Swisse

Main information

Documents

Localization

  • Available in:
  • Swisse Men's Power Ultivite
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220162
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220162

Swisse Men's Power Ultivite

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

14/02/2014

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. Swisse Men's Power Ultivite

Product Type

Single Medicine Product

Effective date

23/10/2015

Warnings

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

Not for the treatment of iron deficiency conditions (or words to that effect).

The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents

for men.

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.

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

Standard Indications

Specific Indications

A factor in the maintenance of good health. / Supports/maintains general health and wellbeing and vitality/nutritional support. / Helps fill nutritional gaps. /

Provides nutritional support for men.

B vitamins are involved in/important for the metabolism of fats, carbohydrates and protein.

Folate helps the body metabolise protein.

Vitamin B2, B5, B6, and copper may help in tissue formation.

Folate, copper and vitamin B12 support/help maintain red blood cell formation.

Zinc and copper support/maintain connective tissue formation.

Zinc is important/helps to maintain/support healthy skin and supports minor wound healing

Zinc and vitamin A help maintain/support immune function/immune health/healthy immune system.

Contains, vitamin A, vitamin E and selenium, which act as antioxidants for the maintenance of good health/antioxidant support to help protect against

free radical damage.

Vitamin A helps maintain/support healthy eyesight.

Vitamin A helps to maintain skin membranes.

Vitamin A helps in the development and maintenance of healthy night vision.

Vitamin A and D help in the maintenance of bones and teeth/support healthy bones and teeth.

Vitamin D helps/assists in the absorption and utilisation of calcium and phosphorus.

Helps to support healthy vitamin D levels/source of vitamin D.

Choline helps support/maintain liver function.

Tribulus has been used in traditional western herbal medicine as a general tonic.

B Vitamins in the body are lower when lifestyles include processed foods, alcohol, sugar, caffeine and stress. /The body may have an increased need for

B group vitamins during periods of nervous tension and stress.

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:37:59 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

Helps provide nutritional support during periods of nervous tension and stress.

May assist in the management of dietary folate deficiency/source of folic acid.

B vitamins are involved in energy production. / Supports energy production.

B vitamins help support/maintain a healthy nervous system/nervous system support.

Pantothenic acid/Vitamin B5 contributes to normal/healthy mental performance.

Folic acid, vitamin B2, vitamin B6, vitamin B12 contribute to a reduction in tiredness & fatigue/help reduce fatigue.

Zinc may help support male reproductive health.

Healthy adrenal gland function plays an important role in an individual's stress response. Vitamin B5 and vitamin B6 are important for adrenal function,

helping to support the adrenal glands during periods of stress. Provides adrenal support during times of stress. During stress vitamin B5 and B6 may be

decreased/may/can be lower during times of stress. / The body may have an increased need for B group vitamins during periods of nervous tension and

stress. Vitamins B5 & B6 are important for the adrenals. Healthy adrenal function helps support the body's response to stress.

High potency multivitamin.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Biotin

100 microgram

Calcium pantothenate

130.99 mg

Choline bitartrate

120.35 mg

Chromium picolinate

32 microgram

colecalciferol

.025 mg

Copper gluconate

1 mg

Cyanocobalamin

240 microgram

d-alpha-Tocopheryl acid succinate

41.33 mg

Folic acid

500 microgram

Inositol

50 mg

Iron amino acid chelate

25 mg

Lysine hydrochloride

62.47 mg

Manganese amino acid chelate

10 mg

molybdenum trioxide

150 microgram

Nicotinamide

240 mg

Phytomenadione

50 microgram

potassium iodide

100 microgram

pyridoxine hydrochloride

60.77 mg

retinol acetate

.8625 mg

Reynoutria japonica

20 mg

Equivalent: Reynoutria japonica (Dry)

Riboflavin

120 mg

Selenomethionine

126 microgram

Serenoa repens

37.5 mg

Equivalent: Serenoa repens (Dry)

150 mg

Spearmint Oil

2 mg

Taurine

75 mg

Thiamine hydrochloride

134.55 mg

Tribulus terrestris

30 mg

Equivalent: Tribulus terrestris (Dry)

1.5 g

Tribulus terrestris

30 mg

Equivalent: Tribulus terrestris (Dry)

1.5 g

Vitis vinifera

8.33 mg

Equivalent: Vitis vinifera (Dry)

zinc amino acid chelate

40 mg

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:37:59 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

© 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 12:37:59 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