PURPREP

Posology PurPrep may be used on patient populations 1 year of age or older. Single use applicator. 4). 3). Elderly PurPrep should only be applied after a careful consideration in elderly patients with thyroid disorder. Method of administration For cutaneous use.

5 ml or 26 ml cutaneous solution. The appropriate PurPrep applicator should be chosen based on the invasive procedure being undertaken and the size of the area to be prepped to avoid excess of solution and the risk of product pooling.

5 ml 26 ml 25 x 30 50 x 50 - Minor and major surgical procedures. - Implantable device placement. - Prosthetic device placement or removal. - Midline, Peripheral Intravascular Central Catheter (PICC) & CVC insertion and maintenance. - Cardiac catheterisation and Cardiac Cath Lab procedures.

- Interventional Radiology procedure. The applicator is removed from the wrapper and held with the sponge facing downward. 5 ml applicator, the wings are squeezed. For the 26 ml applicator, the lever is pressed. This will break the ampoule containing the antiseptic solution, which is released onto the sponge with a controlled flow.

Wings or lever are pinched or pressed respectively once only to activate the applicator and release the antiseptic. Do not repeatedly pinch or pump in an attempt to accelerate the saturation of the sponge. The broken ampoule remains safely contained within the applicator.

The sponge is pressed against the patient’s skin in order to apply the antiseptic solution. Once the solution is visible on the skin, back and forth strokes should be applied to prep the site for 30 seconds. The area covered should be allowed to air dry completely.

It is recommended that PurPrep remains on the skin post-procedure to provide continued antimicrobial activity. If removal is necessary, remove with soap and water or alcohol.

4), after prolonged use or application over large coverage areas. Hypothyroidism: after prolonged use or application over large coverage areas, increase of the absorption of iodine through non-intact skin. Electrolyte imbalance, renal insufficiency, metabolic acidosis: may occur after absorption of large amounts of iodine as iodinated povidone, due to application on large coverage areas.

Chemical burns: cases have been associated with the use of alcohol-based solutions, especially in neonates. Application-site reactions such as pruritus, erythema, rash, papules, and vesicles may occur when the solution has been applied in an over-vigorous manner to very fragile or sensitive skin or after repeated use.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The solution is flammable. PurPrep should be used in a well-ventilated area. Electrocautery procedures or other ignition sources must not be used until the skin is completely dry. Any soaked materials, drapes or gowns should be removed before proceeding with the intervention.

The solution must not be used in excessive quantities and must not 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 PurPrep, care must be taken to ensure no excess product is present prior to application of the dressing.

Single use applicator, for external use only and on intact skin. PurPrep contains iodine as iodinated povidone. Iodine, as iodinated povidone, may induce hypersensitivity, including skin reaction and sensitisation. The prevalence of hypersensitivity to iodine, as iodinated povidone is not known but available literature suggests this is likely to be rare.

8). The solution is an irritant to eyes and mucous membranes. It should therefore be kept away from these areas. If the solution comes in contact with the eyes, they should be washed promptly and thoroughly with water. PurPrep must not be used: - on open skin wounds or as a general skin cleanser.

- on broken or damaged skin or mucous membranes. In addition, direct contact with neural tissue or the middle ear must be avoided. 6). 2). Prolonged skin contact with alcohol containing solutions should be avoided unless necessary. 8). At the first sign of local skin reaction, application of PurPrep should be stopped.

8). e hyperthyroidism, mild nodular goitre) and patients with renal insufficiency due to prolonged time of elimination. Very rare cases of iodine-induced hyperthyroidism have been reported with products containing iodine as iodinated povidone.

8). If re-operation within a few days following application of PurPrep is necessary, the use of a preoperative antiseptic that does not contain iodine as iodinated povidone, or close monitoring of thyroid function, should be determined by the clinician.

1; - Children less than 1 year of age; - Patients with dermatitis herpetiformis; - Patients with hyperthyroidism and other thyroid dysfunction.