Santé Canada
Symbole du Gouvernement du Canada
Médicaments et produits de santé

Produits d'Huiles fixes -Ingrédients Multiples -Oral

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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 à ingrédients multiples à base d'huiles qui contient au moins deux ingrédients médicinaux apparaissant au tableau 1. Elle ne vise pas à être une étude approfondie des ingrédients médicinaux
  • Pour les produits qui contiennent une seule huile comme ingrédient médicinal, consultez la monographie à ingrédient unique correspondante.
  • Les huiles hydrogénées et partiellement hydrogénées dépassent le cadre de cette monographie.
Nota
  • Les parenthèses contiennent des éléments d'information facultatifs; il n'est pas nécessaire de les inclure dans la demande de licence de mise en marché (DLMM) ou sur l'étiquette du produit.
  • La barre oblique (/) indique que les termes sont synonymes. Le demandeur peut utiliser n'importe lequel des termes indiqués.

Date

7 janvier 2015

Noms(s) propre(s), nom(s) commun(s) et matière(s) d'origine

Tableau 1 : Nom(s) propre(s), Nom(s) commun(s) et Matière(s) d?origine des ingrédients médicinaux
Nom(s) propre(s)Table 1 footnote 1 Nom(s) commun(s)Table 1 Footnote2           Matière(s) d?origine

Tableau 1 note de bas de page

Tableau 1 note de bas de page 1

Noms propres et noms communs : Base de données des ingrédients de produits de santé naturels (BDIPSN)

Retour à la référence 1,2 de la note de bas de page du tableau 1

Borago officinalis Huile de bourrache Graine (Martindale 2012; Hoffmann 2003)
Brassica napus
  • Huile de canola
  • Huile de colza
Graine (FCC 2014)
Brassica juncea
Brassica rapa
Camelina sativa Huile de caméline
Huile de faux lin
Graine (Dubois et al. 2007)
Cannabis sativa Huile de chanvre Graine (Callaway et al. 2005)
Carthamus tinctorius Huile de carthame Graine (USP 37)
Cocos nucifera Huile de noix de coco Endosperme de la graine (FCC 2014)
Huile de foie de morue Huile de foie de morue Tel qu?indiqué dans la monographie Huile de foie de morue de la DPSNSO
Cucurbita pepo var. pepo Huile de graine de citrouille Graine (Dubois et al. 2007)
Huile de poisson Huile de poisson Tel qu?indiqué dans la monographie Huile de poisson de la DPSNSO
Helianthus annuus Huile de tournesol Graine (FCC 2014)
Hippophae rhamnoides Huile d?argousier Graine (Yang et al. 1999)
Huile de krill Huile de krill Tel qu?indiqué dans la monographie Huile de krill de la DPSNSO
Linum usitatissimum
  • Huile de lin
  • Huile de graine de lin
Tel qu?indiqué dans la monographie Huile de lin de la DPSNSO
Oenothera biennis Huile d?onagre Tel qu?indiqué dans la monographie Huile d?onagre de la DPSNSO
Olea europaea Huile d?olive Fruit (NF 32)
Prunus dulcis var. dulcis
  • Huile d?amande
  • Huile d?amande douce
Noyau (NF 32)
Ribes nigrum Huile de pépin de cassis Graine (Linnamaa et al. 2010)
Salvia hispanica Huile de graine de chia Graine (Dubois et al. 2007)
Schizochytrium spp Huile de schizochytrium Schizochytrium spp. (Yurko-Mauro et al. 2010)
Huile de phoque Huile de phoque Tel qu?indiqué dans la monographie Huile de phoque de la DPSNSO
Huile de calmar Huile de calmar Todarodes pacificus - whole (ITIS 2014)
Docidicus gigas - whole (ITIS 2014)
Illex argentinus - whole (ITIS 2014)
Illex illecebrosus - whole (ITIS 2014)
Triticum aestivum Huile de germe de blé Germe (Ph.Eur 2013)
Vitis vinifera Huile de pépin de raisin Graine (Dubois et al. 2007)

Voie(s) d'administration

Orale

Forme(s) posologique(s)

  • Les formes posologiques pharmaceutiques acceptables comprennent, notamment les capsules, les formes posologiques à croquer (p. ex. les comprimés), les liquides, les poudres, les bandelettes ou les comprimés.
  • Les aliments ou les formes posologiques semblables aux aliments, telles que les barres, les gommes à mâcher ou les breuvages, l?huile pour la cuisson et l?huile de table, sont exclus de cette monographie.

Usage(s) ou fin(s) recommandés

Énoncé(s) précisant ce qui suit:

Nota
  • Tous les produits doivent citer au moins un énoncé concernant les usage(s) ou fin(s) recommandés.
  • Un énoncé concernant les usage(s) ou fin(s) recommandés est acceptable seulement si au moins un ingrédient médicinal associé à cet énoncé est présent à une dose quotidienne égale ou supérieure à la valeur de la dose minimale énoncée au tableau 2.
  • Les ingrédients médicinaux dont la dose quotidienne ne satisfait pas à la valeur de la dose minimale seront considérés comme ingrédients médicinaux additionnels acceptables dans les formulations de produits.
Tableau 2 : Usage(s) ou fin(s) recommandés selon les constituants d?acides gras
Constituants requis des acides grasTableau 2 la note1 Dose quotidienne minimaleTableau 2 la note 2(mg par jour) Usage(s) ou fin(s) recommandés

Tableau 2 notes de bas de page

Tableau 2 note de bas de page 1

Pour les produits proposant des allégations sur ce tableau, les activités doivent être indiquées pour les constituants d?acides gras correspondants. Consulter l?annexe I pour les activités des constituants et leurs pourcentages respectifs.

Retour à la référence 1 de la note de bas de page du tableau 2

Table 2 footnote 2

Au moins une des références suivantes a été consultée pour les doses minimales et les usages ou fins recommandés : DPSNSO 2014; EFSA 2010a; EFSA 2010b; EFSA 2009; Simopolous 2007; IOM 2006; IOM 2002; Simopolous 1999;

Retour à la référence 2 de la note de bas de page du tableau 2

AL (Acide linoléique) 850
  • Source d?acide linoléique (AL) pour le maintien d?une bonne santé
  • Source d?acide gras oméga-6 pour le maintien d?une bonne santé
  • Source d?acide gras essentiel pour le maintien d?une bonne santé
AAL (Acide alpha-linolénique) 80
  • Source d?acide alpha-linolénique (AAL) pour le maintien d?une bonne santé
  • Source d?acide gras oméga-3 pour le maintien d?une bonne santé
  • Source d?acide gras essentiel pour le maintien d?une bonne santé
AL + AAL 850 AL + 80 AAL Source d?acides gras essentiels pour le maintien d?une bonne santé
AEP + ADH + ADP
(Acide eicosapentaénoïque + Acide docosahexaénoïque + Acide docosapentaénoïque (n-3))
100 AEP+ADH+ADP Source d?acides gras oméga-3 pour le maintien d?une bonne santé
AEP 100 Source d?acide eicosapentaénoïque (AEP) pour le maintien d?une bonne santé
ADH 100 Source d?acide docosahexaénoïque (ADH) pour le maintien d?une bonne santé
250
  • Aide au soutien/maintien du fonctionnement des yeux
  • Aide au soutien/maintien de la santé oculaire
  • Aide au soutien/maintien des fonctions cérébrales normales
ADP 100 Source d?acide docosapentaénoïque (ADP) pour le maintien d?une bonne santé
AEP+ADH 250 AEP+ADH Aide au soutien/maintien de la santé/des fonctions du coeur/cardiovasculaire(s) (normales)
2000 AEP+ADH Aide au soutien/maintien de niveaux normaux de triglycérides/triacylglycérols du sang/sérum
AGL (Acide gamma-linoléique) 100 Source d?acide gamma-linoléique
AO (Acide oléique) 100 Source d?acide oléique
Produits renfermant de l?huile de noix de coco, de l?huile d?olive et/ou de l?huile de germe de blé

Fournit/Source des antioxydants (Marina et al. 2009; Alessandri et al. 2006; Fito et al. 2005; Visioli et al. 2005; Marrugat et al. 2004; Weinbrenner et al. 2004)

Produits renfermant de l?huile de schizochytrium, de l?huile de bourrache, de l?huile de foie de morue, de l?huile de krill, de l?huile d?onagre, de l?huile de phoque et/ou produits pour fonctions cognitives

Les allégations permises sont celles indiquées dans les monographies respectives de la DPSNSO pour ces ingrédients. Les doses et les activités des monographies individuelles doivent être respectées.

Dose(s)

Sous-population(s)

Tous les produits

Adulte (≥ 18 ans)

Produits renfermant de l?huile de poisson, de l?huile de lin, de l?huile de phoque et/ou de l?huile de foie de morue

Tel qu?indiqué dans les monographies de la DPSNSO respectives.

Preparations

Huile fixe; Huile fixe normalisée

Tableau 3 : Doses quotidiennes maximales des ingrédients médicinaux
Ingrédients médicinaux Doses quotidiennes maximales (g par jour)
Borago officinalis/Huile de bourrache Tel qu?indiqué dans la monographie Huile de bourrache de la DPSNSO
Brassica napus/B. juncea/B. rapa/Huile de canola 15,0 (DPSNSO 2014)
Camelina sativa/Huile de caméline 15,0 (DPSNSO 2014)
Cannabis sativa/Huile de chanvre 15,0 (DPSNSO 2014)
Carthamum tinctorius/Huile de carthame 15,0 (DPSNSO 2014)
Cocos nucifera/Huile de noix de coco 15,0 (DPSNSO 2014)
Huile de foie de morue Tel qu?indiqué dans la monographie Huile de foie de morue de la DPSNSO
Cucurbita pepo var. pepo/Huile de graine de citrouille 15,0 (DPSNSO 2014)
Huile de poisson Tel qu?indiqué dans la monographie Huile de poisson de la DPSNSO
Helianthus annuus/Huile de tournesol 15,0 (DPSNSO 2014)
Hippophae rhamnoides/Huile d?argousier 5,0 (Yang et al. 1999)
Huile de krill Tel qu?indiqué dans la monographie Huile de krill de la DPSNSO
Linum usitatissimum/Huile de lin Tel qu?indiqué dans la monographie Huile de lin de la DPSNSO
Oenothera biennis/Huile d?onagre Tel qu?indiqué dans la monographie Huile d?onagre de la DPSNSO
Olea europaea/Huile d?olive 15,0 (DPSNSO 2014)
Prunus dulcis var. dulcis/Huile d?amande 15,0 (DPSNSO 2014)
Ribes nigrum/Huile de pépin de cassis 10,5 (Leventhal et al. 1994)
Salvia hispanica/Huile de chia 4,5 (NNHPD 2014)
Schizochytrium spp./Huile de schizochytrium Quantité d?huile fournissant au plus 2000 mg ADH par jour (Quinn et al. 2010)
Huile de phoque Tel qu?indiqué dans la monographie Huile de phoque de la DPSNSO
Huile de calmar 5,0 (NNHPD 2014)
Triticum aestivum/Huile de germe de blé 15,0 (DPSNSO 2014)
Vitis vinifera/Huile de pépin de raisin 15,0 (DPSNSO 2014)
Mode(s) d?emploi

Énoncé non requis

Règles et restrictions pour les associations
Les ingrédients médicinaux inclus dans cette monographie peuvent être associés selon les restrictions suivantes :
  • La dose quotidienne maximale d?un produit contenant des associations d?huiles ne doit pas dépasser 15,0 g par jour (DPSNSO 2014).
  • Les doses quotidiennes maximales des ingrédients médicinaux individuels, indiquées au tableau 2, s?appliquent.
  • La dose quotidienne maximale d?une association AEP+ADH+ADP dans un produit ne doit pas dépasser 5,0 g par jour (EFSA 2012).
  • Les doses maximales pour AEP+ADH+ADP pour l?huile de schizochytrium s?appliquent.
  • Les doses maximales pour AEP+ADH+ADP pour l?huile de krill, l?huile de poisson, et l?huile de phoque s?appliquent telles qu?indiquées dans les monographies individuelles respectives de la DPSNSO.
  • Les doses maximales pour AEP+ADH et pour la vitamine A et D s?appliquent pour l?huile de foie de morue, telles qu?indiquées dans la monographie Huile de foie de morue de la DPSNSO

Durée(s) d'utilisation

Énoncé non requis.

Mention(s) de risque

Énoncé(s) précisant ce qui suit

Précaution(s) et mise(s) en garde

Produits renfermant de l?huile de chanvre, de l?huile d?argousier, de l?huile de krill, de l?huile de pépin de cassis et/ou de l?huile de calmar

Si vous êtes enceinte ou allaitez, consulter un praticien de soins de santé avant l?utilisation.

Contre-indications(s)

Énoncé non requis.

Réaction(s) indésirable(s) connue(s)

Produits renfermant de l?huile de krill et/ou de l?huile de calmar

Une hypersensibilité/allergie peut se manifester (lors de la consommation de crustacés et de mollusques); dans ce cas, cesser l?utilisation (Martindale 2012).

Ingrédients non médicinaux

Doivent être choisis parmi ceux de la version actuelle de la Base de données sur les ingrédients des produits de santé naturels de la DPSNSO et respecter les restrictions mentionnées dans cette base de données.

Conditions d'entreposage

Tous les produits

Entreposer dans un contenant hermétique, dans un endroit frais et à l?abri de la lumière (Ph.Eur. 2012; USP 35).

Produits renfermant de l?huile de schizochytrium, de l?huile de caméline, de l?huile de chanvre, de l?huile de foie de morue, de l?huile de poisson, de l?huile d?argousier, de l?huile de krill, de l?huile de lin, de l?huile de pépin de cassis, de l?huile de chia, de l?huile de phoque et/ou de l?huile de calmar sauf les produits encapsulés

Réfrigérer après l?ouverture (Wille et Gonus 1989).

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 DPSNSO. L?huile de foie de morue, l?huile de poisson, l?huile de krill, l?huile de phoque et l?huile de calmar sont des huiles marines et doivent respecter la section 3.3.8 Contaminants dans les huiles marines du Guide de référence sur la qualité des produits de santé naturels de la DPSNSO pour les produits renfermant ces ingrédients.
  • Pour tous les produits renfermant un ou plusieurs ingrédients de cette monographie, la section 3.3.11 Résistance des huiles à l?oxydation du Guide de référence sur la qualité des produits de santé naturels de la DPSNSO doit être respectée.
  • L?ingrédient médicinal doit être conforme aux exigences mentionnées dans la BDIPSN. De plus, l?ingrédient médicinal peut être conforme aux spécifications énoncées dans les pharmacopées américaines (USP), britanniques (BP) et/ou européennes (Ph.Eur.).
  • Les produits renfermant de l?huile de chanvre ne doivent pas contenir plus de 10 ppm de delta-9-tétrahydro-cannabinol (THC) et leurs productions doivent respecter le Règlement sur le chanvre industriel (GC 2014).
  • Pour tous les produits ayant une ou plusieurs des activités indiquées dans la section des doses, une analyse doit être faite afin de confirmer l?activité en question.
  • Pour les ingrédients suivants, veuillez consulter les exigences supplémentaires concernant la qualité dans les monographies de la DPSNSO respectives : Huile de bourrache, Huile de foie de morue, Huile de poisson, Huile de krill, Huile de lin, Huile d?onagre, Huile de phoque.

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Annexe I

Tableau 1 Composition en acides gras des ingrédients médicinaux (%)Appendix Table 1 Footnote 1>Appendix Table 1 Footnote 2
Ingrédient médicinal Acide linoléi-que 18:2 (n-6) (AL) Acide alpha-linoléni-que 18:3(n-3) (AAL) Acide eicosa-penta-noïque 20:5(n-3) (AEP) Acide docosa-hexa-noïque 22:6(n-3) (ADH) Acide docosapen-taénoïque 22:5(n-3) (ADP) Acide gammali-nolénique 18:3(n-6) (AGL) Acide oléique 18:1(n-9) (AO)

Appendix table 1 Footnotes

Table 1 Footnote 1

Toutes les quantités d?activités acceptables des constituants sont indiquées pour chacun des ingrédients médicinaux (en pourcentages). Les plages de pourcentages sont indiquées en tant que référence uniquement et peuvent présenter des variations naturelles selon la matière d?origine utilisée et/ou la méthode de préparation.

Return to Appendix Table 1 footnote 1 referrer

Appendix table 1 Footnote 2

Au moins une des références suivantes a été utilisée pour les plages d?activités : FCC 2014; USP 37; Quinn et al. 2010; Arafiles et al. 2011; BP 2014; Ph.Eur. 2013; Schirmer et Phinney 2007; Hoffman 2003; Takwale et al. 2003; van Gool et al. 2003; Ziboh et al. 2004; Mills et Bone 2005; WHO 2002; HC 2009; Cunnane et al. 1993; NF 32; Mansour et al. 2014; Hrastar et al. 2009; Kirkhus et al. 2013; Leizer et al. 2000; Bagci et al. 2002; Dubois et al. 2007; Laureles et al. 2002; Murkovic et al. 1996; Kirbaslar et al. 2012; Stevenson et al. 2007; Beveridge et al. 1999; Yang et al. 2001; Fatima et al. 2012; Kazantis et al. 2003; Soler et al. 1988; Ziboh et Fletcher, 1992; Ruiz del Castillo et al. 2002; Ixtaina et al. 2011; Segura-Campos et al. 2014; Ayerza, 2009; Grahl-Nielsel et Miaavtten, 1991; Gregersen et al. 2010; Bjorkkjaer et al. 2009; Mann et al. 2010; AU TGA 2013; Sabir et al. 2011; Lutterodt et al. 2011; Crews et al. 2006; Beveridge et al. 2005.

Return to Appendix Table 1 footnote 2 referrer

Huile de schizochytrium -- -- Up to 3,9 22-55 -- -- --
Huile de bourrache 23-37 0,2-10 -- -- -- 18-27 12-22
Huile de canola 16-40 6-14 -- -- -- -- 50-67
Huile de caméline 15-25 29-40 -- -- -- -- 11-36
Huile de chanvre 49-70 12-25 -- -- -- 1-6 8-16
Huile de carthame 7-84 Up to 1,5 -- -- -- -- 7-84
Huile de noix de coco 1-4 Up to 0,2 -- -- -- -- 1-10
Huile de foie de morue 0,5-3 Up to 2 7-16 6-18 -- -- 12-21
Huile de graine de citrouille 42-71 -- -- -- -- -- 17-47
Huile de poisson -- -- Minimum 4 Minimum9 -- -- --
Huile de tournesol 20-75 Up to 0,5 -- -- -- -- 14-65
Huile d?argousier 29-44 20-39 -- -- -- -- 12-27
Huile de krill 1,4-3 0,5-3,5 14-22,1 7,5-13,2 Up to 0,7 -- 7-14,5
Huile de lin 11-24 35-65 -- -- -- -- 11-35
Huile d?onagre 65-85 Up to 0,5 -- -- -- 7-14 5-12
Huile d?olive 3,5-20 Up to 1,2 -- -- -- -- 56-85
Huile d?amande 10-30 Up to 0,4 -- -- -- -- 59-86
Huile de pépin de cassis 30-49 11-34 -- -- -- 11-23 11-15
Huile de chia 16-23 52-69 -- -- -- -- 6-11
Huile de phoque Up to 1,5 Up to 2,1 3-8 7-13 3-5 -- 14-29
Huile de calmar -- -- Minimum 5 Minimum18 -- -- --
Huile de germe de blé 52-59 3-10 -- -- -- -- 12-23
Huile de pépin de raisin 53-76 Up to 1,8 -- -- -- -- 12-32