{"id":11634,"date":"2021-11-21T23:25:39","date_gmt":"2021-11-22T04:25:39","guid":{"rendered":"https:\/\/www.phytonutriment.ca\/rhodiola-roseola-health-canada-product-monograph\/"},"modified":"2021-11-21T23:25:40","modified_gmt":"2021-11-22T04:25:40","slug":"rhodiola-roseola-health-canada-product-monograph","status":"publish","type":"post","link":"https:\/\/www.phytonutriment.ca\/en\/rhodiola-roseola-health-canada-product-monograph\/","title":{"rendered":"Rhodiola roseola &#8211; Health Canada Product Monograph"},"content":{"rendered":"<h2><strong>SOURCE- HEALTH CANADA: Compendium of Medicinal Ingredients Nomenclature<\/strong><\/h2>\n<h2><strong>Drugs and natural health products<\/strong><\/h2>\n<h2><strong>Product Monograph: Rhodiola roseola<\/strong><\/h2>\n<p style=\"text-align: justify;\">The purpose of this monograph is to serve as a guide for industry in the preparation of licence applications (MMDLs) and labels for the purpose of obtaining a product market authorization. It is not intended to be an in-depth study of the medicinal ingredient.<\/p>\n<p><strong>Note<\/strong><\/p>\n<ul>\n<li style=\"text-align: justify;\">Parentheses contain optional pieces of information; they do not need to be included in the DLMM or on the product label.<\/li>\n<li>The forward slash (\/) indicates that the terms or statements are synonymous. The applicant may use any of the terms or statements indicated.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Date<\/strong><\/p>\n<p>October 24, 2013<\/p>\n<p><strong>Proper name(s)<\/strong><\/p>\n<p><em>Rhodiola rosea<\/em> L. (crassulaceae) (USDA 2007; McGuffin et al. 2000)<br \/>\n(Synonym: <em>Sedum rosea<\/em> (L.) Scop. (USDA 2007; McGuffin et al. 2000)))<\/p>\n<p><strong>Common name(s)<\/strong><\/p>\n<ul>\n<li>Rhodiola (McGuffin et al. 2000)<\/li>\n<li>Rose orpin (health passport 2011)<\/li>\n<\/ul>\n<p><strong>Original material(s)<\/strong><\/p>\n<ul>\n<li>Racine (Winston and Maimes 2007)<\/li>\n<li>Root and rhizome (EMA 2012)<\/li>\n<\/ul>\n<p><strong>Route(s) of administration<\/strong><\/p>\n<p style=\"padding-left: 30px;\">Oral<\/p>\n<p><strong>Dosage form(s)<\/strong><\/p>\n<ul>\n<li>Acceptable dosage forms include, but are not limited to, strips, capsules, tablets, chewable dosage forms (e.g., tablets, gummies), liquids or powders.<\/li>\n<li>Foods or food-like dosage forms such as bars, chewing gum or beverages are excluded from this monograph.<\/li>\n<\/ul>\n<p><strong>Recommended use(s) or purpose(s)<\/strong><\/p>\n<p>Statement(s) specifying the following<\/p>\n<ul>\n<li>(Used in herbal medicine\/herbalism) (as an adaptogen) (for) temporarily assisting in the relief of stress symptoms (such as intellectual fatigue and feeling weak) (EMA 2012; Olsson et al. 2009; Winston and Maimes 2007; Pizzorno and Murray 2006; Hoffman 2003)<\/li>\n<li>(Used in herbal medicine\/herbalism for) helps(r) maintain cognitive functions (such as concentration and intellectual vigor) (Olsson et al. 2009; Winston and Maimes 2007).<\/li>\n<li>Provides antioxidants (Skarpanska-Stejnborn et al. 2009; Winston and Maimes 2007; Kim et al. 2006).<\/li>\n<\/ul>\n<p><strong>Dose(s)<\/strong><\/p>\n<p><strong>Subpopulation(s)<\/strong><\/p>\n<p>Adults (\u2265 18 years)(EMA 2012)<\/p>\n<p><strong>Quantity(ies)<\/strong><\/p>\n<p><em>Stress symptoms and cognitive function<\/em><\/p>\n<p>Standardized extract:<br \/>\n144 to 680 mg of rhodiola extract per day, not to exceed 200 mg per single dose (EMA 2012; Darbinyan et al. 2007; Pizzorno and Murray 2006)<\/p>\n<p>Activity:<\/p>\n<ul>\n<li>0.8-3% salidroside (Olsson et al. 2009; AT THE 2008 TGA; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).<\/li>\n<li>1-6% rosavin (Olsson et al. 2009; AT THE 2008 TGA; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).<\/li>\n<\/ul>\n<p>Dye:<br \/>\n1.2-1.8 g dried root\/rhizome, daily (1:4; 4.8-7.2 ml) (Winston and Maimes 2007)<\/p>\n<p><em>Symptoms of stress<\/em><\/p>\n<p>Unsized dry extract:<br \/>\n144 to 400 mg dry extract, daily, not more than 200 mg per single dose [1.5-5:1, 67-70% ethanol v\/v] (EMEA 2012)<\/p>\n<p><em>Antioxidant<\/em><\/p>\n<p><u>Standardized extract:<\/u><br \/>\nUp to 600 mg of rhodiola extract per day, not to exceed 200 mg per single dose (EMA 2012; Pizzorno and Murray 2006).<\/p>\n<p>Activity:<\/p>\n<ul>\n<li>0.8-3% salidroside (Olsson et al. 2009; AT THE 2008 TGA; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).<\/li>\n<li>1-6% rosavin (Olsson et al. 2009; AT THE 2008 TGA; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).<\/li>\n<\/ul>\n<p>Unsized dry extract:<br \/>\n144 to 400 mg dry extract, daily, not more than 200 mg per single dose [1.5-5:1, 67-70% ethanol v\/v] (EMEA 2012)<\/p>\n<p>Dye:<br \/>\nUp to 1.8 g rhizome\/dried root per day (1:4; up to 7.2 ml) (Winston and Maimes 2007)<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Instructions for use<\/strong><\/p>\n<p>Do not take immediately before bedtime (Iovieno et al. 2011; Pizzorno and Murray 2006; Kelly 2001).<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Duration(s) of use<\/strong><\/p>\n<p>Statement not required.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Risk statement(s)<\/strong><\/p>\n<p>Statement(s) specifying the following<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Precaution(s) and warning(s)<\/strong><\/p>\n<ul>\n<li>If symptoms persist or worsen, consult a health care practitioner.<\/li>\n<li>If you are pregnant or breastfeeding, consult a health care practitioner (EMA 2012).<\/li>\n<li>If you are taking an antidepressant, consult a health care practitioner (Iovieno et al. 2011; Olsson et al. 2009; Brown et al. 2002).<\/li>\n<li>If you are taking hormone replacement therapy or taking oral contraceptives, consult a health care practitioner before using them (HC 2013; Brown et al. 2002).<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Contraindication(s)<\/strong><\/p>\n<p>Do not use if you have bipolar disorder or bipolar spectrum disorder (Iovieno et al. 2011; Winston and Maimes 2007; Brown et al. 2002).<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Known adverse reaction(s)<\/strong><\/p>\n<p>If you suffer from irritability or insomnia, stop taking the product (Pizzorno and Murray 2006; Kelly 2001).<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Non-medicinal ingredients<\/strong><\/p>\n<p>Must be selected from NNHPD (NHPD) and comply with the restrictions set out in this database.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Storage conditions<\/strong> the current version of the Natural Health Product Ingredients Database<\/p>\n<p>Statement not required.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Specifications<\/strong><\/p>\n<ul>\n<li style=\"text-align: justify;\">Finished product specifications must be established in accordance with the requirements outlined in the NNHPD Natural Health Product Quality Reference Guide.<\/li>\n<li style=\"text-align: justify;\">The medicinal ingredient must comply with the requirements set out in the NHPID Natural Health Product Ingredients Database<\/li>\n<li style=\"text-align: justify;\">Brown RP, Gerbarg PL, Ramazanov Z. <em>Rhodiola rosea:<\/em>A Phytomedicinal Overview. HerbalGram 2002;56:40-52.<\/li>\n<\/ul>\n<ul>\n<li style=\"text-align: justify;\">Darbinyan V, Aslanyan G, Amroyan E, Gabrielyan E, Malmstrom C, Panossian A. Clinical trial of Rhodiola rosea L. extract SHR-5 in the treatment of mild to moderate depression. Nordic journal of psychiatry 2007;61(5):343-348.<\/li>\n<li style=\"text-align: justify;\">Iovieno, N., Dalton, ED., Fava, M., Mischoulon, D. Second-tier natural antidepressants: review and critique. Journal of Affective Disorders 2011; 130(3): 343-357<\/li>\n<li style=\"text-align: justify;\">Kelly GS. <em>Rhodiola rosea:<\/em>A Possible Plant Adaptogen. Alternative Medicine Review 2001; 6(3): 293-302<\/li>\n<li style=\"text-align: justify;\">Kim SH, Hyun SH, Choung SY. Antioxidant effects of Cinnamomi cassiae and <em>Rhodiola rosea<\/em> extracts in liver of diabetic mice. Biofactors 2006;26(3): 209-219<\/li>\n<li style=\"text-align: justify;\">McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2<sup>nd<\/sup> edition. Silver Spring (MD): American Herbal Products Association; 2000.<\/li>\n<li style=\"text-align: justify;\">Health Passport 2011: Rhodiola<a href=\"http:\/\/www.passeportsante.net\/fr\/Solutions\/PlantesSupplements\/Fiche.aspx?doc=rhodiole_ps\">.<\/a> Montreal (QC): Totalmedia Inc.; 2011. [Consult\u00e9 le 12 avril 2013] .<\/li>\n<li style=\"text-align: justify;\">Pizzorno JE, Murray MT, editors. Textbook of Natural Medicine. Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier; 2006.<\/li>\n<li style=\"text-align: justify;\">e (MD). [<em>Arnica montana<\/em> L. Updated on 29 May 2007; Accessed April 12, 2013].<\/li>\n<li style=\"text-align: justify;\">Winston D, Maimes S. Adaptogens: Herbs for Strength, Stamina, and Stress Relief. Rochester (VT): Healing Arts Press, 2007.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>References consulted<\/strong><\/p>\n<ul>\n<li style=\"text-align: justify;\">Abidov M, Grachev S, Seifulla RD, Ziegenfuss TN. Extract of <em>Rhodiola rosea<\/em> radix reduces the level of C-reactive protein and creatinine kinase in the blood. Bulletin of Experimental Biology and Medicine 2004;138:63-64.<\/li>\n<li style=\"text-align: justify;\">Blomkvist J, Taube A, Larhammar D. Perspective on roseroot (<em>Rhodiola rosea<\/em>) studies. Planta Medica 2009;75:1187-1190.<\/li>\n<li style=\"text-align: justify;\">Brinker F. Herb Contraindications and Drug Interactions, 3<sup>rd<\/sup> edition. Sandy (OR): Eclectic Medical Publications; 2001.<\/li>\n<li style=\"text-align: justify;\">Bystritsky A, Kerwin L, Feusner JD. A pilot study of <em>Rhodiola rosea<\/em> (Rhodax\u00ae) for Generalized Anxiety Disorder (GAD). The Journal of Alternative and Complementary Medicine 2008;14:175-180.<\/li>\n<li style=\"text-align: justify;\">Darbinyan V, Kteyan A, Panossian A, Gabrielian E, Wikman G, Wagner H. <em>Rhodiola rosea<\/em> in stress induced fatigue &#8211; a double blind cross-over study of a standardized extract SHR-5 with a repeated low-dose regimen on the mental performance of healthy physicians during night duty. Phytomedicine 2000;7:365-371.<\/li>\n<li style=\"text-align: justify;\">De Bock K, Eijnde BO, Ramaekers M, Hespel P. Acute <em>Rhodiola Rosea<\/em> Intake Can Improve Endurance Exercise Performance. International Journal of Sport Nutrition and Exercise Metabolism 2004;14:298-307.<\/li>\n<li style=\"text-align: justify;\">Edward D, Heufelder A, Zimmermann Z. Therapeutic Effects and Safety of <em>Rhodiola rosea<\/em> Extract WS\u00ae 1375 in Subjects with Life-stress Symptoms &#8211; Results of an Open-label Study. Phytotherapy Research 2012;26:1220-1225.<\/li>\n<li style=\"text-align: justify;\">Hung SK, Perry R, Ernst E. The effectiveness and efficacy of <em>Rhodiola rosea<\/em> L: A systematic review of randomized clinical trials. Phytomedicine 2011;18:235-244.<\/li>\n<li style=\"text-align: justify;\">Ishaque S, Shamseer L, Bukutu C, Vohra S. <em>Rhodiola rosea<\/em> for physical and mental fatigue: a systematic review. Complementary &amp; Alternative Medicine 2012;12:70-78.<\/li>\n<li style=\"text-align: justify;\">Noreen EE, Buckley JG, Lewis SL, Brandauer J, Stuempfle KJ. The effects of an acute dose of <em>Rhodiola rosea on<\/em> endurance exercise performance. Journal of Strength and Conditioning Association 2013;27(3):839-847.<\/li>\n<li style=\"text-align: justify;\">Panossian A, Wilkman G, Sarris J. Rosenroot (<em>Rhodiola rosea<\/em>): Traditional use, chemical composition, pharmacology and clinical efficacy. Phytomedicine 2010;17:481-493.<\/li>\n<li style=\"text-align: justify;\">Parisi A, Tranchita E. Duranti G, Ciminelli E, Quaranta I, Ceci R, Cerulli C, Borrione P, Sabatini S. Effects of chronic <em>Rhodiola rosea<\/em> supplementation on sport performance and antioxidant capacity in trained male : preliminary results. The Journal of Sports Medicine and Physical Fitness 2010;50:57-63.<\/li>\n<li style=\"text-align: justify;\">Peschel W, Prieto JM, Karkour C, Williamson EM. Effect of provenance, plant part and processing on extract profiles from cultivated European <em>Rhodiola rosea<\/em> L. for medicinal use. Phytochemistry 2013;86:92-102.<\/li>\n<li style=\"text-align: justify;\">Shevtsov VA, Zholus BI, Shervarly VI, Vol&rsquo;skij VB, Korovin YP, Khristich MP, Roslyakova NA, Wikman G. A randomized trial of two different doses of a SHR-5 <em>Rhodiola rosea<\/em> extract versus placebo and control of capacity for mental work. Phytomedicine 2003;10:95-105.<\/li>\n<li style=\"text-align: justify;\">Skarpanska-Stejnborn A, Pilaczynska-Szczesniak L, Basta P, Deskur-Smielecka E. The influence of supplementation with <em>Rhodiola rosea<\/em> L. extract on selected redox parameters in professional rowers. International Journal of Sport Nutrition and Exercise Metabolism 2009; 19(2): 186-199<\/li>\n<li style=\"text-align: justify;\">Spasov AA, Wikman GK, Mandrikow VB, Mironova IA, Neumoin VV. A double-blind, placebo-controlled pilot study of the stimulating and adaptogenic effect of <em>Rhodiola rosea<\/em> SHR-5 extract on the fatigue of students caused by stress during an examination period with a repeated low-dose regimen. Phytomedicine 2000;7:85-89.<\/li>\n<li style=\"text-align: justify;\">Walker TB, Altobelli SA, Caprihan A, Robergs RA. Failure of <em>Rhodiola rosea<\/em> to alter skeletan muscle phosphate kinetics in trained men. Metabolism 2007:56(8):1111-1117.<\/li>\n<\/ul>\n<p><strong> <\/strong><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>SOURCE- HEALTH CANADA: Compendium of Medicinal Ingredients Nomenclature Drugs and natural health products Product Monograph: Rhodiola roseola The purpose of<\/p>","protected":false},"author":1,"featured_media":11635,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"colormag_page_container_layout":"default_layout","colormag_page_sidebar_layout":"default_layout","footnotes":""},"categories":[830],"tags":[],"class_list":["post-11634","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-phytonutrient-blog"],"_links":{"self":[{"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/posts\/11634","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/comments?post=11634"}],"version-history":[{"count":1,"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/posts\/11634\/revisions"}],"predecessor-version":[{"id":11636,"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/posts\/11634\/revisions\/11636"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/media\/11635"}],"wp:attachment":[{"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/media?parent=11634"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/categories?post=11634"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.phytonutriment.ca\/en\/wp-json\/wp\/v2\/tags?post=11634"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}