Omega

Main information

Documents

Localization

  • Available in:
  • Omega Cardio Max
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217426
  • Last update:
  • 10-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217426

Omega Cardio Max

ARTG entry for

Medicine Listed

Sponsor

Hazel Pharmaceuticals Pty Ltd

Postal Address

14 Junction Street,MARRICKVILLE, NSW, 2204

Australia

ARTG Start Date

18/11/2013

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. Omega Cardio Max

Product Type

Single Medicine Product

Effective date

18/11/2013

Warnings

Do not take while on warfarin therapy without medical advice.

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

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

Standard Indications

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

For vitamin (may state the vitamin) supplementation.

Helps maintain normal blood/blood tonic (Note: These claims are appropriate for folic acid, vitamin B12 and iron, but must not imply anaemic conditions)

Protects capillaries.

Maintain health of capillaries.

May assist in the maintenance of normal blood pressure in healthy individuals.

May help to support normal blood pressure in healthy individuals.

Source of vitamin B12. Can assist in maintaining normal blood. Blood tonic.

May help reduce the oxidation of LDL cholesterol.

Source of folic acid. Can assist in maintaining normal blood.

Source of folic acid. Can assist in maintaining normal blood. Blood tonic.

Source of vitamin B12. Can assist in maintaining normal blood.

Specific Indications

* Coenzyme Q10 is essential for the production of energy in the body.

* Coenzyme Q10 is involved in the production of ATP, or cellular energy.

* Coenzyme Q10 is found in the mitochondria of the body cells, where it plays an essential role in the electron transport chain and ATP synthesis.

* Coenzyme Q10 is involved in the production of energy through its essential role in the electron transport chain.

* Cyanocobalamin are involved in energy metabolism/the production of energy in the body.

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:20:04 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

* Helps the body convert food into energy.

* Contains nutrients that assist in energy metabolism in the body.

* Coenzyme Q10 is a potent antioxidant, or free radical scavenger.

* The antioxidant properties of Coenzyme Q10 assists in protecting the cells from potential free radical damage/damage attributed to free radicals.

* Contains ingredients with potent antioxidant activity and therefore assists in protecting the body from the damaging effects of free radicals.

* Fallopia japonica is a rich source of the antioxidant, resveratrol.

* Assist in the maintenance of a normal/healthy cardiovascular system.

* Assists in the maintenance of heart function.

* Maintains healthy heart tissue.

* Supports the health of the blood vessels.

* Contains nutrients that help maintain cardiovascular health.

* A source of pyridoxine, folic acid and cyanocobalamin. Low plasma levels of these vitamins has been associated with high blood levels of

homocysteine, a biologic marker associated with an increased risk of reduced or diminished well being.

* The amount of coenzyme Q10 in the body decreases with age.

* Assists in the maintenance of a healthy immune system.

* Coenzyme Q10 supports healthy immune function.

* Supports healthy immune system function.

* Supports the health and function of the immune system.

* Contains nutrients that play important roles in the proper functioning of the immune system.

* Pyridoxine and cyanocobalamin are involved in immune system processed in the body.

* Maintains normal healthy brain function.

* Supports brain health.

* Helps to maintain healthy cognitive function.

* Maintains normal healthy nervous system.

* Omega 3 fatty acids help to maintain a healthy nervous system.

* Omega-3 essential fatty acids are necessary for healthy nervous system function.

* Supports the health and function of the nervous system.

* Omega 3 fatty acids are very important as the body cannot produce them and they can therefore only obtain them from the diet.

* Contains nutrients essential for carbohydrate, protein and fat metabolism.

* Supports healthy metabolism of proteins, carbohydrates and fats in the body.

* Supports red blood cell health.

* Folic acid can assist in maintaining normal blood.

* Folic acid is one of the nutrients necessary for the production of normal red blood cells.

* Contains nutrients that can assist in maintaining normal blood. Blood tonic.

* Contains Polygonum cuspidatum, which has a long history of use in Traditional Chinese Medicine to relieve symptoms of cough with phlegm and

menstrual pain.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

concentrated fish Omega-3 triglycerides

650.0009 mg

Cyanocobalamin

.75 mg

Folic acid

200 microgram

Levocarnitine

100 mg

pyridoxal 5-phosphate

25 mg

Reynoutria japonica

85 mg

Equivalent: Reynoutria japonica (Dry)

8.5 g

Ubidecarenone

50 mg

© 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 06:20:04 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