MONOCLATE-P- antihemophilic factor human

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ANTIHEMOPHILIC FACTOR HUMAN (UNII: 839MOZ74GK) (ANTIHEMOPHILIC FACTOR HUMAN - UNII:839MOZ74GK)

Tilgjengelig fra:

CSL Behring LLC

INN (International Name):

ANTIHEMOPHILIC FACTOR HUMAN

Sammensetning:

ANTIHEMOPHILIC FACTOR HUMAN 250 [iU] in 2.5 mL

Indikasjoner:

Monoclate-P® is indicated for treatment of classical hemophilia (Hemophilia A). Affected individuals frequently require therapy following minor accidents. Surgery, when required in such individuals, must be preceded by temporary corrections of the clotting abnormality. Surgical prophylaxis in severe AHF deficiency can be accomplished with an appropriately-dosed pre-surgical IV bolus of Monoclate-P® followed by intermittent maintenance doses (see DOSAGE AND ADMINISTRATION ). Monoclate-P® is not effective in controlling the bleeding of patients with von Willebrand's disease. Known hypersensitivity to mouse protein is a contraindication to Monoclate-P® .

Produkt oppsummering:

Monoclate-P® is supplied in a single dose vial with Sterile Water for Injection, USP, double-ended needle for reconstitution, vented filter spike for withdrawal, filter needle for withdrawal, winged infusion set and alcohol swabs. Factor VIII activity in IU is stated on the label of each vial. Each product package consists of the following:

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

MONOCLATE-P- ANTIHEMOPHILIC FACTOR HUMAN
CSL BEHRING LLC
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ANTIHEMOPHILIC FACTOR (HUMAN)
MONOCLATE-P
FACTOR VIII:C PASTEURIZED
MONOCLONAL ANTIBODY PURIFIED
R ONLY
DESCRIPTION
Antihemophilic Factor (Human), Monoclate-P , Factor VIII:C
Pasteurized, Monoclonal Antibody
Purified, is a sterile, stable, lyophilized concentrate of Factor
VIII:C with reduced amounts of VWF:Ag
and purified of extraneous plasma-derived protein by use of affinity
chromatography. A murine
monoclonal antibody to VWF:Ag is used as an affinity ligand to first
isolate the Factor VIII Complex.
Factor VIII:C is then dissociated from VWF:Ag, recovered, formulated
and provided as a sterile
lyophilized powder.
The concentrate as formulated contains Albumin (Human) as a
stabilizer,
resulting in a concentrate with a specific activity between 4 and 10
units/mg of total protein. In the
absence of this added Albumin (Human) stabilizer, specific activity
has been determined to exceed 3000
units/mg of protein.
Monoclate-P has been prepared from pooled human plasma and is intended
for
use in therapy of classical hemophilia (Hemophilia A).
All Source Plasma used in the manufacture of this product was tested
by FDA-licensed Nucleic Acid
Testing (NAT) for HBV, HCV, and HIV-1 and found to be nonreactive
(negative).
This concentrate has been pasteurized by heating at 60°C for 10 hours
in aqueous solution form during
its manufacture in order to further reduce the risk of viral
transmission.
However, no procedure has
been shown to be totally effective in removing viral infectivity from
coagulant factor concentrates (see
CLINICAL PHARMACOLOGY and WARNINGS).
Monoclate-P is a highly purified preparation of Factor VIII:C. When
stored as directed, it will
maintain its labeled potency for the period indicated on the container
and package labels.
Upon reconstitution of the 250, 500 and 1000 IU concentrates, a clear,
colorless solution is obtained,
containing 50 to 150 times as much Factor VIII:C as does an equal
volume of plasma.
Upon reconstitution of the 1500