Chlorhexidine Gluconate 2% W/V Impregnated Pad
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chlorhexidine Gluconate 2% w/v Impregnated Pad
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine gluconate 2% w/v solution (equivalent to 500 mg chlorhexidine gluconate per pad).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Impregnated pad.
White 19 cm by 19 cm pads.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Skin antisepsis as part of an advance preoperative cleansing regimen and general skin antisepsis.
4.2 Posology and method of administration
Cutaneous use only.
Use only on intact skin.
To open, tear seal where indicated (2-pack) or peel open the resealable package (6- pack). Remove pads from package. Avoid contact between pads and outside of package to reduce risk of contamination.
For use as part of an advance preoperative cleansing regimen: Regimen should be performed the night before and the morning of a surgical procedure. Use one pad to prepare each desired area of the body by washing skin, completely wetting treatment area.
2-pack: Use one pad to prepare each desired area of the body by washing skin, completely wetting treatment area.
6-pack: Use one pad to prepare each area of the body by washing skin, completely wetting treatment area as follows:
• Wipe the neck, chest and stomach;
• Wipe both arms, starting each with the shoulder and ending at the fingertips paying particular attention to the axillary area;
• Wipe the right and left hips followed by the groin paying particular attention to the skin folds in the abdominal and groin areas;
• Wipe both legs, starting at the thigh and ending at the toes;
• Wipe the back, starting at the base of the neck and ending at the waistline;
• Wipe the buttocks.
Do not rinse or apply any lotions, moisturizers or cosmetics after prepping.
For General Skin Antisepsis and cleansing:
Use one pad for each area of the body where skin antisepsis is desired. Do not use on open skin wounds or broken skin.
General
information:
Discard each pad after a single use. After package has been opened, discard any unused pads.
4.3 Contraindications
Do not use on premature or low birthweight infants, or infants less than 2 months of age or receiving phototherapy. Do not use immediately prior to invasive techniques, such as venepuncture, lumbar puncture or surgery. Do not use on open skin wounds or broken skin.
The pads are contraindicated in patients who have previously shown hypersensitivity to the active substance(s) or to any of the excipients.
4.4 Special warnings and precautions for use
Product and packaging are not sterile.
Keep out of eyes, ears and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with water immediately.
Keep out of the reach and sight of children.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Pregnancy and breast-feeding
No effects during pregnancy are anticipated, since systemic exposure to chlorhexidine is negligible taking into consideration the low systemic exposure following topical use of the chlorhexidine impregnated pads.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to to chlorhexidine is negligible.
However Chlorhexidine Gluconate 2% Impregnated Pad should not be used at the breast to avoid any uptake by the newborn during breast feeding.
4.7 Effects on ability to drive and use machines
Not relevant
4.8 Undesirable effects
Skin and subcutaneous tissue disorders:
Common (>1/100 to <1/10): Skin irritation
Immune system disorders:
Very rare (<1/10,000): Generalised allergic reactions.
When using the chlorhexidine gluconate 2% impregnated pads, the skin should be completely dry and cool. Showering or shaving immediately before using chlorhexidine gluconate 2% impregnated pads may increase skin irritation. Shaving should be suspended at least 2 days prior to surgery on all areas of the body, including the face, legs, underarms, etc. If skin irritation persists, rinse the affected areas and discontinue use.
4.9 Overdose
Overdosage is unlikely because of the low dermal absorption. Ingestion is highly unlikely.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiseptics and disinfectants, ATC code: D08AC02
Chlorhexidine is a disinfectant which is effective against a wide range of vegetative
Gram-positive and Gram-negative bacteria. The wide range of microorganisms
against which chlorhexidine is active makes it suitable for broad spectrum
disinfection of skin prior to surgery to reduce risk of infection. Effective against
MRSA, VRE, Acinetobacter baumannii, Pseudomonas aeruginosa and various
Streptococcus species.
The effect against some gram-negative bacteria (Pseudomonas- and Proteus-types)
and against certain yeasts, dermatophytes and mycobacteria is poor. It is ineffective
against bacteria spores and fungus spores, viruses and putrefactive fungi.
Chlorhexidine gluconate is effective against enveloped viruses (e.g. herpes simplex
virus, HIV, cytomegalovirus, influenza, and RSV) but it is substantially less
active against non-enveloped viruses (e.g., rotavirus, adenovirus, and
enteroviruses).
Chlorhexidine significantly reduces the number of microorganisms on intact skin and
demonstrates continued antimicrobial activity for up to 6 hours after application.
Chlorhexidine is inactive against bacterial spores.
5.2 Pharmacokinetic properties
No formal pharmacokinetic studies have been performed with chlorhexidine gluconate solution in an impregated pad. Chlorhexidine binds strongly to skin and is very poorly absorbed. Percutaneous absorption is minimal.
5.3 Preclinical safety data
Chlorhexidine is a well established active ingredient and relevant information is provided in other sections of the SmPC.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Aloe Vera gel (contains sodium benzoate and potassium sorbate)
Dimeticone
Fragrance F750485
Gluconolactone
Glycerol
Nonoxinol 9
Polysorbate 20
Propylene glycol
Water, purified
Polyester pad
6.2 Incompatibilities
Not applicable
6.3 Shelf life
15 months for 2-pad package 18 months for 6-pad package
6.4 Special precautions for storage
Do not store above 25°C Do not refrigerate or freeze Store flat
6.5 Nature and contents of container
Flexible film, heat-sealed packages contain either 2 or 6 impregnated polyester pads
Impregnated pads contain 24.75 ml of solution per pad.
The 2-pack product consists of a stack of 2 polyester pads impregnated with chlorhexidine, a polyethylene foam carrier and film overwrap with polyethylene inner layer.
The 6-pack product consists of a stack of 6 pads impregnated with chlorhexidine, wrapped in a polyethylene foam carrier and film overwrap with polyethylene inner layer.
Cartons containing 24 packages each comprising of 2 impregnated pads. Cartons containing 20 packages each comprising of 6 impregnated pads.
6.6 Special precautions for disposal
Dispose of as solid waste. Do not flush pads in toilet.
7 MARKETING AUTHORISATION HOLDER
Baggerman FarmaNet NV Barrierweg 3G 5622 CL Eindhoven The Netherlands
Tel: +31 (0)402372879 www.farmanet.nl
8 MARKETING AUTHORISATION NUMBER(S)
PL 27821/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/07/2010
10 DATE OF REVISION OF THE TEXT
14/02/2013