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Mit Herkunft.

Warnungen, berichtete Effekte und verneinte Studienbefunde werden getrennt ausgewiesen und mit eindeutig bezeichneten Wirkstoffen verknüpft. Jede Aussage gilt im Zubereitungs- und Anwendungskontext der Quelle. Ein klinischer Schweregrad wird daraus nicht abgeleitet.

• warfarin

  Berichteter Effekt

  Etablierte Anwendung · Quellenspalte · Keine wirkstoffbezogene Einschränkung abgeleitet · Schweregrad: nicht angegeben

  Die Quelle beschreibt einen möglichen oder beobachteten Effekt; auch ein Verdachtsfall ist damit möglich. Allgemeine Warnungen und weitere Bedingungen bleiben im Originalzitat erhalten. Daraus wurde hier keine zusätzliche Einschränkung für den einzelnen Wirkstoff abgeleitet.

  HOS-216002→HOS-085950RxNorm 11289

  A few cases of suspected interactions with warfarin have been reported. Increased INR- values have been described.

  Original-PDF · Seite 3 ↗Beziehung HOS-216100
  Zubereitungskontext & Beleg

  Wortlaut der zugeordneten Aussage:

  A few cases of suspected interactions with warfarin have been reported.

  1. Name of the medicinal product
  To be specified for the individual finished product.
  
  
  2. Qualitative and quantitative composition 1,2
  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
  
  Serenoa repens, fructus (saw palmetto, fruit)                   Serenoa repens, fructus (saw palmetto, fruit)
  
  i) Herbal substance                                             i) Herbal substance
  
  Not applicable.                                                 Not applicable.
  
  ii) Herbal preparation                                          ii) Herbal preparations
  
  a) Soft extract (DER 7-11:1) 3, extraction                      a) Soft extract (DER 7.5-14.3:1), extraction
                                                                     solvent: ethanol 90% to 96% m/m
      solvent: hexane
  
  
  
  3. Pharmaceutical form
  Well-established use                                            Traditional use
  
  Herbal preparations in solid dosage forms for oral              Herbal preparations in solid dosage forms 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 symptomatic                    Traditional medicinal product for the relief of lower
  treatment of benign prostatic hyperplasia.                      urinary tract symptoms related to benign prostatic
                                                                  hyperplasia, after serious conditions have been
                                                                  excluded by a doctor.
  
                                                                  The product is a traditional herbal medicinal
  
  
  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 (ref.: 1848).
  3
    Containing 92% of fatty acids (free or esterified) and 2% of an unsaponifiable part.
  
  
  European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus
  EMA/HMPC/280079/2013                                                                                                 Page 2/5
  Well-established use                                           Traditional use
  
                                                                 product for use in the 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
  
  a) 320 mg once daily or 160 mg 2 times daily.                  a) 320 mg once daily.
  
  There is no relevant indication for women,                     There is no relevant indication for women,
  children and adolescents.                                      children and adolescents.
  
  Duration of use                                                Duration of use
  Long-term use is possible (see section 4.4 ‘Special            Long-term use is possible (see section 4.4 ‘Special
  warnings and precautions for use’).                            warnings and precautions for use’).
  If the symptoms persist during the use of the                  If the symptoms persist during the use of the
  medicinal product, a doctor or a pharmacist                    medicinal product, a doctor or a qualified health
  should be consulted.                                           care practitioner should be consulted.
  
  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
  
  A few cases of suspected interactions with                     A few cases of suspected interactions with
  warfarin have been reported. Increased INR-                    warfarin have been reported. Increased INR-
  
  
  European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus
  EMA/HMPC/280079/2013                                                                                          Page 3/5
  Well-established use                                           Traditional use
  
  values have been described.                                    values have been described.

  PDF SHA-256: 1d9827c8ebe4f65d4ea30a8e57a0dd31ac1c3910be7626f150774c98bdf4a3be

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

• warfarin

  Berichteter Effekt

  Traditionelle Anwendung · Quellenspalte · Keine wirkstoffbezogene Einschränkung abgeleitet · Schweregrad: nicht angegeben

  Die Quelle beschreibt einen möglichen oder beobachteten Effekt; auch ein Verdachtsfall ist damit möglich. Allgemeine Warnungen und weitere Bedingungen bleiben im Originalzitat erhalten. Daraus wurde hier keine zusätzliche Einschränkung für den einzelnen Wirkstoff abgeleitet.

  HOS-216002→HOS-085950RxNorm 11289

  A few cases of suspected interactions with warfarin have been reported. Increased INR- values have been described.

  Original-PDF · Seite 3 ↗Beziehung HOS-216101
  Zubereitungskontext & Beleg

  Wortlaut der zugeordneten Aussage:

  A few cases of suspected interactions with warfarin have been reported.

  1. Name of the medicinal product
  To be specified for the individual finished product.
  
  
  2. Qualitative and quantitative composition 1,2
  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
  
  Serenoa repens, fructus (saw palmetto, fruit)                   Serenoa repens, fructus (saw palmetto, fruit)
  
  i) Herbal substance                                             i) Herbal substance
  
  Not applicable.                                                 Not applicable.
  
  ii) Herbal preparation                                          ii) Herbal preparations
  
  a) Soft extract (DER 7-11:1) 3, extraction                      a) Soft extract (DER 7.5-14.3:1), extraction
                                                                     solvent: ethanol 90% to 96% m/m
      solvent: hexane
  
  
  
  3. Pharmaceutical form
  Well-established use                                            Traditional use
  
  Herbal preparations in solid dosage forms for oral              Herbal preparations in solid dosage forms 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 symptomatic                    Traditional medicinal product for the relief of lower
  treatment of benign prostatic hyperplasia.                      urinary tract symptoms related to benign prostatic
                                                                  hyperplasia, after serious conditions have been
                                                                  excluded by a doctor.
  
                                                                  The product is a traditional herbal medicinal
  
  
  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 (ref.: 1848).
  3
    Containing 92% of fatty acids (free or esterified) and 2% of an unsaponifiable part.
  
  
  European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus
  EMA/HMPC/280079/2013                                                                                                 Page 2/5
  Well-established use                                           Traditional use
  
                                                                 product for use in the 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
  
  a) 320 mg once daily or 160 mg 2 times daily.                  a) 320 mg once daily.
  
  There is no relevant indication for women,                     There is no relevant indication for women,
  children and adolescents.                                      children and adolescents.
  
  Duration of use                                                Duration of use
  Long-term use is possible (see section 4.4 ‘Special            Long-term use is possible (see section 4.4 ‘Special
  warnings and precautions for use’).                            warnings and precautions for use’).
  If the symptoms persist during the use of the                  If the symptoms persist during the use of the
  medicinal product, a doctor or a pharmacist                    medicinal product, a doctor or a qualified health
  should be consulted.                                           care practitioner should be consulted.
  
  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
  
  A few cases of suspected interactions with                     A few cases of suspected interactions with
  warfarin have been reported. Increased INR-                    warfarin have been reported. Increased INR-
  
  
  European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus
  EMA/HMPC/280079/2013                                                                                          Page 3/5
  Well-established use                                           Traditional use
  
  values have been described.                                    values have been described.

  PDF SHA-256: 1d9827c8ebe4f65d4ea30a8e57a0dd31ac1c3910be7626f150774c98bdf4a3be

  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 Aussagen bleiben im Originalabschnitt nachlesbar; verneinte Befunde gelten nur für die beschriebenen Bedingungen.