Anesiva, Inc.

Anesiva, Inc. Drugs

• Zingo
  

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  Zingo

  

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  Apply one Zingo™ (0.5 mg lidocaine hydrochloride monohydrate) to the site planned for venipuncture or intravenous cannulation, one to three minutes prior to needle insertion.

  Perform the procedure within 10 minutes after Zingo™ administration.

  Use Zingo™ only on intact skin.

  Application of one additional Zingo™ at a new location is acceptable after a failed attempt at venous access. Multiple administrations of Zingo™ at the same location are not recommended.

  When Zingo™ is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all sources should be considered, as local anesthetics are thought to have at least additive toxicities.

  2.1      Instructions for Use

  Prepare the Treatment Site and Device: Examine the treatment site to ensure that the skin is intact. Clean the site, according to standard practice.Visually inspect the pouch. Do not use if the pouch has been torn, or damaged or if the device has been dropped.Tear open the pouch using the notch provided (Figure 1a). Remove Zingo™ from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination (Figure 1b). Figure 1a Figure 1b Position Zingo™: Grip Zingo™ and place on the application site, with one hand, as illustrated in Figure 2, or with both hands, as shown in Figure 3. Figure 2 Figure 3 Ensure that the patient’s treatment site is supported to prevent movement. Seal the purple Zingo™ outlet against the patient’s skin. Hold the device perpendicular to the skin, making sure that your thumb can reach the green start button.Avoid gaps between the skin and the Zingo™ outlet, like the one illustrated in Figure 4, as gaps will impede drug delivery. Figure 4 Release the Safety Interlock: Apply adequate downward pressure to release the safety interlock, while maintaining the seal between Zingo™ and the skin.Zingo™ is ready for administration when the green start button has moved into the upward position, as illustrated in Figure 5a. Figure 5a Zingo™ cannot be actuated without releasing the internal safety interlock, as illustrated in Figure 5b. Figure 5b Administer Zingo™: While maintaining downward pressure, administer the dose by pressing the green start button, as illustrated in Figure 6. Do not move Zingo™ during administration. Actuation is accompanied by a “popping” sound, indicating that the dose has been discharged. Figure 6 Remove Zingo™: Remove Zingo from the application site and dispose. Begin Procedure: Start the venipuncture or intravenous cannulation procedure 1–3 minutes after Zingo™ administration. 

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