FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use NovoThirteen
Danish: Brug ikke NovoThirteen
English: Bring the powder and solvent vials to a temperature not above 25°C, by holding them in the hands until they feel as warm as your hands.
Danish: Temperer hætteglassene med pulver og solvens til stuetemperatur, ikke over 25°C, ved at holde hætteglassene i hænderne indtil de føles ligeså varme som dine hænder.
English: FXIII B-subunit deficiency is associated with a much reduced half-life of the administered pharmacologically active A-subunit.
Danish: Mangel på FXIII B-subunit er forbundet med en stærkt reduceret halveringstid af den administrerede, farmakologisk aktive A-subunit.
English: In clinical trials, NovoThirteen has been administered to 82 patients with congenital factor XIII Asubunit deficiency (3112 doses of NovoThirteen).
Danish: I kliniske studier er NovoThirteen givet til 82 patienter med medfødt mangel på faktor XIII A-subunit (3112 doser NovoThirteen).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere omlysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: There are no clinical data on the use of NovoThirteen in pregnant women.
Danish: Der foreligger ingen kliniske data om anvendelse af NovoThirteen til gravide.
English: The active substance is produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Danish: Den aktive substans er produceret i gærceller (Saccharomyces cerevisiae) ved rekombinant DNAteknologi.
English: The medicinal product contains less than 1 mmol sodium (23 mg) per injection, indicating that it is essentially ‘sodium free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per injektion, hvilket indikerer at det stort set er 'natrium-frit'.
English: It is not recommended to use NovoThirteen and recombinant coagulation factor VIIa (another blood clotting factor) together.
Danish: Det anbefales ikke at bruge NovoThirteen og rekombinant koagulationsfaktor VIIa (en anden koagulationsfaktor) sammen.
English: NovoThirteen is a recombinant coagulation factor XIII A-subunit produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Danish: NovoThirteen er en rekombinant koagulationsfaktor XIII A-subunit produceret i gærceller (Saccharomyces cerevisiae) ved rekombinant DNA-teknologi.
English: The dilution should be performed in accordance with aseptic rules.
Danish: Fortyndingen skal udføres i overensstemmelse med en aseptisk fremgangsmåde.
English: In patients with FXIII deficiency, NovoThirteen is not effective if used for monthly prophylactic treatment of bleeding in patients with congenital FXIII B-subunit deficiency.
Danish: Hos patienter med FXIII mangel, er NovoThirteen ikke effektivt til anvendelse af månedlig profylaktisk behandling af blødning hos patienter med medfødt mangel på FXIII B-subunit.
English: The half-life of NovoThirteen was assessed in the F13CD-1725 trial from a limited blood sampling scheme at 1 hour, 14 and 28 days post dose.
Danish: Halveringstiden af NovoThirteen blev vurderet i F13CD-1725 studiet fra et begrænset blodprøveskema ved 1 time, 14 og 28 dage efter dosisindgivelse.
English: Non-neutralising antibodies have been seen in 4 of the 82 exposed patients with congenital FXIII deficiency.
Danish: Ikke-inhiberende antistoffer er observeret hos 4 ud af de 82 eksponerede patienter med medfødt FXIII-mangel.
English: Based on the actual concentration of NovoThirteen, the volume (in millilitres) to be administered to patients weighing at least 24 kg can be calculated from the formula below:
Danish: Baseret på den faktiske koncentration af NovoThirteen, kan volumen (i milliliter) beregnes til patienter, der vejer mindst 24 kg, efter nedenstående formel:
English: Check the injection solution for particulate matter and for discolouration.
Danish: Kontrollér injektionsvæsken for partikler og misfarvning.
English: Gently swirl the vial until all the powder is dissolved.
Danish: Sving hætteglasset forsigtigt rundt, til alt pulveret er opløst.
English: • The risks of off-label use within FXIII congenital deficiency
Danish: • Risikoen ved off label-brug ved medfødt FXIII-mangel
English: After reconstitution, the medicinal product should be used immediately due to the risk of microbiological contamination.
Danish: Lægemidlet skal anvendes straks efter rekonstitution, da der er risiko for mikrobiologisk forurening.
English: The reconstituted product must be handled in accordance with section 6.3.
Danish: Det rekonstituerede produkt skal håndteres i overensstemmelse med pkt.
English: Frequency descriptions of all adverse reactions identified from 82 patients with congenital FXIII deficiency exposed in clinical trials are presented in the below table by system organ class.
Danish: Beskrivelse af frekvensen af alle bivirkninger, der blev identificeret hos 82 patienter med medfødt FXIII-mangel, som viste sig i kliniske studier, er anført ud fra organsystemklasser i nedenstående tabel.
English: Renal insufficiency Patients with renal insufficiency requiring dialysis have not been studied in clinical trials.
Danish: Nyreinsufficiens Patienter med nedsat nyrefunktion, som kræver dialyse, er ikke undersøgt i kliniske studier.
English: Reconstituted NovoThirteen is a clear, colourless solution.
Danish: Rekonstitueret NovoThirteen er en klar, farveløs opløsning.
English: • If you experience bleeding during your treatment with NovoThirteen occurring spontaneously and/or requiring treatment.
Danish: • Hvis du oplever uventet blødning, der opstår spontant og/eller er behandlingskrævende, under behandlingen med NovoThirteen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2500 IU
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 2500 IE
English: INFORMATION IN BRAILLE NovoThirteen
Danish: INFORMATION I BRAILLESKRIFT
English: Twenty-one children between the age of 6 to less than 18 years old and six children less than 6 years old have been treated with NovoThirteen for a total of 986 exposures.
Danish: 21 børn i alderen mellem 6 og 18 år og seks børn under 6 år, blev eksponeret for NovoThirteen sammenlagt 986 gange.
English: In plasma, FXIII circulates as a heterotetramer [A2B2] composed of 2 FXIII A-subunits and 2 FXIII Bsubunits held together by strong non-covalent interactions.
Danish: I plasma cirkulerer FXIII som en heterotetramer [A2B2] bestående af 2 FXIII A-subunits og 2 FXIII Bsubunits bundet sammen af stærke, ikke-kovalente interaktioner.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Your treatment with NovoThirteen should be initiated by a doctor experienced in the treatment of rare bleeding disorders.
Danish: Påbegyndelse af behandling med NovoThirteen skal foretages af en læge, som har erfaring med behandling af sjældne blødersygdomme.
English: Treatment should be initiated under the supervision of a doctor experienced in the treatment of rare bleeding disorders.
Danish: Påbegyndelse af behandling skal overvåges af en læge, som har erfaring med behandling af sjældne blødersygdomme.
English: Hold the syringe with the vial upside down and pull the plunger to draw up the amount calculated for the injection.
Danish: Hold sprøjten med hætteglasset opad, og træk stemplet ud for at trække den beregnede injektionsmængde ind i sprøjten.
English: METHOD AND ROUTE OF ADMINISTRATION Intravenous use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Intravenøs anvendelse
English: NovoThirteen may not be effective in patients with hepatic impairment if the hepatic impairment is severe enough to result in decreased levels of FXIII B-subunits.
Danish: NovoThirteen er muligvis ikke effektivt hos patienter med nedsat leverfunktion, hvis denne er tilstrækkelig svær til, at den medfører et reduceret niveau af FXIII B-subunits.
English: What NovoThirteen contains
Danish: NovoThirteen indeholder
English: A pivotal prospective, open-label, single-arm phase 3 trial (F13CD-1725) including 41 patients with FXIII A-subunit deficiency was conducted to investigate the haemostatic efficacy of rFXIII in patients with congenital FXIII deficiency as reflected by the rate of bleeding episodes requiring treatment with a FXIII-containing product.
Danish: Et pivotalt, prospektivt, åbent, enkeltarmet fase 3-studie (F13CD-1725) med 41 patienter med mangel på FXIII A-subunit er gennemført for at undersøge den hæmostatiske effekt af rFXIII hos patienter med medfødt FXIII-mangel afspejlet ved antallet af blødningsepisoder, som krævede behandling med et produkt indeholdende FXIII.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Solvent for NovoThirteen
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Solvens til NovoThirteen
English: In the primary endpoint analysis covering the referred period, the age-adjusted rate (number per subject year) of treatment-requiring bleeds during the rFXIII treatment period was 0.048/year (95% CI: 0.009 - 0.250; model-based estimate corresponding to the mean age of 26.4 years for the 41 patients).
Danish: I den primære endpoint-analyse var den aldersjusterede frekvens (antal pr. forsøgspersonår) af behandlingskrævende blødninger under behandlingsperioden med rFXIII 0,048/år (95 % CI: 0,0090,250; modelbaseret estimat svarende til gennemsnitsalderen på 26,4 år hos de 41 patienter).
English: The congenital factor XIII A-subunit deficiency should be confirmed by appropriate diagnostic procedures including factor XIII activity and immunoassay and if applicable genotyping.
Danish: Medfødt mangel på faktor XIII A-subunit skal bekræftes med hensigtsmæssige diagnostiske procedurer, inklusiv faktor XIII-aktivitet og immuno-assay og om nødvendigt genotypebestemmelse.
English: Powder: Sodium chloride, sucrose, polysorbate 20, L-histidine, hydrochloric acid, sodium hydroxide Solvent: water for injections
Danish: Pulver: Natriumchlorid, saccharose, polysorbat 20, L-histidin, saltsyre, natriumhydroxid Solvens: vand til injektionsvæsker
English: The crude bleeding rates in the two trials, F13CD-1725 and F13CD-3720, not adjusted for age, were 0.138 and 0.043 respectively, corresponding to a total of 13 bleeds over 223 subject-years and a pooled rate of 0.058.
Danish: De ikke-filtrede blødningsfrekvenser i de to studier, F13CD-1725 og F13CD-3720, som ikke er justeret i forhold til alder, var 0,138 og 0,043, respektivt, svarende til en total på 13 blødninger over 223 forsøgspersonår med en samlet frekvens på 0,058.
English: Patients with hepatic impairment have not been studied.
Danish: Patienter med nedsat leverfunktion er ikke undersøgt.
English: One healthy subject developed low-titer, transient non-neutralising antibodies after receiving the first dose of NovoThirteen.
Danish: En rask forsøgsperson udviklede forbigående ikke-inhiberende antistoffer i lav titer efter at have fået første dosis NovoThirteen.
English: In a post-authorisation safety study transient non-neutralising antibodies were seen in a child with congenital FXIII deficiency after several years of treatment with NovoThirteen.
Danish: I et sikkerhedsstudie udført efter markedsføring blev der hos et barn med medfødt mangel på FXIII observeret forbigående ikke-neutraliserende antistoffer efter flere års behandling med NovoThirteen.
English: NovoThirteen (A-subunit) binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2] with a similar half-life to endogenous [A2B2].
Danish: NovoThirteen (A-subunit) binder til frit human FXIII B-subunit, hvilket resulterer i en heterotetramer [rA2B2] med en halveringstid, der svarer til det endogene [A2B2].
English: Instructions of how to dilute the reconstituted NovoThirteen
Danish: Vejledning til fortynding af det opblandede NovoThirteen
English: EXP After reconstitution, use the medicine immediately due to the risk of microbiological contamination.
Danish: EXP Lægemidlet skal anvendes straks efter opblanding, da der er risiko for mikrobiologisk forurening.
English: No dose adjustment is required when NovoThirteen is used in paediatric patients and the dose of 35 IU/kg body weight should be used (see section 5.2 ‘Paediatric population').
Danish: Dosisjustering er ikke nødvendig når NovoThirteen bruges hos pædiatriske patienter, og en dosis på 35 IE/kg legemsvægt bør anvendes (se pkt.
English: The enzymatic activity resides with the FXIII A-subunit.
Danish: Den enzymatiske aktivitet ligger i FXIII A-subunit.
English: Before you can use NovoThirteen for injection you need to reconstitute the product.
Danish: Før du kan injicere NovoThirteen, skal du opblande produktet.
English: Long term prophylactic treatment of bleeding in patients with congenital factor XIII A-subunit deficiency.
Danish: Langtidsprofylaktisk behandling mod blødning hos patienter med medfødt mangel på faktor XIII Asubunit.
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Danish: 6.3 for det rekonstituerede produkts opbevaringsbetingelser.
English: Once prepared, NovoThirteen for injection should be used immediately.
Danish: Når NovoThirteen er klargjort til injektion, skal det anvendes straks.
English: OTHER For reconstitution
Danish: ANDET Til opblanding
English: No effects on reproductive organs were noted in the repeated dose toxicity studies.
Danish: Der er ikke påvist nogen effekt på forplantningsorganerne i toksicitetsforsøg med gentagen dosis.
English: NovoThirteen should be inspected visually for extraneous (for any foreign) particulate matter and discoloration prior to administration.
Danish: NovoThirteen skal efterses for fremmede partikler og misfarvning inden administration.
English: If you stop using NovoThirteen
Danish: Hvis du holder op med at bruge NovoThirteen
English: Your doctor will explain what might happen if you stop treatment and discuss other options with you.
Danish: Du må ikke holde op med at bruge NovoThirteen uden først at have talt med din læge om det. Din læge vil forklare, hvad der kan ske, hvis du stopper behandlingen, og drøfte andre behandlingsmuligheder med dig.
English: In the reported cases of NovoThirteen overdose up to 2.3 times, no clinical symptoms have been observed.
Danish: Ingen kliniske symptomer er observeret i de rapporterede tilfælde af overdosering, op til 2,3 gange, med NovoThirteen.
English: Children above 6 years were investigated through the pivotal phase 3 trial (F13CD-1725) and the extension study (F13CD-3720) assessing the safety of monthly replacement therapy with NovoThirteen.
Danish: Børn, der var over 6 år, blev undersøgt i det afgørende fase 3-studie (F13CD-1725) og forlængelsesstudie (F13CD-3720), som vurderer sikkerheden af månedlig substitutionsterapi med NovoThirteen.
English: 21 patients were between the age of 6 to less than 18 years old and 6 patients were less than 6 years old (total of 986 exposures of NovoThirteen in paediatric subjects (less than 18 years old).
Danish: 21 patienter var i alderen 6 til 18 år og seks patienter var yngre end 6 år (i alt blev den pædiatriske population (under 18 år) eksponeret for NovoThirteen 986 gange).
English: Please see NovoThirteen user instructions.
Danish: Se NovoThirteen brugervejledningen.
English: What you need to know before you use NovoThirteen
Danish: Det skal du vide, før du begynder at bruge NovoThirteen
English: The FXIII B-subunit acts as a carrier molecule for the FXIII A-subunit in circulation, and is present in excess in plasma.
Danish: FXIII B-subunit fungerer som et bæremolekyle for FXIII A-subunit i cirkulation og findes i store mængder i plasma.
English: The antibodies had no inhibitory action and the patients did not experience any adverse events or bleeding in association with these antibodies.
Danish: Antistofferne havde ingen inhiberende virkning, og patienterne oplevede ingen bivirkninger eller blødning i forbindelse med disse antistoffer.
English: The 6 patients below 6 years were investigated through a single dose pharmacokinetic phase 3b trial (F13CD-3760) and then, included in the long-term follow-up trial (F13CD-3835) assessing the safety and the efficacy of monthly replacement therapy with NovoThirteen.
Danish: De seks patienter under 6 år, blev undersøgt i et enkeltdosis farmakokinetisk fase 3b-studie (F13CD3760) og efterfølgende inkluderet i det længerevarende opfølgningsstudie (F13CD-3835), som vurderer sikkerheden og virkningen af månedlig substitutionsterapi med NovoThirteen.
English: The subunit deficiency of patients should be determined prior to treatment by appropriate diagnostic procedures including factor XIII activity and immunoassay and if applicable genotyping.
Danish: Før behandling påbegyndes, skal patienters subunit-mangel bekræftes ved hensigtsmæssige diagnostiske procedurer, som kan inkludere faktor XIII aktivitet og immunoassay og om nødvendigt genotypebestemmelse.
English: Upon activation, the FXIII A-subunit dissociates from the FXIII B-subunit and thereby exposes the active site of the FXIII A-subunit.
Danish: Ved aktivering adskilles FXIII A-subunit fra FXIII Bsubunit, hvorved det aktive område i FXIII A-subunit eksponeres.
English: In case of any questions ask your doctor or nurse.
Danish: Hvis du har nogle spørgsmål, skal du kontakte din læge eller sygeplejerske.
English: In a pharmacokinetic trial 6 children (age 1 to less than 6 years old) with congenital FXIII A-subunit deficiency were exposed to one single i.v.
Danish: I et farmakokinetisk studie blev seks børn (i alderen 1 til 6 år) med medfødt FXIII A-subunit mangel eksponeret for en enkelt dosis NovoThirteen 35 IE/kg indgivet i.v.
English: Pull the plunger to draw in a volume of air equal to the total amount of solvent in the solvent vial.
Danish: Træk stemplet tilbage for at trække luft ind i sprøjten svarende til det totale volumen af solvens i hætteglasset med solvens.
English: The product is reconstituted using the vial adapter included.
Danish: Produktet rekonstitueres ved hjælp af den medfølgende hætteglasadapter.
English: NovoThirteen user instructions
Danish: NovoThirteen brugervejledning
English: Powder (2500 IU) in a vial (glass type I) with rubber stopper (chlorobutyl) and 3.2 ml solvent in a vial (glass type I) with rubber stopper (bromobutyl) and a vial adapter for reconstitution.
Danish: Pulver (2500 IE) i hætteglas (glas type 1) med gummiprop (chlorobutyl) og 3,2 ml solvens i hætteglas (glas type 1) med gummiprop (bromobutyl) og en hætteglasadapter til rekonstitution.
English: The antibodies had no inhibitory activity, and the subject did not experience any adverse events or bleeding in association with these antibodies.
Danish: Antistofferne havde ingen inhiberende aktivitet, og forsøgspersonen oplevede ingen bivirkninger eller blødning i forbindelse med disse antistoffer.
English: The Marketing Authorisation Holder (MAH) shall ensure that, at launch, a letter is sent to all expected and actual prescribers of NovoThirteen with an Educational Pack containing the following: Physician brochure Patient brochure
Danish: Indehaveren af markedsføringstilladelsen skal ved lancering sikre, at læger, som forventes at skulle udskrive NovoThirteen, er blevet forsynet med en undervisningspakke, der indeholder følgende: 1.
English: When the FXIII Asubunit is bound to the FXIII B-subunit [A2B2], the half-life of the FXIII A-subunit [A2] is prolonged.
Danish: Når FXIII Asubunit bindes til FXIII B-subunit [A2B2], forlænges halveringstiden for FXIII A-subunit [A2].
English: • The other ingredients are for the powder sodium chloride, sucrose and polysorbate 20, L-histidine, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH adjustment) and for the solvent water for injections.
Danish: • De øvrige indholdsstoffer i pulveret er natriumchlorid, sakkarose, polysorbat 20, L-histidin, saltsyre (til pH-regulering), natriumhydroxid (til pH-regulering) og i solvensen vand til injektionsvæsker.
English: Reporting of side effects
Danish: Indberetning af bivirkninger.
English: On-demand treatment
Danish: Behovsbehandling
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for powder vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket til hætteglas med pulver
English: Do not shake the vial as this will cause foaming.
Danish: Ryst ikke hætteglasset, da dette vil forårsage skumdannelse.
English: Based on the concentration of NovoThirteen solution, the dose volume to be injected (in millilitres) can be calculated from this formula:
Danish: Baseret på koncentrationen af NovoThirteen opløsning kan dosismængden til injektion (i milliliter) beregnes efter nedenstående formel:
English: To reconstitute and administer this product the following tools are needed: a 10 ml syringe or a syringe of a convenient size according to injection volume, alcohol swabs, the included vial adapter and an infusion set (tubing, butterfly needle).
Danish: Til rekonstitution og administration af dette produkt skal der bruges følgende redskaber: en 10 ml sprøjte eller en sprøjte af passende størrelse til injektionsmængden, alkoholservietter, den medfølgende hætteglasadapter og et infusionssæt (slange, sommerfuglenål).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for solvent vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket til hætteglas med solvens
English: Bring the powder and solvent vials to a temperature not above 25°C by holding them in the hands.
Danish: Temperer hætteglassene med pulver og solvens til stuetemperatur (ikke over 25 °C), ved at holde hætteglassene i hænderne.
English: Once attached, remove the protective cap from the vial adapter.
Danish: Så snart den er sat på, fjernes beskyttelseshætten fra hætteglasadapteren.
English: In the F13CD-1725 extension trial F13CD-3720, the age-adjusted rate of bleeds that required treatment with a FXIII-containing product was estimated to be 0.021 bleeds per subject year with a 95% CI of [0.0062; 0.073] (model-based estimate corresponding to a mean age of the trial population of 31.0 years).
Danish: I F13CD-3720, som er et forlængelsesstudie til F13CD-1725, var den alderjusterede frekvens af blødninger, som krævede behandling med et FXIII-indeholdende produkt vurderet til at være 0,021 blødninger per forsøgspersonår med et 95% CI på [0,0062; 0,073](modelbaseret estimat svarende til en gennemsnitlig alder på studiepopulationen på 31,0 år).
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: NovoThirteen contains sodium This medicine contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) per injektion, hvilket betyder at det stort set er 'natrium-frit'.
English: Preparing the solution
Danish: Klargøring af opløsningen
English: Based on the non-clinical study (see section 5.3) it is not recommended to combine NovoThirteen and recombinant activated FVII (rFVIIa).
Danish: 5.3) anbefales det ikke at kombinere NovoThirteen og rekombinant aktiveret FVII (rFVIIa).
English: Common (≥ 1/100 to < 1/10) Common (≥ 1/100 to < 1/10)
Danish: Almindelig (≥ 1/100 til < 1/10) Almindelig (≥ 1/100 til < 1/10)
English: General instructions for dilution
Danish: Generel vejledning til fortynding
English: NAME OF THE MEDICINAL PRODUCT NovoThirteen 2500 IU powder and solvent for solution for injection
Danish: LÆGEMIDLETS NAVN NovoThirteen 2500 IE pulver og solvens til injektionsvæske, opløsning
English: • The active substance is catridecacog (recombinant coagulation factor XIII: 2500 IU/3 ml, after reconstitution, corresponding to a concentration of 833 IU/ml.
Danish: • Det aktivte stof er catridecacog (rekombinant koagulationsfaktor XIII: 2500 IE/3 ml, efter opblanding, svarende til en koncentration på 833 IE/ml).
English: Powder and solvent for solution for injection 2500 IU powder in a vial, 3.2 ml solvent in a vial, 1 vial adapter
Danish: Pulver og solvens til injektionsvæske, opløsning 2500 IE pulver i et hætteglas, 3,2 ml solvens i et hætteglas, 1 hætteglasadapter