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License no: 3LAB-0516-5.0
XYNTHA, Antihemophilic Factor (Recombinant), is indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:
For intravenous use after reconstitution only.
XYNTHA is available as a white to off-white lyophilized powder in the following nominal dosages:
XYNTHA is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins.
Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with XYNTHA. Inform patients...
The most common adverse reactions (≥10%) with XYNTHA in adult and pediatric previously treated patients (PTPs) were headache, arthralgia, pyrexia, and cough.
It is not known whether...
The active ingredient in XYNTHA, Antihemophilic Factor (Recombinant), is a recombinant antihemophilic factor (rAHF), also called coagulation factor VIII, which is produced by recombinant DNA technology. It is...
XYNTHA temporarily replaces the missing clotting factor VIII that is needed for effective hemostasis.
No studies have been conducted with XYNTHA to assess its mutagenic or carcinogenic...
Three completed multicenter, open-label studies support the analysis of safety and efficacy of XYNTHA in on-demand treatment and control of bleeding episodes and perioperative management, and routine...
Each XYNTHA Vial Kit contains: one prefilled diluent syringe containing 4 mL 0.9...
Advise patients to:
XYNTHA® /ZIN-tha/[Antihemophilic Factor (Recombinant)]
XYNTHA is supplied as a...
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