Dextrose and Sodium Chloride Injection USP 5%+0.45%

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Dextrose and Sodium Chloride Injection, USP (5% +0.9%)
B. Dextrose and Sodium Chloride Injection, USP (5%+0.45%)
C. Dextrose and Sodium Chloride Injection, USP (5%+0.20%)
D. Dextrose and Sodium Chloride Injection, USP (5%+0.225%)
E. Dextrose and Sodium Chloride Injection, USP (3.3%+0.30%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Dextrose and Sodium Chloride Injection, USP (5% +0.9%)
Composition:
Each 100 ml contains:
Dextrose Hydrous……………………………5g
Sodium Chloride……………………………900mg
In Water for Injection
Electrolytes per 1000mL: Na 154 mEq; Cl 154 mEq.
560 mOsmol/Liter (Calc) pH 4.3(3.5 to 6.5)

B. Dextrose and Sodium Chloride Injection, USP (5%+0.45%)
Composition:
Each 100 ml contains:
Dextrose Hydrous……………………………5g
Sodium Chloride……………………………450mg
In Water for Injection
Electrolytes per 1000mL: Na 154 mEq; Cl 154 mEq.
560 mOsmol/Liter (Calc) pH 4.3(3.5 to 6.5)

C. Dextrose and Sodium Chloride Injection, USP (5%+0.20%)
Composition:
Each 100 ml contains:
Dextrose Hydrous……………………………5g
Sodium Chloride……………………………200mg
In Water for Injection
Electrolytes per 1000mL: Na 154 mEq; Cl 154 mEq.
560 mOsmol/Liter (Calc) pH 4.3(3.5 to 6.5)

D. Dextrose and Sodium Chloride Injection, USP (5%+0.225%)
Composition:
Each 100 ml contains:
Dextrose Hydrous……………………………5g
Sodium Chloride……………………………225mg
In Water for Injection
Electrolytes per 1000mL: Na 154 mEq; Cl 154 mEq.
560 mOsmol/Liter (Calc) pH 4.3(3.5 to 6.5)

E. Dextrose and Sodium Chloride Injection, USP (3.3%+0.30%)
Composition:
Each 100 ml contains:
Dextrose Hydrous……………………………3.3g
Sodium Chloride……………………………300mg
In Water for Injection
Electrolytes per 1000mL: Na 154 mEq; Cl 154 mEq.
560 mOsmol/Liter (Calc) pH 4.3(3.5 to 6.5)

THERAPEUTIC INDICATIONS:

Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.

DIRECTION OF USE:

When introducing additives, use aseptic technique, mix thoroughly & do not store.
For I.V. use only.

CAUTION & WARNING:

CAUTION: The overwrap is a moisture barrier. Use immediately once removed from overwrap.
The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C. Protect from freezing.
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.

Dextrose and Sodium Chloride Injection USP 5%+0.45% Technical Specification:

Product Name:Dextrose and Sodium Chloride Injection USP 5%+0.45%
Brand Name:Generics
Strength:(5%+0.9%), (5%+0.45%), (5%+0.20%), (5%+0.225%), (3.3%+0.30%)
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL, 200mL, 250mL, 300mL, 350mL, 500mL, 540mL, 1000mL 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:Nutrient, Fluid Replenisher
Indication: Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.
Storage:Store at 20°C to 25°C. Protect from freezing.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Dextrose and Sodium Chloride Injection, USP (5% +0.45%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dextrose and Sodium Chloride Injection, USP (5% +0.45%)
    Composition:
    Each 100 ml contains:
    Dextrose Hydrous……………………………5g
    Sodium Chloride……………………………450mg
    In Water for Injection
    Electrolytes per 1000mL: Na 154 mEq; Cl 154 mEq.
    560 mOsmol/Liter (Calc) pH 4.3(3.5 to 6.5)

THERAPEUTIC INDICATIONS:

Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.

DIRECTION OF USE:

When introducing additives, use aseptic technique, mix thoroughly & do not store.

For I.V. use only.

CAUTION & WARNING:

CAUTION: The overwrap is a moisture barrier. Use immediately once removed from overwrap.

The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

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

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C. Protect from freezing.

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.