GENERIC NAME OF THE MEDICINAL PRODUCT:

Sterile Water for Irrigation USP

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Sterile Water for Irrigation USP
Water for Injection USP…………q.s.
No antimicrobial agent or other substance has been added.
pH: 5.7 (5.0-7.0)

THERAPEUTIC INDICATIONS:

Sterile Water for Irrigation USP is utilized for a variety of clinical indications. Because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures.

DIRECTION OF USE:

For irrigation only.
Not for Injection.

CAUTION & WARNING:

CAUTION: Use only if solution is clear & container & seal are intact.
Discard unused portion.
PVC-free & DEHP-free.
WARNING: Do not warm above 66°C.
Hypotonic & Hemolytic.

STORAGE & DOSAGE:

Storage: Room temperature (25°C). Avoid excessive heat. 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 Irrigation USP Technical Specification:

Product Name:Sterile Water for Irrigation USP
Brand Name:Generics
Strength:
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:250mL, 500mL, 1000mL, 1500mL, 2000mL, 3000mL 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:Irrigation solution
Indication: Sterile Water for Irrigation USP is utilized for a variety of clinical indications. Because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures.
Storage:Room temperature (25°C). Avoid excessive heat. Protect from freezing.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Sterile Water for Irrigation USP

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Sterile Water for Irrigation USP
    Water for Injection USP…………q.s.
    No antimicrobial agent or other substance has been added.
    pH: 5.7 (5.0-7.0)

THERAPEUTIC INDICATIONS:

Sterile Water for Irrigation USP is utilized for a variety of clinical indications. Because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures.

DIRECTION OF USE:

For irrigation only.
Not for Injection.

CAUTION & WARNING:

CAUTION: Use only if solution is clear & container & seal are intact.

Discard unused portion.
PVC-free & DEHP-free.

WARNING: Do not warm above 66°C.

Hypotonic & Hemolytic.

STORAGE & DOSAGE:

Storage: Room temperature (25°C). Avoid excessive heat. 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.