Spitaderm

Package Leaflet: Information for the User

Spitaderm,(70 g + 0,5g + 1,5 g) /100 g, solution for the skin
(Isopropyl alcohol + Chlorhexidine digluconate + Hydrogen peroxide 30 percent)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient/user.

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.
Keep this leaflet, you may need to read it again.

• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, contact a doctor.

Table of Contents of the Leaflet:

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

1. What is Spitaderm and what is it used for

Medicine for hygienic and surgical hand and skin disinfection

Spitaderm is a complex product containing active substances with proven clinical efficacy.
In this medicine, the active substances used are isopropyl alcohol, chlorhexidine digluconate, and hydrogen peroxide, which complement each other's range of action, providing a broad spectrum of action.
This medicine is effective against microorganisms on the skin: bacteria (including tuberculosis bacillus), fungi, and viruses (HBV, HIV).
Efficacy against hepatitis B virus (HBV) has been confirmed by the MADT test (Morphological Alteration and Disintegration Test).
The medicine is self-sterilizing (European Patent No. 0016319). Hydrogen peroxide ensures that the medicine is free from spores during production, pouring, and filling. The hydrogen peroxide contained in the medicine destroys bacterial spores that may re-enter the solution.

2. Important information before using Spitaderm

When not to use Spitaderm

If the patient has been diagnosed with hypersensitivity to the active substances or any excipient.
This medicine must not be used to disinfect mucous membranes or wounds. Do not use near the eyes.

Warnings and precautions

Do not allow Spitaderm to come into contact with the eyes, due to the risk of vision damage. In case of contact with the eyes, rinse them immediately and thoroughly with water. If irritation, redness, or eye pain occurs or vision disturbances appear, contact a doctor immediately.
After using medicines containing chlorhexidine digluconate, severe cases of permanent corneal damage (eye surface damage) have been reported in patients under general anesthesia (deep, painless sleep) during surgical procedures, which may require corneal transplantation.
The medicine is flammable; do not spray near flames; Flash point (according to DIN 51755) 20°C; follow application times and safety rules; wait for the medicine to dry before turning on electrical devices; use with caution on surfaces sensitive to alcohol action. Enzymatic glucose test can be performed only after at least 1 minute after using the medicine. Chemical burns have been reported due to the use of chlorhexidine gluconate in newborns and infants. Premature babies are at particular risk due to the immaturity of the skin barrier. Therefore, Spitaderm should be used in newborns and infants only when there are no alternative medicines, and the expected therapeutic benefits outweigh the risk. It is recommended to remove all unnecessary liquid immediately. Concurrent use of products containing anionic surfactants may cause deactivation of chlorhexidine.

Pregnancy, breastfeeding, and fertility

Pregnancy

There are no results of controlled clinical trials on the use of the medicine in pregnant women. No animal studies have been conducted.
When using the medicine in pregnant women, caution should be exercised.

Breastfeeding

No clinical data are available.

Driving and using machines

The effect of Spitaderm on the ability to drive and use machines is not known.

Important information about some ingredients of Spitaderm

Possible allergic skin irritation caused by chlorhexidine.

3. How to use Spitaderm

This medicine should always be used as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Method of use:
The medicine is for external use only.
Solution for use undiluted.
Surgical hand disinfection:
At least 5 ml of the medicine should be rubbed into the hands and forearms for 1.5 minutes.
The procedure should be repeated. Hands should remain moist during disinfection.
Hygienic hand disinfection:
3 ml of the medicine should be rubbed in for 30 seconds.
Disinfection of the skin before injections:
The skin should be exposed to the medicine for 15 seconds.
Disinfection of the skin before punctures, operations:
The skin should be exposed to the medicine for 1 minute.

Using more than the recommended dose of Spitaderm

In case of accidental ingestion: rinse the mouth,
consult a doctor.
Procedure in case of accidental eye contact:
immediately rinse the eyes with clean water for at least 10 minutes, consult a doctor. In case of doubts related to the use of the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effect is short-term skin redness, which does not pose any risk and resolves on its own.
Hives and allergic reactions, including anaphylactic shock, have occurred rarely (from >1/10000 to <1>1/100 to <1>Corneal damage (eye surface damage) and permanent eye damage, including permanent vision impairment (after accidental eye exposure during surgical procedures on the head, face, and neck) in patients under general anesthesia (deep, painless sleep) - after using medicines containing chlorhexidine digluconate (frequency not known).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, 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,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Spitaderm

Store the medicine at a temperature below 25°C.
Shelf life after first opening the immediate packaging: 6 months.
Keep out of the reach and sight of children.

Do not use after the expiry date.

For packages over 1000 ml: any refilling with the medicine should be done under sterile conditions (sterile workstation).
Medicines should 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 pack and other information

What Spitaderm contains

100 g of solution contains active substances: 70 g isopropyl alcohol, 0.5g chlorhexidine digluconate, 1.5g 30% hydrogen peroxide solution.
Other ingredients are: macrogol-6-glycerol caprylocaprate, fragrance 70/0676, purified water.

What Spitaderm looks like and contents of the pack

Spitaderm is a clear, slightly yellow, transparent solution with a characteristic isopropyl alcohol smell.
pH: 6.5-7.5.
Packaging: bottles of 500 ml or cans of 5000 ml.

Marketing authorization holder:

Ecolab Sp. z o.o. ul. Opolska 114
31-323 Kraków
Poland
+48 12 2616100

Manufacturer:

Ecolab Deutschland GmbH
Reisholzer Werftstrasse 38-42 D-40589
Düsseldorf
Germany

Date of last revision of the leaflet: