Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (UNII: P89DR4NY54) (Antihemophilic Factor, Human Recombinant - UNII:P89DR4NY54)
CSL Behring LLC
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 250 [iU] in 2.5 mL
Helixate® FS is a recombinant antihemophilic factor indicated for: Helixate FS is not indicated for the treatment of von Willebrand disease. Helixate FS is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). Pregnancy Category C Animal reproduction studies have not been conducted with Helixate FS. It is also not known whether Helixate FS can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Helixate FS should be given to a pregnant woman only if clearly needed. There is no information available on the effect of factor VIII replacement therapy on labor and delivery. Helixate FS should be used only if clinically needed. It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution sho
How Supplied Helixate FS is available as a kit in the following single-use glass vial sizes. A suitable volume of Sterile Water for Injection, USP and Mix2Vial® filter transfer device are provided in the kit. 0053-8131-02 250 2.5 0053-8132-02 500 2.5 0053-8133-02 1000 2.5 0053-8134-02 2000 5.0 0053-8135-02 3000 5.0 Actual factor VIII activity in IU is stated on the label of each Helixate FS vial. Use the actual potency as indicated on the vial label to calculate the dose. Storage and Handling The product vial and diluent vial are not made with natural rubber latex. Product as Packaged for Sale Product After Reconstitution
Biologic Licensing Application
HELIXATE FS- ANTIHEMOPHILIC FACTOR, RECOMBINANT CSL BEHRING LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HELIXATE FS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HELIXATE FS. HELIXATE FS [ANTIHEMOPHILIC FACTOR (RECOMBINANT), FORMULATED WITH SUCROSE] FOR INTRAVENOUS USE, LYOPHILIZED POWDER FOR RECONSTITUTION INITIAL U.S. APPROVAL: 1993 INDICATIONS AND USAGE Helixate FS is an Antihemophilic Factor (Recombinant) indicated for: (1) • • • • Helixate FS is not indicated for the treatment of von Willebrand disease. (1) DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE ONLY. Each vial of Helixate FS contains the labeled amount of recombinant factor VIII in international units (IU, unit). CONTROL OF BLEEDING EPISODES AND PERIOPERATIVE MANAGEMENT (2.1): • • • FOR ROUTINE PROPHYLAXIS IN ADULTS: 25 units per kg three times a week (2.1). FOR ROUTINE PROPHYLAXIS IN CHILDREN: 25 units per kg every other day (2.1). DOSAGE FORMS AND STRENGTHS Available as lyophilized powder in single use vials containing nominally 250, 500, 1000, 2000, and 3000 IU (3). CONTRAINDICATIONS Do not use in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (4). WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS The most common adverse reactions (≥4%) in clinical trials are inhibitor formation (neutralizing antibodies) in previously untreated and minimally treated patients (PUPs and MTPs), skin-associated hypersensitivity reactions (e.g., rash, pruritus, urticaria), infusion site reactions (e.g., inflammation, pain), and central venous access device (CVAD) associated infections. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CSL BEHRING PHARMACOVIGILANCE DEPARTMENT AT 1-866- 915-6958 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6) USE IN SPECIFIC POPULATIONS On-demand treatment and control of bleeding episodes in adults and children with Přečtěte si celý dokument