FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy have been demonstrated in a published randomized controlled study in 24 SJIA patients treated with Kineret for up to 1 year.
Danish: Sikkerheden og virkningen er blevet vist i et publiceret, randomiseret, kontrolleret studie af 24 SJIA-patienter, der blev behandlet med Kineret i op til 1 år.
English: Adverse events data in patients with Still's disease is based on a partially open-label and partially blinded, placebo-controlled study of 15 SJIA patients, treated for up to 1.5 years.
Danish: Data fra bivirkninger hos patienter med Stills sygdom er baseret på et delvist open-label og delvist blindet, placebokontrolleret studie af 15 SJIA-patienter, der blev behandlet i op til 1,5 år.
English: Neutropenia (ANC < 1.5 x 109/l) was reported in 2.4% patients receiving Kineret compared with 0.4% of placebo patients.
Danish: Neutropeni (ANC <1,5 x 109/l) blev rapporteret hos 2,4% af patienterne som fik Kineret sammenlignet med 0,4% af placebopatienterne.
English: In addition cases of non-infectious hepatitis, including occasional events of acute liver failure, have been reported in patients with Still's disease during Kineret treatment.
Danish: Desuden er der blevet indberettet tilfælde af ikke-infektiøs hepatitis, herunder lejlighedsvise hændelser af akut leversvigt, hos patienter med Stills sygdom i løbet af behandlingen med Kineret.
English: There are no indications either from this study or from post-marketing adverse reaction reports that the overall safety profile in patients with CAPS or Still's disease is different from that in patients with RA, with the exception of the risk for development of MAS in patients with Still's disease.
Danish: Der er ingen indikationer på, hverken fra dette studie eller fra bivirkningsrapporter efter markedsføring, at den samlede sikkerhedsprofil hos patienter med CAPS eller Stills sygdom er forskellig fra profilen hos patienter med RA, med undtagelse af risikoen for at udvikle MAS hos patienter med Stills sygdom.
English: In 43 CAPS patients followed for up to 5 years neutropenia was reported in 2 patients.
Danish: Hos 43 CAPS-patienter, der blev fulgt i op til 5 år, blev neutropeni indberettet for 2 patienter.
English: • the upper outer areas of the buttocks; and
Danish: • øverst på den udvendige side af ballerne, og
English: Concurrent Kineret and etanercept treatment has not demonstrated increased clinical benefit.
Danish: Samtidig behandling med Kineret og etanercept har ikke vist forøgede kliniske fordele.
English: • Contact details of their physician
Danish: • Kontaktinformation for deres læge
English: Put your thumb on the plunger rod and push slowly until the plunger front has reached the scale mark of your Kineret dose.
Danish: Placér tommelfingeren på stempelstangen, og tryk langsomt, indtil stemplets forreste ende når den skalamarkering, der angiver Deres Kineret-dosis.
English: Kineret contains sodium
Danish: Kineret indeholder natrium
English: Neutrophil decreases occurred more frequently in patients receiving Kineret compared with placebo.
Danish: Fald i antal af neutrofile granulocytter opstod oftere hos patienter, som fik Kineret, sammenlignet med placebo.
English: If you develop signs of an infection or worsening of your Still's disease symptoms you should contact your health care provider as soon as possible.
Danish: Hvis De udvikler tegn på en infektion eller forværring af Deres symptomer på Stills sygdom, skal De snarest muligt kontakte Deres læge.
English: Still's disease, in addition to various degrees of arthritis, is characterised by systemic inflammatory features such as spiking fever, skin rash, hepatosplenomegaly, serositis, and increased acute phase reactants driven by IL-1 activity.
Danish: Udover forskellige grader af artrit er Stills sygdom karakteriseret ved systemiske inflammatoriske kendetegn, såsom høj feber, hududslæt, hepatosplenomegali, serositis og et øget niveau af reaktanter i den akutte fase, ansporet af IL-1-aktiviteten.
English: In Kineret treated CAPS patients, there is a risk for disease flares when discontinuing Kineret treatment.
Danish: Hos Kineretbehandlede CAPS-patienter er der risiko for sygdomsopblussen, når Kineret-behandlingen seponeres.
English: Store in original carton in order to protect from light.
Danish: Opbevares i den originale æske for at beskytte mod lys.
English: Furthermore, the overall incidence of malignancies was not increased during 3 years of patient exposure to Kineret.
Danish: Endvidere er den generelle hyppighed af malignitet ikke øget i de 3 år, hvor patienter har modtaget behandling med Kineret.
English: The therapeutic response is primarily reflected by reduction in clinical symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.
Danish: Det terapeutiske respons afspejles primært i en reduktion af de kliniske symptomer som f.eks. feber, udslæt, ledsmerte og hovedpine, men også i de inflammatoriske serummarkører (CRP/SAA-niveauer) eller forekomst af opblussen.
English: No data are available on either the effects of live vaccination or on the secondary transmission of infection by live vaccines in patients receiving Kineret.
Danish: Der er ikke tilgængelige data vedrørende effekten af levende vaccine eller den sekundære transmission af infektion ved levende vacciner hos patienter, der behandles med Kineret.
English: How to prepare a 100 mg dose
Danish: Sådan klargøres en 100 mg dosis
English: Place a sterile gauze or tissue on a flat surface and hold the syringe above it with the needle pointing towards the gauze or tissue, as shown in Figure C. Make sure the needle does not touch the gauze or tissue.
Danish: Placér et stykke steril gaze eller en steril serviet på en flad overflade, og hold sprøjten over den, idet kanylen peger ned på det sterile gazestykke eller den sterile serviet som vist i figur C. Sørg for, at kanylen ikke berører gazen eller servietten.
English: You must not be given live vaccines while being treated with
Danish: De må aldrig få levende vacciner, mens De bliver behandlet med Kineret.
English: Your doctor will have to decide if you can still be given Kineret; - if you have a history of increased levels of liver enzymes; - if you require vaccinations.
Danish: Deres læge vil afgøre om De kan anvende Kineret; hvis De tidligere har haft forhøjede leverenzymer; hvis De har behov for at blive vaccineret.
English: You should try to have the injection at the same time each day.
Danish: De skal forsøge at injicere Kineret på cirka samme tidspunkt hver dag.
English: At a dose of 100 mg/day, 71% of RA patients developed an ISR compared to 28% of the placebo treated patients.
Danish: Ved en dosis på 100 mg/dag udviklede 71% af RA-patienterne en reaktion på injektionsstedet sammenlignet med 28% af de placebobehandlede patienter.
English: How do you or the person injecting you, use the Kineret pre-filled syringe?
Danish: Sådan skal De eller den person, der giver Dem injektionen, anvende den fyldte injektionssprøjte med Kineret
English: Systemically, IL-1 is known to cause the hypothalamic fever response and promote hyperalgesia.
Danish: Systemisk vides IL-1 at forårsage feberresponset fra hypothalamus og anspore hyperalgesi.
English: Always use this medicine exactly as your doctor has told you.
Danish: Brug altid Kineret nøjagtigt efter lægens anvisning.
English: The clearance of anakinra in RA patients increased with increasing creatinine clearance.
Danish: Clearance af anakinra hos RA-patienter øgedes med en øget kreatininclearance.
English: The instructions for use and handling are given in section 6.6.
Danish: Instruktioner for anvendelse og håndtering er beskrevet under pkt.
English: This section contains information on how to give yourself or your child an injection of Kineret.
Danish: Dette afsnit indeholder information om, hvorledes De injicerer Kineret til Dem selv eller Deres barn.
English: Mild thrombocytopenia has also been observed in CAPS patients.
Danish: Let trombocytopeni er også set hos CAPS-patienter.
English: Pack sizes of 1, 7 or 28 (multipack containing 4 packs of 7 pre-filled syringes) pre-filled syringes.
Danish: Pakningsstørrelser med 1, 7 eller 28 (multipakning indeholdende 4 pakninger med 7 fyldte injektionssprøjter) fyldte injektionssprøjter.
English: Administration of Kineret results in a decrease in the acute phase reactants and a decrease in IL-6 expression level has been observed.
Danish: Administration af Kineret resulterer i et fald i akutfasereaktanter, lige som der er observeret en nedsat udtrykkelse af IL-6.
English: If you develop signs of lung disease you should contact your health care provider as soon as possible.
Danish: Hvis De udvikler tegn på lungesygdom, skal De snarest muligt kontakte Deres læge.
English: Single use.
Danish: Til engangsbrug.
English: Physicians should be attentive to symptoms of infection or worsening of Still's disease, as these are known triggers for MAS.
Danish: Lægerne skal være opmærksomme på infektionssymptomer eller forværring af Stills sygdom, da disse er kendte udløsningsfaktorer for MAS.
English: The recommended starting dose in all CAPS subtypes is 1-2 mg/kg/day by subcutaneous injection.
Danish: Den anbefalede startdosis til alle CAPS-undertyper er 1-2 mg/kg/dag ved subkutan injektion.
English: The safety and efficacy of Kineret have been demonstrated in CAPS patients with varying degrees of disease severity.
Danish: Kinerets sikkerhed og virkning er blevet påvist hos CAPS-patienter med forskellig sværhedsgrad af sygdom.
English: These data support that no dose adjustment is required for patients with hepatic dysfunction of Child-Pugh Class B. See section 4.2.
Danish: Disse data understøtter, at der ikke er behov for nogen dosisjustering i tilfælde af patienter med hepatisk dysfunktion af Child-Pugh-klasse B. Se pkt.
English: Additional published data in Still's disease indicate that Kineret induces a rapid resolution of systemic features such as fever, rash, and elevation of acute phase reactants.
Danish: Yderligere publicerede data for Stills sygdom indikerer, at Kineret inducerer en hurtig normalisering af systemiske karakteristika, såsom feber, udslæt og forhøjelse af reaktanter i den akutte fase.
English: Do not try to inject yourself if you have not been trained.
Danish: Forsøg ikke at injicere Dem selv, før De har fået vist, hvordan De skal gøre.
English: In placebo-controlled studies in RA patients, the most frequently reported adverse reactions with Kineret were injection site reactions (ISRs), which were mild to moderate in the majority of patients.
Danish: I placebokontrollerede undersøgelser med RA-patienter var de hyppigst rapporterede bivirkninger med Kineret reaktioner på injektionsstedet, som var lette til moderate hos hovedparten af patienterne.
English: These have shown no deleterious effect on joint cartilage.
Danish: Denne viste ingen skadelig effekt på ledbrusk.
English: Symptoms of lung disease can be e.g. shortness of breath during light exercise, morning cough, and difficulties breathing.
Danish: Symptomerne på lungesygdom kan f.eks. være stakåndethed under let træning, morgenhoste og vejrtrækningsbesvær.
English: These were typically characterised by 1 or more of the following: erythaema, ecchymosis,
Danish: De blev typisk karakteriseret ved et eller flere af følgende symptomer: erytem, ekkymose, inflammation og smerte.
English: No dose adjustment is required for patients with moderate hepatic impairment (Child-Pugh Class B).
Danish: Dosisjustering er ikke nødvendig for patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B).
English: After injecting the liquid, remove the needle and let go of the skin.
Danish: Efter injektion af væsken fjernes kanylen, og huden slippes.
English: You should position the syringe in one hand with the needle pointing straight upwards as shown in Figure B. Put your thumb on the plunger rod and push slowly until you see a tiny liquid drop at the tip of the needle.
Danish: Tag fat om sprøjten med den ene hånd med kanylen opad som vist i figur B. Placér tommelfingeren på stemplet, og tryk langsomt, indtil De kan se en lille væskedråbe ved kanylens spids.
English: In severe renal insufficiency and end stage renal disease (creatinine clearance < 30 ml/min), mean plasma clearance declined by 70% and 75%, respectively.
Danish: Ved svær nyreinsufficiens og terminal nyresygdom (kreatininclearance <30 ml/min) faldt den gennemsnitlige plasma-clearance med henholdsvis 70% og 75%.
English: There is limited experience in treating elderly CAPS and Still's disease patients.
Danish: Der er begrænset erfaring med behandling af ældre patienter med CAPS og Stills sygdom.
English: During post-marketing use events of interstitial lung disease, pulmonary alveolar proteinosis and pulmonary hypertension have been reported mainly in paediatric patients with Still's disease treated with IL-6 and IL-1 inhibitors, including Kineret.
Danish: Der er indberettet hændelser af interstitiel lungesygdom, pulmonal alveolær proteinose og lungehypertension ved anvendelse efter markedsføringen, primært hos pædiatriske patienter med Stills sygdom behandlet med IL-6- og IL-1-hæmmere, herunder Kineret.
English: For CAPS, Kineret is used to treat the signs and symptoms of inflammation associated with the disease such as rash, joint pain, fever, headache and fatigue in adults and children (age 8 months and older).
Danish: Ved CAPS anvendes Kineret til behandling af tegn og symptomer på inflammation, der ses i forbindelse med sygdommen, som f.eks. udslæt, ledsmerte, feber, hovedpine og træthed hos voksne og børn (i alderen 8 måneder og ældre).
English: A corresponding decrease in creatinine clearance was seen in the hepatic failure population.
Danish: Et tilsvarende fald i kreatininclearance sås i populationen med leversvigt.
English: The majority of patients have been treated for Still's disease or have had predisposing factors, e.g. a history of transaminase elevations.
Danish: Størstedelen af patienterne er blevet behandlet for Stills sygdom, eller har haft prædisponerende faktorer, som f.eks. forhøjede aminotransferaser i anamnesen.
English: The thrombocytopenias have been mild, i.e. platelet counts have been > 75 x109/l.
Danish: Der har været tale om lette tilfælde af trombocytopeni, dvs. med trombocyttal >75 x109/l.
English: The mean plasma clearance of Kineret in subjects with mild (creatinine clearance 50-80 ml / min) and moderate (creatinine clearance 30-49 ml/min) renal insufficiency was reduced by 16% and 50%, respectively.
Danish: Kinerets gennemsnitlige plasma-clearance hos forsøgspersoner med mild (kreatininclearance 50-80 ml/min) og moderat (kreatininclearance 30-49 ml/min) nyreinsufficiens blev reduceret med henholdsvis 16% og 50%.
English: In patients who become neutropenic (ANC < 1.5 x 109/l) the ANC should be monitored closely and Kineret treatment should be discontinued.
Danish: Hos de patienter som bliver neutropeniske (ANC <1,5 x 109/l) bør ANC kontrolleres tæt og behandling med Kineret seponeres.
English: Very common side effects (may affect more than 1 in 10 people): - Redness, swelling, bruising or itching at the injection site.
Danish: Meget almindelige bivirkninger (kan ramme mere end 1 ud af 10 personer): - Rødme, hævelse, blåt mærke eller kløe på injektionsstedet.
English: Alternating the injection site is recommended to avoid discomfort at the site of injection.
Danish: Det anbefales at benytte forskellige injektionssteder for at undgå gener på injektionsstedet.
English: Citric acid, anhydrous Sodium chloride Disodium edetate dihydrate Polysorbate 80
Danish: Citronsyre, vandfri Natriumchlorid Dinatriumedetatdihydrat Polysorbat 80
English: There are no indications from post-marketing experience that types and severity of infections in patients with Still's disease differ from those in RA or CAPS patients.
Danish: Fra erfaring efter markedsføring er der ingen indikationer for, at typerne og sværhedsgraden af infektioner hos patienter med Stills sygdom er forskellig fra infektionerne hos RA- eller CAPS-patienter.
English: The development of ISRs in patients who had not previously experienced ISRs was uncommon after the first month of therapy.
Danish: Udvikling af reaktioner på injektionsstedet hos patienter, som ikke tidligere havde oplevet en reaktion på injektionsstedet, var ikke almindelig efter den første måneds behandling.
English: Physicians should exercise caution when administering Kineret to patients with a history of recurring infections or with underlying conditions which may predispose them to infections.
Danish: Læger bør udvise forsigtighed ved administration af Kineret til patienter, som har haft gentagne infektioner, eller som har en anden sygdom, som bevirker, at de er udsatte for at få infektioner.
English: Each graduated pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml).
Danish: Hver gradueret, fyldt injektionssprøjte indeholder 100 mg anakinra* per 0,67 ml (150 mg/ml).
English: Only clear, colourless-to-white solutions that may contain some product-related translucent-to-white amorphous particles should be injected.
Danish: Kun opløsninger, som er klare, farveløse til hvide, og som evt. indeholder produktrelaterede semitransparente eller hvide amorfe partikler, må injiceres.
English: Blood cholesterol increase
Danish: Forhøjet kolesterol
English: No patient withdrew from Kineret treatment due to adverse reactions.
Danish: Der var ingen patienter, der trak sig fra Kineret-behandlingen på grund af bivirkninger.
English: Still's disease: Data in elderly patients are limited.
Danish: Stills sygdom: Der er begrænsede data hos ældre patienter.
English: INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF KINERET
Danish: VEJLEDNING I KLARGØRING OG INJEKTION AF KINERET
English: In clinical studies in RA patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
Danish: I kliniske studier med RA-patienter er trombocytopeni blevet indberettet hos 1,9 % af de behandlede patienter sammenlignet med 0,3 % i placebogruppen.
English: In clinical studies transient elevations of liver enzymes have been seen.
Danish: I kliniske studier er der set forbigående forhøjelser af leverenzymer.
English: Prior to launch of the new indication Still's disease for Kineret in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme,
Danish: Inden markedsføring af den nye indikation Stills sygdom for Kineret i hvert medlemsland skal indehaveren af markedsføringstilladelsen aftale uddannelsesprogrammets indhold og format, herunder kommunikationsmedia, distributionsmodaliteter og andre aspekter af programmet med den kompetente nationale myndighed.
English: CAPS: Data in elderly patients are limited.
Danish: CAPS: Der er begrænsede data hos ældre patienter.
English: 0.67 ml of solution for injection in a graduated pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber) and 29 gauge needle.
Danish: 0,67 ml injektionsvæske, opløsning, i en gradueret fyldt injektionssprøjte (type 1 glas) med stempelprop (brombutylgummi) og 29 G kanyle.
English: The impact of treatment with Kineret on pre-existing malignancy has not been studied.
Danish: Virkningen af behandling med Kineret hos patienter med eksisterende malignitet er ikke blevet undersøgt.
English: - Serious infections such as pneumonia (a chest infection) or infections of the skin.
Danish: - Alvorlig infektion såsom lungebetændelse eller infektioner i huden.
English: Kineret was commonly associated with neutropenia (ANC < 1.5 x 109/l) in placebo-controlled studies in RA and cases of neutropenia have been observed in patients with CAPS and Still's disease.
Danish: Kineret blev ofte associeret med neutropeni (ANC <1,5 x 109/l) i placebokontrollerede undersøgelser af RA, og der er observeret tilfælde af neutropeni hos patienter med CAPS og Stills sygdom.
English: Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still's disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
Danish: Kineret er indiceret til voksne, unge, børn og spædbørn i alderen 8 måneder og ældre med en kropsvægt på 10 kg eller derover til behandling af Stills sygdom, herunder systemisk juvenil idiopatisk artrit (SJIA) og Stills sygdom debuterende hos voksne (adult-onset Still's disease, AOSD), med aktive systemiske karakteristika af moderat til høj sygdomsaktivitet, eller hos patienter med vedvarende sygdomsaktivitet efter behandling med non-steroide anti-inflammatorika (NSAID'er) eller glukokortikoider.
English: Kineret is a clear, colourless-to-white solution for injection and is supplied ready for use in a pre-filled syringe.
Danish: Kineret er en klar, farveløs eller hvidlig injektionsvæske, opløsning og leveres klar til brug i en fyldt injektionssprøjte.
English: Hepatic events during post-marketing use have mainly been reported in patients that have been treated for Still's disease and in patients with predisposing factors, e.g. a history of transaminase elevations before start of Kineret treatment.
Danish: Leverhændelser under brugen efter markedsføringen er hovedsageligt blevet indberettet for patienter, der er blevet behandlet for Stills sygdom, og hos patienter med prædisponerende faktorer, som f.eks. forhøjede transaminaser i anamnesen før påbegyndelsen af Kineret-behandlingen.
English: The safety and efficacy of Kineret in patients with neutropenia have not been evaluated.
Danish: Kinerets sikkerhed og virkning hos patienter med neutropeni er ikke blevet evalueret.
English: - Increased total blood cholesterol levels.
Danish: - Forhøjet kolesterol i blodet.
English: You can now use the pre-filled syringe as described in the “Where should you give your injection?” section and “How do you give your injection?” section.
Danish: De er nu klar til at anvende den fyldte injektionssprøjte som beskrevet i afsnittet "Hvor skal injektionen gives?"
English: Method of administration Kineret is administered by subcutaneous injection.
Danish: Administration Kineret indgives ved subkutan injektion.
English: Kineret treatment should be discontinued in RA patients if a serious infection develops.
Danish: Kineretbehandling skal seponeres hos RA-patienter, hvis der udvikles en alvorlig infektion.
English: Hepatic events in patients with Still's disease predominantly occur during the first month of Kineret treatment.
Danish: Leverhændelser hos patienter med Stills sygdom forekommer hovedsageligt i løbet af den første måned af behandling med Kineret.
English: A causal relationship between Kineret and MAS has not been established.
Danish: Et kausalt forhold mellem Kineret og MAS er ikke klarlagt.
English: Therefore the use of Kineret in patients with pre-existing malignancy is not recommended.
Danish: Derfor kan det ikke anbefales at anvende Kineret hos patienter med eksisterende malignitet.
English: Kineret should be used with caution in patients with severe hepatic impairment.
Danish: Kineret skal anvendes med forsigtighed hos patienter med svært nedsat leverfunktion.
English: Disinfect the skin by using the alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
Danish: Desinficer huden med desinfektionsservietten, og klem huden med Deres pege- og tommelfinger uden at klemme hårdt til.
English: In clinical trials, the crude incidence rate of malignancy was the same in the Kineret-treated patients and the placebo-treated patients and did not differ from that in the general population.
Danish: I kliniske forsøg var hyppigheden af malignitet den samme hos de Kineret-behandlede og de placebobehandlede patienter, og den var ikke forskellig fra forekomsten i baggrundspopulationen.
English: • The importance of explaining the use of the syringe and correct injection technique to patients and/or caregivers
Danish: • Vigtigheden at at forklare patienter og/eller plejepersonale om brugen af injektionssprøjten og den korrekte injektionsteknik