SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

STERILLIUM, Cutaneous Solution

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

100 g of solution contains:

Propan-2-ol    45 g

Propan-1-ol    30 g

Mecetroniumetilsulfate 0.2 g For full list of excipients see section 6.1

3    PHARMACEUTICAL FORM

Cutaneous Solution

Coloured solution with the odour of perfume.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Hygienic and surgical hand disinfection.

Skin disinfection prior to injections and punctures.

4.2    Posology and method of administration

For hygienic hand disinfection: At least 3 ml of STERILLIUM should be rubbed onto the dry hands within 30 seconds without rinsing.

For surgical hand disinfection: STERILLIUM should be distributed onto dry hands and forearms in order to entirely cover them. As many portions as necessary to keep them wet for at least 1.5 minutes should be rubbed in without rinsing.

Skin disinfection: STERILLIUM should be rubbed onto the area of the dry skin for 15 seconds prior to injections and punctures; prior to punctures of joints, body cavities and hollow organs as well as surgical interventions keep wet for 1 minute. Skin containing many sebaceous glands must be kept moist for 10 minutes.

STERILLIUM is used undiluted.

4.3    Contraindications

STERILLIUM is not suitable for the disinfection of mucous membranes and must not be used in the immediate proximity of the eyes or open wounds. Hypersensitivity to the active substances or to any of the exipients.

4.4    Special warnings and precautions for use

STERILLIUM should not be used in neonates and premature infants.

Contact with eyes has to be avoided.

If the solution gets in contact with the eyes wash them with open palpebral fissure for several minutes under running water.

Decanting STERILLIUM from one container to another should be avoided in order to prevent contamination. Should decanting be inevitable, it should be carried out under aseptic conditions (e.g., use of sterile containers under laminar flow).

Do not use electrical equipment until the preparation has dried.

Do not bring into contact with naked flames.

Do not use near to sources of ignition. Flash point 23°C, flammable.

When the product is used correctly fire and explosion are unlikely.

In case of spilling the disinfectant the following measures have to be taken: Clean up the solution immediately, dilute with plenty of water, aerate the room, and remove easily ignited sources. Do not smoke.

In case of fire extinguish with water, a fire extinguisher, foam, or CO2.

4.5    Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6    Fertility, pregnancy and lactation

No known risk during fertility, pregnancy and lactation.

4.7    Effects on ability to drive and use machines

Not relevant.

4.8    Undesirable effects

Slight dryness or irritation of the skin is uncommon. In such a case it is recommended to intensify general skin care. The frequency of allergic reactions is rare.

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

If swallowed by accident the main symptoms of intoxication are similar to those of an ethanol intoxication. Danger of respiratory paralysis.

From 3-4 %% and above: secondary elimination of the poison by means of haemodialysis.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

STERILLIUM is for topical use only and has no pharmacological properties in man.

ATC-Code: D08A X 53 Antiseptics and Disinfectants Mechanism of action

In microorganisms STERILLIUM modifies the permeability of the cytoplasmic membrane, acts by protein coagulation, and inactivates enzymes. Antimicrobial properties

In-vitro and in-vivo studies have shown that STERILLIUM is active against a range of common bacteria and fungal pathogens. STERILLIUM reduces the transient skin flora by more than 99.99 % within 30 seconds for hygienic disinfection and is also active against the resident skin flora within 1.5 minutes in case of surgical disinfection.

The residual effect of STERILLIUM against microorganisms is, under surgical gloves, at least 3 hours.

5.2    Pharmacokinetic properties

The percutaneous absorption of all constituents of STERILLIUM was not investigated.

Recent studies on percutaneous absorption of Mecetroniumetil sulfate in the rats indicate minor substance absorption only.

5.3    Preclinical safety data

The acute (oral, dermal) and subacute (dermal) toxicity of STERILLIUM is low.

Acute toxicity

LD50 (mouse) oral, after 14 days 13.0 ml/ kg BW LD50 (rat) oral, after 14 days 15.6 ml/ kg BW LD50 (rabbit) dermal > 10.0 ml/ kg BW Repeated dose toxicity

A 28-day dermal study in rabbits with 1.0 and 5.0 ml STERILLIUM per kg body weight revealed no substance related effects on body weight, clinical appearance, organ weights and histopathology of liver and kidneys. Blood levels of Propan-1-ol, Propan-2-ol and Acetone were not elevated. Reproductive toxicity

From in-vitro and in-vivo data on skin absorption it is calculated that only negligible amounts of the active ingredients of STERILLIUM may permeate the skin during hygienic and surgical hand disinfection. The alcohols are evaporated within the application time. Mecetroniumetil sulfate is barely absorbed through intact skin. Therefore studies on fetal toxicity and reproductive toxicity may be omitted according to Council Directive 75/318/EEC. Teratogenic effects of lower alcohols in humans and animals after dermal application are not known from literature.

Genotoxicity

Genotoxicity tests were negative with Propan-1-ol, Propan-2-ol and Mecetroniumetil sulfate.

Local tolerance

The active ingredients of STERILLIUM are not irritating to the skin at concentrations used in the product. Propan-1-ol, Propan-2-ol and Mecetroniumetil sulfate have no sensitizing properties. STERILLIUM causes irritation to mucous membranes.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Glycerol 85%,

Tetradecan-1-ol,

Perfume,

Colour (E 131),

Purified water.

6.2    Incompatibilities

STERILLIUM attacks acrylic glass and similar materials.

6.3    Shelf life

The finished product in the unopened packaging: 5 years.

After first opening of the container: 1 year.

6.4    Special precautions for storage

Keep the container tightly closed.

Do not store in the proximity of heating elements or expose to solar radiations of high intensity. Do not store above 40°C.

Water risk class 1: slightly dangerous to water.

6.5    Nature and contents of container

In bottles taking 50 ml, 100 ml, 350 ml, 500 ml or 1000 ml; in canisters to 5 L, 25 L or 500 L; in drums taking 200 L, all made of HDPE.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

See section 4.4.

Dispensers with adjustable pump system for use of original bottles are offered on request.

The standard delivery amount is set at 1.5 ml per pump actuation and can be altered.

Waste disposal: Any unused product or waste material should be disposed of in accordance with local requirements. Medicines should not be disposed of via wastewater.

7    MARKETING AUTHORISATION HOLDER

Bode Chemie GmbH Melanchthonstrasse 27 D-22525 Hamburg Germany

8    MARKETING AUTHORISATION NUMBER(S)

PL 15411/0001

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/11/2010

10 DATE OF REVISION OF THE TEXT

14/08/2014