Nutrition

Main information

Documents

Localization

  • Available in:
  • Nutrition Care Formula SF88
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220419
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220419

Nutrition Care Formula SF88

ARTG entry for

Medicine Listed

Sponsor

Nutrition Care Pharmaceuticals Pty Ltd

Postal Address

25-31 Keysborough Avenue,Keysborough, VIC, 3173

Australia

ARTG Start Date

24/02/2014

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. Nutrition Care Formula SF88

Product Type

Single Medicine Product

Effective date

24/02/2014

Warnings

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

WARNING - this medication may be dangerous when used in large amounts or for a long time; or WARNING - this product contains [insert pyridoxine

hydrochloride or pyridoxal 5-phosphate as applicable], which may be dangerous when used in large amounts or for a long time.

Standard Indications

Prevention/treatment of vitamin [XX] and/or mineral [YY] and/or nutritional deficiencies (This indication is not be to used for the treatment of iron

deficiency conditions).

For mineral (may state the mineral) supplementation.

Specific Indications

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

Contains nutrients with free radical scavenging activity. Antioxidant, or free radical scavenger.

Assists in protecting the cells of the body from free radical damage.

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.

Riboflavin, pantothenic acid, pyridoxine, cyanocobalamin, vitamin C and vitamin E are involved in immune system processed in the body.

Contains nutrients that are essential for healthy nervous system function.

Supports the health and function of the nervous system.

Contains nutrients that are required in the body for nerve cell function and muscle action.

Supports healthy brain function.

Contains nutrients necessary for healthy brain function.

Helps maintain normal blood/blood tonic

Supports red blood cell health.

Vitamin C improves iron absorption.

Folic acid can assist in maintaining normal blood.

Folic acid is one of the nutrients necessary for the production of normal red blood cells.

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

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

Supports healthy skin, hair and nails.

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:35:08 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

Contains nutrients that support the health of the skin and are involved in minor wound healing.

Assists in the healing and repair of the skin.

Supports healthy skin.

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

Beneficial during times of stress

Helps the body/you cope with stress

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 C, Vitamin B6, 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 folic acid, inositol and vitamin B6 are involved in the

manufacture and action of mood supporting hormones such as serotonin.

Provides vitamins to help maintain a healthy nervous system.

Supports healthy nervous system function.

Supports the synthesis of adrenal hormones.

Supports neurotransmitter biosynthesis.

Contains nutrients that are involved in hormone synthesis and modulation.

Protects capillaries

Maintains health of capillaries

Maintains a normal/healthy cardiovascular system.

Supports the health of the cardiovascular system.

B vitamins work synergistically.

Vitamin C is necessary for the manufacture of collagen in the body.

Vitamin C plays a role in collagen formation.

May assist in the maintenance of cholesterol within the normal range in healthy individuals

May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals

May assist in the maintenance of cholesterol within the normal/healthy range in healthy individuals and improve HDL:LDL ratio.

May assist in the maintenance of normal/healthy HDL:LDL cholesterol ratio.

May help to reduce the oxidation of LDL cholesterol.

May assist in the maintenance of normal healthy blood sugar/glucose balance in healthy individuals. May assist in the maintenance of normal healthy

glycaemic controls in healthy individuals.

May assist in the maintenance of normal healthy blood sugar/glucose levels in healthy individuals.

Zinc supports the health of the male reproductive system.

Zinc is an important nutrient in supporting male reproductive health and function

Zinc is an important mineral for the formation and maturation of spermatozoa.

Zinc supports the health and function of the female reproductive system.

Zinc is an essential mineral for healthy ovulation in women.

Zinc and vitamin B6 support healthy hormonal balance.

Zinc supports healthy testosterone levels in men.

Supports healthy vision and eye function.

Zinc is important for healthy eye function.

Zinc plays an important role in the visual system.

Contains nutrients that are 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.

Thiamine, pantothenic acid, riboflavin, 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 enzymes which are involved

in the metabolism of carbohydrates, fats and proteins.

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

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

B vitamins in this formula participate in many biochemical reactions in the body, including the conversion of foods into energy and the regulation of

metabolism.

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

Helps the body convert food into energy.

Riboflavin functions as a component of important enzymes that are involved in energy production.

Riboflavin is crucial in the production of energy in the body.

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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:35:08 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

Active Ingredients

Ascorbic acid

50 mg

Betacarotene

3 mg

Biotin

20 microgram

Calcium amino acid chelate

50 mg

Calcium pantothenate

100 mg

Choline bitartrate

50 mg

colecalciferol

.0025 mg

Copper gluconate

295 microgram

Cyanocobalamin

100 microgram

d-alpha-Tocopheryl acid succinate

20.834 mg

dibasic potassium phosphate

30 mg

Folic acid

95 microgram

Glutamine

50 mg

Inositol

25 mg

Lysine hydrochloride

10 mg

Magnesium aspartate dihydrate

10 mg

magnesium phosphate pentahydrate

34 mg

Manganese sulfate monohydrate

.37 mg

Nicotinamide

200 mg

Nicotinic acid

10 mg

Potassium aspartate monohydrate

10 mg

pyridoxine hydrochloride

50 mg

retinol palmitate

.417 mg

riboflavine

20 mg

Scutellaria lateriflora

25 mg

Equivalent: Scutellaria lateriflora (Dry)

100 mg

Thiamine hydrochloride

50 mg

Valeriana officinalis

25 mg

Equivalent: Valeriana officinalis (Dry)

100 mg

Zinc gluconate

10 mg

Zinc sulfate monohydrate

19.2 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 12:35:08 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