ULTRA

Main information

  • Trade name:
  • ULTRA FLORA RESTORE METAGENICS
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ULTRA FLORA RESTORE METAGENICS
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207049
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207049

ULTRA FLORA RESTORE METAGENICS

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

15/03/2013

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. ULTRA FLORA RESTORE METAGENICS

Product Type

Single Medicine Product

Effective date

15/03/2013

Warnings

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

Products containing bovine colostrum powder contain lactose and cow's milk proteins (or words to that effect). This product is not suitable for use in

children under the age of 12 months except on professional health advice.

Standard Indications

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

Specific Indications

Lactobacillus acidophilus and Lactobacillus rhamnosus may help to maintain a normal and / or healthy gastrointestinal system / health.

Lactobacillus acidophilus and Bifidobacterium lactis may promote the growth and increase the numbers of healthy flora within the body.

Ultra Flora Restore may assist in the restoration / balance healthy gut flora within the digestive system and healthy digestive function.

If you have been taking a course of antibiotics, Ultra Flora Restore may assist in restoring / maintaining the levels of normal healthy flora or friendly

bacteria that may have been disrupted.

All strains used are acid, bile and pancreatin resistant, survive the digestive tract and colonise the human gut.

High potency probiotic capsules.

Assists in restoring the levels of normal friendly bacteria.

Metagenics Ultra Flora Restore is a proprietary blend of Lactobacillus acidophilus (NCFM), Bifidobacterium lactis (Bi07) and Lactobacillus rhamnosus

(LGG) to restore healthy flora within the digestive system. If you have been taking a course of antibiotics, Ultra Flora Restore may assist in restoring the

levels of normal healthy flora (friendly bacteria) that may have been disrupted. Ultra Flora Restore helps to maintain a normal healthy gastrointestinal

system and digestive function.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Public Summary

Page 1 of

Produced at 28.11.2017 at 12:51:34 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

Route of Administration

Oral

Visual Identification

Active Ingredients

Bifidobacterium lactis

11.5 billion organisms

bovine colostrum powder

62 mg

Lactobacillus acidophilus

11.5 billion organisms

Lactobacillus rhamnosus

2 billion organisms

© 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 28.11.2017 at 12:51:34 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

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

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