Faulding

Main information

  • Trade name:
  • Faulding Vita-Shot Vitality
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Faulding Vita-Shot Vitality
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220458
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220458

Faulding Vita-Shot Vitality

ARTG entry for

Medicine Listed

Sponsor

Symbion Pty Ltd

Postal Address

PO Box 7300,Melbourne, VIC, 3008

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.

Products

1. Faulding Vita-Shot Vitality

Product Type

Single Medicine Product

Effective date

9/04/2014

Warnings

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.

Standard Indications

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

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)

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

Beneficial during times of stress. [Warning S required]

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

Specific Indications

* Supplies essential nutrients to help meet normal daily requirements.

* Contains antioxidant nutrients, which can assist in protecting the body from the damaging effects of free radicals.

* Contains nutrients with free radical scavenging activity.

* 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.

* Pantothenic acid, pyridoxine and cyanocobalamin are involved in immune system processes in the body.

* 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, nicotinamide, pantothenic acid and cyanocobalamin are involved in energy metabolism/the production of energy in the body.

* Helps the body convert food into energy.

* Pantothenic acid plays a critical role in energy production.

* Provides nutrients that are essential in the body for the production of energy.

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

* Contains nutrients 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.

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:23:51 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

* Thiamine, pantothenic acid, biotin and cyanocobalamin are involved in the metabolism of carbohydrates in the body.

* Biotin functions in the human body as an essential co-factor for enzyme that are involved in the metabolism of carbohydrates, fats and proteins.

* Pantothenic acid, biotin and cyanocobalamin are involved in the metabolism of protein, or amino acids in the body.

* Thiamine, pantothenic acid and cyanocobalamin are involved in the metabolism of carbohydrates in the body.

* Contains nutrients essential for healthy nervous system function.

* Supports the health and function of the nervous system.

* Contains nutrients required in the body for nerve cell function.

* Supports neuromuscular function.

* Supports healthy brain function.

* Contains nutrients necessary for healthy brain function.

* Vitamin B6 is an essential cofactor in the synthesis of neurotransmitters such as dopamine, norepinephrine, and serotonin.

* Supports red blood cell health.

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

* 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 the B group) and minerals during periods of stress.

* During stress, nutrients such as Vitamin B6 and vitamin B5 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.

* Some of the B group vitamins, such as vitamin B6 are involved in the manufacture and action of mood enhancing hormones such as serotonin.

* Provides support to the nervous system.

* Supports healthy nervous system function.

* Supports the health and function of the nervous system.

* Contains nutrients that are involved in hormone synthesis and modulation.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Oral Liquid

Route of Administration

Oral

Visual Identification

Active Ingredients

Biotin

100 microgram/mL

Calcium pantothenate

50 mg/mL

Cyanocobalamin

12 microgram/mL

Nicotinamide

18 mg/mL

pyridoxine hydrochloride

40 mg/mL

Thiamine nitrate

10 mg/mL

© 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 02:23:51 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