Public Summary

Summary for ARTG Entry: 22460 BIOLOGICAL THERAPIES SODIUM ASCORBATE 30g WITH ETHANOL powder for injection 100mL vial

ARTG entry for Medicine Registered

Sponsor Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

Postal Address PO Box 702, BRAESIDE, VIC, 3195
Australia
ARTG Start Date 8/10/1991
Product Category Medicine
Status Active
Approval Area Drug Safety Evaluation Branch

Conditions

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Applying to Therapeutic Goods
Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

Products

1 . BIOLOGICAL THERAPIES SODIUM ASCORBATE WITH ETHANOL 30g powder for injection vial
Product Type Single Medicine Product Effective Date 3/07/2002

Public Summary
Permitted Indications
No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. Indications held in ARTG paper records. (Old
code)

Specific Indications

Sodium Ascorbate Injections are indicated for the treatment of vitamin C deficiency when oral treatment is not feasible

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type Material Life Time Temperature Closure Conditions

Vial Glass Type I Coloured 1 Years Store below 30 Not recorded Protect from Light
degrees Celsius

Pack Size/Poison information

Pack Size Poison Schedule

1 X 30g powder in 100mL vial. Not scheduled. Not considered by committee

Components
1 . Medicine Component

Dosage Form Injection, powder for

Route of Administration Intravenous
Visual Identification White or very slightly yellow crystalline powder

Active Ingredients

sodium ascorbate 30 g

Other Ingredients (Excipients)

ethanol absolute

Page 1 of 2 Produced at 15.08.2020 at 11:07:50 AEST

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 2 Produced at 15.08.2020 at 11:07:50 AEST

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