BLACKMORES

Main information

Documents

Localization

  • Available in:
  • BLACKMORES PREGNANCY & BREAST-FEEDING GOLD
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218462
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218462

BLACKMORES PREGNANCY & BREAST-FEEDING GOLD

ARTG entry for

Medicine Listed

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725,WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

12/12/2013

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. BLACKMORES PREGNANCY & BREAST-FEEDING GOLD

Product Type

Single Medicine Product

Effective date

6/07/2015

Warnings

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).

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

Drink plenty of water (or words to that effect).

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.

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.]

Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.

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

Specific Indications

Supplies a more bio-available form of iron (compared to some other forms of iron such as ferrous sulphate) if taken [as directed/with food].

Supplies a bioavailable form of iron.

Contains a low-nausea form of iron.

Contains a low-constipation form of iron.

Contains a form of iron that is well tolerated and gentle on the digestive system.

Formulated with a low-nausea dose of iron (which is gentle on the digestive system).

Formulated with a low-constipation dose of iron (which is gentle on the digestive system).

With a low-nausea and low-constipation form and dose of iron

Iron needs increase during pregnancy because of increased needs for red blood cell formation and foetal growth.

Low levels of iron during pregnancy [can be one of the causes of fatigue/can be associated with fatigue].

Healthy levels of iron support energy levels during pregnancy.

Contains vitamin D for healthy bone and teeth development.

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:49:41 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

DHA is [essential / especially important] (particularly during the last trimester and the early postnatal months) for the normal development of the baby's

brain, nervous system and eyesight

Iodine requirement is increased during the first 20 weeks of pregnancy. Iodine is essential for the production of thyroid hormones which are critical for the

development of a baby's brain, visual motor skills and hearing.

Iodine supports the development of normal intelligence and IQ

Blackmores Pregnancy and Breastfeeding Gold was developed, based on the nutrient requirements of pregnant and breast feeding women, to provide

extra nutritional support.

Provides nutritional support (for pregnant and breastfeeding women and their babies) (with vitamins and minerals and omega-3 fatty acids).

Provides 20 important nutrients, including 12 vitamins (vit B1,B2,B3,B5,B6,B12 folic acid, vit C, vit E, vit D, biotin, betacarotene), 7 minerals (iron, zinc,

selenium, chromium, iodine, calcium, magnesium) and omega-3 fatty acids.

Contains vitamins B2 and B12 which help the body to use folate.

Provides (cofactors) vitamins B2 and B12 to help the body to use folic acid.

With zinc and vitamins C and D and betacarotene for immune [health/support].

With B vitamins (B1,B2,B3,B5) which play a role in cellular energy production.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

30 mg

Betacarotene

2.4 mg

Biotin

15 microgram

Calcium carbonate

125 mg

Calcium pantothenate

2.73 mg

Chromium picolinate

121 microgram

colecalciferol

12.5 microgram

concentrated fish Omega-3 triglycerides

250 mg

Cyanocobalamin

.0013 mg

d-alpha-Tocopherol

3.5 mg

Folic acid

250 microgram

heavy magnesium oxide

58.1 mg

Iron (II) glycinate

19.22 mg

Nicotinamide

9 mg

potassium iodide

98.3 microgram

pyridoxine hydrochloride

1.16 mg

Riboflavin

700 microgram

Selenomethionine

81.3 microgram

Thiamine nitrate

700 microgram

zinc oxide

6.82 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 2 of

Produced at 23.11.2017 at 12:49:41 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