NEUPOGEN- filgrastim injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

FILGRASTIM (UNII: PVI5M0M1GW) (FILGRASTIM - UNII:PVI5M0M1GW)

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

FILGRASTIM

Sammensetning:

FILGRASTIM 300 ug in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

NEUPOGEN® is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (see CLINICAL EXPERIENCE ). A complete blood count (CBC) and platelet count should be obtained prior to chemotherapy‚ and twice per week (see LABORATORY MONITORING ) during NEUPOGEN® therapy to avoid leukocytosis and to monitor the neutrophil count. In phase 3 clinical studies‚ NEUPOGEN® therapy was discontinued when the ANC was ≥ 10‚000/mm3 after the expected chemotherapy-induced nadir. NEUPOGEN® is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML. NEUPOGEN® is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ eg‚ febrile neutropenia‚ in patients with nonmyeloid malignancies undergoi

Produkt oppsummering:

NEUPOGEN® : Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration. Use only one dose per prefilled syringe. Discard unused portions. Do not save unused drug for later administration. Single-dose‚ preservative-free vials containing 300 mcg (1 mL) of Filgrastim (300 mcg/mL). 1 Vial (NDC 54868-2522-0 );  Dispensing packs of 10 (NDC 54868-2522-1 ). Single-dose‚ preservative-free, prefilled syringes with 27 gauge, ½ inch needles with an UltraSafe® Needle Guard, containing 300 mcg (0.5 mL) of Filgrastim (600 mcg/mL). Dispensing packs of 10 (NDC 54868-5020-0 ). Single-dose‚ preservative-free, prefilled syringes with 27 gauge, ½ inch needles with an UltraSafe® Needle Guard, containing 480 mcg (0.8 mL) of Filgrastim (600 mcg/mL). Dispensing packs of 10 (NDC 54868-3050-0 ). The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex). NEUPOGEN® should be stored at 2° to 8°C (36° to 46°F). Avoid shaking.

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

NEUPOGEN - FILGRASTIM INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Filgrastim is a human granulocyte colony-stimulating factor (G-CSF)‚
produced by recombinant DNA
technology. NEUPOGEN is the Amgen Inc. trademark for Filgrastim‚
which has been selected as the
name for recombinant methionyl human granulocyte colony-stimulating
factor (r-metHuG-CSF).
NEUPOGEN is a 175 amino acid protein manufactured by recombinant DNA
technology.
NEUPOGEN is produced by _Escherichia coli (E coli) _bacteria into
which has been inserted the human
granulocyte colony-stimulating factor gene. NEUPOGEN has a molecular
weight of 18‚800 daltons.
The protein has an amino acid sequence that is identical to the
natural sequence predicted from human
DNA sequence analysis‚ except for the addition of an N-terminal
methionine necessary for expression
in _E coli_. Because NEUPOGEN is produced in _E coli‚_ the product
is nonglycosylated and thus differs
from G-CSF isolated from a human cell.
NEUPOGEN is a sterile‚ clear‚ colorless‚ preservative-free
liquid for parenteral administration
containing Filgrastim at a specific activity of 1.0 ± 0.6 x 10 U/mg
(as measured by a cell mitogenesis
assay). The product is available in single use vials and prefilled
syringes. The single use vials contain
either 300 mcg or 480 mcg Filgrastim at a fill volume of 1.0 mL or 1.6
mL, respectively. The single
use prefilled syringes contain either 300 mcg or 480 mcg Filgrastim at
a fill volume of 0.5 mL or 0.8
mL, respectively. See table below for product composition of each
single use vial or prefilled syringe.
300 MCG/
1.0 ML VIAL
480 MCG/
1.6 ML VIAL
300 MCG/
0.5 ML SYRINGE
480 MCG/
0.8 ML SYRINGE
Filgrastim
300 mcg
480 mcg
300 mcg
480 mcg
Acetate
0.59 mg
0.94 mg
0.295 mg
0.472 mg
Sorbitol
50.0 mg
80.0 mg
25.0 mg
40.0 mg
Polysorbate 80
0.04 mg
0.064 mg
0.02 mg
0.032 mg
Sodium
0.035 mg
0.056 mg
0.0175 mg
0.028 mg
Water for Injection
USP q.s. ad
1.0 mL
1.6 mL
0.5 mL
0.8 mL
CLINICAL PHARMACOLOGY
Colony-stimulating Factors
Colon