Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Ecolab Deutschland GmbH, Ecolab-Allee 1, D-40789 Monheim am Rhein, Germany
Avoid contact with eyes, middle ear, brain and meninges.
Known hypersensitivityto 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).
For external use only.
Keep out of the reach and sight of children.
Do not use in body cavities.
Hydrex Surgical Scrub 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. Hydrex Surgical Scrub 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 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 drips sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to Hydrex Surgical Scrub, care must be taken to ensure no excess product is present prior to application of the dressing.
None known.
No special precautions need to be taken when used in pregnancy and lactation.
None known.
Frequency not known:
Frequency not known:
| System Organ Class | Very Common (≥1/10) | Common (≥1/100 <1/10) | Uncommon (≥1/1,000 <1/100) | Rare (≥1/10,000 <1/1,000) | Very Rare (<1/10,000) | Not known (cannot be estimated from available data) |
|---|---|---|---|---|---|---|
| Immune System Disorders | Hypersensitivity Anaphylactic shock | |||||
| Skin and Subcutaneous Tissue Disorders | Allergic skin reactions Chemical Burns (Neonates and infants) |
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Not applicable.
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