FrancophonIA/ELRC3.0 huggingface dataset:
English: The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the treatment of patients with haemophilia A. Your doctor may wish to carry out tests to monitor inhibitor development.
Danish: Dannelse af neutraliserende antistoffer over for faktor VIII (inhibitorer) er en kendt komplikation i behandlingen af patienter med hæmofili A. Din læge vil måske foretage undersøgelser for at overvåge udviklingen af inhibitorer.
English: Antibodies (Inhibitors)
Danish: Antistoffer (inhibitorer)
English: Degree of haemorrhage/ Type of surgical procedure
Danish: Blødningsgrad/ Type af kirurgi
English: • You must filter the reconstituted product before administration to remove potential particulate matter in the solution.
Danish: • Du skal filtrere det rekonstituerede præparat før administration for at fjerne eventuelle partikler i opløsningen.
English: Under certain circumstances larger amounts than those calculated may be required, especially for the initial dose.
Danish: Under visse omstændigheder kan det være nødvendigt at indgive større doser end de beregnede, især hvad angår initialdosis.
English: Frequencies have been evaluated according to the following convention: very common: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000),
English: In one observational study, the incidence of inhibitor development in previously untreated patients with severe haemophilia A was 64/183 (37.7%) with Helixate NexGen (followed up to 75 exposure days).
Danish: I et observationsstudie var forekomsten af inhibitorudvikling hos tidligere ubehandlede patienter med svær hæmofili A 64/183 (37,7%) med Helixate NexGen (fulgt op til 75 eksponeringsdage).
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
Danish: 1 International Enhed (IE) af faktor VIII-aktivitet svarer til indholdet af faktor VIII i 1 ml normal human plasma.
English: METHOD OF ADMINISTRATION For reconstitution of Helixate NexGen, see package leaflet.
Danish: ADMINISTRATIONSMETODE Til rekonstitution af Helixate NexGen, se indlægssedlen.
English: Helixate NexGen has no influence on the ability to drive or to use machines.
Danish: Helixate NexGen påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Infusion rate (in IU/kg/h) = Clearance (in ml/h/kg) × desired factor VIII level (in IU/ml)
Danish: Indgiftshastigheden (i IE/kg/time) = Clearance (i ml/time/kg) × ønsket faktor VIII-niveau (i IE/ml).
English: In clinical studies, Helixate NexGen has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated paediatric patients (MTPs, defined as having ≤4 exposure days) with residual FVIII:C < 2 IU/dl.
Danish: I kliniske studier har Helixate NexGen været anvendt til behandling af blødningstilfælde hos 37 tidligere ubehandlede patienter (TUP) og 23 minimalt behandlede pædiatriske patienter (MBP, defineret som patienter med 4 eksponeringsdage eller mindre) med residual-FVIII:C < 2 IE/dl.
English: The speed of administration should be based on the patient's comfort, but should not be faster than 2ml/min maximum rate of infusion.
Danish: Infusionshastigheden bør afstemmes efter patientens velbefindende, men må ikke være hurtigere end maksimalt 2 ml/min.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Danish: Dannelsen af neutraliserende antistoffer (inhibitorer) mod faktor VIII er en kendt komplikation i behandlingen af patienter med hæmofili A. Disse inhibitorer er sædvanligvis IgG-immunoglobuliner rettet mod faktor VIIIs prokoagulante aktivitet, som kvantificeres i modificerede Bethesda Enheder (BE) pr. ml plasma ved brug af den modificerede test.
English: Infusion rate for 75 kg patient ml/h
Danish: Indgiftshastighed i ml/time for patient på 75 kg
English: Inject the solution intravenously over several minutes, keeping an eye on the position of the needle.
Danish: Injicér opløsningen intravenøst i løbet af nogle minutter, idet der holdes øje med kanylens position.
English: MedDRA Standard System Organ Class
Danish: MedDRA standard
English: Helixate NexGen is used for treatment and prophylaxis of bleeding adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Danish: Helixate NexGen anvendes til behandling og profylakse af blødning hos voksne, unge og børn i alle aldre med blødersygdommen hæmofili A (medfødt faktor VIII-mangel).
English: Expected factor VIII rise (% of normal) = 2 × administered IU body weight (kg)
Danish: Forventet faktor VIII-stigning (% af normal) = 2 × indgivet IE legemsvægt (kg)
English: It is strongly recommended that every time that Helixate NexGen is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Danish: Det anbefales på det kraftigste at registrere navn og batch-nr. på produktet, hver gang Helixate NexGen administreres til patienten, så der opretholdes en forbindelse mellem patienten og den pågældende batch af lægemidlet.
English: It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that Helixate NexGen can be used for continuous infusion in surgeries (pre-, during and postoperative).
Danish: Et klinisk studie med voksne hæmofili A-patienter, som gennemgik et større kirurgisk indgreb, har vist, at Helixate NexGen kan administreres som kontinuerlig infusion ved kirurgi (præ-, per- og postoperativt).
English: This medicine should be injected intravenously over several minutes.
Danish: Dette lægemiddel skal indsprøjtes i en blodåre (vene) over adskillige minutter.
English: Therefore, Helixate NexGen should be used during pregnancy and breast-feeding only if clearly indicated.
Danish: Helixate NexGen bør derfor kun anvendes under graviditet og amning på tvingende indikation.
English: In extensive post-registration observational studies with Helixate NexGen, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors.
Danish: Der blev observeret følgende i store observationsstudier med mere end 1000 patienter efter registreringen af Helixate NexGen: Mindre end 0,2% af TBP-patienterne udviklede de-noveinhibitorer.
English: You may have developed factor VIII inhibitors and your doctor may carry out tests to confirm this.
Danish: Du kan have dannet antistoffer mod faktor VIII (faktor VIII-inhibitorer), og din læge ønsker måske at foretage undersøgelser, der kan bekræfte dette.
English: • formation of neutralising antibodies to factor VIII (inhibitors) in previously untreated patients
Danish: • dannelse af neutraliserende antistoffer mod faktor VIII (inhibitorer) hos tidligere ubehandlede patienter
English: In clinical studies with 73 previously treated patients (PTP, defined as having ≥100 exposure days), followed over 4 years, no de-novo inhibitors were observed.
Danish: I kliniske studier med 73 tidligere behandlede patienter (TBP, defineret som patienter med mere end 100 eksponeringsdage), der blev fulgt over 4 år, observerede man ingen de novo-inhibitorer.
English: • formation of neutralising antibodies to factor VIII (inhibitors) in previously treated patients
Danish: • dannelse af neutraliserende antistoffer mod faktor VIII (inhibitorer) hos tidligere behandlede patienter
English: The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 ml/min).
Danish: Indgiftshastigheden bør afgøres af patientens velbefindende (maksimal infusionshastighed 2 ml/min).
English: • If for the administration of Helixate NexGen you will require a central venous access device (CVAD), the risk of CVAD-related complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
Danish: • Hvis det er nødvendigt at anlægge centralt venekateter (CVK) til administration af Helixate NexGen, skal lægen tage hensyn til risikoen for CVK-relaterede komplikationer, herunder infektioner ved kateterstedet, bakterier i blodet (bakteriæmi) og dannelse af en blodprop (trombose) i det blodkar, hvor kateteret indsættes.
English: • If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.
Danish: • Hvis du tidligere har dannet antistoffer mod faktor VIII, og du skifter til et andet faktor VIIIpræparat, kan du risikere, at du igen danner antistoffer mod faktor VIII.
English: Do not use Helixate NexGen if you notice visible particulate matter or turbidity.
Danish: Anvend ikke Helixate NexGen, hvis der er synlige partikler eller uklarheder.
English: 16 Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution.
Danish: Lad blod flyde tilbage til den åbne ende af venepunkturslangen, og fastgør dernæst sprøjten med opløsningen.
English: Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.
Danish: I visse tilfælde kan det være nødvendigt at indgive større doser end de beregnede, især når det gælder den første dosis.
English: For calculation of ml/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/ml).
Danish: Til beregning af ml/time multipliceres indgiftshastigheden i IE/time/kg med kg legemsvægt/opløsningskoncentration (IE/ml).
English: Inhibitor development in previously untreated and treated patients (PUPs / PTPs) has been reported (see section 4.4).
Danish: Der er blevet rapporteret inhibitorudvikling hos tidligere ubehandlede og behandlede patienter (TUP'er / TBP'er) (se pkt.
English: Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe.
Danish: Når al opløsning er overført til sprøjten, hold da godt fast i sprøjtecylinderen (mens stemplet vender nedad) og afmonter den transparente Mix2Vial-adapter fra sprøjten.
English: If no further dose is required, remove the venipuncture set and syringe.
Danish: Hvis yderligere dosis ikke er nødvendig, fjernes venepunkturslangen og sprøjte.
English: After reconstitution, the solution is drawn through the Mix2Vial filter transfer device into the sterile disposable syringe (both supplied).
Danish: Efter opløsning trækkes opløsningen gennem det sterile Mix2Vial-filtersystem ind i den sterile engangssprøjte (begge medfølger).
English: Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII.
Danish: Patienter med hæmofili A kan udvikle neutraliserende antistoffer (inhibitorer) mod faktor VIII.
English: Systemic Hypersensitivit y reactions (including anaphylactic reaction, nausea, blood pressure abnormal and, dizziness)
Danish: Systemiske overfølsomhedsreaktioner (herunder anafylaktisk reaktion, kvalme, unormalt blodtryk og svimmelhed)
English: • one vial with solvent (6 ml clear glass type 1 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal)
Danish: • Et hætteglas med solvens (6 ml hætteglas i klart glas type 1 med latex-fri grå klorbutylgummiprop og aluminiumsforsegling)
English: Experience regarding fertility or the use of Helixate NexGen during pregnancy and breast-feeding is not available.
Danish: Der ingen erfaring angående påvirkning af frugtbarheden eller med brug af Helixate NexGen under graviditet og amning.
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Danish: Behandling af sådanne patienter bør ledes af læger med erfaring i behandling af hæmofili og faktor VIII-inhibitorer.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om Helixate NexGen findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Filtering is achieved by using the Mix2Vial adapter.
Danish: Filtreringen finder sted ved at anvende Mix2vial-forbindelsesstykket.
English: This preparation does not contain von Willebrand factor and is therefore not to be used in von Willebrand's disease.
Danish: Helixate NexGen indeholder ikke von Willebrand-faktor og må derfor ikke anvendes ved von Willebrands sygdom.
English: Rare: may affect up to 1 in 1,000 users
Danish: Sjælden: Kan forekomme hos op til 1 ud af 1.000 brugere:
English: • one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)
Danish: • Et hætteglas med pulver (10 ml hætteglas i klart glas (type 1) med latex-fri grå halogenbutylgummiprop og aluminiumsforsegling)
English: Usually, the substitution therapy with Helixate NexGen is a life-time treatment.
Danish: Behandling med Helixate NexGen som erstatning for faktor VIII-mangel, er normalt en livsvarig behandling.
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Danish: Bortskaf vandhætteglasset med den monterede blå Mix2Vial-adapter.
English: General Disorders and Administratio n Site
Danish: Almene symptomer og reaktioner på administrationssted et
English: Determine the point of injection and prepare antiseptically.
Danish: Bestem indstikssted og rengør dette med en antiseptisk swab.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om Helixate NexGen på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with Helixate NexGen.
Danish: Hvis inhibitoren er til stede med niveauer på mindre end 10 Bethesda Enheder (BE) pr. ml, kan indgift af yderligere rekombinant koagulationsfaktor VIII muligvis neutralisere inhibitoren og tillade fortsat klinisk effektiv behandling med Helixate NexGen.Hvis der er en inhibitor til stede, varierer den nødvendige dosis imidlertid, og dosis må justeres i forhold til den kliniske respons og overvågningen af aktiviteten i faktor VIII i plasma.
English: Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved.
Danish: Roter forsigtigt pulverhætteglasset med detn monterede transparente adapter, indtil pulveret er helt opløst.
English: Solvent Water for injections, sterilised.
Danish: Solvens: Vand til injektionsvæske, sterilt.
English: Factor VIII inhibitors are antibodies in the blood which block the factor VIII you are using, and makes it less effective to prevent and control bleeding.
Danish: Faktor VIII-inhibitorer er antistoffer i blodet, som blokerer det faktor VIII, som du tager.
English: 1 vial with 2.5 ml water for injections.
Danish: 1 hætteglas med 2,5 ml vand til injektionsvæsker.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer Pharma AG 13342 Berlin Germany
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Bayer Pharma AG 13342 Berlin Tyskland
English: 1 vial with 5.0 ml water for injections.
Danish: 1 hætteglas med 5,0 ml vand til injektionsvæsker.
English: Concentrations of rFVIII solution 100 IU/ml 200 IU/ml 400 IU/ml
Danish: Clearance: 3 ml/time/kg rFVIII-opløsningskoncentrationer 100 IE/ml 200 IE/ml 400 IE/ml
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteket hvis der er noget, du er i tvivl om.
English: Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
Danish: Tag blisterpakningen med Mix2Vial-sættet og skub spidsen på den blå adapterdel lige ned gennem vandhætteglassets prop.
English: • If your bleeding is not being controlled with your usual dose of this medicine, consult your doctor immediately.
Danish: • Kontakt straks din læge, hvis din blødning ikke kan kontrolleres med din sædvanlige dosis af dette lægemiddel.
English: Inhibitor Formation to FVIII (reported in PUPs and MTPs)*
Danish: Dannelse af faktor FVIIIinhibitorer (set hos TUP'er og MBP'er )*
English: Inhibitor development
Danish: Inhibitorudvikling
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Danish: Tag forsigtigt blisterpakningen væk fra Mix2Vial-sættet ved at holde i kanten og trække lodret opad.
English: Hold a swab firmly over the injection site on the outstretched arm for approx. 2 minutes.
Danish: Hold en swab fast imod indstiksstedet i ca. 2 minutter, med patientens arm strakt ud.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for the presence of factor VIII inhibitor should be performed.
Danish: Hvis de forventede plasmaniveauer af faktor VIII ikke opnås, eller hvis blødningen ikke kan kontrolleres med en passende dosis, bør der testes for tilstedeværelse af faktor VIII-inhibitor.
English: He/she should always adjust the amount of this medicine to be administered and the frequency of administration according to your individual needs.
Danish: Din læge vil altid tilpasse den mængde af dette lægemiddel, som du skal have, og hvor hyppigt du skal have det, til dine behov.
English: NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Vand til injektionsvæsker
English: Ensure product and solvent vial flip caps are removed and the stoppers are treated with an aseptic solution and allowed to dry prior to opening the Mix2Vial package.
Danish: Tør propperne af med en aseptisk opløsning, og lad dem tørre, før Mix2Vial-pakningen åbnes.
English: MARKETING AUTHORISATION HOLDER Bayer Pharma AG 13342 Berlin Germany
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Bayer Pharma AG 13342 Berlin Tyskland
English: • If you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).
Danish: • Hvis du er allergisk over for octocog alfa eller et af de øvrige indholdsstoffer i Helixate NexGen
English: Helixate NexGen powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Danish: Helixate NexGen-pulver må kun opløses i den medfølgende solvens (2,5 ml vand til injektionsvæske) ved brug af det medfølgende sterile Mix2Vial-filtersystem til overførsel af lægemidlet.
English: If the expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present.
Danish: Hvis de forventede faktor VIIIaktivitetsniveauer i plasma ikke opnås, eller hvis blødning ikke kan kontrolleres med en passende dosis, bør der udføres en analyse for at fastslå, om en faktor VIII-inhibitor er til stede.
English: Helixate NexGen powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Danish: Helixate NexGen-pulver må kun opløses i den medfølgende solvens (5,0 ml vand til injektionsvæske) ved brug af det medfølgende sterile Mix2Vial-filtersystem til overførsel af lægemidlet.
English: Inject air into the product vial.
Danish: Sprøjt luft ind i pulverhætteglasset.
English: Use only the medical devices for reconstitution and administration that are provided with each package of this medicine.
Danish: Brug kun det injektionssæt, der følger med hver pakke af dette lægemiddel til opløsning og indsprøjtning.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH 5.0 ML WATER FOR INJECTIONS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS MED 5,0 ML VAND TIL INJEKTIONSVÆSKER
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH 2.5 ML WATER FOR INJECTIONS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS MED 2,5 ML VAND TIL INJEKTIONSVÆSKER
English: The solvent will automatically flow into the product vial.
Danish: Vandet flyder automatisk ned i pulverhætteglasset.
English: Common: may affect up to 1 in 10 users:
Danish: Kan forekomme hos op til 1 ud af 10 brugere:
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial with powder for solution for injection.
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 1 hætteglas med pulver til injektionsvæske, opløsning.
English: It is recommended that every time that you use Helixate NexGen, the name and batch number of the product are documented.
Danish: Det anbefales at dokumentere navn og batchnummer for produktet, hver gang du bruger Helixate NexGen.
English: Do not shake.
Danish: Ryst ikke glasset.
English: Additional pharmacokinetic parameters for Helixate NexGen for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/h.Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/h corresponding to 3.0 ml/h/kg (range 1.6-4.6 ml/h/kg).
Danish: Yderligere farmakokinetiske parametre for Helixate NexGen til bolusindgift er: en mean residence time [MRT (0 - 48)] på omkring 22 timer og en clerance på omkring 160 ml/time.
English: Open the Mix2Vial package by peeling away the lid. Do not remove the Mix2Vial from the blister package!
Danish: Fjern ikke Mix2Vial fra blisterpakningen!
English: While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting.
Danish: Hold pulverhætteglasset lodret og skru sprøjten på Mix2Vial-sættet Luer-lås.
English: Place the solvent vial on an even, clean surface and hold the vial tight.
Danish: Placer vandhætteglasset på et plant og rent underlag, og hold det fast.
English: With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully into two pieces.
Danish: Tag med den ene hånd fat i den del af Mix2Vial-sættet, hvor pulverhætteglasset sidder, og tag med den anden hånd fat i den del, hvor vandhætteglasset sidder, og skru forsigtigt sættet fra hinanden.
English: What Helixate NexGen 250 IU contains
Danish: Helixate NexGen 250 IE indeholder
English: Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper.
Danish: Vend vandhætteglasset med det monterede Mix2Vial-sæt, og tryk spidsen på den gennemsigtige adapter del lige ned gennem proppen på pulverhætteglasset.
English: • You must use aseptic conditions (meaning clean and germ free) during reconstitution and administration.
Danish: • Opløsning og indsprøjtning skal foretages under sterile (rene og kimfrie) forhold.
English: What Helixate NexGen 2000 IU contains
Danish: Helixate NexGen 2000 IE indeholder
English: Puncture the vein and secure the venipuncture set with a plaster.
Danish: Stik kanylen ind i venen, og fastgør venepunkturslangen med plaster.
English: Do not use Helixate NexGen 250 IU
Danish: Brug ikke Helixate NexGen 250 IE
English: If you forget to use Helixate NexGen 250 IU
Danish: Hvis du har glemt at bruge Helixate NexGen 250 IE
English: Do not use Helixate NexGen 2000 IU
Danish: Brug ikke Helixate NexGen 2000 IE