Section 4.4 - items in red added

Anaphylactic/anaphylactoid reactions to chlorhexidine have been reported. Manifestations of such reactions have included hypotension, bronchospasm, rash, erythema, tachycardia, and shock. Fatal anaphylactic reaction has been     reported.

Hypersensitivity reactions have been reported on contact with Chlorhexidine acetate or Cetrimide

If any signs or symptoms of a suspected hypersensitivity reaction develop, immediately stop use. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

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 Chlorhexidine Acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation Solution, care must be taken to ensure no excess product is present prior to application of the dressing.

Caution should be exercised when chlorhexidine is used in preoperative skin preparations for face or head. (See section 4.3 Contraindications).            This product should only be used in specialist units familiar with the appropriate selection of patients.

            Section 4.8 items in red added/ changed

Immune system disorders:

Hypersensitivity reactions including anaphylactic/anaphylactoid reactions (which might be fatal) manifested by cardiac arrest, shock, circulatory collapse, hypotension, bronchospasm, tachycardia, rash, erythema and urticaria

Skin and subcutaneous tissue disorders:

Rash

Other Adverse Reactions:

The adverse events reported and/or observed with other chlorhexidine products include:

.  Chemical burns in neonates (See Section 4.4 Special Warnings and Precaustions for Use)

The following reactions have been noted when Chlorhexidine containing irrigation solutions have been used intravesically, intravaginally or topically on traumatised skin: Hypotension, paraesthesia, dyspnea, tachycardia, cold sweat, generalised erythema, urticaria and loss of consciousness.

Chemical burns in neonates (frequency unknown).

Section 4.4 - items in red added

Anaphylactic/anaphylactoid reactions to chlorhexidine have been reported. Manifestations of such reactions have included hypotension, bronchospasm, rash, erythema, tachycardia, and shock. Fatal anaphylactic reaction has been     reported.

Hypersensitivity reactions have been reported on contact with Chlorhexidine acetate or Cetrimide

If any signs or symptoms of a suspected hypersensitivity reaction develop, immediately stop use. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

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 Chlorhexidine Acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation Solution, care must be taken to ensure no excess product is present prior to application of the dressing.

Caution should be exercised when chlorhexidine is used in preoperative skin preparations for face or head. (See section 4.3 Contraindications).            This product should only be used in specialist units familiar with the appropriate selection of patients.

            Section 4.8 items in red added/ changed

Immune system disorders:

Hypersensitivity reactions including anaphylactic/anaphylactoid reactions (which might be fatal) manifested by cardiac arrest, shock, circulatory collapse, hypotension, bronchospasm, tachycardia, rash, erythema and urticaria

Skin and subcutaneous tissue disorders:

Rash

Other Adverse Reactions:

The adverse events reported and/or observed with other chlorhexidine products include:

.  Chemical burns in neonates (See Section 4.4 Special Warnings and Precaustions for Use)

The following reactions have been noted when Chlorhexidine containing irrigation solutions have been used intravesically, intravaginally or topically on traumatised skin: Hypotension, paraesthesia, dyspnea, tachycardia, cold sweat, generalised erythema, urticaria and loss of consciousness.

Chemical burns in neonates (frequency unknown).