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Drugs and Health Products

ECHINACEA- ECHINACEA ANGUSTIFOLIA

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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

  • 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 statements are synonymous. Either term or statement may be selected by the applicant.

Date

December 18, 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) Preparation(s)

Echinacea angustifolia

  • Black sampson
  • Black- sampson echinacea
  • Echinacea
  • Kansas snakeroot
  • Narrow-leaf coneflower
  • Narrow-leaf echinacea
  • Narrow-leaf purple-coneflower

Echinacea angustifolia

  • Root
  • Rhizome

Dried

References: Proper name: USDA 2018; Common names: USDA 2018, McGuffin et al. 2000, McGuffin et al. 1997, Bradley 1992; Source materials: Barnes et al. 2007, Grieve 1971.

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 by age group:

Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/ liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 3-5 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.

Use(s) or Purpose(s)

  • Traditionally used in Herbal Medicine to help relieve the symptoms of upper respiratory tract infections (Barnes et al. 2007; Blumenthal et al. 2000; Ellingwood 1983; Felter and Lloyd 1983; Grieve 1971).
  • Traditionally used in Herbal Medicine to help relieve sore throats (Blumenthal et al. 2000; Moerman 1998).

The following combined use(s) or purpose(s) is/are also acceptable:

Traditionally used in Herbal Medicine to help relieve sore throats and symptoms of upper respiratory tract infections (Barnes et al. 2007; Blumenthal et al. 2000; Moerman 1998; Ellingwood 1983; Felter and Lloyd 1983; Grieve 1971).

Note

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

Dose(s)

Subpopulation(s)

As specified below.

Quantity(ies)

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

Table 2. Dose information for Echinacea angustifolia root and/or rhizome per day
Subpopulation(s) Dried root/rhizome (gram/day)
Minimum Maximum

Children1

2-4 years

0.17

0.5

5-9 years

0.25

0.8

10-11 years

0.5

1.5

Adolescents1

12-14 years

0.5

1.5

15-17 years

1.0

3.0

Adults2,3

18 years and older

1.0

3.0

1Children and adolescent doses were calculated as a proportion of the adult dose (JC 2018). The use of Echinacea angustifolia in children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.

2Adult dose supported by the following references: Barnes et al. 2007; Blumenthal et al. 2000; Bradley 1992

3Includes pregnant and breastfeeding women

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 8 weeks (Brinker 2010).

Risk Information

Caution(s) and warning(s)

  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen.
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have a progressive systemic disease such as tuberculosis, collagenosis, multiple sclerosis, AIDS and/or HIV infection or an auto-immune disorder (Brinker 2010; McGuffin et al. 1997).
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking medications to suppress the immune system (immunosuppressive medications) (Brinker 2010; Mills and Bone 2005).

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

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

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

References Cited

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EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Formulation of choice for the paediatric population. Adopted September 2006.

EMEA/CHMP/PEG/194810/2005. [Accessed 2018 September 27]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf

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