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Vitamin B12 1mg/2ml Injection Philo Composition: **Active Ingredient:** Cyanocobalamin (Vitamin B12) - 1 mg per 2 mL **Excipients:** Sodium Chloride (for isotonicity) Water for Injection Hydrochloric Acid (for pH adjustment) Sodium Hydroxide (for pH adjustment) #### Dosage: **Adults:** **Initial Dose:** 1 mg (1 mL) intramuscularly or subcutaneously, administered once daily for 1 week

Finally, we disagree with the applicant's assertion that the healthcare setting in which procedures utilizing the aprevo Cervical ACDF System device and the aprevo (IFD)are typically performed has relevance to the device category discussion

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