| Product Name: | Cinacalcet Hydrochloride Tablets |
| Brand Name: | Generics |
| Strength: | 30mg, 60mg, 90mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Stimulant, Calcimimetic |
| Indication: | Cinacalcet is used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). |
| Storage: | Store below 25˚C. Protect from Light and moisture.… |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cinacalcet Hydrochloride Tablets 30mg
- Cinacalcet Hydrochloride Tablets 60mg
- Cinacalcet Hydrochloride Tablets 90mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cinacalcet Hydrochloride Tablets 30mg
Each Film-coated tablet contains:
Cinacalcet Hydrochloride IP
Equivalent to Cinacalcet ……………………30mg
Excipients…………………………q.s.
Colours: Ferric oxide Yellow USP-NF - Cinacalcet Hydrochloride Tablets 60mg
Each Film-coated tablet contains:
Cinacalcet Hydrochloride IP
Equivalent to Cinacalcet ……………………60mg
Excipients…………………………q.s.
Colours: Ferric oxide Yellow USP-NF - Cinacalcet Hydrochloride Tablets 90mg
Each Film-coated tablet contains:
Cinacalcet Hydrochloride IP
Equivalent to Cinacalcet ……………………90mg
Excipients…………………………q.s.
Colours: Ferric oxide Yellow USP-NF
THERAPEUTIC INDICATIONS:
Cinacalcet is used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Store below 25˚C. Protect from Light and moisture.
Dosage: As directed by the Physician.