Irinotecan hydrochloride Injection 100 mg in 5 mL (11)

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:
irinotecan hydrochloride trihydrate
Available from:
Pfizer (Perth) Pty Ltd
Authorization status:
Listed (Export Only)
Authorization number:
322606

Public Summary

Summary for ARTG Entry:

322606

Irinotecan hydrochloride Injection 100 mg in 5 mL (11)

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Pfizer (Perth) Pty Ltd

Postal Address

PO Box 1007,BENTLEY DC, WA, 6983

Australia

ARTG Start Date

3/09/2019

Product category

Medicine

Status

Active

Approval area

Export only Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i)

each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each

overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1. Irinotecan hydrochloride Injection 100 mg in 5 mL (11)

Product Type

Single Medicine Product

Effective date

3/09/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Irinotecan is indicated for single-agent or combination treatment of patients with:

·Metastatic carcinoma of the colon or rectum that has recurred or progressed following 5-flurouracil (5-FU) - based therapy.

· Previously untreated metastatic carcinoma of the colon or rectum.

· Non-small cell lung cancer.

· Small cell lung cancer.

· Cervical cancer.

· Ovarian cancer.

· Inoperable or recurrent gastric cancer.

· Esophageal cancer.

Irinotecan in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR) - expressing, KRAS

wild-type metastatic colorectal cancer, who had not received prior treatment for metastatic disease after failure of irinotecan including cytotoxic therapy.

Irinotecan in combination with 5-FU, folinic acid (FA) and bevacizumab is indicated for first line treatment of patients with metastatic carcinoma of the

colon or rectum.

Irinotecan in combination with capecitabine with or without bevacizumab is indicated for first-line treatment of patients with metastatic colorectal

carcinoma.

Irinotecan is indicated for single-agent treatment of patients with:

· Inoperable or recurrent breast cancer.

· Squamous cell carcinoma of skin.

· Malignant melanoma.

· Malignant lymphoma.

· Pancreatic cancer.

· Glioma.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

24 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Public Summary

Page 1 of

Produced at 23.10.2019 at 06:21:22 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

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 5 mL

(S1) This Schedule is intentionally blank

Components

1.

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

Clear, light yellow solution, free from visible particles.

Active Ingredients

irinotecan hydrochloride trihydrate

20 mg/mL

© 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 23.10.2019 at 06:21:22 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

Similar products

Search alerts related to this product

Share this information