ImmunoFactors

Main information

  • Trade name:
  • ImmunoFactors
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ImmunoFactors
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217424
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217424

ImmunoFactors

ARTG entry for

Medicine Listed

Sponsor

FIT-BioCeuticals Limited

Postal Address

PO Box 6454,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

18/11/2013

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. ImmunoFactors

Product Type

Single Medicine Product

Effective date

22/06/2016

Warnings

If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.

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

for men.

WARNING - When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.

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).

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

Products containing [insert name of sugar alcohol(s)] may have a laxative effect or cause diarrhoea [or words to that effect].

Standard Indications

May reduce the severity and duration of colds. [Warning COLD required]

Specific Indications

P245 Assists in the management of mild upper respiratory tract infections.

P247 Helps to shorten the duration of upper respiratory tract infections (eg common cold).

P248 Supportive therapy in the management of mild upper respiratory tract infections (eg Common colds).

P252 Helps reduce the duration of colds.

P255 Relieves the symptoms of mild upper respiratory tract infections.

P256 Helps reduce the severity and duration of colds.

P257 Helps reduce the severity of colds.

P258 Helps reduce the severity of symptoms of colds.

P261 Helps to relieve the symptoms of mild upper respiratory tract infections (eg common cold).

P263 Assists in the management of colds.

P113 Traditionally used in herbal medicine to support a healthy immune system.

P114 Supports a healthy immune system.

[1] May provide nutritional support (Vitamin C, vitamin A and zinc) for a normal healthy immune system/ support the body's first line natural defences.

[2] May help provide relief from the symptoms of colds, including nasal congestion and sinusitis.

[3] For the symptomatic relief of mild upper respiratory tract infections.

[4] ImmunoFactors contains a blend of immunosupportive antioxidant nutrients, including vitamin C, vitamin A, quercetin and zinc.

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:20:29 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

[5] Elderflower has been used for centuries in traditional Western Herbal medicine to aid in the relief of symptoms of the common cold, including nasal

catarrah/sinus congestion (sinusitis).

[6] Elderberry has traditionally been used in Western herbal medicine as a diaphoretic and to support a healthy immune system.

[7] Numerous clinical studies support the use of vitamin C in reducing the severity and duration of colds.

[8] Vitamin C is a protective water soluble antioxidant. It can readily quench a variety of reactive free radicals.

[9] Vitamin C is involved in normal healthy iron metabolism.

[10] In vitro studies suggest quercetin down regulates the allergic response by reducing the release of histamine and supporting mast cell and basophil

integrity.

[11] Vitamin A plays an important role in the maintenance and integrity of mucous membranes which are in the first line of defence against minor

infections of the respiratory tract.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

80 mg/g

quercetin dihydrate

40 mg/g

retinol acetate

35.3855 microgram/g

Sambucus nigra

2 mg/g

Equivalent: Sambucus nigra (Dry)

100 mg/g

Sambucus nigra

66.67 mg/g

Equivalent: Sambucus nigra (Dry)

400 mg/g

zinc amino acid chelate

5 mg/g

© 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 06:20:29 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