GINSENG À CINQ FOLIOLES - PANAX QUINQUEFOLIUS
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La présente monographie vise à servir de guide à l'industrie pour la préparation de demandes de licence de mise en marché (DLMM) et d'étiquettes dans le but d'obtenir une autorisation de mise en marché d'un produit de santé naturel. Elle ne vise pas à être une étude approfondie de l'ingrédient médicinal.
Notes:
- Les parenthèses contiennent des éléments d'information additionnels (facultatifs) qui peuvent être inclus sur l'étiquette à la discrétion du demandeur.
- La barre oblique (/) indique que les termes et/ou énoncés sont synonymes. Le demandeur peut utiliser n'importe lequel des termes ou énoncés indiqués sur l'étiquette.
Date
29 novembre 2024
Nom(s) propre(s), Nom(s) commun(s), Information(s) d'origine
Nom(s) propre(s) | Nom(s) commun(s) | Information(s) d'origine | ||
---|---|---|---|---|
Matière(s) d'origine | Partie(s) | Préparation(s) | ||
Panax quinquefolius |
|
Panax quinquefolius | Racine | Sèche |
Références : Nom propre : USDA 2024; Noms communs : USDA 2024; PPRC 2020; Marie-Victorin 2002; Small et Catling 1999; Information d'origine : PPRC 2020; Lust 1974; Wren 1956.
Voie d'administration
Orale
Forme(s) posologique(s)
Cette monographie exclut les aliments et les formes posologiques semblables aux aliments tel qu'indiqué dans le document de référence Compendium des monographies.
Les formes posologiques acceptables pour la voie d'administration orale sont indiquées dans la liste déroulante dans le formulaire web de demande de licence de mise en marché pour les demandes officinales.
Usage(s) ou fin(s)
- Utilisé en médecine traditionnelle chinoise (MTC) pour l'insuffisance du qi et du yin, pour la chaleur interne, pour la toux, pour le feu lors du syndrome d'insuffisance, pour la dysphorie et la fatigue, pour la soif, la bouche et la gorge sèches (PPRC 2020).
- Utilisé en phytothérapie comme thérapie de soutien pour aider au contrôle du taux de glucose/sucre (sanguin) (Dascalu et al 2007; Vuksan et al 2000a,b,c).
- Utilisé (traditionnellement) en phytothérapie pour aider à soulager l'agitation et/ou la nervosité (nervin/calmant) (Bartram 1998; Ellingwood 1998).
- Utilisé (traditionnellement) en phytothérapie pour aider à soulager la dyspepsie nerveuse/pour aider à la digestion dans les cas de nervosité et/ou de stress (Bartram 1998; Felter et Lloyd 1983; Wren 1956).
- Utilisé en phytothérapie comme adaptogène pour aider au maintien du système immunitaire (Upton 2012; Godfrey et al. 2010; Bartram 1998).
- Utilisé en phytothérapie comme adaptogène pour aider à augmenter l'énergie et la résistance au stress au cours du temps (par ex., dans les cas de fatigue mentale et physique liées au stress) (Upton 2012; Winston et Maimes 2007).
Notes
- Les usages ci-dessus peuvent être combinés sur l'étiquette du produit s'ils proviennent du même système de médecine traditionnelle ou non-traditionnelle (par ex., Utilisé en phytothérapie pour aider à la digestion dans les cas de nervosité ou de stress et comme thérapie de soutien pour aider au contrôle du taux de glucose).
- Pour les produits à ingrédients multiples
- Afin d'empêcher que le produit soit représenté comme une « médecine traditionnelle », toute allégation traditionnelle doit faire référence à/aux ingrédient(s) médicinal(aux) et au système de médecine traditionnelle reconnu d'où l'allégation provient lorsque 1) des allégations à la fois traditionnelles et modernes sont présentes ou 2) lorsque les allégations proviennent de multiples systèmes de médecine traditionnelle (par ex., Le ginseng d'Amérique est utilisé en médecine traditionnelle chinoise (MTC) pour l'insuffisance du qi et du yin, pour la chaleur interne, pour la toux, pour le feu lors du syndrome d'insuffisance, pour la dysphorie et la fatigue, pour la soif, la bouche et la gorge sèches).
- Lorsque TOUS les ingrédients médicinaux (IM) du produit sont utilisés au sein du MÊME système de médecine traditionnelle identifié ET que le produit n'a QUE des allégations traditionnelles, l'inclusion de l'/des ingrédient(s) médicinal(aux) dans l'/les allégation(s) traditionnelle(s) n'est pas requise.
Dose(s)
Sous-population(s)
Adultes 18 ans et plusQuantité(s)
Taux de glucose; Agitation/Nervosité; Dyspepsie nerveuse/Digestion
Méthodes de préparation : Sec, poudre, extraits non normalisés (extrait sec*, teinture, extrait fluide, décoction, concentré de décoction, infusion, concentré d'infusion)
0,5 à 12 grammes de racines séchées, par jour (Bartram 1998; Felter et Lloyd 1983; Wren 1956).
*Note : Les solvants permis pour la méthode de préparation « Extraits non-normalisés (extrait sec) » au sein de cette monographie sont l'éthanol et/ou l'eau uniquement.
Adaptogène - énergie et résistance au stress; Adaptogène - système immunitaire
Méthodes de préparation : Sec, poudre, extraits éthanoliques non normalisés (extrait sec, teinture, extrait fluide)
1 à 3 grammes de racines séchées, par jour (Upton 2012; Winston et Maimes 2007).
Adaptogène - énergie et résistance au stress
Méthodes de préparation : Extraits aqueux non normalisés (extrait sec, décoction, concentré de décoction, infusion, concentré d'infusion)
6 à 9 grammes de racines séchées, par jour; Ne pas dépasser 3 grammes par dose unique (Winston et Maimes 2007).
MTC
Méthodes de préparation : Décoction, concentré de décoction
2,4 à 9 grammes de racines séchées, par jour (PPRC 2020; Bensky et al. 2004).
Mode(s) d'emploi
Énoncé non requis.
Durée(s) d'utilisation
Énoncé non requis.
Mention(s) de risque
Précautions et mise en garde
Tous les produits
- Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant l'utilisation si vous prenez des anticoagulants ou de la digoxine (Brinker 2010; Dasgupta et al. 2007; Elmer et al 2007; Yuan et al 2004).
- Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant l'utilisation si vous avez le diabète (Brinker 2010; Dascalu et al 2007; Vuksan et al 2000a,b,c).
Tous les produits sauf pour les usages pour Taux de glucose et Adaptogène - système immunitaire
Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si les symptômes persistent ou s'aggravent.
Contre-indications(s)
Énoncé non requis.
Réaction(s) indésirable(s) connue(s)
Énoncé non requis.
Ingrédients non médicinaux
Doivent être choisis parmi ceux de la version actuelle de la Base de données des ingrédients des produits de santé naturels (BDIPSN) et respecter les restrictions mentionnées dans cette base de données.
Conditions d'entreposage
Doivent être établies conformément aux exigences décrites dans le Règlement sur les produits de santé naturels
Spécifications
- Les spécifications du produit fini doivent être établies conformément aux exigences décrites dans le Guide de référence sur la qualité des produits de santé naturels de la Direction des produits de santé naturels et sans ordonnance (DPSNSO).
- L'ingrédient médicinal doit être conforme aux exigences mentionnées dans la BDIPSN.
EXEMPLE D'INFO-PRODUIT :
Veuillez consulter la ligne directrice, Étiquetage des produits de santé naturels pour plus de détails.
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