FrancophonIA/ELRC3.0 huggingface dataset:
English: Ruconest should be administered by a healthcare professional.
Danish: Ruconest skal administreres af sundhedspersonale.
English: Adverse reactions were usually mild to moderate in severity.
Danish: Bivirkningerne var som regel milde til moderate.
English: Your dose, up to 2 vials, will be worked out based on your weight.
Danish: Din dosis, op til 2 hætteglas, udregnes på basis af din vægt.
English: Although cross-reactivity between cow milk and rabbit milk is considered unlikely, the possibility of such a cross-reactivity in a patient who has evidence of clinical allergy to cow milk cannot be excluded and the patient should be observed for signs and symptoms of hypersensitivity following Ruconest administration.
Danish: Selvom krydsreaktion mellem komælk og kaninmælk anses for usandsynligt, kan muligheden for en sådan krydsreaktion hos en patient, der har tegn på klinisk allergi over for komælk ikke udelukkes, og patienten bør observeres for tegn og symptomer på overfølsomhed efter Ruconest administration.
English: Before Ruconest can be administered, the powder needs to be dissolved in the solvent included in the package (see section 3).
Danish: Før Ruconest kan administreres af sundhedspersonale, skal pulveret opløses i solvensen, som er indeholdt i pakningen (se punkt 3).
English: • Disinfect the injection site thoroughly with an alcohol pad and let the skin dry.
Danish: • Desinficér injektionsstedet grundigt med en alkoholswab, og lad huden tørre.
English: These patients have a shortage of the C1 inhibitor protein in their blood.
Danish: Disse patienter mangler proteinet C1-inhibitor i blodet.
English: The complement component (protein) C4, is a substrate for activated C1s.
Danish: Komplementkomponenten (protein) C4 er et substrat for aktiverede C1'er.
English: • Repeat steps 4 and 5 if you need to prepare a second solution.
Danish: • Gentag trin 4 og 5 hvis du skal brug en opløsning mere.
English: C1INH exerts an inhibitory effect on several proteases (target proteases) of the contact and complement systems.
Danish: C1INH udøver en hæmmende virkning på adskillige proteaser (targetproteaser) i kontakt- og komplementsystemerne.
English: Nine adolescent HAE patients (aged 13 to 17 years) were treated with 50 U/kg for 26 acute angioedema attacks, and 7 (aged 16 to 17 years) with 2100 U for 24 acute angioedema attacks.
Danish: Ni unge HAE-patienter (fra 13 til 17 år) blev behandlet med 50 E/kg mod 26 akutte anfald af angioødem og 7 (fra 16 til 17 år) med 2100 E ved 24 akutte anfald af angioødem.
English: The expiry date on the outer carton reflects the date of the component with the shortest shelf-life.
Danish: Udløbsdatoen, som er angivet på den ydre emballage, svarer til udløbsdatoen for komponenten med den korteste udløbsdato.
English: Check with your doctor or nurse if you are not sure.
Danish: Du skal rådspørge din læge eller din sygeplejerske, hvis du er i tvivl.
English: Dose calculation Determine the patient's body weight.
Danish: Dosisberegning Bestem patientens vægt.
English: Pharmacotherapeutic group: Other haematological agents, drugs used in hereditary angioedema, ATC code: B06AC04.
Danish: Farmakoterapeutisk klassifikation: Andre hæmatologiske midler, midler til arvelig angioødem, ATCkode: B06AC04.
English: Patients should be advised not to drive and use machines if they experience headache or vertigo.
Danish: Patienterne bør rådes til ikke at betjene maskiner eller føre motorkøretøj, hvis de oplever hovedpine eller svimmelhed.
English: Ruconest will be given to you directly into a vein over a period of approximately 5 minutes by your doctor or by a nurse.
Danish: Ruconest indgives direkte i en blodåre over et tidsrum på ca. 5 minutter af din læge eller en sygeplejerske.
English: For instructions on reconstitution of Ruconest before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af Ruconest før administration, se pkt.
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal præparatet anvendes omgående.
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: Hvis du har yderligere spørgsmål vedrørende brugen af dette lægemiddel, skal du kontakte din læge.
English: Patients with HAE have low levels of C4 in the circulation.
Danish: Patienter med HAE har lave niveauer af C4 i kredsløbet.
English: • Check that no air is present in the syringe, infusion tube or the needle.
Danish: • Kontrollér, at der ikke er luft tilstede i sprøjten, infusionsslangen eller nålen.
English: Emergency medical treatment should be available immediately to be administered in case of anaphylactic reactions or shock.
Danish: Akut medicinsk behandling skal være umiddelbart tilgængelig i tilfælde af anafylaktiske reaktioner eller shock.
English: 2100 U of conestat alfa.
Danish: 2100 E conestat alfa.
English: Do not drive or use machinery if you feel dizzy or suffer from headache after using Ruconest.
Danish: Lad være med at køre bil eller arbejde med maskiner, hvis du føler dig svimmel eller har hovedpine efter brug af Ruconest.
English: • Immediately after removing the needle, press the sterile pad on the injection site for a few minutes to reduce bleeding.
Danish: • Umiddelbart efter at nålen er fjernet, presses den sterile tampon ned mod injektionsstedet i et par minutter for at mindske eventuel blødning.
English: The distribution volume of conestat alfa was approximately 3 L, comparable to plasma volume.
Danish: Distributionsmængden af conestat alfa var ca. 3 l i forhold til plasmavolumen.
English: The medicinal product should be used immediately (see section 6.3).
Danish: Lægemidlet skal anvendes omgående (se pkt.
English: Home-treatment and self-administration
Danish: Hjemmebehandling og selvadministration
English: • Secure the needle by applying the plaster, around 7 cm long, over the wings of the needle.
Danish: • Nålen sikres ved at sætte plasteret, som er ca. 7 cm langt, henover nålens vinger.
English: • 1 vial of 20 ml solvent
Danish: • 1 hætteglas med 20 ml solvens
English: • 1 self-adhesive plaster
Danish: • 1 selvklæbende plaster
English: • Copies of the patient card to be given to patients before they receive Ruconest.
Danish: • Kopier af patientkort, som skal gives til patienter, før de får Ruconest.
English: • The decision on the use of home treatment for an individual patient should be made by the treating physician.
Danish: • En beslutning om, hvorvidt den enkelte patient skal have hjemmebehandling, skal tages af den behandlende læge.
English: This can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms.
Danish: Dette kan føre til gentagne anfald af hævelse, mavesmerter, vejrtrækningsbesvær og andre symptomer.
English: • The importance of monitoring for clinical signs and symptoms of hypersensitivity and that patients should immediately seek medical care if they develop such symptoms during or after receiving
Danish: • Vigtigheden af, at der monitoreres for kliniske tegn og symptomer på overfølsomhed, og at patienten skal søge øjeblikkelig lægehjælp, hvis sådanne symptomer udvikles under eller efter behandling med Ruconest.
English: It is not recommended to use Ruconest during pregnancy or breast-feeding.
Danish: Det kan ikke anbefales at bruge Ruconest under graviditet eller amning.
English: • The existence of a post marketing registry in which healthcare professionals are encouraged to enter patients.
Danish: • At oplyse om eksistensen af et postmarketing register med en opfordring til sundhedspersonalet om at indtaste patientoplysninger heri.
English: • After disinfection, do not touch the stoppers with your fingers or anything else.
Danish: • Efter desinfektion må propperne ikke berøres med fingrene eller med noget andet.
English: For IV use.
Danish: Til IV-anvendelse.
English: Step 8: Check prepared syringes • Recheck that the volume in the syringe(s) you prepared in step 7 is correct.
Danish: Trin 8: Kontrollér de klargjorte sprøjter • Kontrollér én gang til, at volumenet i sprøjten (sprøjterne), du klargjorde i trin 7, er korrekt.
English: • If there is no blood in the tubing, remove the needle, repeat all steps from beginning of step 11 and reposition the needle.
Danish: • Hvis der ikke er blod i slangen, fjernes nålen, og alle trin fra og med trin 11 gentages, og nålen sættes ind igen.
English: Your dose will be worked out based on your bodyweight.
Danish: Din dosis udregnes på basis af din legemsvægt.
English: What you need to know before you use Ruconest Do not use Ruconest:
Danish: Det skal du vide, før du begynder at bruge Ruconest Brug ikke Ruconest:
English: • Diary to be given to patients before they receive Ruconest.
Danish: • Dagbog skal udleveres til patienterne før de modtager Ruconest.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Ensure that the tourniquet is released.
Danish: Sørg for, at årepressen løsnes.
English: Preparation and handling
Danish: Forberedelse og håndtering
English: The results of the open label studies were consistent with the above findings and support the repeated use of Ruconest in the treatment of subsequent attacks of angioedema.
Danish: Resultaterne af de åbne studier var i overensstemmelse med ovenstående data og understøtter gentagen brug af Ruconest til behandling af efterfølgende anfald af angioødem.
English: Once reconstituted, the product should be used immediately.
Danish: Når først produktet er opløst, skal det anvendes omgående.
English: • Put the powder and solvent vials required on a flat and clean surface.
Danish: • Læg pulver- og solvenshætteglassene, du skal bruge, på en flad og ren overflade.
English: There is no experience with the use of Ruconest in pregnant and breast-feeding women.
Danish: Der er ingen erfaring med brug af Ruconest hos gravide og ammende kvinder.
English: In one animal study reproductive toxicity was observed (see section 5.3).
Danish: I et dyreforsøg blev der observeret reproduktionstoksicitet (se pkt.
English: • That patients treated with Ruconest should be monitored for clinical signs and symptoms of hypersensitivity during administration.
Danish: • Patienter, som behandles med Ruconest, skal overvåges for kliniske tegn og symptomer på overfølsomhed under administrationen.
English: • Educational material for non-Healthcare Professionals.
Danish: • Oplysningsmateriale til ikke uddannet sundhedspersonale.
English: Before initiating treatment with Ruconest, patients should be queried about prior exposure to rabbits and signs and symptoms suggestive of an allergic reaction.
Danish: Før påbegyndelse af behandlingen med Ruconest skal patienterne spørges om tidligere kontakt med kaniner og om tegn og symptomer, der kan tyde på en allergisk reaktion.
English: • 1 infusion set with 35 cm tubing and 25G needle
Danish: • 1 infusionssæt med 35 cm slange og 25G nål
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: How to use Ruconest
Danish: Sådan skal du bruge Ruconest
English: If you are receiving tissue type plasminogen activator as acute treatment for blood clots, you should not be treated with Ruconest at the same time.
Danish: Hvis du modtager akut behandling med vævsplasminogenaktivator (tPA) mod blodpropdannelse, må du ikke samtidig behandles med Ruconest.
English: • Take a sterile syringe out of its packaging.
Danish: • Tag en steril nål ud af pakningen.
English: Step 5: Adding solvent to powder and dissolving
Danish: Trin 5: Tilsætning af solvens til pulveret og dannelse af en opløsning
English: • date and time of the administration
Danish: • Dato og tidspunkt for administrationen
English: No dose adjustment is necessary in patients with renal impairment since conestat alfa does not undergo renal clearance.
Danish: Dosisregulering er ikke nødvendig for patienter med nyrelidelse, da conestat alfa ikke gennemgår renal clearance.
English: Ruconest is supplied with an administration kit in a carton box containing:
Danish: Ruconest leveres som et administrationskit i en kartonæske, som indeholder:
English: After swirling, leave the vial on the surface for several minutes until the solution has become clear.
Danish: Efter det er hvirvlet rundt, skal hætteglasset ligge på arbejdsoverfalden i flere minutter, indtil opløsningen er blevet klar.
English: Broekman Institute B.V. Schoolstraat 21
Danish: Broekman Institute B.V.
English: A solution exhibiting particulates or discoloration should not be used.
Danish: En opløsning med partikler eller misfarvning må ikke anvendes.
English: The decision on the use of home-treatment for an individual patient should be made by the treating physician, who should ensure that appropriate training is provided and the use reviewed at intervals.
Danish: En beslutning om enkeltpatienters hjemmebehandling skal tages af den behandlende læge, som skal sørge for grundig oplæring og sørge for, at brugen gennemgås med jævne mellemrum.
English: • Do not use the prepared solution if it is cloudy, contains particles or has changed colour.
Danish: • Opløsningen må ikke bruges, hvis den er sløret, indeholder partikler eller har ændret farve.
English: • It is the responsibility of the physician to provide the patient or a caregiver with instructions and training on administration outside of a clinic setting.
Danish: • Det er lægens ansvar at give patienten eller en støtteperson instruktioner og træning i administrationen uden for et klinisk miljø.
English: Hepatic impairment may prolong the plasma half-life of conestat alfa, but this is not thought to be a clinical concern.
Danish: Leverlidelser kan forlænge plasmahalveringstiden for conestat alfa, men dette anses ikke for at være et klinisk problem.
English: Repeat this step if two powder vials need to be reconstituted.
Danish: Gentag dette trin hvis det er nødvendigt at rekonstituere to pulverhætteglas.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ruconest in one or more subsets of the paediatric population in treatment of acute angioedema attacks (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Ruconest i en eller flere undergrupper af den pædiatriske population ved behandling for akutte anfald af angioødem (se pkt.
English: Disinfect the injection site with an alcohol pad.
Danish: Desinficer injektionsstedet med en alkoholswab.
English: • That they should be asked to carry the card and always show it to any Healthcare Professional treating them for acute attacks of hereditary angioedema.
Danish: • At patienterne skal bære kortet på sig og altid vise det til det sundhedspersonale, som behandler for akutte anfald af hereditært angioødem.
English: The plasma protein C1INH is the main regulator of activation of the contact and complement systems in vivo.
Danish: Det plasmabaserede protein C1INH er hovedregulatoren for aktivering af kontakt- og komplementsystemerne in vivo.
English: The efficacy and safety of Ruconest as a treatment of acute angioedema attacks in patients with HAE has been evaluated in two double blind randomized placebo controlled and four open label clinical studies.
Danish: Effektiviteten og sikkerheden af Ruconest til behandling af akutte anfald af angioødem hos patienter med HAE er blevet evalueret i to dobbelt-blindede randomiserede placebo-kontrollerede og fire åbne kliniske undersøgelser.
English: No recommendation on a dose adjustment can be made.
Danish: Der kan ikke gives anbefaling om dosisregulering.
English: Possible side effects
Danish: Eventuelle bivirkninger
English: No more than 2 doses should be given within 24 hours.
Danish: Der må ikke gives mere end 2 doser inden for 24 timer.
English: Scientific literature indicates an interaction of tissue-type plasminogen activator (tPA) and C1INH containing medicinal products.
Danish: Faglitteraturen indikerer en interaktion mellem vævsplasminogenaktivator (tPA) og C1INH, som indeholder medicin.
English: • The potential risk of an immune complex-mediated type III hypersensitivity reaction due to the formation of antibodies directed against Host Related Impurities (HRI).
Danish: • Den potentielle risiko for en immunkompleks-medieret type III overfølsomhedsreaktion på grund af dannelsen af antistoffer direkte mod HRI.
English: • Educational material for the Healthcare Professional.
Danish: • Oplysningsmateriale til sundhedspersonalet.
English: • After the powder has dissolved, the solution should be clear and colourless.
Danish: • Når pulveret er opløst, er opløsningen klar og farveløs.
English: In the randomized controlled trials 39/41 (95%) of patients treated with Ruconest reached time to beginning of relief within 4 hours.
Danish: I de randomiserede, kontrollerede studier nåede 39/41 (95 %) af patienter, som blev behandlet med Ruconest, tidspunktet for begyndende lindring inden for 4 timer.
English: • 2 alcohol pads
Danish: • 2 alkoholswabs
English: After dissolving the powder in water for injections, the solution is clear and colourless.
Danish: Efter at pulveret er opløst i vand til injektionsvæsker, er opløsningen klar og farveløs.
English: Do not remove the adapter packaging.
Danish: Fjern ikke adapternes indpakning.
English: There is no excretion, as conestat alfa is cleared from the circulation via receptor-mediated endocytosis followed by complete hydrolysis/degradation in the liver.
Danish: Der er ingen ekskretion, da conestat alfa elimineres fra blodcirkulationen via receptormedieret endocytose efterfulgt af komplet hydrolyse/nedbrydning i leveren.
English: 1 Unit of conestat alfa activity is defined as the equivalent of C1 esterase inhibiting activity present in 1 ml of pooled normal plasma.
Danish: 1 enhed conestat alfa-aktivitet defineres som svarende til den C1-esterasehæmmende aktivitet, der findes i 1 ml poolet, normal plasma.
English: • Check that all required components are on the work surface: - 1 or 2 syringes with prepared solution - 1 infusion set with 25G needle - 1 alcohol pad - 1 sterile non-woven pad - 1 self-adhesive plaster - 1 tourniquet - 1 plaster for securing the needle
Danish: • Kontroller, at alle nødvendige komponenter ligger på arbejdsoverfladen: - 1 eller 2 sprøjter med klargjort opløsning - 1 infusionssæt med 25G nål - 1 alkoholswab - 1 steril ikke-vævet tampon - 1 selvklæbende plaster - 1 staseslange (årepresse) - 1 plaster til sikring af nålen
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: ENTYDIG IDENTIFIKATOR 2D-STREGKODE
English: If your symptoms get worse and/or you develop a rash, tingling, difficulty breathing or your face or tongue swells up, get medical attention immediately.
Danish: Hvis symptomerne bliver værre og/eller der udvikles udslæt, opstår prikken/snurren, åndedrætsbesvær eller hævelse af ansigt eller tunge, søg da straks lægehjælp.
English: • Allow the number of powder and solvent vials required according to step 1, to reach room temperature.
Danish: • Lad det nødvendige antal pulver- og solvenshætteglas, ifølge trin 1, opnå stuetemperatur.
English: As for plasma-derived C1INH, the pharmacodynamic effects of conestat alfa on C4 show dose-dependent restoration of complement homeostasis in HAE patients at a plasma C1INH activity level greater than 0.7 U/ml, which is the lower limit of the normal range.
Danish: Hvad angår plasmaudvundet C1INH, viser farmakodynamiske virkninger af conestat alfa på C4 dosisafhængig genetablering af komplement-homeostase hos HAEpatienter med et plasma C1INH aktivitetsniveau på over 0,7 E/ml, hvilket er den nedre grænse i normalområdet.
English: An aseptic technique should be used for reconstitution, combining and mixing the solutions.
Danish: Der skal anvendes aseptisk teknik under rekonstitution, kombinering og blanding af opløsningerne.
English: While keeping it vertical, slowly draw in 14 ml solvent.
Danish: Mens det holdes lodret, trækkes 14 ml solvent langsomt op.
English: • the batch number written on the label of the powder vial
Danish: • Batchnummeret, der er angivet på hætteglassets mærkat
English: • Never exceed the volume of 14 ml per syringe.
Danish: • Et volumen på 14 ml pr. sprøjte må aldrig overstiges.
English: Not more than two doses should be administered within 24 hours.
Danish: Der må ikke administreres mere end to doser inden for 24 timer.
English: There is no clinical experience with Ruconest in patients with hepatic impairment.
Danish: Der er ingen klinisk erfaring med Ruconest hos patienter med leverlidelser.
English: The information collected should include:
Danish: Den indsamlede information skal indeholde:
English: • Feel, with your other hand, for an appropriate vein.
Danish: • Søg og mærk med den anden hånd efter en passende vene.
English: • Use one alcohol pad to disinfect all vial stoppers and wait for at least 30 seconds until the stoppers have dried.
Danish: • Brug en alkoholswab til at desinficere alle hætteglaspropperne med, og vent i mindst 30 sekunder,
English: HAE patients have a heterozygous deficiency of the plasma protein C1INH.
Danish: HAE-patienterne har en heterozygot defekt i plasmaproteinet C1INH.
English: Contact your doctor or nearest hospital if this occurs.
Danish: Hvis dette sker, skal du kontakt din læge eller det nærmeste hospital.
English: Ruconest is indicated for treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.
Danish: Ruconest er indiceret til akut anfaldsbehandling af angioødem hos voksne og unge med hereditært angioødem (HAE) på grund af C1-esterase-inhibitor-mangel.
English: Tighten it to compress the vein.
Danish: Stram den til, så den komprimerer venen.
English: Always use this medicine exactly as described in this leaflet or as your doctor or nurse have told you.
Danish: Ruconest skal anvendes præcis, som det er beskrevet i denne indlægsseddel, eller ifølge vejledningen, du har modtaget af din læge eller sygeplejerske.
English: - 2 adapters if 1 powder and 1 solvent vial is required - 4 adapters if 2 powder and 2 solvent vials are required
Danish: - 2 adaptere hvis der skal bruges 1 pulver- og 1 solvenshætteglas - 4 adaptere hvis der skal bruges 2 pulvere- og 2 solvenshætteglas
English: • Sensation of tingling, prickling or numbness in the skin or limb (paraesthesia)
Danish: • Følelse af prikken/snurren, prikken eller følelsesløshed i huden eller i arme eller ben (paræstesi)
English: The amino acid sequence of conestat alfa is identical to that of endogenous C1INH.
Danish: Aminosyresekvensen for conestat alfa er den samme som for endogen C1INH.
English: Ruconest is to be used by adults and adolescents with a rare inherited blood disorder, called Hereditary Angioedema (HAE).
Danish: Ruconest er beregnet til voksne og unge med en sjælden arvelig blodsygdom, som kaldes hereditært angioødem (HAE).
English: If you experience allergic reactions e.g. hives, rash, itching, dizziness, wheezing, difficulty breathing or your tongue swells up following the administration of Ruconest, you should seek emergency medical assistance so that symptoms of your allergic reaction can be treated urgently.
Danish: Hvis du oplever allergiske reaktioner, f.eks. nældefeber, udslæt, kløe, svimmelhed, hvæsende vejrtrækning, åndedrætsbesvær, eller hvis tungen hæver efter du har fået Ruconest, skal du straks søge lægehjælp, således at symptomerne på den allergiske reaktion straks bliver behandlet.
English: Based on animal data, conestat alfa is cleared from the circulation by the liver via receptor-mediated endocytosis followed by complete hydrolysis/degradation.
Danish: Baseret på dyreforsøg elimineres conestat alfa fra blodcirkulationen af leveren via receptormedieret endocytose efterfulgt af komplet hydrolyse/nedbrydning.