FrancophonIA/ELRC3.0 huggingface dataset:
English: Compatibility with the product was demonstrated for the system consisting of a 50 ml syringe (polypropylene), a 2 m infusion tube (polyethylene) and an inline filter with a 5 micrometer pore size.
Danish: Kompatibilitet med produktet blev påvist for et system bestående af en 50 ml sprøjte (polypropylen), en 2 m infusionsslange (polyethylen) og et in-line-filter med en porestørrelse på 5 mikrometer.
English: • Blood clots in arteries in the heart (which could lead to a heart attack or angina), in the brain (which could lead to a stroke) or in the intestine and kidneys.
Danish: • Blodpropper i arterierne i hjertet (som kan føre til hjertetilfælde eller hjertekrampe), i hjernen (som kan føre til slagtilfælde) eller i tarmene og nyrerne.
English: NovoSeven should be given as early as possible after the start of a bleeding episode.
Danish: NovoSeven bør gives så hurtigt som muligt efter starten af en blødningsepisode.
English: In patients with factor VII deficiency, where the recommended dose is 15 - 30 µg/kg rFVIIa, one episode of overdose has been associated with a thrombotic event (occipital stroke) in an elderly (> 80 year) male patient treated with 10 - 20 times the recommended dose.
Danish: Hos patienter med faktor VII mangel, hvor den anbefalede dosis er 15-30 μg/kg rFVIIa, har en episode med overdosis været associeret med en tromboembolisk hændelse (occipital slagtilfælde) hos en ældre (> 80 år) mandlig patient, behandlet med 10-20 gange den anbefalede dosis.
English: • Blood clots in the veins in lungs, legs, liver, kidneys or at site of injection.
Danish: • Blodpropper i venerne i lungerne, benene, leveren, nyrerne eller ved injektionsstedet.
English: If continued therapy is indicated, the dose interval can then be increased to 3 hours for 1 - 2 days.
Danish: Såfremt fortsat terapi er påkrævet, kan doseringsintervallet øges til 3 timer i 1-2 dage.
English: Disposal • After injection, safely dispose of the syringe with the administration set, the vial with the vial adapter, any unused NovoSeven and other waste materials as instructed by your doctor or nurse.
Danish: Bortskaffelse • Efter injektion kasseres sprøjten med administrationssættet, hætteglasset med hætteglasadaptoren og ikke anvendt NovoSeven samt andet affald, som instrueret af din læge eller sygeplejerske.
English: The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight.
Danish: Den anbefalede initiale dosis, der gives som intravenøs bolusinjektion, er 90 µg pr. kg legemsvægt.
English: It works in all types of bleeds, including joint bleeds.
Danish: Det virker på alle typer blødninger, inklusive blødninger i led.
English: • Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
Danish: • Injektion ind i et CVAD kræver muligvis en steril 10 ml plastiksprøjte til udtræk af den opblandede injektionsvæske.
English: Contents of the pack and other information What NovoSeven contains
Danish: Pakningsstørrelser og yderligere oplysninger NovoSeven indeholder
English: Administration through a needleless connector may require withdrawal of the reconstituted solution into a standard 10 ml sterile luer-lock plastic syringe.
Danish: For at indgivelse kan ske via en forbindelse uden nål, kan det være nødvendigt at trække den rekonstituerede opløsning op i en standard 10 ml steril luer-lock plastiksprøjte.
English: Only after consultation with the haemophilia treatment centre can continued home treatment be considered.
Danish: Fortsat hjemmebehandling bør kun overvejes efter konsultation med hæmofili-behandlingscenteret.
English: NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:
Danish: NovoSeven er indiceret til behandling af blødningsepisoder og til forebyggelse af blødning ved kirurgi eller invasive procedurer hos følgende patientgrupper:
English: • Ensure that a vial adapter is used irrespective of presentation.
Danish: • Det skal sikres, at der anvendes en hætteglasadapter, uanset hvilken variant af produktet der anvendes.
English: In addition, the development of antibodies against NovoSeven and FVII has been associated with overdose in one patient with factor VII deficiency.
Danish: Desuden har dannelsen af antistoffer mod NovoSeven og faktor VII været associeret med overdosis hos en patient med faktor VII mangel.
English: Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 - 26G) or other suitable device.
Danish: Anvend en engangssprøjte af passende størrelse og en hætteglasadapter, nål til overførsel (20 - 26G) eller andet passende udstyr.
English: Four cases of overdose have been reported in patients with haemophilia in 16 years.
Danish: Over en periode på 16 år er der rapporteret om fire tilfælde af overdosis hos patienter med hæmofili.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton text
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton tekst
English: Check the solution for visible particles and discolouration.
Danish: Kontrollér injektionsvæsken for synlige partikler og misfarvning.
English: • Repeat the procedure with the appropriate number of additional vials, solvent vials/pre-filled syringes and vial adapters.
Danish: • Gentag proceduren med det passende antal supplerende hætteglas, hætteglas med solvens/fyldte sprøjter med solvens og hætteglasadaptere.
English: Pooling of vials (hospital use only):
Danish: Pooling af hætteglas (kun til brug i hospitalsregi):
English: Follow the instructions for use for the needleless connector.
Danish: Følg vejledningen i brug af forbindelser uden nåle.
English: Pharmacokinetics of NovoSeven in patients with Glanzmann's thrombasthenia have not been investigated, but are expected to be similar to the pharmacokinetics in haemophilia A and B patients.
Danish: NovoSevens farmakokinetiske egenskaber hos patienter med Glanzmanns trombasteni er ikke undersøgt, men forventes at svare til de farmakokinetiske egenskaber hos patienter med hæmofili A og B.
English: You should talk to your doctor before using NovoSeven with these medicines.
Danish: Kontakt din læge inden du bruger NovoSeven med denne type medicin.
English: Thrombin leads to the activation of platelets and factors V and VIII at the site of injury and to the formation of the haemostatic plug by converting fibrinogen into fibrin.
Danish: Trombin fører til aktivering af blodplader samt faktor V og VIII på selve læsionsstedet og til dannelse af en hæmostatisk prop ved omdannelse af fibrinogen til fibrin.
English: The most frequently reported adverse drug reactions are decreased therapeutic response, pyrexia, rash, venous thromboembolic events, pruritus and urticaria.
Danish: Den hyppigst rapporterede bivirkning under behandling er nedsat terapeutisk respons, pyreksi, udslæt, venøse tromboemboliske hændelser, pruritus og urticaria.
English: • Use NovoSeven at once after mixing the powder with the solvent to avoid infection.
Danish: • Brug NovoSeven straks efter pulveret er opblandet med solvensen for at undgå infektion.
English: Other rare side effects
Danish: Andre sjældne bivirkninger
English: Using the FVIIa assay, the pharmacokinetic properties of rFVIIa were studied in 12 paediatric (212 years) and 5 adult patients in non-bleeding state.
Danish: Ved hjælp af et faktor VIIa assay blev de farmakokinetiske egenskaber for rFVIIa undersøgt hos 12 pædiatriske- (2 - 12 år) og 5 voksne patienter i blødningsfri tilstand.
English: Leave the plunger rod untouched in the carton.
Danish: Lad stempelstangen forblive urørt i kartonen.
English: Each NovoSeven pack contains:
Danish: Hver NovoSeven pakning indeholder:
English: • If you were born with haemophilia and do not respond normally to factors VIII or IX treatment
Danish: • Hvis du blev født med hæmofili og ikke reagerer normalt på faktor VIII eller IX behandling
English: In an observational registry (F7HAEM-3578) covering subjects with congenital FVII deficiency, the median dose for long term prophylaxis against bleeding in 22 paediatric patients (below 12 years of age) with Factor VII deficiency and a severe clinical phenotype was 30 µg/kg (range 17 µg/kg to 200 µg/kg; the dose most often used was 30 µg/kg in 10 patients) with a median dose frequency of 3 doses per week (range 1 to 7; the dose frequency most often reported was 3 per week in 13 patients).
Danish: I et observationelt register (F7HAEM-3578) med personer med kongenital FVII-mangel var den gennemsnitlige dosis ved langtidsvarende profylakse mod blødning hos 22 pædiatriske patienter (under 12 år) med faktor VII-mangel og en alvorlig klinisk fænotype 30 µg/kg (i intervallet 17 µg/kg til 200 µg/kg; den dosis, der oftest blev givet, var 30 µg/kg hos 10 patienter) med en gennemsnitlig doseringsfrekvens på 3 doser per uge (i intervallet 1 til 7; den doseringsfrekvensen der oftest blev rapporteret var 3 per uge hos 13 patienter).
English: Improper technique can introduce germs that can infect the blood.
Danish: Forkert fremgangsmåde kan forårsage en bakterieinfektion i blodet.
English: • If you have severe liver disease
Danish: • Hvis du har en alvorlig leversygdom
English: It is recommended to use NovoSeven immediately after reconstitution, unless as described in section
Danish: Det anbefales at bruge NovoSeven straks efter rekonstitution, medmindre anvisningen under pkt.
English: For single dose administration Administration should preferably take place immediately after reconstitution Read package leaflet before use
Danish: Til enkeltdosis brug Skal helst anvendes straks efter opblanding Læs indlægssedlen før brug
English: - Anaphylactic reaction
Danish: - Anafylaktisk reaktion
English: The reconstituted NovoSeven must be injected into your vein (intravenous injection).
Danish: Det opblandede NovoSeven skal injiceres i en vene (intravenøs injektion).
English: What you need to know before you use NovoSeven Do not use NovoSeven
Danish: Det skal du vide, før du begynder at bruge NovoSeven Brug ikke NovoSeven
English: Data on a limited number of exposed pregnancies within approved indications indicate no adverse effects of rFVIIa on pregnancy or on the health of the foetus/new-born child. To date, no other relevant epidemiological data are available.
Danish: Data fra et begrænset antal opgjorte graviditeter inden for godkendte indikationer, indikerer ingen bivirkninger af rFVIIa på graviditet eller helbredstilstanden af fosteret/det nyfødte barn.
English: If a larger dose is needed, repeat the procedure with additional vials, pre-filled syringes and vial adapters.
Danish: Hvis større dosis er nødvendig, gentag da proceduren med yderligere hætteglas, fyldte sprøjter og hætteglasadaptere.
English: Clinical trials conducted in 484 patients (including 4297 treatment episodes) with haemophilia A and B, acquired haemophilia, factor VII deficiency or Glanzmann's thrombasthenia have shown that adverse drug reactions are common (≥ 1/100 to < 1/10).
Danish: Der er blevet udført kliniske studier hos 484 patienter (herunder 4297 behandlingsepisoder) med hæmofili A og B, erhvervet hæmofili, faktor VII mangel eller Glanzmanns trombasteni, som har vist, at bivirkninger er almindelige (≥ 1/100 til < 1/10).
English: Under these conditions, chemical and physical stability has been demonstrated for 24 hours at 25°C when stored in a 50 ml syringe (polypropylene).
Danish: Under sådanne betingelser er der blevet påvist kemisk og fysisk stabilitet i 24 timer ved 25°C ved opbevaring i en 50 ml sprøjte (polypropylen).
English: After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) when reconstituted with solvent.
Danish: Efter rekonstitution indeholder produktet 1 mg/ml eptacog alfa (aktiveret), når det opløses med solvens.
English: No cases of overdose have been reported in patients with acquired haemophilia or Glanzmann's thrombasthenia.
Danish: Ingen tilfælde af overdosis er rapporteret hos patienter med erhvervet hæmofili eller Glanzmanns trombasteni.
English: The mean steady state volume of distribution ranged from 130 to 165 ml/kg, the mean values of clearance ranged from 33.3 to 37.2 ml/h×kg.
Danish: Den gennemsnitlige fordelingsvolumen ved steady state varierede fra 130-165 ml/kg, den gennemsnitlige clearance varierede fra 33,3 til 37,2 ml/time x kg.
English: • Nausea (feeling sick)
Danish: • Kvalme (opkast)
English: Initially 2 - 3 hours to obtain haemostasis.
Danish: Initialt 2-3 timer for at opnå hæmostase.
English: After reconstitution, chemical and physical stability has been demonstrated for 6 hours at 25°C and 24 hours at 5°C.
Danish: Det er blevet påvist, at produktet efter rekonstitution er kemisk og fysisk stabilt i 6 timer ved 25°C og i 24 timer ved 5°C.
English: - Increase of alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin
Danish: - Forhøjede niveauer af alaninaminotransferase, alkalisk fosfatase, laktatdehydrogenase og protrombin
English: Each pack contains: 1 vial of powder 1 vial of solvent
Danish: Hver pakning indeholder: 1 hætteglas med pulver 1 hætteglas med solvens
English: - Store powder and solvent below 25°C.
Danish: - Pulver og solvens opbevares under 25°C.
English: • NovoSeven is now ready for injection.
Danish: • NovoSeven er nu klar til injektion.
English: No studies on the effect on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: • If you recently had a crush injury
Danish: • Hvis du for nylig har haft et traume
English: The most frequent adverse drug reactions are pyrexia and rash (uncommon: > 1/1,000 to < 1/100), and the most serious adverse drug reactions are thromboembolic events.
Danish: De hyppigst forekommende bivirkninger er pyreksi og udslæt (ikke almindelig: ≥ 1/1.000 til < 1/100), og de alvorligste bivirkninger er tromboemboliske hændelser.
English: Some needleless connectors with an internal spike are incompatible with the pre-filled syringe.
Danish: Nogle forbindelser uden nål, der har en indvendig spids, passer ikke sammen med den fyldte sprøjte.
English: Instructions on how to use NovoSeven READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOSEVEN
Danish: NovoSeven Brugervejledning LÆS DENNE BRUGERVEJLEDNING OMHYGGELIGT, INDEN DU BRUGER NOVOSEVEN
English: Dose and frequency of injections for prophylaxis should be based on clinical response and adapted to each individual.
Danish: Injektionsdosis og doseringsfrekvens for profylakse skal tilpasses den enkelte patient baseret på klinisk respons.
English: Vial: Type I glass vial closed with a chlorobutyl rubber stopper, covered with an aluminium cap.
Danish: Hætteglas: Type I hætteglas, som er lukket med en chlorobutylgummiprop, dækket med en aluminiumskapsel.
English: The following dose varies according to the type and severity of the haemorrhage.
Danish: Den efterfølgende dosering afhænger af blødningens type og sværhedsgrad.
English: Pack sizes: 1 mg (50 KIU), 2 mg (100 KIU), 5 mg (250 KIU) and 8 mg (400 KIU).
Danish: Pakningsstørrelser: 1mg (50 KIE), 2 mg (100 KIE), 5 mg (250 KIE) og 8 mg (400 KIE).
English: • Store powder and solvent below 25°C.
Danish: • Pulver og solvens opbevares under 25°C.
English: The efficacy rates were 81% and 82%, respectively, in patients with positive or negative refractoriness to platelet transfusions, and 77% and 85%, respectively, in patients testing positive or negative for antibodies to platelets.
Danish: Effektivitetsraterne var 81% og 82% hos patienter med henholdsvis positiv eller negativ refraktærstatus over for trombocyttransfusioner, og
English: Overleaf: NovoSeven user instructions
Danish: NOVOSEVEN BRUGERVEJLEDNING
English: Following the initial dose of NovoSeven further injections may be repeated.
Danish: Efter den første dosis NovoSeven kan der være behov for yderligere injektioner.
English: Pre-filled syringe: Type I glass barrel with a polypropylene backstop and bromobutyl rubber plunger.
Danish: Fyldt sprøjte: Type I glas-cylinder med en polypropylen-bagstopper og en brombutylgummiprop.
English: Injecting NovoSeven with pre-filled syringe via needleless connectors for intravenous (IV) catheters
Danish: Injektion af NovoSeven med fyldt sprøjte via forbindelser uden nål til intravenøse (i.v.)
English: Do not dispose of any of the items until after you have injected the reconstituted solution.
Danish: Smid ikke nogle af delene ud før du har afsluttet injektionen af den opblandede opløsning.
English: The NovoSeven reconstituted solution is colourless and should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Rekonstitueret NovoSeven opløsning er farveløs og skal kontrolleres visuelt for partikler og misfarvning før administration.
English: • in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration
Danish: • patienter med medfødt hæmofili, som forventes at få et højt anamnestisk respons efter indgivelse af faktor VIII eller faktor IX
English: Following the initial dose of NovoSeven further injections may be given if required.
Danish: Om påkrævet kan der efter den initiale dosis af NovoSeven gives yderligere injektioner.
English: For those patients who are not refractory, platelets is the first line treatment for Glanzmann's thrombasthenia.
Danish: Patienter, som ikke er resistente, bør i første omgang behandles med blodplader for Glanzmanns trombasteni.
English: Table 1 lists adverse reactions reported during clinical trials and from spontaneous (post-marketing) reports.
Danish: Tabel 1 angiver bivrkninger, som er rapporteret under kliniske studier og fra spontane (post-maketing) rapporteringer.
English: If you forget an injection, or if you want to stop the treatment, get your doctor's advice.
Danish: Spørg din læge til råds, hvis du glemmer en injektion, eller hvis du ønsker at stoppe behandlingen.
English: - Store powder and solvent protected from light.
Danish: - Pulver og solvens opbevares beskyttet mod lys.
English: • in patients with congenital haemophilia with inhibitors to coagulation factors VIII or
Danish: • patienter med medfødt hæmofili med inhibitorer over for koagulationsfaktor VIII eller
English: • Inject the reconstituted solution as instructed by your doctor or nurse.
Danish: • Injicér den opblandede injektionsvæske som instrueret af din læge eller sygeplejerske.
English: The reconstituted solution is colourless.
Danish: Den opblandede opløsning er farveløs.
English: • in patients with Glanzmann's thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.
Danish: • patienter med Glanzmanns trombastheni der er eller har været behandlingsrefraktære over for trombocyttransfusioner, eller hvor trombocytter ikke er tilgængelige.
English: • Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible.
Danish: • Tør gummiproppen på hætteglasset af med en steril alkoholserviet og lad den lufttørre i nogle sekunder før brug, for at sikre at den er så bakteriefri som muligt.
English: The NovoSeven powder must be reconstituted with its solvent and injected into a vein.
Danish: NovoSeven pulveret skal opblandes med solvensen og injiceres i en vene.
English: If you have Factor VII deficiency: The usual dose range is 15 to 30 micrograms for every 1 kilogram you weigh, for each injection.
Danish: Hvis du har faktor VII-mangel: Den normale dosis er 15 til 30 mikrogram per kilo legemsvægt for hver injektion.
English: The recommended dose for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 90 µg (range 80 - 120 µg) per kg body weight at intervals of two hours (1.5 - 2.5 hours).
Danish: Til behandling af patienter med blødningsepisoder og til forebyggelse af blødning ved kirurgi eller invasive procedurer anbefales en dosis på 90 µg (80-120 μg) pr. kg legemsvægt med 2 timers interval (1,5-2,5 timer).
English: Thrombosis has been reported in FVII deficient patients receiving NovoSeven during surgery but the risk of thrombosis in factor VII deficient patients treated with NovoSeven is unknown (see section 5.1).
Danish: Der er blevet rapporteret tromboser hos patienter med faktor VII-mangel der har fået NovoSeven under operation, men risikoen for trombose hos patienter med faktor VII mangel behandlet med NovoSeven er ukendt (se pkt.
English: • The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium hydroxide.
Danish: • Øvrige indholdsstoffer i pulveret: natriumchlorid, kalciumchloriddihydrat, glycylglycin, polysorbat 80, mannitol, saccharose, methionin, saltsyre, natriumhydroxid.
English: Lightly squeeze the protective cap with the thumb and index finger.
Danish: Tryk let på beskyttelseshætten med tommel- og pegefinger.
English: Do not freeze the mixed NovoSeven solution and keep it protected from light.
Danish: NovoSeven oplandingen må ikke fryses og skal opbevares beskyttet mod lys.
English: Other medicines and NovoSeven
Danish: Brug af anden medicin sammen med NovoSeven
English: Do not take the vial adapter out of the protective cap with your fingers.
Danish: Fjern ikke beskyttelseshætten på hætteglasadaptoren med dine fingre.
English: Using the FVII clotting assay, the pharmacokinetics of rFVIIa were investigated in 35 healthy Caucasian and Japanese subjects in a dose-escalation study.
Danish: Ved hjælp af et faktor VII koagulations-assay blev de farmakokinetiske egenskaber for rFVIIa undersøgt i et dosis-eskaleringsstudie med 35 raske kaukasiske og japanske personer.
English: Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, histidine, water for injections
Danish: Natriumchlorid, calciumchloriddihydrat, glycylglycin, polysorbat 80, mannitol, saccharose, methionin, histidin, vand til injektionsvæsker
English: • 1 vial with NovoSeven powder
Danish: • 1 hætteglas med NovoSeven pulver
English: Unscrew the empty syringe from the vial adapter and for both presentations ensure that a vial adapter is attached to the vial containing reconstituted product.
Danish: Skru den tomme sprøjte af hætteglasadapteren, og uanset hvilken variant af produktet der bruges, skal der være sat en hætteglasadapter på hætteglasset indeholdende rekonstitueret produkt.
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Danish: Saltsyre (til pH-justering) Natriumhydroxid (til pH-justering)
English: - Venous thromboembolic events (deep vein thrombosis, thrombosis at i.v.
Danish: - Venøse tromboemboliske hændelser (dyb venetrombose, tromboser omkring i.v.
English: Patients with factor VII deficiency treated with NovoSeven should be monitored for factor VII antibodies (see section 4.4).
Danish: Patienter, med faktor VII mangel, der behandles med NovoSeven, skal monitoreres for faktor VII antistoffer (se pkt.
English: Do not use the reconstituted solution if you notice particles in it or if it is discoloured.
Danish: Brug ikke den opblandede opløsning, hvis du opdager, at den indeholder partikler eller hvis den er misfarvet.
English: Do not touch the rubber stopper after wiping it.
Danish: Rør ikke gummiproppen efter den er tørret af.
English: • If your arteries are narrowed by disease (atherosclerosis)
Danish: • Hvis dine pulsårer er forsnævrede på grund af sygdom (åreforkalkning)
English: Serious bleeding episodes
Danish: Alvorlige blødningsepisoder
English: Do not treat yourself for longer than 24 hours without consulting your doctor.
Danish: Din behandling hjemme må ikke overskride 24 timer uden konsultation hos en læge.
English: • Store powder and solvent protected from light.
Danish: • Pulver og solvens opbevares beskyttet mod lys.
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 syringe).
Danish: • Sørg for at stemplet er skubbet helt ind, før sprøjten vendes (stemplet kan være blevet presset lidt ud af trykket i sprøjten).