Gemmotherapy

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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 ingredients.

Notes

• By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.
• 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 the statements are synonymous. Either term or statement may be selected by the applicant.
• The use of the electronic Product License Application form (ePLA) is not possible for products associated with this monograph.

Date

June 24, 2013

Proper name(s), Common name(s), and Source material(s)

Table 1 Products may contain one or more of the following ingredients

Proper name(s)	Common name(s)	Source material(s)
Abies alba	Silver fir	Buds; Young shoots
Abies balsamea	Balsam fir	Buds; Young shoots
Acer campestre	Field maple; Hedge maple	Buds
Aesculus hippocastanum	Horse chestnut	Buds
Alnus glutinosa	Alder; Black alder; European alder	Buds
Alnus incana	Mountain alder	Buds
Ampelopsis veitchii	Boston ivy; Virgin vine; Wild woodvine	Young shoots
Betula alba; Betula pubescens	White birch; Downy birch	Buds; Catkin; Inner bark of stems/roots; Radicles; Sap
Betula verrucos; Betuala pendula	European white birch; Silver birch	Buds; Seeds; Sap
Buxus sempervirens	Boxwood	Young shoots
Calluna vulgaris	Heather	Young shoots
Carpinus betulus	Hornbeam	Buds
Castanea vesca/sativa	Chestnut; Sweet chestnut; Spanish chestnut	Buds
Cedrus libani	Cedar of Lebanon	Young shoot
Cercis siliquastrum	Judas tree	Buds
Citrus limonum	Lemon; Lemon tree	Stem bark; Young shoot
Cornus sanguinea	Dogwood	Buds
Corylus avellana	Hazel	Buds
Crataegus oxyacantha/laevigata	Hawthorn	Young shoot; Buds
Equisetum arvense	Horsetail	Young shoot
Fagus sylvatica	European beech; Common beech; Beech	Buds
Ficus carica	Fig	Buds
Fraxinus excelsior	Ash	Buds
Ginkgo biloba	Ginkgo	Buds; Leaves
Hippophae rhamnoides	Sea buckthorn	Buds
Ilex aquifolium	English Holly; Holly	Young shoots
Juglans regia	English walnut; Walnut; Walnut tree	Buds
Juniperus communis	Common juniper; Juniper	Young shoots
Ligustrum vulgare	Privet	Young shoots
Lonicera nigra	Honeysuckle	Young shoots
Malus sylvestris	Crab apple; European crab apple	Buds
Morus nigra	Black Mulberry	Buds
Olea europaea	Olive	Young shoots
Pinus montana/mugo	Mountain pine	Buds
Platanus orientalis	Oriental planetree	Buds
Populus nigra	Black poplar	Buds
Prunus amygdalus/dulcis	Almond; Sweet almond	Buds; Root bark (rootlet)
Quercus robur/pedunculata	English Pedunculate oak	Buds
Ribes nigrum	Black currant	Buds
Rosa canina	Dog rose	Young shoots
Rosmarinus officinalis	Rosemary	Young shoots
Rubus fruticosus	Blackberry; Bramble	Young shoots
Rubus idaeus	Raspberry	Young shoots
Sambucus nigra	Black elder	Buds
Salix alba	White willow	Buds; Catkins
Secale cereale	Rye	Root bark (rootlet)
Sequoia gigantea	Giant sequoia; Giant Redwood	Young shoots
Sorbus domestica	Servicetree; Rowan tree	Buds
Syringa vulgaris	Lilac	Buds
Tamarix gallica	Tamarisk	Young shoots
Tilia tomentosa	Silver linden; Linden tree	Buds
Ulmus campestris/minor	European field elm; Elm	Buds
Vaccinium myrtillus	Bilberry; European blueberry	Buds; Young shoots
Vaccinium vitis-idaea	Ligonberry; Cowberry; Wine berry	Young shoots
Viburnum lantana	Wayfaring tree	Buds
Vinca minor	Common periwinkle; Lesser periwinkle	Young shoots
Viscum album	European mistletoe; Mistletoe	Young shoots
Vitis vinifera	Grape; Grape vine	Buds
Zea mays	Corn; Maize	Root bark (rootlet)

Route(s) of administration

• Oral

Dosage form(s)

• The acceptable pharmaceutical dosage forms are liquids only.
• This monograph is not intended to include dosage forms such as beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of

Gemmotherapy preparation/remedy/medicine

Dose

Statement(s) to the effect of

Subpopulation(s)

Adults (≥ 18 years)

Quantity(ies)

Medicinal ingredients with extract ratio 1:20

Maximum 37.5 mg QCE of medicinal ingredient per day.

Products containing a single medicinal ingredient:
Maximum 2.5 mg Quantity Crude Equivalent (QCE) of medicinal ingredient per drop.

Products containing multiple medicinal ingredients*:
Maximum 2.5 mg QCE of medicinal ingredients per drop (Refer to Appendix I for examples).

Medicinal ingredients with extract ratio 1:200

Maximum 56.25 mg QCE of medicinal ingredient per day.

Products containing a single medicinal ingredient:
Maximum 0.25 mg QCE of medicinal ingredient per drop.

Products containing multiple medicinal ingredients*:
Maximum 0.25 mg QCE of medicinal ingredients per drop (Refer to Appendix I for examples).

Betula (alba/pubescens/verrucosa/pendula) sap

Maximum 300 drops or 15 ml or 1 tablespoon per day.
Maximum 0.05 ml of fresh sap per drop.

*The quantity per drop and the quantity crude equivalent (QCE) of each medicinal ingredient will depend on the number of medicinal ingredients and their proportions in the product. Please refer to Appendix II for examples.

Method of preparation

The method of preparation must be one of the following:

• PhF glycerine macerate
• Ph. Eur.

Directions for use

All products

Take as directed by a health care practitioner.

Products containing Betula (alba/pubescens/verrucosa/pendula)sap

Drink plenty of water when using this product.

Duration of use

Statement(s) to the effect of

No statement required.

Risk information

Statement(s) to the effect of

Cautions and warnings

• If symptoms persist or worsen, consult a health care practitioner.
• If you are pregnant or breastfeeding, consult a health care practitioner prior to use.

Contraindications

No statement required.

Known adverse reactions

No statement required.

Non-medicinal Ingredients

Must be chosen from the current NNHPD Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Specifications

• The finished product specifications must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide.
• The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database (NHPID).

References reviewed

• Andrianne P. La gemmothérapie: Médecine des bourgeons. Éditions Amyris, 2002.
• Andrianne P. Guide de Gémmothérapie, Éditions Amyris, 2008.
• Andrianne P. Bio Info. Éditions Changer d'R. No 83.
• Greaves M. Gemmotherapy and Oligotherapy Regenerators of Dying Intoxicated Cells. (US): Xlibris, 2008.
• Goetz P. Quelques éléments pratiques de gemmothérapie. Phytothérapie 2006;2:83-86.
• Fédération Européenne d'Herboristerie. 2008. [Accessed 2013 May 29 ].
• Henry P. Gemmothérapie : Thérapeutique par les extraits embryonnaires végétaux. St.Norbert Westerlo (BE), 2008.
• Rozencwajg J. Dynamic Gemmotherapy: Integrative Embryonie Phytotherapy, 2008.
• Tétau M. Nouvelles cliniques de gemmothérapie. Éditions Similia, 1991.

Appendix I

Quantity per drop and quantity crude equicalent (QCE) for medicinal ingredients in various sample products based on their proportions

Example	Medicinal ingredients in the product	Proportion of each ingredient in the product (%)	QCE (mg) per drop for ratio 1:20 (maximum 2.5 mg)	QCE (mg) per drop for ratio 1:200 (maximum 0.25 mg)
1	Betula alba	100	2.5	0.25
2	Betula alba Juglans regia	50 50	1.25 1.25	0.125 0.125
3	Alnus incana Lonicera nigra	75 25	1.875 0.625	0.1875 0.0625
4	Abies alba Malus sylvestris Zea mays	33.3 33.3 33.3	0.83 0.83 0.83	0.083 0.083 0.083
5	Citrus limonum Rosa canina Vitis vinifera	60 30 10	1.5 0.75 0.25	0.15 0.075 0.025

Appendix II

Quantity per drop and quantity crude equivalent (QCE) for various proportions of medicinal ingredients based on product with 1 drop = 0.05mL

Proportion of medicinal ingredient in the product (%)	Quantity per drop (mL)	Quantity crude equivalent for ratio 1:20 (mg)	Quantity crude equivalent for ratio 1:200 (mg)
10	0.005	0.25	0.025
20	0.01	0.5	0.05
30	0.015	0.75	0.075
40	0.02	1.0	0.1
50	0.025	1.25	0.125
60	0.03	1.5	0.15
70	0.035	1.75	0.175
80	0.04	2.0	0.2
90	0.045	2.25	0.225
100	0.05	2.5	0.25

Note: For proportions not represented in this table, the following calculations are required to determine the quantity per dosage unit and the quantity crude equivalent.

Calculations of QCE of medicinal ingredients (MIs):

QCE (1:20) of MI = Proportion of MI in product (in %) x QCE of all MIs (maximum 2.5 mg)

QCE (1:200) of MI = Proportion of MI in product (in %) x QCE of all MIs (maximum 0.25 mg)