Levomefolate glucosamine 426 views0 applications

Australian approved name (AAN): Levomefolate glucosamine

Common names and synonyms:
(6S)-5-methyltetrahydrofolic acid glucosamine salt
(6S)-5-methylfolate glucosamine salt
Folate
Vitamin B9

Molecular formula: C32H51N9O16

Molecular weight: 817.80

Conversion (% Levomefolic acid): 56.18  (% Glucosamine): 43.81

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

Maximum daily dose: The maximum recommended daily dose must provide no more than 500mcg of Levomefolic acid from Levomefolate glucosamine. When used in combination with folic acid, folinic acid and/or their derivatives, the medicine must not provide more than a total of 500 mcg of folic acid, folinic acid 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)

Acceptance criteria for Levomefolate glucosamine  is 96 – 102% (on anhydrous basis), equivalent to (6S)-5-methyltetrahydro folic acid 53.8 – 57.1% (on anhydrous basis) and glucosamine 42.2 – 44.9% (on anhydrous basis).

Allowable purpose of the ingredient: Active

TGA reference:  CHEMID plus (National Library of Medicine)

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