Summary of Product Characteristics (SmPC) - Hydrex Surgical Scrub Chlorhexidine 4% w/v Skin Cleanser
1 NAME OF THE MEDICINAL PRODUCT
Hydrex Surgical Scrub Chlorhexidine 4% w/v Skin Cleanser
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 4% w/v.
3 PHARMACEUTICAL FORM
Solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For use as an antiseptic hand wash, a pre-operative hand scrub and a pre-operative skin preparation to surgery.
4.2 Posology and method of administration
Antiseptic hand wash - wet the hands and forearms, apply 5 ml of skin cleanser and wash for one minute. Rinse thoroughly and dry.
Pre-operative Surgical Scrub - wet hands and forearms, apply 5 ml of skin cleanser and wash for one minute, cleaning the finger nails with a brush. Rinse and repeat the procedure using a further 5 ml of skin cleanser and wash for 2 minutes. Rinse thoroughly and dry.
Pre-operative Skin Preparation - the patient should wash his whole body with 25 ml of the cleanser on at least two occasions, usually the day before and on the day of the operation.
4.3 Contraindications
Avoid contact with eyes, middle ear, brain and meninges.
Known hypersensitivity to 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).
4.4 Special warnings and precautions for use
For external use only.
Keep out of the reach and sight of children.
Do not use in body cavities.
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 Hydrex Surgical Scrub, care must be taken to ensure no excess product is present prior to application of the dressing.
Hydrex Surgical Scrub 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 Hydrex Surgical Scrub 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 Hydrex Surgical Scrub comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist’s advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No special precautions need to be taken when used in pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Immune disorders
- Frequency not known
- Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4) to chlorhexidine gluconate or amine oxide, particularly on repeated use.
Skin disorders
Frequency not known:
- Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticarial, skin irritation, and blisters.
- Chemical burns in neonates.
Eye Disorder
Frequency not known:
- Corneal erosion, epithelium defect/corneal injury, significant permanent visual impairment*
*Cases of severe corneal erosion and permanent significant visual impairment due to inadvertent ocular exposure have been reported post-marketing, leading to some patients requiring corneal transplant (see section 4.4).
Reporting of suspected adverse reactions
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 | |||||
| Eye Disorder | Corneal erosion, epithelium defect/corneal injury, significant permanent visual impairment* |
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 the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Chlorhexidine is poorly absorbed. If swallowed treat with gastric lavage. Employ supportive measures as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Chlorhexidine is a bisbiguanide disinfectant which is active against a wide range of Gram-positive and Gram-negative vegetative bacteria. It is also active against some viruses and fungi. It is most active at neutral or slightly acid pH.
5.2 Pharmacokinetic properties
Percutaneous absorption of chlorhexidine gluconate is negligible and leads to clinically insignificant plasma concentrations.
5.3 Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, carcinogenic potential and toxicity to reproduction.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ponceau 4R
Dialkylamine Oxide
Glycerine
Industrial Methylated Spirit
Hydroxyethyl Cellulose
Purified Water
Perfume
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
Hydrex Surgical Scrub is packaged in:
100ml HDPE container with a Black Polypropylene Screw Cap with EPE Wad 250 ml HDPE container with a White Polypropylene Flip Top Cap 500 ml HDPE container with a Black Polypropylene Screw Cap with EPE Wad 2000 ml HDPE container with a Black Polypropylene Screw Cap with EPE Wad 5000 ml HDPE container with a Black Polypropylene Screw Cap with EPE Wad
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Ecolab Ltd, Unit 1, Wernddu Court, Caerphilly, CF83 3SG, UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 04509/0020
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/03/2003
10 DATE OF REVISION OF THE TEXT
17/09/2024