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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 ingredients.
Notes
August 5, 2019
Notes
The acceptable route(s) of administration must be acceptable as per the NNHPD Evidence for Homeopathic Medicines guidance document.
The acceptable pharmaceutical dosage forms include, but are not limited to those indicated in Table 1 below.
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Homeopathic preparation/remedy/medicine.
As specified below.
Dosage Form(s) | Subpopulation(s) | General dosing | Maximum Acute Dosing (Optional) | ||
---|---|---|---|---|---|
Maximum Dosing | Maximum Frequency | ||||
Globules (small pellets, pills) (Oral) |
Adolescents 12-17 years and Adults 18 years and older |
1 whole unit dose(tube or container) |
1 time per day |
10-20 granules, 2-3 times per day |
|
Children 1-11 years* |
|||||
Infants 0-11 months* |
|||||
Granules (regular or large pellets) |
Adolescents 12-17 years and Adults 18 years and older |
3-5 granules |
2-3 times per day |
Every 15-60 minutes (not to exceed 12 times per day) or until improvement of symptoms. Then resume general dosing. |
|
Children 1-11 years* |
|||||
Infants 0-11 months* |
|||||
Tablets |
Adolescents 12-17 years and Adults 18 years and older |
1-4 tablets |
1-4 times per day |
Every 15-60 minutes (not to exceed 12 times per day) or until improvement of symptoms. Then resume general dosing. |
|
Children 6-11 years |
1-3 tablets |
1-4 times per day |
|||
Children 1-5 years* |
½-3 tablets |
1-3 times per day |
|||
Infants 0-11 months* |
½-3 tablets |
1-2 times per day |
|||
Oral Drops |
Adolescents 12-17 years and Adults 18 years and older |
10-30 drops |
1-3 times per day |
Every 15-60 minutes (not to exceed 12 times per day) or until improvement of symptoms. Then resume general dosing. |
|
Children 6-11 years |
5-15 drops |
||||
Children 1-5 years |
5-10 drops |
||||
Infants 0-11 months |
1-5 drops |
||||
Liquid(Oral drinkable vials) |
Adolescents 12-17 years and Adults 18 years and older |
1 ampoule |
1-3 times per day |
Not to exceed 3 times per day |
|
Children 6-11 years |
2/3 ampoule |
||||
Children 1-5 years |
½ ampoule |
||||
Infants 0-11 months |
1/3 ampoule |
||||
Oral solution (Unit dose) |
Adolescents 12-17 years and Adults 18 years and older |
Unit oral dose |
1-3 times per day |
Give one unit dose upon onset of symptoms. Repeat two more times at 15-minute intervals. Repeat process up to 9 times per day if symptoms reappear. |
|
Children 1-11 years |
|||||
Infants 0-11 months |
|||||
Oral Syrup |
Adolescents 12-17 years and Adults 18 years and older |
1-2 tsp |
Every 4 to 6 hours |
N/A |
|
Children 1-11 years |
½-1 tsp |
1-3 times per day |
|||
Infants 0-11 months |
½ tsp |
1-3 times per day |
|||
Cream or Ointment |
Infants 0-11 months, Children 1-11 years, Adolescents 12-17 and Adults 18 years and older |
Cover affected area |
Use as needed |
N/A |
|
Nasal spray |
Adolescents 12-17 years and Adults 18 years and older |
1-2 sprays/ nostril |
3-5 times per day |
N/A |
|
Children 1-11 years |
1 spray/nostril |
4 times per day |
|||
Infants 0-11 months |
1 spray/nostril |
4 times per day |
|||
Eye Drops |
Adolescents 12-17 years and Adults 18 years and older |
2-3 drops |
3 times per day |
1 drop in the affected eye every 15 minutes for a maximum of 3 hours. |
|
Children 1-11 years |
1-2 drops |
3 times per day |
|||
Infants 0-11 months |
1 drop |
2 times per day |
|||
Ear Drops |
Adolescents 12-17 years and Adults 18 years and older |
1 complete vial |
3 times per day |
Every 15-60 minutes (not to exceed 12 times per day) or until improvement of symptoms. Then resume general dosage. |
|
Children 1-11 years |
3-4 drops |
||||
Infants 0-11 months |
2-3 drops |
||||
Suppositories |
Adolescents 12-17 years and Adults 18 years and older |
1 suppository |
1-4 times per day |
Maximum 5 times per day |
|
Children 6-11 years |
1-3 times per day |
Maximum 4 times per day |
|||
Children 1-5 years |
1-2 times per day |
Maximum 3 times per day |
|||
Infants 0-11 months |
1-2 times per day |
Maximum 2 times per day |
*Dissolve dose in a small amount of water before administration to infants and children 0-5 years old.
The homeopathic potency of each medicinal ingredient must be at or above the minimum potency specified in the Natural Health Products Ingredients Database (NHPID).
The minimum potencies indicated in the NHPID are generally based on the following unless specific safety concerns have been identified:
The method(s) of preparation must be as per the homeopathic monograph referenced as the Standard or Grade (please refer to the specifications). It is also acceptable to use another method from an NNHPD accepted homeopathic pharmacopoeia not referenced as the Standard or Grade. In this case, the selected method of preparation must be appropriate for the medicinal ingredient.
Use as directed by a health care practitioner/health care provider/health care professional/doctor/physician.
No statement required.
No statement required.
No statement required.
Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
No statement required.
Must reference a homeopathic monograph in one of the most recent versions of NNHPD accepted homeopathic pharmacopoeias: HPUS1, HAB/GHP2, PhF3, Ph.Eur.4, EHP5.
1Homeopathic Pharmacopeia of the United States (HPUS)
2Homöopathisches ArzneiBuch (HAB) or German Homeopathic Pharmacopoeia (GHP)
3Pharmacopée française or French Pharmacopoeia (PhF)
4European Pharmacopoeia (Ph.Eur.)
5Encyclopedia of Homeopathic Pharmacopoeia (EHP)