| Product Name: | Sevelamer Hydrochloride Tablet |
| Brand Name: | SEVELOR |
| Strength: | 400mg, 800mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 28s, 30s, 50s, 150s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Diuretic |
| Indication: | Sevelamer is used to treat hyperphosphatemia (too much phosphate in the blood) in patients with chronic kidney disease who are on dialysis. This medicine is available only with your doctor’s prescription. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Sevelamer Hydrochloride Tablet 400mg
- Sevelamer Hydrochloride Tablet 800mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Sevelamer Hydrochloride Tablet 400mg
Each Film-coated tablet contains:
Sevelamer Hydrochloride ………………400mg
Excipients…………………………………q.s.
Color: Ferric Oxide Yellow USP - Sevelamer Hydrochloride Tablet 800mg
Each Film-coated tablet contains:
Sevelamer Hydrochloride…………………800mg
Excipients…………………………………..q.s.
Color: Ferric Oxide Red USP
THERAPEUTIC INDICATIONS:
Sevelamer is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis (medical treatment to clean the blood when the kidneys are not working properly). Sevelamer is in a class of medications called phosphate binders.
CAUTION & WARNING:
CAUTION: Read the enclosed leaflet before use.Keep the medicine out of reach of children.SWALLOW WHOLE DO NOT CHEW OR CRUSH.WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician