Docetaxel Sandoz

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Docetaxel 10 mg/mL

Dostupné z:

Novartis New Zealand Ltd

INN (Medzinárodný Name):

Docetaxel 10 mg/mL

Dávkovanie:

80 mg/8mL

Forma lieku:

Concentrate for infusion

Zloženie:

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

Počet v balení:

Vial, glass, with latex-free rubber stopper & flip-off aluminium crimp, 8 mL

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

Sicor de Mexico SA de CV

Terapeutické indikácie:

Metastatic Breast Cancer Docetaxel Sandoz is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. Docetaxel Sandoz in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

Prehľad produktov:

Package - Contents - Shelf Life: Vial, glass, with latex-free rubber stopper & flip-off aluminium crimp - 8 mL - 24 months from date of manufacture stored at or below 25°C 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Dátum Autorizácia:

2012-09-17

Príbalový leták

 
Docetaxel Sandoz


1 

DOCETAXEL SANDOZ

_ _
DOCETAXEL CONCENTRATED INJECTION FOR INFUSION
_ _

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about Docetaxel Sandoz.  

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 this medicine 
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. 
You may need to read it again. 
WHAT DOCETAXEL SANDOZ IS USED FOR 
The name of the medicine is called Docetaxel Sandoz. It contains the active ingredient docetaxel. 
Docetaxel belongs to a group of medicines called antineoplastic or cytotoxic medicines. These may also 
be called chemotherapy medicines. It works by killing cancer cells and stopping cancer cells from 
growing and multiplying. 

This medicine is used to treat
_ _


  breast cancer_ _

  ovarian cancer_ _

  some types of lung cancer_ _

  head and neck cancer_ _

  prostate cancer._ _

ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. 
Your doctor may have prescribed Docetaxel Sandoz for another reason. 

Docetaxel Sandoz may be used alone or in combination with other medicines to treat cancer. 

This medicine is not addictive. 
This medicine is available only with a doctor’s prescription.  
There is not enough information to recommend the use of this medicine for children.  

Docetaxel Sandoz


2

BEFORE YOU ARE GIVEN DOCETAXEL SANDOZ 
_WHEN YOU MUST NOT BE GIV

Súhrn charakteristických

_New Zealand Data Sheet_
Page 1 of 39
_Docetaxel Sandoz 20mg/2ml & 80mg/8ml concentrated injection for
infusion _
_ 12/2014_
_Sandoz Pty Ltd _
_ _
_ _
DATA SHEET
DOCETAXEL SANDOZ
®
20MG/2ML& 80MG/8ML
CONCENTRATEDINJECTION FOR INFUSION
NAME OF THE MEDICINE
_ _
Generic name:
Docetaxel
Chemical name:
1,7β, 10β-Trihydroxy-9-oxo-5β,20-epoxytax-11-ene-2α,4,13α-triyl
4-
acetate 2-benzoate 13-[(2_R_,3_S_)-3-[[(1,1-
dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoate]
CAS: 114977-28-5
Empirical formula: C
43
H
53
NO
14
MW: 807.88
DESCRIPTION
Docetaxel is a white to almost white powder. It is highly lipophilic
and practically insoluble
in water. The concentrated injection for infusion is a sterile clear,
colourless to pale yellow
solution free from visible particulates.
Docetaxel SandozConcentrated Injection for Infusion
Single-dose vials of Docetaxel Sandoz concentratedinjection for
infusion contain either 20mg
or 80mg of docetaxel, in 2.0mL or 8.0mL of solvent, respectively. The
sterile pyrogen-free
viscous solution contains a concentration of 10mg/mL docetaxel. Each
mL of Docetaxel
Sandoz concentrated injection for infusion contains the inactive
ingredients ethanol590.85mg,
polysorbate 80 268.25mgand citric acid, anhydrous 1mg.
_New Zealand Data Sheet_
Page 2 of 39
_Docetaxel Sandoz 20mg/2ml & 80mg/8ml concentrated injection for
infusion _
_ 12/2014_
_Sandoz Pty Ltd _
_ _
_ _
PHARMACOLOGY
Approval of Docetaxel Sandoz in New Zealand is on the basis of its
chemical similarity to the
New Zealand innovator product.
Docetaxel is an antineoplastic agent which acts by promoting the
assembly of tubulin into
stablemicrotubules and inhibits their disassembly which leads to a
marked decrease of free
tubulin. Thebinding of docetaxel to microtubules does not alter the
number of
protofilaments.Docetaxel has been shown _in vitro _to disrupt the
microtubular network in cells
which is essential for vital mitotic and interphase cellular
functions.
Pharmacodynamics
Docetaxel was found to be cytotoxic _in vitro _against vario