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CHLORHEXIDINE GLUCONATE 0.05% SOLUTION

Active substance: CHLORHEXIDINE GLUCONATE SOLUTION

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Chlorhexidine Gluconate 0.05% Solution

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate solution BP 0.05%

3.

PHARMACEUTICAL FORM
Sterile topical antiseptic solution.

4.

CLINICAL PARTICULARS

4.1

Therapeutic Indications
For use as a topical antimicrobial agent for swabbing of wounds and burns and
in obstetrics. Also for cleaning surfaces and instrument disinfection.

4.2

Posology and Method of Administration
Method of administration
Posology
Adults, elderly & children

4.3

Contra-indications
I)
II)
III)

4.4

Topical irrigation or swabbing solution.
Sterile 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.

4.5
Interactions with other Medicinal Products and other Forms of
Interaction
None known.

4.6

Pregnancy and Lactation
There is no known reason why this product may not be used during pregnancy
or by breast-feeding mothers.

4.7

Effects on Ability to Drive and Use Machines
None known.

4.8

Undesirable Effects
Skin sensitivity to Chlorhexidine preparations has been reported. Generalised
allergic reactions to Chlorhexidine have been reported but are extremely rare.

4.9

Overdose
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.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties
Chlorhexidine Gluconate confers a broad spectrum of antimicrobial activity.

5.2

Pharmacokinetic Properties
There are no known relevant pharmacokinetics for Chlorhexidine Gluconate
used as a wound irrigant.

5.3

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.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of Excipients
Nonoxynol 10 HSE
Carmoisine Red E122 HSE
Sodium Hydroxide BP
Water For Injections Ph Eur

6.2

Incompatibilities
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.

6.3

Shelf Life
Unopened container:
Diluted solution:
Opened container:

24 months
Not Applicable
Not Applicable

6.4

Special Precautions for Storage
Do not store above 25°C. Do not refrigerate.

6.5

Nature and Contents of Container
Low density polyethylene ampoule manufactured using blow-fill-seal
technology. The ampoule is filled with 20 ml of solution.

6.6

Instructions for Use/Handling
1) Twist off top to reveal no-touch nozzle.
2) For directional irrigation

3) For drop by drop dispensing

7.

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
Albert Basin
Royal Docks
London
E16 2QJ
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 00530/0689

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
8th June 2005

10.

DATE OF (PARTIAL) REVISION OF THE TEXT

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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