Transcription

1

2 TECHNICAL SHEET

3

4

5

6 SKIN IRRITATION TEST (24 HOURS) DEIONIZED AND PURIFIED WATER BASED SOLUTION Free from: solvents, dyes, perfumes and substantially physiological ph SKIN IRRITATION TEST Patch Test Evaluation of the possible irritating power of a class 1 st medical device following the amended Draize classification 40 OUTPATIENTS x 24 HOURS Record No. 0603A13P 10 January 2006 UNIVERSITY OF STUDY PAVIA ITALY INTERNAL MEDICINE AND MEDICAL THERAPY DEPARTMENT PHARMACOLOGY AND CELLULAR AND MOLECULAR TOXICOLOGY SECTION (Director: Prof. Plinio Richelmi)

7 SKIN IRRITATION TEST Record No. 0507M24P VALUES OF IRRITATING INDICES AND THEIR CLASSIFICATION (See table 2) Erythema Edema Erythema Edema Erythema Edema

8 SKIN IRRITATION TEST (24 HOURS) Record No. 0507M24P CONCLUSIONS The table and the charts listed above contain the values of the erythema and edema indexes found out for each volunteer, so that the product can be classified - following the amended Draize classification - as: NON IRRITATING MONITOR Prof. Plinio RICHELMI EXPERIMENTER Dott.ssa Evelyn FALCONI KLEIN QUALITY CONTROL Dott. Claudio ANGELINETTA SPONSOR

9 IRRITATING TEST (28 DAYS) DEIONIZED AND PURIFIED WATER BASED SOLUTION Free from: solvents, dyes, perfumes and substantially physiological ph IRRITATING TEST Evaluation of the possible irritating or sensitizing powers of a class 1 st medical device through repeated skin tests (Shelanski and Shelanski test with some changes in it) 40 OUTPATIENTS x 28 DAYS Record No. 0507M24I 10 January 2006 UNIVERSITY OF STUDY PAVIA ITALY INTERNAL MEDICINE AND MEDICAL THERAPY DEPARTMENT PHARMACOLOGY AND CELLULAR AND MOLECULAR TOXICOLOGY SECTION (Director: Prof. Plinio Richelmi)

10 IRRITATING TEST Record No. 0507M24I VALUES OF IRRITATING INDICES AND THEIR CLASSIFICATION (See table 2) Irritation index NUMBER OF SENSITIZING SUBJECT AND THEIR CLASSIFICATION (See table 3)

11 IRRITATING TEST (28 DAYS) Record No. 0507M24I CONCLUSIONS The table and the charts listed above contain the values of the erythema and edema indexes found out for each volunteer, so that the product: can be classified - after repeated skin tests which evaluate its possible irritating and/or sensitizing powers - as: NON IRRITATING and HYPOALLERGENIC (Low Sensitization) MONITOR Prof. Plinio RICHELMI EXPERIMENTER Dr. Fernando Marco BIANCHI QUALITY CONTROL Dott. Claudio ANGELINETTA SPONSOR

12 CYTOTOXICITY TEST DEIONIZED AND PURIFIED WATER BASED SOLUTION Free from: solvents, dyes, perfumes and substantially physiological ph CYTOTOXICITY TEST In vitro evaluation of the cytotoxicity of a class 1 st medical device through an assay on keratinocyte cell culture CULTURED HUMAN CELLS Record No 0507M24V 16 December 2005 I. Z. S. Experimental Institute della Lombardia e dell Emilia Romagna (PUBLIC LAW HEALTH SERVICE) RESEARCH CENTER APPLIED TO CELL SUBSTRATES BRESCIA (ITALY)

13 CYTOTOXICITY TEST Record No. 0507M24V EVALUATION OF PRODUCT CYTOTOXICITY DOSE (mg/ml) 5 1,67 0,56 0,19 0,06 0,02 % inhibition of cell growth (compared to untreated control) Absence of inhibition 5 Regression analysis doses/cytotoxicity None of the concentration used give inhibition of cell growth indicated absence of any cytotoxic/irritating effect SUMMARY OF THE DATA TAKEN AND EVALUATION OF THE POTENTIAL CYTOTOXICITY OF THE PRODUCT THE PRODUCT NAMED: HAS NOT PROVED TO HAVE CYTOTOXIC EFFECTS AT THE TESTED CONCENTRATIONS ON KERATINOCYTES IN VITRO QUALITY CONTROL Dott. Claudio ANGELINETTA SPONSOR

14 CHALLENGE TEST Record No. 0603D06M2 CHALLENGE TEST Evaluation of microbiologic stability of a 1 st class medical device Record No 0603D06M2 24 MAY 2006 BIO BASIC EUROPE MILANO (Tecnica Director - Quality Control: Dottor Claudio Angelinetta, degree in chemistry) Microorganisms used in culture plates Were used these selected microorganism strains Gram - : Pseudomonas aeruginosa (ATCC 9027) Gram + : Staphylococcus aureus (ATCC 6538) Yeast : Candida albicans (ATCC 10231) Mold : Aspergillus niger (ATCC 16404) ENCLOSURE A

15 BRIEF INFORMATION ON: LAPACHO (TABEBUIA AVELLANEDAE), MSM, ALOE VERA AND GSE

16

17

18 BIBLIOGRAPHY Fu SC, Chau YP, Lu KS, Kung HN. Lapachone accelerates the recovery of burn-wound skin. National Taiwan University Histol Histopathol Jul Farahnejad Z, Ghazanfari T, Yaraee R. Immunomodulatory effects of Aloe vera and its fractions on response of macrophages against Candida albicans. AJA University of Medical Sciences, Tehran, Iran. Immunopharmacol Immunotoxicol Mar Kwok SC, Schelenz S, Wang X, Steverding D. In vitro effect of DNA topoisomerase inhibitors on Candida albicans. University of East Anglia, Norwich 2010 Feb Renato A.S. Oliveira a, Eulalia Azevedo-Ximenes b, Roberto Luzzati c and Rodolfo C. Garcia. The hydroxy-naphthoquinone lapachol arrests mycobacterial growth and immunomodulates host macrophages International Centre for Genetic Engineering and Biotechnology, Trieste, Italy Nov Hsiu-Ni Kung, Mei-Jun Yang, Chi-Fen Chang, Yat-Pang Chau and Kuo-Shyan Lu. In vitro and in vivo wound healing-promoting activities of ß-lapachone Am J Physiol Cell Physiol 295:C931-C943, 2008 Maurizio Di Leo. Il Lapacho Tintura Madre SP Agirica. Un valido aiuto per candidosi, disbiosi intestinale, intolleranze e Allergie TERZO CONGRESSO MONDIALE MEDICINA INTEGRATA Settembre 2006 Monastero di Santo Spirito a Maiella Roccamorice - Pescara Suresh Awale, Tsukasa Kawakami, Yasuhiro Tezuka, Jun-ya Ueda, Ken Tanaka and Shigetoshi Kadota. Nitric Oxide (NO) Production Inhibitory Constituents of Tabebuia avellanedae from Brazil Japan January 28, 2005 Balassiano IT, De Paulo SA, Henriques Silva N, Cabral MC, da Gloria da Costa Carvalho M. Demonstration of the lapachol as a potential drug for reducing cancer metastasis. Universidade Federal do Rio de Janeiro 2005 Feb Portillo A, Vila R, Freixa B, Adzet T, Cañigueral S. Antifungal activity of Paraguayan plants used in traditional medicine. J Ethnopharmacol Jun; 76(1): Unitat de Farmacologia i Farmacognòsia, Facultat de Farmàcia, Avenida Diagonal 643, E-08028, Barcelona, Spain Müller K, Sellmer A, Wiegrebe W. Potential antipsoriatic agents: lapacho compounds as potent inhibitors of HaCaT cell growth. Münster, Germany J Nat Prod Aug; 62(8): K. Nagata, K.-I. Hirai, J. Koyama, Y. Wada, T. Tamura. Antimicrobial Activity of Novel Furanonaphthoquinone Analogs Antimicrobial agents and chemotherapy. Japan Mar Selway JW. Antiviral activity of flavones and flavins. Prog Clin Biol Res. 1986; 213: Oga S and Sekino T. Toxicidade e atividade anti-anflamatoria de Tabebuia Avell. Lorentz e Griesbach. Rev. Fac Farm Bioquim S. Paulo 7, 47-53, 1969 F. Pinto, Solange M.S.V. Wardell and James L. Wardell. Research for more potent anticancer, antibacterial and antibiotic compounds. A versatile biologically active compound, present in the heartwood of several Tabebuia species from Central and South America, especially Tabebuia avellanedae. In addition, ß-Lapachone also possesses a variety of pharmacological effects, including antibacterial, antifungal, and trypanocidal activities. Instituto de Quimica, Universidade Federal do Rio de Janeiro, CP 68563; Brazil and Departement of Chemistry, University of Aberdeen, Old Aberdeen, AB24 3EU, Scotland. ARKAT USA, Inc. Published 22 Aug 2003

19

20 Euro-Pharma s.r.l. Torino - Tel Fax [email protected] /11