GENERIC NAME OF THE MEDICINAL PRODUCT:

Compound Sodium Lactate Intravenous Infusion BP

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Compound Sodium Lactate Intravenous Infusion BP
Composition:
One liter contains:
Sodium Lactate ……………………………3.20g
Sodium Chloride………………………….6.00g
Potassium Chloride…………………….0.40g
Calcium Chloride 2H₂O………………0.27g
Water for Injection to …………………… 1000ml
Equivalent to approx.
Na+………131 mmol/L
Ca++………2 mmol/L
K+…………5 mmol/L
Cl-…………111mmol/L
Bicarbonate (as lactate) ……………… 29mmol/L
Their. Osmolarity: ……………… 278 mOsm/L
pH…………………………………………5.0-7.0

THERAPEUTIC INDICATIONS:

Compound Sodium Lactate will be given to you by your doctor or specially trained nurse by infusion or drip into the vein. This allows the Compound Sodium Lactate to reach the body quickly, where it will treat dehydration and replace mineral salts.

DIRECTION OF USE:

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

CAUTION & WARNING:

CAUTION: Do not use if bottle is leaking, solution cloudy or contains particles.
Discard unused portion.
Do not mix with phosphate containing solutions.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Do not store above 25°C.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.

Compound Sodium Lactate Intravenous Infusion BP Technical Specifications:

Product Name:Compound Sodium Lactate Intravenous Infusion BP
Brand Name:Generics
Strength:See Detailed Composition
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:Minerals
Indication: Compound Sodium Lactate will be given to you by your doctor or specially trained nurse by infusion or drip into the vein. This allows the Compound Sodium Lactate to reach the body quickly, where it will treat dehydration and replace mineral salts.
Storage:Do not store above 25°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Compound Sodium Lactate Intravenous Infusion BP

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Compound Sodium Lactate Intravenous Infusion BP
    Composition:
    One liter contains:
    Sodium Lactate ……………………………3.20g
    Sodium Chloride………………………….6.00g
    Potassium Chloride…………………….0.40g
    Calcium Chloride 2H₂O………………0.27g
    Water for Injection to …………………… 1000ml
    Equivalent to approx.
    Na+………131 mmol/L          Ca++………2 mmol/L
    K+…………5 mmol/L              Cl-…………111mmol/L
    Bicarbonate (as lactate) ……………… 29mmol/L
    Their. Osmolarity: ……………… 278 mOsm/L
    pH…………………………………………5.0-7.0

THERAPEUTIC INDICATIONS:

Compound Sodium Lactate will be given to you by your doctor or specially trained nurse by infusion or drip into the vein. This allows the Compound Sodium Lactate to reach the body quickly, where it will treat dehydration and replace mineral salts.

DIRECTION OF USE:

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

For I.V. use only.

CAUTION & WARNING:

CAUTION: Do not use if bottle is leaking, solution cloudy or contains particles.

Discard unused portion.
Do not mix with phosphate containing solutions.

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

STORAGE & DOSAGE:

Storage: Do not store above 25°C.

STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.

Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.

Dosage: As directed by the Physician.