Swisse

Main information

Documents

Localization

  • Available in:
  • Swisse Men's Ultivite 50+
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219832
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219832

Swisse Men's Ultivite 50+

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

4/02/2014

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.

The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph

Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27) as in force or existing from time to time. This

condition does not apply to powdered or dried leaf.

Products

1. Swisse Men's Ultivite 50+

Product Type

Single Medicine Product

Effective date

20/10/2015

Warnings

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).

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

Do not take while on warfarin therapy without medical advice.

Contains lactose (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.

Standard Indications

Specific Indications

A factor in the maintenance of good health. / Helps support general health and wellbeing.

Helps provide nutritional support during periods of nervous tension and stress. / B vitamins help support/maintain a healthy nervous system.

B Vitamins help support energy production.

Helps support/Assists with men's health and wellbeing. / Helps fill nutritional gaps.

Contains vitamins, minerals, antioxidants and herbs to help meet/support the nutritional needs and maintain general wellbeing of men aged 50+.

Vitamin C, selenium and cranberry act as antioxidants to help protect against potential free radical damage/provide antioxidant support.

May assist in/support the management of dietary folate deficiency.

Folate, iron, vitamin B6 and vitamin B12 support/maintain red blood cell formation. Iron supports/assists/helps maintain proper red blood cell function.

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

Zinc helps support/maintain connective tissue formation.

Zinc helps to maintain/support/is essential for healthy skin.

Zinc may help support male reproductive health.

B complex vitamins are needed for the metabolism of food into energy, they assist with energy production, stamina, vitality.

Vitamin C helps to regulate normal immune function. / Vitamin C helps to support healthy immune function. / Vitamin C is essential/important for

maintaining/supporting a healthy immune response.

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:41:31 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

Vitamin C helps/is involved in the synthesis of collagen which is important/essential for the development/maintenance of healthy skin, bones, tendons,

cartilage and gums.

B Vitamins in the body may be lower when lifestyles include processed foods, alcohol, sugar, or caffeine.

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 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.

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

Contains vitamins D, K and manganese. These nutrients are required for bone health.

Contains zinc; the prostate gland has the highest concentration of zinc of any organ in the male body.

Contains vitamin B6; vitamin B6 is important/essential for the synthesis of some neurotransmitters.

Contains folic acid; folic acid has a role in a number of reactions in the body essential for normal brain function.

Contains zinc; zinc is found in high concentrations in the retina of the eye. Retinal zinc content may decline with age.

Contains lutein, one of the key antioxidant carotenoids found in healthy eyes/to support healthy eye function.

Vitamin D helps/supports the absorption of calcium and phosphorus. Vitamin D and vitamin A help in/support the development and maintenance of

bones and teeth.

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

Folate helps the body metabolise protein.

Vitamin A helps in the maintenance of eyesight/supports healthy eyesight/supports healthy eyesight and in the maintenance and development of night

vision.

Vitamin A helps to maintain skin membranes/structure.

Adequate levels of zinc help to support healthy skin and minor wound healing. / Zinc assists with minor wound healing.

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

Biotin

100 microgram

calcium ascorbate dihydrate

100 mg

Calcium orotate

50 mg

Calcium pantothenate

37.5 mg

Chromium picolinate

201 microgram

Citrus bioflavonoids extract

10 mg

colecalciferol

.0025 mg

Copper gluconate

6.07 mg

Crataegus monogyna

15 mg

Equivalent: Crataegus monogyna (Dry)

60 mg

Cyanocobalamin

60 microgram

Cynara scolymus

6.25 mg

Equivalent: Cynara scolymus (Fresh)

25 mg

d-alpha-Tocopheryl acid succinate

12.5 mg

Dulacia inopiflora

10 mg

Equivalent: Dulacia inopiflora (Dry)

100 mg

Ferrous fumarate

8 mg

Folic acid

250 microgram

Ginkgo biloba

10 mg

Equivalent: Ginkgo biloba (Dry)

500 mg

lutein

.5 mg

Magnesium aspartate dihydrate

50 mg

Manganese amino acid chelate

20 mg

molybdenum trioxide

33.75 microgram

Nicotinamide

12.5 mg

Phytomenadione

35 microgram

potassium iodide

98 microgram

pyridoxine hydrochloride

12.5 mg

retinol acetate

.4312 mg

Riboflavin

17.5 mg

Scutellaria lateriflora

6.25 mg

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:41:31 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

Equivalent: Scutellaria lateriflora (Dry)

25 mg

Selenomethionine

32.5 microgram

Serenoa repens

15 mg

Equivalent: Serenoa repens (Dry)

150 mg

Silybum marianum

12.14 mg

Equivalent: Silybum marianum (Dry)

850 mg

soy phosphatidylserine-enriched soy lecithin powder

5 mg

Spearmint Oil

1 mg

Thiamine hydrochloride

17.5 mg

Tribulus terrestris

5 mg

Equivalent: Tribulus terrestris (Dry)

250 mg

Tribulus terrestris

5 mg

Equivalent: Tribulus terrestris (Dry)

250 mg

Ubidecarenone

1.5 mg

Urtica dioica

5 mg

Equivalent: Urtica dioica (Dry)

25 mg

Vaccinium macrocarpon

10 mg

Equivalent: Vaccinium macrocarpon (Fresh)

500 mg

Vaccinium myrtillus

500 microgram

Vitis vinifera

4.17 mg

Equivalent: Vitis vinifera (Dry)

500.4 mg

zinc amino acid chelate

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 3 of

Produced at 23.11.2017 at 12:41:31 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