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Drugs and Health Products

ELDER - SAMBUCUS

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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

July 1, 2019

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

Sambucus nigra subsp. nigra

  • Black elder
  • European elder

Sambucus nigra subsp. nigra

  • Flower
  • Fruit

Dried

Sambucus nigra subsp. canadensis

  • American elder
  • Canadian elder
  • Sweet elder

Sambucus nigra subsp. canadensis

References: Proper names: USDA 2019a,b, McGuffin et al. 2000; Common names: NHPID 2019; Source materials: EMA 2018, Godfrey and Saunders 2010, Hoffman 2003.

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; EMA/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; EMA/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)

Adults 18 years and older

Flower

  • (Traditionally) used in Herbal Medicine to promote sweating (diaphoretic) to help relieve fever (in cases of common colds, flus) (Godfrey and Saunders 2010; Bone 2003; Hoffman 2003; WHO 2002; BHC 1992; BHP 1983; Grieve 1931; Sayre 1917; Felter and Lloyd 1898).
  • (Traditionally) used in Herbal Medicine to help relieve symptoms of colds and flus (such as coughs, sore throat and mucus buildup (catarrh) of the (upper) respiratory tract) (Godfrey and Saunders 2010; Barnes et al. 2007; Bone 2003; Hoffman 2003; WHO 2002; BHP 1983; Grieve 1931).
  • Used in Herbal Medicine to help relieve nasal congestion and discharge associated with sinusitis, hay fever/allergic rhinitis (Godfrey and Saunders 2010; Barnes et al. 2007; Bone 2003; Hoffman 2003).
  • (Traditionally) used in Herbal Medicine as a diuretic (Winston and Kuhn 2008; Barnes et al. 2007; Williamson 2003; BHC 1992; Felter 1922; Culbreth 1927; Fyfe 1903).
  • (Traditionally) used in Herbal Medicine (as an alterative) to help remove accumulated waste products via the kidneys, skin and mucus membranes (Williamson 2003; Tilgner 1999; Felter 1922; Culbreth 1921; Fyfe 1903; Felter and Lloyd 1898).

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

Used in Herbal Medicine to help relieve symptoms of colds and flus (such as coughs, sore throat and mucus buildup (catarrh) of the (upper) respiratory tract) and to help relieve nasal congestion and discharge associated with sinusitis, hay fever/allergic rhinitis (Godfrey and Saunders 2010; Barnes et al. 2007; Bone 2003; Hoffman 2003; WHO 2002; BHP 1983; Grieve 1931).

Fruit

  • (Traditionally) used in Herbal Medicine to promote sweating (diaphoretic) to help relieve fever (in cases of common colds, flus) (Winston and Kuhn 2008; Hoffman 2003; Shook 1992; Grieve 1931; Remington et al. 1918).
  • (Traditionally) used in Herbal Medicine to help relieve symptoms of colds and flus (such as coughs, sore throat and mucus buildup (catarrh) of the (upper) respiratory tract) (Winston and Kuhn 2008; Hoffman 2003; Tillotson 2001; Shook 1992).
  • (Traditionally) used in Herbal Medicine to help relieve joint pain associated with conditions such as arthritis (Godfrey and Saunders 2010; Hoffman 2003; Tilgner 1999; Grieve 1931; Remington et al. 1918).
  • (Traditionally) used in Herbal Medicine as a diuretic (Hoffman 2003; Shook 1992; Fyfe 1903).
  • (Traditionally) used in Herbal Medicine (as an alterative) to help remove accumulated waste products via the kidneys, skin and mucus membranes (Tilgner 1999; Shook 1992; Grieve 1931; Remington et al. 1918; Fyfe 1903).
  • Source of/Provides antioxidants (Youdim et al. 2004; Abuja et al. 1998).

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

(Traditionally) used in Herbal Medicine to promote sweating (diaphoretic) to help relieve fever (in cases of the common cold, flus) and to help relieve symptoms of colds and flus (such as coughs, sore throat and mucus buildup (catarrh) of the (upper) respiratory tract) (Winston and Kuhn 2008; Hoffman 2003; Tillotson 2001; Shook 1992; Grieve 1931; Remington et al. 1918).

Children 2-11 years and Adolescents 12-17 years

Flower and/or Fruit

  • (Traditionally) used in Herbal Medicine to promote sweating (diaphoretic) to help relieve fever (in cases of common colds, flus) (Godfrey and Saunders 2010; Winston and Kuhn 2008; Bone 2003; Hoffman 2003; WHO 2002; Shook 1992; BHC 1992; BHP 1983; Grieve 1931; Remington et al. 1918; Sayre 1917; Felter et Lloyd 1898).
  • (Traditionally) used in Herbal Medicine to help relieve symptoms of colds and flus (such as coughs, sore throat and mucus buildup (catarrh) of the (upper) respiratory tract) (Godfrey and Saunders 2010; Winston and Kuhn 2008; Barnes et al. 2007; Bone 2003; Hoffman 2003; WHO 2002; Tillotson 2001; Shook 1992; BHP 1983; Grieve 1931).

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

(Traditionally) used in Herbal Medicine to promote sweating (diaphoretic) to help relieve fever (in cases of the common cold, flus) and to help relieve symptoms of colds and flus (such as coughs, sore throat and mucus buildup (catarrh) of the (upper) respiratory tract) (Godfrey and Saunders 2010; Winston and Kuhn 2008; Barnes et al. 2007; Bone 2003; Hoffman 2003; WHO 2002; Tillotson 2001; Shook 1992; BHP 1983; Grieve 1931; Remington et al. 1918; Sayre 1917; Felter et Lloyd 1898).

Flower

Used in Herbal Medicine to help relieve nasal congestion and discharge associated with sinusitis, hay fever/allergic rhinitis (Godfrey and Saunders 2010; Barnes et al. 2007; Bone 2003; Hoffman 2003).

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)

Flower

Methods of preparation: Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

Table 2. Dose information for dried flower presented as grams per day
Use(s) or purpose(s) Subpopulation(s) Dried flowers (grams/day)
Minimum Maximum
  • Diaphoretic
  • Sinusitis, hay fever
  • Symptoms of colds and flus

Children1

2-4 years 0.25 2.5
5-9 years 0.375 3.75

Children1

10-11 years 0.75 7.5

Adolescents1

12-13 years 0.75 7.5

Adolescents1

14-17 years 1.5 15
  • Diaphoretic
  • Symptoms of colds and flus
  • Sinusitis, hay fever
  • Diuretic
  • Alterative

Adults2

18 years and older

1.5 15

1 Children and adolescent doses were calculated as a proportion of the adult dose (JC 2008). The use of Elder spp. in children and adolescents is supported by the following references: McIntyre 2005; Bove 2001; Gladstar 1999.

2 Adult dose supported by the following references: Hoffman 2003 Williamson 2003;WHO 2002; BHC 1992.

Method of preparation: Infusion

Table 3. Dose information for dried flower presented as grams per day
Use(s) or purpose(s) Subpopulation(s) Dried flowers (grams/day)
Minimum Maximum
  • Diaphoretic
  • Symptoms of colds and flus
  • Sinusitis, hay fever

Children1

2-4 years 1 2.5
5-9 years 1.5 3.75

Children1

10-11 years 3 7.5

Adolescents1

12-13 years 3 7.5

Adolescents1

14-17 years 6 15
  • Diaphoretic
  • Symptoms of colds and flus
  • Sinusitis, hay fever
  • Diuretic
  • Alterative

Adults2

18 years and older

6 15

1 Children and adolescent doses were calculated as a proportion of the adult dose (JC 2008). The use of Elder spp. in children and adolescents is supported by the following references: McIntyre 2005; Bove 2001; Gladstar 1999.

2 Adult dose supported by the following references: Hoffman 2003 Williamson 2003;WHO 2002; BHC 1992.

Fruit

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

Table 4. Dose information for dried fruit presented as grams per day
Use(s) or purpose(s) Subpopulation(s) Dried fruit (grams/day)
Minimum Maximum
  • Diaphoretic
  • Symptoms of colds and flus

Children1

2-4 years 0.217 3
5-9 years 0.325 4.5

Children1

10-11 years 0.65 9

Adolescents1

12-13 years 0.65 9

Adolescents1

14-17 years 1.3 18
  • Diaphoretic
  • Symptoms of colds and flus
  • Sinusitis, hay fever
  • Diuretic
  • Alterative

Adults2

18 years and older

1.3 18

Antioxidants

Adults3

18 years and older

- 18

1 Children and adolescent doses were calculated as a proportion of the adult dose (JC 2008). The use of Sambucus spp. in children and adolescents is supported by the following references: McIntyre 2005; Bove 2001; Gladstar 1999.

2 Adult dose supported by the following references: Winston and Kuhn 2008; Tillotson 2001; Fyfe 1903.

3 Adult dose supported by the following reference: Winston and Kuhn 2008.

Direction(s) for use

No statement required.

Duration(s) of Use

Diuretic

For occasional use only (APhA 2002; CPhA 2002).

All other products

No statement required.

Risk Information

Caution(s) and warning(s)

All products

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.

Diaphoretic; Symptoms of colds, flus; Sinusitis, hay-fever; Joint pain

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)

All products

Stop use if hypersensitivity/allergy occur (Forster-Waldl et al. 2003).

Products without diuretic claim

Diuretic effect may occur (Bradley 1992; Winston and Kuhn 2008; Barnes et al. 2007; Hoffman 2003).

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

  • Abuja PM, Murkovic M., Pfannhauser W. Antioxidant and Prooxidant Activities of Elderberry (Sambucus nigra) Extract in Low-Density Lipoprotein Oxidation. Journal of Agricultural and Food Chemistry 1998;46(10):4091-4096.
  • APhA 2002: Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
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  • BHC 1992: Bradley PR, editor. British Herbal Compendium Volume 1: A Handbook of Scientific Information on Widely Used Plant Drugs-Companion to Volume 1 of the British Herbal Pharmaocopeia. Bournemouth (GB): British Herbal Medicine Association; 1992.
  • BHP 1983: British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1983.
  • Bone K. A Clinical Guide to Blending Liquid Herbs: Herbal Formulations for the Individual Patient. St. Louis (MI): Churchill Livingstone; 2003.
  • Bove M. An Encyclopedia of Natural Healing for Children and Infants. 2nd edition. Toronto (ON): McGraw-Hill; 2001.
  • Carlsen J.E., Kober L., Torp-Pedersen C., Johansen P. Relation between dose of bendrofluazide, antihypertensive effect and adverse biochemical effects. British Medical Journal 1990; 300(6730): 975.
  • CPhA 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.
  • Culbreth DMR. A Manual of Materia Medica and Pharmacology [Internet] 7th edition; 1927. Abridged and edited; herbs and botanicals in use today. Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ).[ Accessed 2019 May 8].
  • Available from: http://www.swsbm.com/ManualsOther/Culbreth.html
  • EMA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Formulations of choice for the paediatric population. Adopted September 2006. EMA/CHMP/PEG/194810/2005. [Accessed on 2019 June 12]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-formulations-choice-paediatric-population_en.pdf
  • EMA 2018: Sambuci flos. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (CHMP). [Accessed 20194 June 12]. Available from: https://www.ema.europa.eu/en/medicines/herbal/sambuci-flos
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References Reviewed

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  • Murkovic M, Abuja PM, Bergmann AR, Zirngast A, Adam U, Winklhofer-Roob BM, Toplak H. Effects of elderberry juice on fasting and postprandial serum lipids and low-density lipoprotein oxidation in healthy volunteers; a randomized, double-blind, placebo-controlled study. European Journal of Clinical Nutrition 2004;58:244-249.
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