Xeloda

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Capecitabine 150mg;  

Sẵn có từ:

Roche Products (NZ) Ltd

INN (Tên quốc tế):

Capecitabine 150 mg

Liều dùng:

150 mg

Dạng dược phẩm:

Film coated tablet

Thành phần:

Active: Capecitabine 150mg   Excipient: Croscarmellose sodium Hypromellose Lactose Magnesium stearate Microcrystalline cellulose Opadry pink 03A14309

Các đơn vị trong gói:

Blister pack, PVC/PVDC, 60 tablets

Lớp học:

Prescription

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

F Hoffmann-La Roche Ltd

Chỉ dẫn điều trị:

Xeloda is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated. Xeloda in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 60 tablets - 36 months from date of manufacture stored at or below 30°C

Ngày ủy quyền:

1997-11-27

Tờ rơi thông tin

R 

Xeloda
®
 CMI 110427 

1 of 8 
DS110427 
CONSUMER MEDICINE INFORMATION 
XELODA
®
CAPECITABINE  
150MG AND 500MG FILM-COATED TABLETS  
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about XELODA tablets.

It does not contain all the available information. It does not take
the place of talking to your doctor or pharmacist. 
All medicines have risks and benefits.  Your doctor has weighed the
risks of you taking XELODA tablets against the benefits 
they expect it will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE.   
You may need to read it again. 
WHAT XELODA IS USED FOR  
XELODA contains the active ingredient capecitabine. 
XELODA belongs to a group of medicines called
anti-neoplastic agents. Within this group, XELODA belongs to a
class of 
medicines called fluoropyrimidine analogues.  
XELODA is used to treat cancer of the bowel and
rectum (colorectal), oesophagus, stomach and breast.  It may be
prescribed 
alone or in combination with other medicines used to treat cancer.

The medicine contained in XELODA tablets, capecitabine, is converted
by liver and cancer cells to another substance called 5-
fluorouracil (also called 5-FU). 
It is 5-FU that acts to kill or stop the growth of cancer
cells. 
Your doctor may have prescribed XELODA for another purpose.   
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY XELODA HAS BEEN
PRESCRIBED FOR YOU.  
This medicine is available only with a doctor’s prescription. 
XELODA is not addictive. 
R 

Xeloda
®
 CMI 110427 

2 of 8 
DS110427 
BEFORE YOU TAKE XELODA 
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE XELODA IF: 
1.  YOU HAVE HAD AN ALLERGY TO  
•  CAPECITABINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET 
•  5-FLUOROURACIL (ALSO KNOWN AS 5-FU), A MEDICINE USED TO TREAT
CANCER 
•  OTHER FLUOROPYRIMIDINE MEDICINES 
Some of

Đặc tính sản phẩm

Xeloda
®
 DS 120302 

1 of 23 
CDS 8.0, AUS PI 110202

DATA SHEET

XELODA
®

_Capecitabine tablets 150 mg and 500 mg _
_CYTOSTATIC AGENT _
PHARMACEUTICAL FORM 
Film-coated tablets 150 mg and 500 mg. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
ACTIVE INGREDIENT 
Capecitabine. 
_ _
EXCIPIENTS 
Anhydrous lactose, croscarmellose sodium,
hypromellose, microcrystalline cellulose, magnesium 
stearate, titanium dioxide, talc, yellow and red iron oxide. 

APPEARANCE 
Xeloda 150 mg film-coated tablets are light peach in colour,
biconvex/oblong in shape with Xeloda 
engraved on one face and 150 engraved on the reverse.  

Xeloda 500 mg film-coated tablets are peach in colour,
biconvex/oblong in shape with Xeloda 
engraved on one face and 500 on the reverse. 
CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
BREAST CANCER 
Xeloda is indicated for the treatment of patients with locally
advanced or metastatic breast cancer after 
failure of taxanes and an anthracycline containing chemotherapy
regimen unless therapy with these 
and other standard agents are clinically contraindicated.   

Xeloda in combination with docetaxel is indicated for the
treatment of patients with locally advanced or 
metastatic breast cancer after failure of prior anthracycline
containing chemotherapy 

COLON CANCER 
Xeloda is indicated for the adjuvant treatment of patients with
Dukes’ Stage C and high-risk Stage B 
colon cancer, either as monotherapy or in combination with
oxaliplatin. 

Xeloda
®
 DS 120302 

2 of 23 
CDS 8.0, AUS PI 110202

COLORECTAL CANCER 
Xeloda is indicated for first-line treatment of patients with
metastatic colorectal cancer. 

OESOPHAGOGASTRIC CANCER 
Xeloda is indicated for the first-line treatment of patients with
advanced oesophagogastric cancer in 
combination with a platinum-based regimen. 

_DOSAGE AND ADMINISTRATION _
STANDARD DOSAGE 
Xeloda tablets should be swallowed with water within 30 minutes after
a meal.�