Actual Medicinal Product (AMP) Renvela 800mg tablets (Originalis B.V.)
Stability Information
(Some stability information inherited from generic)
- Stability
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Lack of data and/or stability concerns exist. MCA use may be acceptable but is likely to be off-label and require mitigation measures. Keep medicines in MCAs for the shortest time necessary. Generally, up to 5 weeks maximum unless otherwise specified, or up to 8 weeks if the MCA is airtight (sealed). Consider the risk of potency loss or dose variability and monitor for changes in efficacy or adverse effects after MCA initiation.
- Notes
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Moisture sensitive medicine. Store in airtight (sealed) MCA. Original packaging may contain desiccant. Stability study supports 3 months in MCA (sevelamer carbonate) No stability data in MCAs available (sevelamer hydrochloride)
- Provenance
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This recommendation is based on the products Renagel 800mg tablets (SANOFI), Renvela 800mg tablets (SANOFI), sevelamer carbonate 800mg tablets (Viatris) and sevelamer hydrochloride 800mg tablets (Sovereign Medical).
- Generic
- Sevelamer
- Formulation
- Sevelamer 800mg tablets
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Sevelamer
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Sevelamer 800mg tablets
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Renvela 800mg tablets (Originalis B.V.)
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Sevelamer 403mg capsules