ZOFRASET ondansetron (as hydrochloride dihydrate) 4 mg/2 mL solution for injection pre-filled syringe

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

Buy It Now

Active ingredient:
ondansetron hydrochloride dihydrate
Available from:
Accord Healthcare Pty Ltd
Authorization status:
Registered
Authorization number:
338223

Read the complete document

Public Summary

Summary for ARTG Entry:

338223

ZOFRASET ondansetron (as hydrochloride dihydrate) 4 mg/2 mL solution for injection pre-filled syringe

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street, Melbourne, VIC, 3000

Australia

ARTG Start Date

9/11/2020

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 . ZOFRASET ondansetron (as hydrochloride dihydrate) 4 mg/2 mL solution for injection pre-filled syringe

Product Type

Single Medicine Product

Effective Date

12/11/2020 11:49:45 AM

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Ondansetron injection is indicated

· For the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

· For the prevention and treatment of post-operative nausea and vomiting.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Coloured 24 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

Pack of 1 pre-filled syringe

(S4) Prescription Only Medicine

Components

1 . ZOFRASET 4 mg/2 mL ondansetron injection 4 mg/2 mL solution for injection pre-filled syringe

Dosage Form

Injection, solution

Route of Administration

Intravenous

Intramuscular

Visual Identification

Clear, colourless solution in an amber glass pre-filled syringe

Active Ingredients

ondansetron hydrochloride dihydrate

4.99 mg

Public Summary

Page 1 of

Produced at 12.01.2021 at 07:27:23 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

Equivalent: ondansetron

4 mg

Other Ingredients (Excipients)

citric acid monohydrate

hydrochloric acid

sodium chloride

sodium citrate dihydrate

sodium hydroxide

water for injections

© 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 12.01.2021 at 07:27:23 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