Sterillium
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STEGERILLUM® (STERILLIUM®)
Composition:
Active substances: 100 g of solution contains: 2-propanol – 45 g, 1-propanol – 30 g, methyldesethylammonium ethylsulfate – 0.2 g;
Excipients: myristyl alcohol, glycerol (85%), flavoring agent "Orange PH 799867", patent blue V (85%) dye E 131, purified water.
Pharmaceutical form.
Topical solution.
Main physicochemical properties: clear, light-blue solution with a fresh alcoholic odor; density at 20 °C — 0.847–0.855 g/cm³; refractive index n20/D — 1.376–1.381.
Pharmacotherapeutic group.
Antiseptics and disinfectants.
ATC code D08AX53.
Pharmacological properties.
Pharmacodynamics.
The product is intended for topical use.
Mechanism of action.
Sterillium® alters the permeability of the cytoplasmic membrane in microorganisms, causes protein coagulation, and inactivates enzymes.
Microbiological efficacy.
In vitro and in vivo studies have shown that Sterillium® is active against a range of common bacteria and fungal pathogens, and exhibits virucidal activity against enveloped viruses, including human immunodeficiency virus (HIV), hepatitis B and C viruses (HBV, HCV), as well as limited virucidal activity against adenoviruses, noroviruses, and rotaviruses. Within 30 seconds, Sterillium® reduces transient skin flora by more than 99.99% (hygienic hand antisepsis), and resident skin flora within 1.5 minutes (surgical hand antisepsis).
Information on microbiological efficacy
| Application and antimicrobial activity |
Application time (minimum) |
| Hygienic hand antisepsis (according to EN 1500; VAH standards) |
30 seconds |
| Surgical hand antisepsis (according to EN 12791; VAH standards) |
1.5 minutes |
| Antisepsis of skin with low sebaceous gland density (according to DGHM method [German Society for Hygiene and Microbiology]): |
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| before puncture and injection |
15 seconds |
| before joint, body cavity and hollow organ punctures, as well as before surgical procedures |
1 minute |
| Antisepsis of skin with high sebaceous gland density (according to DGHM method): |
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| before puncture and injection |
10 minutes |
| before joint, body cavity and hollow organ punctures, as well as before surgical procedures |
10 minutes |
| Bactericidal activity (according to EN 1040 standard) |
30 seconds |
| Fungicidal activity (according to EN 1275 standard) |
30 seconds |
| Mycobactericidal activity (according to EN 14348 standard) |
30 seconds |
| Virucidal activity against enveloped viruses (according to EN 14476 standard) |
30 seconds |
| Limited spectrum virucidal activity against adenoviruses, noroviruses and rotaviruses (according to EN 14476 standard) |
1 minute |
Pharmacokinetics.
The skin absorption of all components of the medicinal product Sterillium® has not been studied. Recent studies in rats have shown negligible skin absorption of ethylmethylol sulfonate.
Clinical Characteristics
Indications.
Hygienic and surgical antiseptic treatment of hands and antiseptic treatment of the skin prior to injections, punctures, blood collection, and vaccinations.
Contraindications. Hypersensitivity to the components of the product.
Do not use for antiseptic treatment of mucous membranes, open wounds, or areas around the eyes. Avoid contact with the eyes.
Interaction with other medicinal products and other forms of interaction. Not established.
Special precautions for use
Avoid contact with eyes.
If the solution comes into contact with the eyes, rinse them thoroughly by holding the eyelids open and flushing with running water for several minutes.
If contact lenses are worn, remove them if this can be done easily. Continue rinsing the eyes with copious amounts of water, including under the eyelids, for at least 10 minutes. If irritation persists, seek medical advice.
Do not transfer Sterillium® from one container to another, as this may lead to contamination of the product. If transfer cannot be avoided, it should be carried out under sterile conditions (e.g., using sterile containers under a laminar flow hood).
Do not use electrical equipment until the skin treated with the medicinal product is completely dry.
Avoid contact with open flames.
Do not use near sources of ignition. The substance is highly flammable — flash point is 23 °C. Observe safety precautions when handling alcohol-containing preparations.
When used according to recommendations, fire or explosion is unlikely.
In case of spillage, take the following measures: immediately collect the spilled solution, dilute with large amounts of water, ventilate the area, and eliminate all sources of ignition. Do not smoke.
In case of fire, extinguish using water, fire extinguishers (powder, foam, or carbon dioxide).
Use during pregnancy or breastfeeding
The risks associated with the use of the medicinal product during pregnancy or breastfeeding are unknown.
Ability to affect reaction speed when driving or operating machinery
No warnings apply.
Method of Administration and Dosage
For external use only, applied by rubbing into dry skin. Can be used anywhere, even in the absence of sinks or water. It is recommended to dispense Sterillium® using a dosing device. Available dispensing systems allow for contact-free dispensing of Sterillium®. Dispensers can be installed independently of the presence of sinks or washbasins, in locations where hygienic antiseptic treatment of the hands is required. Sterillium® should be used undiluted.
Hygienic antiseptic treatment of the hands is directed against transient microflora of the hands without disrupting the resident microflora.
Procedure for hygienic antiseptic treatment of the hands
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Take at least 3 ml (2 × 1.5 ml) of Sterillium® antiseptic directly from the plastic bottle or using a dispenser by pressing the lever with your elbow into the hollow of dry palm. Thoroughly distribute it over the entire surface of the skin of hands and wrists. Rub vigorously for 30 seconds following the standard technique (see Figure 1). |
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Ensure that hands remain moist with the product throughout the entire application time; if necessary, add another portion of Sterillium® antiseptic. Do not rinse off. |
- In case of minor contamination of hands – thoroughly remove contamination with a single-use wipe moistened with Sterillium® solution, then treat hands with the antiseptic agent Sterillium® according to the standard method (see Figure 1).
- In case of heavy contamination of hands with secretions, discharges, or blood – first wash hands with water, then with regular soap or antimicrobial soap, taking care to avoid splashing water and preventing it from reaching clothing (e.g., in case of blood contamination). Dry hands thoroughly using a lint-free disposable towel. After this, hands must be treated with an antiseptic according to the standard method (see Figure 1). If necessary, disinfect the contaminated area and put on clean protective clothing.
The sequence of stages for rubbing in antiseptic for hygienic hand treatment, according to the European standard EN 1500, is shown in Figure 1.
Figure 1.
Standard method of rubbing in antiseptic for hygienic hand treatment according to EN 1500.
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The final portion of antiseptic must be rubbed into the skin until completely dry. The entire procedure requires at least 6 ml (2 × 3 ml) of the product. Do not rinse off. |
| WARNING! Do not wear gloves on hands still wet with antiseptic; wait until the skin is completely dry. |
Skin antisepsis. Perform skin antisepsis prior to injections, body cavity or hollow organ punctures, and also prior to surgical procedures.
Antisepsis of skin with low sebaceous gland activity (according to DGHM method):
- before puncture and injection — 15 seconds;
- before joint, body cavity or hollow organ punctures, as well as prior to surgical procedures — 1 minute.
Antisepsis of skin with high sebaceous gland activity (according to DGHM method):
- before puncture and injection — 10 minutes;
- before joint, body cavity or hollow organ punctures, as well as prior to surgical procedures — 10 minutes.
Children.
Do not use the preparation for skin antisepsis in newborns and premature infants.
In other cases, use the preparation as prescribed by a physician.
Overdose.
In case of accidental ingestion, the main symptoms of intoxication are similar to those following ethanol ingestion. There is a risk of respiratory depression.
At 3–4‰ and above: elimination of secondary symptoms of poisoning by hemodialysis.
Side effects.
Rarely, mild dryness or irritation of the skin may occur. In such cases, enhanced general skin care is recommended. Allergic reactions are rare.
In case of accidental ingestion, alcohol poisoning may occur — rinse the mouth with drinking water and have the person drink several glasses of water. In case of accidental contact with eyes, irritation of the mucous membrane of the eyes may occur — rinse eyes with running water for several minutes and seek medical advice immediately.
If any adverse effects occur, consult a doctor or pharmacist.
Reporting of adverse reactions after marketing authorization is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.
Shelf life. 5 years from the date of "in-bulk" manufacturing.
Storage conditions.
Store at temperatures not exceeding 25 °C. Keep out of reach of children.
Incompatibilities.
Sterillium® corrodes acrylic glass and similar materials.
Packaging.
Plastic bottles of 100 ml, 500 ml, or 1000 ml, plastic canisters of 5 l.
Supply classification. Over-the-counter.
Manufacturer.
LLC "NVP "VILAN", Ukraine,
packaging from "in-bulk" supplied by BODE Chemie GmbH (Germany).
Manufacturer's location and address of business operation.
12-A Aerodromna Street, Kyiv, 03151, Ukraine.
Tel. (044) 249-04-40, Fax: (044) 246-17-43.