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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
October 30, 2018
Proper name(s) | Common name(s) | |||
---|---|---|---|---|
Source material(s) | Part(s) | Preparation(s) | ||
Foeniculum vulgare subsp. vulgare var. vulgare |
|
Foeniculum vulgare subsp. vulgare var. vulgare |
Seed |
Dried and crushed |
References: Proper name: USDA 2018, EMEA 2007a, EMEA 2007b; Common names: USDA 2018, EMEA 2007a, EMEA 2007b; Source information: EMEA 2007a, EMEA 2007b.
Proper name(s) | Common name(s) | ||
---|---|---|---|
Source material(s) | Part(s) | ||
Foeniculum vulgare subsp. vulgare var. vulgare |
Bitter fennel essential oil |
Foeniculum vulgare subsp. vulgare var. vulgare |
Seed |
References: Proper name: USDA 2018, EMEA 2007a, EMEA 2007b; Source information: USDA 2018, EMEA 2007a, EMEA 2007b.
Oral
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms by age group:
Children 4-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).
Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the Compendium of Monographs Guidance Document.
All products (seed and essential oil)
Traditionally used in Herbal Medicine as an expectorant to help relieve coughs associated with colds (EMEA 2007a; EMEA 2007b).
Seed (except essential oil)
The following combined use(s) or purpose(s) is/are also acceptable:
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
ESSENTIAL OIL
Adults 18 years and older (EMEA 2007b)
Method of preparation: Oil, Essential (water steam distillation)
0.2 millilitres of essential oil, per day (EMEA 2007b)
SEED
Children 4-11 years, Adolescents 12-17 years and Adults 18 years and older (EMEA 2007a)
Methods of preparation: Dry, Infusion
Children 4-11 years
3-5 grams of comminuted (crushed) dried seed, per day; Not to exceed 1.6 grams per single dose (EMEA 2007a)
Adolescents 12-17 years and Adults 18 years and older
4.5-7.5 grams of comminuted (crushed) dried seed, per day; Not to exceed 2.5 grams per single dose (EMEA 2007a)
Note: Comminuted (crushed) dried seeds should be prepared as an infusion (see direction for use).
Dried seeds
Pour 250 ml (1 cup) of boiling water over seed and infuse for 15 minutes (EMEA 2007a).
Children 4-11 years
Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 1 week (EMEA 2007a).
Adolescents 12-17 years and Adults 18 years and older
Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 2 weeks (EMEA 2007a; EMEA 2007b).
All products
Essential oil
Consult a health care practitioner prior to use if you are taking oral contraceptives, hormone therapy, hormone replacement therapy or other medications or natural health products (EMEA 2007b).
No statement required.
Stop use if hypersensitivity/allergy occurs (EMEA 2007a; EMEA 2007b).
Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
No statement required.