Sodium Bicarbonate Injection B.P 8.4%

GENERIC NAME OF THE MEDICINAL PRODUCT:

Sodium Bicarbonate Injection B.P. (8.4%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Sodium Bicarbonate Injection B.P. (8.4%)
Composition:
Each 100ml contains:
Sodium Ions……………………………100mmol in 100ml
Bicarbonate Ions……………………100mmol in 100ml
Disodium Edetate……………………10mg in 100ml

THERAPEUTIC INDICATIONS:

Sodium Bicarbonate Injection, BP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particle.
Discard unused contents.
Contains no antimicrobial agents.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 30°C. Protect from light & moisture. Do not freeze.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.

Sodium Bicarbonate Injection B.P 8.4% Technical Specification:

Product Name:Sodium Bicarbonate Injection B.P  8.4%
Brand Name:Generics
Strength:8.4%
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL, 200mL, 250mL, 300mL, 350mL, 500mL, 540mL,1000 mL IV Bottle
Route of Administration:For I.V. 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:Alkalinizing Agent
Indication: Sodium Bicarbonate Injection, BP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis.
Storage:Store below 30°C. Protect from light & moisture. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Sodium Bicarbonate Injection B.P. (8.4%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Sodium Bicarbonate Injection B.P. (8.4%)
    Composition:
    Each 100ml contains:
    Sodium Ions……………………………100mmol in 100ml
    Bicarbonate Ions……………………100mmol in 100ml
    Disodium Edetate……………………10mg in 100ml

THERAPEUTIC INDICATIONS:

Sodium Bicarbonate Injection, BP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.

For I.V. use only.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particle.

Discard unused contents.
Contains no antimicrobial agents.

WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 30°C. Protect from light & moisture. Do not freeze.

STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.

Keep medicine out of reach of children.
FOR HUMAN USE ONLY

Dosage: As directed by the Physician.