| Product Name: | Calcium Gluconate Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 1g/10ml, 5g/50ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 10ml Ampoule |
| Route of Administration: | For IM/slow IV use. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Calcium Deficiency, Nutritional Supplement |
| Indication: | Calcium gluconate is the calcium salt of gluconic acid, an intravenous medication used to treat conditions arising from calcium deficiencies such as hypocalcemia tetany, hypocalcemia related to hypoparathyroidism, and hypocalcemia due to rapid growth or pregnancy. |
| Storage: | Store below 30°C. Protected from light & moisture. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Calcium Gluconate Injection USP 1g/10ml
- Calcium Gluconate Injection USP 5g/50ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Calcium Gluconate Injection USP 1g/10ml
Each 10ml contains
Calcium Gluconate…………………………………………..1gm
Water for Injection…………………………………………..q.s. - Calcium Gluconate Injection USP 5g/50ml
Each 50ml contains
Calcium Gluconate…………………………………………..5gm
Water for Injection…………………………………………..q.s.
THERAPEUTIC INDICATION:
Calcium gluconate is the calcium salt of gluconic acid, an intravenous medication used to treat conditions arising from calcium deficiencies such as hypocalcemia tetany, hypocalcemia related to hypoparathyroidism, and hypocalcemia due to rapid growth or pregnancy.
CAUTION & WARNING:
CAUTION:
- NOT TO BE USED IF THE SOLUTION CONTAINS VISIBLE SOLID PARTICLES.
- DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
- Discard any unused solution.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protected from light & moisture.
Dosage: As directed by the Physician.