PANAX GINSENG

Notes

• Les parenthèses contiennent des éléments d'information additionnels (facultatifs) qui peuvent être inclus dans la DLMM ou sur l'étiquette du produit à la discrétion du demandeur.
• La barre oblique (/) indique que les termes ou les énoncés sont synonymes. Le demandeur peut utiliser n'importe lequel des termes ou énoncés indiqués.

Date

23 Février 2024

Nom(s) propre(s), Nom(s) commun(s), Information(s) d'origine

Références: Nom propre: USDA 2024; Gardner et McGuffin 2013; Noms communs: USDA 2024; USP-NF 2023; PPRC 2015; Gardner et McGuffin 2013; Vuksan et al. 2008; Reay et al. 2006; Kim et al. 2005; Sünram-Lea et al. 2005; OMS 1999; Informations d'origine: USP-NF 2023; PPRC 2015; Ph. Eur 2008; Vuksan et al. 2008; Sievenpiper et al. 2006; ESCOP 2003; OMS 1999; Bradley 1992; BHP 1983; Wren 1907.

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 phytothérapie comme) thérapie de soutien pour aider au contrôle du taux de glucose (Vuksan et al. 2008; Sievenpiper et al. 2006; Williamson 2003; Tetsutani et al. 2000; OMS 1999; Sotaniemi et al. 1995).
• (Utilisé en phytothérapie pour) aide(r) au maintien des fonctions cognitives et/ou à la réduction de fatigue mentale (dans les cas de tension mentale) (Reay et al. 2006; Reay et al. 2005; Sünram-Lea et al. 2005; Kennedy et al. 2004; ESCOP 2003; Kennedy et al. 2002; Scholey et Kennedy 2002; Kennedy et al. 2001; Sorensen et Sonne 1996; Bradley 1992; D'Angelo et al. 1986; BHP 1983).
• Aide au maintien de la cognition (Reay et al. 2006; Reay et al. 2005; Sünram-Lea et al. 2005; Kennedy et al. 2004; ESCOP 2003; Kennedy et al. 2002; Scholey et Kennedy 2002; Kennedy et al. 2001; Sorensen et Sonne 1996; Bradley 1992; D'Angelo et al. 1986; BHP 1983).
• (Utilisé en phytothérapie pour) aide(r) à accroître les capacités physiques/la performance physique (dans les cas de stress physique) (Kim et al. 2005; ESCOP 2003; Gross et al. 2002; OMS 1999; Gross et al. 1995; Sotaniemi et al. 1995; Schepdael 1993).
• Utilisé en phytothérapie comme adaptogène pour aider à augmenter l'énergie et la résistance au stress (par ex., dans les cas de fatigue mentale et physique liées au stress) (Winston et Maimes 2007, Bone 2003, Hoffman 2003, Blumenthal et al. 2000, OMS 1999, Bradley 1992).
• Utilisé en médecine traditionnelle chinoise (MTC) pour renforcer le Qi, aider la rate et le poumon, soulager les symptômes de la soif associés au manque de liquides organiques et à la chaleur interne (PPRC 2015; Bensky et a. 2004; Chen et Chen 2004).

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 aide(r) au maintien des fonctions cognitives et/ou à la réduction de fatigue mentale et comme adaptogène pour aider à augmenter l'énergie et la résistance au stress).
• 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 panax ginseng est utilisé en médecine traditionnelle chinoise (MTC) pour renforcer le Qi, aider la rate et le poumon, soulager les symptômes de la soif associés au manque de liquides organiques et à la chaleur interne).
  • 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 plus

Quantité(s)

Taux de glucose; Fonction cognitive/cognition; Stress mental; Stress physique; Adaptogène

Méthodes de préparation : Extraits normalisés (extrait sec)

200 à 600 milligrammes d'extrait, par jour; normalisé à 4 à 7% de ginsénosides totaux; Ne pas dépasser 9 grammes de racine/radicelle séchée, par jour (Vuksan et al. 2008; Reay et al. 2006; Sievenpiper et al. 2006; Reay et al. 2005; Sünram-Lea et al. 2005; Kennedy et al. 2004; ESCOP 2003; Kennedy et al. 2002; Scholey et Kennedy 2002; Engels et al. 2001; Kennedy et al. 2001; Scaglione et al. 2001; Blumenthal et al. 2000; Tetsutani et al. 2000; Engels et al. 1996; Scaglione et al. 1996; Gross et al. 1995; Scaglione et al. 1994; Scaglione et al. 1990; Petkov et Mosharrof 1987; D'Angelo et al. 1986; Soldati et Sticher 1980).

Méthodes de préparation : Sec, poudre, extraits non-normalisés (extrait sec, teinture, extrait fluide, décoction, infusion)

0,5 à 9 grammes de racine/radicelle séchée, par jour (Vuksan et al. 2008; Reay et al. 2006; Sievenpiper et al. 2006; Reay et al. 2005; Sünram-Lea et al. 2005; Kennedy et al. 2004; ESCOP 2003; Kennedy et al. 2002; Scholey et Kennedy 2002; Engels et al. 2001; Kennedy et al. 2001; Scaglione et al. 2001; Blumenthal et al. 2000; Tetsutani et al. 2000; Engels et al. 1996; Scaglione et al. 1996; Gross et al. 1995; Scaglione et al. 1994; Scaglione et al. 1990; Petkov et Mosharrof 1987; D'Angelo et al. 1986; Soldati et Sticher 1980).

Médecine traditionnelle chinoise

Méthodes de préparation: Décoction, décoction concentrée

3 à 10 grammes de racine séchée, par jour (PPRC 2015; Bensky et al. 2004, Chen et Chen 2004).

Méthodes de préparation: Poudre (non-extraite)

0,5 à 4 grammes de racine séchée, par jour (PPRC 2015, Bensky et al. 2004, Chen et Chen 2004).

Mode(s) d'emploi

Énoncé non requis.

Durée(s) d'utilisation

Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si l'utilisation se prolonge au-delà de 3 mois (Mills et Bone 2005; Blumenthal et al. 2000; Bradley 1992).

Mention(s) de risque

Précautions et mise en garde

• Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant l'utilisation si vous êtes enceinte ou si vous allaitez.
• 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; Vuksan et al. 2008; Seely et al. 2008; Sievenpiper et al. 2006; ESCOP 2003; Tetsutani et al. 2000; Sotaniemi et al. 1995; Chin 1991).
• 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 antidépresseurs, des anticoagulants ou de la digoxine (Brinker 2010; Lee et al. 2008a; Dasgupta et Reyes 2005; Janetzki et Morreale 1997; Gonzalez-Seijo et al. 1995; Shader et Greenblatt 1988; Jones et Runikis 1987; Shader et Greenblatt 1985).

Contre-indications(s)

Médecine traditionnelle chinoise

Ne pas utiliser en cas de déficience du Yin accompagnée de symptômes de chaleur, de chaleur excessive, ou en l'absence d'une déficience importante du Qi (Bensky et al. 2004).

Réaction(s) indésirable(s) connue(s)

Cessez d'utiliser et consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si vous développez de l'insomnie, de l'anxiété ou des maux de tête (Lee et al. 2008b; Vuksan et al 2008; de Andrade et al.2007; Sievenpiper et al. 2006; Coon et Ernst 2002; Ellis et Reddy 2002; Scaglione et al. 2001; Siegel 1979).

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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