| Product Name: | Sodium Chloride Injection BP |
| Brand Name: | (GENERICS) |
| Strength: | 0.9% w/v |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1ml, 5ml, 10ml, 20ml Ampoule 25 mL vial |
| Route of Administration: | For Intravenous 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: | Hyponatremia, Electrolytes |
| Indication: | Sodium Chloride Injection is of value as a source of water and electrolytes and is indicated for replenishing fluid and for restoring and maintaining the concentrations of sodium and chloride ions. It is also of value in the treatment of poisoning, by aiding excretion. |
| Storage: | Store in a cool & dry place. |
GENERIC NAME OF MEDICINAL PRODUCT:
Sodium Chloride Injection BP 0.9% w/v
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Sodium Chloride Injection BP 0.9% w/v
Each ml contains:
Sodium Chloride BP…………………….9mg
Sodium ions…………………………………….1.54 mmol
Chloride ions…………………………………….1.54 mmol
Water for Injection BP…………………….q.s.
Hydrochloric Acid & Sodium Hydroxide for pH adjustment
THERAPEUTIC INDICATION:
Sodium Chloride Injection BP can be used for the restoration of electrolytes, as the vehicle for parenteral drug administration, or as a sterile irrigation medium.
CAUTION & WARNING:
CAUTION:
Do not use if any particle, leakage, or breakage is found.
DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
No other medication or substance should be added to this fluid unless the compatibility is known.
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 in a cool & dry place.
Dosage: As directed by the Physician.