RECOMBINATE- antihemophilic factor recombinant

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (UNII: P89DR4NY54) (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT - UNII:P89DR4NY54)

Pieejams no:

Baxter Healthcare Corporation

SNN (starptautisko nepatentēto nosaukumu):

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

Kompozīcija:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 25 [iU] in 1 mL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 RECOMBINATE is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia). RECOMBINATE can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL.3   In clinical studies with RECOMBINATE, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE should be controlled by frequent laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient. RECOMBINATE is not indicated in von Willebrand’s disease. RECOMBINATE is contraindicated in patients w

Produktu pārskats:

RECOMBINATE is available in three different strengths in single-dose vials. The strength is designated on the outer box and on the vial label using the following color codes: RECOMBINATE is packaged with 10 mL of Sterile Water for Injection, USP, a BAXJECT II Needleless Transfer Device, one physician insert and one patient insert.

Autorizācija statuss:

Biologic Licensing Application

Produkta apraksts

RECOMBINATE- ANTIHEMOPHILIC FACTOR RECOMBINANT
BAXTER HEALTHCARE CORPORATION
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RECOMBINATE
[ANTIHEMOPHILIC FACTOR (RECOMBINANT)]
LYOPHILIZED POWDER FOR RECONSTITUTION FOR INJECTION
RECONSTITUTE WITH 10 ML OF STERILE WATER FOR INJECTION USING BAXJECT
II
DESCRIPTION
RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein
synthesized by a genetically
engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO
cell line secretes recombinant
Factor VIII (rFVIII) into the cell culture medium. The rFVIII is
purified from the culture medium
utilizing a series of chromatography columns. A key step in the
purification process is an
immunoaffinity chromatography methodology in which a purification
matrix, prepared by immobilization
of a monoclonal antibody directed to Factor VIII, is utilized to
selectively isolate the rFVIII in the
medium. The synthesized rFVIII produced by the CHO cells has the same
biological effects as human
Factor VIII. Structurally the protein has a similar combination of
heterogenous heavy and light chains as
found in human Factor VIII.
RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to
faint yellow, lyophilized
powder preparation of concentrated recombinant Factor VIII for
intravenous injection.
RECOMBINATE is available in single-dose vials, which contain nominally
250, 500 and 1000
International Units per vial. When reconstituted with the appropriate
volume of diluent, the product
contains the following stabilizers in maximum amounts: For 10 mL
reconstitution volume: 12.5 mg/mL
Albumin (Human), 0.20 mg/mL calcium, 1.5 mg/mL polyethylene glycol
(3350), 180 mEq/L sodium, 55
mM histidine, 1.5 µg/Factor VIII International Unit (IU)
polysorbate-80. Recombinant Von Willebrand
Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize
it. The final product contains not
more than 2 ng rVWF/IU rFVIII, which will not have any clinically
relevant effect in patients with von
Willebrand’s disease. The product contains no preservative.
Manufacturing of R