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Q: How fast does Revonto™, the enhanced-reconstituting product, compare to the original version of Dantrolene Sodium for Injection?
A: Revonto™, the enhanced-reconstituting product, mixes in 20 seconds or until solution is clear.
Q: What has changed to make Revonto™ mix more rapidly?
A: Revonto™ utilizes a patented TBA co-solvent system in its' manufacturing process.
Q: Do you still use sterile water for injection (without bacteriostatic agent) to reconstitute Revonto™?
A: Yes, the diluent and amount of diluent remains the same, but there is no longer the need to vigorously shake. Revonto™ now mixes in 20 seconds or until solution is clear.
Q: Why should normal saline not be used to reconstitute Revonto™?
A: US WorldMeds has thoroughly preformed reasearch reguarding this question and determined that, although normal saline has approximately the same pH as the recommended sterile water, it cannot be used to reconstitute Revonto™.
Upon the introduction of 60 mL of sterile normal saline into Revonto™ vials, a cloudy (milky) suspension is formed indicating the formation of insoluble particles. Centrifugation with subsequent filtration of the particles resulted in their isolation. The separated precipitate was shown to be the sodium salt of dantrolene when tested by high performance liquid chromatography (HPLC) and elemental analysis for sodium. Importantly, the supernatant solution resulting from filtration of the Revonto suspension, was shown to exhibit a loss of 40 ± 5% of its strength by HPLC analysis (i.e., a substantial reduction of its dantrolene content).
The data indicates the administration of Revonto™ reconstituted with normal saline to MH patients not only represents a treatment with a preparation of reduced strength but also results in the administration of a heterogeneous suspension containing insoluble particles.
Click here for full article on SCIENTIFIC REASONS WHY NORMAL SALINE CANNOT BE USED…
Q: Any change expected to the administration of Revonto™?
A: No, it remains as per PI “…by continuous rapid IV push beginning at a minimum dose of 1 mg/kg and continuing until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached”.
Q: Is there any change in the way Revonto™ is stored?
A: There is no change in the storage. Store Revonto™ at USP controlled room temperature for unreconstituted product and avoid prolonged exposure to light.
Q: How do I know I received Revonto™, the new enhanced-reconstituting product?
A: When Revonto™ is launched, US WorldMeds will only ship the enhanced-reconstituting product. You can be assured that you are receiving Revonto™ by the new label on the product.
Q: Who do I contact with additional questions about Revonto™?
A: US WorldMeds sales team is available to assist you.
US WorldMeds Sales Team: (877) 411-8796
After Hours/Emergency Order Information: (866) 916-0581
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