natgillin/translations-raw huggingface dataset:
Længere tids behandling med adalimumab 40 mg ugentlig viste ingen nye sikkerhedsfund.
Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
respons
response
Behandling med Hefiya bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Hefiya er indiceret til.
Hefiya treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Hefiya is indicated.
Det primære endepunkt i RA-studie I, II og III og det sekundære endepunkt i RA-studie IV var den procentdel af patienter, som fik ACR 20-respons i uge 24 eller 26.
The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percentage of patients who achieved an ACR 20 response at week 24 or 26.
Samtidig behandling med azathioprin/6-mercaptopurin
Concurrent treatment with azathioprine/6-mercaptopurine
• astma
• asthma;
Der er rapporteret om maligne lidelser, i visse tilfælde letale, hos børn, unge og unge voksne (op til 22 år), som blev behandlet med TNF-antagonister (initiering af behandling ≤ 18-års alderen), inklusive adalimumab post marketing.
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post marketing setting.
- Aktivt stof: adalimumab.
− The active substance is adalimumab.
Pakningsstørrelser og yderligere oplysninger Hefiya indeholder
Contents of the pack and other information What Hefiya contains
Patienter bør testes for HBV-infektion inden behandling med Hefiya.
Patients should be tested for HBV infection before initiating treatment with Hefiya.
Gnid ikke på injektionsstedet.
Do not rub the injection site.
Resultater fra Short Form Health Survey (SF 36) for alle doser/skemaer for adalimumab i alle fire studier understøtter disse resultater med statistisk signifikant værdi for physical component summary (PCS)-score såvel som med statistisk signifikant værdi for smerte- og vitalitetsområde for 40 mg dosering hver anden uge.
Results from the Short Form Health Survey (SF 36) for all doses / schedules of adalimumab in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
primær analyse (ITT) placebo adalimumab tid til behandlingssvigt i eller efter uge 2 i Studie UV II
primary analysis (ITT) placebo adalimumab time to treatment failure at or after week 2 in study UV II
Humørsvingninger (inklusive depression), angst, insomni
Mood alterations (including depression), anxiety, insomnia
Andelen af patienter, som ophørte med behandling på grund af bivirkninger i løbet af den dobbeltblindede, kontrollerede del af de pivotale studier, udgjorde 5,9 % for patienter, der fik adalimumab, og 5,4 % for kontrolbehandlede patienter.
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for controltreated patients.
Selvom det ikke var statistisk signifikant, viste størstedelen af patienterne klinisk bedring i sekundære endepunkter, såsom antallet af steder med entesopatirelateret artrit, antallet af ømme led (TJC), antallet af hævede led (SJC), pædiatrisk ACR50-respons og pædiatrisk ACR70-respons.
Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Tabel 24 Vedligeholdelse af klinisk remission og respons (procent af patienterne) placebo 40 mg adalimumab hver anden uge
Table 24 maintenance of clinical remission and response (percent of patients) placebo 40 mg adalimumab every other week
Sørg for at læse, forstå og følge denne brugsvejledning, før du injicerer Hefiya.
Be sure that you read, understand, and follow these Instructions for use before injecting Hefiya.
Behandling med Hefiya skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
Treatment with Hefiya must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Blandt de patienter, der afbrød studiet inden uge 78, blev 11 % afbrudt på grund af bivirkninger og 5 % på grund af utilstrækkelig respons på adalimumab behandling.
Among the patients who discontinued the study prior to week 78, 11 % discontinued due to adverse events, and 5 % due to insufficient response to adalimumab treatment.
Hos patienter, der udvikler reaktivering af HBV, bør Hefiya seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres.
In patients who develop HBV reactivation, Hefiya should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Hvis sådan en dosis er påkrævet, så skal en anden medicin med adalimumab bruges.
If such a dose is required, other adalimumab medicines should be used.
Ankyloserende spondylitis (AS)
Ankylosing spondylitis (AS)
Der bør derfor udvises forsigtighed, når der anvendes TNF-antagonister til KOL-patienter og til patienter med en forøget risiko for malignitet på grund af massiv rygning.
Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
I et prospektivt kohorte registerstudie, blev 257 kvinder med reumatoid artrit (RA) eller Crohns sygdom (CD) behandlet med adalimumab i minimum det første trimester og 120 kvinder med RA eller CD, som ikke blev behandlet med adalimumab inkluderet.
In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
klinisk remission klinisk respons * p-værdi for sammenligning af standarddosis versus lavdosis.
clinical remission clinical response * p-value for standard dose versus low dose comparison.
Figur B: ting, der ikke er inkluderet i pakningen Se ”4.
Figure B: items not included in the carton See “4.
Patienter, som fik methotrexat, og som opnåede et ≥ PASI 50-respons ved uge 8 og/eller 12, fik ikke yderligere dosisøgning.
Patients receiving MTX who achieved a ≥PASI 50 response at week 8 and / or 12 did not receive further dose increases.
Den anden fik 20 mg adalimumab hver uge i 52 uger.
The second received 20 mg of adalimumab every week for 52 weeks.
Moderat til svær hjerteinsufficiens (NYHA, klasse III/IV) (se pkt.
Moderate to severe heart failure (NYHA class III / IV) (see section 4.4).
Disse infektioner kan være alvorlige og inkluderer tuberkulose, infektioner forårsaget af virus, svampe, parasitter eller bakterier eller andre usædvanlige infektionsorganismer og sepsis (blodforgiftning).
These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
Aktiv tuberkulose eller andre alvorlige infektioner, såsom sepsis og opportunistiske infektioner (se pkt.
Active tuberculosis or other severe infections such as sepsis, and opportunistic infections
Hepatitis B-reaktivering
Hepatitis B reactivation
Adalimumab viste en behandlingsfordel hos patienter med neglepsoriasis med forskellig omfang af hudinvolvering (BSA ≥ 10 % (60 % af patienterne) og BSA < 10 % og ≥5 % (40 % af patienterne)).
Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10 % (60 % of patients) and BSA < 10 % and ≥ 5 % (40 % of patients)).
Patienter, der udvikler en ny infektion under behandling med Hefiya, bør monitoreres nøje og gennemgå en fuldstændig diagnostisk evaluering.
Patients who develop a new infection while undergoing treatment with Hefiya should be monitored closely and undergo a complete diagnostic evaluation.
Tabel 21 Effektresultater ved uge 12, HS-Studie I og II
Table 21 efficacy results at 12 weeks, HS studies I and II
Adalimumabs sikkerhed hos pædiatriske patienter med plaque-psoriasis blev vurderet i gennemsnitligt 13 måneder.
The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbeltblindede, placebokontrollerede AS-studie II på 82 voksne patienter med aktiv ankyloserende spondylitis.
Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo-controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Denne undersøgelse bør omfatte patientens detaljerede sygdomshistorie med tuberkulose i anamnesen eller eventuel tidligere eksponering for personer med aktiv tuberkulose samt tidligere og/eller aktuel immunsuppressiv behandling.
This evaluation should include a detailed medical assessment of patient history of tuberculosis or possible previous exposure to people with active tuberculosis and previous and/or current immunosuppressive therapy.
Hvis du har moderat til alvorlig aktiv reumatoid artrit, vil du evt. først få andre sygdomsmodificerende antireumatiske lægemidler, såsom methotrexat.
If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate.
Patienternes tilstand forbedredes efter ophør med behandlingen.
The patients improved following discontinuation of therapy.
Efter doser på 0,5 mg/kg (~40 mg) var clearance 11-15 ml/time, fordelingsvolumen (Vss) var mellem 5 og 6 liter, og den gennemsnitlige terminale halveringstid var cirka to uger.
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.
Hverken karcinogenicitetsstudier eller standardvurdering af fertilitet og postnatal toksicitet blev udført med adalimumab, da der ikke findes passende modeller for et antistof med begrænset krydsreaktivitet over for gnaver-TNF og til udviklingen af neutraliserende antistoffer hos gnavere.
Neither carcinogenicity studies, nor a standard assessment of fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralising antibodies in rodents.
Studierne III og V havde yderligere primære endepunkter i uge 52 med forsinket sygdomsprogression (bestemt ud fra røntgenresultater).
RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
• ikke bruger sprøjten, hvis forseglingen på blisterkortet er itu, da den i så fald måske ikke er sikker for dig at bruge.
• do not use the syringe if the seals of the blister are broken, as it may not be safe for you to use.
Patienterne fortsatte på faste doser NSAID og/eller prednison (≤ 0,2 mg/kg/dag eller maksimalt 10 mg/dag).
Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg / kg / day or 10 mg / day maximum).
Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. 0,8 ml dosis, dvs. den er i det væsentlige natriumfri.
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free'.
Efter 5 års adalimumab-behandling var 74,0 % (37/50) af de 50 patienter, som stadig var i studiet, fortsat i klinisk remission, og 92,0 % (46/50) af patienterne havde fortsat klinisk respons i henhold til PCDAI.
After 5 years of adalimumab therapy, 74.0 % (37 / 50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0 % (46 / 50) of patients continued to be in clinical response per PCDAI.
Dannelse af adalimumab-antistoffer er forbundet med øget clearance og reduceret effekt af adalimumab.
Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Hvis du får feber, som ikke vil forsvinde, blå mærker eller bløder meget let eller er meget bleg, skal du omgående henvende dig til din læge.
If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away.
Blandt de patienter, som havde et respons ved uge 8, var 47 % i respons, 29 % var i remission, 41 % havde slimhindeheling, og 20 % var i steroidfri remission i ≥ 90 dage ved uge 52.
Of those patients who had a response at week 8, 47 % were in response, 29 % were in remission, 41 % had mucosal healing, and 20 % were in steroid-free remission for ≥ 90 days at week 52.
Demyeliniserende sygdom
Demyelinating disease
Hefiya indeholder natrium
Hefiya contains sodium
Inflammationen kan føre til nedsat syn og/eller fluer i øjet (sorte pletter eller sværm af uklarheder i øjet, som bevæger sig i synsfeltet).
The inflammation leads to a decrease of vision and / or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Note: behandlingssvigt i eller efter uge 6 (studie UV I) eller i eller efter uge 2 (studie UV II) blev talt med som hændelser.
Note: treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
Et embryoføtalt udviklingstoksicitets-/perinatalt udviklingsstudie foretaget på cynomolgusaber med 0, 30 og 100 mg/kg (9-17 aber/gruppe) viste ingen tegn på fosterskader på grund af adalimumab.
An embryo-foetal developmental toxicity / perinatal developmental study has been performed in cynomolgus 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.
Den tilsyneladende plasmakoncentration af adalimumab som tilsyneladende giver 50 % sandsynlighed for PedACR 50 respons (EC50) var 3 μg/ml (95 % CI: 1-6 μg/ml).
The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
• Merkelcellekarcinom (en type hudkræft)
• Merkel cell carcinoma (a type of skin cancer);
• Hold din pen i en vinkel på 90° mod det rensede injektionssted (se Figur G).
• Hold your pen at 90 degrees to the cleaned injection site (see Figure G).
Opbevares i køleskab (2 - 8°C).
Store in a refrigerator (2°C-8°C).
Hvis du udvikler nye eller får forværrede symptomer på hjerteinsufficiens (f.eks. stakåndethed eller hævede fødder), skal du kontakte din læge øjeblikkeligt.
If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Hyppigheden af alvorlige infektioner var højere hos adalimumab-behandlede patienter over 65 år (3,7 %) end hos patienter under 65 år (1,5 %).
The frequency of serious infections among adalimumab-treated subjects over 65 years of age (3.7 %) was higher than for those under 65 years of age (1.5 %).
• alvorlige infektioner (inklusive blodforgiftning og influenza)
• serious infections (including blood poisoning and influenza);
Adalimumab er vurderet hos mere end 3.000 patienter i de kliniske reumatoid artrit-studier.
Adalimumab was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Ved uge 16 havde en statistisk signifikant større andel af de patienter, som fik adalimumab opnået PGA ”clear” eller ”almost clear” for psoriasis på hænder og/eller fødder sammenlignet med patienter, som fik placebo (30,6 % versus 4,3 % [P=0,014]).
At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3 %, respectively [P = 0.014]).
Vertigo og svækket syn kan forekomme efter administration af Hefiya (se pkt.
Vertigo and visual impairment may occur following administration of Hefiya (see section 4.8).
Adalimumabs virkning til behandling af unge patienter med HS er baseret på den demonstrerede virkning og eksponering-respons-forhold hos voksne HS-patienter og sandsynligheden for, at sygdomsforløb, patofysiologi og lægemidlets virkning i det væsentligste svarer til voksnes ved samme eksponeringsniveau.
Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
• Hold stemplet presset helt ned, mens du forsigtigt løfter kanylen lige ud af injektionsstedet og giver slip på din hud (se Figur J).
• Keep the plunger fully pressed down while you carefully lift the needle straight out from the injection site and let go of your skin (see Figure J).
Inden start af behandling med Hefiya skal profylaktisk behandling mod tuberkulose også overvejes hos patienter med adskillige eller signifikante risikofaktorer for tuberkulose på trods af en negativ test for tuberkulose samt hos patienter, der tidligere har haft latent eller aktiv tuberkulose, hvor det ikke har kunnet bekræftes, at behandlingen har været tilstrækkelig.
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Hefiya in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Lad det tørre, før du injicerer (se Figur F).
Leave it to dry before injecting (see Figure F).
Patienter i behandling med adalimumab havde signifikant større forbedringer ved uge 12, som blev opretholdt frem til uge 24, i både SF36 og ankyloserende spondylitis livskvalitetsspørgeskema (ASQoL).
Adalimumab-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 (ASQoL).
Livskvalitet
Quality of Life
Hvis der diagnosticeres aktiv tuberkulose, må Hefiya-terapi ikke påbegyndes (se pkt.
If active tuberculosis is diagnosed, Hefiya therapy must not be initiated (see section 4.3).
c Ankylosing Spondylitis Disease Activity Score d Delvis opblussen af sygdom er defineret som ASDAS ≥ 1,3 men < 2,1 ved 2 på hinanden følgende besøg.
Ankylosing Spondylitis Disease Activity Score d partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
• Kontroller udløbsdatoen (EXP) på din sprøjte.
• Look at the expiration date (EXP) on your syringe.
Hvis du har spørgsmål, skal du tale med din læge.
If you have questions, please ask your doctor.
Diagnosticering og empirisk antimykotisk behandling af disse patienter bør tages i samråd med en læge med ekspertise i behandling af invasive svampeinfektioner.
Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Studiets primære effektmål var andelen af patienter uden opblussen af sygdommen ved uge 68.
The primary efficacy endpoint was the proportion of patients with no flare by Week 68 of the study.
Fortæl din læge, hvis du får lægemidlerne azathioprin eller mercaptopurin sammen med Hefiya.
Tell your doctor if you are taking azathioprine or mercaptopurine with Hefiya.
Forbedring i antallet af led med aktiv artrit blev opretholdt i den åbne del i 156 uger for 26 ud af 31 (84 %) patienter i adalimumab-gruppen, som forblev i studiet.
Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84 %) patients in the adalimumab group who remained in the study.
Efter enkeltvise intravenøse doser på mellem 0,25 og 10 mg/kg var koncentrationerne dosisrelaterede.
After single intravenous doses ranging from 0.25 to 10 mg / kg, concentrations were dose proportional.
Sikkerheden af den anbefalede adalimumab-dosis i den unge HS-population er baseret på adalimumabs sikkerhedsprofil på tværs af indikationer hos både voksne og pædiatriske patienter ved samme eller hyppigere dosering (se pkt.
Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section 5.2).
Adalimumab havde numerisk en fordel ved de fleste af underscorerne med statistisk signifikante gennemsnitlige forskelle i generelt syn, okulær smerte, nærsyn, mental sundhed og totalscore i studie UV I og for generelt syn og mental sundhed i studie UV II.
Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in study UV I, and for general vision and mental health in study UV II.
Målet for adalimumab er et andet protein kaldet tumornekrosefaktor (TNFα), som er til stede i øgede mængder i de inflammatoriske sygdomme nævnt ovenfor.
The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med referencelægemidlet, der indeholder adalimumab, i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).
ACR-respons
ACR response
Ikke-infektiøs uveitis er en betændelseslignende (inflammatorisk) sygdom, som påvirker bestemte dele af øjet.
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger.
Healthcare professionals are asked to report any suspected adverse reactions.
Ikke almindelig Kolecystit og cholelithiasis, hepatisk steatose, forhøjet bilirubin
Cholecystitis and cholelithiasis, hepatic steatosis, bilirubin increased
Pædiatrisk ACR 30/50/70-responser ved uge 48 er signifikant bedre end responserne for placebo- behandlede patienter b p = 0,015
14 weeks a ped ACR 30/50/70 responses week 48 significantly greater than those of placebo-treated patients b p = 0.015
Hos nogle patienter, som er behandlet tilfredsstillende for aktiv tuberkulose, er aktiv tuberkulose reaktiveret, mens de har været i behandling med adalimumab.
Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Note: P# = Placebo (antal af hændelser/antal med risiko); A# = Adalimumab (antal af hændelser/antal med risiko).
Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk).
Koncentrationen af adalimumab i synovialvæsken fra adskillige reumatoid artritpatienter målt i serum var 31-96%.
Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96 % of those in serum.
I studie UV I blev en statistisk signifikant forskel til fordel for adalimumab versus placebo observeret for alle komponenter for behandlingssvigt.
In Study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.