Skinsept pur

Skinsept Pur
(46g + 27g + 1g)/100g, solution
Alcohol ethylicus + Alcohol isopropylicus + Alcohol benzylicus
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If any adverse reactions occur in the patient, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Skinsept Pur is and what it is used for
2. Important information before using Skinsept Pur
3. How to use Skinsept Pur
4. Possible side effects
5. How to store Skinsept Pur
6. Contents of the pack and other information

1. WHAT IS SKINSEPT PUR AND WHAT IS IT USED FOR?

Antiseptic medicinal product for skin disinfection prior to surgery, injections, punctures, vaccinations,
blood collection, or dressing changes.
Skinsept Pur is a combination medicinal product containing active substances with proven clinical
efficacy.
The active ingredients in this product – isopropanol, ethanol, and benzyl alcohol – complement each
other’s spectrum of activity, ensuring broad-spectrum effectiveness. The excipient – hydrogen
peroxide – provides self-sterilizing properties, which persist even in case of recontamination with
bacterial spores (e.g., upon opening the container).
Skinsept Pur is effective against skin-colonizing microorganisms, including bacteria (including
Mycobacterium tuberculosis and MRSA), fungi, and viruses: Hepatitis B, HIV, Herpes, Rota, Adeno.
Skinsept Pur disinfects and degreases the skin.

2. IMPORTANT INFORMATION BEFORE USING SKINSEPT PUR
When not to use Skinsept Pur:

Do not use if the patient is allergic to the active substances or to any of the other ingredients of this medicine listed in section 6.

• Skinsept Pur must not be used for disinfection of large open wounds.
• Skinsept Pur must not be used for disinfection of mucous membranes.
• Do not use near the eyes.
• Do not use in premature newborns.

Warnings and precautions

Before using Skinsept Pur, discuss it with your doctor, pharmacist, or nurse.

• Skinsept Pur should not be used for disinfection of the umbilical stump in newborns.
• Use with caution in full-term newborns, and only when necessary due to the disinfection procedure.
• Use with caution on areas sensitive to alcohol.
• Avoid contact with eyes.

Handling the product

Flammable product; do not spray near flame; flash point (according to DIN 51755 standard) is 21°C; observe application times and safety instructions for use; wait until the medicinal product has dried before switching on electrical equipment; protect from high temperatures, sparks, and open flame.
Open the container carefully.

First aid measures

In case of accidental contact with eyes
Immediately rinse eyes thoroughly with large amounts of water, occasionally lifting upper and lower eyelids. Remove contact lenses, if present. Continue rinsing for at least 15 minutes. Seek medical help if symptoms persist or worsen.

In case of accidental ingestion
Rinse mouth with water. Remove dental prostheses, if present. Move or carry the affected person to fresh air and ensure rest in a position allowing free breathing. Do not induce vomiting unless instructed by medical personnel. If vomiting occurs, keep the head low to prevent vomit from entering the lungs. Seek medical help if symptoms persist or worsen.
Never give anything orally to an unconscious person. If consciousness is lost, place in recovery position and seek immediate medical help.
Ensure adequate ventilation. Loosen tight clothing, such as collars, ties, or belts.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
There are no data or only limited data on the use of Skinsept Pur in pregnant women.

Breastfeeding
There is insufficient data on the passage of ethanol, isopropyl alcohol, and benzyl alcohol into human milk.

Fertility
No data available.

Driving and operating machinery
Not applicable.

3. HOW TO USE SKINSEPT PUR

Always use this medicine as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Method of administration:
For external use only.
Topical solution for application to the skin. Apply the solution undiluted.
Skin disinfection prior to surgery and punctures
Apply the undiluted product using a sterile swab onto the skin, spread over the skin surface, and wait 1 minute until dry. In case of risk of HBV virus, repeat the disinfection procedure and extend the contact time to 2 minutes.
Skin disinfection prior to injections, blood collection, vaccinations, and dressing changes
Spray the skin area before puncture and wait 15 seconds. To broaden the spectrum of activity to include viruses, extend the contact time to 1 minute. In case of risk of HBV virus, extend the contact time to 2 minutes by respraying the skin.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Very rare (occurring in fewer than 1 in 1,000 treated patients): hypersensitivity reactions.
Not common (occurring in fewer than 1 in 10,000 individuals): mild skin dryness and skin irritation (redness, stinging).
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE SKINSEPT PUR

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging (EXP).
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Skinsept Pur contains
100 g of solution contains:
Active substances: 46.0 g ethanol (96% denatured), 27.0 g isopropyl alcohol, 1.0 g benzyl alcohol.
Other ingredients: hydrogen peroxide, purified water.

What Skinsept Pur looks like and contents of the pack
Skinsept Pur is a clear, colourless, transparent solution with a characteristic alcoholic odour.
HDPE bottle with PP cap, 100 ml.
HDPE bottle with pump dispenser, 250 ml.
HDPE bottle with spray pump, 350 ml.

Parts of the spray pump which are in contact with the product are made of the following plastics:
polyoxymethylene (POM)
high-density polyethylene (HDPE)
polypropylene (PP)
polyethylene (PE)
low-density polyethylene (PE-LD)
poly(ethylene-co-vinyl acetate) (EVA)

HDPE bottle with PP cap, 1000 ml.
HDPE canister with HDPE cap, 5000 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ecolab Sp. z o.o.
Opolska 114
31-323 Kraków
Poland

Manufacturer:
Ecolab Deutschland GmbH
Ecolab-Allee 1
D-40789 Monheim am Rhein
Germany