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Public Summary
Summary for ARTG Entry: 183797 Ostelin Vitamin D Liquid Kids
ARTG entry for Medicine Listed
Sponsor Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
Postal Address PO Box 403, VIRGINIA, QLD, 4014
Australia
ARTG Start Date 23/05/2011
Product category Medicine
Status Active
Approval area Listed Medicines
Conditions
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.,
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'.
Products
1. Ostelin Vitamin D Liquid Kids
Product Type Single Medicine Product Effective date 23/05/2011
Warnings
Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.
Standard Indications
Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life,
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 vitamin (may state the vitamin) supplementation.
Specific Indications
May help maintain muscle strength. Vitamin D promotes calcium absorption and helps to form and maintain strong bones. Vitamin D is important for both
lactating women and nursing infants. Vitamin D is important for bone and muscle development, function, and preservation. Vitamin D is required to
develop and maintain healthy bones/ healthy skeleton
Vitamin D is essential for the absorption and use of calcium and phosphorus, which are vital for functions such as the development of bones; healthy
nervous and immune systems; regulation of some hormones; and normal cell growth and maturation. For Vitamin D supplementation of infants and
children in at-risk groups. During pregnancy, maternal 1,25(OH)2D requirements can increase up to four- to five-fold to facilitate the availability of extra
calcium required for fetal skeletal growth. Increased vitamin D requirements in pregnancy must be met through dietary intake, supplements, and sun
exposure. Women pregnant at high latitude locations, during winter or effectively sun protected, e.g. darkly pigmented and/or veiled, are at increased risk
of vitamin D insufficiency. Infants who are breast-fed and dark-skinned may require vitamin D supplementation to maintain adequate vitamin D nutrition.
Vitamin D is needed for optimal bone mineralisation in children especially during times when sunlight exposure is limited. Vitamin D affects many organ
systems, including bone, immune system, intestines, kidneys, parathyroid glands and pancreas. Improving and/or maintaining adequate vitamin D status
may have significant long term health benefits/ may have protective effects on long term health. Vitamin D is required to develop and maintain healthy
bones/ healthy skeleton. Adequate vitamin D is required to maintain normal calcium metabolism and peak bone mass. May help to increase bone
mineral density. Maintaining adequate vitamin D status assists general health and wellbeing. Vitamin D may help maintain a healthy immune system/
involved in regulation of the immune system. Helps maintain colon health. The requirement for vitamin D increases in pregnant women due to calcium
deposition and bone mineralisation in the developing baby. Cholecalciferol (vitamin D3) may be more effective at increasing serum 25-hydroxyvitamin D,
a measure of vitamin D status, than ergocalciferol (vitamin D2). The people who can most benefit from supplementation are the elderly, those who avoid
the sun, people with dark skin or who wear concealing clothing and people with reduced absorption of nutrients from the gut.
Additional Product information
Public Summary
Page 1 of 2
Produced at 05.05.2015 at 01:19:47 EST
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
Pack Size/Poison information
Pack Size Poison Schedule
Components
1. Formulation 1
Dosage Form Oral Liquid
Route of Administration Oral
Visual Identification
Active Ingredients
Cholecalciferol 10 microgram/mL
© 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.
至少是写明了，给孩子吃的液体维生素D
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