FrancophonIA/ELRC3.0 huggingface dataset:
English: After 16 weeks, about 71% of patients (588 out of 825) receiving Tremfya had a reduction of at least 90% in PASI scores, compared with 48% (282 out of 582) of those receiving adalimumab and under 3% (11 out of 422) receiving placebo.
Danish: Efter 16 uger havde omkring 71 % af de patienter (588 ud af 825), der fik Tremfya, fået reduceret PASI-scoren med mindst 90 % sammenholdt med 48 % (282 ud af 582) af dem, som fik adalimumab, og under 3 % (11 ud af 422) af dem, der fik placebo.
English: A main measure of effectiveness was a reduction of at least 90% in PASI scores.
Danish: Virkningen blev hovedsageligt målt på et fald i PASI-score på mindst 90 %.
English: Patients are likely to continue treatment with Tremfya because it is injected every 8 weeks (after the first 4 weeks) and patients can inject it themselves, making it convenient to use.
Danish: Patienterne vil sandsynligvis fortsætte behandlingen med Tremfya, fordi det indsprøjtes hver 8. uge (efter de første 4 uger), og fordi patienterne selv kan indsprøjte det, hvilket gør det bekvemt at bruge.
English: Other information about Tremfya
Danish: Andre oplysninger om Tremfya
English: The Agency considered that Tremfya is effective and longer-term studies have shown that it remains effective with continued use.
Danish: Agenturet fandt, at Tremfya er effektivt, og at længerevarende studier har vist, at det forbliver effektivt ved fortsat anvendelse.
English: The most common side effects with Tremfya (which may affect more than 1 in 10 people) are infections in the nose and throat.
Danish: De hyppigste bivirkninger ved Tremfya (som kan forekomme hos mere end 1 ud af 10 patienter) er infektioner i næse og svælg.
English: What measures are being taken to ensure the safe and effective use of Tremfya?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tremfya?
English: Side effects reported with Tremfya are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Tremfya vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: It is injected under the skin in an area that is clear of psoriasis.
Danish: Det indsprøjtes under huden i et område, der er fri for psoriasis.
English: An overview of Tremfya and why it is authorised in the EU
Danish: En oversigt over Tremfya, og hvorfor det er godkendt i EU
English: Tremfya contains the active substance guselkumab.
Danish: Tremfya indeholder det aktive stof guselkumab.
English: For more information about using Tremfya, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Tremfya, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: These T cells, which are part of the body's immune system (the body's natural defences), are involved in causing inflammation that is linked to the formation of plaque psoriasis.
Danish: Disse T-celler, som er en del af kroppens naturlige forsvar (immunsystemet), medvirker til den betændelse, der er knyttet til dannelsen af plaque-psoriasis.
English: Tremfya must not be used in patients who have an ongoing infection that the doctor considers important.
Danish: Tremfya må ikke anvendes hos patienter, der har en aktiv infektion, som lægen anser for vigtig.
English: It is used in adults with moderate to severe disease for whom treatments applied to the skin are not suitable.
Danish: Det anvendes hos voksne med moderat til svær sygdom, hvor lokal behandling af huden ikke er egnet.
English: Interleukin 23 is a messenger substance that controls the growth and maturation of some types of T cells.
Danish: Interleukin 23 er et signalstof, der styrer vækst og modning af visse typer af T-celler.
English: What is Tremfya and what is it used for?
Danish: Hvad er Tremfya, og hvad anvendes det til?
English: Why is Tremfya authorised in the EU?
Danish: Hvorfor blev Tremfya godkendt i EU?
English: Patients whose psoriasis did not improve sufficiently after 16 weeks either received Tremfya or continued treatment with ustekinumab for at least 24 weeks.
Danish: De patienter, hos hvem der ikke var tilstrækkelig bedring i psoriasis efter 16 uger, fik enten Tremfya eller fortsatte behandling med ustekinumab i mindst 24 uger.
English: By blocking the action of interleukin 23, guselkumab reduces inflammation and symptoms associated with the disease.
Danish: Ved at blokere virkningen af interleukin 23 mindsker guselkumab den betændelse og de symptomer, der er knyttet til sygdommen.
English: After training, patients may inject Tremfya themselves if the doctor considers it appropriate.
Danish: Efter oplæring kan patienten selv foretage indsprøjtningen med Tremfya, hvis lægen finder det hensigtsmæssigt.
English: The European Medicines Agency decided that Tremfya's benefits are greater than its risks in the treatment of moderate and severe plaque psoriasis, and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Tremfya opvejer risiciene ved behandling af moderat og svær plaque-psoriasis, og at det kan godkendes til anvendelse i EU.
English: Tremfya can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating plaque psoriasis.
Danish: Tremfya udleveres kun efter recept og bør anvendes under opsyn af en læge med erfaring i at diagnosticere og behandle plaque-psoriasis.
English: The active substance in Tremfya, guselkumab, is a monoclonal antibody (a type of protein) which is designed to attach to interleukin 23 and block its activity.
Danish: Det aktive stof i Tremfya, guselkumab, er et protein af typen monoklonalt antistof, som er udformet, så det binder til interleukin 23 og blokerer dettes virkning.
English: Improvement in psoriasis symptoms was maintained beyond 48 weeks with Tremfya treatment.
Danish: Bedringen i psoriasissymptomerne holdt sig ud over 48 uger ved behandling med Tremfya.
English: What are the risks associated with Tremfya?
Danish: Hvilke risici er der forbundet med Tremfya?
English: Three main studies involving 2,700 adults found Tremfya effective for treating moderate to severe plaque psoriasis in patients for whom treatments applied to the skin did not work well enough.
Danish: I tre hovedstudier med deltagelse af 2.700 voksne var Tremfya effektivt til behandling af moderat til svær plaque-psoriasis hos patienter, som ikke havde tilstrækkelig gavn af midler til påføring på huden.
English: During this period, symptoms of psoriasis improved to a greater extent in patients receiving Tremfya than in those remaining on ustekinumab.
Danish: I denne periode var der større bedring i psoriasis-symptomerne hos de patienter, der fik Tremfya, end hos dem, der fortsatte med ustekinumab.
English: The third study involved 871 patients who were treated with ustekinumab (another medicine used for treating psoriasis).
Danish: Det tredje studie omfattede 871 patienter, der blev behandlet med et andet middel mod psoriasis (ustekinumab).
English: PASI is a measure of disease severity and area of skin affected.
Danish: PASI er et mål for sygdommens sværhed og det angrebne hudareal.
English: Tremfya is available as a solution for injection in pre-filled syringes or pens.
Danish: Tremfya fås som injektionsvæske i fyldte sprøjter eller penne.
English: The first two studies compared Tremfya with adalimumab (another medicine used for treating psoriasis) and placebo (a dummy treatment).
Danish: I de to første studier blev Tremfya sammenlignet med et andet middel mod psoriasis (adalimumab) og placebo (ikke-aktivt stof).
English: Tremfya is a medicine that acts on the immune system and is used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Danish: Tremfya er et lægemiddel, der virker på immunsystemet, og det anvendes til behandling af plaquepsoriasis, der giver røde, skællende hudområder.
English: How is Tremfya used?
Danish: Hvordan anvendes Tremfya?
English: What benefits of Tremfya have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Tremfya?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tremfya have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Tremfya.
English: How does Tremfya work?
Danish: Hvordan virker Tremfya?
English: Tell your doctor if you experience these symptoms.
Danish: Fortæl det til lægen, hvis De oplever disse symptomer.
English: Very rare to < 1/10)
Danish: Sjælden Meget sjælden til < 1/10)
English: • It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
Danish: • Det er vigtigt, at De ikke forsøger at give Dem selv injektionen, medmindre De har fået oplæring af Deres læge eller sundhedspersonalet.
English: - breathing problems.
Danish: - åndedrætsproblemer.
English: B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
Danish: B PRES stemplet ned med et langsomt og konstant tryk, indtil De mærker eller hører et ”klik”.
English: If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Danish: Hvis der opstår en alvorlig allergisk reaktion, skal passende behandling administreres med nøje patientopfølgning i flere dage.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1409/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1409/001
English: to < 1/100)
Danish: til < 1/100)
English: In order to improve the traceability of biologic medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts navn og batchnummeret tydeligt registreres.
English: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Danish: Muligheden for interaktion med lithium, som også øger frigivelsen af neutrofiler, er ikke blevet specifikt undersøgt.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease.
Danish: Disse celler er meget modtagelige for effekterne af kemoterapi, hvilket kan medføre, at antallet af disse celler i Deres krop mindskes.
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Danish: Giv ikke injektionen på steder, hvor huden er øm, forslået, rød eller hård.
English: Push all the way down through the snap.
Danish: Pres hele vejen ned gennem ”klikket”.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Danish: Derfor bør miltstørrelsen overvåges nøje (f.eks. ved klinisk undersøgelse, ultralyd).
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2º C - 8º C).
English: 2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults that supported the marketing authorisation.
Danish: 2 Denne bivirkning er påvist i forbindelse med overvågning efter markedsføring, men ikke observeret i de randomiserede, kontrollerede kliniske studier hos voksne, der udgjorde grundlaget for markedsføringstilladelsen.
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product.
Danish: En sådan forhøjelse i leukocytter er forbigående, ses typisk 24 til 48 timer efter administration og er i overensstemmelse med de farmakodynamiske effekter af dette lægemiddel.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendix V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: - you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine.
Danish: - De er allergisk over for pegfilgrastim, filgrastim, proteiner stammende fra E. coli, eller et af de øvrige indholdsstoffer i dette lægemiddel.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30° C) it must either be used within 4 days or disposed of.
Danish: I det øjeblik en sprøjte tages ud af køleskabet, og har nået stuetemperatur (ikke over 30º C), skal den anvendes inden for 4 dage eller bortskaffes.
English: Do not try to warm the syringe by using a heat source such as hot water or microwave.
Danish: Opvarm ikke den fyldte injektionssprøjte ved hjælp af en varmekilde, som fx varmt vand eller mikrobølgeovn.
English: Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment.
Danish: Stevens-Johnsons syndrom (SJS), som kan være livstruende eller dødelig, er sjældent blevet rapporteret i forbindelse med behandlig med pegfilgrastim.
English: If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
Danish: Hvis patienten udvikler SJS ved anvendelse af pegfilgrastim, må behandling med pegfilgrastim ikke genstartes hos denne patient på noget tidspunkt.
English: 3P BIOPHARMACEUTICALS SL C/ Mocholi 2, Poligono Industrial Mocholi 31110 Noain Spain
Danish: 3P BIOPHARMACEUTICALS SL C/ Mocholi 2, Poligono Industrial Mocholi 31110 Noain
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
Danish: Der skal udvises særlig omhu for at skelne diagnosen blasttransformation af kronisk myeloid leukæmi fra AML.
English: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults.
Danish: Begrænsede data indikerer at farmakokinetikken for pegfilgrastim hos ældre forsøgspersoner (> 65 år) er tilsvarende den hos voksne.
English: Only a solution that is clear and colourless should be injected.
Danish: Kun en opløsning, der er klar og farveløs, bør injiceres.
English: Single doses of 300 μg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Danish: Der er indgivet enkeltdoser på 300 μg/kg subkutant til et begrænset antal raske frivillige og patienter med ikke-småcellet lungecancer uden alvorlige bivirkninger.
English: 6.6 Special precautions for disposal and other handling Before administration, Pegfilgrastim Mundipharma solution should be inspected visually for particulate matter.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Før administration bør Pegfilgrastim Mundipharma-opløsningen undersøges visuelt for partikler.
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Danish: Der er rapporteret pulmonale bivirkninger, især interstitiel pneumoni, efter administration af G-CSF.
English: Then LIFT the syringe off skin.
Danish: LØFT derefter sprøjten væk fra huden..
English: Accidental exposure to freezing temperatures for two periods of less than 72 hours each does not adversely affect the stability of Pegfilgrastim Mundipharma.
Danish: Utilsigtet eksponering for frysende temperaturer i 2 enkeltperioder, hver på under 72 timer, påvirker ikke Pegfilgrastim Mundipharmas stabilitet negativt.
English: Pegfilgrastim Mundipharma may be used if it is accidentally frozen for two periods of less than 72 hours each.
Danish: Pegfilgrastim Mundipharma kan bruges, hvis det utilsigtet fryses i 2 perioder, hver under 72 timer.
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40 % incidence of febrile neutropenia.
Danish: Ved fravær af vækstfaktorstøtte har det været rapporteret, at regimet resulterede i genemsnitlig varighed af grad 4 neutropeni på 5-7 dage, og en incidens for febril neutropeni på 30-40 %.
English: • Pegfilgrastim Mundipharma is given as an injection into the tissue just under the skin (subcutaneous injection).
Danish: • Pegfilgrastim Mundipharma gives som en injektion i vævet lige under huden (subkutan injektion).
English: Calle García Ximénez, nº3-1º 31002 Pamplona (Navarra) Spain
Danish: Calle García Ximénez, nº3-1º 31002 Pamplona (Navarra) Spanien
English: However, the long-term effects of Pegfilgrastim Mundipharma have not been established in AML; therefore, it should be used with caution in this patient population.
Danish: Den langsigtede virkning af Pegfilgrastim Mundipharma er dog ikke blevet fastslået ved AML, og skal derfor anvendes med forsigtighed i denne patientpopulation.
English: Stop using Pegfilgrastim Mundipharma and seek medical attention immediately if you notice any of the symptoms described in section 4.
Danish: Hold op med at bruge Pegfilgrastim Mundipharma, og søg øjeblikkeligt lægehjælp, hvis De bemærker et eller flere af de symptomer, der er beskrevet i afsnit 4.
English: Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Danish: Behandling med Pegfilgrastim alene forhindrer ikke thrombocytopeni og anæmi, da fuld dosis myelosuppressiv kemoterapi opretholdes efter foreskrevet skema.
English: Blood and lymphatic system Disorders
Danish: Blod og lymfesystem
English: Figure 1: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Danish: Figur 1: Profil over median pegfilgrastim serumkoncentration og absolut neutrofiltal (ANC) hos kemoterapi-behandlede patienter efter en enkelt 6 mg injektion
English: Pegfilgrastim Mundipharma has not been tested in pregnant women.
Danish: Pegfilgrastim Mundipharma er ikke blevet testet på gravide kvinder.
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pegfilgrastim Mundipharma.
Danish: Der er rapporteret om alvorlige hudreaktioner (Stevens-Johnsons syndrom) ved brug af Pegfilgrastim Mundipharma.
English: Your doctor has given you Pegfilgrastim Mundipharma to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Danish: Deres læge har ordineret Pegfilgrastim Mundipharma til Dem for at støtte Deres knoglemarv (hvor blodceller dannes) til at producere flere hvide blodlegemer, der hjælper Deres krop med at bekæmpe infektion.
English: Your doctor will check your blood and urine regularly as Pegfilgrastim Mundipharma can harm the tiny filters inside your kidneys (glomerulonephritis).
Danish: Deres læge vil regelmæssigt kontrollere Deres blod og urin, da Pegfilgrastim Mundipharma kan beskadige de bittesmå filtre i nyrerne (glomerulonefritis).
English: Step 1: Prepare A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Danish: Trin 1: Forberedelse A Tag bakken med den fyldte injektionssprøjte ud af pakningen og saml de ting sammen, der skal bruges til injektionen: afspritningsservietter, vat eller gazekompresser, plaster og en kanylebøtte (følger ikke med).
English: - if you have sickle cell anaemia.
Danish: - hvis De har seglcelleanæmi.
English: Pegfilgrastim Mundipharma may be exposed to room temperature (not above 30º C) for a maximum single period of up to 96 hours.
Danish: Pegfilgrastim Mundipharma kan udsættes for stuetemperatur (ikke over 30º C) i maksimalt en enkelt periode på op til 96 timer.
English: • The needle cap is missing or not securely attached.
Danish: • Kanylehætten mangler eller er ikke sat ordentligt på.
English: White blood cell (WBC) counts of 100 × 109/L or greater have been observed in less than 1 % of patients receiving pegfilgrastim therapy.
Danish: Leukocyttal (WBC) på 100 x 109/l eller højere er set hos mindre end 1 % af patienter, behandlet med Pegfilgrastim.
English: If you forget to inject Pegfilgrastim Mundipharma If you have forgotten a dose of Pegfilgrastim Mundipharma, you should contact your doctor to discuss when you should inject the next dose.
Danish: Hvis De har glemt at indsprøjte Pegfilgrastim Mundipharma Hvis De har glemt en dosis Pegfilgrastim Mundipharma, kontakt da Deres læge for at aftale, hvornår De skal indsprøjte den næste dosis.
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Danish: * Produceret i Escherichia coli-celler vha. rekombinant dna-teknologi efterfulgt af konjugation med polyethylenglykol (PEG).
English: Pegfilgrastim Mundipharma left at room temperature for more than 96 hours should be discarded.
Danish: Pegfilgrastim Mundipharma opbevaret ved stuetemperatur i mere end 96 timer skal kasseres.
English: Do not shake Pegfilgrastim Mundipharma vigorously as this may affect its activity.
Danish: Ryst ikke Pegfilgrastim Mundipharma kraftigt, da dette kan påvirke virkningen.
English: In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy.
Danish: I kliniske studier er Pegfilgrastim blevet givet uden risiko 14 dage før kemoterapi.
English: Median Serum Pegfilgrastim Conc.
Danish: Median serum pegfilgrastim konc.
English: Rare side effects (may affect up to 1 in 1,000 people) - Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Danish: Sjældne bivirkninger (kan ramme op til 1 ud af 1.000 personer): - betændelse i aorta (den store pulsåre, der transporterer blod fra hjertet ud i kroppen), se afsnit 2.
English: Stop using Pegfilgrastim Mundipharma if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Hold op med at bruge Pegfilgrastim Mundipharma, hvis De udvikler disse symptomer, og søg øjeblikkeligt lægehjælp eller kontakt Deres læge.
English: Its important to keep the skin pinched when injecting.
Danish: Det er vigtigt, at huden også klemmes sammen under injektionen.
English: Pegfilgrastim Mundipharma therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Danish: Pegfilgrastim Mundipharma-terapi skal påbegyndes og overvåges af læger, der har erfaring med onkologi og/eller hæmatologi.
English: - cutaneous vasculitis (inflammation of the blood vessels in the skin).
Danish: - kutan vaskulitis (irritation eller betændelse i blodkarrene i huden).
English: If you develop or are likely to develop cancers of the blood, you should not use Pegfilgrastim Mundipharma, unless instructed by your doctor.
Danish: Hvis De udvikler kræft i blodet, eller det er sandsynligt, at De vil gøre det, bør De ikke bruge Pegfilgrastim Mundipharma, medmindre Deres læge sagt, at De skal gøre det.
English: Talk to your doctor, pharmacist or nurse before using Pegfilgrastim Mundipharma:
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før De bruger Pegfilgrastim Mundipharma: