Actual Medicinal Product (AMP) Salazopyrin EN-Tabs 500mg (Necessity Supplies Ltd)
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. Protect from light. Stability study supports 5 weeks in airtight (sealed) MCA when protected from light and moisture.
- Provenance
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This recommendation is based on the products Salazopyrin En-Tabs 500 mg gastro-resistant tablets (Pfizer limited) and sulfasalazine 500mg tablets (Hualan Pharmaceuticals Limited).
- Generic
- Sulfasalazine
- Formulation
- Sulfasalazine 500mg gastro-resistant tablets
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Sulfasalazine
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Sulfasalazine 500mg gastro-resistant tablets
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Salazopyrin EN-Tabs 500mg (Necessity Supplies Ltd)
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Sulfasalazine 3g/100ml retention enema