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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
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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 January 2008 Ansell Europe 2007 Gammex ® PF XP™ Extra protection for handling cytostatic agents.
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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) January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents. PPE Pictograms!
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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. January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents.
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January 2008 Ansell Europe 2008 Healthcare risks associated with Cytostatics 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 Remember : One (carcinogen) molecule is able to induce cancer ! Dr J.M.Sessink – GERPAC 2004 Gammex ® PF XP™ Extra protection for handling cytostatic agents.
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January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents. 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
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January 2008 Ansell Europe 2008 Leading the research on cytostatics permeability http://www.ansell.eu ACPP Brochure (2) Cytostatic handling and glove handling (5) Ansell Cares Gammex ® PF XP™ Extra protection for handling cytostatic agents.
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January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents.
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January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents. Dynamic simulation device Movement Full training presentation on ACPP in launch pack included!
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January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents. 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 Dynamic versus static testing
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January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents. 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)
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January 2008 Ansell Europe 2008 n "Council Directive" of 21 Dec. 1989 on the approximation of the laws of the Member States relating to personal protective equipment (89/686/EEC) n “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” Gammex ® PF XP™ Extra protection for handling cytostatic agents. Regulatory Requirements (Personal Protective Equipment)
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January 2008 Ansell Europe 2008 Product Codes: 353081Size 5.5 40 pairs per box / 240 pairs per case 353082Size 6.0 40 pairs per box / 240 pairs per case 353083Size 6.5 40 pairs per box / 240 pairs per case 353084Size 7.0 40 pairs per box / 240 pairs per case 353085Size 7.5 40 pairs per box / 240 pairs per case 353086Size 8.0 40 pairs per box / 240 pairs per case 353087Size 8.5 40 pairs per box / 240 pairs per case 353088Size 9.0 40 pairs per box / 240 pairs per case CE mark – CE0493 Personal Protective Equipment Made in Sri Lanka, 3 years shelf-life Ansell launches Gammex ® PF XP™: April 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents.
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January 2008 Ansell Europe 2008 Promotion Mix / Launch Pack Product Leaflet Technical Datasheet How to prepare cytostatic drugs safely Updated ACPP Brochure Press release Give-a-way On-line support: Web-Site (New banner) In Touch Newsletter e-mail alert Gammex ® PF XP™ Extra protection for handling cytostatic agents.
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January 2008 Ansell Europe 2008 Test reports and clinical literature (1)Gammex PF XP Technical Datasheet, Ansell Healthcare Europe, Belgium 2008 (2)Ansell Cares: ACPP Brochure 2008 (3)Safe handling of cytostatic agents, Broschure 2008 (4)ACPP test performed at the University of St. Luc, Belgium 2007 (5)Cytotoxic handling and the importance of appropriate gloving - Johan Vandenbroucke – April 2007 (6)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 (7)EN 374-3 Permeation of liquid chemical through protective clothing, 2007 (8)EN 388 – Cytostatic Glove testing, 2007 (9)Cytotoxity Study, Pending (10)Iso Sensitization Study, Pending (11)Primary Skin Irritation Study, Pending (12)Fitkit by Quatromed, 2007 Fine more information: http//:www.ansell.eu Gammex ® PF XP™ Extra protection for handling cytostatic agents.
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