Levomefolate calcium 635 views0 applications

Australian approved name (AAN): Levomefolate calcium

Common names and synonyms:
Levomefolate calcium anhydrous
Levomefolinate calcium
Calcium L-5-methyltetrahydrofolate
Folate
Vitamin B9

Molecular formula: C20H23CaN7O6

Molecular weight: 497.52

Conversion (% Levomefolic acid): 92.35

RDI for Vitamin B9 as per NHMRC:
Infants 0-6 months 65µg/day (as folate) (AI)
Infants 7-12 months 80µg/day
Children – 1-3 years – 150µg/day (AI)
Children – 4-8 years – 200µg/day (AI)
Children – 9-13 years – 300µg/day
Children – 14–18 years – 400µg/day
Adults – 400µg/day
Pregnancy – 600µg/day
Lactation – 500µg/day

Maximum daily dose: 500µg. The maximum recommended daily dose must provide no more than 500 micrograms of Levomefolic acid from Levomefolate calcium. When folic acid, folinic acid, levomefolate salts and/or their derivatives are used in combination, the medicine must provide no more than a total of 500 micrograms of folic acid, folinic acid, levomefolate salts and/or their derivatives in total per maximum recommended daily dose.

Mandatory component: Levomefolic acid

Warnings and restrictions:  Only for use in oral medicines.

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

When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects:
a) the maximum daily dose must provide 400 – 500 micrograms of folic acid; and
b) the following statements must be included on the label:
NEUR – Warning: 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).

Alllowable purpose of the ingredient: Active

TGA reference: Merck Index

Apply for this resource
Share this resource
footer

Advanced Wellness Regulatory Solutions are a team of highly skilled professionals who specialise in providing timely and reliable regulatory and research & development advice.



logo22

DISCLAIMER

While we take all measures to ensure that the information provided on this site is accurate, before relying on the material in any important matter, users should carefully evaluate its accuracy, completeness and relevance for their purposes, and should obtain any appropriate professional advice relevant to their particular circumstances.

NEWSLETTER

Want to stay up to date with the latest industry changes and updates? Signup to our newsletter below.

CONTACT US