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"RUBIN DISINFECTANT EUR HANDS AND SKIN

Cutaneous solution

composition: 100 g of solution contains: -Medically active ingredients: Propan-2-ol 45.0 g, 'an-1-ol 30.0 g, Mecetroniumetilsulfate 0.2 g.

jqredients: Glycerol 85 %, Tetradecan-1-ol, 'Perfume, Colour (E131), Purified Water.

UK- Mar keti n g Authorisation N⁹: PL 15411/0001 Irfc.anu-Marketing Authorisation N®: PA 808/1/1 Keep medicines out of reach and sight of children.

S3 Batdino.: i Use by;

REF 965150

(>50(L

031678

001873

45 mm

PROJEKT -> KUNDE PRODUKTION BEDRUCKSTOFF

BODE CHEMIE GmbH PM Hande PE-Folie transparent

Sterillium®EN(GB/IRL) 500 ml VS REF 965150 I Pantone 280 DWeiB

4 031678 001873

PROJEKT -> KUNDE PRODUKTION BEDRUCKSTOFF

BODE CHEMIE GmbH PM Hande PP-Folie weiB

Sterillium® EN (GB/IRL) 500 ml RS REF 965150 Pantone 280

MICHAELSDESIGN.COM | MAILBOX@MICHAELSDESIGN.COM

Fertility, pregnancy and lactation: Sterillium can be used during pregnancy and lactation.

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 the 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 C0₂.

Keep medicines out of reach and sight of children.

Interaction with other medicinal products and

intensify general skin care. The frequency of allergic reactions is rare.

Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Instructions and notes referring to the stability of the drug: Please note the expiry date on the label. Do not use this disinfectant after the expiry date. Once the bottle has been opened, the solution will keep for one year. Keep the container tightly closed. Do not store in the proximity of heating elements or expose to direct sunlight. Do not store above 40 °C. Disposal: Any unused product or waste material should be disposed of in accordance with local requirements. Medicines should not be disposed of via wastewater.

Composition: 100 g of solution contains: Medically active ingredients: Propan-2-ol 45.0 g, Propan-1-ol 30.0 g, Mecetroniumetilsulfate 0.2 g. Other substances: Glycerol 85 %, Tetradecan-1-ol, Perfume, Colour (E131), Purified Water.

otherforms of interaction: No interaction studies have been performed.

Posology and method of administration:

Sterillium is used undiluted.

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.

Misuse and 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%o and above: secondary elimination of the poison by means of haemodialysis. Side effects: Slight dryness or irritation of the skin is uncommon. In such a case it is recommended to

Dosage form: Cutaneous Solution.

Contents: Bottles to 50 ml, 100 ml, 350 ml, 500 ml, 1000 ml solution. Canister to 51, 251 and 5001 solution. Drums to 2001 solution.

Marketing authorisation holder and manufacturer: BODE Chemie GmbH, Melanchthonstrasse 27,22525 Hamburg, Germany. Last revision of the text: June 2014.

In case additional information is required please turn to an infection control practitioner or to the pharmaceutical entrepreneur and manufacturer.

Mechanism of action: In microorganisms Sterillium modifies the permeability of the cytoplasmic membrane, acts by protein coagulation, and inactivates enzymes. Antimicrobial properties: In-vitroand 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 sec. for hygienic disinfection and is also active against the resident skin flora within 1.5 min. in case of surgical disinfection. The residual effect of Sterillium against microorganisms is, under surgical gloves, at least 3 hours.

54 mm