ULTRA

Main information

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

Documents

Localization

  • Available in:
  • ULTRA FLORA SB DYSBIOSIS METAGENICS
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212870
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212870

ULTRA FLORA SB DYSBIOSIS METAGENICS

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

2/08/2013

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 SB DYSBIOSIS METAGENICS

Product Type

Single Medicine Product

Effective date

2/08/2013

Warnings

If diarrhoea persists for more than 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3-6 years or 48 hours

in adults and children over 6 years, seek medical advice (or words to that effect).

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

Drink plenty of water (or words to that effect).

Standard Indications

Relief or treatment of diarrhoea. [Warning DIAR required]

Specific Indications

Saccharomyces boulardii may assist with the management of dysbiosis.

Saccharomyces boulardii may assist in supporting normal healthy gastrointestinal immunity.

Saccharomyces boulardii may enhance the cellular immune response in normal healthy individuals.

Saccharomyces boulardii may reduce the risk of travellers diarrhoea.

Saccharomyces boulardii may be beneficial for the relief of acute diarrhoea.

Saccharomyces boulardii may reduce the frequency of diarrhoea.

Saccharomyces boulardii may assist with the relief and treatmeent of diarrhoea.

Saccharomyces boulardii may be beneficial in maintaining a normal healthy gut function.

Saccharomyces boulardii may assist in maintaining normal healthy gut flora.

If you have been taking a course of antibiotics, a probiotic yeast product such as Saccharomyces boulardii may assist with maintaining / supporting

normal healthy gut flora.

Bifidobacterium lactis Bi-07, when used in combination with other probiotics, may help to maintain normal healthy gut flora.

Ultra Flora SB Dysbiosis contains Saccharomyces cerevisiae (Boulardii) which may be beneficial for the treatmeent and relief of diarrhoea, reducing the

risk of traveller's diarrhoea and reducing the frequency of diarrhoea.

Saccharomyces cerevisiae (Boulardii) may assist in the management of dysbiosis and in maintaining healthy gut function and flora. Ultra Flora SB

Dysbiosis may also enhance the cellular immune response in healthy people.

Dysbiosis Control.

Additional Product information

Pack Size/Poison information

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:57:00 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 Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Bifidobacterium lactis

5 billion organisms

Saccharomyces cerevisiae (Boulardii)

7.5 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 26.11.2017 at 11:57:00 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

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

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