SAGE - SALVIA OFFICINALIS
Buccal
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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
October 30, 2018
Proper name(s), Common name(s), Source information
Proper name(s) | Common name(s) | |||
---|---|---|---|---|
Source material(s) | Part(s) | Preparation(s) | ||
Salvia officinalis |
|
Salvia officinalis |
Leaf |
Dried |
References: Proper name: USDA 2018, McGuffin et al. 2000; Common names: USDA 2018, McGuffin et al. 2000; Source information: Blumenthal et al. 2000, BHP 1983, Cook 1869.
Route of Administration
Buccal (Barnes 2007; BHP 1983)
Dosage Form(s)
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.
Note
Dosage forms must be suited for buccal administration which allow for direct contact between the affected tissue and the medicinal ingredient (i.e. liquid preparations, gargles and mouthwashes).
Use(s) or Purpose(s)
(Traditionally) used in Herbal Medicine to provide relief for the inflammation of nose and throat mucosa (such as sore throat), gingivitis and (aphthous) ulcer/canker sore (BHC 2006; Mills and Bone 2005; Wichtl 2004; Blumenthal et al. 2000; ESCOP 1996; BHP 1983; Culbreth 1927; Felter 1922).
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Method of preparation: Fluid extract
3-12 grams of dried leaf, per day (BHP 1983).
Methods of preparation: Dry, Infusion
1-12 grams of dried leaf, per day (Mills and Bone 2005; BHP 1983).
Note: Dried leaves should be prepared as an infusion (see direction for use).
Direction(s) for use
Fluid extract
For gargle and/or mouthwash use, dilute each milliliter (1 ml) of fluid extract with 30 milliliters of water. Rinse and/or gargle as needed (Blumenthal et al. 2000).
AND/OR
For local use in the mouth, apply the undiluted fluid extract to the affected area with a brush or swab (Blumenthal et al. 2000).
Dried leaf
- For each gram (1 g) of dried leaf, add 30 millilitres of boiling water and infuse (BHC 2006).
- Rinse and/or gargle as needed.
Infusion
Rinse and/or gargle as needed.
Duration(s) of Use
No statement required.
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.
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
- Barnes J, Anderson LA, Philipson JD. Herbal Medicines.3rd edition. London (GB): The Pharmaceutical Press; 2007.
- BHC 2006: Bradley PR, editor. British Herbal Compendium Volume 2: A Handbook of Scientific Information on Widely Used Plant Drugs - Companion to the British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 2006.
- BHP 1983: British Herbal Pharmacopoeia. Bournemouth (GB): The British Herbal Medicine Association; 1983.
- Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Newton (MA): Integrative Medicine Communications; 2000.
- Bone K. A Clinical Guide to Blending Liquid Herbs: Herbal Formulations for the Individual Patient. St. Louis (MI): Churchill Livingstone; 2003.
- Cook WMH. The Physio-Medical Dispensatory: A Treatise on Therapeutics, Materia Medica, and Pharmacy, in Accordance with the Principles of Physiological Medication. [Internet] Cincinnati (OH): WM.H. Cook; 1869. Reprint version by Medical Herbalism and medherb.com, Boulder (CO). [Accessed 2018 August 14]. Available from: http://www.henriettesherbal.com/eclectic/cook/index.html
- Culbreth DMR. A Manual of Materia Medica and Pharmacology [Internet] 7th ed. Philadelphia (PA): Lea & Febiger; 1927. Abridged and alphabetized by Michael Moore, director. The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2018 August 14]. Available from: http://www.swsbm.com/ManualsOther/Culbreth.html
- ESCOP 1996: European Scientific Cooperative of Phytotherapy. Monographs on the Medicinal Uses of Plant Drugs. Exeter (GB): European Scientific Cooperative on Phytotheraphy; 1996.
- Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics [Internet]. Cincinnati (OH): John K. Scudder; 1922. Reprint version by Michael Moore, The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2018 August 14]. Available from: http://www.swsbm.com/FelterMM/Felters.html
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
- Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
- USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 August 14]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
- Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.
References Reviewed
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- Bartram T. Bartram's Encyclopaedia of Herbal Medicine: The definitive guide to the herbal treatment of diseases. New York: Marlowe & Company; 1998.
- Blumenthal M, Brusse WR, Goldberg A, Gruenwald J, Hall T, Riggins CW, Rister RS. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council in Cooperation with Integrative Medicine Communications; 1998
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- Brinker F. Herb Contraindications & Drug Interactions. 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
- Brinker, F. Updates and Additions for Herb Contraindications and Drug Interactions, 3rd ed including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals and complementary adjuncts with drugs. [Internet] Sandy (OR): Eclectic Medical Publications. [Updated July 13, 2010; Accessed 2012 April 18]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
- Canadian Nutrient File (CNF), 2012 [Internet]. Ottawa (ON): Food and Nutrition, Health Canada. [Date Modified 2012-02-10; Accessed 2012 Apr 18]. Available from: http://webprod3.hc-sc.gc.ca/cnf-fce/index-eng.jsp
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- Cook WMH. The Physio-Medical Dispensatory: A Treatise on Therapeutics, Materia Medica, and Pharmacy, in Accordance with the Principles of Physiological Medication. [Internet] Cincinnati (OH): WM.H. Cook; 1869. Reprint version by Medical Herbalism and medherb.com, Boulder (CO). [Accessed 2012 April 18]. Available from: http://www.henriettesherbal.com/eclectic/cook/index.html
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- European Medicines Agency. Public statement on Salvia officinalis L., aetheroleum. London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 19 October 2010. [Accessed 2012 April 18] Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2010/10/WC500098 002.pdf
- European Medicines Agency. Community Herbal Monograph on Salvia officinalis L., Folium. London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 03 February 2010. [Accessed 2012 April 18] Available from: http://www.ema.europa.eu/docs/
- European Medicines Agency. Community Herbal Monograph on Salvia officinalis L., Folium. London (GB): EMEA Committee on Herbal Medicinal Products (HMPC); 12 November 2009. [Accessed 2012 April 18] Available from: http://www.ema.europa.eu/
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- Grieve, M. A Modern Herbal, Volume 1-2. New York (NY): Dover Publications, 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
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- Health Canada. Canada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2011. [Accessed 2012 April 18]. Available from: http://webprod3.hc-sc.gc.ca/arquery-rechercheei/index-eng.jsp
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