CHLORHEXIDINE GLUCONATE 0.05% SOLUTION
NAME OF THE MEDICINAL PRODUCT
Chlorhexidine Gluconate 0.05% Solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate solution BP 0.05%
Sterile topical antiseptic solution.
For use as a topical antimicrobial agent for swabbing of wounds and burns and
in obstetrics. Also for cleaning surfaces and instrument disinfection.
Posology and Method of Administration
Method of administration
Adults, elderly & children
Topical irrigation or swabbing solution.
Use undiluted for topical applications.
Do not use in body cavities or as an enema.
The presentation is not suitable for use as an injection.
Chlorhexidine Gluconate 0.05% is contraindicated in patients who have
previously shown a hypersensitivity reaction to Chlorhexidine.
However, such reactions are extremely rare.
Special Warnings and Special Precautions for Use
Do not use unless the product is clear or if there is any evidence of leaking
prior to breaking the seal.
Check for leaks by squeezing the ampoule before use.
Discard any surplus.
Avoid contact with the eyes, brain, meninges and middle ear.
If solution comes into contact with the eyes, wash out promptly and
thoroughly with water.
For external use only.
Interactions with other Medicinal Products and other Forms of
Pregnancy and Lactation
There is no known reason why this product may not be used during pregnancy
or by breast-feeding mothers.
Effects on Ability to Drive and Use Machines
Skin sensitivity to Chlorhexidine preparations has been reported. Generalised
allergic reactions to Chlorhexidine have been reported but are extremely rare.
Chlorhexidine is poorly absorbed following oral ingestion. Do not induce
vomiting. Treat with gastric lavage, using milk, egg white, gelatin or mild
soap and employ appropriate supportive measures.
Chlorhexidine Gluconate confers a broad spectrum of antimicrobial activity.
There are no known relevant pharmacokinetics for Chlorhexidine Gluconate
used as a wound irrigant.
Pre-clinical Safety Data
Chlorhexidine Gluconate 0.05% contains Chlorhexidine Gluconate which is
not pharmaceutically active in this product. Specific toxicology studies have
not been conducted to demonstrate the safety of this product.
List of Excipients
Nonoxynol 10 HSE
Carmoisine Red E122 HSE
Sodium Hydroxide BP
Water For Injections Ph Eur
Chlorhexidine is incompatible with soap and other anionic materials. This
product will also be incompatible with borates, bicarbonates, carbonates,
chlorides, citrates, phosphates and sulphates. Fabrics which have been in
contact with Chlorhexidine will be stained when bleached with hypochlorite.
Special Precautions for Storage
Do not store above 25°C. Do not refrigerate.
Nature and Contents of Container
Low density polyethylene ampoule manufactured using blow-fill-seal
technology. The ampoule is filled with 20 ml of solution.
Instructions for Use/Handling
1) Twist off top to reveal no-touch nozzle.
2) For directional irrigation
3) For drop by drop dispensing
Point the nozzle and squeeze firmly.
Discard any surplus after use.
Invert and squeeze gently.
Discard any surplus after use.
MARKETING AUTHORISATION HOLDER
Norton Healthcare Limited
T/A IVAX Pharmaceuticals UK
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF
8th June 2005
DATE OF (PARTIAL) REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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