Pregnancy Plus 1-2-3

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
ascorbic acid,betacarotene,Biotin,calcium folinate,calcium pantothenate,calcium phosphate,choline bitartrate,chromium picolinate,colecalciferol,folic acid,inositol,iron amino acid chelate,magnesium amino acid chelate,manganese amino acid chelate,mecobalamin (co-methylcobalamin),mixed (low-alpha type) tocopherols concentrate,molybdenum trioxide,nicotinamide,potassium iodide,pyridoxine hydrochloride,riboflavin,selenomethionine,thiamine nitrate,zinc citrate dihydrate
Available from:
Herbs of Gold Pty Ltd
INN (International Name):
Ascorbic acid,Betacarotene,Biotin,colecalciferol,Calcium folinate,Calcium pantothenate,Calcium phosphate,Choline bitartrate,Chro
Authorization status:
Listed
Authorization number:
290544

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Public Summary

Summary for ARTG Entry:

290544

Pregnancy Plus 1-2-3

ARTG entry for

Medicine Listed

Sponsor

Herbs of Gold Pty Ltd

Postal Address

PO Box 3143,KIRRAWEE, NSW, 2232

Australia

ARTG Start Date

22/06/2017

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. Pregnancy Plus 1-2-3

Product Type

Single Medicine Product

Effective date

22/06/2017

Warnings

WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible.

[Contains vitamin B6].

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.

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

Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice (or

words to that effect).

Standard Indications

Provides a daily dose of 400-500mcg of folic acid or folate. Contains folic acid which, if taken daily for one month before conception and during

pregnancy, may reduce the risk of having a child with spina bifida/neural tube defects. [Warning NEUR required].

Provides a daily dose of 400-500mcg of folic acid or folate. Contains folic acid which, if taken daily for one month before conception and during

pregnancy, may reduce the risk of women having a child with birth defects of the brain and/or spinal chord such as the neural tube defects known as

spina bifida and anencephaly. [Warning NEUR required.]

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

Source of iron. Can assist in maintaining normal blood.

For vitamin (may state the vitamin) supplementation.

Provides a minimum daily dose of 400-500micrograms of folic acid or folate. If taken daily when trying to conceive and during the first trimester of

pregnancy and/or for at least four weeks before conception and during the first trimester of pregnancy, folic acid may help to prevent neural tube defects

such as spina bifida and/or anencephaly. [Warning NEUR required]

For mineral (may state the mineral) supplementation.

Specific Indications

Folic acid and vitamin B12 are important for DNA replication, cell division and growth.

Maintains/supports normal/healthy red blood cells.

Aids/assists/helps normal/healthy red blood cell function.

Public Summary

Page 1 of

Produced at 24.11.2017 at 08:41:13 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

Aids/assists/helps normal/healthy red blood cell production.

May help maintain/support transport of oxygen in the body.

Maintains/supports healthy blood function.

Maintains/supports normal blood in healthy individuals.

May aid/assist in the maintenance of healthy/normal haemoglobin production to assist oxygen transport to body tissue.

Aids/assists/helps in the maintenance of blood levels of oxygen.

Vitamins B6, B12 and folic acid can assist in maintaining/supporting normal blood function.

For iodine supplementation. Iodine requirements are increased during pregnancy.

To meet the increased demands of pregnancy, it is recommended that iodine supplementation be taken prior to trying to conceive and throughout

pregnancy and breastfeeding.

During pregnancy adequate maternal iodine levels are important for healthy/normal brain development.

Zinc is an essential trace element that plays an important role in growth and development.

Zinc is important for DNA replication, cell division and growth.

For zinc supplementation.

Choline is required for the healthy development of the brain and nervous system during pregnancy and breastfeeding.

Vitamin D increases the absorption of calcium and phosphorous, therefore plays a role in the development of healthy bones.

Vitamin D is important for the development of healthy bones and teeth.

Thiamin (vitamin B1), riboflavin (vitamin B2), nicotinamide (vitamin B3) and pantothenic acid (vitamin B5) assist in energy production to help support the

increased energy demands of pregnancy and lactation.

Selenium supports normal growth and development.

Vitamin C helps in the development and maintenance of bones, cartilage, teeth and gums.

Vitamin C helps in connective tissue formation.

Chromium supports healthy glucose metabolism.

Aids/assists/helps glucose metabolism.

Contains betacarotene, which is converted to vitamin A in the body and is an alternative to vitamin A supplementation during pregnancy.

Betacarotene supports the development and maintenance of bones and teeth.

Helps maintain a healthy immune system. (betacarotene, vitamin C, vitamin E, selenium, zinc)

A multivitamin, mineral and nutritional formula to assist in maintaining the health of both mother and baby during preconception, pregnancy and

breastfeeding.

Assists in general well-being prior to conception and during pregnancy and breastfeeding.

Helps maintain normal and healthy infant development.

Formulated to help meet the increased nutritional demands during pregnancy and breastfeeding.

Formulated to provide extra nutritional support for pregnant and breastfeeding women.

Contains 24 important vitamins and minerals to help support the increased nutritional needs of pregnant and breastfeeding women.

May help maintain/support normal blood in healthy individuals.

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

Ascorbic acid

50 mg

Betacarotene

3 mg

Biotin

200 microgram

Calcium folinate

69.44 microgram

Calcium pantothenate

20 mg

Calcium phosphate

68.5 mg

Choline bitartrate

75 mg

Chromium picolinate

201 microgram

colecalciferol

.0125 mg

Folic acid

200 microgram

Inositol

10 mg

Iron amino acid chelate

50 mg

Public Summary

Page 2 of

Produced at 24.11.2017 at 08:41:13 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

Magnesium amino acid chelate

100 mg

Manganese amino acid chelate

10 mg

mecobalamin (co-methylcobalamin)

250 microgram

mixed (low-alpha type) tocopherols concentrate

5.001 mg

molybdenum trioxide

38 microgram

Nicotinamide

20 mg

potassium iodide

176 microgram

pyridoxine hydrochloride

50 mg

Riboflavin

20 mg

Selenomethionine

62 microgram

Thiamine nitrate

20 mg

zinc citrate dihydrate

31.15 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 24.11.2017 at 08:41:13 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

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