FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean volume of distribution at steady state was 196 ml/kg in paediatric patients versus 159 ml/kg in adults.
Danish: Den gennemsnitlige fordelingsvolumen ved steady state var 196 ml/kg hos pædiatriske patienter versus 159 ml/kg hos voksne.
English: Read all of this leaflet carefully before you are given this injection because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: You will also need an administration set (tubing and butterfly needle, sterile alcohol swabs, gauze pads and plasters).
Danish: Du behøver desuden et administrationssæt (slange og sommerfuglenål, sterile alkoholservietter, gazekompresser og plaster).
English: It is recommended to use NovoSeven immediately after reconstitution.
Danish: Det anbefales at bruge NovoSeven straks efter rekonstitution.
English: Mild to moderate bleeding episodes (including home therapy) Early intervention has been shown to be efficacious in the treatment of mild to moderate joint, muscle and mucocutaneous bleeds.
Danish: Milde til moderate blødningsepisoder (herunder ”hjemmebehandling”) Tidlig intervention har vist sig at være effektiv i behandlingen af milde til moderate blødninger i led, muskler og slimhinder.
English: • In case you only need part of the reconstituted solution, use the scale on the syringe to see how much of the solution you withdraw, as instructed by your doctor or nurse.
Danish: • I tilfælde af, at du kun har brug for en del af den opblandede injektionsvæske, skal du bruge skalaen på sprøjten, for at se hvor meget af injektionsvæsken du trækker op, sådan som din læge eller sygeplejerske har instrueret.
English: Dose limiting toxicities of NovoSeven have not been investigated in clinical trials.
Danish: Dosisbegrænsende toksicitet af NovoSeven er ikke undersøgt i kliniske studier.
English: The pharmacodynamic effect of factor VIIa gives rise to an increased local formation of factor Xa, thrombin and fibrin.
Danish: Den farmakodynamiske effekt af faktor VIIa resulterer i en øget lokal dannelse af faktor Xa, trombin og fibrin.
English: Experience with concomitant administration of anti-fibrinolytics and rFVIIa treatment is however limited.
Danish: Erfaringen med samtidig anvendelse af antifibrinolytika og rFVIIa er dog begrænset.
English: • Bring the vial and the pre-filled syringe to room temperature (not above 37°C).
Danish: • Hætteglasset og den fyldte sprøjte skal have stuetemperatur (ikke over 37°C).
English: • In case of a severe bleed you should contact your doctor.
Danish: • I tilfælde af alvorlig blødning skal du kontakte din læge.
English: • Draw approximately 5 ml of sterile air into the 50 ml syringe (polypropylene).
Danish: • Træk cirka 5 ml steril luft ind i 50 ml sprøjten (polypropylen).
English: Subjects were stratified according to sex and ethnic group and dosed with 40, 80 and 160 µg rFVIIa per kg body weight (3 doses each) and/or placebo.
Danish: Personerne blev stratificeret i henhold til køn og etnisk gruppe og doseret med 40, 80 og 160 µg rFVIIa per kg kropsvægt (3 doser hver) og/eller placebo.
English: Solvent for NovoSeven
Danish: Solvens til NovoSeven
English: Solvent: clear colourless solution.
Danish: Solvens: Klar, farveløs opløsning.
English: Locate a suitable site, and slowly inject NovoSeven into a vein over a period of 2 - 5 minutes without removing the needle from the injection site.
Danish: Find et passende sted, og injicér langsomt NovoSeven i en vene over en periode på 2-5 minutter uden at fjerne nålen fra injektionsstedet.
English: In case the factor VIIa activity fails to reach the expected level or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed.
Danish: I de tilfælde, hvor faktor VIIa aktiviteten ikke har nået det forventede niveau, eller hvor blødningen ikke er under kontrol, efter behandling med de anbefalede doser, bør dannelse af antistoffer mistænkes, og der skal analyseres herfor.
English: As the total number of treatment episodes in clinical trials is below 10,000, the lowest possible frequency of adverse drug reactions that can be assigned is rare (> 1/10,000 to < 1/1,000).
Danish: Da det totale antal behandlingsepisoder under kliniske studier er under 10.000, er den lavest mulige bivirkningsfrekvens, som kan tildeles, sjælden (≥ 1/10.000 til < 1/1.000).
English: - Therapeutic response decreased*
Danish: - Nedsat terapeutisk respons*
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 hos cynomolgusabe resulterede i en voldsom farmakologisk effekt (trombose og død) ved et lavere dosisniveau end efter administration af de enkelte stoffer.
English: Patients undergoing major surgery may be treated for up to 2 - 3 weeks until healing has occurred.
Danish: Patienter, der undergår større operationer, kan behandles i op til 2-3 uger, indtil heling er opnået.
English: • If you have just had surgery
Danish: • Hvis du netop har gennemgået en operation
English: A major bleeding episode may be treated for 2 - 3 weeks but can be extended beyond this if clinically warranted.
Danish: En større blødning kan behandles i 2-3 uger, men behandlingen kan forlænges herudover, såfremt det er klinisk ønskeligt.
English: • If you have a serious blood infection
Danish: • Hvis du har en alvorlig blodforgiftning
English: 1) Two to three injections of 90 µg per kg body weight administered at three-hour intervals.
Danish: 1) To eller tre injektioner på 90 µg pr. kg legemsvægt, der administreres med tre timers interval.
English: If not used immediately, storage time and storage conditions prior to use are the responsibility of the user, and should not be longer than 24 hours at 2°C - 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis produktet ikke anvendes straks, er opbevaringstid og opbevaringsbetingelser brugerens ansvar og bør ikke være mere end 24 timer ved 2°C - 8°C, medmindre rekonstitutionen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: - Nausea
Danish: - Kvalme
English: Store protected from light
Danish: Opbevares beskyttet mod lys
English: This incompatibility may prevent administration of the drug and/or result in damage to the needleless connector.
Danish: Dette kan forhindre indgivelse af lægemidlet og/eller resultere i at forbindelsen uden nål beskadiges.
English: There is no requirement for monitoring of NovoSeven therapy.
Danish: Der er ingen krav om monitorering ved behandling med NovoSeven.
English: Thromboembolic events - arterial and venous
Danish: Tromboemboliske hændelser - arterielle og venøse
English: Risk factors that may have contributed to antibody development including previous treatment with human plasma and/or plasma-derived factor VII, severe mutation of FVII gene, and overdose of NovoSeven, were present.
Danish: Risikofaktorer, der kan have bidraget til antistofdannelse, herunder tidligere behandling med human plasma og/eller plasma-afledt faktor VII, alvorlig mutation af FVII-genet og overdosis af NovoSeven, var til stede.
English: The dose will be worked out by your doctor, based on your body weight, condition and type of bleed.
Danish: Dosis fastsættes af lægen på baggrund af din legemsvægt, tilstand og blødningstype.
English: When NovoSeven is administered to patients outside approved indications, arterial thromboembolic events are common (≥ 1/100 to < 1/10).
Danish: Når NovoSeven administreres til patienter uden for godkendte indikationer, er arterielle tromboemboliske hændelser almindelige (≥ 1/100 til <1/10).
English: Before injection (administration) it must be reconstituted with the solvent supplied in the syringe.
Danish: Før injektion (administration) skal det blandes (rekonstitueres) med solvens, der leveres i en sprøjte.
English: NovoSeven was used in 157 surgical procedures, at a median dose of 92 µg/kg (up to 270 µg/kg).
Danish: NovoSeven blev anvendt ved 157 kirurgiske indgreb, med en mediandosis på 92 μg/kg (op til 270 μg/kg).
English: - Related laboratory findings, including elevated levels of Ddimmer and decreased levels of AT (see section
Danish: - Relaterede laboratoriefund, herunder forhøjede niveauer af D-dimerer og nedsatte niveauer af AT (antitrombin) (se pkt.
English: Pharmacological doses of NovoSeven activate factor X directly on the surface of activated platelets, localized to the site of injury, independently of tissue factor.
Danish: Farmakologiske doser af NovoSeven aktiverer faktor X direkte på overfladen af aktiverede blodplader på selve læsionsstedet uafhængigt af vævsfaktor.
English: These devices are not included in the NovoSeven package.
Danish: Dette udstyr er ikke inkluderet i pakningen med NovoSeven.
English: Make sure not to aim the stream of solvent directly at the NovoSeven powder as this will cause foaming.
Danish: Pas på, at solvensen ikke sprøjtes direkte ned i NovoSeven pulveret, da dette vil forårsage skumdannelse.
English: • Use a clean and germ free (aseptic) technique.
Danish: • Anvend en ren og bakteriefri (aseptisk) fremgangsmetode.
English: Inhibitory antibody formation
Danish: Dannelse af inhibitoriske antistoffer
English: Factor VII deficient patients should be monitored for prothrombin time and factor VII coagulant activity before and after administration of NovoSeven.
Danish: Patienter med faktor VII mangel skal monitoreres for protrombin-tid og faktor VII koagulationsaktivitet før og efter administration af NovoSeven.
English: • in patients with congenital FVII deficiency
Danish: • patienter med medfødt FVII-mangel
English: You should talk to your doctor before using NovoSeven if you also use Factor VIII or IX products.
Danish: Fortæl det altid til lægen, inden du bruger NovoSeven, hvis du også bruger factor VIII eller IX produkter.
English: • The syringe with adequately reconstituted product is now ready for administration in a CEmarked infusion pump (accepting a 50 ml syringe).
Danish: • Sprøjten med tilstrækkeligt rekonstitueret produkt er nu klar til administration i en CE-mærket infusionspumpe (som passer til en 50 ml sprøjte).
English: Table 1 Adverse reactions from clinical trials and spontaneous (post-marketing) reports
Danish: Tabel 1 Bivirkninger fra kliniske forsøg og spontane (post-marketing) rapporter
English: Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Danish: Injektion af opløsningen gennem et udstyr til central venøs adgang (CVAD), såsom et centralt venøst kateter eller en permanent port:
English: There is limited experience of using NovoSeven together with medicines called antifibrinolytic drugs (such as aminocaproic acid or tranexamic acid) which are also used to control bleeding.
Danish: Der er kun begrænset erfaring med samtidig brug af NovoSeven og antifibrinolytisk medicin (såsom aminocapronsyre eller tranexamsyre), som også bruges til at kontrollere blødninger.
English: In major surgery, the dose should be continued at 2 - 4 hour intervals for 6 - 7 days.
Danish: Ved større operationer skal doseringen fortsætte med 2-4 timers interval i 6-7 dage.
English: It is important that the dosage regimen of NovoSevenis compliant with the recommended dosage as stated in section 4.2.
Danish: Det er vigtigt, at dosisregimet med NovoSeven er i overensstemmelse med anbefalingerne omkring dosering i pkt.
English: There is no clinical experience with administration of a single dose of 270 µg per kg body weight in elderly patients.
Danish: Der er ingen klinisk erfaring med administration af enkeltdosis på 270 µg pr. kg. legemsvægt hos ældre patienter.
English: - Injection site reaction including injection site pain
Danish: - Reaktion på injektionsstedet, herunder smerte på injektionsstedet
English: • Do not throw it out with the ordinary household waste.
Danish: • Smid ikke ud med husholdingsaffaldet.
English: Limited clinical experience in long term prophylaxis has been gathered in the paediatric population below 12 years of age, with a severe clinical phenotype (see section 5.1).
Danish: Begrænset klinisk erfaring med langtidsvarende profylakse er blevet indsamlet hos den pædiatriske population under 12 år, der har en alvorlig klinisk fænotype (se pkt.
English: Plunger rod: made of polypropylene.
Danish: Stempelstang: lavet af polypropylen.
English: An initial dose of 90 µg per kg body weight should be given immediately before the intervention.
Danish: Den første dosis på 90 µg pr. kg legemsvægt skal gives umiddelbart før operationen.
English: If further treatment is required, one additional dose of 90 µg per kg body weight can be administered.
Danish: Hvis yderligere behandling er påkrævet, kan der gives en ekstra dosis på 90 µg pr. kg legemsvægt.
English: Dose proportionality was established in children for the investigated doses of 90 and 180 µg per kg body weight, which is in accordance with previous findings at lower doses (17.5 - 70 µg/kg rFVIIa).
Danish: Der blev fundet dosisproportionalitet hos børn for de undersøgte doser på 90 og 180 µg/kg kropsvægt, hvilket er i overensstemmelse med tidligere resultater ved lavere doser (17,5-70 µg/kg rFVIIa).
English: Store below 25°C Do not freeze Store protected from light
Danish: Opbevares under 25 °C Må ikke fryses Opbevares beskyttet mod lys
English: ► If any of these conditions apply to you, talk to your doctor before using the injection.
Danish: ► Hvis nogle af disse tilstande gør sig gældende, kontakt din læge, før du tager en injektion.
English: The initial dose interval should be 2 - 3 hours.
Danish: Det initiale dosisinterval bør være 2-3 timer.
English: - Rash (including allergic dermatitis and rash erythematous)
Danish: - Udslæt (herunder allergisk dermatitis og erytematøs udslæt)
English: If not used immediately, the conditions prior to use are the responsibility of the user and the in-use storage time must not be longer than as stated above.
Danish: Hvis produktet ikke anvendes straks, er betingelserne før anvendelse brugerens ansvar og opbevaringstiden under brug må ikke overskride, det der er angivet ovenfor.
English: The pharmacokinetics were similar across sex and ethnic groups.
Danish: Farmakokinetikken var uafhængig af køn og etnicitet.
English: In pathological conditions in which tissue factor may be expressed more extensively than considered normal, there may be a potential risk of development of thrombotic events or induction of Disseminated Intravascular Coagulation (DIC) in association with NovoSeven treatment.
Danish: I patologiske tilstande, hvor vævsfaktorer kan forventes at forekomme i højere grad end normalt, kan der være potentiel risiko for udvikling af tromboseepisoder eller induktion af dissemineret intravaskulær koagulation (DIC) i forbindelse med behandling med NovoSeven.
English: NovoSeven contains activated recombinant coagulation factor VII.
Danish: NovoSeven indeholder aktiveret rekombinant koagulationsfaktor VII.
English: As recombinant coagulation factor VIIa NovoSeven may contain trace amounts of mouse IgG, bovine IgG and other residual culture proteins (hamster and bovine serum proteins), the remote possibility exists that patients treated with the product may develop hypersensitivity to these proteins.
Danish: Da rekombinant koagulationsfaktor VIIa NovoSeven kan indeholde spormængder af muse-IgG, okse-IgG og andre restproteiner fra kulturen (hamster- og okseserumproteiner), er der en teoretisk risiko for, at patienter, som behandles med produktet, kan udvikle overfølsomhed over for disse proteiner.
English: Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia or DIC.
Danish: Sådanne tilstande kan omfatte patienter med fremskreden arteriosklerose, knusningstraumer, sepsis eller DIC.
English: Eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Daltons produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology.
Danish: Eptacog alfa (aktiveret) er rekombinant koagulationsfaktor VIIa (rFVIIa) med en molekylmasse på ca. 50.000 dalton, produceret i babyhamster-nyreceller (BHK-celler) ved rekombinant DNA-teknologi.
English: • The active substance is recombinant coagulation factor VIIa (activated eptacog alfa).
Danish: • Aktivt stof: rekombinant koagulationsfaktor VIIa (aktiveret eptacog alfa).
English: NovoSeven is used to treat bleeding, and to prevent excessive bleeding after surgery or other important treatments.
Danish: NovoSeven anvendes til behandling af blødninger og til forebyggelse af kraftig blødning efter kirurgi eller andre vigtige behandlinger.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders.
Danish: Påbegyndelse af behandling skal overvåges af en læge, som har erfaring med behandling af hæmofili og/eller blødersygdomme.
English: Haemophilia A and B with inhibitors
Danish: Hæmofili A og B med inhibitorer
English: In post-marketing experience, there have been no reports of inhibitory antibodies against NovoSeven or FVII in patients with haemophilia A or B. Development of inhibitory antibodies to NovoSeven has been reported in a post-marketing observational registry of patients with congenital FVII deficiency.
Danish: Der foreligger ingen post-marketing-rapporter om inhibitoriske antistoffer mod NovoSeven eller FVII hos patienter med hæmofili A eller B. Udvikling af inhiberende antistoffer mod NovoSeven er blevet rapporteret i et observationelt post-marketing-register med patienter med kongenital FVII-mangel.
English: • If you have Glanzmann's thrombasthenia (a bleeding disorder) and your condition cannot be treated effectively with platelet transfusion, or if platelets are not readily available.
Danish: • Hvis du har Glanzmanns trombasteni (en blødersygdom), og din tilstand ikke kan behandles med blodpladetransfusion, eller hvis blodpladerne ikke er tilgængelige.
English: The recommended route of administration is bolus injection as lack of efficacy may appear in connection with continuous infusion.
Danish: Det anbefales at give en bolus injektion, da der kan forekomme manglende effekt i forbindelse med kontinuerlig infusion.
English: NovoSeven must not be mixed with infusion solutions or be given in a drip.
Danish: NovoSeven må ikke blandes med infusionsvæsker eller gives i drop.
English: Early treatment with NovoSeven reduces how much you bleed and for how long.
Danish: Tidlig behandling med NovoSeven reducerer mængden og varigheden af blødningen.
English: Because of the risk of thromboembolic complications, caution should be exercised when administering NovoSeven to patients with a history of coronary heart disease, to patients with liver disease, to patients post-operatively, to neonates, or to patients at risk of thromboembolic phenomena or disseminated intravascular coagulation.
Danish: På grund af risikoen for tromboemboliske komplikationer, skal der udvises forsigtighed når NovoSeven administreres til patienter med hjertesygdomme, til patienter med leversygdom, til postoperative patienter, til nyfødte eller til patienter med risiko for tromboemboliske fænomener eller udbredt intravaskulær koagulation.
English: If you cannot use it at once, see section 5 How to store NovoSeven on the other side of this leaflet.
Danish: Hvis du ikke kan bruge det straks, se punkt 5 Opbevaring på den anden side af indlægssedlen.
English: Glanzmann's thrombasthenia
Danish: Glanzmanns trombasteni
English: Use the reconstituted NovoSeven at once to avoid infections.
Danish: Brug det opblandede NovoSeven straks for at undgå infektioner.
English: Clinical trials conducted in 61 patients with acquired haemophilia with a total of 100 treatment episodes, showed that certain adverse drug reactions were reported more frequently (1% based on treatment episodes): Arterial thromboembolic events (cerebral artery occlusion, cerebrovascular accident), venous thromboembolic events (pulmonary embolism and deep vein thrombosis), angina pectoris, nausea, pyrexia, erythematous rash and investigation of increased levels of fibrin degradation products.
Danish: Kliniske studier udført hos 61 patienter med erhvervet hæmofili med i alt 100 behandlingsepisoder viste, at visse bivirkninger blev indberettet hyppigere (1 % baseret på behandlingsepisoder): Arterielle tromboemboliske hændelser (okklusion af cerebralarterie, cerebrovaskulært tilfælde), venøse tromboemboliske hændelser (lungeemboli, dyb venetrombose), angina pectoris, kvalme, pyreksi, erytematøst udslæt og undersøgelse for forhøjet niveau af fibrin-nedbrydningsprodukt.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Anti-fibrinolytics have been reported to reduce blood loss in association with surgery in haemophilia patients, especially in orthopaedic surgery and surgery in regions rich in fibrinolytic activity, such as the oral cavity.
Danish: Det er rapporteret, at antifibrinolytika reducerer blodtab i forbindelse med kirurgi hos hæmofilipatienter, specielt ved ortopædisk kirurgi og ved kirurgi i områder med stor fibrinolytisk aktivitet, såsom i mundhulen.
English: If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Danish: Hvis din dosis kræver mere end et hætteglas, gentages trinene A til J med yderligere hætteglas, fyldte sprøjter og hætteglasadaptere, indtil du når den nødvendige dosis.
English: Mean clearance was approximately 50% higher in paediatric patients relative to adults (78 versus 53 ml/h×kg), whereas the mean terminal half-life was determined to 2.3 hours in both groups.
Danish: Den gennemsnitlige clearance var cirka 50% højere i pædiatriske patienter i forhold til voksne (78 versus 53 ml/time x kg), hvorimod den gennemsnitlige terminalhalveringstid var 2,3 timer i begge grupper.
English: • Grasp the plunger rod by the wide top-end and take it out of the carton.
Danish: • Tag fat i stempelstangen ved den brede ende, og tag den ud af kartonen.
English: Dose and frequency of injections should be adapted to each individual.
Danish: Injektionsdosis og doseringsfrekvens skal tilpasses den enkelte patient.
English: - Pyrexia
Danish: - Pyreksi
English: The expiry date is printed after ‘EXP' on the outer carton, on the vial, on the vial adapter and on the pre-filled syringe.
Danish: Udløbsdatoen står på etiketten efter 'EXP' på den ydre karton, på hætteglasset, på hætteglasadapteren og på den fyldte sprøjte.
English: 2) One single injection of 270 µg per kg body weight.
Danish: 2) En enkelt injektion på 270 µg pr. kg legemsvægt.
English: The first dose should be given as early as possible after bleeding has started.
Danish: Den første dosis skal gives så hurtigt som muligt efter, blødningen er opstået.
English: • If you have acquired haemophilia
Danish: • Hvis du har erhvervet hæmofili
English: NovoSeven reconstituted product is a clear, colourless solution.
Danish: Rekonstitueret NovoSeven er en klar, farveløs opløsning.
English: • Do not use any other way to warm the vial and pre-filled syringe.
Danish: • Der må ikke benyttes andre metoder til at varme hætteglasset og den fyldte sprøjte.
English: Patients/carers should inform the physician/supervising hospital at the earliest possible opportunity about all usages of NovoSeven.
Danish: Patienter/behandlere bør hurtigst muligt rapportere enhver brug af NovoSeven til lægen/det behandlende hospital.
English: The dose interval may then be increased to 6 - 8 hours for another 2 weeks of treatment.
Danish: Doseringsintervallet kan herefter øges til 6-8 timer i yderligere 2 uger.