BULGARICUM

Main information

  • Trade name:
  • BULGARICUM
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BULGARICUM
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 83245
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

83245

BULGARICUM

ARTG entry for

Medicine Listed

Sponsor

Tass Allis T/a BioMedData Services

Postal Address

PO Box 431,KINGSFORD, NSW, 2032

Australia

ARTG Start Date

24/06/2002

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. BULGARICUM

Product Type

Single Medicine Product

Effective date

11/04/2011

Warnings

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

Contains lactose (or words to that effect).

Standard Indications

Helps maintain healthy digestive function.

Aids digestion.

Specific Indications

Lactobacillus delbrueckii subspecies bulgaricus is a specially selected type of beneficial microorganism in natural yogurt. An important transient flora that

helps maintain healthy intestinal flora, aids digestion and absorption. A. A transient yet important, bacterium in human ecology. B. Facultative anaerobic

lactobacilli which produce lactic acid as a main product from their usage of dietary carbohydrate. C. Optimum growth is at 40-43 degrees C [ 104-109

degrees F ] as with other lactobacilli, these bacteria produce small amounts of hydrogen peroxide, which is inhibitory to many undesirable

microorganisms and yeasts. D. Some strains produce natural antibiotic substances. E. When eaten or taken supplementally, these bacteria can benefit

humans by enhancing digestion of milk sugar by producing the enzyme lactase. F. As with other lactic acid bacteria, their production of lactic acid

creates a more acidic environment which strongly inhibits less desirable microorganisms. G. The immune system of the host may be modulated by the

consumption of these bacteria. H. Mild proteolytic activity of these bacteria may aid the digestion of nutrients, particularly milk protein. I. Helps in lactose

metabolism and enhances digestion of milk products. J. May improve nutrient absorption. K. Helps alleviate gas, bloating and upper G.I. problems. L.

Helps maintain normal healthy cholesterol levels. M. Encourages and acidic intestinal environment which strongly inhibits less desirable microorganisms.

N. Contributes to growth and viability of the beneficial resident microorganisms [ Lactobacillus acidophilus, Bifidobacterium bifidum, etc ] by supporting

their growth and activity. O. Helps the body digest complex carbohydrates and proteins. P. Helps to increase the bioavailability of minerals, especially

calcium. The absorption is doubly important in lactose-intolerant individuals who may also experience a deficiency of dietary calcium. Q. May also

produce anti-microbial substances antagonistic to various bad bacteria. . . .

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Public Summary

Page 1 of

Produced at 01.12.2017 at 10:35:01 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

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

Lactobacillus delbrueckii ssp bulgaricus

2 billion organisms/g

© 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 01.12.2017 at 10:35:02 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

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