PACLITAXEL injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

PACLITAXEL (UNII: P88XT4IS4D) (PACLITAXEL - UNII:P88XT4IS4D)

Dostępny od:

WG Critical Care, LLC

INN (International Nazwa):

PACLITAXEL

Skład:

PACLITAXEL 6 mg in 1 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma ). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included

Podsumowanie produktu:

Paclitaxel Injection, USP (6 mg/mL) is available as follows: NDC 44567-504-01 30 mg/5 mL multidose vial individually packaged in a carton NDC 44567-505-01 100 mg/16.7 mL multidose vial individually packaged in a carton NDC 44567-506-01 300 mg/50 mL multidose vial individually packaged in a carton Store the vials in original cartons between 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature]. Retain in the original package to protect from light. See DOSAGE AND ADMINISTRATION, Preparation and Administration Precautions.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

PACLITAXEL- PACLITAXEL INJECTION
WG CRITICAL CARE, LLC
----------
PACLITAXEL INJECTION, USP
(Patient Information Included)
Rx only
WARNING
Paclitaxel should be administered under the supervision of a physician
experienced
in the use of cancer chemotherapeutic agents. Appropriate management
of
complications is possible only when adequate diagnostic and treatment
facilities are
readily available.
Anaphylaxis and severe hypersensitivity reactions characterized by
dyspnea and
hypotension requiring treatment, angioedema, and generalized urticaria
have
occurred in 2 to 4% of patients receiving paclitaxel in clinical
trials. Fatal reactions
have occurred in patients despite premedication. All patients should
be pretreated
with corticosteroids, diphenhydramine, and H antagonists (see DOSAGE
AND
ADMINISTRATION). Patients who experience severe hypersensitivity
reactions to
paclitaxel should not be rechallenged with the drug.
Paclitaxtel therapy should not be given to patients with solid tumors
who have
baseline neutrophil counts of less than 1,500 ccells/mm and should not
be given
to patients with AIDS-related Kaposi’s sarcoma if the baseline
neutrophil count is
less than 11,000 cells/mm . In order to monitor the occurrence of bone
marrow
suppression, primarily neutropenia, which may be severe and result in
infection, it
is recommended that frequent peripheral blood cell counts be performed
on all
patients receiving paclitaxel.
.
DESCRIPTION
Paclitaxel Injection, USP is a clear, colorless to slightly yellow
viscous solution. It is
supplied as a nonaqueous solution intended for dilution with a
suitable parenteral fluid
prior to intravenous infusion. Paclitaxel Injection, USP is available
in 30 mg (5 mL), 100
mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile
nonpyrogenic
solution contains 6 mg paclitaxel, USP, 527 mg of purified polyoxyl 35
castor oil* and
49.7% (v/v) dehydrated alcohol, USP.
*Polyoxyl 35 castor oil is further purified by Corden Pharma before
use.
Paclitaxel is a natural product with ant