MultiGest

Main information

  • Trade name:
  • MultiGest Enzymes
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MultiGest Enzymes
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216328
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216328

MultiGest Enzymes

ARTG entry for

Medicine Listed

Sponsor

FIT-BioCeuticals Limited

Postal Address

PO Box 6454,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

22/10/2013

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. MultiGest Enzymes

Product Type

Single Medicine Product

Effective date

22/10/2013

Warnings

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

Standard Indications

Helps maintain healthy digestive function.

Aids digestion.

Specific Indications

P381 Used in herbal medicine to aid digestion.

P382 Aids digestive function/digestion.

P370 Traditionally used in herbal medicine to help relieve digestive disturbances including bloating and flatulence.

P371 Traditionally used in herbal medicine for the symptomatic relief of digestive disturbances including bloating and flatulence.

P369 Traditionally used in herbal medicine to help relieve digestive disturbances (dyspepsia).

P375 Traditionally used in herbal medicine to help relieve digestive disturbances such as flatulent dyspepsia (carminitive).

P361 Traditionally used in herbal medicine as a bitter to increase appetite.

P384 Traditionally used in herbal medicine as a bitter to aid digestion.

P393 Traditionally used in herbal medicine as a digestive tonic to aid digestion.

P143 Helps the body to metabolise proteins.

P388 Digestive enzyme to assist in the digestion of foods containing lactose (e.g. dairy foods, milk).

1.By assisting healthy digestion supplemental enzymes potentially help maintain general wellbeing and healthy nutritional status.

2.The enzymes in this blend may help to maintain healthy digestive function and improve bioaccessibility to nutrients.

3.F. vulgare (fennel) has been traditionally used in Roman and Egyptian herbal medicine to improve digestion / as a carminitive, aromatic digestive, for

dyspepsia, bloating, flatulence and poor appetite.

4. F. vulgare (fennel) has been traditionally used in Iranian herbal medicine as a carminitive and stomach tonic.

5. F. vulgare (fennel) has been traditionally used in Serbian herbal medicine to relieve digestive problems, improve appetite, as a carminitive and as an

anti-spasmodic.

6. F. vulgare (fennel) has been traditionally used in Indonesia herbal medicine for the symptomatic relief of digestive ailments.

7.G. lutea (gentian) promotes the secretion of saliva, gastric juices and bile by stimulation of the vagus nerve.

8. The bitter herb G.lutea (gentian) was traditionally used in ancient Greece and Rome herbal medicine for gastrointestinal symptoms/digestive

disturbances/as a digestive tonic/to aid digestion (for nausea relief and to stimulate appetite).

9. Bromelain assists in the digestion of protein.

10. Bromelains digestive activity is based on its ability to hydrolyze proteins to oligopeptides and amino acids.

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:27:59 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

11. Bromelains proteolytic enzymes are cysteine proteases. Cysteine proteases cleave peptide bonds by nucleophilic attack via active-site cysteine

residues.

12. Protease aids in the digestion of protein.

13. Cellulase aids in the digestion of cellulose.

14. Lipase assists in the digestion of lipids.

15. Lactase assists in the digestion of milk sugar (lactose).

16. Amylase aids in the digestion of carbohydrates.

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

Amylase

12 thousand DU

Bromelains

40 mg

cellulase

1000 CU

Foeniculum vulgare

167 mg

Equivalent: Foeniculum vulgare (Dry)

1.67 g

Gentiana lutea

134 mg

Equivalent: Gentiana lutea (Dry)

670 mg

Lipase

500 LipU

Protease

30 Thousand HUT

Tilactase

1.5 thousand ALU

© 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 07:27:59 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