Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Septol contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalized allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Septol should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see section 4.3 and 4.8).

Accidental ingestion: chlorhexidine is poorly absorbed orally. Treat with gastric lavage using milk, egg white, gelatine or mild soap. Employ supportive measures as appropriate.
Septol SPC MW Minor updates Aug 2024
Accidental intravenous infusion – blood transfusion may be necessary to counteract hemolysis.

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, the 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 of sheets or other material in direct contact with the patient. Where occlusive dressing are to be applied to areas previously exposed to Septol, care must be taken to ensure no excess product is present prior to application of the dressing.

Septol 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 measure due to migration of solution beyond the intended surgical preparation area. Extreme care must be taken during application to ensure that Septol 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 Septol comes into contact with the eyes, wash out promptly and thoroughly with ater. A ophthal ologist’s ad i e should e sought.

4.5 .

Effects on Driving

4.7 Effects on ability to drive and use machines
None stated.