REOPRO- abciximab injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

abciximab (UNII: X85G7936GV) (abciximab - UNII:X85G7936GV)

Dostupné z:

Janssen Biotech, Inc.

INN (Medzinárodný Name):

abciximab

Zloženie:

abciximab 2 mg in 1 mL

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Abciximab is indicated as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications - in patients undergoing percutaneous coronary intervention - in patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours Safety and efficacy of Abciximab use in patients not undergoing percutaneous coronary intervention have not been established. Abciximab is intended for use with aspirin and heparin and has been studied only in that setting, as described in CLINICAL STUDIES. Because Abciximab may increase the risk of bleeding, Abciximab is contraindicated in the following clinical situations: - Active internal bleeding - Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance - History of cerebrovascular accident (CVA) within two years, or CVA with a significant residual neurological deficit - Bleeding diathesis - Administration of oral anticoagulan

Prehľad produktov:

Abciximab (ReoPro® ) 2 mg/mL is supplied in 5 mL vials containing 10 mg (NDC 57894-200-01). Vials should be stored at 2 to 8 °C (36 to 46 °F). Do not freeze. Do not shake. Do not use beyond the expiration date.

Stav Autorizácia:

Biologic Licensing Application

Súhrn charakteristických

REOPRO- ABCIXIMAB INJECTION, SOLUTION
JANSSEN BIOTECH, INC.
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REOPRO
ABCIXIMAB
FOR INTRAVENOUS ADMINISTRATION
DESCRIPTION:
Abciximab, ReoPro
, is the Fab fragment of the chimeric human-murine monoclonal antibody
7E3.
Abciximab binds to the glycoprotein (GP) IIb/IIIa receptor of human
platelets and inhibits platelet
aggregation. Abciximab also binds to the vitronectin (α β ) receptor
found on platelets and vessel wall
endothelial and smooth muscle cells.
The chimeric 7E3 antibody is produced by continuous perfusion in
mammalian cell culture. The 47,615
dalton Fab fragment is purified from cell culture supernatant by a
series of steps involving specific
viral inactivation and removal procedures, digestion with papain and
column chromatography.
ReoPro
is a clear, colorless, sterile, non-pyrogenic solution for intravenous
(IV) use. Each single-
dose vial contains 2 mg/mL of Abciximab in a buffered solution (pH
7.2) of 0.01 M sodium phosphate,
0.15 M sodium chloride and 0.001% polysorbate 80 in Water for
Injection. No preservatives are added.
CLINICAL PHARMACOLOGY:
GENERAL- Abciximab binds to the intact platelet GPIIb/IIIa receptor,
which is a member of the integrin
family of adhesion receptors and the major platelet surface receptor
involved in platelet aggregation.
Abciximab inhibits platelet aggregation by preventing the binding of
fibrinogen, von Willebrand factor,
and other adhesive molecules to GPIIb/IIIa receptor sites on activated
platelets. The mechanism of
action is thought to involve steric hindrance and/or conformational
effects to block access of large
molecules to the receptor rather than direct interaction with the RGD
(arginine-glycine-aspartic acid)
binding site of GPIIb/IIIa.
Abciximab binds with similar affinity to the vitronectin receptor,
also known as the α β integrin. The
vitronectin receptor mediates the procoagulant properties of platelets
and the proliferative properties
of vascular endothelial and smooth muscle cells. In _in vitro_ studies
using a model cell line derived from
me