FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are not sure, ask your doctor before using this medicine.
Danish: Hvis du ikke er sikker, skal du spørge din læge, før du begynder at bruge lægemidlet.
English: • If you have or have ever had a higher risk of blood clots forming (thrombosis), as NovoThirteen may increase the severity of a pre-existing blood clot.
Danish: • Hvis du har eller har haft en forøget risiko for blodpropper (trombose), da NovoThirteen kan forværre en allerede eksisterende blodprop.
English: Analyses of data from paediatric patients included in clinical trials have not identified differences in treatment response according to age.
Danish: Analyser af data fra pædiatriske patienter, der var inkluderet i kliniske studier, har ikke identificeret forskel i behandlingsrespons i forhold til alder.
English: Following reconstitution the product should be administered separately and not mixed with infusion solutions nor be given in a drip.
Danish: Efter rekonstitution skal produktet administreres separat og må ikke blandes med infusionsvæsker eller gives i drop.
English: NovoThirteen has no influence on the ability to drive and use machines.
Danish: NovoThirteen påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Use in children and adolescents (weighing more than 24 kg) NovoThirteen can be used in children and adolescents in the same way as in adults.
Danish: Brug til børn og teenagere (der vejer over 24 kg) NovoThirteen kan anvendes på samme måde til børn og unge som til voksne.
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 within 60 days as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.
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: 4 patients received at least 2 doses of NovoThirteen.
Danish: Alle fire patienter fik mindst 2 doser NovoThirteen.
English: At present there are no markers that can quantitatively assess the in vivo pharmacodynamics of FXIII.
Danish: Der er i øjeblikket ingen markører, som kvantitativt kan vurdere in vivo-farmakodynamikken for FXIII.
English: Remove the plastic caps from the 2 vials.
Danish: Fjern plastikhætterne fra de to hætteglas.
English: There is limited information on overdose with NovoThirteen.
Danish: Der er begrænsede oplysninger om overdosering med NovoThirteen.
English: • How to safely store, handle, reconstitute and administer the product
Danish: • Hvordan produktet opbevares sikkert, håndteres, opblandes og administreres
English: The suggested dose of 35 IU/kg has shown to be appropriate to provide haemostatic coverage in this young population.
Danish: Den foreslåede dosis på 35 IE/kg er påvist at være passende for at opnå hæmostase hos denne unge population.
English: 3 of these patients discontinued the study due to the adverse reaction.
Danish: Tre af disse patienter afbrød studiet som følge af bivirkningen.
English: In this last case your doctor will prescribe an alternative treatment to treat the bleeding.
Danish: I sidst nævnte tilfælde kan din læge udskrive en alternativ behandling for blødningen.
English: These antibodies were seen at the start of treatment with NovoThirteen.
Danish: Disse antistoffer blev observeret i begyndelsen af behandlingen med NovoThirteen.
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology and repeated dose toxicity.
Danish: De ikke-kliniske data afslører ingen særlig risiko for mennesker baseret på sikkerhedsfarmakologi og gentagen dosis-toksisitet.
English: As NovoThirteen contains a recombinant protein it may cause allergic reactions including anaphylactic reactions.
Danish: Da NovoThirteen indeholder et rekombinant protein, kan det forårsage allergiske reaktioner, herunder anafylaktiske reaktioner.
English: NovoThirteen is given as an injection into a vein.
Danish: NovoThirteen gives som en injektion i en vene.
English: • Embolic and thrombotic events including the increased risk of vessel occlusion in patients at risk of thrombosis
Danish: • Emboliske og trombotiske hændelser inklusive den øgede risiko for karokklusioner hos patienter med risiko for trombose
English: The usual dose is 35 IU for each kilogram of body weight.
Danish: Den sædvanlige dosis er 35 IE for hvert kilogram legemsvægt.
English: The specific activity of NovoThirteen is approximately 165 IU/mg protein.
Danish: Den specifikke aktivitet af NovoThirteen er svarende til ca. 165 IE/mg protein.
English: If allergic or anaphylactic-type reactions occur, the administration should be immediately discontinued and further treatment with NovoThirteen should not be given.
Danish: Hvis der opstår allergiske reaktioner eller reaktioner af anafylaktisk karakter, skal administrationen straks ophøre, og der må ikke gives yderligere behandling med NovoThirteen.
English: It is unknown whether rFXIII is excreted in human breast milk.
Danish: Det er ukendt, om rFXIII udskilles i human modermælk.
English: The product is now ready for injection.
Danish: Produktet er nu klar til injektion.
English: The antibodies disappeared in the 6-month follow up.
Danish: Antistofferne var forsvundet ved opfølgningen efter 6 måneder.
English: NovoThirteen replaces the missing factor XIII and helps to stabilise the initial blood clot by producing a mesh around the clot.
Danish: NovoThirteen erstatter det manglende faktor XIII og hjælper med at stabilisere en begyndende størkning af blodet, ved at producere et net omkring størkningen.
English: For instructions on reconstitution of the medicinal product prior to administration, see section 6.6.
Danish: For instruktioner om rekonstitution af lægemidlet inden administration, se pkt.
English: The excretion of rFXIII in milk has not been studied in animals.
Danish: Udskillelse af rFXIII i mælk er ikke undersøgt hos dyr.
English: FXIII is a pro-enzyme (pro-transglutaminase), which is activated by thrombin in the presence of Ca2+.
Danish: FXIII er et pro-enzym (pro-transglutaminase), som aktiveres af trombin ved tilstedeværelse af Ca2+.
English: The powder is white and the solvent is clear and colourless.
Danish: Pulveret er hvidt og solvensen er klar og farveløs.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan forkomme hos op til 1 ud af 10 personer):
English: • What to do in the event of incorrect storage, thrombosis or embolism
Danish: • Forholdsregler der skal tages i tilfælde af ukorrekt opbevaring, trombose eller embolisme
English: Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use.
Danish: Rens gummipropperne på hætteglassene med alkoholservietter, og lad dem tørre inden brug.
English: In case of predisposition to conditions of thrombosis, caution should be exercised due to the fibrinstabilising effect of NovoThirteen.
Danish: I tilfælde af disponering for trombosetilstande skal der udvises forsigtighed på grund af NovoThirteens fibrinstabiliserende virkning.
English: One continued to receive rFXIII and the antibodies decreased below detection limit.
Danish: Én fortsatte med at modtage rFXIII og mængden af antistoffer faldt til under målegrænsen.
English: Use in the paediatric population
Danish: Brug hos den pædiatriske population
English: A potential synergistic effect of combined treatment with rFXIII and rFVIIa in an advanced cardiovascular model in cynomolgus monkey resulted in exaggerated pharmacology (thrombosis and death) at a lower dose level than when administering the individual compounds.
Danish: En potentiel synergieffekt ved kombineret behandling med rFXIII og rFVIIa i en avanceret kardiovaskulær model i cynomolgusabe resulterede i overdreven farmakologi (trombose og død) ved et lavere dosisniveau end ved administration af de enkelte bestanddele.
English: Until further results are available, alternative treatment should be considered in such situations.
Danish: Alternativ behandling bør overvejes i sådanne situationer, indtil yderligere resultater er tilgængelige.
English: One patient with pre-existing neutropenia experienced a mild aggravation of neutropenia and leucopenia during treatment with NovoThirteen.
Danish: En patient med eksisterende neutropeni oplevede en let forværring af neutropeni og leukopeni under behandlingen med NovoThirteen.
English: In patients below 6 years, no anti-rFXIII antibodies, no thromboembolic adverse events or other safety issues were reported.
Danish: Hos patienter under 6 år blev der ikke rapporteret om anti-rFXIII antistoffer, tromboemboliske bivirkninger eller andre sikkerhedsmæssige anliggender.
English: The mean t½ of FXIII was approximately 15 days (range: 10 to 25 days).
Danish: Gennemsnitlig t½ af FXIII var ca. 15 dage (i intervallet: 10 til 25 dage).
English: Animal reproductive or developmental toxicity studies have not been performed.
Danish: Der er ikke foretaget undersøgelser af reproduktivitets- eller udviklingsmæssig toksicitet hos dyr.
English: No treatment requiring bleeding episodes have been detected in patients below 6 years during 17 years of cumulative follow-up, representing a total of 214 doses.
Danish: Der er ikke blevet observeret behandlingskrævende blødningsepisoder hos patienter under 6 år i løbet af 17 års samlet opfølgning, der repræsenterer i alt 214 doser.
English: NovoThirteen has been shown to have the same pharmacodynamic properties in plasma as endogenous FXIII.
Danish: NovoThirteen har vist sig at have de samme farmakodynamiske egenskaber i plasma som endogen FXIII.
English: There are no clinical data available on interaction between NovoThirteen and other medicinal products.
Danish: Der foreligger ingen kliniske data om interaktion mellem NovoThirteen og andre lægemidler.
English: NovoThirteen contains the active substance catridecacog, which is identical to human coagulation factor XIII, an enzyme necessary for blood clotting.
Danish: NovoThirteen indeholder det aktive stof catridecacog, som er identisk med human koagulationsfaktor XIII, et enzym der er nødvendigt for at blodet kan størkne.
English: FXIII activity levels should be monitored in patients with severe hepatic impairment.
Danish: FXIII-aktivitetsniveauer skal monitoreres hos patienter med svær nedsat leverfunktion.
English: The four events of non-neutralising antibodies occurred in patients below the age of 18 (age 8, 8, 14 and 16).
Danish: De fire tilfælde af ikke-inhiberende antistoffer indtraf hos patienter under 18 år (8, 8, 14 og 16 år).
English: Side effects include:
Danish: Bivirkninger kan være:
English: Inhibitors may be suspected in the event of lack of therapeutic response which is observed as bleeding or demonstrated by laboratory findings including FXIII activity that fails to reach expected levels.
Danish: Der kan være mistanke om inhiberende antistoffer i tilfælde af manglende terapeutisk respons, observeret i form af blødning eller påvist ved laboratoriefund, herunder FXIII-aktivitet, som ikke når det forventede niveau.
English: Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the vial).
Danish: Sørg for, at stemplet er skubbet helt ind, før sprøjten vendes på hovedet (stemplet kan være blevet presset lidt ud af trykket i hætteglasset).
English: Pharmacotherapeutic group: Antihaemorrhagics, Blood Coagulation factor, ATC code: B02BD11.
Danish: Farmakoterapeutisk klassifikation: Anti-hæmoragisk, blodkoagulationsfaktor, ATC-kode: B02BD11.
English: Talk to your doctor before using NovoThirteen:
Danish: Kontakt lægen, før du bruger NovoThirteen:
English: No clinical findings were associated with these antibodies.
Danish: Ingen kliniske fund blev forbundet med disse antistoffer.
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: Patienter skal informeres om de tidlige tegn på overfølsomhedsreaktioner (herunder nældefeber, generaliseret urticaria, strammen for brystet, hvæsen, hypotension) og anafylakse.
English: Dose adjustment can be considered necessary by the physician in certain situations where the prevention of bleeding is not appropriately covered by the recommended 35 IU/kg/month dose.
Danish: Lægen kan i visse tilfælde skønne, at en dosisjustering er nødvendig, i tilfælde hvor forebyggelse af blødninger ikke er tilstrækkeligt dækket af den anbefalede dosis på 35 IE/kg/måned.
English: Inject air into the vial by pushing the plunger until you feel a clear resistance.
Danish: Sprøjt luft ind i hætteglasset ved at trykke stemplet ind, indtil du møder tydelig modstand.
English: It is structurally identical to the human FXIII A-subunit [A2].
Danish: Den er strukturelt identisk med den humane FXIII A-subunit [A2].
English: Following discontinuation of NovoThirteen the patient's neutrophil count returned to levels similar to those prior to treatment with NovoThirteen.
Danish: Efter seponering af NovoThirteen vendte patientens neutrofiltælling tilbage til samme niveau som før behandlingen med NovoThirteen.
English: NovoThirteen should be injected at a rate not higher than 2 ml/minute.
Danish: NovoThirteen skal injiceres med en hastighed der ikke overstiger 2 ml/minut.
English: Four cases of non-neutralising antibodies were reported at the start of the treatment in patients from 6 to 18 years of age.
Danish: Fire tilfælde af ikkeinhiberende antistoffer blev rapporteret i begyndelsen af behandlingen hos patienter i alderen 6 til 18 år.
English: • Correct handling and the risks associated with mishandling
Danish: • Korrekt håndtering og risikoen forbundet med ukorrekt håndtering
English: Currently available data are described in section 4.8, 5.1 and 5.2.
Danish: 4.8, 5.1 og 5.2.
English: A clot solubility assay is widely used as an indicator of FXIII deficiency, but the assay is qualitative, and when performed correctly the test is positive only when the FXIII activity in the sample is close to zero.
Danish: En analyse af koaglets opløselighed anvendes almindeligvis som indikator for FXIII-mangel, men analysen er kvalitativ, og når den foretages korrekt, er testen kun positiv, når FXIII-aktiviteten i prøven er tæt på nul.
English: One patient was treated on demand in a phase 3b extension study (F13CD-3720).
Danish: En patient var behandlet efter behov i et fase 3b forlængelsesstudie (F13CD-3720).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP der fremgår af, modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: In clinical studies, adverse reactions were more frequently reported in patients aged from 6 to less than 18 years old than in adults.
Danish: I kliniske studier er bivirkninger oftere rapporteret hos patienter i alderen fra 6 og op til 18 år end hos voksne.
English: This is in agreement with the elimination pharmacokinetics estimated from a clinical pharmacology trial in healthy subjects, which determined the half-life to be 11.8 days.
Danish: Dette er i overensstemmelse med elimineringsfarmakokinetikken, som er estimeret på basis af et klinisk farmakologisk studie hos raske forsøgspersoner, hvor halveringstiden blev fastlagt til 11,8 dage.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 September 2012
Danish: Dato for første markedsføringstilladelse: 03 September 2012 Dato for seneste opdatering:
English: Congenital FXIII B-subunit deficiency
Danish: Medfødt FXIII B-subunit mangel
English: The active transglutaminase cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot and contributes to enhanced platelet and clot adhesion to the injured tissue.
Danish: Den aktive transglutaminase krydsbinder fibrin og andre proteiner, hvilket resulterer i øget mekanisk styrke og modstandsdygtighed over for fibrinolyse af fibrinproppen og medvirker til at øge trombocytternes og koaglets adhæsion til det beskadigede væv.
English: The preparation should be administered as a slow bolus intravenous injection at a rate not higher than 2 ml/minute.
Danish: Præparatet administreres som en langsom, intravenøs bolusinjektion med en hastighed, som ikke overstiger 2 ml/minut.
English: Patients known to have neutralising antibodies to FXIII should not be treated with NovoThirteen without close monitoring.
Danish: Patienter, som man ved har inhiberende antistoffer mod FXIII, må ikke behandles med NovoThirteen uden nøje monitorering.
English: Take care not to touch the spike on the vial adapter.
Danish: Vær forsigtig med ikke at røre spidsen på hætteglasadapteren.
English: Five bleeding episodes requiring treatment with a FXIII-containing product have been observed in four patients during treatment with rFXIII in the trial.
Danish: Fem blødningsepisoder, som krævede behandling med et produkt indeholdende FXIII, er observeret hos fire patienter under behandling med rFXIII i studiet.
English: The on-demand treatment of acute bleeds or breakthrough bleeds with NovoThirteen was allowed per protocol in the late phase clinical development programme.
Danish: Behovsbehandlingen med NovoThirteen af akutte blødninger eller gennembrudsblødninger var tilladt i protekollen i den sene fase af det kliniske udviklingsprogram.
English: If the caps are loose or missing, do not use the vials.
Danish: Hvis hætterne er løse eller mangler, må hætteglassene ikke anvendes.
English: The dosing scheme used was 35 IU/kg/month (every 28 days ± 2 days).
Danish: Det anvendte doseringsregime var 35 IE/kg/måned (hver 28. dag ± 2 dage).
English: NovoThirteen is used to prevent bleeding in patients who do not have enough or are missing part of factor XIII (that is called A-subunit).
Danish: NovoThirteen anvendes til at forhindre blødning hos patienter, som ikke har nok eller delvist mangler faktor XIII (kaldet A-subunit).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Indenfor hver frekvensgruppe, er bivirkninger opstillet efter, hvor alvorlige de er.
English: Monitoring NovoThirteen activity levels using a standard FXIII activity assay is recommended.
Danish: Det anbefales at monitorere aktivitetsniveauet af NovoThirteen med en standard FXIII aktivitetsanalyse.
English: • The risks associated with incorrect storage and mishandling
Danish: • Risikoen forbundet med ukorrekt opbevaring og ukorrekt håndtering
English: • Appropriate diagnostic procedures to confirm FXIII A-subunit deficiency
Danish: • Hensigtsmæssige dianogstiske procedurer for at bekræfte mangel på FXIII A-subunit
English: 3 patients (14%) aged between 6 and 18 years experienced serious adverse reactions in comparison to 0 patients over 18 years that experienced serious adverse reactions.
Danish: Tre patienter (14%) i alderen fra 6 og op til 18 år oplevede alvorlige bivirkninger, sammenlignet med nul patienter over 18 år der oplevede alvorlige bivirkninger.
English: In the event of either being observed, discard the medicinal product.
Danish: Hvis en af delene observeres, skal lægemidlet kasseres.
English: All findings in the non-clinical safety programme have been related to expected exaggerated pharmacology (general thrombosis, ischaemic necrosis and ultimately mortality) of rFXIII and non-proteolytically activated recombinant FXIII at dose levels in excess (>48 fold) of the maximum recommended clinical dose of 35 IU/kg.
Danish: Alle fund i det ikke-kliniske sikkerhedsprogram er relateret til forventet, overdreven farmakologi (generel trombose, iskæmisk nekrose og endelig mortalitet) for rFXIII og ikke-proteolytisk aktiveret rekombinant FXIII ved dosisniveauer, som overstiger (>48 gange) den maksimale anbefalede kliniske dosis på 35 IE/kg.
English: In all cases, the non-neutralising antibodies were found to be of no clinical significance.
Danish: I alle tilfælde blev de ikke-inhiberende antistoffer vurderet til ikke at være kliniske signifikante.
English: In this trial, the mean clearance in children was 0.15 ml/h/kg.
Danish: I dette studie var den gennemsnitlige clearance hos børn 0,15 ml/time/kg.
English: The recommended dose is 35 IU/kg body weight (bw) once monthly (every 28 days ± 2 days), administered as an intravenous bolus injection.
Danish: Den anbefalede dosis er 35 IE/kg legemsvægt en gang månedligt (hver 28. dag ± 2 dage), givet som en intravenøs bolusinjektion.
English: In the event that inhibitors are suspected analysis for antibodies should be performed.
Danish: I tilfælde af mistanke om inhibitorer skal der foretages en analyse for inhiberende antistoffer.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with NovoThirteen should be made taking into account the benefit of breast-feeding to the child and the benefit of NovoThirteen therapy to the mother.
Danish: Det skal besluttes, om amning skal fortsætte eller ophøre, eller om behandling med NovoThirteen skal fortsætte eller seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til NovoThirteens terapeutiske fordele for moderen.
English: No effects on reproductive organs have been seen in non-clinical studies.
Danish: Der er ikke påvist nogen effekt på forplantningsorganerne i ikke-kliniske studier.
English: A stabilisation of the thrombus might occur, resulting in increased risk of vessel occlusions.
Danish: En stabilisering af tromben kan forekomme, hvilket øger risikoen for karokklusioner.
English: Do not use this medicine if there are particles in it or it is discoloured when reconstituted.
Danish: Brug ikke lægemidlet, hvis det indeholder partikler eller er misfarvet efter opblanding.
English: In this trial the mean volume of distribution at steady state was 47 ml/kg, mean residence time was 15.5 days and mean clearance was 0.13 ml/kg.
Danish: I dette studie var middelvolumen for distribution ved steady state 47 ml/kg, gennemsnitlig opholdstid (MRT) var 15,5 dage, og gennemsnitlig clearance var 0,13 ml/kg.
English: Based on FXIII activity measured by the Berichrom assay in patients with congenital FXIII deficiency, a geometric mean half-life of 11.8 days was estimated.
Danish: Baseret på FXIII-aktivitet målt ved Berichrom analyse hos patienter med medfødt FXIII-mangel, blev der estimeret en geometrisk gennemsnithalveringstid på 11,8 dage.
English: The product is now ready for injection in the vein.
Danish: Produktet er nu klar til injektion i venen.
English: There is limited clinical experience in administering NovoThirteen to elderly patients with congenital FXIII deficiency.
Danish: Der er begrænset klinisk erfaring med administration af NovoThirteen til ældre patienter med medfødt FXIII-mangel.
English: The mean rate of treatment-requiring bleeds was determined to 0.138 per subject year.
Danish: Middelfrekvensen for behandlingskrævende blødninger blev fastlagt til 0,138 pr. forsøgspersonår.
English: Make sure not to aim the stream of solvent directly at the powder as this will cause foaming.
Danish: Pas på, at solvensen ikke sprøjtes direkte ned i pulveret, da dette vil forårsage skumdannelse.
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Danish: Hydrogenchlorid (til pH-justering) Natriumhydroxid (til pH-justering)
English: • If you are allergic to catridecacog or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for catridecacog eller et af de øvrige indholdsstoffer i lægemidlet
English: After dilution proceed to the step ‘Injecting the solution'.
Danish: Efter fortynding fortsættes til næste trin 'Injektion af opløsningen'.