M e d i c i n e A ve 2 Important Safety Information • Synera" is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures • Synera’"' is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, or any other component of the product and in patients with para-aminobenzoic acid (PABA) hypersensitivity • Synera'" may lead to diminished or blocked sensation in the treated skin; therefore, patients should avoid inadvertent trauma (rubbing, scratching, or exposure to heat or cold) before complete sensation returns • Keeping a patch on longer than recommended or applying multiple patches simultaneously or sequentially could result in systemic absorption sufficient to result in serious adverse effects that are typical of drugs in this class • Even a used Synera'" patch contains a large amount of lidocaine and tetracaine (at least 90% of the initial amount). Chewing or ingesting a new or used Synera’" patch may result in serious adverse effects. Store and dispose of Synera" out of the reach of children and pets • Synera" should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and tetracaine, including the acutely ill, the debilitated, and those with compromised hepatic function. Patients with severe hepatic disease or pseudocholinesterase deficiency are at greater risk of developing toxic plasma concentrations AGENCY: Euro RSCG Lfe MetaMax CREATIVE TEAM: Bebe Lee, Rochelle Melton, Rodney Sexton, Astrid Reynolds CLIENT: Endo Pharmaceuticals 174
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