Wound Irrigation Solution

GENERIC NAME OF THE MEDICINAL PRODUCT:

Wound Irrigation Solution

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Wound Irrigation Solution
Composition:
Undecylenamidopropyl Betaine……………………………0.1%
Polyaminopropyl Biguanide ………………………………0.1%
(Polyhexamide [PHMB]), Purified Water
pH may be adjusted with
Sodium Hydroxide

THERAPEUTIC INDICATIONS:

Wound irrigation is indicated in the management of both acute and chronic wounds, and especially those that will be undergoing suturing, surgical repair, or debridement.

DIRECTION OF USE:

Rinse wounds thoroughly with Wound Irrigation Solution. For thirdly encrusted wounds: allow solution to soak in for 15 minutes. No rinsing required afterwards. Dressings & scarf sticking to wounds can be removed by soaking with Wound Irrigation Solution.

CAUTION & WARNING:

CAUTION: For external use on skin wounds only.
Do not use for infusion or injection.
Do not ingest.
Do not resterilize.
Use this product within 28 days after opening, Close bottle immediately after use.
Not made with natural rubber latex or DEHP.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at room temperature. Avoid excessive heat. Do not refrigerate or freeze.
STERILE by aseptic filtration <1 CFU/mL, until the product is first opened.
NONPYROGENIC fluid & fluid path prior to removal of cap.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.

Wound Irrigation Solution Technical Specification:

Product Name:Wound Irrigation Solution
Brand Name:Generics
Strength:
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:350mL, 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:Irrigation solution
Indication: Wound irrigation is indicated in the management of both acute and chronic wounds, and especially those that will be undergoing suturing, surgical repair, or debridement.
Storage:Store at room temperature. Avoid excessive heat. Do not refrigerate or freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Wound Irrigation Solution

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Wound Irrigation Solution
    Composition:
    Undecylenamidopropyl Betaine……………………………0.1%
    Polyaminopropyl Biguanide ………………………………0.1%
    (Polyhexamide [PHMB]), Purified Water
    pH may be adjusted with
    Sodium Hydroxide

THERAPEUTIC INDICATIONS:

Wound irrigation is indicated in the management of both acute and chronic wounds, and especially those that will be undergoing suturing, surgical repair, or debridement.

DIRECTION OF USE:

Rinse wounds thoroughly with Wound Irrigation Solution. For thirdly encrusted wounds: allow solution to soak in for 15 minutes. No rinsing required afterwards. Dressings & scarf sticking to wounds can be removed by soaking with Wound Irrigation Solution.

CAUTION & WARNING:

CAUTION: For external use on skin wounds only.

Do not use for infusion or injection.
Do not ingest.
Do not resterilize.

Use this product within 28 days after opening, Close bottle immediately after use.
Not made with natural rubber latex or DEHP.

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

STORAGE & DOSAGE:

Storage: Store at room temperature. Avoid excessive heat. Do not refrigerate or freeze.

STERILE by aseptic filtration <1 CFU/mL, until the product is first opened.

NONPYROGENIC fluid & fluid path prior to removal of cap.

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

Dosage: As directed by the Physician.