Transcript Cefasabal - AvitaFarma

Active ingredients:
- Sabal fructus
- Solidaginis virgaureae herba
- Hippocastani semen
Indication:
Micturition problems
Saw palmetto
Horse chestnut
Goldenrod
Botany - Saw palmetto
Sabal fructus,
syn. Serenoa repens (BARTR.)
Family:
Arecaceae (palm plants)
German names: Amerikanische Säge- oder Zwergpalme
Origin:
Pine forests and dunes from North
Carolina to Florida, grows preferentially
on friable, sandy soils
Botany - Saw palmetto
Medicinal drug:
Ingredients:
Saw palmetto berries
Sabalis serrulatae fructus
- free fatty acids
- fatty oil with phytosterols
(β-sitosterol derivates)
- polysaccharides
Therapeutic principle: - antiandrogenic
- antiexsudative
- antiedematous
- anti-inflammatory
- antiproliferative
- anticongestive
Botany - Saw palmetto
Folk medicine:
Fruits used to be collected by
the Indians as foodstuff
Later they were used for
medicinal purposes as tonic for sexual
organs, as diuretic and sedative
The steam of the boiling fruit was inhaled
when suffering from diseases of the nose
Brief profile - Saw palmetto

Saw palmetto is a bushy palm tree with a low trunk.
Its leaves are fan-shaped and sharply sawed.

Like a lot of palm trees, it prospers at best with
warmth and high amounts of rainfall.

The small blossoms bundle to flower spadices from
which the fruits are developed in autumn.

They have a size of 2 to 3 cm and are about 1.5 cm
thick.

The deep purple, nearly black drupes taste at first
sweet, later hot-burning.
Botany - Goldenrod
Solidago virgaureae herba
Family:
Asteraceae (composites)
German names: Goldrute, Wundkraut, Heilwundkraut,
Heidengoldkraut
Origin:
Europe, Asia, North Africa, North
America. Grows on the edges of forests
and clearings as well as in bushes. In the
Alps as mountain plant up to 1500 m.
Botany - Goldenrod
Medicinal drug:
Ingredients:
Goldenrod herb
Solidaginis virgaureae herba
- saponins
- essential oil
- phenolic compounds
Therapeutic principle: - diuretic
- slight spasmolytic
- antiphlogistic
Botany - Goldenrod
Folk medicine:
By the Teutons it was
appreciated as herb for
wounds.
For eczema and exanthems, lip herpes,
solution for gargling.
Further fields of application:
Rheumatism, gout, haemorrhoids,
diabetes, hepatic engorgement.
Brief profile - Goldenrod

Goldenrod is an enduring plant which can reach a
height of up to 1 m.

The upright stem has long-elliptic, acuminate leaves
which are toothed.

The golden blossoms are grouped in individual
or combined clusters.

Goldenrod blooms from July to September.
Botany - Horse chestnut
Hippocastani semen
Family:
Hippocastanaceae
(horse chestnut plants)
German name: Roßkastanie
Origin:
Mountains of the Balkan, in the Caucasus
and Himalaya. In 16th century spread from
Vienna over whole Europe.
Botany - Horse chestnut
Medicinal drug:
Ingredients:
Horse chestnut seed,
Hippocastani semen
- triterpene saponine compound
(escin)
- flavonoids
- tanning agents and mineral substances
Therapeutic principle: - anti-inflammatory
- antiedematous
Botany - Horse chestnut
Folk medicine:
In Middle Ages it was used
as fodder supplement for
horses.
In form of ointments for injuries,
haematoma, pains in the vertebral
column and edema.
In form of baths for treatment of venous
diseases and haemorrhoids.
Brief profile - Horse chestnut

Regular, dense leafy crown; thick trunk with cracked
bark.

Big, finger-shaped 5 to 7-fold leaves with long stem.

Inflorescence, shaped like a candle; panicle-like.

Blooms from April to May, the fruits can be collected
from September to October.

Fruits are spiny balls with auburn gleaming seeds.

Not related to the edible Chestnut.
Benign prostatic hyperplasia (BPH)
The disease of men elder than sixty
Benign prostatic hyperplasia (BPH)
Normale prostate
Adenoma of the prostate
urinary
bladder
Adenoma of
the prostate
seminal
hillcock
urethra
prostatic
tissue
Cowper‘s gland
Compressed
urethra
Initial stage
Problems in connection with urinary
evacuation of the bladder (micturition):
 weakend urinary stream,
decrease in the urinary stream
 problem to start micturition (delayed start of
micturition)
 discontinued micturition
 urinary evacuation of the bladder is hardly possible
 frequent evacuation of small urine amounts (pollakisuria)
 increased nocturnal urinary frequency (nycturia)
 sudden strong urinary urgency
 after-dripping of urine after micturition
Advanced stage

increase in micturition disorders

complete evacuation of the bladder is no
longer possible

continuous urinary urgency

augmented urinary tract infections,
formation of bladder stones

pains during micturition
Final stage

urine congestion upwards in both kidneys
(overflow bladder)

irreversible injuries of bladder and kidneys

urinary retention

painful extension of the bladder

urinary incontinence
Therapeutic principle
Therapeutic principle
Fig.:
Antiandrogenic principle of
effect of an extract from Saw
Palmetto berries in case of
BPH
Points of action
Solidago
diuretic,
antiseptic
(saponins)
Hippocastanum
decongestant on the
veins of the small
pelvis (escin)
antiedematous
Sabal
decongestant on the
periurethral gland
(sitosterols,
polysaccharides)
a-reductase-blocker
Toxicology

When used as prescribed non-toxic.

Positive monographs of the German Federal Institute for
Drugs and Medical Devices (Commission E) for all three
components.

In very rare cases complaints resp. irritation of the
mucosa of the gastro-intestinal tract.

Contra-indications and interactions have not become
known up to now.
Therapeutic success with Cefasabal®
Clinical studies
1. Monocentre practice study:
Cefasabal®, a therapeutic agent with numerous uses in urology
Barsom S, Zeitschrift für Allg. Med. 53, 1311-1313 (1977)
Indication:
Examination period:
Patient collective:
Medication:
prostatic complaints
up to 8 weeks
705 patients
20-30 drops, four times daily
 Very good success for neurogenic vesical
neck disorders
Therapeutic success with Cefasabal®
Clinical studies
2. Monocentre practice study:
Conservative therapy of mictional disorders
Zamfirescu C, Zeitschrift für Allg. Med. 56, 2244 - 2247 (1980)
Indication:
Examination period:
Patient collective:
Medication:
prostatic complaints
6 years
181 patients
4 x 1 tablet or 30 drops three times daily
 Good therapeutic results for irritable bladder
 Successful therapy of chronic vesical neck
inflammations
Therapeutic success with Cefasabal®
Clinical study on 181 patients
Quelle: * Zamfirescu C: Conservative therapy of mictional disorders. Zeitschrift für Allg. Medizin 56, 2244-2247 (1980)
Therapeutic success with Cefasabal®
Clinical studies
3. Randomised, double-blind, placebo-controlled study
with Cefasabal®:
Phytotherapeutic treatment of micturition disorders with benign
prostatic hyperplasia (stage I-II)
Hess K, Extracta urologica 12, 316 (1989)
Indication:
prostatic complaints
Examination period: 3 months
Patient collective:
30 patients
Medication:
4 x 2 tablets daily
 Positive effect of Cefasabal® on micturition
disorders (BHP stage I-II)
 Maintenance dose: 3 x 1 tablet daily
Therapeutic success with Cefasabal®
Clinical studies
4. On the conservative treatment of the prostate symptom complex
Hammer O, Zeitschrift für Allg. Med. 46, 1720 g. (1970)
Indication:
Examination period:
Patient collective:
Medication:
prostatic disorders
4 weeks
380 patients
3 times daily 1 tablet
(ampoule)
Therapeutic success with Cefasabal®
Clinical studies
5. Evaluation on Clinical Efficacy of Cefasabal® in the Treatment
with BPH
Urological Surgery Dept., Beijing Hospital, (1996)
Indication:
Examination period:
Patient collective:
Medication:
prostatic complaints
4 weeks
36 patients
1 tablet twice to four times daily
 Effective and safe preparation for the
treatment of BPH
Therapeutic success with Cefasabal®
Clinical studies
6. Randomised, double-blind, placebo-controlled study
with Cefasabal®:
Value of the treatment with natural extract in non complicated BPH
Nunez Chavez U, Murietta Vela R, Monitor Medico, Vol. 3 No. 10, 31 - 42 (2001)
Indication:
Examination period:
Patient collective:
Medication:
prostatic complaints
12 weeks
60 patients
extract (tablets)
Double-blind study
Results
 relieves typical symptoms associated
with growth of the prostate
 improves urinary flow
 improves quality of life
 reduces the size of the prostate
 does not affect libido or potency
 very well tolerated
Double-blind study
The scores were obtained by using international Prostate Symptom Score
(IPSS), following symptoms: Urinary stream and size of prostate gland in
patients with BPH were evaluated.
Double-blind study
Variance over time of percentage of patients with positive clinical response
as to total symptoms score
Double-blind study
Effect of extract over the time on maximum urinary stream (Qmax) rate
compared to placebo
Cefasabal® advantages at a glance

harmonisation of coordination of
detrusor and sphincter

tranquilising and invigorating effect on bladder
and urethra

reduction of micturition frequency

reinforcement of urinary stream

decrease in the amount of residual urine
Basic information
Indications:
Adenoma of the prostate (stage 1), micturition disorders,
congestive prostatitis, hyperemia of the small pelvis.
Composition
Active ingredients:
1 tablet contains: Dry extracts from: Sabalis serrulatae fructus (4:1) 1.25 mg,
Solidaginis herba (stand. on at least 0.2 mg total flavonoids, calc. as rutoside) 3.75
mg, Hippocastani semen (stand. on at least 0.75 mg escin) 6.25 mg.
Excipients:
Lactose monohydrate, maize starch, talc, gelatin powder, colloidal anhydrous silica,
magnesium stearate.
Contra-indications
None known.
Warning
None known.
Basic information
Dosage
Unless otherwise prescribed, adults take 2 tablets with some liquid 4 times a day.
Kind and duration of application
Cefasabal® tablets can be swallowed with some liquid e.g. water.
Side effects
The components Fruct. Sabal. Serr. and Semen Hippocastani shall be able to cause
complaints resp. irritation of the mucosa of the gastro-intestinal tract in very rare
cases. Up to now, these side effects have not been observed with the finished
preparation Cefasabal®.
Commercial form
Tablets: 100 pcs.
Monograph
Saw Palmetto berry, Sabal fructus
Official Monograph of the Bundesinstitut für Arzneimittel und Medizinprodukte
(BfArM) (German Federal Institute for Drugs and Medical Devices)
Commission E (Phytotherapy), BAnz.-No. 43 dated March 02, 1989, No. 22a dated Feb. 1, 1990 and
No. 11, Jan. 17, 1991
Name of Drug
Sabal fructus, saw palmetto berry.
Composition of Drug
Saw palmetto berry consists of the ripe, dried fruit of Serenoa repens (Bartram)
Small (syn. Sabal serrulata (Michaux) Nuttall ex Schultes) [Fam. Arecaceae] as well
as its preparations in effective dosage. The drug contains fatty oil with phytosterols
and polysaccharides.
Uses
Urination problems in benign prostatic hyperplasia stages I and II.
Contraindications
None known.
Monograph
Side Effects
In rare cases, stomach problems.
Interaction with Other Drugs
None known.
Dosage
Daily dosage:
1 – 2 g saw palmetto berry or 320 mg lipophilic ingredients extracted with lipophilic
solvents (hexane or ethanol 90 percent v/v); equivalent preparations.
Mode of Administration
Comminuted herb and other galenical preparations for oral use.
Actions
Antiandrogenic
Anti-exudative
Note: This medication relieves only the symptoms associated with an enlarged
prostate without reducing the enlargement. Please consult a physician at regular
intervals.
Monograph
Goldenrod, Solidago
Official Monograph of the Bundesinstitut für Arzneimittel und Medizinprodukte
(BfArM) (German Federal Institute for Drugs and Medical Devices)
Commission E (Phytotherapy), BAnz.-No. 193a dated October 15, 1987 and No. 50 dated March 13,
1990
Name of Drug
Solidaginis virgaureae herba, European goldenrod herb.
Solidaginis herba, goldenrod herb.
Composition of Drug
European goldenrod herb consists of the above-ground parts of Solidago virgaurea
L. [Fam. Asteraceae] gathered during the flowering season and dried carefully, as
well as their preparations in effective dosage.
Goldenrod herb consists of the above-ground parts of S. serotina Aiton (synonym S.
gigantea Willdenow), S. Canadensis L. and hybrids thereof gathered during the
flowering season and carefully dried, as well as their preparations in effective
dosage.
The herb contains flavonoids, saponins, and phenol glycosides.
Monograph
Uses
As irrigation therapy for inflammatory diseases of the lower urinary
tract, urinary calculi and kidney gravel, as prophylaxis for urinary
calculi and kidney gravel.
Contraindications
None known.
Note: No irrigation therapy in case of edema due to impaired heart and kidney
function.
Side Effects
None known.
Interaction with Other Drugs
None known.
Dosage
Daily dosage:
6 - 12 g herb; equivalent preparations.
Monograph
Mode of Administration
Comminuted drug for teas and other galencial preparations for
internal use.
Note: Observe copious intake of fluids.
Actions
Diuretic
Mildly antispasmodic
Antiphlogistic
Monograph
Horse Chestnut seed, Hippocastani semen
Official Monograph of the Bundesinstitut für Arzneimittel und Medizinprodukte
(BfArM) (German Federal Institute for Drugs and Medical Devices)
Commission E (Phytotherapy), BAnz.-No. 228 dated Dec. 5, 1984
Name of Drug
Hippocastani semen, horse chestnut seed.
Composition of Drug
A dry extract manufactured from horse chestnut seeds, Aesculus hippocastanum L.
[Fam. Hippocastanaceae], adjusted to a content of 16 – 20 percent triterpene
glycosides (calcaluated as anhydrous aescin).
Monograph
Pharmacological Properties, Pharmacokinetics, Toxicology
As found in different animal experiments, the principal ingredient
in horse chestnut seed extract is the triterpene glycoside mixture,
aescin (escin), which has an anti-exudative and vascular-tightening effect.
There are indications that horse chestnut seed extract reduces the activity of
lysosomal enzymes that is increased in chronic pathological conditions of the veins,
so that the breakdown of glycoacalyx (mucopolysaccharides) in the region of the
capillary walls is inhibited. The filtration of low-molecular proteins, electrolytes and
water into the interstitium is inhibited through a reduction of vascular permeability.
Using placebo as reference, a significant reduction of transcapillary filtration has
been demonstrated in pharmacological studies involving human subjects, and a
significant improvement shown in the symptoms of chronic venous insufficiency
(sensation of tiredness, heaviness and tension, pruritus, pain and swelling in the
legs) in various randomized double-blind studies and/or cross-over studies.
Pilot studies are available on the toxicology of horse chestnut seed extract. The oral
LD50 of the extract is 990 mg per kg body weight in the mouse, 2150 mg per kg body
weight in the rat, 1530 mg per kg body weight in the rabbit, and 130 mg per kg body
weight in the dog. In the rat, the “no effect” dose is between 9 and 30 mg per kg
body weight after intravenous administration of horse chestnut seed extract over a
period of 8 weeks.
Monograph
Chronic administration above 80 mg per kg body weight over a
period of 34 weeks produced gastric irritation in dogs. In rats, no
toxic changes were observed throughout the same period up to an
oral dose of 400 mg per kg body weight.
Clinical Data
1. Indications
Treatment of complaints found in pathological conditions of the veins of the legs
(chronic venous insufficiency), for example, pains and a sensation of heaviness in
the legs, nocturnal systremma (cramps in the calves), pruritis and swelling of the
legs.
Note: Other non-invasive treatment measures prescribed by a physician, such as leg
compresses, wearing of supportive elastic stockings, or cold water applications, must
be observed under all circumstances.
2. Contraindications
None known.
Monograph
3. Side Effects
Pruritis, nausea, and gastric complaints may occur in isolated cases
after oral intake.
4. Special Caution for Use
None.
5. Use During Pregnancy and Lactation
No restriction known.
6. Interaction with Other Drugs
None known.
7. Dosage and Mode of Administration
Daily dose: 100 mg aescin (escin) corresponding to 250 – 312.5 mg extract 2 times
per day in delayed release form.
Monograph
8. Overdosage
None known.
9. Special Warnings
None.
10. Effect on Operators of Vehicles and Machinery
None.