FrancophonIA/ELRC3.0 huggingface dataset:
English: Rilonacept Regeneron should not be used in people who may be hypersensitive (allergic) to rilonacept or any of the other ingredients.
Danish: Rilonacept Regeneron bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for rilonacept eller andre af indholdsstofferne.
English: Blocking interleukin-1 may interfere with the body's immune response to infection and there have been reports of serious infections in patients taking Rilonacept Regeneron.
Danish: Når interleukin-1 blokeres, kan det påvirke kroppens immunforsvar over for infektioner, og der er blevet indberettet tilfælde af svære infektioner hos patienter, der tager Rilonacept Regeneron.
English: After the sixweek treatment, patients who received Rilonacept Regeneron had a reduction in symptoms of 2.5 points on the scale compared with 0.3 points in patients who received placebo.
Danish: Efter seks ugers behandling havde patienter, der fik Rilonacept Regeneron, en symptomreduktion på 2,5 point på skalaen sammenlignet med 0,3 point hos patienter, der fik placebo.
English: Five symptoms (rash, fever or chills, joint pain, tiredness and eye redness or pain) were assessed by patients themselves on a scale from 0 to 10 points.
Danish: Patienterne bedømte fem symptomer (udslæt, feber eller kuldegysninger, ledsmerter, træthed og røde øjne eller øjensmerter) hver på en skala fra 0 til 10 point.
English: Treatment with Rilonacept Regeneron should be started and supervised by a specialist doctor experienced in diagnosing and treating CAPS.
Danish: Behandling med Rilonacept Regeneron skal indledes og overvåges af en speciallæge, der har erfaring i diagnosticering og behandling af CAPS.
English: The starting dose is 4.4 mg per kilogram body weight (up to a maximum of 320 mg), which is followed a week later by once weekly injections of 2.2 mg/kg (up to a maximum of 160 mg).
Danish: For unge i alderen 12 til 17 år afhænger dosis af patientens kropsvægt Startdosis er 4,4 mg pr. kilo kropsvægt (op til maksimalt 320 mg), og en uge efter indgivelse af startdosen følges der op med injektioner på 2,2 mg/kg (op til maksimalt 160 mg) én gang om ugen.
English: The most common side effects with Rilonacept Regeneron (seen in more than 1 patient in 10) are reactions at the injection site, upper respiratory tract infections (colds), sinusitis (inflammation of the sinuses) and headache.
Danish: De hyppigste bivirkninger ved Rilonacept Regeneron (som optræder hos flere end 1 ud af 10 patienter) er reaktioner på injektionsstedet, infektioner i de øvre luftveje (forkølelser), bihulebetændelse, og hovedpine.
English: The active substance in Rilonacept Regeneron, rilonacept, is an interleukin inhibitor.
Danish: Det aktive stof i Rilonacept Regeneron, rilonacept, er en interleukinhæmmer.
English: Rilonacept Regeneron is given as injections under the skin.
Danish: Rilonacept Regeneron gives ved injektion under huden.
English: The company that makes Rilonacept Regeneron will provide regular information on the safety and effectiveness of Rilonacept Regeneron in adults and children from a registry and will perform a study in children to further investigate what happens to the medicine in the body.
Danish: Virksomheden, der fremstiller Rilonacept Regeneron, skal regelmæssigt fremlægge oplysninger fra et register om sikkerhed og virkning ved brug af Rilonacept Regeneron hos voksne og børn, og den skal udføre en undersøgelse af børn for nærmere at granske, hvad der sker med lægemidlet i kroppen.
English: Rilonacept Regeneron is used to treat CAPS that are causing severe symptoms in adults and children aged 12 years and older, including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS).
Danish: Rilonacept Regeneron anvendes til behandling af voksne og unge i alderen 12 år og derover med svære symptomer på CAPS, herunder også symptomer på familiært autoinflammatorisk kuldesyndrom (FCAS) og Muckle-Wells syndrom (MWS).
English: In the second part of the study, symptoms increased more in patients switched to placebo (0.9 points) compared with patients who remained on Rilonacept Regeneron (0.1 points).
Danish: I anden del af undersøgelsen øgedes symptomerne mere hos patienter, der skiftede til placebo (0,9 point) end hos patienter, der fortsatte med Rilonacept Regeneron (0,1 point).
English: In the first part of one main study involving 47 patients with CAPS, patients were given either Rilonacept Regeneron or placebo (a dummy treatment) for six weeks.
Danish: I den første del af hovedundersøgelsen, hvori der indgik 47 patienter med CAPS, fik patienterne enten Rilonacept Regeneron eller placebo (en virkningsløs behandling) i seks uger.
English: The CHMP decided that Rilonacept Regeneron's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Rilonacept Regeneron opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Rilonacept Regeneron.
English: In the second part of the study, all patients were given Rilonacept Regeneron treatment before receiving either Rilonacept Regeneron or placebo for another nine weeks.
Danish: I den anden del af undersøgelsen blev alle patienter behandlet med Rilonacept Regeneron, inden de fik Rilonacept Regeneron eller placebo i yderligere ni uger.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Rilonacept Regeneron is available here.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Rilonacept Regeneron findes her.
English: The company that makes Rilonacept Regeneron will provide doctors in all Member States who will use Rilonacept Regeneron with a pack containing the prescribing information, a patient alert card and information for doctors explaining the risk of side effects and how to use the medicine properly.
Danish: Virksomheden, der fremstiller Rilonacept Regeneron, skal sørge for, at læger i alle medlemsstater, som anvender Rilonacept Regeneron, får en pakke med ordineringsoplysninger, et patientinformationskort og oplysninger til læger om risikoen for bivirkninger og oplysninger om, hvordan lægemidlet anvendes korrekt.
English: By attaching to interleukin-1 beta, it blocks its activity, helping to relieve the symptoms of the disease.
Danish: Ved at binde sig til interleukin-1 beta blokerer rilonacept dette signalstofs aktivitet og er dermed med til at lindre symptomerne på sygdommen.
English: Other information about Rilonacept Regeneron:
Danish: Andre oplysninger om Rilonacept Regeneron:
English: Rilonacept Regeneron is a powder and solvent that are made up into a solution for injection.
Danish: Rilonacept Regeneron er et pulver og en solvens, som blandes til en injektionsvæske, opløsning.
English: Patients treated with Rilonacept Regeneron must be given an alert card that summarises the key safety information about the medicine.
Danish: Patienter, som behandles med Rilonacept Regeneron, skal have udleveret et særligt patientinformationskort med de vigtigste oplysninger om sikkerhed i forbindelse med dette lægemiddel.
English: What information is still awaited for Rilonacept Regeneron?
Danish: Hvilke oplysninger afventes der stadig for Rilonacept Regeneron?
English: What measures are being taken to ensure the safe use of Rilonacept Regeneron?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Rilonacept Regeneron?
English: For the full list of all side effects reported with Rilonacept Regeneron, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Rilonacept Regeneron fremgår af indlægssedlen.
English: What is the risk associated with Rilonacept Regeneron?
Danish: Hvilken risiko er der forbundet med Rilonacept Regeneron?
English: Rilonacept Regeneron rilonacept
Danish: Rilonacept Regeneron1
English: Why has Rilonacept Regeneron been approved?
Danish: Hvorfor blev Rilonacept Regeneron godkendt?
English: A week later, the patient should start receiving once weekly injections of 160 mg. For children aged from 12 to 17 years, the dose will depend on the patient's weight.
Danish: Efterfølgende skal patienten have injektioner på 160 mg én gang om ugen med start en uge efter startdosen.
English: How has Rilonacept Regeneron been studied?
Danish: Hvordan blev Rilonacept Regeneron undersøgt?
English: What is Rilonacept Regeneron?
Danish: Hvad er Rilonacept Regeneron?
English: How is Rilonacept Regeneron used?
Danish: Hvordan anvendes Rilonacept Regeneron?
English: What is Rilonacept Regeneron used for?
Danish: Hvad anvendes Rilonacept Regeneron til?
English: What benefit has Rilonacept Regeneron shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rilonacept Regeneron?
English: Before you begin
Danish: Inden du starter
English: • Wash your hands carefully.
Danish: • Vask hænderne grundigt.
English: Date of first authorisation: 28 October 2010 Date of latest renewal: 18 September 2015
Danish: Dato for første markedsføringstilladelse: 28. oktober 2010 Dato for seneste fornyelse: 18. september 2015
English: If you use more Ruconest than you should
Danish: Hvis du bruger mere Ruconest end du burde
English: Do not give this medicine to children under 12 years old.
Danish: Giv ikke dette lægemiddel til børn og unge under 12 år.
English: Data in patients older than 65 years are limited.
Danish: Data fra patienter over 65 år er begrænsede.
English: Hypersensitivity reactions cannot be excluded.
Danish: Overfølsomhedsreaktioner kan ikke udelukkes.
English: Genotoxic and carcinogenic potential is not expected.
Danish: Genotoksicitet og karcinogenicitet forventes ikke.
English: The table below shows the results (primary and secondary endpoints) of the two randomized controlled trials:
Danish: Tabellen nedenfor viser resultaterne (primære og sekundære endepunkter) af de to randomiserede kontrollerede forsøg:
English: Ruconest should not be administered simultaneously with tPA.
Danish: Ruconest må ikke administreres samtidigt med tPA.
English: Step 9: Required components
Danish: Trin 9: Nødvendige komponenter
English: Sanofi-Chimie Route d'Avignon Aramon 30390 France
Danish: Sanofi-Chimie Route d'Avignon Aramon 30390 Frankrig
English: = body weight (kg)
Danish: = legemsvægt (kg)
English: Some side effects may occur during treatment with Ruconest: Common: may affect up to 1 in 10 people
Danish: Visse bivirkninger kan forekomme under behandling med Ruconest: Almindelige: kan forekomme i op til 1 ud 10 personer
English: Step 13: After administration
Danish: Trin 13: Efter administration
English: In the study in rats there were no malformed fetuses in either the conestat alfa or the control group.
Danish: I undersøgelsen af rotter var der ingen misdannede fostre hverken i conestat alfa-gruppen eller i kontrolgruppen.
English: Small amounts of foam are acceptable.
Danish: Små mængder af skum er acceptabelt.
English: All adapters supplied with the kit are identical.
Danish: Alle adaptere, der leveres i kittet, er ens.
English: The incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administrations.
Danish: Forekomsten af bivirkninger var ensartet for alle dosisgrupper og øgedes ikke ved gentagne administrationer.
English: 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),
Danish: 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),
English: If undissolved powder is still present, repeat the procedure.
Danish: Hvis der stadig er pulver, der ikke er opløst, gentages proceduren.
English: Repeat steps 3 and 4 if you need to prepare a second solution (this requires a second kit).
Danish: Gentag trin 3 og 4, hvis du skal forberede en yderligere opløsning (dette kræver et yderligere kit).
English: 5711 CP Someren The Netherlands
Danish: 5711 CP Someren Holland
English: No formal distribution studies have been performed.
Danish: Ingen formelle distributionsundersøgelser er gennemført.
English: Excipient with known effect:
Danish: Hjælpestof med kendt virkning:
English: The elimination half-life of conestat alfa was approximately 2 hours.
Danish: Halveringstiden for elimination af conestat alfa var ca. 2 timer.
English: The clinical experience supporting safety of Ruconest consists of 300 administrations (83 administrations to healthy subjects or asymptomatic HAE patients and 217 administrations to 119 HAE patients).
Danish: Den kliniske erfaring, som understøtter sikkerheden ved Ruconest, består af 300 administrationer (83 administrationer til raske personer eller asymptomatiske HAE-patienter og 217 administrationer til 119 HAE-patienter).
English: Marketing Authorisation Holder: Pharming Group N.V.
Danish: Indehaver af markedsføringstilladelsen: Pharming Group N.V.
English: Chemical and physical in-use stability has been demonstrated for 48 hours between 5˚C and 25˚C.
Danish: Kemisk og fysisk stabilitet i brug er påvist i 48 timer ved temperaturer mellem 5 ˚C og 25 ˚C.
English: It is very important that the prepared solution is injected directly into a vein and not into an artery or the surrounding tissue.
Danish: Det er yderst vigtigt, at den klargjorte opløsning sprøjtes direkte ind i en vene, og ikke ind i en arterie eller det omgivende væv.
English: - check the expiry date.
Danish: Kontroller udløbsdatoen.
English: Fertility There are no data on the effects of Ruconest on male or female fertility.
Danish: Fertilitet Der er ingen data om virkningerne af Ruconest på den mandlige eller kvindelige fertilitet.
English: The adapter must remain in its plastic packaging.
Danish: Adapteren skal forblive i plastikindpakningen.
English: The instructions for use are clearly described in the doctor's information leaflet and are attached.
Danish: Brugsanvisningen er tydeligt angivet i lægens informationsfolder og er vedhæftet.
English: Patients must be closely monitored and carefully observed for any symptoms of hypersensitivity throughout the administration period.
Danish: Patienterne skal nøje overvåges og omhyggeligt observeres for ethvert symptom på overfølsomhed i hele administrationsperioden.
English: Preparation of solution Step 1: Cleaning and other requirements
Danish: Klargøring af opløsningen Trin 1: Rengøring og andre krav
English: Within a single kit box, different components may have different expiry dates.
Danish: Forskellige komponenter, der findes i samme kit, kan have forskellige udløbsdatoer.
English: No clinical information on overdose is available.
Danish: Der er ingen tilgængelig klinisk information om overdosering.
English: Mostly a single dose is sufficient, but a second dose may be needed.
Danish: I de fleste tilfælde er en enkelt dosis tilstrækkelig, men der kan være behov for endnu en dosis.
English: • Ensure the kit package is complete and contains all components listed in section 6 of this leaflet.
Danish: • Sørg for, at kittet er komplet og indeholder alle komponenterne, der er angivet i punkt 6 i denne indlægsseddel.
English: The required volume of the reconstituted solution should be administered as a slow intravenous injection over approximately 5 minutes.
Danish: Den påkrævede mængde af den rekonstituerede opløsning skal administreres som en langsom intravenøs injektion over ca. 5 minutter.
English: This may indicate that you have developed an allergy to Ruconest.
Danish: Dette kan være tegn på, at du har udviklet allergi over for Ruconest.
English: Uncommon: may affect up to 1 in 100 people
Danish: Sjældne: kan forekomme i op til 1 ud 100 personer
English: The most common adverse reaction observed after administration of Ruconest is headache.
Danish: Den mest almindelige bivirkning observeret efter administration af Ruconest er hovedpine.
English: Time (minutes) to minimal symptoms median (95% CI)
Danish: Tid (minutter) til minimale symptomer median (95 % CI)
English: Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Danish: Ikke kendt, (kan ikke estimeres ud fra forhåndenværende data).
English: There is no rationale for patients older than 65 years to respond differently to Ruconest.
Danish: Der findes ingen begrundelse for, at patienter over 65 år reagerer anderledes over for Ruconest.
English: Potential risks associated with home-treatment are related to the administration itself as well as the handling of adverse reactions, particularly hypersensitivity.
Danish: Potentielle risici, der er forbundet med hjemmebehandling, er relateret til administrationen såvel som håndteringen af bivirkninger, specielt hypersensivitet.
English: • Next, put the self-adhesive plaster on the injection site.
Danish: • Sæt derefter det selvklæbende plaster på injektionsstedet.
English: Inform your healthcare professional if this occurs.
Danish: Informer sundhedspersonalet, hvis det er tilfældet.
English: The table below lists all adverse reactions occurring within 7 days after treatment with Ruconest, as reported in the six treatment studies.
Danish: Tabellen nedenfor viser alle bivirkninger, som er opstået inden for 7 dage efter behandling med Ruconest, som rapporteret i seks behandlingsundersøgelser.
English: • Hold the adapter with one hand.
Danish: • Hold adapteren med én hånd.
English: • Take the syringe with solvent that you prepared in step 4.
Danish: • Tag fat i sprøjten med solvens, som du forberedte i trin 4.
English: The effect of conestat alfa on the following target proteases was assessed in vitro: activated C1s, kallikrein, factor XIIa and factor XIa.
Danish: Virkningen af conestat alfa på følgende targetproteaser blev bedømt in vitro: aktiverede C1'er, kallikrein, faktor XIIa og faktor XIa.
English: • The risk of formation of anti-C1INH antibodies and therefore the potential risk of formation of neutralising antibodies.
Danish: • Risikoen for dannelse af anti-C1INH-antistoffer og dermed den potentielle risiko for dannelse af neutraliserende antistoffer.
English: However headache or vertigo have been reported following the use of Ruconest, but may also occur as a result of an attack of HAE.
Danish: Der er dog rapporteret om hovedpine eller svimmelhed efter brug af Ruconest, men det kan også forekomme som følge af et anfald af HAE.
English: Pack size of 1.
Danish: Pakningsstørrelse af 1 stk.
English: Do not mix or administer Ruconest with other medicines or solutions.
Danish: Ruconest må ikke blandes eller administreres sammen med andre lægemidler eller opløsninger.
English: Pharming Group N.V., Darwinweg 24, NL-2333 CR LEIDEN, The Netherlands
Danish: Pharming Group N.V., Darwinweg 24, NL-2333 CR LEIDEN, Holland
English: • Batch number and dose
Danish: • Batch nummer og dosis
English: One case of hypersensitivity was observed in clinical trials with Ruconest.
Danish: Ét tilfælde af overfølsomhed blev observeret i klinisk forsøg med Ruconest.
English: In the majority of cases a single dose of Ruconest is sufficient to treat an acute angioedema attack.
Danish: I de fleste tilfælde er en enkelt dosis Ruconest tilstrækkelig til behandling af et akut anfald af angioødem.
English: Paediatric population The safety and efficacy of Ruconest in children (age 0 to 12 years) have not yet been established.
Danish: Pædiatrisk population Ruconests sikkerhed og virkning hos børn i alderen 0-12 år er endnu ikke klarlagt.
English: Based on the known pharmacology and adverse reaction profile of Ruconest, effects on the ability to drive and use machines are not expected.
Danish: Baseret på den kendte farmakologi og bivirkningsprofilen for Ruconest forventes der ingen virkning på evnen til at føre motorkøretøjer og betjene maskiner.
English: Continue to fill the syringe with the volume required.
Danish: Fortsæt med at fylde sprøjten med det nødvendige volumen.
English: Prior to launch of the product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the National Competent Authority (NCA).
Danish: Før markedsføring af produktet i hvert medlemsland skal indehaveren af markedsføringstilladelsen nå til enighed om oplysningsmaterialets indhold og format med de relevante nationale myndigheder.
English: • Fold down the yellow protection cap over the needle.
Danish: • Fold den gule beskyttelseshætte ned over nålen.
English: Talk to your doctor before using Ruconest.
Danish: Kontakt lægen, før du bruger Ruconest.
English: An additional dose of 50 U/kg was administered for 13/133 (10%) attacks.
Danish: En yderligere dosis på 50 E/kg blev givet for 13/133 (10 %) anfald.
English: Embryofetal studies in rat and rabbit; Daily single doses of vehicle or 625 U/kg/administration of rhC1INH were administered intravenously to mated rats and rabbits.
Danish: Embryoføtale undersøgelser af rotte og kanin; Daglige enkelt-doser af vehikel eller 625 E/kg/administration af rhC1INH blev administreret intravenøst til parrede rotter og kaniner.
English: The medicinal product should be used immediately.
Danish: Lægemidlet skal anvendes omgående.
English: Time (minutes) to beginning of relief median (95% CI)
Danish: Tid (minutter) til begyndende lindring median (95 % CI)
English: If these symptoms occur after administration, they should alert their physician.
Danish: Hvis disse symptomer opstår efter administrationen, skal lægen kontaktes.
English: Each vial of Ruconest is for single use only.
Danish: Hvert hætteglas Ruconest er kun til engangsbrug.
English: The following describes how Ruconest solution must be prepared and administered.
Danish: I det følgende beskrives, hvordan Ruconest-opløsningen klargøres og administreres.
English: • If you need to use a second powder and solvent vial, repeat the above steps.
Danish: • Hvis du skal bruge yderligere et pulverhætteglas og et solvenshætteglas, gentages de ovennævnte trin.
English: Ruconest is not recommended for use during pregnancy or breast-feeding, unless the treating physician judges the benefits to outweigh the possible risks.
Danish: Ruconest bør ikke anvendes under graviditeten eller amning, medmindre den behandlende læge skønner, at fordelene opvejer de mulige ricisi.
English: This should be boosted by tightening your fist.
Danish: Dette skal forstærkes ved, at du knytter din hånd.
English: If you plan becoming pregnant, discuss with your doctor before starting to use Ruconest.
Danish: Hvis du planlægger at blive gravid, skal du spørge din læge til råds, før du tager Ruconest.
English: In a rabbit embryotoxicity study an increase in the incidence of fetal cardiac vessel defects (1.12% in the treatment group versus 0.03% in historical controls) was observed for animals that were administered conestat alfa.
Danish: I en undersøgelse af embryotoksisitet hos kaniner blev der observeret en stigning i forekomsten af føtale hjertekardefekter (1,12 % i behandlingsgruppen mod 0,03 % i historiske kontroller) for dyr, som fik administreret conestat alfa.
English: • Leave the packaging on the adapter until you attach the syringe in steps 4 and 5.
Danish: • Lad indpakningen blive siddende på adapteren, indtil du sætter kanylen på i trin 4 og 5.
English: The frequency of adverse reactions listed below is defined using the following convention:
Danish: Frekvensen af bivirkninger i nedenstående tabel er defineret ved brug af følgende konvention:
English: administered (ml) = body weight (kg) times 50 (U/kg) 150 (U/ml)
Danish: administreres (ml) = legemsvægt (kg) gange 50 (E/kg) 150 (E/ml)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis præparatet ikke straks anvendes, er opbevaringstider under brug og forhold før brug brugerens ansvar og må normalt ikke vare længere end 24 timer ved temperaturer fra 2 til 8 ºC, medmindre rekonstitution har fundet sted under kontrollerede og validerede aseptiske forhold.
English: The efficacy and safety in adolescent patients were consistent with that seen in adults.
Danish: Sikkerheden og virkningen hos unge patienter var i overensstemmelse med den, der ses hos voksne.