FrancophonIA/ELRC3.0 huggingface dataset:
English: TRISTAR was a 26-week active-controlled open label study comparing Trimbow with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients).
Danish: TRISTAR var et 26-ugers, åbent, aktivt kontrolleret studie, der sammenlignede Trimbow med en ekstemporær kombination bestående af en fastdosiskombination af fluticason/vilanterol 92/22 mikrogram inhalationspulver, en inhalation én gang dagligt plus tiotropium 18 mikrogram inhalationspulver, hård kapsel, en inhalation én gang dagligt (1.157 randomiserede patienter).
English: You should not use Trimbow during breast-feeding.
Danish: Du må ikke anvende Trimbow under amning.
English: Τηλ: + 30 210 6179763
Danish: Chiesi Hellas AEBE Τηλ: + 30 210 6179763
English: Additionally, due to the anticholinergic effect of glycopyrronium, the long-term co-administration of Trimbow with other anticholinergic-containing medicinal products is not recommended (see section 4.5).
Danish: Desuden bør en langvarig administration af Trimbow sammen med andre lægemidler, der indeholder antikolinergika, ikke anvendes, på grund af den antikolinerge virkning af glycopyrronium (se pkt.
English: Compared with a fixed combination of indacaterol and glycopyrronium, Trimbow reduced the rate of moderate/severe exacerbations over 52 weeks by 15% (rate: 0.50 versus 0.59 events per patient/year; p = 0.043).
Danish: Sammenlignet med en fastdosiskombination af indacaterol og glycopyrronium nedsatte Trimbow hyppigheden af moderate/svære eksacerbationer i løbet af 52 uger med 15 % (hyppighed: 0,50 versus 0,59 hændelser pr. patient/år, p = 0,043).
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trimbow significantly improved 2-hour post dose FEV1 by 117 mL after 26 weeks of treatment and by 103 mL after 52 weeks of treatment (p < 0.001).
Danish: Sammenlignet med en fast kombination af beclometasondipropionat og formoterol forbedrede Trimbow FEV1 2-timer efter dosering med 117 ml efter 26 ugers behandling, og med 103 ml efter 52 ugers behandling (p < 0,001).
English: Trimbow 87/5/9 micrograms pressurised inhalation beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium Inhalation use
Danish: Trimbow 87/5/9 mikrogram inhalationsspray beclometasoni dipropionas/formoteroli fumaras dihydricus/glycopyrronium Til inhalation
English: Compared with tiotropium, Trimbow reduced the rate of moderate/severe exacerbations over 52 weeks by 20% (rate: 0.46 versus 0.57 events per patient/year; p = 0.003).
Danish: Sammenlignet med tiotropium nedsatte Trimbow hyppigheden af moderate/svære eksacerbationer i løbet af 52 uger med 20 % (hyppighed: 0,46 versus 0,57 hændelser pr. patient/år, p = 0,003).
English: Package leaflet: Information for the user Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Danish: Indlægsseddel: Information til brugeren Trimbow 87 mikrogram/5 mikrogram/9 mikrogram inhalationsspray, opløsning beclometasondipropionat/formoterolfumaratdihydrat/glycopyrronium (beclometasoni dipropionas/formoteroli fumaras dihydricus/glycopyrronium)
English: Trimbow 87/5/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Danish: Trimbow 87/5/9 mikrogram inhalationsspray, opløsning beclometasoni dipropionas/formoteroli fumaras dihydricus/glycopyrronium
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trimbow improved pre-dose FEV1 by 81 mL after 26 weeks of treatment and by 63 mL after 52 weeks of treatment.
Danish: Sammenlignet med en fast kombination af beclometasondipropionat og formoterol forbedrede Trimbow FEV1 før dosering med 81 ml efter 26 ugers behandling og med 63 ml efter 52 ugers behandling.
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trimbow reduced the rate of moderate/severe exacerbations over 52 weeks by 23% (rate: 0.41 versus 0.53 events per patient/year; p = 0.005).
Danish: Sammenlignet med en fastdosiskombination af beclometasondipropionat og formoterol nedsatte Trimbow hyppigheden af moderate/svære eksacerbationer i løbet af 52 uger med 23 % (hyppighed: 0,41 versus 0,53 hændelser pr. patient/år, p = 0,005).
English: The daily dose of Trimbow corresponds to a medium dose of inhaled corticosteroid; furthermore, these effects are much less likely to occur than with oral corticosteroids.
Danish: Den daglige dosis af Trimbow svarer til en medium dosis af inhaleret kortikosteroid.
English: How to use Trimbow
Danish: Sådan skal du bruge Trimbow
English: • fungal infections of the throat or of the food pipe (oesophagus)
Danish: • svampeinfektioner i halsen eller i spiserøret
English: What Trimbow is and what it is used for What you need to know before you use Trimbow How to use Trimbow
Danish: Det skal du vide, før du begynder at bruge Trimbow Sådan skal du bruge Trimbow Bivirkninger
English: Study TRINITY compared Trimbow with tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily; in addition, effects were compared with an extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (2,691 randomised patients).
Danish: Desuden blev virkningerne sammenlignet med en ekstemporær trippelkombination, der bestod af en fast kombination af to inhalationer af beclometasondipropionat og formoterol 100/6 mikrogram to gange dagligt plus tiotropium 18 mikrogram inhalationspulver, hård kapsel, en inhalation én gang dagligt (2.691 randomiserede patienter).
English: Compared with tiotropium, Trimbow also reduced the rate of severe exacerbations (i.e. excluding moderate exacerbations) by 32% (rate: 0.067 versus 0.098 events per patient/year; p = 0.017).
Danish: moderate eksacerbationer) med 32 % (hyppighed: 0,067 versus 0,098 hændelser pr. patient/år, p = 0,017).
English: Cardiac disorders
Danish: (hjertediagrammet)
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, administrationsveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: Beerse, Belgium
Danish: Beerse, Belgien
English: 5026 RH Tilburg The Netherlands
Danish: 5026 RH Tilburg The Holland
English: JANSSEN-CILAG A/S Bregnerødvej 133 3460 Birkerød Denmark
Danish: Janssen-Cilag A/S Bregnerødvej 133 3460 Birkerød Danmark
English: Oral drops,
Danish: Orale dråber,
English: Vorgartenstraße 206B AT-1020 Vienna Austria
Danish: Vorgartenstraße 206B AT-1020 Vienna Østrig
English: 56 Eirinis Ave, Pefki Athens GR-151 21 Greece
Danish: 56 Eirinis Ave, Pefki Athens GR-151 21
English: Turnhoutseweg 30, B2340 Beerse Belgium
Danish: Turnhoutseweg 30, B2340 Beerse Belgien
English: 2 mg/ml in bottles of 15 ml, 30 ml, 100 ml and 195 ml
Danish: 2mg/ml i flasker med 15 ml, 30 ml, 100 ml og 195 ml
English: Haldol-Janssen 2 mg/ ml in bottles of 30 ml and 100 ml)
Danish: Haldol-Janssen 2 mg/ml i flasker med 30 ml og 100 ml)
English: Oral drops, solution Oral use
Danish: Orale dråber, opløsning
English: Intramuscular use; Intravenous use
Danish: Intravenøs anvendelse
English: a. Hold the pen so that you can see the window.
Danish: a. Hold pennen så du kan se vinduet.
English: Wait 30 minutes.
Danish: Vent i 30 minutter.
English: For more information see section on vaccination.
Danish: For mere information se afsnit om vaccination.
English: Date of first authorisation: 10 September 2013 Date of latest renewal: 21 June 2018
Danish: Dato for første markedsføringstilladelse: 10 september 2013 Dato for seneste markedsfornyelse: 21. juni 2018
English: • The expiration date has passed.
Danish: • Udløbsdatoen er overskredet.
English: The medicinal product must be discarded if not used within the 14-day period.
Danish: Lægemidlet skal bortskaffes, hvis det ikke bruges inden for en 14-dages periode.
English: Baseline Week 6
Danish: Baseline Uge 6
English: Call your healthcare provider immediately.
Danish: Ring straks til sundhedspersonalet.
English: a. Wash your hands with soap and water and dry them thoroughly.
Danish: a. Vask dine hænder med sæbe og vand og tør dem grundigt.
English: Remsima is indicated for:
Danish: Remsima er indiceret til:
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt:hyppighed kan ikke estimeres ud fra forhåndenværende data
English: Missed dose for 8 days or more
Danish: Glemt dosis i 8 dage eller mere
English: Note: You may see air bubbles in the liquid.
Danish: Bemærk: Der kan forekomme luftbobler i væsken.
English: This will depend on your disease, weight and how well you respond to Remsima.
Danish: Dette vil afhænge af din sygdom, vægt og hvor godt, du reagerer på Remsima.
English: Note: If the olive green plunger rod does not fill the window completely, you did not receive your full dose.
Danish: Bemærk: Hvis den olivengrønne stempelstang ikke fylder vinduet helt, har du ikke modtaget den fulde dosis.
English: A damaged pen may not function properly.
Danish: En beskadiget pen fungerer muligvis ikke korrekt.
English: Missed dose for up to 7 days
Danish: Glemt dosis i op til 7 dage
English: You may inject into:
Danish: Du kan injicere i:
English: EXP, if not refrigerated ___________________
Danish: EXP, hvis ikke opbevaret i køleskab ___________________
English: • properly labelled to warn of hazardous waste inside the container.
Danish: • Er passende markeret med en advarsel om farligt affald inden i beholderen.
English: • upright and stable during use;
Danish: • Kan stå lodret og stabilt under brug;
English: • You will be monitored while you are given Remsima and also for 1 to 2 hours afterwards.
Danish: • Du vil blive overvåget, mens du får Remsima og i 1-2 timer derefter.
English: The subcutaneous administration of Remsima to New Zealand White rabbits was well tolerated at the actual concentration to be used in humans.
Danish: Den subkutane administration af Remsima til hvide New Zealand-kaniner tolereredes godt ved den reelle koncentration, der skal anvendes hos mennesker.
English: Remsima is a biosimilar medicinal product.
Danish: Remsima er et biosimilært lægemiddel.
English: Methotrexate was given concomitantly.
Danish: Methotrexat blev givet samtidigt.
English: The following side effects have been observed with Remsima:
Danish: Følgende bivirkninger er observeret med Remsima:
English: Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of >20 weeks.
Danish: Mellem uge 6 og 26 vendte symptomerne på psoriasis gradvis tilbage med en median tid til sygdomsrelaps på > 20 uger.
English: a. Look at the pen and confirm that the olive green plunger rod is filling the window completely.
Danish: a. Se på pennen og bekræft, at den olivengrønne stempelstang fylder vinduet helt.
English: a. After you hear the 2nd loud “click,” continue to hold the pen firmly against the skin and count slowly to at least five to ensure you inject the full dose.
Danish: a. Når du har hørt det andet høje "klik", skal du fortsætte med at holde pennen fast mod huden og langsomt tælle til mindst fem for at sikre, at du injicerer den fulde dosis.
English: Clinical Responsea Clinical Remission Steroid-Free Remission
Danish: Klinisk responsa Klinisk remission Steroidfri remission
English: If acute reactions occur, medical treatment should be sought immediately.
Danish: Hvis akutte reaktioner opstår, skal der øjeblikkeligt søges lægehjælp.
English: Remsima should be administered
Danish: Remsima bør administreres
English: Long-term studies have not been performed to evaluate the carcinogenic potential of infliximab.
Danish: Langvarige studier er ikke blevet udført for at vurdere det carcinogene potentiale af infliximab.
English: • Blood test result showing ‘antibodies' against your own body.
Danish: • Blodprøveresultater, der viser ‘antistoffer' mod din egen krop
English: Most of these reactions resolved spontaneously without any treatment.
Danish: De fleste af disse reaktioner forsvandt spontant uden behandling.
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system
Danish: • Unormale værdier for et protein i blodet kaldet ‘komplementfaktor', som er en del af immunsystemet
English: b. Keep holding the pen firmly against the skin and listen for the 2nd loud “click.”
Danish: b. Bliv ved med at holde pennen fast mod huden og lyt efter det andet høje ” klik”.
English: If you feel tired, dizzy, or unwell after having Remsima, do not drive or use any tools or machines.
Danish: Hvis du føler dig træt, svimmel eller utilpas efter at have fået Remsima, må du ikke føre motorkøretøj eller betjene nogen form for værktøj eller maskiner.
English: • made of a heavy-duty plastic;
Danish: • Er lavet af kraftigt plastik;
English: Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2
Danish: Tabel 9 Virkninger på ACR og PASI i IMPACT og IMPACT 2
English: a. Press the pen firmly against the skin.
Danish: a. Tryk pennen fast mod huden.
English: 23, Academy-ro, Yeonsu-gu, Incheon, 22014 Republic of Korea
Danish: 23, Academy-ro, Yeonsu-gu, Incheon, 22014 Republikken Korea
English: Remsima will generally be stored by the health professionals.
Danish: Remsima opbevares af sundhedspersonalet.
English: City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
Danish: City North Business Campus Stamullen, Co. Meath K32 YD60 Irland
English: The required total volume of reconstituted Remsima solution has to be calculated.
Danish: Det påkrævede samlede volumen rekonstitueret Remsimaopløsning beregnes.
English: Sustained Steroid-Free Remissionb a Reduction in CDAI ≥25% and ≥70 points.
Danish: Vedblivende steroidfri remissionb a Reduktion i CDAI ≥ 25 % og ≥ 70 point.
English: Patients with a PGA score ≥3 were eligible to receive an additional infusion of the same treatment at week 26.
Danish: Patienter med en PGA score ≥ 3 havde mulighed for at få en yderligere infusion af den samme behandling i uge 26.
English: Always have the outer carton of the medicine with you, even if it is empty.
Danish: Medbring altid lægemidlets ydre karton, også selvom den er tom.
English: There is no specific treatment for Remsima overdose.
Danish: Der findes ingen specifik behandling mod overdosis af Remsima.
English: Do not give this medicine to children and adolescents under 18 years of age because there are no data that show that this medicine is safe and works in this age group.
Danish: Dette lægemiddel må ikke gives til børn og unge under 18, år fordi der ikke foreligger nogen data, der viser, at dette lægemiddel er sikkert og virker hos denne aldersgruppe.
English: Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Danish: Remsima, i kombination med methotrexat, er indiceret til reduktion af sygdomstegn og symptomer samt forbedring af fysisk funktionsevne hos:
English: If you are not sure when to inject Remsima, call your doctor.
Danish: Hvis du ikke er sikker på, hvornår du skal injicere Remsima, skal du ringe til din læge.
English: b Based on patients with PASI >2.5 at baseline for IMPACT, and patients with >3% BSA psoriasis skin involvement at baseline in IMPACT 2.
Danish: b Baseret på patienter med PASI > 2.5 ved baseline for IMPACT, og patienter med > 3 % BSA psoriasis hud påvirkning ved baseline af IMPACT 2.
English: • The doctor will decide your dose and how often you will be given Remsima.
Danish: • Lægen vil bestemme din dosis og hvor ofte, du skal have Remsima.
English: Most of these reactions may occur immediately or within 24 hours after subcutaneous injection.
Danish: De fleste af disse reaktioner kan forekomme umiddelbart eller inden for 24 timer efter subkutan injektion.
English: • The front of the thighs.
Danish: • Forsiden af lårene.
English: b. Let the skin dry before injecting.
Danish: b. Lad huden tørre før injektion.
English: You will find detailed “Instructions for Use” at the end of this leaflet.
Danish: Du finder nærmere ”Instruktioner i anvendelse” sidst i indlægssedlen.
English: Therefore, subcutaneous use of Remsima is recommended for use only in adults.
Danish: Derfor anbefales sukutan brug af Remsima kun hos voksne.
English: b. Remove the pen from the carton stored in your refrigerator.
Danish: b. Fjern pennen fra kartonen, som er opbevaret i dit køleskab.
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥10% and Psoriasis Area and Severity Index [PASI] score ≥12).
Danish: Patienter i begge studier havde plaque psoriasis (Body Surface Area [BSA] ≥ 10 % og Psoriasis Area and Severity Index [PASI] score ≥ 12).
English: Do not use the pen if:
Danish: Pennen må ikke bruges, hvis:
English: Side effects may also occur after your treatment with Remsima has stopped.
Danish: Bivirkninger kan også opstå efter ophør af din behandling med Remsima.
English: The primary endpoint of the study was the treatment difference of the change from baseline of DAS28 (CRP) at Week 22.
Danish: Studiets primære endepunkt var behandlingsforskellen for ændringen fra baseline af DAS28 (CRP) i uge 22.
English: The primary endpoint in both studies was the percent of patients who achieved ≥75% improvement in PASI from baseline at week 10.
Danish: Det primære endepunkt i begge studier var procenten af patienter, som opnåede ≥ 75 % forbedring i PASI fra baseline i uge 10.
English: Your doctor will advise you what other medicines you must keep using while you are having Remsima.
Danish: Din læge vil rådgive dig om, hvilke andre lægemidler du skal blive ved med at tage, mens du er i behandling med Remsima.
English: Do not use Remsima if any of the above applies to you.
Danish: Du må ikke få Remsima, hvis noget af ovenstående passer på dig.
English: Instructions for use and handling - reconstitution, dilution and administration
Danish: Instruktioner i anvendelse og håndtering - rekonstitution, fortynding og administration
English: Forty six percent of patients continued on stable doses of methotrexate (≤25 mg/week).
Danish: 46 % af patienterne fortsatte på stabile doser methotrexat (≤ 25 mg/uge).
English: 6 weeks after your 1st dose
Danish: 6 uger efter din 1. dosis
English: Remsima belongs to a group of medicines called ‘TNF blockers'.
Danish: Remsima tilhører en lægemiddelgruppe kaldet ”TNF-blokkere”.
English: If you forget or miss an appointment to receive Remsima, make another appointment as soon as possible.
Danish: Hvis du glemmer eller kommer for sent til en aftale, hvor Remsima gives, skal du lave en ny aftale så hurtigt som muligt.
English: Table 5 Mean (SD) Actual Values of DAS28 (CRP and ESR)
Danish: Tabel 5 Gennemsnitlige (SD) reelle værdier for DAS28 (CRP og ESR)
English: The apparent volume of distribution during the terminal phase (mean of 7.3 to 8.8 litres) was not dependent on the administered dose.
Danish: Det tilsyneladende fordelingsvolumen i terminalfasen (gennemsnit på 7,0 til 8,8 liter) var ikke afhængigt af den indgivne dosis.
English: Remsima is also used in adults and children 6 years of age or older for:
Danish: Remsima bruges også til voksne og børn fra 6 år og opefter til behandling af:
English: a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
Danish: a. Klargør en ren, flad overflade, såsom et bord eller en køkkenbordplade, i et velbelyst område.
English: It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous) is being administered to the patient, as prescribed.
Danish: Det er vigtigt at kontrollere produktets mærkning for at sikre, at den korrekte formulering (intravenøs eller subkutan) administreres til patienten som ordineret.
English: Prepare for the injection 1.
Danish: Klargør til injektion 1.
English: 5 mg/kg (at week 24)
Danish: 5 mg/kg (i uge 24)
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, en vigtig milepæl
English: 2 weeks after your 1st dose
Danish: 2 uger efter din 1. dosis
English: Table 6 Percent of patients achieving corticosteroid-free clinical remission at Week 26, SONIC
Danish: Tabel 6 Procent af patienter, som opnåede kortikosteroidfri klinisk remission i uge 26, SONIC
English: Only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less) should be used.
Danish: Kun et infusionssæt med et in-line, sterilt, ikke-pyrogent, minimalt proteinbindende filter (porestørrelse 1,2 μm eller derunder) bør anvendes.
English: Remsima should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Danish: Remsima bør kun anvendes til børn, hvis de behandles for Crohns sygdom eller colitis ulcerosa.
English: Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
Danish: Kasser lægemidlet, hvis det ikke er brugt før den nye udløbsdato eller den udløbsdato, der er trykt på æsken, alt efter, hvilken dato der kommer først.
English: • It is cracked or damaged.
Danish: • Den er revnet eller beskadiget.
English: Subcutaneous administration of Remsima is not recommended for paediatric use and no data are available on the use of Remsima administered subcutaneously in the paediatric population.
Danish: Subkutan administration af Remsima anbefales ikke til pædiatrisk brug, og der foreligger ingen data om brugen af Remsima administreret subkutant hos den pædiatriske population.
English: Remsima infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Danish: Remsima-infusioner skal administreres af kvalificeret sundhedspersonale, som er trænet i at detektere infusionsrelaterede problemer.
English: a. Pull the olive green cap straight off and set it aside.
Danish: a. Træk den olivengrønne hætte lige af og læg den til side.
English: It is important that you and your doctor record the brand name and batch number of your medicine.
Danish: Det er vigtigt, at du og din læge noterer produktnavn og lot-nummeret på din medicin.
English: c. Ensure you have the following supplies:
Danish: c. Sørg for, at du har følgende dele:
English: In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required.
Danish: I tilfælde af en overdosis skal patienten behandles symptomatisk, og der skal iværksættes støttende foranstaltninger efter behov.
English: Complete fistula response (%)b a A ≥50% reduction from baseline in the number of draining fistulas over a period of ≥4 weeks.
Danish: Fistelrespons (%) a Komplet fistelrespons (%) b a A ≥ 50 % reduktion fra baseline i antallet af drænede fistler over en periode på ≥ 4 uger.
English: • If you have had a break in your treatment with infliximab of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Danish: • Hvis du har holdt pause i behandlingen med infliximab i over 16 uger, er der en højere risiko for at få en allergisk reaktion, når du starter Remsima-behandlingen igen.
English: It is important to check the product labels to ensure that the correct formulation is being given as prescribed.
Danish: Det er vigtigt at kontrollere produktets mærkning for at sikre, at der gives den korrekte formulering som ordineret.
English: 5 years at 2°C - 8°C.
Danish: 5 år ved 2 °C - 8 °C.