| Product Name: | Sodium Bicarbonate Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 5% w/v (0.5mEq/ml, 5 mEq/10ml), 8.4% w/v (1 mEq/ml, 50 mEq/50ml), |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 10ml, 50ml vial |
| Route of Administration: | For Intravenous use only. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Alkalizing agent, Antidote |
| Indication: | Sodium Bicarbonate belongs to the group of medicines called alkalinizing agents. It is used to treat metabolic acidosis, which can occur in conditions such as severe kidney disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal blood circulation, cardiac arrest, and drug overdoses such as barbiturates, salicylate poisoning, methyl alcohol poisoning, and hemolytic reactions. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Sodium Bicarbonate Injection USP 5% w/v (0.5 mEq/ml) (50 mEq/50ml)
- Sodium Bicarbonate Injection USP 8.4% w/v (1 mEq/ml) (50 mEq/50ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Sodium Bicarbonate Injection USP 5% w/v (1 mEq/ml) (50 mEq/50ml)
Each ml contains:
Sodium Bicarbonate USP…………………….5mg
Water for Injection USP…………………….q.s.
2 mOSmol/ml - Sodium Bicarbonate Injection USP 8.4% w/v (1 mEq/ml) (50 mEq/50ml)
Each ml contains:
Sodium Bicarbonate USP…………………….84mg
Water for Injection USP…………………….q.s.
2 mOSmol/ml
THERAPEUTIC INDICATION:
Sodium Bicarbonate belongs to the group of medicines called alkalinizing agents. It is used to treat metabolic acidosis, which can occur in conditions such as severe kidney disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal blood circulation, cardiac arrest, and drug overdoses such as barbiturates, salicylate poisoning, methyl alcohol poisoning, and hemolytic reactions.
CAUTION & WARNING:
CAUTION:
Do not use if any particle, leakage, precipitate, or breakage is found.
DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
Contains no bacteriostat.
Discard any unused solution.
Do not resterilize.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Sterile.
Non-pyrogenic.
Dosage: As directed by the Physician.