FrancophonIA/ELRC3.0 huggingface dataset:
English: Also at week 4, 13/27 (48%) of infliximab-treated patients achieved a clinical remission (CDAI <150) vs. 1/25 (4%) of placebo-treated patients.
Danish: I uge 4 opnåede endvidere 13/27 (48 %) af infliximab-behandlede patienter en klinisk remission (CDAI < 150) i forhold til 1/25 (4 %) af placebobehandlede patienter.
English: Most of these reactions were mild to moderate and resolved spontaneously without any treatment within a day.
Danish: De fleste af disse reaktioner var lete til moderate og forsvandt spontant uden behandling inden for et døgn.
English: An association between development of antibodies to infliximab and reduced duration of response has also been observed with intravenously administered infliximab.
Danish: En sammenhæng mellem udvikling af antistoffer over for infliximab og reduceret varighed af respons er også blevet observeret med intravenøst administreret infliximab.
English: • Remsima 120 mg solution for injection is administered by injection under the skin (subcutaneous use) only.
Danish: • Remsima 120 mg injektionsvæske, opløsning gives udelukkende ved injektion under huden (subkutan anvendelse).
English: • Tell your doctor before you are given Remsima if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
Danish: • Fortæl din læge, før du får Remsima, hvis du har en lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL, rygerlunger), eller hvis du er storryger.
English: Note: Rotate the injection site each time you give an injection.
Danish: Bemærk: Skift injektionssted hver gang du injicerer.
English: In an exploratory clinical study evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximabtreated patients compared with control patients.
Danish: I et uddybende klinisk studie, der vurderede anvendelsen af infliximab hos patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL), blev der rapporteret flere maligne sygdomme hos patienter behandlet med infliximab sammenlignet med kontrolpatienter.
English: Single subcutaneous injections of 120, 180 and 240 mg of infliximab yielded approximately dose proportional increases in the maximum serum concentration (Cmax) and area under the concentrationtime curve (AUC).
Danish: Enkelte subkutane injektioner på 120, 180 og 240 mg infliximab udviste tilnærmelsesvis dosisproportionale stigninger i den maksimale serumkoncentration (Cmax) samt arealet under koncentrationtid kurven (AUC).
English: • Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
Danish: • Nogle patienter, der får Remsima, har udviklet symptomer på en sygdom i immunsystemet kaldet lupus.
English: This medicine contains 45 mg sorbitol in each 120 mg dose.
Danish: Denne medicin indeholder 45 mg sorbitol i hver 120 mg dosis.
English: Table 1 Adverse reactions in clinical studies and from post-marketing experience
Danish: Tabel 1 Bivirkninger i kliniske studier og efter markedsføring
English: Contents of the pack and other information What Remsima contains
Danish: Pakningsstørrelser og yderligere oplysninger Remsima indeholder
English: If you are not sure, talk to your doctor before you are given Remsima.
Danish: Hvis du er i tvivl, så tal med din læge, før du får Remsima.
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab.
Danish: I et uddybende klinisk studie omfattende patienter, som havde moderat til svær KOL og var enten nuværende eller tidligere rygere, var 157 voksne patienter behandlet med infliximab.
English: • Children and adults taking Remsima may have an increased risk of developing lymphoma or another cancer.
Danish: • Børn og voksne i behandling med Remsima kan have en øget risiko for at udvikle lymfom eller anden form for kræft.
English: Full instructions for use are provided in the package leaflet.
Danish: Indlægssedlen indeholder fulde instruktioner i anvendelse.
English: 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<0.001).
Danish: 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 < 0,001).
English: Always keep the medicinal product out of the sight and reach of children.
Danish: Opbevar altid lægemidlet utilgængeligt for børn.
English: It is recommended that the conduct of these tests should be recorded in the patient reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Danish: Opmærksomheden henledes på risikoen for falsk negative resultater af tuberkulintesten, især hos patienter, der er alvorligt syge eller immunsupprimerede.
English: Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis (see section 4.4).
Danish: Nogle af disse infektioner har været letale; de opportunistiske infektioner, der oftest er set med en mortalitetsrate > 5 %, indbefatter pneumocystose, candidiasis, listeriose og aspergillose (se pkt.
English: Remsima and Orencia should not be used together.
Danish: Du må ikke få Remsima og Orencia samtidig.
English: The required volume of the reconstituted Remsima solution should be diluted to 250 mL with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Danish: Det påkrævede volumen af den rekonstituerede Remsima-opløsning fortyndes til 250 ml med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske.
English: Remsima is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Danish: Remsima leveres som et hætteglas (glasflaske) indeholdende et pulver til koncentrat til infusionsvæske, opløsning.
English: In the second clinical study (IMPACT 2), efficacy and safety of infliximab were studied in 200 patients with active psoriatic arthritis (≥5 swollen joints and ≥5 tender joints).
Danish: I det andet kliniske studie (IMPACT 2) blev virkning og sikkerhed af infliximab undersøgt hos 200 patienter med aktiv psoriasis arthritis (≥ 5 hævede led og ≥ 5 ømme led).
English: * p-values represent each infliximab treatment group vs. AZA monotherapy.
Danish: (p < 0,001)* * P-værdier repræsenterer hver infliximab-behandlingsgruppe vs. AZA monoterapi.
English: In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Danish: For at øge sporbarheden af biologiske lægemidler skal præparatnavnet og lotnummeret på det administrerede lægemiddel tydeligt noteres.
English: • Tell your doctor before you are given Remsima if you have or have ever had a problem that affects your nervous system.
Danish: • Før du får Remsima, skal du fortælle det til din læge, hvis du har eller nogensinde har haft en lidelse, som påvirker dit nervesystem.
English: c. Gently press a cotton ball or gauze over the injection site and apply an adhesive bandage, if necessary.
Danish: c. Tryk forsigtigt en vatrondel eller gaze mod injektionsstedet og sæt et plaster på efter behov.
English: 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<0.01).
Danish: I uge 12 var antallet af BASDAI 50 respondere 3/35 (9 %) i placebogruppen og 20/35 (57 %) i 5 mg/kg gruppen (p < 0,01).
English: Sorbitol content Remsima contains 45 mg sorbitol per 1 mL (in each 120 mg dose).
Danish: Sorbitolindhold Remsima indeholder 45 mg sorbitol pr. 1 ml (i hver dosis på 120 mg).
English: After administration of infliximab 120 mg subcutaneously every 2 weeks (from Week 6 after 2 doses of intravenous infliximab at Weeks 0 and 2) to patients with active rheumatoid arthritis who were concomitantly treated with MTX, the median (CV%) Ctrough level at Week 22 was 12.8 µg/mL
Danish: Efter administration af infliximab 120 mg subkutant hver 2. uge (fra uge 6 efter 2 doser intravenøs infliximab i uge 0 og 2) til patienter med aktiv reumatoid artrit, som samtidigt blev behandlet med MTX, var det gennemsnitlige (CV %) Ctrough-niveau i uge 22 på 12,8 µg/ml (80,1 %).
English: Remsima SC 120 mg (N=165)
Danish: Remsima s.c. 120 mg (N=165)
English: • You should receive recommended vaccinations before starting Remsima treatment.
Danish: • Du skal have de anbefalede vaccinationer, før du starter behandling med Remsima.
English: • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Remsima.
Danish: • Fortæl din læge, hvis du har nogen unormale hudåbninger (fistler), før du får Remsima.
English: Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥220 ≤400) in a randomised, double-blinded, placebo-controlled, dose-response study.
Danish: Induktionsbehandling af moderat til svært aktiv Crohns sygdom Virkningen af en éndosis behandling med infliximab blev vurderet hos 108 patienter med aktiv Crohns sygdom (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) i et randomiseret, dobbeltblindet, placebokontrolleret, dosis-virknings studie.
English: Under aseptic conditions, each Remsima vial should be reconstituted with 10 mL of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Danish: Under aseptiske forhold rekonstitueres hvert Remsima-hætteglas med 10 ml vand til injektionsvæsker ved hjælp af en sprøjte med en gauge 21 (0,8 mm) kanyle eller med en mindre kanyle.
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
Danish: Det primære endepunkt var andelen af patienter, der oplevede en klinisk virkning, bestemt som ≥ 50 % reduktion fra baseline i antallet af fistler, drænet ved forsigtigt tryk, ved mindst to på hinanden følgende besøg (med 4 ugers mellemrum) uden øget brug af lægemidler eller kirurgisk indgreb for Crohns sygdom.
English: Patients with tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections (see section 4.4).
Danish: Patienter med tuberkulose eller andre alvorlige infektioner såsom sepsis, abscesser og opportunistiske infektioner (se pkt.
English: At week 30, the proportion of subjects in clinical remission was higher in the q8 week (59.6%, 31/52) than the q12 week maintenance treatment group (35.3%, 18/51; p=0.013).
Danish: I uge 30 var andelen af personer med klinisk remission højere i 8-ugers gruppen (59,6 %; 31/52) end i 12-ugers gruppen (35,3 %, 18/51; p=0,013).
English: • Tell your doctor before you are given Remsima if you have an infection even if it is a very minor one.
Danish: • Fortæl din læge, før du får Remsima, hvis du har en infektion, også selvom det er en meget let infektion.
English: • Use the syringe ONLY if your healthcare provider has trained you on the right way to prepare for and to give an injection.
Danish: • Brug KUN injektionssprøjten hvis sundhedspersonalet har trænet dig på den rigtige måde til at forberede dig på og at give en injektion.
English: The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Danish: Sikkerhed og virkning ved infliximab blev vurderet i to (ACT 1 og ACT 2) randomiserede, dobbeltblindede, placebokontrollerede kliniske studier hos voksne patienter med moderat til svær, aktiv colitis ulcerosa (Mayo score 6 til 12; Endoskopi subscore ≥ 2) med et utilstrækkeligt respons på konventionel behandling [orale kortikosteroider, aminosalicylater og/eller immunmodulatorer (6-MP, AZA)].
English: Do not inject into skin that is within 5 cm of your belly button (navel), or is tender, damaged, bruised, or scarred.
Danish: Du må ikke injicere i hud, som er inden for 5 cm fra din navle eller som er øm, beskadiget, har blåt mærke eller ar.
English: Once you remove the cap, do not recap the pen.
Danish: Når du fjerner hætten, må du ikke sætte den på pennen igen.
English: Remsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Danish: Remsima er indiceret til behandling af moderat til svær plaque psoriasis hos voksne patienter, som ikke responderede på, eller som har en kontraindikation for eller som ikke tåler anden systemisk behandling inklusive ciclosporin, methotrexat eller psoralen ultra-violet A (PUVA) (se pkt.
English: In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of infliximab therapy.
Danish: Hos patienter med allerede eksisterende eller nyligt opståede demyeliniseringssygdomme skal vurdering af forventet gavn og risiko ved anti-TNF-behandlingen overvejes omhyggeligt før initiering af behandling med Remsima.
English: placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Danish: placebo inflixima b placebo Inflixim ab placebo inflixima b placebo inflixima b
English: Table 1 Adverse reactions in clinical studies and from post-marketing experience of intravenous infliximab
Danish: Tabel 1 Bivirkninger i kliniske studier og erfaringer efter markedsføring af intravenøs infliximab
English: Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects.
Danish: Patienter kan præmedicineres med for eksempel et antihistamin, hydrocortison og/eller paracetamol, for at forebygge lette og forbigående reaktioner.
English: • Talk to your doctor if you have any questions about giving yourself an injection.
Danish: • Tal med din læge, hvis du har spørgsmål om selvinjektion.
English: Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p=0.011]) than in the placebo group
Danish: Der var færre forsøgspersoner, som fik foretaget kolektomi i 5 mg/kg infliximab-gruppen (28/242 eller 11,6 % [N.S.] og 10 mg/kg infliximab-gruppen (18/242 eller 7.4 % [p=0,011]) end i placebogruppen (36/244;14,8 %).
English: Local injection site reactions
Danish: Lokale reaktioner på injektionsstedet
English: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation
Danish: Gastrointestinal blødning, diarré, dyspepsi, gastroøsofageal refluks, forstoppelse.
English: • Patients taking Remsima may have an increased risk of developing lymphoma or another cancer.
Danish: • Patienter i behandling med Remsima kan have en øget risiko for at udvikle lymfom eller anden form for kræft.
English: Do not rub the injection site.
Danish: Du må ikke gnide på injektionsstedet.
English: b. Gently press a cotton ball or gauze over the injection site and hold for 10 seconds.
Danish: b. Pres forsigtigt en vatrondel eller gaze mod injektionsstedet og hold på det i 10 sekunder.
English: Re-administration for ulcerative colitis
Danish: Fornyet administration ved colitis ulcerosa
English: • Do not shake the syringe at any time.
Danish: • Injektionssprøjten må ikke rystes på noget tidspunkt.
English: Mucosal healing at Week 30a a p <0.001, for each infliximab treatment group vs. placebo.
Danish: Slimhindeheling i uge 30a a p < 0,001, for hver infliximab-behandlingsgruppe mod placebo.
English: 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 <0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Danish: 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 < 0,001, samlede ACT 1 & ACT 2 data) og uge 54 (21,0 % mod 8,9 %, p=0,022, ACT 1 data).
English: • Do not use the syringe if it has been dropped or is visibly damaged.
Danish: • Injektionssprøjten må ikke bruges, hvis den er tabt eller synligt beskadiget.
English: Remsima is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Remsima fortyndes dog med natriumchlorid 9 mg/ml (0,9%) infusionsvæske, opløsning.
English: Week 50 a p <0.001, for each infliximab treatment group vs. control.
Danish: Uge50 a p < 0,001, for hver infliximab-behandlingsgruppe versus kontrol.
English: In rheumatoid arthritis patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab.
Danish: Hos patienter med reumatoid arthritis tyder det på, at samtidig anvendelse af methotrexat og andre immunmodulatorer reducerer dannelsen af antistoffer mod infliximab og forøger plasmakoncentrationerne af infliximab.
English: Sixty eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p=0.002).
Danish: Otteogtres procent (21/31)af patienter behandlet med infliximab, der fik et 5 mg/kg doseringsregimen, opnåede en klinisk virkning mod 26 % (8/31) af placebobehandlede patienter (p = 0,002).
English: 1 vial 2 vials 3 vials 4 vials 5 vials
Danish: 1 hætteglas 2 hætteglas 3 hætteglas 4 hætteglas 5 hætteglas
English: Please read the Remsima ‘Package Leaflet' carefully before you start using this medicine.
Danish: Læs indlægssedlen for Remsima grundigt, inden De begynder at tage medicinen.
English: • Signs of an allergic reaction such as swelling of your face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.
Danish: • Tegn på en allergisk reaktion såsom hævelse af ansigt, læber, mund eller svælg, som kan forårsage besvær med at synke eller trække vejret, hududslæt, nældefeber, hævelse af hænder, fødder eller ankler.
English: • Signs of an immune system disorder called lupus such as joint pain or a rash on cheeks or arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash (sarcoidosis).
Danish: • Tegn på en sygdom i immunsystemet kaldet lupus såsom ledsmerter, udslæt på kinder eller arme, som er følsomme over for solen (lupus) eller hoste, åndenød, feber eller hududslæt (sarkoidose).
English: Abdominal pain, nausea
Danish: Abdominalsmerter, kvalme.
English: Give the injection 8.
Danish: Injicér 8.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤18 years of age), including infliximab in the post-marketing setting.
Danish: Efter markedsføring er rapporteret maligniteter, hvoraf nogle har været letale, hos børn, unge og unge voksne (op til 22 år), som er behandlet med TNF-blokerende midler (behandlingsstart før eller ved 18 år), heriblandt infliximab.
English: • you are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6),
Danish: • du er allergisk over for infliximab (det aktive stof i Remsima) eller et af de øvrige indholdsstoffer i Remsima (angivet i punkt 6),
English: b. Without pinching or stretching the skin, place the pen over the injection site at a 90-degree angle.
Danish: b. Placér pennen over injektionsstedet i en 90
English: 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<0.001).
Danish: I uge 24 var antallet af ASAS 20 respondere 15/78 (19 %) i placebogruppen og 123/201 (61 %) i gruppen, der fik 5 mg/kg infliximab (p < 0,001).
English: 1 hour.
Danish: Remsima over 1 time.
English: Hypotension, hypertension, ecchymosis, hot flush, flushing
Danish: Hypotension, hypertension, ekkymose, hedeture, rødmen.
English: Rheumatoid arthritis1
Danish: Reumatoid arthritis1
English: The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leukopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Danish: Følgende bivirkninger forekom hyppigere hos børn: nedsat antal røde blodlegemer (anæmi), blod i afføringen, generelt nedsat samlet indhold af hvide blodlegemer (leukopeni), anfaldsvis ansigtsrødme, virusinfektioner, lavt indhold af hvide blodlegemer, der bekæmper infektion (neutropeni), knoglebrud, bakterieinfektion og allergiske reaktioner i luftvejene.
English: Upper respiratory tract infection, sinusitis
Danish: Øvre luftvejsinfektion, sinuitis.
English: • Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes).
Danish: • Lichenoide reaktioner (kløende, rødligt-lilla hududslæt og/eller trådlignende gråhvide linjer på slimhinderne).
English: Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and in the case of intravenously administered infliximab, a reduction in the frequency of infusion reactions.
Danish: Samtidig administration af immunmodulatorer er blevet forbundet med en lavere hyppighed af antistoffer over for infliximab og i tilfælde af intravenøst administreret infliximab, en reduktion i frekvensen af infusionsreaktioner.
English: PASI 75 response** * ITT-analysis where subjects with missing data were included as non-responders.
Danish: ACR 20 respons* ACR 50 respons* ACR 70 respons* PASI respons (% af patienter)b N PASI 75 resp ons** * ITT-analyser med forsøgspersoner med manglende data blev inkluderet som ikke-responderende.
English: For the two initial intravenous infusions, patients may be pre-treated with, e.g., an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
Danish: Ved de to første intravenøse infusioner kan patienter præmedicineres med fx et antihistamin, hydrocortison og/eller paracetamol og infusionshastigheden kan reduceres for at nedsætte risikoen for infusionsrelaterede reaktioner, især hvis infusionsrelaterede reaktioner er set tidligere (se pkt.
English: In phase III clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.
Danish: I fase III kliniske studier oplevede 18 % af de infliximab-behandlede patienter en infusionsrelateret reaktion sammenlignet med 5 % af de placebobehandlede patienter.
English: Read carefully these instructions before using the Remsima syringe.
Danish: Læs disse instruktioner grundigt, inden du begynder at bruge Remsima injektionssprøjte.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with infliximab cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-celle-lymfom hos patienter, der bliver behandlet med Remsima, kan ikke udelukkes (se pkt.