Eagle CytoPro Balance 50B capsules

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
Bifidobacterium bifidum,Bifidobacterium breve,Bifidobacterium infantis,Bifidobacterium lactis,Bifidobacterium longum,Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus helveticus,Lactobacillus plantarum,Lactobacillus rhamnosus,Streptococcus thermophilus
Available from:
Integria Healthcare Australia Pty Ltd
INN (International Name):
Bifidobacterium bifidum,Bifidobacterium breve,Bifidobacterium infantis,Bifidobacterium lactis,Bifidobacterium longum,Lactobacill
Authorization status:
Listed
Authorization number:
291078

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Public Summary

Summary for ARTG Entry:

291078

Eagle CytoPro Balance 50B capsules

ARTG entry for

Medicine Listed

Sponsor

Integria Healthcare Australia Pty Ltd

Postal Address

PO Box 4854,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

6/07/2017

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. Eagle CytoPro Balance 50B capsules

Product Type

Single Medicine Product

Effective date

25/07/2017

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

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

Aids digestion.

Specific Indications

Helps maintain/support healthy microbial population in the colon and small intestine

Assists in the maintenance of healthy intestinal flora balance after antibiotic use

Helps support healthy intestinal function by helping to balance the brain-gut interaction

Helps decrease digestive symptoms including bloating, gas, abdominal discomfort and constipation caused by an imbalance of intestinal flora

Helps maintain a healthy gastrointestinal system

Helps maintain healthy immune system function

Assists in maintenance of general health and wellbeing

Assists in the management of allergic rhinitis (inflammation of the nasal mucous membranes)

Helps decrease/reduce/relieve mild diarrhoea and bowel discomfort

May assist in the management of symptoms of medically diagnosed IBS such as abdominal pain, bloating, flatulence, constipation, diarrhoea

May assist the digestion of lactose

May improve the symptoms associated with lactose malabsorption

Helps regulate stool frequency and consistency

Helps maintain gut barrier function

Probiotics competitively inhibit pathogenic organisms

May help reduce gastrointestinal symptoms related to stress such as pain and frequency

For the symptomatic relief of medically diagnosed irritable bowel syndrome [GAST5]

Helps to reduce the incidence of and/or risk of anti-biotic-associated diarrhoea / Protects against anti-biotic-associated diarrhoea

May help to support gastro-intestinal health

Helps to maintain immune function / Supports a healthy immune system

Institut Rosell strains are documented as strains that adhere to and colonize the gut

Public Summary

Page 1 of

Produced at 24.11.2017 at 08:19:55 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

A healthy vaginal flora is colonized by various lactobacillus species

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Bifidobacterium bifidum

2.25 billion CFU

Bifidobacterium breve

3.15 billion CFU

Bifidobacterium infantis

.25 billion CFU

Bifidobacterium lactis

.15 billion CFU

Bifidobacterium longum

4.5 billion CFU

Lactobacillus acidophilus

.5 billion CFU

Lactobacillus casei

7.75 billion CFU

Lactobacillus helveticus

11 billion CFU

Lactobacillus plantarum

13 billion CFU

Lactobacillus rhamnosus

5 billion CFU

Streptococcus thermophilus

2.5 billion CFU

© 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 24.11.2017 at 08:19:55 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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