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Product Launch Presentation

Product Launch Presentation . January 2008. Gammex ® PF XP™ Extra protection for handling cytostatic agents January 2008, Ansell Healthcare Europe Marcus Heimann, Group Product Manager Professional Healthcare. Ansell Europe 2008. Gammex ® PF XP™

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Product Launch Presentation

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  1. Product Launch Presentation January 2008 Gammex® PF XP™ Extra protection for handling cytostatic agents January 2008, Ansell Healthcare Europe Marcus Heimann, Group Product ManagerProfessional Healthcare Ansell Europe 2008

  2. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 Agenda Gammex® PF XP™ Technical Features and Benefits Healthcare risks associated with cytostatics Leading the research on cytostatic permeation ACPP: Results corresponding to real life conditions AnsellCares Support Documentation Regulatory Requirements (Personal Protective Equipment) Promotion & Launch Pack Ansell Europe 2007

  3. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 • Technical Features & Benefits • Indigo blue colour for easy identification of personal protection in a high risk environment • - Optimized wall thickness (10% thicker) secures ACPP permeation times for effective barrier protection • Low risk of pin-holes due to increased wall thickness, • visual inspection and water leak testing before packing GL I AQL 0.65 leads to high barrier protection (1) • Polyurethane lining with hydrophilic and hydrophobic elements facilitates damp donning and double gloving (1) • Improved grip level to secure safe handling of laboratory equipment • Provides superior comfort to avoid hand fatigue (specifically against Z+ from Berner) PPE Pictograms! Ansell Europe 2008

  4. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 • Low allergenic profile of Gammex® Technology. • Protein and Endogenous Allergen Reduction Leaching (P.E.A.R.L.) Technology that delivers a glove with extremely low extractible proteins, reducing risk of latex sensitization (Typical values are below < 10 µg/g (Modified Lowry / HPLC). Fitkit ™: Non detectible (very low allergenicity) – Sum of the four clinically relevant allergens • measured below > 0.03 µg/g (9, 10, 11, 12) - Unique (PV100) accelerator becomes gases which are completely consumed during processing leaving non detectable chemical accelerator residue thereby reducing the risk of contact dermatitis. Ansell Europe 2008

  5. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 Healthcare risks associated with Cytostatics • Remember :One (carcinogen) molecule is ableto induce cancer !Dr J.M.Sessink – GERPAC 2004 Drugs known to be likely: • Mutagen • Carcinogen • Teratogenic or foetotoxic • Decrease the fertility • Induce foetal malformation • Induce abortion • Induce extra uterine pregnancy • High toxicity for certain organs Ansell Europe 2008

  6. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 • Cancer rates could further increase by 50% to 15 million new cases in the year 2020 • Steadily ageing populations • smoking habits and the growing adoption of unhealthy lifestyles The proportion of protective gloves used for chemotherapy ranges from 3 to 5 % of the total consumption Ansell Europe 2008

  7. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 Leading the research on cytostatics permeability http://www.ansell.eu Ansell Cares Ansell Europe 2008 ACPP Brochure (2) Cytostatic handling and glove handling (5)

  8. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 Ansell Europe 2008

  9. Gammex® PF XP™ Extra protection for handling cytostatic agents. Movement January 2008 Dynamic simulation device Ansell Europe 2008 Full training presentation on ACPP in launch pack included!

  10. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 Dynamic versus static testing • 1.Reproduce as closely as possible real life physical constraints on gloves to be analyzed for permeation, Incl.: • - Rubbing • - Stress • Tension • 2. Scientific approach • 3. Reproducible Ansell Europe 2008

  11. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 Ansell Europe 2008 Presenting results corresponding to real life conditions – pared with product recommendation for all application steps Now test results available after alcohol disinfection! ACPP Tests(4)

  12. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 Regulatory Requirements (Personal Protective Equipment) • "Council Directive" of 21 Dec. 1989 on the approximation of the laws of the Member States relating to personal protective equipment (89/686/EEC) • “Personal Protective Equipment" means any device or appliance designed to be worn or held by an individual for protection against one or more health & safety hazards" • The primary intention is to protect the “worker”, • no direct contact between the “worker” and the “patient” Ansell Europe 2008

  13. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 Ansell launches Gammex® PF XP™:April 2008 Product Codes: 353081 Size 5.5 40 pairs per box / 240 pairs per case 353082 Size 6.0 40 pairs per box / 240 pairs per case 353083 Size 6.5 40 pairs per box / 240 pairs per case 353084 Size 7.0 40 pairs per box / 240 pairs per case 353085 Size 7.5 40 pairs per box / 240 pairs per case 353086 Size 8.0 40 pairs per box / 240 pairs per case 353087 Size 8.5 40 pairs per box / 240 pairs per case 353088 Size 9.0 40 pairs per box / 240 pairs per case Ansell Europe 2008 CE mark – CE0493 Personal Protective Equipment Made in Sri Lanka, 3 years shelf-life

  14. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 • Promotion Mix / Launch Pack • Product Leaflet • Technical Datasheet • How to prepare cytostatic drugs safely • Updated ACPP Brochure • Press release • Give-a-wayOn-line support: • Web-Site (New banner) • In Touch Newsletter • e-mail alert Ansell Europe 2008

  15. Gammex® PF XP™ Extra protection for handling cytostatic agents. January 2008 • Test reports and clinical literature • Gammex PF XP Technical Datasheet, Ansell Healthcare Europe, Belgium 2008 • Ansell Cares: ACPP Brochure 2008 • Safe handling of cytostatic agents, Broschure 2008 • ACPP test performed at the University of St. Luc, Belgium 2007 • Cytotoxic handling and the importance of appropriate gloving - Johan Vandenbroucke – April 2007 • Permeability of 13 different gloves to 13 cytotoxic agents under controlled dynamic conditions PIERRE E. WALLEMACQ, ARNAUD CAPRON, ROGER VANBINST, ERIC BOECKMANS,JEAN GILLARD, AND BERTRAND FAVIER • EN 374-3 Permeation of liquid chemical through protective clothing, 2007 • EN 388 – Cytostatic Glove testing, 2007 • Cytotoxity Study, Pending • Iso Sensitization Study, Pending • Primary Skin Irritation Study, Pending • Fitkit by Quatromed, 2007 Fine more information: http//:www.ansell.eu Ansell Europe 2008

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