A) Sevelamer Carbonate Tablets 400mg
B) Sevelamer Carbonate Tablets 800mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Sevelamer Carbonate Tablets 400mg
Each film coated tablet contains:
Sevelamer Carbonate……………400mg
Excipients…………………………. q.s.
Colour: Red Oxide of Iron
B) Sevelamer Carbonate Tablets 800mg
Each film coated tablet contains:
Sevelamer Carbonate……………...800mg
Excipients………………………………...q.s.
Colour: Tartrazine
Each film coated tablet contains:
Sevelamer Carbonate……………400mg
Excipients…………………………. q.s.
Colour: Red Oxide of Iron
B) Sevelamer Carbonate Tablets 800mg
Each film coated tablet contains:
Sevelamer Carbonate……………...800mg
Excipients………………………………...q.s.
Colour: Tartrazine
THERAPEUTIC INDICATIONS:
Sevelamer is a phosphate binding medication used to treat hyperphosphatemia in patients with chronic kidney disease. When taken with meals, it binds to dietary phosphate and prevents its absorption.
CAUTION & SCHEDULE:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A NEPHROLOGIST.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A NEPHROLOGIST.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Storage: Store below 25 °C.
Protect from Light and moisture.
Dosage: As directed by the Nephrologist.
Protect from Light and moisture.
Dosage: As directed by the Nephrologist.
Sevelamer Carbonate Tablets 800mg Technical Specification:
| Product Name: | Sevelamer Carbonate Tablets 800mg |
| Brand Name: | Fos-Control |
| Strength: | 400mg, 800mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antihyperphosphatemia |
| Indication: | Sevelamer is used to treat hyperphosphatemia (too much phosphate in the blood) in patients with chronic kidney disease who are on dialysis. |
| Storage: | Store below 25 °C. Protect from Light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Sevelamer Carbonate Tablets 800mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Sevelamer Carbonate Tablets 800mg
Each film coated tablet contains:
Sevelamer Carbonate……………800mg
Excipients…………………………. q.s.
Colour: Tartrazine
THERAPEUTIC INDICATIONS:
Sevelamer is a phosphate binding medication used to treat hyperphosphatemia in patients with chronic kidney disease. When taken with meals, it binds to dietary phosphate and prevents its absorption.
CAUTION & SCHEDULE:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H prescription drug: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A NEPHROLOGIST.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store below 25 °C.
Protect from Light and moisture.
Dosage: As directed by the Nephrologist.
