PACLITAXEL LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PACLITAXEL

Available from:

IVAX PHARMACEUTICALS INCORPORATED

ATC code:

L01CD01

INN (International Name):

PACLITAXEL

Dosage:

6MG

Pharmaceutical form:

LIQUID

Composition:

PACLITAXEL 6MG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0124214001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2015-10-16

Summary of Product characteristics

PRODUCT MONOGRAPH
PACLITAXEL FOR INJECTION
6 mg/mL
ANTINEOPLASTIC AGENT
Manufacturer:
IVAX Pharmaceuticals Inc.
Date of Preparation:
4400 Biscayne Blvd.,
April 1998
Miami, Florida, USA
33137
Date of Revision:
December 20, 2005
Distributed by:
IVAX Pharmaceuticals Canada Inc.
Control #102197
1 Place Ville-Marie, Suite 3900
Montreal, Quebec, Canada
H3B 4M7
1
PRODUCT MONOGRAPH
PACLITAXEL FOR INJECTION
6 mg/mL
THERAPEUTIC CLASSIFICATION
ANTINEOPLASTIC AGENT
PACLITAXEL FOR INJECTION SHOULD BE ADMINISTERED UNDER THE SUPERVISION
OF
A PHYSICIAN EXPERIENCED IN THE USE OF CANCER CHEMOTHERAPEUTIC AGENTS.
PATIENTS RECEIVING PACLITAXEL FOR INJECTION SHOULD BE PRETREATED WITH
CORTICOSTEROIDS,
ANTIHISTAMINES,
AND
H
2
ANTAGONISTS
(SUCH
AS
DEXAMETHASONE, DIPHENHYDRAMINE AND CIMETIDINE OR RANITIDINE) TO
MINIMIZE
HYPERSENSITIVITY REACTIONS (SEE DOSAGE AND ADMINISTRATION). _ALL
CLINICAL_
_STUDIES REFERRED TO IN THIS PRODUCT MONOGRAPH WERE CONDUCTED USING_
_TAXOL® PACLITAXEL. _SEVERE HYPERSENSITIVITY REACTIONS CHARACTERIZED
BY
DYSPNEA
AND
HYPOTENSION
REQUIRING
TREATMENT,
ANGIOEDEMA,
AND
GENERALIZED URTICARIA HAVE OCCURRED IN PATIENTS RECEIVING PACLITAXEL
FOR
INJECTION. THESE REACTIONS ARE PROBABLY HISTAMINE MEDIATED. RARE FATAL
REACTIONS HAVE OCCURRED IN PATIENTS DESPITE PRE-TREATMENT. PATIENTS
WHO
EXPERIENCE SEVERE HYPERSENSITIVITY REACTIONS TO PACLITAXEL FOR
INJECTION
SHOULD NOT BE RECHALLENGED WITH THE DRUG.
ACTIONS AND CLINICAL PHARMACOLOGY
PACLITAXEL FOR INJECTION is a novel antimicrotubule agent that
promotes the assembly of
microtubules from tubulin dimers and stabilizes microtubules by
preventing depolymerization.
_In vitro_, PACLITAXEL FOR INJECTION exhibits cytotoxic activity
against a wide variety of both
human and rodent tumor cell lines including leukemia, non-small cell
lung carcinoma, small cell lung
carcinoma, colon carcinoma, CNS carcinoma, melanoma, renal carcinoma,
ovarian carcinoma and
breast carcinoma (see PHARMACOLOGY).
The pharmacokinetics of paclitaxel have been evaluated over a wide
range of doses, up to
300