GEMPLAN gemcitabine 1000 mg (as hydrochloride) powder for injection vial

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

gemcitabine hydrochloride, Quantity: 1.14 g (Equivalent: gemcitabine, Qty 1 g)

Beschikbaar vanaf:

Medis Pharma Pty Ltd

INN (Algemene Internationale Benaming):

Gemcitabine hydrochloride

farmaceutische vorm:

Injection, powder for

Samenstelling:

Excipient Ingredients: mannitol; sodium hydroxide; sodium acetate trihydrate

Toedieningsweg:

Intravenous Infusion

Eenheden in pakket:

1 x 50 mL vial

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Treatment of patients with locally advanced or metastatic non-small cell lung cancer. Treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Treatment of patients with FU refractory pancreatic cancer. Treatment of patients with bladder cancer, alone or in combination with cisplatin. Treatment, in combination with paclitaxel, of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/ neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. Treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed >six months following platinum based therapy.

Product samenvatting:

Visual Identification: White or almost white lyophilisate; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2010-06-07

Bijsluiter

CONSUMER MEDICINE
INFORM ATION
GEMPLAN

Productkenmerken

PRODUCT INFORMATION
NAME OF THE MEDICINE
GEMPLAN
gemcitabine (as hydrochloride) 200mg powder for injection
gemcitabine (as hydrochloride) 1000mg powder for injection
NON-PROPRIETARY NAME: Gemcitabine Hydrochloride
sustained worsening in any of the parameters. Sustained worsening was
defined as four
consecutive weeks with either an increase in pain intensity or
analgesic consumption or a
20 point decrease in performance status occurring during the first 12
weeks of therapy.
Or
2. The patient was stable on all aforementioned parameters and showed
a marked
sustained weight gain (greater than or equal to 7% increase maintained
for greater than
or equal to four weeks), not due to fluid accumulation.
The first study was a multicentre, prospective, single blinded, two
arm, randomised
comparison of gemcitabine and FU in patients with locally advanced or
metastatic
pancreatic cancer who had received no prior treatment with
chemotherapy. FU was
administered intravenously at a weekly dose of 600 mg/m
2
for 30 minutes. The results
for this randomised trial are shown in TABLE 1. Compared to FU,
patients treated with
gemcitabine had statistically significant increases in symptomatic
improvement, survival
and time to progressive disease (23.8% versus 4.8%).
TABLE 1
Summary of Gemcitabine vs FU in pancreatic cancer
Gemcitabine
FU
Number of patients
63
63
Total: 126
Stage IV disease
71.4%
76.2%
Baseline KPS ≤ 70
69.8%
68.3%
Clinical response
1
23.8%
(N=15)
4.8%
(N=3)
p=0.0022
Survival
p=0.0009
Median
5.7 months
4.2 months
6 month probability
46% (N=30)
29%(N=19)
9 month probability
24%(N=14)
5%(N=4)
1 year probability
18%(N=9)
2%(N=2)
Range
0.2 to 18.6 months
0.4 to 15.1
+
months
Time to progressive disease
p=0.0013
Median
2.1 months
0.9 months
Range
0.1
+
to 9.4 months
0.1 to 12.0
+
months
1
As per previous definition, + =no progression of disease at last
visit, still alive
The second trial was a multicentre, open label study of 63 patients
with advanced pancreatic
cancer previously treated with FU or a FU containing regimen.