PROPOLIS - Oral

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Date

July 31, 2018

Proper name(s), Common name(s), Source material(s)

Table 1.Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s)
Propolis
  • Bee propolis
  • Feng jiao
  • Propolis
  • Propolis balsam
  • Propolis resin
  • Propolis wax
  • Apis mellifera Secretion

    References: Proper name: Lotfy 2006, PPRC 2005; Common names: O'Neil et al. 2013, Lotfy 2006, PPRC 2005, Salatino et al. 2005, Marcucci 1995; Source material: Ramos et al. 2007, Burdock 1998.

    Route of administration

    Oral

    Dosage form(s)

    This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

    Acceptable dosage forms for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

    Use(s) or Purpose(s)

    Note
    Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

    Dose(s)

    Subpopulation(s)

    Adults 18 years and older

    Quantity(ies)

    Antioxidant

    Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

    Not to exceed 0.6 grams dried propolis, per day (PPRC 2005)

    Relief of mouth/throat infections

    Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

    0.2 - 0.6 grams dried propolis, per day (PPRC 2005)

    Direction(s) for use

    No statement required

    Duration(s) of use

    Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 1 month (Jasprica et al. 2007).

    Risk information

    Caution(s) and warning(s)

    All uses

    Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding or if you are allergic to bee products, poplar tree products, or balsam of Peru, (Brinker 2001; Marcucci 1995; Valsecchi and Cainelli 1984; Melli et al. 1983; Rudzki and Gryzwa 1983).

    All uses except as a source of antioxidants

    Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

    Contraindication(s)

    No statement required.

    Known adverse reaction(s)

    Stop use immediately if hypersensitivity/allergy occurs (Scully 2006; PPRC 2005; Hsu et al. 2004; Teraki and Shiohara 2001; Machácková 1988; Hausen et al. 1987; Valsecchi and Cainelli 1984; Melli et al. 1983; Rudzki and Grzywa 1983).

    Non-medicinal ingredients

    Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

    Storage conditions

    No statement required.

    Specifications

    References cited

    References reviewed