STERETS CHLORASOL 0.3 %w/v Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM HYPOCHLORITE

Available from:

Seton Prebbles Ltd

INN (International Name):

SODIUM HYPOCHLORITE

Dosage:

0.3 %w/v

Pharmaceutical form:

Cutaneous Solution

Authorization status:

Withdrawn

Authorization date:

2006-05-23

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sterets Chlorasol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sterets Chlorasol sachets contain:
0.3% w/v available chlorine as sodium hydrochloride solution.
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Topical solution.
A clear colourless sterile solution.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
For topical use only, as determined by the physician.
Sodium hypochlorite is a broad-spectrum anti-microbial agent,
effective against bacteria, bacteriophages, spores, yeasts 
and viruses. Solutions of hypochlorite also have the ability to
lyse necrotic tissue.
Chlorasol may be used for the cleansing and desloughing
of venous stasis ulcers, pressure ulcers and other cutaneous 
ulcers.
It is recommended that Chlorasol be used only until clean,
healthy granulation tissue has developed and that its use be 
discontinued after this time.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
To be used as directed by the physician.
4.3 CONTRAINDICATIONS
Not to be taken internally.
Use in patients with hypersensitivity to the active ingredient.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Any portion of the contents of the sachet remaining
after use should be discarded.
Keep out of reach of children.
Irritant to the eye and other tissue; following
accidental exposure irrigate immediately with
copious water or normal 
saline.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 15/11/2005_
_CRN 2016837_
_page number: 1_
Avoid contact with clothing. In the event of any
complications seek medical advice as soon as possible. It is 
recommended that Chlorasol use be discontinued once healthy
granulation tissue has developed. Idiosyncratic skin 
reactions may occur occasionally.
The sachet sho