Draft Community Herbal Monograph On Agropyron Repens (L.) P. Beauv., Rhizoma
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
27 January 2011
EMA/HMPC/563408/2010
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Agropyron repens (L.) P. Beauv., rhizoma
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Agropyron repens (L.) P. Beauv., rhizoma; Agropyri repentis rhizoma; couch grass rhizome
BG (balgarski): nwpefi, KopeHM^e CS (cestina): oddenek pyru DA (dansk):
DE (Deutsch): Queckenwurzelstock EL (ellinika):
EN (English): Couch grass rhizome ES (espanol):
ET (eesti keel): orasheina juurikas FI (suomi):
FR (français): chiendent (rhizome de) HU (magyar): Tarackbuza gyôkértôrzs IT (italiano):_
LT (lietuviq kalba):
LV (latviesu valoda): Värpatas saknenis MT (malti):
NL (nederlands): kweek PL (polski): Ktqcze perzu PT (portugués):
RO (romana): rizom de pir SK (slovencina): Pyrovy podzemok SL (slovenscina):
SV (svenska): Kvickrot, jordstam IS (íslenska):
NO (norsk): Kvekerot_
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Discussion in Working Party on Community monographs and Community list (MLWP) |
November 2010 January 2011 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
27 January 2011 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 June 2011 |
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Rediscussion in Working Party on Community monographs and Community list (MLWP) | |
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Adoption by Committee on Herbal Medicinal Products (HMPC) |
Keywords
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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Agropyron repens (L.) P. Beauv., rhizoma
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 Agropyron repens (L.) P. Beauv., rhizoma (couch grass rhizome) i) Herbal substance Not applicable. ii) Herbal preparations a) Comminuted herbal substance b) Liquid extract (DER 1: 1), extraction solvent ethanol 20-25% V/V c) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 40% V/V |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Comminuted herbal substance as herbal tea for oral use. Herbal preparations in liquid dosage forms for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
1 The material complies with the Ph. Eur. monograph (ref.: 01/2008:1306 corrected 6.0).
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
4. Clinical particulars
4.1. Therapeutic indications
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Well-established use |
Traditional use |
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Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints. The product is a traditional herbal medicinal product for use in specified indication 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 Adults and elderly a) Comminuted herbal substance as infusion Single dose: 3-6 g Daily dose: 10-20 g b) Liquid extract Single dose: 4-8 ml, 2 to 4 times daily c) Tincture Single dose: 5-15 ml, 3 times daily The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Duration of use The herbal substance is traditionally used over a period of 2 up to 4 weeks. 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 Oral use. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance(s). Conditions where a reduced fluid intake is recommended (e.g. severe cardiac or renal disease). |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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The use in children and adolescents under 18 years of age is not recommended because of concerns requiring medical advice. If complaints or symptoms such as fever, dysuria, spasms, or blood in urine occur during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. For tinctures and extracts containing ethanol, the appropriate labelling for ethanol, taken from the 'Guideline on excipients in the label and package leaflet of medicinal products for human use', must be included. |
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. 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. |
4.7. Effects on ability to drive and use machines
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Well-established use |
Traditional use |
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No studies on the effect on the ability to drive and use machines have been performed. |
4.8. Undesirable effects
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Well-established use |
Traditional use |
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None known. If adverse reactions 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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No case of overdose has been reported. |
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 reproductive toxicity, genotoxicity 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
27 January
Page 8/6
Community herbal monograph on Agropyron repens (L.) P. Beauv., rhizoma
EMA/HMPC/563408/2010