Monograph: Galactosidase, alpha-

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. Notes: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.
Date: 2019-04-29

NHPID name

alpha-Galactosidase ( Enzyme Nomenclature )

Proper name(s)

alpha-D-galactoside galactohydrolase ( IUBMB 1961 )

Common name(s)

alpha-galactosidase ( IUBMB 1961 )

Source material

Aspergillus niger - WHOLE (CABI 2012, Bisby et al. 2010)

Route Of administration

Oral

Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Digestive enzyme; Reduce gas production
Dose(s):

not to exceed 3000 FCC alpha-galactosidase units per day

Directions for use: Take with first bite of food/meal ( Pray 2006 , CPS 2005 , Lettieri and Dain 1998 , Ganiats et al. 1994 )

Prevent gastrointestinal intolerance
Dose(s):

260 - 3000 FCC alpha-galactosidase units per day

Directions for use: Take with first bite of food/meal ( Pray 2006 , CPS 2005 , Lettieri and Dain 1998 , Ganiats et al. 1994 )

Duration of use

For prolonged use, consult a health care practitioner.

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Contraindication(s): No statement is required Known Adverse Reaction(s): Stop use if hypersensitivity/allergy occurs.

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.

Specifications

References cited

References reviewed