SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Hibicet Hospital Concentrate

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine gluconate 1.5% w/v

(incorporated as Chlorhexidine gluconate Solution Ph.Eur. 7.5% v/v) Cetrimide 15% w/v

(incorporated as strong cetrimide solution BP)

Excipient with known effect Benzyl benzoate 1.4mg/ml

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Liquid

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Hibicet Hospital Concentrate is an antimicrobial preparation with cleansing properties for general antiseptic purposes.

4.2 Posology and method of administration

For external use only.

Dilute as follows:

Method of Preparation	Dilution	Use
10 ml made up to 1 litre with water	1 in 100 (1%) aqueous	Cleansing/antiseptic treatment of wounds and burns * Swabbing in obstetrics, gynaecology and urology. Cleansing/disinfectant soak for used metal instruments. Clean instrument disinfection where no means of sterilisation is available (30 minutes immersion)** Cleansing/disinfection of equipment, furniture and fittings in the vicinity of the patient. Storage of clinical thermometers and sterile instruments.
35 ml made up to	1 in 30	Cleansing/antiseptic treatment of wounds and burns

1 litre with water	(approx.) aqueous	where greater cleansing/antisepsis is required* Cleansing/disinfectant soak for soiled instruments.
35 ml with 200ml water made up to 1 litre with 95% alcohol	1 in 30 (approx.) in 70% alcohol	Rapid skin antisepsis before operation and other invasive procedures. Disinfection of clean instruments and equipment (2 minutes immersion)** Disinfection of clinical thermometers.

* sterilise the dilution by autoclaving at 115° - 116°C for 30 minutes or 121° -123°C for 15 minutes

** endoscopes should not be placed in solution of Hibicet

Children and elderly patients: there are no special dosage recommendations for either elderly patients or children. The normal adult dose is appropriate unless otherwise recommended by the physician.

4.3 Contraindications

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

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

For external use only. Dilute before use. Not for injection. Do not use in body cavities or as an enema.

Do not allow contact with the brain, meninges or ears.

Syringes and needles which have been immersed in chlorhexidine solutions should be thoroughly rinsed in sterile water or saline before use.

Reports of arachnoiditis have been received following accidental exposure to the meninges and/or contamination of equipment used for central neuraxial blockade with chlorhexidine. Therefore, if chlorhexidine is used for procedures that pose a risk of exposure to the meninges, extra care must be taken to minimise the risk of contamination of equipment used.

When using to disinfect the skin prior to procedures where there is a risk of meningeal exposure, allow to dry before inserting needle.

The concentrated solution is an irritant to eyes and mucous membranes. Keep all solutions out of the eyes. If solutions do come into contact with eyes, wash out promptly and thoroughly with water.

If concentrated cetrimide solutions come into contact with the skin, rinse promptly and thoroughly with water.

Prolonged skin contact with alcoholic solutions should be avoided. The solution is flammable. Do not use with electrocautery procedures or other ignition sources until dry. Remove any soaked materials, drapes or gowns before proceeding. Do not allow the solution to pool. Allow to dry before proceeding.

Solutions applied to wounds, burns or broken skin should be sterilised according to BP recommendations.

Hibicet solutions may affect glass cement and therefore are not suitable for the disinfection of endoscopes.

4.5 Interaction with other medicinal products and other forms of interaction

See section 6.2.

4.6 Fertility, pregnancy and lactation

There is no evidence of any adverse effects on the foetus arising from the use of Hibicet Hospital Concentrate during pregnancy. Therefore no special precautions are recommended.

4.7 Effects on ability to drive and use machines

None have been reported or are known.

4.8 Undesirable effects

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 the available data).

Skin and subcutaneous tissue disorders:

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.

Immune system disorders:

Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

Injury, poisoning and procedural complications:

Frequency not known: Chemical burns in neonates.

In addition, cetrimide has been reported to cause dry skin and in rare cases chemical burn after repeated application.

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

Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

This has not been reported.

Accidental oral or rectal administration:

If the product is swallowed give large quantities of milk, raw egg, gelatin or mild soap. Avoid vomiting or lavage if it is believed that a concentrated solution has been ingested.

Central paralysis cannot be countered by curare antagonists or CNS stimulants but sympathomimetic drugs have been given.

Mechanically assisted ventilation with oxygen may be necessary. Persistent convulsions may be controlled with cautious doses of diazepam or a shortacting barbiturate. Do not give alcohol in any form.

Accidental intravenous infusion:

Massive haemolysis can occur which will require blood transfusion.

Accidental intra-uterine administration:

Introduction into the uterus can lead to haemolysis and pulmonary embolism.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Hibicet Hospital Concentrate is a topical antiseptic for external use only and is not intended to be administered orally or parenterally. The active agents, chlorhexidine gluconate and cetrimide are strongly cationic, binding to skin, mucosa and exposed tissues, this percutaneous absorption is poor. There are, as a consequence, no general pharmacological studies available on the effects of Hibicet Hospital Concentrate or other topically administered chlorhexidine/cetrimide formulations.

If chlorhexidine is systemically absorbed there is no evidence of metabolic cleavage of the drug, however, animal studies suggest that systemically absorbed cetrimide may be metabolised to some extent.

Both active agents have a broad spectrum of antimicrobial activity and are bacteriostatic at low concentrations whilst at higher concentrations their activity is rapidly bactericidal. They are both active against dermatophytic fungi (including the yeast C. albicans) and enveloped viruses such as HIV.

5.2 Pharmacokinetic properties

Precutaneous absorption of the active agents in Hibicet Hospital Concentrate is poor. Studies in animals using ¹⁴C-labelled cetrimide have shown that even after oral dosing only small amounts were found in the blood plasmas and approximately 2% was excreted in the bile during the first 12 hours after treatment: only small amounts of radioactivity were found in the liver, kidneys, spleen, heart, lungs and skeletal muscle and tissue radioactivity declined rapidly.

Similarly, attempts to detect percutaneous absorption of chlorhexidine gluconate in man have shown that, if it occurs at all, the level is exceedingly small and insignificant - the limit of detection used being of the order of 0.005mg/litre.

Furthermore, it is very unlikely that the pharmacokinetic properties of either chlorhexidine gluconate or cetrimide will be altered significantly in special situations, such as hepatic failure, renal failure, treatment of children, the elderly, in pregnancy or nursing mothers.

5.3 Preclinical safety data

Chlorhexidine and cetrimide are drugs on which extensive clinical experience has been obtained. All relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl benzoate D-gluconolactone Isopropyl alcohol Liquid deodoriser Purified water Sodium hydroxide Sunset yellow FCF (E110)

Terpineol

6.2 Incompatibilities

Hypochiorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with preparations containing chlorhexidine. Chlorhexidine and cetrimide are incompatible with soap and other anionic agents.

6.3    Shelf life

4 years.

6.4    Special    precautions    for storage

Do not store above 30°C.

6.5    Nature    and contents of container

White HDPE bottle (5 litres).

6.6    Special    precautions    for disposal

Dilute for use

Dilute with tap water of an acceptable bacteriological standard or alcohol (ethanol, industrial methylated spirits or isopropanol). Add diluent slowly to prevent excessive foaming.

As a precaution against bacterial contamination, aqueous stock solutions should contain at least 4%v/v of isopropanol or 7%v/v of ethanol which may be denatured (i.e. industrial methylated spirit).

Hibicet solutions used for instrument storage should contain 0.4%w/v sodium nitrite to inhibit metal corrosion. Such solutions must be changed every 7 days. Prolonged immersion of rubber appliances in Hibicet solutions is undesirable.

As cork may protect certain gram-negative organisms from the action of antiseptics, Hibicet solutions must be stored in bottles with glass, plastic or rubber closures.

See also section 4.2 and 4.4

7 MARKETING AUTHORISATION HOLDER

Regent Medical Ltd Medlock Street Oldham Lancashire OL1 3HS United Kingdom

MARKETING AUTHORISATION NUMBER(S)

PL 22099/0002

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/02/1973    / 08/08/2002

10    DATE OF REVISION OF THE TEXT

11/08/2015