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First, we agree with the applicant that the LithoVue TM Elite Ureteroscope is used for one patient only, comes in contact with human tissue, and is surgically implanted or inserted or applied in or on a wound or other skin lesion

The diluent of choice is USP-grade bacteriostatic water containing 0.9% benzyl alcohol see the bacteriostatic water product page for reconstitution-grade water

What to record for each reconstitution Date: When you added water to the vial

Absorption problems Even with adequate intake, absorption can be reduced by: Certain gastrointestinal conditions affecting the stomach or small intestine Some medications Age-related reduction in stomach acid (which can affect absorption) Autoimmune gastritis (often historically referred to as pernicious anaemia) This is a well-recognised cause of B12 deficiency and may require ongoing management

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