Docetaxel Ebewe

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Docetaxel 10 mg/mL

Available from:

Novartis New Zealand Ltd

INN (International Name):

Docetaxel 10 mg/mL

Dosage:

80 mg/8mL

Pharmaceutical form:

Concentrate for injection

Composition:

Active: Docetaxel 10 mg/mL Excipient: Citric acid Ethanol Macrogol 300 Nitrogen Polysorbate 80

Units in package:

Vial, glass, 80 mg/8 mL x 1 vial, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sicor de Mexico SA de CV

Product summary:

Package - Contents - Shelf Life: Vial, glass, 80 mg/8 mL x 1 vial - 1 dose units - 18 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 80 mg/8 mL x 5 vials - 5 dose units - 18 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2008-08-18

Patient Information leaflet

Docetaxel Ebewe_CMI_V2_Dec14_clean.doc Page 1 of 5
DOCETAXEL EBEWE
Docetaxel Concentrated Injection Vial
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Docetaxel Ebewe.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits
and risks. Your doctor has
weighed the risks of you taking
Docetaxel against the benefits
this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET,
YOU MAY
NEED TO READ IT AGAIN.
It is important to remember
that Docetaxel Ebewe is a
PRESCRIPTION ONLY
MEDICINE.
Docetaxel Ebewe will only be
given to you by specially
trained personnel in a hospital
environment.
WHAT DOCETAXEL EBEWE IS
USED FOR
Docetaxel Ebewe is used to
treat breast cancer, ovarian
cancer, some types of lung
cancer and prostate cancer.
Docetaxel Ebewe works by
stopping cells from growing
and multiplying.
Docetaxel Ebewe belongs to a
group of medicines called
antineoplastic or cytotoxic
medicines. You may also hear
of these being called
chemotherapy medicines.
YOUR DOCTOR MAY HAVE
PRESCRIBED DOCETAXEL EBEWE
FOR ANOTHER REASON. ASK YOUR
DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
DOCETAXEL EBEWE HAS BEEN
PRESCRIBED FOR YOU.
You may have previously been
given another medicine to treat
your breast, ovarian, lung or
prostate cancer. However, your
doctor has now decided to treat
you with Docetaxel Ebewe.
Docetaxel Ebewe may be used
alone or in combination with
other medicines to treat cancer.
Docetaxel Ebewe is not
addictive.
BEFORE YOU ARE GIVEN
DOCETAXEL EBEWE
TELL YOUR DOCTOR IF YOU ARE
TAKING ANY OTHER MEDICINES,
INCLUDING PRESCRIPTION
MEDICINES OR ANY THAT YOU
BUY WITHOUT A PRESCRIPTION
FROM YOUR PHARMACY,
SUPERMARKET OR HEALTH FOOD
SHOP.
Docetaxel is not recommended
for use in children.
_WHEN YOU MUST NOT BE GIVEN _
_THIS MEDICINE: _
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE HAD AN
ALLERGIC RE

Summary of Product characteristics

Page 1 of 47 
DATA SHEET 
DOCETAXEL EBEWE 
NAME OF THE MEDICINE 
_NON-PROPRIETARY NAME _
Docetaxel 

_CHEMICAL STRUCTURE _

_CAS NUMBER _
114977-28-5 

_CHEMICAL NAME: _
(2R, 3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13 ester with 5
, 20-
epoxy-1,2
,4,7,10
-hexahydroxytax-11-en-9-one  4-  acetate  2- 
benzoate N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol. 

DESCRIPTION 
_DOCETAXEL _

Docetaxel  is  a  white  to  almost  white  powder  with  the  empirical  formula 
C
43
H
53
NO
14
 and a molecular weight of 807.55. It is
practically insoluble in water 
and poorly soluble in hexane, butanol, octanol
and propylene glycol. 
_ _

_DOCETAXEL EBEWE CONCENTRATED INJECTION  _
Single-dose  vials  of  Docetaxel  Ebewe  concentrated  injection  contains  20  or 
80mg of docetaxel (anhydrous). Each mL of docetaxel solution contains 10mg 
docetaxel anhydrous, 4mg citric acid anhydrous, 648mg macrogol 300, 80mg 
polysorbate 90, 275.90mg ethanol 96%. 

Page 2 of 47 

PHARMACOLOGY 

_CLASS _
Docetaxel  Ebewe  is  an  antineoplastic  agent  which  acts  by  promoting  the 
assembly  of  tubulin  into  stable  microtubules  and  inhibits  their  disassembly 
which leads to a marked decrease of free tubulin. The binding of docetaxel to 
microtubules does not alter the number of protofilaments. 

_SITE AND MODE OF ACTION _
Docetaxel has been shown _in vitro_ to disrupt the microtubular network in cells 
which is essential for vital mitotic
and interphase cellular functions. 

_PHARMACODYNAMICS _
PRECLINICAL DATA 
Docetaxel  was  found  to  be  cytotoxic  _in  vitro_  against  various  murine  and 
human  tumour  cell  lines  and  against  freshly  excised  human  tumour  cells  in 
clonogenic assa