FrancophonIA/ELRC3.0 huggingface dataset:
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: Fremstillerne af disse produkter indbygger også trin under behandlingen af blod eller plasma, der kan inaktivere eller fjerne vira.
English: Remove the plastic package from the transfer device and discard it. Take care not to touch the exposed end of the transfer device.
Danish: Fjern plasticpakningen fra overførselsanordningen og bortskaf den. Vær forsigtig med ikke at røre ved den eksponerede ende af overførselsanordningen.
English: Cinryze contains the human protein called “C1 inhibitor” as the active substance.
Danish: Cinryze indeholder det humane protein, der kaldes “C1-inhibitor” som aktivt stof.
English: No specific studies on fertility, early embryonic and postnatal development, or carcinogenicity studies were conducted (see section 5.3).
Danish: Der er ikke udført specifikke studier af fertilitet, tidlig embryonal og postnatal udvikling eller karcinogenicitetsstudier (se pkt.
English: A randomised, parallel group, open-label pharmacokinetic study of Cinryze was performed in subjects with non-symptomatic HAE.
Danish: En randomiseret, parallel-gruppe, åben farmakokinetisk undersøgelse af Cinryze blev udført hos forsøgspersoner med ikke-symptomatisk HAE.
English: Marketing Authorisation Holder Shire Services BVBA Rue Montoyer 47
Danish: Indehaver af markedsføringstilladelsen Shire Services BVBA Rue Montoyer 47
English: to prevent capillary leak syndrome.
Danish: /kg) til forebyggelse af Capillary leak-syndrom.
English: There is limited information on the safety of Cinryze use during pregnancy and breast-feeding.
Danish: Der er begrænset information om sikkerheden ved at bruge Cinryze under graviditet og amning.
English: Overall, the safety and tolerability of Cinryze are similar in children, adolescents and adults.
Danish: Samlet var Cinryzes sikkerhed og tolerabilitet sammenlignelig hos børn, unge og voksne.
English: Each pack of Cinryze contains:
Danish: Hver pakning med Cinryze indeholder:
English: Pharmacotherapeutic group: Drugs used in hereditary angioedema, C1 inhibitor, plasma derived, ATC code: B06AC01.
Danish: Farmakoterapeutisk klassifikation: Midler til arvelig angioødem, C1-inhibitor, plasmaderiveret, ATC-kode: B06AC01.
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Danish: Dette omfatter nøje udvælgelse af blod- og plasmadonorer så det sikres, at personer med risiko for at være smittebærere udelukkes, og hver donation og plasmaportion kontrolleres for tegn på virus/infektioner.
English: Reconstitution and administration of Cinryze
Danish: Rekonstitution og administration af Cinryze
English: As with any biological product hypersensitivity reactions may occur.
Danish: Som for alle biologiske præparater, kan der forekomme overfølsomhedsreaktioner.
English: Cinryze has minor influence on the ability to drive and use machines.
Danish: Cinryze påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Adverse reactions to treatment with Cinryze are classified by MedDRA System Organ Class and absolute frequency in Table 1.
Danish: Bivirkninger ved Cinryze-behandlingen er klassificeret via MedDRA systemorganklasse og absolut hyppighed i tabel 1.
English: If these symptoms occur after administration, they should alert their physician.
Danish: Hvis disse symptomer opstår efter indgivelse, skal de informere lægen.
English: Based upon the clinical data currently available, Cinryze has minor influence on the ability to drive and use machines.
Danish: Baseret på de aktuelt tilgængelige kliniske data, påvirker Cinryze i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: No studies on fertility, early embryonic and post-natal development, or carcinogenicity studies were conducted because chronic dosing in animals would be expected to be associated with development of neutralising antibodies to the human protein.
Danish: Der blev ikke udført studier af fertilitet, tidlig embryonal og postnatal udvikling eller karcinogenitetsstudier, da det forventes, at kronisk dosering af dyr vil føre til, at neutraliserende antistoffer til humant protein udvikles.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Danish: Standardprocedurer til at undgå infektioner som følge af brugen af lægemidler fremstillet ud fra humant blod eller plasma inkluderer udvælgelse af donorer, screening af de enkelte donationer og plasmaportioner for specifikke infektionsmarkører samt inklusion af effektive fremstillingstrin til inaktivering/fjernelse af vira.
English: This includes any possible side effects not listed in this leaftlet.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: C1 is the most important inhibitor of contact activation and regulates the contact system and the intrinsic coagulation pathway by binding to and inactivating kallikrein and factor XIIa.
Danish: C1 er den vigtigste inhibitor af kontaktaktivering og regulerer kontaktsystemet og den intrinsiske koagulationsvej ved at binde og inaktivere kallikrein og faktor XIIa.
English: Your doctor may recommend that you consider having vaccinations against hepatitis A and B if you regularly or repeatedly receive C1 inhibitor products that have been taken from human plasma.
Danish: Din læge kan anbefale, at du overvejer at få vaccinationer mod hepatitis A og B, hvis du regelmæssigt eller gentagne gange får C1-inhibitor-præparater, som er udvundet fra humant plasma.
English: Do not remove the device from the package.
Danish: Anordningen må ikke fjernes fra pakningen.
English: A doctor or nurse may prepare and inject Cinryze for you.
Danish: En læge eller sygeplejerske kan klargøre og injicere Cinryze for dig.
English: 2 to 11 years, >25 kg:
Danish: 2 til 11 år, > 25 kg:
English: What you need to know before you take Cinryze
Danish: Det skal du vide, før du begynder at tage Cinryze
English: Only use a silicone-free syringe (provided in the pack) for administration of the product.
Danish: Anvend kun en silikonefri injektionssprøjte (leveres i pakningen) til administration af præparatet.
English: The dosing interval and dose may need to be adjusted according to individual response.
Danish: Der kan være behov for at justere doseringsintervallet og dosis i henhold til individuelt respons.
English: The safety and efficacy of Cinryze in children less than 2 years old has not been established.
Danish: Cinryzes sikkerhed og virkning hos børn under 2 år er ikke klarlagt.
English: Cinryze for the pre-procedure prevention of HAE attacks Open-label Cinryze was administered within 24 hours prior to a total of 91 medical, dental, or surgical procedures across the clinical programme (40 procedures in children and 51 procedures in adults).
Danish: Cinryze til forebyggelse af HAE-anfald før en procedure Åben Cinryze blev indgivet inden for 24 timer af i alt 91 medicinske, dentale eller kirurgiske procedurer i hele det kliniske program (40 procedurer hos børn og 51 procedurer hos voksne).
English: Regular review of the administration by the patient/carer needs to be performed to ensure maintenance of optimal practice.
Danish: Regelmæssig gennemgang af patientens/plejerens indgivelse skal udføres for at sikre, at optimal praksis opretholdes.
English: Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.
Danish: Rutinemæssig forebyggelse af angioødem-anfald hos voksne, unge og børn (fra 6 år og opefter) med alvorlige og tilbagevendende anfald af hereditært angioødem (HAE), som er intolerante over for eller utilstrækkeligt beskyttede af orale forebyggende behandlinger, og hos patienter, hvor gentagen akut behandling er en utilstrækkelig behandling.
English: Do not take Cinryze
Danish: Tag ikke Cinryze
English: Educational material for healthcare professionals
Danish: Uddannelsesmateriale for sundhedspersonale
English: Cinryze is usually injected into a vein (intravenously) by your doctor or nurse.
Danish: Cinryze injiceres normalt i en vene (intravenøst) af din læge eller sygeplejerske.
English: Their prescribing physician will provide training on the following elements: Precaution for storage
Danish: Deres ordinerende læge vil forsyne dem med træning i de følgende elementer: Opbevaringsforhold
English: The total protein content of the reconstituted solution is 15 ± 5 mg/ml.
Danish: Det totale proteinindhold af den rekonstituerede opløsning er 15 ± 5 mg/ml.
English: Cleanse stoppers with a disinfection swab and allow them to dry prior to use.
Danish: Rens propperne med en desinficerende vådserviet, og lad dem tørre før brug.
English: Your doctor will regularly review the preparation and administration process with you or a family member or carer.
Danish: Lægen vil regelmæssigt gennemgå proceduren for klargøring og indgivelse med dig, et familiemedlem eller en omsorgsperson.
English: PSUR Cycle
Danish: PSUR-cyklus
English: • For patients experiencing laryngeal attacks or if initiation of treatment is delayed, the second dose can be given sooner than 60 minutes.
Danish: • Til patienter med laryngeale anfald, eller hvis behandlingsstart forsinkes, kan den anden dosis gives tidligere end efter 60 minutter.
English: Doses and indications of treatment
Danish: Dosis og indikationer for behandling
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Danish: De forholdsregler, der tages, anses for effektive til indkapslede vira, såsom HIV, HBV og HCV og for de ikke-indkapslede vira HAV og parvovirus B19.
English: Cinryze is a white powder contained in a vial.
Danish: Cinryze er et hvidt pulver i et hætteglas.
English: C1 inhibitor inhibits the complement system by binding C1r and C1s, two of the active enzyme subunits of the first component of the complement system (C1) in the classical pathway, as well as to mannose-binding lectin-associated serine proteases in the lectin pathway.
Danish: C1-inhibitoren hæmmer komplementsystemet ved at binde C1r og C1s, to af de aktive enzymunderenheder af den første komponent af komplementsystemet (C1) i den klassiske aktiveringsvej, samt til mannose-bindende lectin-associerede serinproteaser i lectin-aktiveringsvejen.
English: Reconstitution, product administration and handling of the administration set and needles must be done with caution.
Danish: Rekonstitution, administration af præparatet og håndtering af administrationssæt og kanyler skal udføres med forsigtighed.
English: C1 inhibitor is a single chain glycoprotein found in plasma which, in its mature state, consists of 478 amino acids with an apparent molecular weight of 105 kD.
Danish: C1-inhibitoren er et enkeltkædet glykoprotein, som findes i plasma, der i den modne form består af 478 aminosyrer med en tilsyneladende molekylvægt på 105 kD.
English: Proceed to administration process if patients receive a dose of 500 IU.
Danish: Fortsæt til administrationsproceduren, hvis patienten skal have en dosis på 500 IE.
English: Cinryze for the treatment of HAE attacks
Danish: Cinryze til behandling af HAE-anfald
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også for alle hidtil ukendte vira eller andre infektionstyper.
English: Educational materials for non-healthcare professionals
Danish: Uddannelsesmateriale for personer, der ikke er sundhedspersonale
English: Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
Danish: Pludselig pibende vejrtrækning, vejrtrækningsbesvær, hævelse af øjenlåg, ansigt eller læber, udslæt eller kløe (især hvis hele kroppen er påvirket).
English: 2 protective mats
Danish: 2 beskyttelsesunderlag
English: Your treatment will be initiated and managed under supervision of a doctor experienced in the care of patients with hereditary angioedema (HAE).
Danish: Din behandling vil blive påbegyndt og håndteret under opsyn af en læge med erfaring i at behandle patienter med hereditært angioødem (HAE).
English: 2 to 11 years, 10-25 kg:
Danish: 2 til 11 år, 10-25 kg:
English: Adverse reaction frequencies were estimated from 2 pivotal placebo-controlled and 2 open-label studies in 251 unique subjects.
Danish: Hyppighederne af bivirkninger blev estimeret ud fra to pivotale placebo-kontrollerede studier og to ublindede studier med 251 unikke forsøgspersoner.
English: The primary substrate of the activated C1 enzyme is C4; uninhibited C1 results in diminished C4 levels.
Danish: Det primære substrat for det aktiverede C1-enzym er C4. C1, der ikke er hæmmet, resulterer i nedsatte C4-niveauer.
English: Across clinical studies, there were 61 unique paediatric subjects enrolled and exposed to over 2,500 infusions of Cinryze (2-5 years, n=3; 6-11 years, n=32; 12-17 years, n=26).
Danish: I de kliniske studier indgik 61 unikke børn og unge, som blev indrulleret og eksponeret for over 2.500 infusioner af Cinryze (2-5 år, n=3; 6-11 år, n=32; 12-17 år, n=26).
English: Because C1 inhibitor is an endogenous human plasma protein, it is not subject to metabolism by Cytochrome P450 iso-enzymes, excretion, or pharmacokinetic drug-drug interactions exhibited by many low molecular weight compounds.
Danish: Da C1-inhibitor er et endogent humant plasmaprotein, metaboliseres det ikke af cytokrom P450 iso-enzymer, udskillelse eller giver de farmakokinetiske lægemiddel-lægemiddelinteraktioner, som mange lavmolekylære stoffer udviser.
English: The mean pharmacokinetic parameters for functional C1 inhibitor derived from baseline-corrected concentration data are presented in Table 2.
Danish: De gennemsnitlige farmakokinetiske parametre for funktionel C1-inhibitor afledt fra baseline-korrigerede koncentrationsdata fremgår af tabel 2.
English: Mean increases from baseline in functional C1 inhibitor activity measured 1 hour post-dose in children 2 to <18 years of age ranged from 20% to 88% in Study LEVP 2006-1 (treatment) and from 22% to 46% in Study LEVP 2006-4 (prevention) compared with 21% to 66% and 25% to 32% in adults, respectively.
Danish: Gennemsnitlige forhøjelser fra baseline i funktionel C1-inhibitor-aktivitet målt 1 time efter dosis hos børn i alderen 2 til <18 år varierede fra 20 % til 88 % i undersøgelse LEVP 2006-1 (behandling) og fra 22 % til 46 % i undersøgelse LEVP 2006-4 (forebyggelse) sammenlignet med hhv. 21 % til 66 % og 25 % til 32 % hos voksne.
English: Data from two randomised, double-blind, placebo-controlled studies (LEVP 2005-1/A and LEVP 2005-1/B), data from two open-label studies (LEVP 2006-1 and LEVP 2006-4) and 2 paediatric clinical studies (0624-203 and 0624-301) demonstrated the efficacy of Cinryze for the treatment and prevention of angioedema attacks in subjects with HAE.
Danish: Data fra to randomiserede, dobbeltblinde, placebo-kontrollerede studier (LEVP 2005-1/A og LEVP 2005-1/B), data fra to ublindede studier (LEVP 2006-1 og LEVP 2006-4) og 2 pædiatriske kliniske studier (0624-203 og 0624-301) viste virkningen af Cinryze til behandling og forebyggelse af angioødem-anfald hos forsøgspersoner med HAE.
English: In clinical studies local reactions (described as pain, bruising, or rash at the injection/catheter site, venous burning or phlebitis) occurred in association with approximately 0.2% of infusions.
Danish: I kliniske studier forekom lokale reaktioner (beskrevet som smerter, blå mærker eller udslæt på injektions-/kateterstedet, venøs brændende fornemmelse eller flebitis) i forbindelse med ca. 0,2 % af infusionerne.
English: Administration of C1 inhibitor increases serum levels of C1 inhibitor activity and temporarily restores the natural regulation of the contact, complement, and fibrinolytic systems thereby controlling the swelling or the propensity to swell.
Danish: Administration af C1-inhibitor forhøjer serumniveauer af C1-inhibitor og genetablerer midlertidigt den naturlige regulering af kontakt-, komplement- og de fibrinolytiske systemer, hvilket derved kontrollerer hævelsen eller tilbøjeligheden til at hæve.
English: Study LEVP 2006-1: Twenty-two paediatric subjects were treated for 121 acute HAE attacks.
Danish: Studie LEVP 2006-1: 22 børn og unge blev behandlet for 121 akutte HAE-anfald.
English: Double Dose (1000 Units dose followed by a second 1000 Units dose 60 minutes later)
Danish: Dobbelt dosis (dosis på 1000 enheder efterfulgt af en anden dosis på 1000 enheder 60 minutter senere)
English: There was a statistically significant (p=0.0017) difference in the changes in mean values from baseline between treatment groups at 12 hours, demonstrating the association of Cinryze treatment with an increase in C4 activity (Cinryze + 2.9 mg/dl versus placebo + 0.1 mg/dl).
Danish: Der var en statistisk signifikant (p=0,0017) forskel i ændringer fra gennemsnitsværdier fra baseline mellem behandlingsgrupperne efter 12 timer, hvilket påviser forbindelsen mellem Cinryze-behandlingen og en forøgelse af C4-aktiviteten (Cinryze + 2,9 mg/dl versus placebo + 0,1 mg/dl).
English: After it has been dissolved in the water for injections the solution is clear and colourless to slightly blue.
Danish: Efter det er blevet opløst i vand til injektionsvæsker er opløsningen gennemsigtig og farveløs eller let blålig.
English: Prevention of swelling attacks prior to surgery
Danish: Forebyggelse af anfald med hævelse før kirurgi
English: The educational material for non-healthcare professionals should include information on the following key elements:
Danish: Uddannelsesmaterialet for personer, der ikke er sundhedspersonale, skal indeholde information om de følgende nøgleelementer:
English: Aseptic technique should be used during the reconstitution procedure.
Danish: Anvend aseptisk teknik under rekonstitutionsproceduren.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Danish: Patienterne bør informeres om tidlige tegn på overfølsomhedsreaktioner, herunder nældefeber, generaliseret urticaria, trykken for brystet, pibende vejrtrækning, hypotension og anafylaksi.
English: As such, the pharmacokinetics and excretion of Cinryze are not expected to be altered by renal or hepatic impairment.
Danish: Som sådan forventes farmakokinetikken og udskillelsen af Cinryze ikke at ændres af nedsat nyre- eller leverfunktion.
English: The mean elimination half-life of functional C1 inhibitor after administration of Cinryze was 56 hours for a single dose and 62 hours for the double dose.
Danish: Den gennemsnitlige elimineringshalveringstid for funktionel C1-inhibitor efter indgivelse af Cinryze var 56 timer for en enkelt dosis og 62 timer for den dobbelte dosis.
English: You will be required to keep a diary in order to document each treatment received at home and to bring it to each of your visits to the doctor.
Danish: Det vil være påkrævet, at du fører dagbog for at dokumentere hver behandling, du får i hjemmet, og at bringe dagbogen med dig til hvert lægebesøg.
English: Use either the filter transfer device provided with Cinryze or a commercially available double-ended needle.
Danish: Anvend enten overførselsordningen med filter, der følger med Cinryze, eller en kommercielt tilgængelig kanyle med to ender.
English: tmax (hr) [median (range)]
Danish: tmax (t) [median (interval)]
English: Remove plastic caps from the powder and solvent vials.
Danish: Fjern plasticlågene fra hætteglassene med pulver og solvens.
English: Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE).
Danish: Behandling og forebyggelse af angioødem-anfald inden en procedure hos voksne, unge og børn (fra 2 år og opefter) med hereditært angioødem (HAE).
English: After intravenous administration of a single dose of Cinryze to HAE subjects, the serum concentration of functional C1 inhibitor doubled within 1 to 2 hours.
Danish: Efter intravenøs administration af en enkeltdosis Cinryze til forsøgspersoner med HAE, fordobledes serum-koncentrationen af funktionel C1-inhibitor i løbet af 1 til 2 timer.
English: Among these children, the only adverse reactions with Cinryze included headache, nausea, pyrexia, and infusion site erythema.
Danish: Blandt disse børn var de eneste bivirkninger med Cinryze hovedpine, kvalme, pyreksi og erytem på infusionsstedet.
English: After reconstitution, the product should be used immediately.
Danish: Efter rekonstitution skal dette præparat straks bruges.
English: Store the remaining vial and administration equipments for the next dose.
Danish: Gem det ubrugte hætteglas og administrationsudstyr til den næste dosis.
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived C1 inhibitor product.
Danish: Hensigtsmæssig vaccination (hepatitis A og B) skal overvejes for patienter, som regelmæssigt eller gentagne gange får human plasmaderiveret C1-inhibitor-præparat.
English: There are limited data on the use of this medicinal product in home or self-administration.
Danish: Der er begrænsede data om anvendelsen af dette lægemiddel i hjemmet eller selvindgivelse.
English: • The dosing interval may be adjusted by your doctor depending upon your response to Cinryze.
Danish: • Doseringsintervallet kan justeres af lægen, afhængig af dit respons til Cinryze.
English: Ensure the powder vial and the solvent vial are at room temperature (15ºC - 25ºC).
Danish: Sørg for, at hætteglassene med pulver og solvens er ved stuetemperatur (15 ºC - 25 ºC).
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses, and for the non-enveloped hepatitis A and parvovirus B19 viruses.
Danish: De anvendte forholdsregler anses for at være effektive til indkapslede vira såsom humant immundefektvirus (HIV), hepatitis B- og hepatitis C-vira og til ikke-indkapslede hepatitis A- og parvovirus B19-vira.
English: The vacuum in the powder vial will draw in the solvent.
Danish: Vakuum i hætteglasset med pulver vil trække solvensen ind.
English: In open-label study LEVP 2006-1, 101 subjects were treated for a total of 609 acute HAE attacks (median 3 attacks per subject; range: 1-57).
Danish: I den ublindede undersøgelse LEVP 2006-1 blev 101 forsøgspersoner behandlet for i alt 609 akutte HAE-anfald (median 3 anfald pr. forsøgsperson, interval: 1-57).
English: Home-treatment and self-administration
Danish: Hjemmebehandling og selvindgivelse
English: Functional C1 inhibitor activity was measured in children in the two open label studies (see section 5.1).
Danish: Funktionel C1-inhibitor-aktivitet hos børn blev målt i to ublindede studier (se pkt.
English: Because these pathways are part of enzyme amplification cascades, without C1 inhibitor, spontaneous or trigger-induced activation of these pathways can lead to unopposed activation and swelling.
Danish: Da disse aktiveringsveje er dele af enzymets amplifikationskaskader, kan spontan eller trigger-induceret aktivering af disse aktiveringsveje føre til uhindret aktivering og hævelse uden C1-inhibitoren.
English: For some patients the prescribing physician may decide that Cinryze may be administered at home by a non-healthcare professional such as a family member or by self-administration.
Danish: Den ordinerende læge kan for nogle patienter bestemme, at Cinryze kan indgives i hjemmet af personer, der ikke er sundhedspersonale, såsom et familiemedlem eller ved selvindgivelse.