GEMZAR 1gm POWDER FOR SOLUTION FOR INFUSION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

GEMCITABINE HCL 1144mg EQV GEMCITABINE

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

L01BC05

Dosage:

1000mg

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

GEMCITABINE HCL 1144mg EQV GEMCITABINE 1000mg

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Vianex S.A. - Plant C (Bulk Manufacturer and Primary Packager)

Authorization status:

ACTIVE

Authorization date:

2006-12-22

Patient Information leaflet

1 
1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

'Gemzar'. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Gemcitabine hydrochloride equivalent to 200mg gemcitabine. 

Gemcitabine hydrochloride equivalent to 1g gemcitabine. 

Gemcitabine (INN) is a pyrimidine analogue. 

3. 
PHARMACEUTICAL FORM 

Vials containing powder for solution for infusion. 

4. 
CLINICAL PARTICULARS 

4.1 
Therapeutic indications 

_Non-Small Cell Lung Cancer: _
Gemcitabine in combination with cisplatin is indicated as a first
line treatment of patients 
with locally advanced (inoperable Stage IIIA or IIIB) or metastatic
(Stage IV) non-small cell 
lung cancer. 

Gemcitabine is indicated for the palliative treatment of adult
patients with locally advanced 
or metastatic non-small cell lung cancer. 

_Pancreatic Cancer: _
Gemcitabine is indicated for the treatment of adult patients with
locally advanced or 
metastatic adenocarcinoma of the pancreas. Gemcitabine is indicated
for patients with 5-FU 
refractory pancreatic cancer. 

_Bladder Cancer: _
Gemcitabine is indicated for treatment of advanced
bladder cancer (muscle invasive Stage IV 
tumours with or without metastases) in combination with cisplatin
therapy. 

_Breast Cancer: _
Gemcitabine, in combination with paclitaxel, is indicated for the
treatment 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. 

4.2_ _
Posology and method of administration 

_Non-Small Cell Lung Cancer:_ 
2 
_Combination use: _Adults: Gemcitabine in combination with cisplatin
has been investigated 
using two dosing regimen. One regimen used a three week schedule
and the other used a four 
week schedule._ _
The three week schedule used gemcitabine 1250mg/m
2
, given by 30 minute intravenous 
infusion, on

Summary of Product characteristics

Page
1
of
24
1.
NAME OF THE MEDICINAL PRODUCT
Gemzar 200mg powder for solution for infusion
Gemzar 1,000mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains gemcitabine hydrochloride equivalent to 200mg
gemcitabine.
One vial contains gemcitabine hydrochloride equivalent to 1,000mg
gemcitabine.
After reconstitution, the solution contains 38 mg/ml of gemcitabine.
EXCIPIENTS
Each 200mg vial contains 3.5mg (< 1mmol) sodium.
Each 1000mg vial contains 17.5mg (<1 mmol) sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white plug or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC)
Gemcitabine, in combination with cisplatin, is indicated as a first
line treatment of patients with
locally advanced (inoperable Stage IIIA or IIIB) or metastatic (Stage
IV) NSCLC.
Gemcitabine is indicated for the palliative treatment of adult
patients with locally advanced or
metastatic NSCLC.
Pancreatic cancer
Gemcitabine is indicated for the treatment of adult patients with
locally advanced or metastatic
adenocarcinoma of the pancreas. Gemcitabine is indicated for patients
with 5- FU refractory
pancreatic cancer.
Bladder cancer
Page
2
of
24
Gemcitabine is indicated for the treatment of advanced bladder cancer
(muscle invasive Stage
IV tumours with or without metastases) in combination with cisplatin
therapy.
Breast Cancer
Gemcitabine, in combination with paclitaxel, is indicated for the
treatment 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Non-Small Cell Lung Cancer (NSCLC):
_Monotherapy_: The recommended dose of gemcitabine is 1,000 mg/m
2
, given by 30-minute
intravenous infusion. This should be repeated once weekly for 3 weeks,
followed by