Studiets primære endepunkt var kortikosteroidfri klinisk remission i uge 26, defineret som patienter i klinisk remission (CDAI &lt; 150), som i mindst 3 uger ikke havde taget orale systemiske kortikosteroider (prednison eller lignende) eller budesonid i en dosis på &gt; 6 mg/dag.
The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of &lt; 150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose &gt; 6 mg/day.
Infliximab bÃ¸r kun anvendes pÃ¥ tvingende indikation under graviditet.
Infliximab should only be used during pregnancy if clearly needed.
Infliximab er et monoklonalt antistof - en type protein, der binder sig til et specifikt mÃ¥l i kroppen kaldet TNF (tumor nekrose faktor) alfa.
Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
I uge 16 blev 47 placebopatienter med &lt; 10 % forbedring fra udgangspunktet i både hævede og ømme led flyttet til infliximab induktion (tidlig overflytning).
At week 16, 47 placebo patients with &lt; 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
&gt; 54 uger
&gt; 54 weeks
I genbehandlingsarmen fik 4 % (8/219) af patienterne en alvorlig infusionsrelateret reaktion sammenlignet med &lt; 1 % (1/222) på vedligeholdelsesbehandling.
In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus &lt; 1% (1/222) on maintenance therapy.
Infusionsreaktioner og overfÃ¸lsomhed
Infusion reactions and hypersensitivity
Infliximab forbedrede livskvaliteten i ACT 1 og ACT 2, hvilket bekrÃ¦ftedes ved statistisk signifikant forbedring i bÃ¥de et sygdomsspecifikt mÃ¥l, IBDQ, og ved forbedring i den almindelige 36-punkt korte udgave af spÃ¸rgeskema SF-36.
In ACT 1 and ACT 2, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF-36.
Ved 54 uger var 44,9 % af patienterne i den kombinerede infliximab-behandlingsgruppe i klinisk respons sammenlignet med 19,8 % i placebobehandlingsgruppen (p &lt; 0,001).
At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p &lt; 0.001).
De co-primære endepunkter var forholdet af patienter i klinisk remission (CDAI &lt; 150) ved uge 30 og tiden til tab af respons efter uge 54.
The co-primary endpoints were the proportion of patients in clinical remission (CDAI &lt; 150) at week 30 and time to loss of response through week 54.
Nogle af disse infektioner har været letale; de opportunistiske infektioner, der oftest er set med en mortalitetsrate &gt; 5 %, indbefatter pneumocystose, candidiasis, listeriose og aspergillose.
Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of &gt; 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis.
Infliximab forebyggede sygdom hos transgene mus, der udvikler polyarthritis som resultat af konstitutiv ekspression af human TNFï¡, og fik ved indgift efter sygdomsstart eroderede led til at heles.
Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFï¡ and when administered after disease onset, it allowed eroded joints to heal.
Sekundære endepunkter omfattede andelen af patienter i klinisk remission i uge 4 (CDAI &lt; 150) og den kliniske respons på længere sigt.
Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI &lt; 150) and clinical response over time.
&gt; 40 uger
&gt; 40 weeks
Infliximab er et kimerisk human-murin monoklonalt antistof, der binder sig med hÃ¸j affinitet til bÃ¥de oplÃ¸selige og transmembrane former af TNFï¡, men ikke til lymphotoxin ï¡ (TNFï¢).
Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFï¡ but not to lymphotoxin ï¡ (TNFÃ).
Infusionsrelaterede reaktioner efter fornyet indgift af Remicade Der var designet et klinisk studie med patienter med moderat til svÃ¦r psoriasis for at undersÃ¸ge effekt og sikkerhed af langtidsvedligeholdelsesbehandling i forhold til fornyet indgift med et induktionsregime med Remicade (hÃ¸jst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom.
Infusion reactions following re-administration of Remicade A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of Remicade (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
Infliximab har vÃ¦ret forbundet med akutte infusionsrelaterede reaktioner, omfattende anafylaktisk shock samt forsinkede overfÃ¸lsomhedsreaktioner (se pkt.
Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Alle infliximab doser er givet i kombination med methotrexat og folat samt eventuelt kortikosteroider og/eller NSAIDs p &lt; 0,001, for hver infliximab-behandlingsgruppe versus kontrol
all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs p &lt; 0.001, for each infliximab treatment group vs. control greater values indicate more joint damage.
I uge 4 opnåede endvidere 13/27 (48 %) af infliximab-behandlede patienter en klinisk remission (CDAI &lt; 150) i forhold til 1/25 (4 %) af placebobehandlede patienter.
Also at week 4, 13/27 (48%) of infliximab-treated patients achieved a clinical remission (CDAI &lt; 150) vs. 1/25 (4%) of placebo-treated patients.
I SPIRIT var andelen af patienter, der opnåede PASI 75 i uge 10 71,7 % i 3 mg/kg infliximabgruppen, 87,9 % i 5 mg/kg infliximab-gruppen og 5,9 % i placebogruppen (p &lt; 0,001).
In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p &lt; 0.001).
I uge 54 var tallene 55,8 % (29/52) og 23,5 % (12/51) for henholdsvis 8-ugers gruppen og 12-ugers gruppen (p &lt; 0,001).
At week 54, the figures were 55.8% (29/52) and 23.5% (12/51) in the q8 weeks and q12 weeks maintenance groups, respectively (p &lt; 0.001).
Nogle af disse infektioner har været letale; de opportunistiske infektioner, der oftest er set med en mortalitetsrate &gt; 5 %, indbefatter pneumocystose, candidiasis, listeriose og aspergillose (se pkt.
Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of &gt; 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis (see section 4.4).
Infliximabs effekt og sikkerhed blev undersÃ¸gt i to multicenter, dobbelblind, placebokontrollerede studier hos patienter med aktiv ankyloserende spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [ BASDAI] scoreâ¥ 4 og spinalsmerte â¥ 4 pÃ¥ en skala pÃ¥ 1-10).
Efficacy and safety of infliximab were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
I uge 12 var antallet af BASDAI 50 responders 3/35 (9 %) i placebogruppen og 20/35 (57 %) i 5 mg/kg gruppen (p &lt; 0,01).
At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p &lt; 0.01).
Infunder ikke Remicade i den samme intravenÃ¸se slange med andre midler.
Do not infuse Remicade concomitantly in the same intravenous line with other agents.
Infliximabs sikkerhed og virkning blev vurderet i et multicenter, randomiseret, open-label, parallelgruppe klinisk studie (C0168T72) hos 60 pÃ¦diatriske patienter i alderen 6 til 17 Ã¥r (medianalder 14,5 Ã¥r) med moderat til svÃ¦r aktiv colitis ulcerosa (Mayo-score pÃ¥ 6-12; endoskopisk subscore â¥ 2) med utilstrÃ¦kkelig respons pÃ¥ konventionel behandling.
The safety and efficacy of infliximab were assessed in a multicenter, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Infliximab blev indgivet med en dosis pÃ¥ 5 mg/kg i ugerne 0, 2, 6 og derefter hver 8. uge.
Infliximab was administered at a dose of 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks.
En større andel patienter i den kombinerede infliximab-behandlingsgruppe var i stand til at afbryde kortikosteroider og stadig blive i klinisk remission sammenlignet med placebobehandlingsgruppen i både uge 30 (22,3 % mod 7,2 %, p &lt; 0,001, samlede ACT 1 &amp; ACT 2 data) og uge 54 (21,0 % mod 8,9 %, p = 0,022, ACT 1 data).
A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p &lt; 0.001, pooled ACT 1 &amp; ACT 2 data) and week 54 (21.0% vs. 8.9%, p = 0.022, ACT1 data).
p &lt; 0,001, for hver infliximab-behandlingsgruppe mod placebo.
p &lt; 0.001, for each infliximab treatment group vs. placebo.
I uge 24 var antallet af ASAS 20 responders 15/78 (19 %) i placebogruppen og 123/201 (61 %) i gruppen, der fik 5 mg/kg infliximab (p &lt; 0,001).
At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p &lt; 0.001).
Infliximabvedligeholdelse 5 mg/kg (n = 113) (p-vÃ¦rdi)
Infliximab Maintenance 5 mg/kg (n = 113) (p value)
Infliximabvedligeholdelse 10 mg/kg (n = 112) (p-vÃ¦rdi)
Infliximab Maintenance 10 mg/kg (n = 112) (p value)
Andelen af patienter med slimhindeheling i uge 26 var signifikant større i grupperne, der fik infliximab plus AZA (43,9 %; p &lt; 0,001) eller infliximab-monoterapi (30,1 %; p = 0,023) sammenlignet med AZA-monoterapigruppen (16,5 %).
The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p &lt; 0.001) and infliximab monotherapy groups (30.1%, p = 0.023) compared to the AZA monotherapy group (16.5%).
Hud og subkutane væv Almindelig: Debuterende eller forværring af allerede eksisterende psoriasis, inklusive pustuløs psoriasis (primært palmoplantaris), urticaria, udslæt, pruritus, øget svedtendens, tør hud, svampedermatitis, eksem, alopeci.
Common: New onset or worsening psoriasis including pustular psoriasis (primarily palm &amp; soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
p &lt; 0,001, for hver infliximab-behandlingsgruppe mod kontrol.
p &lt; 0.001, for each infliximab treatment group vs. control.
I uge 4 efter indgivelse af en enkelt dosis opnåede 22/27 (81 %) af de infliximab-behandlede patienter, der fik 5 mg/kg dosen en klinisk effekt mod 4/25 (16 %) af placebopatienterne (p &lt; 0,001).
At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p &lt; 0.001).
Klinisk remission og slimhindeheling forekom i en større andel af patienterne i den kombinerede infliximab behandlingsgruppe sammenlignet med placebobehandlingsgruppen i uge 54 (henholdsvis 34,6 % mod16,5 %, p &lt; 0,001 og 46,1 % mod 18,2 %, p &lt; 0,001).
Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p &lt; 0.001 and 46.1% vs. 18.2%, p &lt; 0.001, respectively).
Andelene af patienter i vedvarende respons og vedvarende remission i uge 54 var større i den kombinerede infliximab-behandlingsgruppe end i placebobehandlingsgruppen (henholdsvis 37,9 % mod 14,0 %, p &lt; 0,001 og 20,2 % mod 6,6 %, p &lt; 0,001).
The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p &lt; 0.001; and 20.2% vs. 6.6%, p &lt; 0.001, respectively).
Infliximab med eller uden AZA blev vurderet i et randomiseret, dobbeltblind studie med aktiv komparator (SONIC) hos 508 voksne patienter med moderat til svÃ¦r Crohns sygdom (CDAI â¥ 220 â¤ 450).
Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI â¥ 220 â¤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Endepunkt blev målt ved ændring fra baseline i samlet modificeret vdH-S score (middel ± SD score var 0,82 ± 2,62 i placebogruppen sammenlignet med -0,70 ± 2,53 i infliximab-gruppen; p &lt; 0,001).
Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean Â± SD score was 0.82 Â± 2.62 in the placebo group compared with -0.70 Â± 2.53 in the infliximab group; p &lt; 0.001).
De patienter, der fik kortikosteroider ved baseline, fik ikke kortikosteroider i de 3 måneder forud for uge 54.
CDAI &lt; 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54 among patients who were receiving corticosteroids at baseline.
Nanotop er et radiofarmaceutisk diagnostisk prÃ¦parationssÃ¦t, der indeholder denatureret humant serumalbumin (HSA), som efter radioaktiv mÃ¦rkning med en oplÃ¸sning af natriumpertechnetat (99mTc) danner et technetium- (99mTc-) nanokolloid.
Nanotop is a diagnostic radiopharmaceutical kit containing denatured human serum albumin (HSA), which after radiolabelling with Sodium Pertechnetate (99mTc) solution results in Technetium (99mTc) Nanocolloid.
&lt; Fremstiller af batchfrigivelse: &gt;
&lt; Manufacturer responsible for batch release: &gt;
Færdiggøres nationalt {Navn og adresse} &lt; {tfl.
To be completed nationally {Name and address} &lt; {Tel} &gt; &lt; {Fax} &gt; &lt; {E-mail} &gt;
&lt; Indehaver af markedsføringstilladelsen &lt; og fremstiller af batchfrigivelse &gt; :
&lt; Marketing authorisation holder &lt; and manufacturer responsible for batch release &gt; :
Ved doser ≥ 50 mg/kg legemsvægt i fem dage var der histologiske tegn på en skadelig indvirkning på artikulær brusk i slagtekyllinger,
At doses ≥ 50 mg/kg bodyweight/day administered for 5 days there was histological evidence of a detrimental effect on articular cartilage in broilers, but leg lesions were only clinically apparent in chickens and turkeys at doses &gt; 100 mg/kg administered for ≥ 5 days.
{måneder/år} eller &lt; måneder/år &gt;
&lt; Date of last renewal: &gt; &lt; {DD/MM/YYYY} &gt; &lt; {DD month YYYY} &gt; .
&lt; {dage/måneder/år} &gt; &lt; {dage/måneder/år} &gt; …
{Name and address} &lt; {tel} &gt; &lt; {fax} &gt; &lt; {e-mail} &gt;
Begge behandlingsgrupper viste statistisk og klinisk signifikante middelfald fra baseline i det dårligste øjes IOP på alle kontroltidspunkter gennem hele studiet (p &lt; 0,001).
Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP at all follow up timepoints throughout the study (p &lt; 0.001).
Denne indlægsseddel blev senest ændret &lt; {MM/ÅÅÅÅ} &gt; &lt; {måned ÅÅÅÅ}
This leaflet was last revised in &lt; {MM/YYYY} &gt; &lt; {month YYYY}
Femten procent (15 %) af forsøgsdeltagerne havde lymfeknuder i bækkenet &lt; 2 cm, da de indgik i studiet.
Fifteen percent (15%) of subjects had &lt; 2 cm pelvic lymph nodes at study entry.
Hududslæt af grad 3 (defineret som dækkende &gt; 30 % af legemsoverfladearealet [BSA]) blev indberettet hos 5,2 % af patienterne i behandling med Erleada.
Grade 3 skin rashes (defined as covering &gt; 30% body surface area [BSA]) were reported with Erleada treatment in 5.2% of patients.
De forsøgsdeltagere, der blev behandlet med Erleada og ADT, udviste signifikant forbedring i forhold til dem, der blev behandlet med ADT alene, hvad angik følgende sekundære endepunkter for tid til metastase (HR = 0,28; 95 % CI: 0,23; 0,34; p &lt; 0,0001), progressionsfri overlevelse (PFS) (HR = 0,30; 95 % CI: 0,25; 0,36; p &lt; 0,0001); tid til symptomatisk progression (HR = 0,45; 95 % CI: 0,32; 0,63; p &lt; 0,0001); og en tendens for samlet overlevelse (OS) (HR = 0,70; 95 % CI: 0,47 1,04; p = 0,0742).
Subjects treated with Erleada and ADT showed significant improvement over those treated with ADT alone for the following secondary endpoints of time to metastasis (HR = 0.28; 95% CI: 0.23, 0.34; p &lt; 0.0001), progression-free survival (PFS) (HR = 0.30; 95% CI: 0.25, 0.36; p &lt; 0.0001); time to symptomatic progression (HR = 0.45; 95% CI: 0.32, 0.63; p &lt; 0.0001); and a trend for overall survival (OS) (HR = 0.70; 95% CI: 0.47 1.04; p = 0.0742).
I apalutamid-armen udviklede 64 (7,9 %) af forsøgsdeltagerne symptomatisk progression sammenlignet med 63 (16 %) i placeboarmen, med en hazard ratio på 0,447 (95 % CI: 0,315; 0,634), hvorved den forudbestemte O'Brien Fleming-signifikansgrænse for effekt blev nået, p &lt; 0,00008.
In the apalutamide arm 64 (7.9%) subjects developed symptomatic progression compared with 63 (16%) in the placebo arm, with a hazard ratio of 0.447 (95% CI: 0.315, 0.634), which met the pre-specified O'Brien Fleming type efficacy boundary for significance, p &lt; 0.00008.
Der var en længere overlevelse efter progression (PFS-2, defineret som tiden til sygdomsprogression efter første efterfølgende behandling eller død) hos de patienter, der blev behandlet med Erleada, i forhold til dem, der blev behandlet med placebo (HR = 0,489; 95 %CI: 0,361; 0,662; p &lt; 0,0001).
Post-progression survival (PFS-2, defined as the time to disease progression after first subsequent therapy or death) was longer for subjects treated with Erleada compared to those treated with placebo (HR = 0.489; 95%CI: 0.361, 0.662; p &lt; 0.0001).
Erleada reducerede den relative risiko for fjernmetastaser eller død med 70 % i forhold til placebo (HR = 0,30; 95 % CI: 0,24; 0,36; p &lt; 0,0001).
Erleada decreased the relative risk of distant metastasis or death by 70% compared to placebo (HR = 0.30;
(2-sidet 90 % øvre CI: 16,0 msek.).
95% CI: 0.24, 0.36; p &lt; 0.0001).
INFORMATION I BRAILLE &lt; Lansoprazol AbZ 30 mg &gt; [udfyldes nationalt]
INFORMATION IN BRAILLE &lt; Lansoprazol AbZ 30 mg &gt; [to be completed nationally]
INFORMATION I BRAILLE &lt; Lansoprazol AbZ 15 mg &gt;
INFORMATION IN BRAILLE &lt; Lansoprazol AbZ 15 mg &gt; [to be completed nationally]
LÆGEMIDLETS NAVN &lt; Lansoprazol AbZ og tilknyttede navne (se Bilag I) 15 mg gastro-resistent hård kapsel &gt; &lt; Lansoprazol AbZ og tilknyttede navne (se Bilag I) 30 mg gastro-resistent hård kapsel &gt;
&lt; Lansoprazol AbZ and associated names (see Annex I) 15 mg , gastro-resistant capsules, hard &gt; &lt; Lansoprazol AbZ and associated names (see Annex I) 30 mg , gastro-resistant capsules, hard &gt;
NAME OF THE MEDICINAL PRODUCT &lt; Lansoprazol AbZ og tilknyttede navne (se Bilag I) 15 mg gastro-resistente hårde kapsler &gt; [se Bilag I - udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT &lt; Lansoprazol AbZ and associated names (see Annex I) 15 mg , gastro-resistant capsules, hard &gt; [see Annex I - to be completed nationally]
&lt; Lansoprazol AbZ og tilknyttede navne (se Bilag I) 30 mg gastro-resistente hårde kapsler &gt; Lansoprazol
&lt; Lansoprazol AbZ and associated names (see Annex I) 30 mg, gastro-resistant capsules, hard &gt; Lansoprazol
&lt; Lansoprazol AbZ og tilknyttede navne (se Bilag I) 15 mg gastro-resistente hårde kapsler &gt; Lansoprazol
&lt; Lansoprazol AbZ and associated names (see Annex I) 15 mg, gastro-resistant capsules, hard &gt; Lansoprazol
LÆGEMIDLETS NAVN &lt; Lansoprazol AbZ og tilknyttede navne (se Bilag I) 30 mg gastro-resistent hård kapsel &gt; lansoprazol
NAME OF THE MEDICINAL PRODUCT &lt; Lansoprazol AbZ and associated names (see Annex I) 30 mg , gastro-resistant capsules, hard &gt; lansoprazole
LÆGEMIDLETS NAVN &lt; Lansoprazol AbZ og tilknyttede navne (se Bilag I) 15 mg gastro-resistent hård kapsel &gt; lansoprazol
NAME OF THE MEDICINAL PRODUCT &lt; Lansoprazol AbZ and associated names (see Annex I) 15 mg , gastro-resistant capsules, hard &gt; lansoprazole