SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sterexidine 200 Solution 0.5%w/v

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Active Ingredient:

Chlorhexidine Gluconate Solution 20%w/v BP - 2.5%v/v Equivalent to Chlorhexidine Gluconate BP 0.5%w/v

3    PHARMACEUTICAL FORM

Sterile solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the topical irrigation of skin wounds and in obstetrics only.

4.2.    Posology and Method of Administration

To be administered topically.

Adults, the elderly and children: Use as required.

4.3    Contraindications

Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).

Avoid contact with eyes, brain, meninges, middle ear or external ear with perforated tympanic membrane. Not for intravenous administration.

4.4 Special warnings and precautions for use

Sterexidine 200 solution 0.5% w/v contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be rare. Sterexidine 200 solution 0.5% w/v should not be administered to anyone with a potential history of an allergic reaction to chlorhexidine-containing compound (see sections 4.3 and 4.8).

The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates. Based on available case reports and the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.

Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to Sterexidine 200 solution 0.5% w/v, care must be taken to ensure no excess product is present prior to application of the dressing.

Do not use unless the solution is clear and the container is intact. Discard any unused contents.

4.5. Interactions with other Medicaments and other forms of Interaction

None stated.

4.6. Pregnancy and Lactation

None stated.

4.7. Effects on Ability to Drive and Use Machines

None stated.

4.8 Undesirable effects Skin Disorders

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation and blisters.

Immune Disorders

Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

Chemical Burns in Neonates

Frequency unknown.

When used for bladder irrigation, chlorhexidine solutions may irritate the mucosa and cause burning and haematuria (in which case they should be discontinued).

4.9.    Overdose

Accidental Ingestion

Chlorhexidine is poorly absorbed orally. Treat with gastric lavage using milk, egg white, gelatin or mild soap. Employ supportive measures as appropriate.

Accidental Intravenous Administration

Blood transfusion may be necessary to counteract haemolysis

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

None stated

5.2    Pharmacokinetic Properties

None stated.

5.3    Preclinical Safety Data

Not Applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Polysorbate 80 Ph Eur

Carmoisine Dye (E122) Water for Injections BP

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months from the date of manufacture.

6.4    Special Precautions for Storage

Store between 2 - 25 °C.

6.5    Nature and Contents of Container

A rigid polypropylene pack.

Pack sizes: 1000ml, 500ml and 150ml.

6.6    Instruction for Use/Handling None stated.

Terumo BCT Ltd. Old Belfast Road Millbrook Larne

Northern Ireland BT40 2SH United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 21538/0016

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/03/2006

10    DATE OF REVISION OF THE TEXT

19/05/2015