GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Dextrose Injection, USP (10%w/v)
C. Dextrose Injection, USP (25%w/v)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Each 100 ml contains:
Dextrose Hydrous……………………………5g
In Water for Injection
mOsmol/L.: 252 pH4.3 (3.2 to 6.5)
B. Dextrose Injection, USP (10%w/v)
Composition:
Each 100 ml contains:
Dextrose Hydrous……………………………10g
In Water for Injection
mOsmol/L.: 252 pH4.3 (3.2 to 6.5)
C. Dextrose Injection, USP (25%w/v)
Composition:
Each 100 ml contains:
Dextrose Hydrous……………………………25g
In Water for Injection
mOsmol/L.: 252 pH4.3 (3.2 to 6.5)
THERAPEUTIC INDICATIONS:
PACKING:
5%w/v, 10%w/v---- 100ml, 200ml, 250ml, 300ml, 350ml, 500ml, 540ml,1000ml
25%w/v---- 300ml, 500ml
DIRECTION OF USE:
For I.V. use only.
CAUTION & WARNING:
Dextrose solutions without salts should not be used in blood transfusion.
Additives may be incompatible, consult with pharmacist, if available.
Use only if solution is clear & container is undamaged.
Must not be used in series connections.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.
Dextrose Injection USP 5%w/v Technical Specification:
| Product Name: | Dextrose Injection USP 5%w/v |
| Brand Name: | Generics |
| Strength: | 5%w/v, 10%w/v, 25%w/v |
| 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: | Nutrient, Fluid replenisher |
| Indication: | Dextrose injection is a sterile solution used to provide your body with extra water and carbohydrates (calories from sugar). It is used when a patient is not able to drink enough liquids or when additional fluids are needed. |
| Storage: | Store at room temperature (25°C). Avoid excessive heat. Protect from freezing. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Dextrose Injection, USP (5%w/v)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Dextrose Injection, USP (5%w/v)
Composition:
Each 100 ml contains:
Dextrose Hydrous……………………………5g
In Water for Injection
mOsmol/L.: 252 pH4.3 (3.2 to 6.5)
THERAPEUTIC INDICATIONS:
Dextrose injection is a sterile solution used to provide your body with extra water and carbohydrates (calories from sugar). It is used when a patient is not able to drink enough liquids or when additional fluids are needed.
PACKING:
| Strength | Pack size |
| 5%w/v, 10%w/v | 100ml, 200ml, 250ml, 300ml, 350ml, 500ml, 540ml,1000ml |
| 25%w/v | 300ml, 500ml |
DIRECTION OF USE:
Mix thoroughly & do not store.
For I.V. use only.
CAUTION & WARNING:
CAUTION: Hypertonic. Administer only after dilution.
Dextrose solutions without salts should not be used in blood transfusion.
Additives may be incompatible, consult with pharmacist, if available.
Use only if solution is clear & container is undamaged.
Must not be used in series connections.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store below 25°C. Protect from light. 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.


















