Transcript Cefadian - Avita Farma

Active ingredient:
Dry extract from Silverweed
Indication:
Dysmenorrhea
Silverweed - gentle and natural
in case of dysmenorrhea
The so-called dysmenorrhea is a painful
menstruation and is widespread.
Especially young girls and women aged
between 14 and 25 are suffering from this
menstrual disorder.
The complaints, mostly spasmodic, in the
hypogastric region can radiate into the back and the legs.
Moreover, there are complaints such as nausea, vomiting,
headache, migraine and mental depressive moods.
Here, the therapy is directed to the causes: in addition to
synthetic spasmolytics, analgesics or hormones are used.
Botany
Potentilla anserina L.
Family:
Rosaceae
(rose plants)
Synonyms:
Crampweed, Goosegrass,
Prince's feathers
Origin:
Spread in the mostly colder zones of
the entire northern hemisphere.
Medicinal drug: Potentillae anserinae herba
(Silverweed), the dried overground plant
parts collected during time of prosperity.
Brief profile - Silverweed
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Enduring, low, creeping plant
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Up to 15 cm high
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Pinnate, dark green leaves, on the bottom
silvery hair
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Golden yellow flowers on long stems
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Time of prosperity: May to August
Pharmacology
Ingredients determining efficacy
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tanning agents
tormentoside
flavonoids
anthocyans
phytosterols
Effects
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spasmolytic
analgetic
normalises contraction frequency of the uterus
Pharmacology
Mechanism of action
Intervention in the hypothalamic-hypophyseal circuit of
regulation is excluded.
 effect of dry extract form Silverweed
probably via direct attack at the smooth
musculature of the uterus
 inhibiting effect on prostaglandin synthesis
Toxicology
In cavies and rabbits 3.1 - 6.2 g drug respectively
0.78 - 1.56 g extract did not show any
evidences of a harmful effect (Bliss 1940).
Clinical efficacy
Dysmenorrhea
The good antidysmenorrheic effect of Silverweed is verified
clinically. In studies it was found out that Silverweed has a
marked spasmolytic effect on the uterus.
In experiments with animals, spasmolytic effects on the
smooth musculature of uterus and intestines could be
verified, too.
Proven therapeutic success with
Cefadian®
Cefadian® - multicentre field study
Therapy of dysmenorrheic complaints with a herbal remedy;
a multicentre field study.
Schauerte W, (1993): Jatros Gynäkologie 9 (6)
Indication:
Examination period:
Patient collective:
Age:
Medication:
dysmenorrheic complaints
8 weeks
97 female patients
14-53 years
2 tablets 2-3 times daily
Proven therapeutic success with
Cefadian®
Multicentre field study
 very good tolerability
 healing and improvement rates of more than 85%
(mainly abdominal pain and backache)
 good alternative to analgesics and/or hormones in case
of slight and moderate dysmenorrheic complaints
Proven therapeutic success with
Cefadian®
Multicentre field study
Chart 1: score average values at the individual examination times
1 = none, 2 = slight, 3 = moderate, 4 = severe
Proven therapeutic success with
Cefadian®
Fig. 1: Cefadian® - progress of the complaints
(score reduction at the individual examination times)
Tolerability
Irritable stomach disorders can aggravate.
The side effects can probably be attributed to
the contained tanning agents.
Cefadian® advantages at a glance
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spasmolytic effect
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analgetic effect
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herbal alternative to analgesics / hormones
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natural and gentle
Basic information
Field of application
Slight dysmenorrheic complaints (disorders during menstruation).
Composition
1 film coated tablet contains:
Active ingredient:
Dry extract from Anserinae herba (5 : 1) 200 mg
Excipients:
Lactose monohydrate, povidone, magnesium stearate, macrogol, titanium dioxide
(E171), hypromellose, talc, polyacrylate, ferric oxide (E172), cellulose powdered.
Contra-indications
None known.
Interaction with other substances
None known.
Basic information
Dosage
Unless otherwise prescribed, adults and adolescents take 2 tablets 2 - 3 times
daily.
Kind and duration of application
Cefadian® film coated tablets are taken without chewing with some liquid (e.g.
water). It would be reasonable to start intake some days before the expected
onset of the menstruation and to continue it for 3 to 4 days after disappearance of
the complaints.
In especially obstinate cases a daily intake over several cycles is possible.
Duration of the application is not limited.
Side effects
Irritable stomach disorders can aggravate.
Commercial form
Film coated tablets: 50 pcs.
Monograph
Potentilla, Potentillae anserinae herba
Official Monograph of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (German
Federal Institute for Drugs and Medical Devices)
Commission E (Phytotherapy), BAnz.-No. 223 dated November 30, 1985, revised March 13, 1990
Name of Drug
Potentillae anserinae herba, potentilla, silverweed.
Composition of Drug
Potentilla herb consists of the fresh or dried leaf and flowers of Potentilla anserine
L., [Fam. Rosaceae], harvested shortly before or during flowering, as well as its
preparations in effective dosage.
The herb contains at least 2 percent tannins when precipitated with casein,
calculated as gallic acid (C7H6 O5, MW 170.1) and related to the dried herb.
Other ingredients are tormentoside, phytosterols, flavonoids and anthocyanins.
Uses
Mild dysmenorrheal disorders, support for treatment of milder, nonspecific, acute
diarrhea, light inflammation of the oral and pharyngeal mucosa.
Monograph
Contraindications
None known.
Side Effects
Gastric irritations could be aggravated.
Interactions with Other Drugs
None known.
Dosage
Daily dosage:
4 – 6 g of herb; equivalent preparations.
Mode of Administration
Cut herb for infusions and decoctions.
Powdered herb and other galenical preparations for oral use.
Actions
Astringent, depending on tannin concentration.
Distinct increase in tonus and contraction frequency on the isolated uterus of
various animals.
Differentiation in the area of
dysmenorrhoea – PMS
(Cefadian® / Cefanorm®)
Cefadian®
Cefanorm®
• girls / young women, 14- 25
• grown-up women over 25
(up to an age of 30)
• no children
• dysmenorrhoea
• (increased prostaglandin)
• does often have children
• PMS
• (imbalance estrogen/progesterone)
• most intensive on 1st day of
menstruation
• complaints during the last 10 days of
the cycle
• colic-like lower abdominal pain
• lower abdominal pain + mastodynia
general accompanying symptoms such as nausea, backache,
headache, mental depressive moods