Faulding

Main information

  • Trade name:
  • Faulding Remedies Glucosamine Plus Chondroitin
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Faulding Remedies Glucosamine Plus Chondroitin
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222006
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222006

Faulding Remedies Glucosamine Plus Chondroitin

ARTG entry for

Medicine Listed

Sponsor

Symbion Pty Ltd

Postal Address

PO Box 7300,Melbourne, VIC, 3008

Australia

ARTG Start Date

4/04/2014

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in

the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,

(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be

kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine

outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. Faulding Remedies Glucosamine Plus Chondroitin

Product Type

Single Medicine Product

Effective date

4/04/2014

Warnings

Derived from seafood.

If symptoms persist consult your healthcare practitioner (or words to that effect).

Standard Indications

May help reduce joint swelling associated with arthritis.

May help reduce joint inflammation associated with arthritis.

May assist in the management of osteoarthritis. [Warning S required]

Symptomatic relief of osteoarthritis. [Warning S required]

May help increase joint mobility associated with arthritis.

Temporary relief of the pain of osteoarthritis (or) Temporary relief of osteoarthritic pain. [Warning S required]

May assist in the management of osteoarthritic pain. [Warning S required]

Temporary relief of the pain of arthritis. (or) Temporary relief of arthritic pain. [Warning S required]

Aids, assists or helps in the maintenance or improvement of general well-being.

For mineral (may state the mineral) supplementation.

Specific Indications

* Glucosamine is produced naturally in the body and are important/vital components of cartilage.

* Glucosamine assists in building and maintaining healthy cartilage, which is essential for healthy function of the joints.

* Glucosamine plays a role in the body in the formation of the articular cartilage, tendons, ligaments, synovial fluid & bone.

* Glucosamine is necessary in the body for the structure and function of the articular cartilage.

* Helps maintain healthy joint function and provides structural support to the joints.

* Glucosamine is a naturally occurring compound that help maintain healthy cartilage.

* Assists in maintaining joint flexibility and function.

* Helps to maintain healthy joint cartilage.

* Helps to maintain the health of the joints.

* Supports/maintains healthy joints.

* Chondroitin is produced naturally in the body and plays a necessary role in maintaining the health of the joints.

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:14:34 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

* Chondroitin is an important/vital component of cartilage.

* Chondroitin assists in building and maintaining healthy cartilage, which is essential for healthy function of the joints.

* Chondroitin helps to build and maintain the cartilage, tendons and ligaments in the joints.

* Chondroitin is necessary in the body for the structure and function of the articular cartilage.

* Chondroitin helps maintain healthy joint function and provides structural support to the joints.

* Chondroitin is a naturally occurring compounds that help maintain healthy cartilage.

* Chondroitin is produced naturally in the body where it assists in maintaining the elasticity and the integrity of the connective tissue.

* Glucosamine sulphate helps in the synthesis of new cartilage and reduces the breakdown of existing cartilage.

* Manganese is involved in the metabolism of carbohydrates, amino acids and lipids.

* Manganese is an essential nutrient that acts as a cofactor in several metabolic and enzymatic reactions.

* Manganese is a component of the principal mitochondrial antioxidant manganese superoxide dismutase.

* Manganese plays a role in the synthesis of proteoglycans that are needed for the formation of healthy bone and cartilage.

* Boron is involved in several functions in the body, including cell membrane function and stability.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Borax

8.8 mg

bovine sodium chondroitin sulfate

400 mg

glucosamine sulfate sodium chloride

942 mg

Manganese gluconate

8.8 mg

© 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 26.11.2017 at 12:14:34 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

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

There are no news related to this product.