FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Remsima are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Remsima vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: What are the risks associated with Remsima?
Danish: Hvilke risici er der forbundet med Remsima?
English: In addition, Remsima and Remicade given by infusion into a vein were compared in one main study involving 606 adults with rheumatoid arthritis.
Danish: Desuden blev Remsima og Remicade givet ved infusion i en vene sammenlignet i et hovedstudie, der omfattede 606 voksne med reumatoid artritis.
English: The company that markets Remsima will provide a card to patients that includes information about the medicine and can be used to record tests they have taken.
Danish: Virksomheden, som markedsfører Remsima, vil udarbejde et patientkort, der indeholder oplysninger om lægemidlet, og som kan anvendes til at registrere de test, de har foretaget.
English: Because Remsima is a biosimilar medicine, the studies on effectiveness and safety of infliximab carried out with Remicade do not all need to be repeated for Remsima.
Danish: Da Remsima er et biosimilært lægemiddel, behøver de studier af virkning og sikkerhed, der er udført for infliximab, ikke gentages for Remsima.
English: By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Danish: Ved at blokere TNFalfa bedrer infliximab inflammationen og andre symptomer på sygdommene.
English: For more information about using Remsima, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Remsima, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Remsima can only be obtained with a prescription and treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remsima can be used to treat.
Danish: Remsima fås kun på recept, og behandlingen bør iværksættes og overvåges af en speciallæge med erfaring i diagnosticering og behandling af de sygdomme, som Remsima anvendes til.
English: The most common side effects with Remsima (which may affect more than 1 in 10 people) are viral infections (such as flu or cold sores), headache, upper respiratory-tract infection (nose and throat infections), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Danish: De hyppigste bivirkninger ved Remsima (som kan forekomme hos mere end 1 ud af 10 personer) er virusinfektioner (som f.eks. influenza og forkølelsessår), hovedpine, infektioner i de øvre luftveje (infektioner i næsen og svælget), bihulebetændelse, kvalme,
English: The active substance in Remsima, infliximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Danish: Det aktive stof i Remsima, infliximab, er et monoklonalt antistof, dvs. en type protein, der er opbygget, så det genkender og binder sig til en særlig struktur (et antigen) i kroppen.
English: Patients can inject Remsima themselves once they have been trained.
Danish: Patienter kan godt selv indsprøjte Remsima, når de er blevet instrueret i det.
English: Therefore, the Agency's view was that, as for Remicade, the benefits of Remsima outweigh the identified risks and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Remsima opvejer de identificerede risici som for Remicade, og at det kan godkendes til anvendelse i EU.
English: Remsima is given as an infusion into a vein lasting one or two hours.
Danish: Remsima gives som en infusion, der varer 1-2 timer.
English: A study was also carried out in 250 patients with ankylosing spondylitis to show that Remsima given by infusion into a vein produces levels of the active substance in the body that are comparable to the reference medicine, Remicade.
Danish: Der blev også gennemført et studie hos 250 patienter med ankyloserende spondylitis for at vise, at Remsima givet ved infusion i en vene giver de samme niveauer af det aktive stof i kroppen som referencelægemidlet, Remicade.
English: All these data were considered sufficient to conclude that Remsima will behave in the same way as Remicade in terms of effectiveness and safety in its authorised uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Remsima vil have de samme egenskaber som Remicade, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: Remsima must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remsima.
Danish: Remsima må ikke anvendes til patienter, der tidligere har haft overfølsomhedsreaktioner (allergiske reaktioner) over for infliximab, eller som er hypersensitive (allergiske) over for museproteiner eller andre af indholdsstofferne i Remsima.
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Remsima or the infusion may be slowed down.
Danish: For at mindske risikoen for infusionsbetingede reaktioner kan patienten få andre lægemidler før eller efter behandlingen med Remsima, eller infusionen kan gives over længere tid.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Remsima has a highly similar structure, purity and biological activity to Remicade and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Remsima har en struktur, renhed og biologisk aktivitet, der svarer nøje til Remicades, og at det fordeles i kroppen på samme måde.
English: For more information on biosimilar medicines, see here.
Danish: Der kan indhentes yderligere information om biosimilære lægemidler her.
English: Remsima given by injection under the skin for rheumatoid arthritis is as effective as Remsima given by infusion and the safety profile is acceptable.
Danish: Remsima givet ved injektion under huden til reumatoid artritis er lige så effektivt som Remsima givet ved infusion, og sikkerhedsprofilen er acceptabel.
English: After 22 weeks, the reduction of symptoms was comparable for treatment given by infusion into a vein and by injection under the skin.
Danish: Efter 22 uger var reduktionen i antallet af symptomer sammenlignelig med behandling givet ved infusion i en vene og ved injektion under huden.
English: Remsima injection to be given under the skin was shown to be as effective as Remsima given by infusion into a vein in a study involving 343 patients with rheumatoid arthritis.
Danish: Remsima givet som injektion under huden blev påvist at være lige så effektivt som Remsima givet ved infusion i en vene i et studie, der omfattede 343 patienter med rheumatoid artritis.
English: Patients received Remsima by infusion twice, two weeks apart and subsequent treatments were given either by infusion or injection under the skin.
Danish: Patienterne fik Remsima ved infusion to gange med to ugers mellemrum, og efterfølgende behandlinger blev givet enten ved infusion eller injektion under huden.
English: Laboratory studies comparing Remsima with Remicade have shown that the active substance in Remsima is highly similar to that in Remicade in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, hvor Remsima sammenlignes med Remicade, har vist, at det aktive stof i Remsima i vid udstrækning svarer til det aktive stof i Remicade for så vidt angår struktur, renhed og biologisk aktivitet.
English: Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Danish: Infliximab er opbygget, så det binder sig til et af kroppens kemiske signalstoffer, der kaldes tumornekrosefaktor-alfa (TNF-alfa).
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Remsima is used to treat.
Danish: Dette signalstof er en medvirkende årsag til betændelsestilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Remsima.
English: In addition, studies in rheumatoid arthritis and ankylosing spondylitis have shown that the safety and effectiveness of Remsima are equivalent to those of Remicade in the conditions.
Danish: Derudover har studier vedrørende reumatoid artritis og ankyloserende spondylitis vist, at Remsimas virkning og sikkerhed svarer til Remicades ved disse sygdomme.
English: • Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulas, abnormal passageways between the gut and other organs);
Danish: • Crohns sygdom (en sygdom, der medfører inflammation i fordøjelseskanalen), når sygdommen er moderat til svær eller har medført dannelse af fistler (unormale passager mellem tarmen og andre organer)
English: How is Remsima used?
Danish: Hvordan anvendes Remsima?
English: What benefits of Remsima have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Remsima?
English: Remsima is available as a powder to be made up into a solution for infusion (drip) into a vein.
Danish: Remsima fås som et pulver, der blandes til en opløsning til infusion (drop) i en vene.
English: For treatment of rheumatoid arthritis, Remsima is also available as a solution for injection under the skin in a pre-filled syringe or pen.
Danish: Til behandling af reumatoid artritis fås Remsima også som en opløsning til injektion under huden i en fyldt sprøjte eller pen.
English: For the full list of all side effects of Remsima, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Remsima fremgår af indlægssedlen.
English: For rheumatoid arthritis, after two treatments with infliximab have been given by infusion, Remsima can be given by injection under the skin for subsequent treatments.
Danish: Til behandling af reumatoid artritis kan Remsima efter to behandlinger med infliximab givet som infusion efterfølgende gives som injektion under huden.
English: • psoriasis (a disease causing red, scaly patches on the skin).
Danish: • psoriasis (en sygdom, der giver røde, afskallende pletter på huden).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Remsima have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Remsima.
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
Danish: • ankyloserende spondylitis (en sygdom, der medfører betændelse og smerter i leddene i rygsøjlen)
English: How does Remsima work?
Danish: Hvordan virker Remsima?
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Danish: • colitis ulcerosa (en sygdom, der forårsager betændelse og sår i tarmslimhinden)
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Danish: • psoriasisgigt (en sygdom, som fremkalder røde, afskallende pletter på huden og ledbetændelse)
English: Remsima is used with methotrexate (another medicine that acts on the immune system);
Danish: • leddegigt (reumatoid artritis, en sygdom, der forårsager betændelse i leddene) Remsima anvendes sammen med methotrexat (et andet lægemiddel, der påvirker immunsystemet)
English: • Wash your hands.
Danish: • Vask hænder.
English: At the final analysis, 1 653 deaths were reported.
Danish: Ved den afsluttende analyse var der indberettet 1.653 dødsfald.
English: Date of first authorisation: 18 December 2007 Date of latest renewal: 15 November 2012
Danish: Dato for første markedsføringstilladelse: 18. december 2007 Dato for seneste fornyelse: 15. november 2012
English: Long-term carcinogenicity studies have not been carried out.
Danish: Der er ikke udført langtids-karcinogenicitetsstudier.
English: Make the next injection as soon as you remember.
Danish: Foretag den næste indsprøjtning, så snart du husker det.
English: This requires urgent treatment.
Danish: Dette kræver øjeblikkelig behandling.
English: This usually takes between 15 and 30 minutes.
Danish: Det tager sædvanligvis mellem 15-30 minutter.
English: 1316 BN Almere The Netherlands
Danish: 1316 BN Almere Nederlandene
English: Adults donating their own blood
Danish: Voksne , som donerer blod til sig selv
English: Treatment with Retacrit is divided into two stages - correction and maintenance phase.
Danish: Behandling med Retacrit opdeles i to trin - korrigerings- og vedligeholdelsesfasen.
English: If the medicinal product has not been used at the end of this period, it should be disposed of.
Danish: Hvis lægemidlet ikke er blevet brugt ved udgangen af denne periode, skal det bortskaffes.
English: Thus, the volume of distribution is slightly greater than the plasma space.
Danish: Fordelingsvolumenet er således lidt større end plasmavolumenet.
English: The recommended dosing regimen is described in the following diagram*:
Danish: Den anbefalede dosis er angivet i følgende diagram*:
English: • Or under the skin (subcutaneously).
Danish: • eller under huden (subkutant).
English: Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults.
Danish: Generelt har børn under 30 kg behov for højere vedligeholdelsesdoser end børn over 30 kg og voksne.
English: Vary the site from day to day.
Danish: Vælg et nyt sted fra dag til dag.
English: Retacrit may not be suitable for you.
Danish: Retacrit er muligvis ikke egnet til dig.
English: • Choose an injection site.
Danish: • Vælg et injektionssted.
English: Patients should only be switched from one ESA to another under appropriate supervision.
Danish: Patienterne bør kun skifte fra et ESA til et andet under passende vejledning.
English: • Only use Retacrit if it has been stored correctly - see section 5, How to Store Retacrit.
Danish: • Brug kun Retacrit, hvis det har været opbevaret korrekt - se afsnit 5, Opbevaring.
English: • porphyria (a rare blood disorder)
Danish: • porfyri (en sjælden blodsygdom)
English: It may affect other treatments or test results.
Danish: Det kan have betydning for behandlingen eller prøveresultater.
English: Uncontrolled hypertension.
Danish: Ukontrolleret hypertension.
English: More severe cases have been observed with long-acting epoetins.
Danish: Der er observeret flere alvorlige tilfælde med langtidsvirkende epoetiner.
English: • If you know you suffer, or have suffered, from:
Danish: • Hvis du ved, at du lider af eller har lidt af:
English: No other ESA therapy should be commenced because of the risk of cross-reaction.
Danish: Ingen anden ESA-behandling bør påbegyndes på grund af risikoen for krydsreaktion.
English: • Take a syringe out of the refrigerator.
Danish: • Tag en sprøjte ud af køleskabet.
English: • Never put used syringes into your normal household waste bin.
Danish: • Læg aldrig brugte sprøjter i dit normale husholdningsaffald.
English: • Do not attempt to inject yourself unless you have been trained to do so by your doctor or nurse.
Danish: • Forsøg ikke selv at indsprøjte, medmindre du er blevet undervist i det af en læge eller sygeplejerske.
English: The following maintenance doses were observed in clinical trials after 6 months of treatment.
Danish: Nedenstående vedligeholdelsesdoser blev observeret i kliniske forsøg efter 6 måneders behandling.
English: Overall, these studies have methodological limitations but treatment was associated with positive trends towards higher haemoglobin levels.
Danish: Samlet set har disse studier metodemæssige begrænsninger, men behandlingen var forbundet med positive tendenser mod højere hæmoglobinniveauer.
English: This temperature range should be closely maintained until administration to the patient.
Danish: Dette temperaturinterval skal overholdes nøje indtil administration til patienten.
English: Retacrit is a biosimilar medicinal product.
Danish: Retacrit er et biosimilært lægemiddel.
English: Administer over at least one to five minutes, depending on the total dose.
Danish: Dosis skal administreres over mindst 1-5 minutter, afhængigt af den totale dosis.
English: If you have these symptoms during injection into the vein, a slower delivery of the injection may help to avoid them in the future.
Danish: Hvis du har disse symptomer under en intravenøs injektion, kan en langsommere indgift af injektionen hjælpe med at undgå dem i fremtiden.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Danish: Ligesom med alle andre vækstfaktorer er der en bekymring for, om epoetiner kan stimulere væksten af tumorer.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge medicinen, da den indeholder vigtige oplysninger.
English: The role of ESAs on tumour progression or reduced progression-free survival cannot be excluded.
Danish: ESA'ernes rolle i forbindelse med tumorprogression eller reduceret progressionsfri overlevelse kan ikke udelukkes.
English: The needle guard will NOT activate unless the ENTIRE dose has been given.
Danish: Nålebeskyttelsen aktiveres IKKE, medmindre HELE dosis er givet.
English: Precautions to be taken before handling or administering the medicinal product.
Danish: Administration Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet.
English: Depending on your individual situation a blood transfusion may be preferable.
Danish: Alt efter din situation kan en blodtransfusion være at foretrække.
English: This is of uncertain significance in the clinical situation.
Danish: Det er usikkert, om dette har klinisk betydning.
English: After approximately two months of therapy, virtually all patients were transfusion-independent.
Danish: Efter ca. to måneders behandling var stort set alle patienter uafhængige af transfusion.
English: Push it slowly and evenly, keeping the skin fold pinched.
Danish: Tryk langsomt og jævnt og hold hudfolden klemt sammen.
English: Hyperkalaemia has been observed in isolated cases though causality has not been established.
Danish: Hyperkalæmi er observeret i isolerede tilfælde, selvom årsagen ikke er klarlagt.
English: • If you have high blood pressure not properly controlled with medicines.
Danish: • hvis du har forhøjet blodtryk, som ikke er tilstrækkeligt kontrolleret med medicin.
English: Retacrit should be administered after the completion of the blood donation procedure.
Danish: Retacrit bør administreres efter at bloddonationsproceduren er afsluttet.
English: The dose of Retacrit you receive is based on your bodyweight in kilograms.
Danish: Den dosis Retacrit, du får, er baseret på din vægt i kilo.
English: The apparent molecular weight of erythropoietin is 32 000 to 40 000 dalton.
Danish: Erytropoietins tilsyneladende molekylevægt er 32.000-40.000 dalton.
English: Eighty-one percent of patients achieved the haemoglobin concentration level.
Danish: 81 % af patienterne opnåede hæmoglobinkoncentrationsniveauet.
English: Raised blood pressure may require treatment with medicines (or adjustment to any medicines you already take for high blood pressure).
Danish: Øget blodtryk kan kræve behandling med medicin (eller justering af medicin, som du allerede tager for for højt blodtryk).
English: • if the seal is broken,
Danish: • hvis forseglingen er brudt
English: A maximum volume of 1 mL at one injection site should generally not be exceeded.
Danish: Generelt må et maksimalt volumen på 1 ml pr. injektionssted ikke overskrides.
English: A defined concentration-time profile with peak and return to baseline was observed for changes in percent reticulocytes.
Danish: En veldefineret koncentration-tid-profil med maksimalværdi og tilbagevenden til baseline blev observeret for ændringer i procentdelen af retikulocytter.
English: Overdosage of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone.
Danish: Overdosering af erythropoietin kan fremkalde virkninger, som er udvidelser af hormonets farmakologiske virkninger.
English: Adults with myelodysplastic syndrome
Danish: Voksne med myelodysplastisk syndrom
English: Frequency estimate: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1 000 to <1/100); rare (>1/10 000 to <1/1 000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Danish: Vurdering af hyppighed: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1 000 til < 1/100); sjælden (≥ 1/10 000 til < 1/1 000); meget sjælden (< 1/10 000); ikke kendt (hyppigheden kan ikke estimeres ud fra de forhåndenværende data).
English: If it occurs, appropriate dose adjustment should be made as provided.
Danish: Hvis dette forekommer, bør passende dosisjustering foretages som foreskrevet.
English: In general, all pharmacodynamic markers increased in a linear manner with dose reaching a maximum response at the highest dose levels.
Danish: Generelt steg alle farmakodynamiske markører lineært med dosis og der opnåedes maksimalt respons ved de højeste dosisniveauer.
English: The pharmacokinetic profile of erythropoietins in children and adolescents appears to be similar to that of adults.
Danish: Erythropoietiners farmakokinetiske profil hos børn og unge synes at svare til profilen hos voksne.
English: Continue bending the needle until the syringe exceeds a 45 degree angle with the flat surface to render it permanently unusable.
Danish: Fortsæt med at bøje nålen, indtil injektionssprøjten overstiger en 45 graders vinkel mod den flade overflade, så den bliver permanent ubrugelig.
English: In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Danish: I lyset af ovenstående bør blodtransfusion i nogle kliniske tilfælde være den foretrukne behandling af anæmi hos patienter med cancer.
English: • have recently had a heart attack or stroke
Danish: • har haft et hjerteanfald eller et slagtilfælde for nyligt
English: Erythropoietins exhibit a dose-related effect on haematological parameters which is independent of route of administration.
Danish: Erythropoietiner udviser en dosisrelateret virkning på hæmatologiske parametre uafhængigt af administrationsvejen.
English: If the product has been shaken vigorously, don't use it.
Danish: Hvis præparatet er blevet rystet voldsomt, må du ikke bruge det.
English: Clinical data with subcutaneous administration in children are limited.
Danish: Kliniske data med subkutan administration hos børn er begrænsede.
English: • Do not pull back on the plunger at any time.
Danish: • Træk ikke på noget tidspunkt stemplet tilbage.
English: If Retacrit is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 ml) in a single injection.
Danish: Hvis Retacrit indsprøjtes under huden (subkutant), er den indsprøjtede mængde normalt ikke mere en milliliter (1 ml) i én enkelt indsprøjtning.
English: Retacrit should not be used and discarded
Danish: Retacrit må ikke anvendes og skal bortskaffes
English: Consequently, epoetin zeta should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Danish: Epoetin zeta bør derfor kun anvendes under graviditet, hvis de potentielle fordele opvejer den potentielle risiko for barnet.