FrancophonIA/ELRC3.0 huggingface dataset:
English: ADVATE 500 IU powder and solvent for solution for injection ADVATE 1000 IU powder and solvent for solution for injection ADVATE 1500 IU powder and solvent for solution for injection ADVATE 2000 IU powder and solvent for solution for injection ADVATE 3000 IU powder and solvent for solution for injection
Danish: ADVATE 500 IE pulver og solvens til injektionsvæske, opløsning ADVATE 1000 IE pulver og solvens til injektionsvæske, opløsning ADVATE 1500 IE pulver og solvens til injektionsvæske, opløsning ADVATE 2000 IE pulver og solvens til injektionsvæske, opløsning ADVATE 3000 IE pulver og solvens til injektionsvæske, opløsning
English: For ADVATE reconstituted with 2 ml sterilised water for injections, misapplication (intra-arterially or paravenously) may lead to mild, short term injection site reactions, such as bruising and erythema.
Danish: Ved forkert (intraarteriel eller paravenøs) indgivelse af ADVATE rekonstitueret i 2 ml sterilt vand kan der opstå milde, kortvarige reaktioner på injektionsstedet, f.eks. udslæt og erytem.
English: Adolescents (n=33)
Danish: Unge (n=33)
English: The end of the 6 months storage at room temperature should be recorded on the product carton.
Danish: SlutdDatoen for 6 månedersperioden med opbevaring ved stuetemperatur skal noteres på produktets karton.
English: Repeat injections every 8 to 24 hours (6 to 12 hours for patients under the age of 6) until threat is resolved.
Danish: Gentag injektionen hver 8. til 24. time (6. til 12. time for patienter under 6 år), indtil faren er drevet over.
English: Do not throw away any medicines via waste water or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Solvent vial: 2 ml sterilised water for injections
Danish: Hætteglas med solvens: 2 ml sterilt vand til injektionsvæsker
English: What ADVATE looks like and contents of the pack ADVATE is a white to off-white friable powder.
Danish: ADVATE er et hvidt til off-white sprødt pulver.
English: ADVATE in BAXJECT III system: Keep the sealed blister in the outer carton in order to protect from light.
Danish: ADVATE i BAXJECT III-system: Opbevar hætteglasset med lægemidlet i den ydre karton for at beskytte mod lys.
English: Solvent vial: 5 ml sterilised water for injections
Danish: Hætteglas med solvens: 5 ml sterilt vand til injektionsvæsker
English: In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly.
Danish: Hos patienter med hæmofili A (en kønsbunden, arvelig blødersygdom) mangler dette stof, eller det virker ikke ordentligt.
English: ADVATE 250 IU powder and solvent for solution for injection ADVATE 500 IU powder and solvent for solution for injection ADVATE 1000 IU powder and solvent for solution for injection ADVATE 1500 IU powder and solvent for solution for injection
Danish: ADVATE 250 IE pulver og solvens til injektionsvæske, opløsning ADVATE 500 IE pulver og solvens til injektionsvæske, opløsning ADVATE 1000 IE pulver og solvens til injektionsvæske, opløsning ADVATE 1500 IE pulver og solvens til injektionsvæske, opløsning
English: Older Children (n=18)
Danish: Større børn (n=18)
English: Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for at least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved.
Danish: Gentag injektionen hver 12. til 24. time (8. til 24. time for patienter under 6 år) mindst 1 dag, indtil blødningsepisoden, kendetegnet ved smerter, er gået i ro eller opheling er begyndt.
English: You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness.
Danish: Du bør være opmærksom på tidlige tegn på allergiske reaktioner, så som udslæt, nældefeber, hævelse, kløen, opsvulmede læber og tunge, åndedrætsbesvær, besværet åndedræt, trykken for brystet, generel følelse af utilpashed og svimmelhed.
English: The table is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Skemaet følger systemorganklasserne i henhold til MedDRA-databasen.
English: Lymphangitis
Danish: Lymfangitis
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse or hamster proteins.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Discard any unused solution appropriately.
Danish: Kassér ubrugt væske på en passende måde.
English: Use only the sterilised water for injections and the reconstitution device for preparation of the solution that are provided with each package of ADVATE.
Danish: Ved tilberedning af opløsningen skal det steriliserede vand til injektionsvæsker og udstyret til opløsning, som følger med hver pakning af ADVATE, anvendes.
English: Half-life (h) Maximum Plasma Concentration Post Infusion (IU/dl) Mean Residence Time (h)
Danish: Maksimal plasmakoncentration efter infusion (IE/dl)
English: Abdominal pain upper
Danish: Smerte i øvre bughule
English: If you or your child's bleeding is not being controlled with ADVATE, tell your doctor immediately.
Danish: Fortæl det straks til lægen, hvis din eller dit barns blødning ikke holdes under kontrol med ADVATE.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ETIKET TIL BLISTER (BAXJECT III-SYSTEM)
English: INFORMATION IN BRAILLE ADVATE 2000
Danish: INFORMATION I BRAILLE-SKRIFT ADVATE 2000
English: After reconstitution, the solution is clear, colourless and free from foreign particles.
Danish: Efter rekonstitution er opløsningen klar, farveløs og fri for fremmede partikler.
English: Mean Residence
Danish: Mean residence time (t)
English: Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for 3 - 4 days or more until pain and acute disability are resolved.
Danish: Gentag injektionen hver 12. til 24. time (8. til 24. time for patienter under 6 år) i 3-4 dage eller mere, indtil smerte og akut nedsat funktion er forsvundet.
English: Connect the syringe to BAXJECT II / BAXJECT III.
Danish: Tilslut sprøjten til BAXJECT II / BAXJECT III.
English: Detailed instructions for self-administration are given at the end of this package leaflet.
Danish: Til sidst i denne indlægsseddel finde du en detaljeret instruktion til selv-indgivelse.
English: Aseptic technique is required during preparation of the solution and administration.
Danish: Anvend en aseptisk teknik under opløsning af opløsningen og ved indgivelse.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Hætteglasset skal opbevares i den ydre karton for at beskytte mod lys.
English: After reconstitution the solution should be clear, colourless and free from foreign particles.
Danish: Efter rekonstitution skal opløsningen fremstå klar, farveløs og fri for fremmede partikler.
English: More extensive haemarthrosis, muscle bleeding or haematoma.
Danish: Mere udbredt hæmarthrose, muskelblødning eller hæmatom.
English: Time (h)
Danish: Halveringstid (t)
English: INFORMATION IN BRAILLE ADVATE 250
Danish: INFORMATION I BRAILLE-SKRIFT ADVATE 250
English: Instructions for preparation and administration
Danish: Instruktioner for opløsning og indgivelse
English: Octocog alfa is a glycoprotein consisting of 2332 amino acids with an approximate molecular mass of 280 kD.
Danish: Octocog alfa er et glycoprotein bestående af 2332 aminosyrer med en omtrentlig molekylemasse på 280 kD. Ved infusion til en hæmofili patient binder octocog alfa sig til endogen von Willebrandfaktor i patientens kredsløb.
English: B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (jf. bilag I: Produktresumé, pkt.
English: Can be stored at room temperature (up to 25 °C) for a single period up to 6 months.
Danish: Kan opbevares ved stuetemperatur (op til 25 °C) i en enkelt periode i højst 6 måneder.
English: Excipients with known effect: 0.45 mmol sodium (10 mg) per vial.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: 0,45 mmol natrium (10 mg) per hætteglas.
English: Connect the syringe to BAXJECT III.
Danish: Tilslut sprøjten til BAXJECT III.
English: In patients under the age of 6, doses of 20 to 50 IU of factor VIII per kg body weight 3 to 4 times weekly are recommended for prophylactic therapy.
Danish: Til profylaktisk behandling anbefales doser på 20 til 50 IE faktor VIII pr. kg. legemsvægt 3 til 4 gange om ugen hos patienter under 6 år.
English: INFORMATION IN BRAILLE ADVATE 1000
Danish: INFORMATION I BRAILLE-SKRIFT ADVATE 1000
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500
Danish: LÆGEMIDLETS NAVN ADVATE 1500 IE
English: INFORMATION IN BRAILLE ADVATE 3000
Danish: INFORMATION I BRAILLE-SKRIFT ADVATE 3000
English: Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development.
Danish: Det er forekommet hos tidligere behandlede patienter med mere end 100 eksponeringsdage, som havde udvikling af inhibitorer i anamnesen.
English: d
Danish: IV
English: ADVATE with BAXJECT II device: Keep the product vial in the outer carton in order to protect from light.
Danish: ADVATE med BAXJECT II-udstyr: Opbevar hætteglasset med lægemidlet i den ydre karton for at beskytte mod lys.
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions: - rash, hives, wheals, generalised itching, - swelling of lips and tongue, - difficulty in breathing, wheezing, tightness in the chest, - general feeling of being unwell, - dizziness and loss of consciousness.
Danish: Du skal kontakte din læge straks, hvis du får en eller flere af følgende tidlige tegn på en allergisk reaktion: - Udslæt, nældefeber, hævelse, kløen, - opsvulmede læber og tunge, - åndedrætsbesvær, besvær med at trække vejret, trykken for brystet, - generel følelse af utilpashed, - svimmelhed og tab af bevidsthed.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000
Danish: LÆGEMIDLETS NAVN ADVATE 2000 IE
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ADVATE 2000
English: Marketing Authorisation Holder Baxter AG
Danish: Indehaver af markedsføringstilladelsen: Baxter AG
English: - Do not refrigerate the preparation after reconstitution.
Danish: - Må ikke opbevares i køleskab efter rekonstitution.
English: Remove the blue cap from BAXJECT II / BAXJECT III.
Danish: Fjern den blå hætte fra BAXJECT II / BAXJECT III.
English: ADVATE 250 IU powder and solvent for solution for injection
Danish: ADVATE 250 IE pulver og solvens til injektionsvæske, opløsning
English: INFORMATION IN BRAILLE ADVATE 1500
Danish: INFORMATION I BRAILLE-SKRIFT ADVATE 1500
English: INFORMATION IN BRAILLE ADVATE 500
Danish: INFORMATION I BRAILLE-SKRIFT ADVATE 500
English: Haematocrit decreased
Danish: Nedsat hæmatokrit
English: Do not remove the blue cap from the BAXJECT II device.
Danish: Fjern ikke den blå hætte fra BAXJECT II-udstyret.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT III SYSTEM)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (BAXJECT III-SYSTEM)
English: What ADVATE is and what it is used for What you need to know before you use ADVATE How to use ADVATE
Danish: Det skal du vide, før du begynder at bruge ADVATE Sådan skal du bruge ADVATE Bivirkninger
English: Additional side effects in children
Danish: Hos børn kan endvidere ses følgende bivirkninger:
English: How to use ADVATE
Danish: Sådan skal du bruge ADVATE
English: Remove the blue cap from BAXJECT III.
Danish: Fjern den blå hætte fra BAXJECT III.
English: • Do not refrigerate the solution after preparation.
Danish: • Opbevar ikke produktet i køleskab efter opløsning.
English: Major
Danish: Større
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000
Danish: LÆGEMIDLETS NAVN ADVATE 3000 IE
English: - ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 5 ml solvent are preassembled with the system for reconstitution).
Danish: - ADVATE i BAXJECT III-system: Hver pakning indeholder et BAXJECT III-system klar til brug i en forseglet blisterpakning (hætteglasset med pulver og hætteglasset, der indeholder 5 ml solvens, er på forhånd samlet med systemet til rekonstitution).
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000
Danish: LÆGEMIDLETS NAVN ADVATE 1000 IE
English: - ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 2 ml solvent and a device for reconstitution (BAXJECT II).
Danish: - ADVATE med BAXJECT II-udstyr: Hver pakning indeholder et hætteglas med pulver, et hætteglas med 2 ml solvens og udstyr til rekonstitution (BAXJECT II).
English: - ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 2 ml solvent are preassembled with the system for reconstitution).
Danish: - ADVATE i BAXJECT III-system: Hver pakning indeholder et BAXJECT III-system klar til brug i en forseglet blisterpakning (hætteglasset med pulver og hætteglasset, der indeholder 2 ml solvens, er på forhånd samlet med systemet til rekonstitution).
English: - ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 5 ml solvent and a device for reconstitution (BAXJECT II).
Danish: - ADVATE med BAXJECT II-udstyr: Hver pakning indeholder et hætteglas med pulver, et hætteglas med 5 ml solvens og udstyr til rekonstitution (BAXJECT II).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)
Danish: MÆRKNING TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS ETIKET TIL PULVER (BAXJECT II-UDSTYR)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU octocog alfa
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 2000 IE octocog alfa
English: For administration the use of a luer-lock syringe is required.
Danish: Det er nødvendigt at anvende en luer-lock sprøjte ved indgivelse.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1500
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ADVATE 1500
English: The product may not be returned to refrigerated storage after storage at room temperature.
Danish: Efter opbevaring ved stuetemperatur må produktet ikke sættes tilbage i køleskab.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT II DEVICE)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (BAXJECT II UDSTYR)
English: Remove the blue cap from BAXJECT II.
Danish: Fjern den blå hætte fra BAXJECT II.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500
Danish: LÆGEMIDLETS NAVN ADVATE 500 IE
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250
Danish: LÆGEMIDLETS NAVN ADVATE 250 IE
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1000
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ADVATE 1000
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 3000
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ADVATE 3000
English: Memory impairment
Danish: Hukommelsesskade
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 250
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ADVATE 250
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 500
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ADVATE 500
English: Prophylaxis
Danish: Profylakse
English: ADVATE contains the active substance octocog alfa, human coagulation factor VIII produced by recombinant DNA technology.
Danish: Det er en rekombinant human koagulationsfaktor VIII fremstillet ved rekombinant DNA teknologi.
English: Powder vial and 5 ml solvent preassembled in BAXJECT III system.
Danish: Hætteglas med pulver og hætteglas med 5 ml solvens, som på forhånd er samlet i BAXJECT IIIsystem.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU octocog alfa
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 250 IE octocog alfa
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU octocog alfa
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 3000 IE octocog alfa
English: If you inject more ADVATE than recommended, tell your doctor as soon as possible.
Danish: Kontakt lægen eller sundhedspersonalet så hurtigt som muligt, hvis du injicerer mere ADVATE end anbefalet.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1500 IU octocog alfa
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1500 IE octocog alfa
English: During the shelf life the blister with the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Danish: I løbet af opbevaringstiden kan blisterpakningen med produktet opbevares ved stuetemperatur (ved højst 25 °C) i en enkelt periode og i højst 6 måneder.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU octocog alfa
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1000 IE octocog alfa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa
Danish: ADVATE 2000 IE pulver og solvens til injektionsvæske, opløsning Octocog alfa
English: During the shelf life, the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Danish: I løbet af holdbarhedstiden kan produktet opbevares ved stuetemperatur (ved højst 25 °C) i en enkelt periode på højst 6 måneder.
English: Powder vial and 2 ml solvent preassembled in BAXJECT III system.
Danish: Hætteglas med pulver og hætteglas med 2 ml solvens, som på forhånd er samlet i et BAXJECT IIIsystem.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 125 IU/ml after reconstitution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas: 250 IE octocog alfa, cirka 125 IE/ml efter opløsning.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection.
Danish: LÆGEMIDLETS NAVN ADVATE 3000 IE pulver og solvens til injektionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000 IU powder for solution for injection Octocog alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ADVATE 2000 IE pulver til injektionsvæske, opløsning Octocog alfa
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU octocog alfa
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 500 IE octocog alfa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection.
Danish: LÆGEMIDLETS NAVN ADVATE 500 IE pulver og solvens til injektionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection.
Danish: LÆGEMIDLETS NAVN ADVATE 250 IE pulver og solvens til injektionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection.
Danish: LÆGEMIDLETS NAVN ADVATE 1500 IE pulver og solvens til injektionsvæske, opløsning.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 750 IU/ml after reconstitution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas: 1500 IE octocog alfa, cirka 750 IE/ml efter opløsning.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 3000 IU powder for solution for injection Octocog alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ADVATE 3000 IE pulver til injektionsvæske, opløsning Octocog alfa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa
Danish: ADVATE 250 IE pulver og solvens til injektionsvæske, opløsning Octocog alfa
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 250 IU powder for solution for injection Octocog alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) ADVATE 250 IE pulver til injektionsvæske, opløsning Octogoc alfa
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret ADVATE til dig personligt.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection.
Danish: LÆGEMIDLETS NAVN ADVATE 2000 IE pulver og solvens til injektionsvæske, opløsning.
English: Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), octocog alfa.
Danish: Hvert hætteglas indeholder nominelt 2000 IE human koagulationsfaktor VIII (rDNA), octocog alfa.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Danish: ADVATE 2000 IE pulver og solvens til injektionsvæske, opløsning Octocog alfa (rekombinant humant koagulationsfaktor VIII)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 500 IU/ml after reconstitution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas: 1000 IE octocog alfa, cirka 500 IE/ml efter opløsning.
English: Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa.
Danish: Hvert hætteglas indeholder nominelt 250 IE human koagulationsfaktor VIII (rDNA), octocog alfa.
English: Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), octocog alfa.
Danish: Hvert hætteglas indeholder nominelt 3000 IE human koagulationsfaktor VIII (rDNA), octocog alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 250 IU/ml after reconstitution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas: 500 IE octocog alfa, cirka 250 IE/ml efter opløsning.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection.
Danish: LÆGEMIDLETS NAVN ADVATE 1000 IE pulver og solvens til injektionsvæske, opløsning.
English: Chest discomfort
Danish: Ubehag i brystet
English: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa.
Danish: Hvert hætteglas indeholder nominelt 500 IE human koagulationsfaktor VIII (rDNA), octocog alfa.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Danish: ADVATE 250 IE pulver og solvens til injektionsvæske, opløsning Octocog alfa (rekombinant humant koagulationsfaktor VIII)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/016
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/271/016
English: During the shelf life the powder vial may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Danish: I løbet af opbevaringstiden kan hætteglasset med pulver opbevares ved stuetemperatur (ved højst 25 °C) i en enkelt periode og i højst 6 måneder.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa
Danish: ADVATE 3000 IE pulver og solvens til injektionsvæske, opløsning Octocog alfa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa
Danish: ADVATE 500 IE pulver og solvens til injektionsvæske, opløsning Octocog alfa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Danish: ADVATE 500 IE pulver og solvens til injektionsvæske, opløsning Octocog alfa (rekombinant humant koagulationsfaktor VIII)
English: Post procedural haemorrhage
Danish: Blødning efter procedure