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.
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.
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.