DBL™ Gemcitabine for Injection

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Gemcitabine hydrochloride 227.7mg Equivalent to 200 mg gemcitabine base;  ;  

から入手可能:

Pfizer New Zealand Limited

INN（国際名）:

Gemcitabine hydrochloride 227.7 mg (Equivalent to 200 mg gemcitabine base)

投薬量:

200mg/vial

医薬品形態:

Powder for injection

構図:

Active: Gemcitabine hydrochloride 227.7mg Equivalent to 200 mg gemcitabine base     Excipient: Hydrochloric acid Mannitol Sodium acetate trihydrate Sodium hydroxide

パッケージ内のユニット:

Vial, glass, 20mm clear Type 1 glass, 10 mL

クラス:

Prescription

処方タイプ:

Prescription

製:

Jiangsu Hansoh Pharmaceutical Co Ltd

適応症:

Non-Small Cell Lung Cancer: gemcitabine, alone or in combination with cisplatin, is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer.

製品概要:

Package - Contents - Shelf Life: Vial, glass, 20mm clear Type 1 glass - 10 mL - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted (not refrigerated) stored at or below 25°C. +/- 5 degrees C, exposed to light when reconstitutes to 38 mg/mL with 0.9% NaCI

承認日:

2007-07-25

製品の特徴

Version: pfdgemsi10620
Supersedes:pfdgemsi10320
Page 1 of 24
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL™ Gemcitabine Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gemcitabine hydrochloride 43.3 mg/mL (equivalent to gemcitabine 38
mg/mL). Each vial
contains gemcitabine hydrochloride. DBL Gemcitabine Injection contains
no antimicrobial
agent or preservatives.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
DBL
Gemcitabine
Injection
is
a
clear,
colourless
to
light
straw-coloured
solution
for
intravenous use.
Gemcitabine hydrochloride is a white to off-white powder. Gemcitabine
is an acidic
compound. The free base is soluble in water, slightly soluble in
methanol, and practically
insoluble in ethanol and polar organic solvents.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER
: gemcitabine, alone or in combination with cisplatin, is
indicated for the first line treatment of patients with locally
advanced or metastatic non-small
cell lung cancer.
PANCREATIC CANCER
: gemcitabine is indicated for treatment of patients with locally
advanced
or metastatic adenocarcinoma of the pancreas. Gemcitabine is indicated
for patients with 5-
FU refractory pancreatic cancer. Patients treated with gemcitabine may
derive improvement
in survival, significant clinical benefit, or both.
BLADDER CANCER
: gemcitabine is indicated for the treatment of patients with bladder
cancer.
BREAST CANCER
: gemcitabine, in combination with paclitaxel, is indicated for the
first line
treatment of patients with unresectable, locally recurrent or
metastatic breast cancer who have
relapsed
following
adjuvant/neoadjuvant
chemotherapy,
containing
anthracycline,
unless
clinically contraindicated.
OVARIAN
CANCER
:
gemcitabine,
in
combination
with
carboplatin,
is
indicated
for
the
treatment of patients with recurrent epithelial ovarian carcinoma who
have relapsed following
platinum-based therapy.
Version: pfdgemsi10620
Supersedes:pfdgemsi10320
Page 2 of 24
4.2 DOSE AND