Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
The solution is flammable. Do not use electrocautery procedures or other ignition sources until the skin is completely dry.

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 ChloraPrep with Tint, care must be taken to ensure no excess product is present prior to application of the dressing.

For external use only on intact skin.

ChloraPrep with Tint 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 very rare. ChloraPrep with Tint should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8). The solution is an irritant to mucous membranes. It should therefore be kept away from these areas.

ChloraPrep with tint must not come into contact with the eye. Serious cases of persistent corneal injury, potentially requiring corneal transplant, were reported following accidental ocular exposure to chlorhexidine containing medicinal products despite taking eye protective measures due to migration of solution beyond the intended surgical preparation area.
Extreme care must be taken during application to ensure that ChloraPrep with Tint does not migrate beyond its intended application site into the eyes. Particular care should be taken in anaesthetised patients, who are unable to immediately report ocular exposure. If ChloraPrep with Tint comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist’s advice should be sought.

Do not use on open skin wounds. Do not use on broken or damaged skin. In addition, direct contact with neural tissue or the middle ear must be avoided.
Prolonged skin contact with alcohol containing solutions should be avoided.

It is important to ensure that the correct method of applications is strictly followed (see section 4.2 above). When the solution has been applied in an over-vigorous manner to very fragile or sensitive skin or after repeated use, local skin reaction may occur including: erythema or inflammation, itching, dry and/or flaky skin and local application site pain. At the first sign of local skin reaction application of ChloraPrep with Tint should be stopped.
Anaphylactic reactions during anaesthesia
Chlorhexidine-containing products are known causes of anaphylactic reactions during anaesthesia.
The symptoms of anaphylactic reactions might be masked in an anesthetized patient e.g. a significant portion of skin may be covered or patient unable to communicate early symptoms.
If symptoms of an anaphylactic reaction are detected during anaesthesia (e.g. abrupt fall in blood pressure, hives, angioedema), chlorhexidine-related allergic reaction should be considered.
When chlorhexidine-related allergic reaction during anaesthesia is suspected, other products containing chlorhexidine used during anaesthesia (e.g. IV lines) should be removed. Special precaution should be taken to avoid patient exposure to any other product containing chlorhexidine during the course of the treatment.

Paediatric population
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.

Effects on Driving

4.7   Effects on ability to drive and use machines
ChloraPrep with Tint has no or negligible influence on the ability to drive and use machines.