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Explizite Einschränkungen aus der Monographie, verknüpft mit eindeutig bezeichneten Wirkstoffen. Die Aussage gilt im Zubereitungs- und Anwendungskontext der Quelle. Ein klinischer Schweregrad wird daraus nicht abgeleitet.

• warfarin

  Laut Quelle überwachen

  Etablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben

  Die Passage enthält sowohl relativierende oder verneinende Befunde als auch eine ausdrückliche Einschränkung. Beides bleibt im Originalzitat erhalten.

  HOS-215920→HOS-085950RxNorm 11289

  Available studies with warfarin do not indicate that there is an interaction between warfarin and G. biloba products, but adequate monitoring is advised when starting, when changing G. biloba dose, when ending G. biloba intake or if changing product.

  Original-PDF · Seite 4 ↗Beziehung HOS-216054
  Zubereitungskontext & Beleg

  Wortlaut der zugeordneten Einschränkung:

  Available studies with warfarin do not indicate that there is an interaction between warfarin and G. biloba products, but adequate monitoring is advised when starting, when changing G. biloba dose, when ending G. biloba intake or if changing product.

  1. Name of the medicinal product
  To be specified for the individual finished product.
  
  
  2. Qualitative and quantitative composition1,2
  Well-established use                                            Traditional use
  
  With regard to the marketing authorisation                      With regard to the registration application of
  application of Article 10(a) of Directive                       Article 16d(1) of Directive 2001/83/EC as
  2001/83/EC as amended                                           amended
  
  Ginkgo biloba L., folium (Ginkgo leaf)                          Ginkgo biloba L., folium (Ginkgo leaf)
  
  i) Herbal substance                                             i) Herbal substance
  
  Not applicable.                                                 Not applicable.
  
  ii) Herbal preparations                                         ii) Herbal preparations
  
  Dry extract (DER 35-67:1), extraction solvent:                  Powdered herbal substance
  acetone 60% m/m3
  
  
  
  3. Pharmaceutical form
  Well-established use                                            Traditional use
  
  Herbal preparations in liquid or solid dosage forms             Herbal preparations in solid dosage forms for oral
  for oral use.                                                   use.
  
  The pharmaceutical form should be described by                  The pharmaceutical form should be described by
  the European Pharmacopoeia full standard term.                  the European Pharmacopoeia full standard term.
  
  
  
  4. Clinical particulars
  
  4.1. Therapeutic indications
  
  Well-established use                                            Traditional use
  
  Herbal medicinal product for the improvement of                 Traditional herbal medicinal product for the relief
  (age-associated) cognitive impairment and of                    of heaviness of legs and the sensation of cold
  quality of life in mild dementia.                               hands and feet associated with minor circulatory
                                                                  disorders, after serious conditions have been
                                                                  excluded by a medical doctor.
  
  
  1
    The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
  quality guidance
  2
    The material complies with the Ph. Eur. Monograph 01/2011: 1828
  3
    The herbal preparation should be in accordance with the Ph. Eur. monograph “Ginkgo dry extract, refined and quantified”
  04/2008: 1827
  
  European Union herbal monograph on Ginkgo biloba L., folium
  EMA/HMPC/321097/2012                                                                                               Page 2/8
  Well-established use                                          Traditional use
  
                                                                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
  
  Well-established use                                          Traditional use
  
  Posology                                                      Posology
  
  Adults and elderly                                            Adults and elderly
  Single dose: 120-240 mg                                       Single dose: 250-360 mg
  Daily dose: 240 mg                                            Daily dose: 750 mg
  
  There is no relevant indication for children and              The use in children and adolescents under
  adolescents.                                                  18 years of age is not recommended (see section
                                                                4.4 ‘Special warnings and precautions for use’).
  Duration of use
                                                                Duration of use
  Treatment should last for at least 8 weeks.
                                                                If the symptoms persist for more than 2 weeks, a
  If there is no symptomatic improvement after
                                                                doctor or a qualified health care practitioner
  3 months, or if pathological symptoms should
                                                                should be consulted.
  intensify, the doctor should check whether
  continuation of treatment is still justified.                 Method of administration
  
  Method of administration                                      Oral use.
  
  Oral use.
  
  4.5. Interactions with other medicinal products and other forms of
  interaction
  
  Well-established use                                          Traditional use
  
  If the medicinal product is taken concomitantly               Ginkgo leaf may increase the effects of
  with anticoagulants (e.g. phenprocoumon and                   anticoagulants such as coumarin derivatives.
  warfarin) or antiplatelet drugs (e.g. clopidogrel,
  acetylsalicylic acid and other non-steroidal anti-
  inflammatory drugs), their effect may be
  influenced.
  
  Available studies with warfarin do not indicate that
  there is an interaction between warfarin and G.
  biloba products, but adequate monitoring is
  advised when starting, when changing G. biloba
  dose, when ending G. biloba intake or if changing
  product.
  
  An interaction study with talinolol indicates that G.
  biloba may inhibit P-glycoprotein at the intestinal
  level. This may give rise to increased exposure of
  drugs markedly affected by P-glycoprotein in the
  intestine such as dabigatran etexilate. Caution is
  advised if combining G. biloba and dabigatran.
  
  One interaction study has indicated that the Cmax
  of nifedipine may be increased by G biloba. In
  some individuals, increases by up to 100% were
  observed resulting in dizziness and increased
  severity of hot flushes.
  
  Concomitant use of G. biloba preparations and
  efavirenz is not recommended; plasma
  concentrations of efavirenz may be decreased
  because of induction of CYP3A4 (see also section
  4.4).
  
  
  
  European Union herbal monograph on Ginkgo biloba L., folium
  EMA/HMPC/321097/2012                                                                                    Page 4/8

  PDF SHA-256: c9a638ea0a54d8cb04800aa5af939386bd2153721acb16fe3971e118036fd95d

  Die Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.

• dabigatran

  Quelle nennt Vorsicht

  Etablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben

  HOS-215920→HOS-112096RxNorm 1546356

  An interaction study with talinolol indicates that G. biloba may inhibit P-glycoprotein at the intestinal level. This may give rise to increased exposure of drugs markedly affected by P-glycoprotein in the intestine such as dabigatran etexilate. Caution is advised if combining G. biloba and dabigatran.

  Original-PDF · Seite 4 ↗Beziehung HOS-216055
  Zubereitungskontext & Beleg

  Wortlaut der zugeordneten Einschränkung:

  Caution is advised if combining G. biloba and dabigatran.

  1. Name of the medicinal product
  To be specified for the individual finished product.
  
  
  2. Qualitative and quantitative composition1,2
  Well-established use                                            Traditional use
  
  With regard to the marketing authorisation                      With regard to the registration application of
  application of Article 10(a) of Directive                       Article 16d(1) of Directive 2001/83/EC as
  2001/83/EC as amended                                           amended
  
  Ginkgo biloba L., folium (Ginkgo leaf)                          Ginkgo biloba L., folium (Ginkgo leaf)
  
  i) Herbal substance                                             i) Herbal substance
  
  Not applicable.                                                 Not applicable.
  
  ii) Herbal preparations                                         ii) Herbal preparations
  
  Dry extract (DER 35-67:1), extraction solvent:                  Powdered herbal substance
  acetone 60% m/m3
  
  
  
  3. Pharmaceutical form
  Well-established use                                            Traditional use
  
  Herbal preparations in liquid or solid dosage forms             Herbal preparations in solid dosage forms for oral
  for oral use.                                                   use.
  
  The pharmaceutical form should be described by                  The pharmaceutical form should be described by
  the European Pharmacopoeia full standard term.                  the European Pharmacopoeia full standard term.
  
  
  
  4. Clinical particulars
  
  4.1. Therapeutic indications
  
  Well-established use                                            Traditional use
  
  Herbal medicinal product for the improvement of                 Traditional herbal medicinal product for the relief
  (age-associated) cognitive impairment and of                    of heaviness of legs and the sensation of cold
  quality of life in mild dementia.                               hands and feet associated with minor circulatory
                                                                  disorders, after serious conditions have been
                                                                  excluded by a medical doctor.
  
  
  1
    The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
  quality guidance
  2
    The material complies with the Ph. Eur. Monograph 01/2011: 1828
  3
    The herbal preparation should be in accordance with the Ph. Eur. monograph “Ginkgo dry extract, refined and quantified”
  04/2008: 1827
  
  European Union herbal monograph on Ginkgo biloba L., folium
  EMA/HMPC/321097/2012                                                                                               Page 2/8
  Well-established use                                          Traditional use
  
                                                                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
  
  Well-established use                                          Traditional use
  
  Posology                                                      Posology
  
  Adults and elderly                                            Adults and elderly
  Single dose: 120-240 mg                                       Single dose: 250-360 mg
  Daily dose: 240 mg                                            Daily dose: 750 mg
  
  There is no relevant indication for children and              The use in children and adolescents under
  adolescents.                                                  18 years of age is not recommended (see section
                                                                4.4 ‘Special warnings and precautions for use’).
  Duration of use
                                                                Duration of use
  Treatment should last for at least 8 weeks.
                                                                If the symptoms persist for more than 2 weeks, a
  If there is no symptomatic improvement after
                                                                doctor or a qualified health care practitioner
  3 months, or if pathological symptoms should
                                                                should be consulted.
  intensify, the doctor should check whether
  continuation of treatment is still justified.                 Method of administration
  
  Method of administration                                      Oral use.
  
  Oral use.
  
  4.5. Interactions with other medicinal products and other forms of
  interaction
  
  Well-established use                                          Traditional use
  
  If the medicinal product is taken concomitantly               Ginkgo leaf may increase the effects of
  with anticoagulants (e.g. phenprocoumon and                   anticoagulants such as coumarin derivatives.
  warfarin) or antiplatelet drugs (e.g. clopidogrel,
  acetylsalicylic acid and other non-steroidal anti-
  inflammatory drugs), their effect may be
  influenced.
  
  Available studies with warfarin do not indicate that
  there is an interaction between warfarin and G.
  biloba products, but adequate monitoring is
  advised when starting, when changing G. biloba
  dose, when ending G. biloba intake or if changing
  product.
  
  An interaction study with talinolol indicates that G.
  biloba may inhibit P-glycoprotein at the intestinal
  level. This may give rise to increased exposure of
  drugs markedly affected by P-glycoprotein in the
  intestine such as dabigatran etexilate. Caution is
  advised if combining G. biloba and dabigatran.
  
  One interaction study has indicated that the Cmax
  of nifedipine may be increased by G biloba. In
  some individuals, increases by up to 100% were
  observed resulting in dizziness and increased
  severity of hot flushes.
  
  Concomitant use of G. biloba preparations and
  efavirenz is not recommended; plasma
  concentrations of efavirenz may be decreased
  because of induction of CYP3A4 (see also section
  4.4).
  
  
  
  European Union herbal monograph on Ginkgo biloba L., folium
  EMA/HMPC/321097/2012                                                                                    Page 4/8

  PDF SHA-256: c9a638ea0a54d8cb04800aa5af939386bd2153721acb16fe3971e118036fd95d

  Die Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.

• efavirenz

  Laut Quelle nicht empfohlen

  Etablierte Anwendung · Quellenspalte · Schweregrad: nicht angegeben

  HOS-215920→HOS-087947RxNorm 195085

  Concomitant use of G. biloba preparations and efavirenz is not recommended; plasma concentrations of efavirenz may be decreased because of induction of CYP3A4 (see also section 4.4).

  Original-PDF · Seite 4 ↗Beziehung HOS-216056
  Zubereitungskontext & Beleg

  Wortlaut der zugeordneten Einschränkung:

  Concomitant use of G. biloba preparations and efavirenz is not recommended; plasma concentrations of efavirenz may be decreased because of induction of CYP3A4 (see also section 4.4).

  1. Name of the medicinal product
  To be specified for the individual finished product.
  
  
  2. Qualitative and quantitative composition1,2
  Well-established use                                            Traditional use
  
  With regard to the marketing authorisation                      With regard to the registration application of
  application of Article 10(a) of Directive                       Article 16d(1) of Directive 2001/83/EC as
  2001/83/EC as amended                                           amended
  
  Ginkgo biloba L., folium (Ginkgo leaf)                          Ginkgo biloba L., folium (Ginkgo leaf)
  
  i) Herbal substance                                             i) Herbal substance
  
  Not applicable.                                                 Not applicable.
  
  ii) Herbal preparations                                         ii) Herbal preparations
  
  Dry extract (DER 35-67:1), extraction solvent:                  Powdered herbal substance
  acetone 60% m/m3
  
  
  
  3. Pharmaceutical form
  Well-established use                                            Traditional use
  
  Herbal preparations in liquid or solid dosage forms             Herbal preparations in solid dosage forms for oral
  for oral use.                                                   use.
  
  The pharmaceutical form should be described by                  The pharmaceutical form should be described by
  the European Pharmacopoeia full standard term.                  the European Pharmacopoeia full standard term.
  
  
  
  4. Clinical particulars
  
  4.1. Therapeutic indications
  
  Well-established use                                            Traditional use
  
  Herbal medicinal product for the improvement of                 Traditional herbal medicinal product for the relief
  (age-associated) cognitive impairment and of                    of heaviness of legs and the sensation of cold
  quality of life in mild dementia.                               hands and feet associated with minor circulatory
                                                                  disorders, after serious conditions have been
                                                                  excluded by a medical doctor.
  
  
  1
    The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
  quality guidance
  2
    The material complies with the Ph. Eur. Monograph 01/2011: 1828
  3
    The herbal preparation should be in accordance with the Ph. Eur. monograph “Ginkgo dry extract, refined and quantified”
  04/2008: 1827
  
  European Union herbal monograph on Ginkgo biloba L., folium
  EMA/HMPC/321097/2012                                                                                               Page 2/8
  Well-established use                                          Traditional use
  
                                                                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
  
  Well-established use                                          Traditional use
  
  Posology                                                      Posology
  
  Adults and elderly                                            Adults and elderly
  Single dose: 120-240 mg                                       Single dose: 250-360 mg
  Daily dose: 240 mg                                            Daily dose: 750 mg
  
  There is no relevant indication for children and              The use in children and adolescents under
  adolescents.                                                  18 years of age is not recommended (see section
                                                                4.4 ‘Special warnings and precautions for use’).
  Duration of use
                                                                Duration of use
  Treatment should last for at least 8 weeks.
                                                                If the symptoms persist for more than 2 weeks, a
  If there is no symptomatic improvement after
                                                                doctor or a qualified health care practitioner
  3 months, or if pathological symptoms should
                                                                should be consulted.
  intensify, the doctor should check whether
  continuation of treatment is still justified.                 Method of administration
  
  Method of administration                                      Oral use.
  
  Oral use.
  
  4.5. Interactions with other medicinal products and other forms of
  interaction
  
  Well-established use                                          Traditional use
  
  If the medicinal product is taken concomitantly               Ginkgo leaf may increase the effects of
  with anticoagulants (e.g. phenprocoumon and                   anticoagulants such as coumarin derivatives.
  warfarin) or antiplatelet drugs (e.g. clopidogrel,
  acetylsalicylic acid and other non-steroidal anti-
  inflammatory drugs), their effect may be
  influenced.
  
  Available studies with warfarin do not indicate that
  there is an interaction between warfarin and G.
  biloba products, but adequate monitoring is
  advised when starting, when changing G. biloba
  dose, when ending G. biloba intake or if changing
  product.
  
  An interaction study with talinolol indicates that G.
  biloba may inhibit P-glycoprotein at the intestinal
  level. This may give rise to increased exposure of
  drugs markedly affected by P-glycoprotein in the
  intestine such as dabigatran etexilate. Caution is
  advised if combining G. biloba and dabigatran.
  
  One interaction study has indicated that the Cmax
  of nifedipine may be increased by G biloba. In
  some individuals, increases by up to 100% were
  observed resulting in dizziness and increased
  severity of hot flushes.
  
  Concomitant use of G. biloba preparations and
  efavirenz is not recommended; plasma
  concentrations of efavirenz may be decreased
  because of induction of CYP3A4 (see also section
  4.4).
  
  
  
  European Union herbal monograph on Ginkgo biloba L., folium
  EMA/HMPC/321097/2012                                                                                    Page 4/8

  PDF SHA-256: c9a638ea0a54d8cb04800aa5af939386bd2153721acb16fe3971e118036fd95d

  Die Zuordnung verbindet dieses HMPC-Quellenprofil mit dem genannten Wirkstoff. Sie ist keine Aussage über jedes Präparat aus dieser Pflanzenart.

Keine oder wenige Zuordnungen bedeuten nicht, dass keine Wechselwirkungen bestehen. Nicht eindeutig zuordenbare und verneinte Aussagen bleiben im Originalabschnitt nachlesbar.