Swisse

Main information

Documents

Localization

  • Available in:
  • Swisse Men's Ultivite 65+
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220441
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220441

Swisse Men's Ultivite 65+

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

25/02/2014

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 65+

Product Type

Single Medicine Product

Effective date

23/10/2015

Warnings

Not for the treatment of iron deficiency conditions (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.

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.

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

for men.

Do not take while on warfarin therapy without medical advice.

Standard Indications

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

Specific Indications

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

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

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

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.

Helps support/assist with men's health and wellbeing.

B vitamins help support energy production.

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

Knotweed is a rich/great source of resveratrol, a potent antioxidant which may act to protect against potential free radical damage.

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

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:34:22 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

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

Assists with/Helps support/maintain/contributes to men's health and wellbeing.

Contains vitamins, minerals, antioxidants and herbs to help meet/support the nutritional needs and maintain general wellbeing of men aged 65+.

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

Vitamin A helps to maintain skin membranes/structure.

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

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

Folate helps the body metabolise protein.

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

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/healthy immune system.

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.

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.

Vitamin C helps with the formation of connective tissue and healing process of minor wounds.

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

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

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 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.

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

200 microgram

calcium ascorbate dihydrate

200 mg

Calcium orotate

100 mg

Calcium pantothenate

109.15 mg

Chromium picolinate

402.3 microgram

Citrus bioflavonoids extract

20 mg

colecalciferol

.025 mg

Copper gluconate

12.14 mg

Crataegus monogyna

30 mg

Equivalent: Crataegus monogyna (Dry)

120 mg

Cyanocobalamin

200 microgram

Cynara scolymus

1 mg

Equivalent: Cynara scolymus (Fresh)

50 mg

d-alpha-Tocopheryl acid succinate

25 mg

Dulacia inopiflora

20 mg

Equivalent: Dulacia inopiflora (Dry)

200 mg

Ferrous fumarate

16.01 mg

Folic acid

500 microgram

Ginkgo biloba

20 mg

Equivalent: Ginkgo biloba (Dry)

lutein

1 mg

Magnesium aspartate dihydrate

100 mg

Manganese amino acid chelate

40 mg

molybdenum trioxide

67.5 microgram

Nicotinamide

100 mg

Phytomenadione

70 microgram

potassium iodide

196 microgram

pyridoxine hydrochloride

50 mg

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:34:22 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

retinol acetate

.8625 mg

Reynoutria japonica

80 mg

Equivalent: Reynoutria japonica (Dry)

Riboflavin

50 mg

Scutellaria lateriflora

12.5 mg

Equivalent: Scutellaria lateriflora (Dry)

50 mg

Selenomethionine

124.2 microgram

Serenoa repens

75 mg

Equivalent: Serenoa repens (Dry)

300 mg

Silybum marianum

24.29 mg

Equivalent: Silybum marianum (Dry)

1.7 g

soy phosphatidylserine-enriched soy lecithin powder

10 mg

Spearmint Oil

2 mg

Thiamine hydrochloride

50 mg

Tribulus terrestris

10 mg

Equivalent: Tribulus terrestris (Dry)

500 mg

Tribulus terrestris

10 mg

Equivalent: Tribulus terrestris (Dry)

500 mg

Ubidecarenone

3 mg

Urtica dioica

5 mg

Equivalent: Urtica dioica (Dry)

50 mg

Vaccinium macrocarpon

2 mg

Equivalent: Vaccinium macrocarpon (Fresh)

Vaccinium myrtillus

1 mg

Equivalent: Vaccinium myrtillus (Fresh)

100 mg

Vitis vinifera

8.33 mg

Equivalent: Vitis vinifera (Dry)

zinc amino acid chelate

100 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 12:34:22 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