AS-DOCETAXEL docetaxel 20mg/0.5mL concentrated solution for injection vial with diluent vial

Main information

  • Trade name:
  • AS-DOCETAXEL docetaxel 20mg/0.5mL concentrated solution for injection vial with diluent vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AS-DOCETAXEL docetaxel 20mg/0.5mL concentrated solution for injection vial with diluent vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 181993
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

181993

AS-DOCETAXEL docetaxel 20mg/0.5mL concentrated solution for injection vial with diluent vial

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

23/10/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. AS-DOCETAXEL docetaxel 20mg/0.5mL concentrated solution for injection vial with diluent vial

Product Type

Single Medicine Product

Effective date

2/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

1. Breast Cancer

a) Metastatic Breast Cancer,AS-DOCETAXEL INJECTION is indicated for the treatment of patients with locally advanced or metastatic breast cancer in

whom previous chemotherapy has failed. AS-DOCETAXEL INJECTION 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. AS-DOCETAXEL INJECTION in combination

with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not

received chemotherapy for metastatic disease.,b). Adjuvant Treatment of Breast Cancer,AS-DOCETAXEL INJECTION in combination with doxorubicin

and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. Doxorubicin and cyclophosphamide followed

by AS-DOCETAXEL INJECTION in combination with trastuzumab (AC- TH) is indicated for the adjuvant treatment of patients with operable breast

cancer whose tumours overexpress HER2. AS-DECETAXEL INJECTION in combination with carboplatin and trastuzumab (TCH) is indicated for the

adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. AS-DOCETAXEL INJECTION in combination with

cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of greater than or equal to 1cm and < 7cm.,2.

Non Small Cell Lung Cancer,AS-DOCETAXEL INJECTION is indicated for the treatment of patients with locally advanced or metastatic non small cell

lung cancer, including those who have failed platinum-based chemotherapy.,3.Ovarian Cancer,AS-DOCETAXEL INJECTION is indicated for the

treatment of metastatic carcinoma of the ovary after failure of first- line or subsequent chemotherapy.,4.Prostate Cancer,AS-DECETAXEL INJECTION is

indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer.,5. Head and Neck Cancer,AS-DOCETAXEL

INJECTION, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients

with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the

tumour is technically unresectable.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

18 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

20mg/0.5ml vial

(S4) Prescription Only Medicine

Components

1. AS-DOCETAXEL docetaxel 20mg/0.5mL concentrated solution for injection vial with diluent vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Clear, colorless to pale yellow viscous solution free from visible particles.

Active Ingredients

Docetaxel

20 mg

Public Summary

Page 1 of

Produced at 29.11.2017 at 07:30:11 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 29.11.2017 at 07:30:11 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information