UM Adrenal

Main information

Documents

Localization

  • Available in:
  • UM Adrenal
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220521
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220521

UM Adrenal

ARTG entry for

Medicine Listed

Sponsor

FIT-BioCeuticals Limited

Postal Address

PO Box 6454,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

26/02/2014

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. UM Adrenal

Product Type

Single Medicine Product

Effective date

26/02/2014

Warnings

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.

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.

Standard Indications

Beneficial during times of stress. [Warning S required]

Aids or assists in the prevention of muscular cramps and spasms.

Relief of muscular cramps and spasms. [Warning S required]

Relief of muscular aches and pains. [Warning S required]

For the symptomatic relief of dysmenorrhoea. [Warning S required]

For the symptomatic relief of pre-menstrual tension/syndrome. [Warning S required]

Relief of menstrual symptoms. [Warning S required]

Relief of menstrual cramps. [Warning S required]

Relief of menstrual pain. [Warning S required]

May help reduce the frequency of migraines.

Specific Indications

[1a] Magnesium supports healthy (cellular) energy production / metabolism, storage and utilisation.

[1b] UM Adrenal contains/provides nutrients that support healthy energy production / are fundamental to the body's energy production.

[1c] Provides nutritional support for the healthy metabolism and synthesis of carbohydrates, proteins and fats.

[2a] Magnesium is required for the healthy synthesis of DNA and glutathione.

[2b] Magnesium may support healthy antioxidant defence.

[3a] Magnesium deficiency has been associated with the activation of low-grade chronic inflammation (by triggering the excessive production and release

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:32:26 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

of IL-1-beta, TNF-a and pro-inflammatory neuropeptides) and increased production of free oxygen radicals.

[3b] Deficient intakes of magnesium and vitamin B6 have been associated with an increased risk of inflammation.

[4a] Magnesium supports healthy bone formation, maintenance and structure.

[4b] Aids normal growth and development of strong healthy bones.

[5a] Magnesium supports healthy muscle contraction and relaxation / release

[5b] Through its role in ion transport between cell membranes, magnesium is intrinsic to the healthy conduction of nerves, muscle contraction and the

normal healthy rhythm of the heart.

[5c] The nutrients magnesium, taurine, pantothenic acid, thiamine, pyridoxine hydrochloride and cyanocobalamin provide support/are involved in healthy

nervous system metabolism/function.

[6a] Magnesium, taurine and folic acid provide nutritional support for a normal healthy heart / cardiovascular system.

[6b] Magnesium supports healthy vascular tone and contractility

[6c] Magnesium is involved in the normal healthy rhythm of the heart.

[7] Magnesium may assist in the maintenance of normal healthy blood sugar/glucose metabolism.

[8a] Magnesium supports healthy hearing.

[8b] A lowered magnesium status has been associated with sensitivity to noise-induced hearing loss.

[8c] Magnesium supplementation may protect against noise-induced hearing loss in healthy young men.

[9a] Magnesium relieves symptoms / reduces the occurrence of symptoms associated with PMS, including mood swings, bloating and breast tenderness.

[9b] A combination of magnesium and B6 may help reduce PMS symptoms including nervous tension, mood swings, irritability and anxiety.

[10] Magnesium may reduce the frequency of nocturnal leg cramps.

[11] Sub-chronic and chronic stress has been associated with lowered magnesium status.

[12] Magnesium and vitamin B6 may support a healthy nervous system.

[13] Adequate magnesium levels are important for/involved in the maintenance of healthy mood.

[14a] Magnesium may help to increase oxygen uptake capacity and reduce blood lactate levels (and may assist to maintain peak performance).

[14b] Adequate magnesium status may contribute to optimal/peak performance by reducing muscular weakness, neural / neuromuscular dysfunction

and/or spasm.

[15] (Preliminary research suggests) Magnesium supplementation may assist strength gains as part of a strength training program.

[16] UM Adrenal provides nutritional support to replace nutrients lost during intense exercise.

[17] Migraine has been associated with a reduced magnesium status.

[18] Vitamins B5 and B6 provide nutritional support for healthy adrenals and neurotransmitter function.

[19] Nutrients are included in UM Adrenal (taurine and B vitamins) that play a role in the maintenance of normal healthy liver metabolism.

[20] Glutamine and magnesium provide nutritional support for a healthy immune system.

[21] Selenium provides antioxidant support.

[22] Requirements for magnesium, thiamine, riboflavin and pyridoxine hydrochloride (B6) may be increased in athletes.

[23] Supplementation with magnesium, thiamine, riboflavin and pyridoxine hydrochloride (B6) may be beneficial to help maintain healthy nutritional status

during times of increased demand, such as regular or intensified periods of exercise activity.

[24] Niacin (nicotinamide) and pantothenic acid are involved in fatty acid and cholesterol synthesis.

[25] Through its involvement in the biosynthesis of GABA and serotonin, adequate Vitamin B6 levels are important for the maintenance of healthy mood.

[26] Tyrosine, vitamins B5, B6 and ascorbic acid support the maintenance of normal healthy adrenal function.

[27] Magnesium, potassium, calcium and vitamin B6 support healthy renal function / kidney activity.

[28] Used in herbal medicine as an adaptogen to help temporarily relieve symptoms of stress (such as mental fatigue and sensation of weakness).

[29] Used in herbal medicine to help support cognitive function (such as mental focus and mental stamina).

[30] [Scientific evidence suggests that] Rhodiola rosea may help reduce/relieve cognitive symptoms of (work-related / stress-related / non-specific)

temporary fatigue.

[31] Rhodiola rosea may aid/support/improve mental performance.

[32] Vitamin C is concentrated in the adrenal glands and is involved in adrenal hormone production.

[33] Vitamin C is involved in a wide range of functions, including neurotransmitter and hormone synthesis, normal healthy immune function, iron

metabolism and the manufacture of connective tissue.

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

40 mg/g

calcium hydrogen phosphate dihydrate

5.94 mg/g

Cyanocobalamin

4 microgram/g

d-alpha-Tocopheryl acid succinate

13.22 mg/g

dibasic sodium phosphate

803 microgram/g

Folic acid

30 microgram/g

Glutamine

100 mg/g

heavy magnesium oxide

12.51 mg/g

Magnesium amino acid chelate

424.35 mg/g

molybdenum trioxide

18 microgram/g

Nicotinamide

4 mg/g

Potassium aspartate

52.36 mg/g

pyridoxine hydrochloride

10 mg/g

Rhodiola rosea

90 mg/g

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:32:26 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: Rhodiola rosea (Dry)

360 mg/g

Selenomethionine

12.42 microgram/g

Taurine

100 mg/g

Thiamine hydrochloride

5 mg/g

Tyrosine

20 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 3 of

Produced at 23.11.2017 at 12:32:26 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