Adhealth

Main information

Documents

Localization

  • Available in:
  • Adhealth F
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220200
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220200

Adhealth F

ARTG entry for

Medicine Listed

Sponsor

Biomedica Nutraceuticals Pty Ltd

Postal Address

PO Box 7052,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

17/02/2014

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. Adhealth F

Product Type

Single Medicine Product

Effective date

3/12/2015

Warnings

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

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

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

Standard Indications

Help reduce effects of mild anxiety and nervous tension. [Warning S required]

Helps relieve nervous unrest. [Warning S required]

Beneficial during times of stress. [Warning S required]

Non-vitamin active ingredients may improve stress adaptation.

Helps relieve nervous tension, stress and mild anxiety. [Warning S required]

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

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

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

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

Herbal blend which helps relieve stress of study or work. [Warning S required]

Specific Indications

* Siberian ginseng supports mental and physical performance.

* Siberian Ginseng may be beneficial during times/cases of stress

*Zinc is an essential mineral for healthy ovulation in women.

*Zinc is necessary for healthy blood sugar regulation and is involved in carbohydrate metabolism.

*Zinc supports normal healthy blood sugar regulation in healthy people.

*Iodine is required for the synthesis of thyroid hormones in the body.

* Supports healthy brain function.

* Contains nutrients necessary for healthy brain function

Public Summary

Page 1 of

Produced at 23.11.2017 at 05:46:24 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

*Contains nutrients that are essential for healthy nervous system function.

*Supports the health and function of the nervous system

*Contains nutrients that are required in the body for nerve cell function and muscle action.

* Supports the health and function of the immune system.

* Zinc and vitamin B6 support immune function.

* Zinc and vitamin B6 support the healthy function of the immune system.

* Zinc and vitamin B6 are important for the health and function of the immune system.

* Zinc and vitamin B6 are important nutrients for a healthy immune response.

* Zinc is important for normal development and function of cells mediating non specific immunity such as neutrophils and natural killer cells and affecting

development of acquired immunity and T-lymphocyte function.

* Zinc is involved in cell-mediated and antibody-mediated immunity, thymus gland function and thymus hormone action.

* 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.

* Zinc and vitamin B6 support healthy hormonal balance.

* Zinc and vitamin B6 are important nutritional antioxidants and therefore assist in protecting the body from the damaging effects of free radicals.

*Contains nutrients that play an essential role in the production of energy in the body.

* Contains nutrients that play an essential role in the production of ATP/cellular energy.

* Thiamine and pantothenic acid are involved in energy metabolism/the production of energy in the body.

* Helps the body convert food into energy.

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

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

* Vitamin B6 assists in the metabolism protein/amino acids and fats.

*. Zinc is an essential trace mineral that is a component in over 200 enzymes in the body.

* Zinc is necessary for the proper action of many body hormones including sex hormones.

* Zinc supports the health and function of the female reproductive system.

*Supports healthy nervous system function and the synthesis of hormones.

*Supports neurotransmitter biosynthesis.

* In Traditional Indian Ayurvedic medicine Withania is used as a strengthening and rejuvenating tonic for weakness, fatigue and convalescence.

* Withania is classed as an adaptogenic herb and may therefore be beneficial during times of stress.

* Helps calm the nerves.

*Contains pantothenic acid, which is required for proper function of the adrenal gland.

*Pantothenic acid supports the adrenal glands in the making of cortisone and other adrenal hormones that counteract the stress response.

*The human body has increased requirements for the vitamins (especially B group)and minerals during periods of stress.

*During stress, nutrients such as Vitamin B5 and Vitamin B6 are important for supporting adrenal function.

*Vitamin B5 has long been considered the "anti-stress" vitamin because of its central role in adrenal function and cellular metabolism.

*Vitamin B6 is involved in the manufacture of mood enhancing hormones such as serotonin.

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

Ascorbic acid

40 mg

Calcium pantothenate

75 mg

chromium nicotinate

133.34 microgram

Eleutherococcus senticosus

40 mg

Equivalent: Eleutherococcus senticosus (Dry)

600 mg

magnesium phosphate pentahydrate

48.4 mg

Nicotinamide

15 mg

potassium iodide

98 microgram

pyridoxine hydrochloride

15 mg

Rehmannia glutinosa

50 mg

Equivalent: Rehmannia glutinosa (Dry)

300 mg

Riboflavin

10 mg

Selenomethionine

37.5 microgram

Thiamine hydrochloride

10 mg

Tyrosine

200 mg

Withania somnifera

80 mg

Equivalent: Withania somnifera (Dry)

1000 mg

zinc citrate dihydrate

9.35 mg

Public Summary

Page 2 of

Produced at 23.11.2017 at 05:46:24 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

© 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 3 of

Produced at 23.11.2017 at 05:46:24 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