GENERIC NAME OF THE MEDICINAL PRODUCT:

Bacteriostatic Water for Injection, USP (100%v/v)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Bacteriostatic Water for Injection, USP (100%v/v)
Composition:
Benzyl alcohol ……………0.9%

THERAPEUTIC INDICATIONS:

This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

DIRECTION OF USE:

When introducing additives, use aseptic technique, mix thoroughly & do not store.
Do not give intravenously unless rendered nearly isotonic.
For drug diluent use only.

CAUTION & WARNING:

CAUTION: Use only if clear & seal is intact & undamaged.
Cleanse stopper with antiseptic.
WARNING: NOT FOR USE IN NEONATES

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C. Protect from freezing.
STERILE, NON-PYROGENIC
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.

Bacteriostatic Water for Injection USP 100%v/v Technical Specification:

Product Name:Bacteriostatic Water for Injection USP  100%v/v
Brand Name:Generics
Strength:100%v/v
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:30mL 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:Solvent for Parenteral Use
Indication: This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Storage:Store at 20°C to 25°C. Protect from freezing.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Bacteriostatic Water for Injection, USP (100%v/v)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bacteriostatic Water for Injection, USP (100%v/v)
    Composition:
    Benzyl alcohol ……………0.9%

THERAPEUTIC INDICATIONS:

This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

DIRECTION OF USE:

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

Do not give intravenously unless rendered nearly isotonic.

For drug diluent use only.

CAUTION & WARNING:

CAUTION: Use only if clear & seal is intact & undamaged.

Cleanse stopper with antiseptic.

WARNING: NOT FOR USE IN NEONATES

STORAGE & DOSAGE:

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

STERILE, NON-PYROGENIC

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

Dosage: As directed by the Physician.