TRASYLOL aprotinin bovine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

aprotinin bovine (UNII: 04XPW8C0FL) (aprotinin bovine - UNII:04XPW8C0FL)

Available from:

Bayer Pharmaceuticals Corporation

INN (International Name):

aprotinin bovine

Composition:

1000000 in 100 mL

Prescription type:

PRESCRIPTION DRUG

Summary of Product characteristics

TRASYLOL- APROTININ BOVINE SOLUTION
BAYER PHARMACEUTICALS CORPORATION
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TRASYLOL
(APROTININ INJECTION)
TRASYLOL® ADMINISTRATION MAY CAUSE FATAL ANAPHYLACTIC OR
ANAPHYLACTOID REACTIONS. FATAL
REACTIONS HAVE OCCURRED WITH AN INITIAL (TEST) DOSE AS WELL AS WITH
ANY OF THE COMPONENTS OF
THE DOSE REGIMEN. FATAL REACTIONS HAVE ALSO OCCURRED IN SITUATIONS
WHERE THE INITIAL (TEST)
DOSE WAS TOLERATED. THE RISK FOR ANAPHYLACTIC OR ANAPHYLACTOID
REACTIONS IS INCREASED
AMONG PATIENTS WITH PRIOR APROTININ EXPOSURE AND A HISTORY OF ANY
PRIOR APROTININ EXPOSURE
MUST BE SOUGHT PRIOR TO TRASYLOL ADMINISTRATION. THE RISK FOR A FATAL REACTION APPEARS TO
BE GREATER UPON RE-EXPOSURE WITHIN 12 MONTHS OF THE MOST RECENT PRIOR
APROTININ EXPOSURE.
TRAS YLOL SHOULD BE ADMINISTERED ONLY IN OPERATIVE SETTINGS WHERE
CARDIOPULMONARY BYPASS
CAN BE RAPIDLY INITIATED. THE BENEFIT OF TRASYLOL TO PATIENTS UNDERGOING PRIMARY CABG
SURGERY SHOULD BE WEIGHED AGAINST THE RISK OF ANAPHYLAXIS ASSOCIATED
WITH ANY SUBSEQUENT
EXPOSURE TO APROTININ. (SEE CONTRAINDICATIONS, WARNINGS AND
PRECAUTIONS.)
DESCRIPTION
Trasylol
(aprotinin injection), C
H
N O S , is a natural proteinase inhibitor obtained from
bovine lung. Aprotinin (molecular weight of 6512 daltons), consists of
58 amino acid residues that are
arranged in a single polypeptide chain, cross-linked by three
disulfide bridges. It is supplied as a clear,
colorless, sterile isotonic solution for intravenous administration.
Each milliliter contains 10,000 KIU
(Kallikrein Inhibitor Units) (1.4 mg/mL) and 9 mg sodium chloride in
water for injection. Hydrochloric
acid and/or sodium hydroxide is used to adjust the pH to 4.5-6.5.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Aprotinin is a broad spectrum protease inhibitor which modulates the
systemic inflammatory response
(SIR) associated with cardiopulmonary bypass (CPB) surgery. SIR
results in the interrelated activation
of the hemostatic, fibrinolytic, cellular and humoral inflammatory
systems. Aprotinin, through its
inhibition of multiple mediators