GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Sterile Water for Injection, USP (100%v/v)
Composition:
Contains no antimicrobial or other substance.
Admixtures should be used promptly with adequate precaution for maintaining sterility.
pH 5.5 (5 to 7)

THERAPEUTIC INDICATIONS:

Sterile Water for Injection, USP is used for fluid replacement only after suitable additives are introduced to approximate isotonicity and to serve as a vehicle for suitable medications. Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.

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: 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.
WARNING: Not Isotonic. Hemolytic.

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
Dosage: As directed by the Physician.

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

Product Name:Sterile Water for Injection USP 100%v/v
Brand Name:Generics
Strength:100%v/v
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL 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: Sterile Water for Injection, USP is used for fluid replacement only after suitable additives are introduced to approximate isotonicity and to serve as a vehicle for suitable medications. Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.
Storage:Store at 20°C to 25°C. Protect from freezing.

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Sterile Water for Injection, USP (100%v/v)
    Composition:
    Contains no antimicrobial or other substance.
    Admixtures should be used promptly with adequate precaution for maintaining sterility.
    pH 5.5 (5 to 7)

THERAPEUTIC INDICATIONS:

Sterile Water for Injection, USP is used for fluid replacement only after suitable additives are introduced to approximate isotonicity and to serve as a vehicle for suitable medications. Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.

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: 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.

WARNING: Not Isotonic. Hemolytic.

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

Dosage: As directed by the Physician.