Examples of using Recombinant factor in English and their translations into German
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Biologically active recombinant factor H was produced in a moss bioreactor for the first time in 2011.
Cooperation agreement with Octapharma for German-speaking markets to offer a recombinant factor VIII preparation.
High-tech production of the recombinant factor VIII, which is fabricated in bioreactors with living cells.
Antifibrinolytic therapy(aminocaproic acid or tranexamic acid) and/or recombinant factor VIIa may increase haemostasis.
Re-dosing of recombinant factor VIIa shall be considered and titrated depending on improvement of bleeding.
In June 2015,we submitted an application to the Japanese MHLW for marketing authorization for the recombinant Factor VIII compound BAY 81-8973 for the treatment of hemophilia A.
The recombinant factor VIII developed by Bayer for treating hemophilia A was one of the first products of its kind.
The pharmacokinetic parameters obtained in studies comparing recombinant Factor IX to plasma derived Factor IX were similar to those obtained in human studies.
The recombinant factor VIII business, comprising the Kogenate® product line for the treatment of hemophilia A, is not part of the transaction and remains in Bayer HealthCare's portfolio.
If life-threatening bleeding cannot be controlled by the above measures,administration of prothrombin complex concentrates(PCCs) or recombinant factor VIIa may be considered.
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and.
Berlin, June 30, 2015- Bayer HealthCare today announced that Bayer Yakuhin, Ltd., Osaka, Japan,has submitted an application for marketing authorization for BAY 81-8973, a recombinant Factor VIII(rFVIII) compound, as a treatment of hemophilia A.
In studies with recombinant factor VIII preparations, development of inhibitors is predominantly observed in previously untreated haemophiliacs.
Berlin, December 4, 2014- Bayer HealthCare today submitted an application for marketing authorization to the European Medicines Agency(EMA)for BAY 81-8973, a recombinant Factor VIII(rFVIII) compound, for the treatment of hemophilia A in children and adults.
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and multiple intravenous doses in different species.
If bleeding cannot be controlled by the above measures, administration of a specific procoagulant reversal agent should beconsidered, such as prothrombin complex concentrate(PCC), activated prothrombin complex concentrate(APCC) or recombinant factor VIIa r-FVIIa.
In the presence of anti-factor IX antibodies, recombinant factor VIIa may be used, as well as activated prothrombin complex concentrates such as Feiba®1.
Leverkusen, March 11, 2014- With an investment of more than 500 millionEuros at its sites in Wuppertal and Leverkusen, Germany, Bayer will establish additional capacities for the manufacturing of the recombinant factor VIII(rFVIII) hemophilia products that are currently in development.
Biotest AG will be adding a recombinant factor VIII preparation to its haemophilia portfolio which will be produced by using a human cell line from early 2017.
Berlin, December 17, 2014- Bayer HealthCare today announced that it has filed a Biologics License Application(BLA) to the U.S. Food and Drug Administration(FDA)seeking approval for BAY 81-8973, a recombinant Factor VIII(rFVIII) compound, for the treatment of hemophilia A in adults and children.
In studies with recombinant factor VIII preparations, development of inhibitors is predominantly observed in previously untreated haemophiliacs.
Berlin, December 18, 2015- The European Committee for Medicinal Products for Human Use(CHMP) has recommended BAY 81-8973,Bayer's new recombinant factor VIII compound, for approval in the EU for the treatment and prophylaxis of bleeding in patients with hemophilia A for all age groups.
Kovaltry is an unmodified full-length recombinant factor VIII product, that in clinical trials has demonstrated control of bleeds, and protection from bleeds in hemophilia A patients when used prophylactically two or three times per week.
Since during clinical studies one PTP treated with BeneFIX developed a clinically relevant low responding inhibitor,and experience on antigenicity with recombinant factor IX is still limited, while being treated with BeneFIX you should be carefully monitored for the development of factor IX inhibitors.
The cleavable linker between the recombinant factor IX and albumin molecules is derived from the endogenous“activation peptide” in native factor IX.
In February 2016, Bayer received approval from the European Commission for KovaltryTM(Bay 81-8973) for the treatment of hemophilia A in patients of all age groups.KovaltryTM is an unmodified recombinant factor VIII product that in clinical trials has demonstrated efficacy and tolerability as an on-demand therapy and for prophylactic use two or three times per week by hemophilia A patients.
BAY 79-4980, is a unique combination of recombinant factor VIII(rFVIII) with Zilip Pharma's proprietary synthetic polyethylene glycol(PEG)-coated liposomes.
Cases of recurrence of inhibitors(low titre)have been observed after switching from one recombinant factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.
Although Bayerand Ba:der had granted distribution licences for recombinant factor VIII to Armour, the quantity ofproduct to which the joint venture would have access was limited, and Baxter and Bayer had theimportant advantage of having entered the German market substantially earlier.
Since during clinical studies one PTP treated with BeneFIX developed a clinically relevant low responding inhibitor andexperience on antigenicity with recombinant factor IX is still limited, patients treated with BeneFIX should be carefully monitored for the development of factor IX inhibitors that should be titrated in Bethesda Units using appropriate biological testing.