Draft European Union Herbal Monograph On Glycine Max (L.) Merr., Oleum
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
12 July 2016
EMA/HMPC/338914/2016
Committee on Herbal Medicinal Products (HMPC)
European Union herbal monograph on Glycine max (L.) Merr., oleum
Draft
Herbal medicinal products; HMPC; European Union herbal monographs; traditional use; Glycine max (L.) Merr., oleum; Soiae oleum raffinatum; soyabean oil, refined
BG (bulgarski): CoeBO Macno, pa^nHwpaHO CS (cestina): cistëny sójovy olej DA (dansk): Sojaolie, renset DE (Deutsch): Raffiniertes Sojaöl EL (elliniká): ZoYiéÂaio e^euYCviapevo EN (English): soya-bean oil, refined ES (español): Soja, aceite de, refinado ET (eesti keel): rafineeritud sojaöli FI (suomi): soijaöljy, puhdistettu FR (français):
HR (hrvatski): Sojino ulje, rafinirano HU (magyar): finomított szójaolaj IT (italiano): olio di semi di soia raffinato
LT (lietuviq kalba): Rafinuotas sojq aliejus LV (latviesu valoda):
MT (Malti): Zejt raffinat tas-sojja NL (Nederlands):
PL (polski): Olej sojowy rafinowany PT (portugués): Óleo de soja, refinado RO (romana): ulei de soia, rafinat SK (slovencina): Sójovy olej rafinovany SL (slovenscina): rafinirano sojino olje SV (svenska): sojaolja, raffinerad IS (íslenska):
NO (norsk): Renset soyaolje
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Discussion in Working Party on European Union monographs and list (MLWP) |
March 2014 November 2015 April 2016 May/June 2016 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
12 July 2016 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
31 October 2016 |
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Re-discussion in MLWP | |
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Adoption by HMPC |
Keywords
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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
European Union herbal monograph on Glycine max (L.) Merr., oleum
1. Name of the medicinal product
To be specified for the individual finished product.
2. Qualitative and quantitative composition1,2
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Well-established use |
Traditional use |
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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Glycine max (L.) Merr., oleum (soya-bean oil, refined) i) Herbal substance Not applicable ii) Herbal preparations Soya-bean oil, refined |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Herbal preparations in liquid dosage forms for use as a bath additive. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
4. Clinical particulars
4.1. Therapeutic indications
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Well-established use |
Traditional use |
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Traditional herbal medicinal product used for the symptomatic relief of dry skin conditions associated with mild recurrent eczema. The product is a traditional herbal medicinal product for use in the specified indication |
1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
The material complies with the Ph. Eur. monograph (ref.: 1473 corrected 6.7)
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Well-established use |
Traditional use |
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exclusively based upon long-standing use. |
4.2. Posology and method of administration
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Well-established use |
Traditional use |
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Posology Liquid preparations containing 70-90% of soya bean oil as bath additive 2-3 times per week Adolescents, adults and elderly Full bath (approximately 100-150 l): 15-45 ml Partial bath (approximately 25-50 l): 5-15 ml Partial bath (approximately 5 l): 1-2.5 ml Shower bath with direct application on skin: 20 ml In particularly dry skin, 2-3 times the above quantities can be used. Children Children's bath (approximately 50 l): 20 ml Children's bath (approximately 25 l): 2.5-10 ml In particularly dry skin, 2-3 times the above quantities can be used. Duration of use Duration of bath: Adolescents, adults and elderly Maximum 20 minutes. Children A few minutes. If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration Use as bath additive. Bath temperature: Do not exceed 36 °C |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance, soya, peanut and to other plants of the Fabaceae (legume) family and to birch pollen.1 Full baths are contraindicated in cases of open wounds, large skin injuries, acute skin diseases, high fever, severe infections, severe circulatory disturbances and cardiac insufficiency. |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Eye contact may cause keratitis and should be avoided. In cases of accidental eye contact, the eye should be rinsed immediately with cold water. If eye irritation remains, a doctor or a qualified health care practitioner should be consulted. |
4.5. Interactions with other medicinal products and other forms of interaction
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Well-established use |
Traditional use |
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None reported |
4.6. Fertility, pregnancy and lactation
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Well-established use |
Traditional use |
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Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. No fertility data available. |
4.7. Effects on ability to drive and use machines
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Well-established use |
Traditional use |
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Soya bean oil has no or negligible influence on the ability to drive and use machines. |
4.8. Undesirable effects
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Well-established use |
Traditional use |
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Skin rashes and hypersensitivity reactions have been reported. The frequency is not known. Accidental eye contact may cause keratitis (see section 4.4 'Special warnings and precautions for use). If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted. |
4.9. Overdose
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Well-established use |
Traditional use |
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There are no known harmful effects resulting from excessive oil concentrations in the bath water. Accidental oral intake may lead to nausea, vomiting and diarrhoea. In case of vomiting aspiration could occur, therefore, vomiting should not be induced. If signs of aspiration occur, such as coughing, wheezing, fever, and chest discomfort, a doctor or a qualified health care practitioner should be consulted. |
5. Pharmacological properties
5.1. Pharmacodynamic properties
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.2. Pharmacokinetic properties
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.3. Preclinical safety data
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product. Adequate tests on genotoxicity have not been performed. Tests on reproductive toxicity and carcinogenicity have not been performed. |
6. Pharmaceutical particulars
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Well-established use |
Traditional use |
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Not applicable |
7. Date of compilation/last revision
12 July 2016
Page 6/6
European Union herbal monograph on Glycine max (L.) Merr., oleum
EMA/HMPC/338914/2016
In accordance with the 'Public statement on the allergenic potency of herbal medicinal products containing soya or peanut protein' (EMA/HMPC/138139/2005).