Clincare International Center Ltd is a REMS certified Spravato treatment center. We will feel proud to be at your service as we have a healing touch. We’re proud to be serving across United States.
SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults.
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.
It is not known if SPRAVATO® is safe and effective in children.
What is the SPRAVATO™ REMS (Risk Evaluation and Mitigation Strategy)?
A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product.
The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO™ administration, and abuse and misuse of SPRAVATO™ by:
- Ensuring that SPRAVATO™ is only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients
- Ensuring pharmacies and healthcare settings that dispense SPRAVATO™ are certified
- Ensuring that each patient is informed about the serious adverse outcomes resulting from sedation and dissociation and need for monitoring
- Enrollment of all patients in a registry to further characterize the risks and support safe use
SPRAVATO™ is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. SPRAVATO™ must never be dispensed directly to a patient for home use.