Health Canada
Symbol of the Government of Canada
Drugs and Health Products

Oligotherapy

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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 ingredients.

Notes

  • By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.
  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.
  • The use of the electronic Product License Application form (ePLA) is not possible for products associated with this monograph.

Date

June 24, 2013

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

Please refer to Table 1 and 2 below.

Route(s) of administration

  • Oral
  • Sublingual

Dosage form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.
  • The acceptable pharmaceutical dosage forms suited to sublingual administration.

Use(s) or Purpose(s)

Statement(s) to the effect of

Oligotherapy preparation/remedy/medicine

Dose(s)

Statement(s) to the effect of

Subpopulation(s)

Adults (≥ 18 years)

Quantity(ies)

All products except those specified below
1 dosage unit, 1-2 times per day.

Dosage information for specific single ingredient products:

Products containing only Bismuth as a medicinal ingredient
1 dosage unit every 3 hours up to 8 times per day for 3-5 days.

Products containing Cobalt as a medicinal ingredient
1 dosage unit per day.

Products containing only Copper as a medicinal ingredient
1 dosage unit every 3 hours up to 8 times per day for 3-5 days.

Products containing only Iodine, Iron, Magnesium, Phosphorus or Zinc as a medicinal ingredient
1 dosage unit, 1-2 times per day

Dosage information for specific multi-ingredient products:

Products containing only Zinc and Copper in combination as medicinal ingredients
1 dosage unit, 1-2 times per day

Products containing Copper, Gold and Silver in combination as medicinal ingredients
1 dosage unit, 1-2 times per day.

Table 1: Proper name(s), Common name(s), Source material(s) and Dosage information for single ingredient preparation
Proper name(s) Common name(s) Source material(s) Maximum quantity per dosage unit (μg)
Aluminium Aluminium Aluminium gluconate 176
Bismuth Bismuth Bismuth gluconate 70
Cobalt Cobalt Cobalt gluconate 59
Chromium Chromium Chromium (III) chloride 25
Copper Copper Copper gluconate 725.2
Fluoride Fluoride Sodium fluoride 200
Iodine Iodine Sodium iodide;
Potassium iodide
24
Iron Iron Iron gluconate 14
Magnesium Magnesium Magnesium gluconate 104.4
Manganese Manganese Manganese gluconate 72.8
Nickel Nickel Nickel gluconate 72.6
Phosphorus Phosphorus Disodium phosphate 140
Potassium Potassium Potassium gluconate 40
Selenium Selenium Selenite sodium 100
Sulphur Sulphur Sodium thiosulfate 122
Zinc Zinc Zinc gluconate 67.4

Table 2: Proper name(s), Common name(s), Source material(s) and Dosage information for multi-ingredient preparation containing one or more of the following ingredients
Proper name(s) Common name(s) Source material(s) Maximum quantity per dosage unit (μg)
Manganese;
Cobalt
Manganese;
Cobalt
Manganese gluconate;
Cobalt gluconate
72.8;
72.6
Manganese;
Copper;
Cobalt
Manganese;
Copper;
Cobalt
Manganese gluconate;
Copper gluconate;
Cobalt gluconate
72.8;
72.6;
72.8
Manganese;
Copper
Manganese;
Copper
Manganese gluconate;
Copper gluconate;
72.6;
72.6
Cobalt;
Nickel
Cobalt;
Nickel
Cobalt gluconate
Nickel gluconate;
72.6;
72.6
Copper;
Zinc
Copper;
Zinc
Coppergluconate;
Zinc gluconate
72.6;
67.4
Cobalt;
Nickel;
Zinc
Cobalt;
Nickel;
Zinc
Cobalt gluconate;
Nickel gluconate;
Zinc gluconate
72.6;
72.6;
67.4
Copper;
Gold;
Silver
Copper;
Gold;
Silver
Copper gluconate;
Gold elemental;
Silver gluconate
31;
98;
50
Copper;
Gold;
Silver
Copper;
Gold;
Silver
Copper gluconate;
Gold elemental;
Silver gluconate
63;
1.4;
21.36
Copper;
Gold;
Silver
Copper;
Gold;
Silver
Copper gluconate;
Gold elemental;
Silver gluconate
500;
0.2;
7.4
Directions for use

All products
Take as directed by a health care practitioner.

Products containing Iron or Zinc

  • Take a few hours before or after taking other medications (HC 2012; Martindale 2011).
  • Take with food (HC 2012; Martindale 2011).

Duration of use

Statement(s) to the effect of

Use for up to two months or as recommended by a health care practitioner (Brigo 1999)

Risk information

Statement(s) to the effect of

Cautions and warnings

All products

  • If symptoms persist or worsen, consult a health care practitioner.
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use.

Products containing Aluminium
If you have renal impairment, consult a health care practitioner prior to use (JECFA 1988)

Products containing Cobalt

  • If you are taking Vitamin B12, consult a health care practitioner prior to use (EVM 2003)
  • If gastrointestinal upset and/or skin rashes occur, discontinue use and consult a health care practitioner.

Products providing doses of Selenium ≥ 200 μg per day
If you have a history of non-melanoma skin cancer, consult a health care practitioner prior to use.

Contraindications

Products containing Cobalt
If you have an iodine deficiency, do not use this product (EVM 2003).

Products containing Manganese
If you have tuberculosis or a history of tuberculosis, do not use this product (Padrazzi 1988; Ménétrier 1983).

Products containing Manganese and Cobalt
If you have tuberculosis or a history of tuberculosis, do not use this product (Ménétrier 1983).

Products containing Zinc and/or Copper
If you have cancer, tuberculosis or a history of tuberculosis, do not use this product (Padrazzi 1988; Ménétrier 1983).

Known adverse reactions

Products containing Fluoride
Using this product in an area where the drinking water has a natural fluorine content in excess of 0.7 parts of fluoride ion per million parts of water or is artificially fluoridated, may result in mottling of the tooth enamel.

Non-medicinal Ingredients

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

Specifications

References reviewed