here is what I found, it was originally posted in German
1. Designation of the medicament
Legalon 70
Active substance: Mariendistelfruechte excerpt
2. Using up status/pharmacy obligation
Pharmacy requiring
3. Composition of the medicament
3,1 material or group of indications
Flavonolignan liver therapeutic agent
3.2 effective components after kind and quantity
1 cap contains:
- arzneilich effective components
70 mg Silymarin with at least 30 mg Silibinin in 90 mg Extr. Fructus Cardui mariae
- further components
Mannitol, natrium carboxymethyl amylum, Polysorbat 80, Polyvidon, magnesium stearate, gel, titanium dioxide, ferric oxides.
4. Areas of application
Toxic liver damage; to the supporting treatment with chronic inflammatory liver illnesses and living ore erring trousers.
5. Contraindications
None admits.
6. Side effects
Isolated an easily laxierende effect is observed.
7. Reciprocal effects with other means
None admits.
8. Warning references
None
9. Most important Inkompatibilitaeten
None admits.
10. Dosage with single and daily gifts
As far as differently does not order, at the beginning of the treatment and in cases of heavy illness 3mal daily 2 caps, when preservation dose 3mal whole with something liquid take daily 1 cap.
11. Kind and duration of application
Caps whole with something liquid take.
On the duration of application the treating physician decides.
12. Emergency measures, symptoms and remedies
A) of symptoms of the intoxication
Intoxication symptoms were so far not observed.
b) therapy of intoxications
A special antidote is not well-known. Symptomatic measures are recommended.
13. Pharmakologi and toxicological characteristics, Pharmakokinetik and bio-availability, as far as these data are necessary for the therapeutic use
13,1 Pharmakologi characteristics
The anti-toxic effectiveness of Silymarin became animal experimental in numerous liver damage models, e.g. with the poisons of the green tuber sheet mushroom Phalloidin and Amanitin, proven with lanthanides, carbon tetrachloride, Galaktosamin, Thioacetamid as well as the hepatotoxischen Kaltblueter virus FV3.
The therapeutic effect of Silymarin is based on several points of attack and/or effect mechanisms: Silymarin possesses an anti-by-oxidative activity due to its characteristic as radical inhibitor. Thus the pathophysiological process becomes the Lipidperoxidation, which is responsible for the destruction of cell membranes, interrupted and/or prevents. Additionally a stimulation of the protein synthesis and a normalization of the Phospholipidstoffwechsels take place in liver cells already damaged via Silymarin. Altogether the cell membrane is stabilized thereby and a loss of solved cell components (e.g. transaminasen) from the liver cells is made more difficult and/or prevented. Certain ones hepatotoxische substances (poisons of the tuber sheet mushroom) are prevented by Silymarin from the entrance into the cell. The increase of the protein synthesis by Silymarin been based on a stimulation of the RNA polymerase i activity located in the cell core, which leads to a increased education of ribosomaler RNA. As consequence of it structure and function proteins (enzymes) are synthesized increased. Altogether thereby Reparationskapazitaet and regeneration ability of the liver are increased.
13.2 toxicological characteristics
Silymarin is characterised by one expressed small toxicity, so that also an application is harmless during longer periods in the therapeutic dosage.
Acute toxicity
Silymarin proved at rats and mice after unique oral application as practically untoxisch, so that the LD 50 with Y2000 can be classified mg/kg.
Chronic toxicity
In the sustained testing over max. 12 months rats and dogs received orally max. 2500 and/or 1200 mg Silymarin/kg. Neither the laboratory data gave nor pathoanato mix findings referring to toxic effects.
Reproduction toxicity
The investigations at rats and rabbits to the Fertilitaet as well as to the prae and/or peri peri-und do not postnatalen toxicity resulted in unwanted effects on the different stages of the reproduction (max. tested dose: 2500 mg/kg). In particular no teratogenes potential could be proven by Silymarin.
Mutagenicity
The accomplished in-vitro and in-vivo-investigations with Silymarin ran negatively.
Kanzerogenitaet
Appropriate in-vivo-studies at rodents were so far not accomplished.
13,3 Pharmakokinetik
The main component of the Silymarins, the Silibinin, is separated predominantly due to clinical investigations after the absorption in the digestive tract over the Galle (Y80 % of the absorbed quantity).
As metabolites Glucuronide and sulfates are proven in the Galle. It is to be accepted that Silibinin is reabsorbiert after Dekonjugation and it to a entero hepatischen cycle comes in such a way, as this could be proven animal experimentally. In agreement with the strong biliaeren elimination (effect place: Liver) the Blutspiegel and the renale elimination are small. The absorption radioactive half-life amounts to 2.2 h, the Eliminationshalbwertzeit 6.3 h.
After unique like repeated gift therapeutic doses of Legalon (3mal 140 mg Silymarin per) are alike in the humanen Galle regained Silibinin mirror. The results show that Silibinin does not accumulate.
After multiple application of 3mal 140 mg Silymarin/Tag a Steady state of the biliaeren elimination is reached.
14. Other references
Is void
15. Duration of the durability
5 years
16. Special Lager-und of storage references
None
17. Darreichungsformen and package sizes
Original packings with 30 N 1, 60 N 2, 100 N 3 and 400 caps institute packings (bundle packing 20g 100) with 2000 caps
18. Conditions of the information
March 1995 (specialized info. CD expenditure 97/2)
19. Name or company and address of the pharmaceutical entrepreneur
WAD FROM AG Ostmerheimer STR 198 51109 Cologne telephone: (02 21) 89 98-1
Central requirement on:
Federal association of the pharmaceutical industry e. V.
Specialized information service
P.o. box 12 55 88322 aula village