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Eleview® submucosal injection agent

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INDICATIONS FOR USE

Eleview® submucosal injectable composition is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

CONTRAINDICATIONS

Patients with known sensitivity to any of the components contained in Eleview®.

WARNINGS AND PRECAUTIONS

  • The endoscopist injecting Eleview® must be experienced in the administration technique.
  • The safety of Eleview® has not been established in pregnant or lactating women, or in children under 18 years of age.
  • Eleview® is provided in single-use ampoules. Eleview® should not be reused after the first opening. Any emulsion not injected during the procedure should not be reused for another endoscopic procedure.
  • Do not use if the primary packaging (ampoule) or secondary packaging (aluminum pouch) is damaged.
  • Do not use if the twist-off cap is damaged.
  • Do not use if the emulsion is not clear, shows any signs of opalescence, or contains floating or precipitated visible particles.
  • The product compatibility with other substances has not been tested.

ADVERSE REACTIONS

Rarely, local bleeding and/or inflammatory reaction could occur which may or may not be associated with Eleview®.

DOSAGE AND ADMINISTRATION

The administered dose of Eleview® should be determined based on the dimensions of the lesion to be removed. Inject into the submucosa the amount of Eleview® needed to form a submucosal cushion of optimal height and shape for the lesion to be removed. During the procedure do not exceed a total dose of 50 mL per patient, either in single or in multiple administrations.

Please see Instructions for Use for complete Important Safety Information.