Desderman N

INFORMATION PLACED ON OUTER PACKAGING

(label-leaflet)

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

desderman N, (79 g + 0.10 g)/100 g, liquid for the skin
(Ethanolum + 2-Biphenylol)

2. CONTENT OF ACTIVE SUBSTANCES

Composition:

100 g of liquid for the skin contains:

• active substances: ethanol 96%, 79 g, contaminated with 1% methyl ethyl ketone, 2-biphenylol, 0.10g;

3. LIST OF EXCIPIENTS

• excipients: isopropyl myristate, hexadecyl/octadecyl [(RS)-2-ethylhexanoate, povidone 30, liquid sorbitol, isopropyl alcohol, purified water

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

Liquid for the skin
150 ml Code: 5909990425464
450 ml Code: 5909990425471
500 ml Code: 5909990667666
1000 ml Code: 5909990425488

5. METHOD AND ROUTE OF ADMINISTRATION

For skin use only.

Read the leaflet carefully before using the medicine.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

Store in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

The medicine is flammable.

8. EXPIRY DATE

Expiry date:

Do not use this medicine after the expiry date.

9. SPECIAL STORAGE CONDITIONS

Storage conditions:

Store at a temperature below 25°C. Due to the low flash point (16°C), special safety precautions should be taken during use and storage.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Marketing authorization holder and manufacturer

Schülke & Mayr GmbH
Robert Koch Strasse 2
22851 Norderstedt
Germany

12. MARKETING AUTHORIZATION NUMBER

Marketing authorization number 13058

13. BATCH NUMBER

Batch number:

14. GENERAL CATEGORY OF AVAILABILITY

OTC - Medicine available without a prescription.

15. INSTRUCTIONS FOR USE

Description of action:

Desderman N medicine has bactericidal, fungicidal, and virucidal effects.
Desderman N medicine acts on microorganisms such as Gram-positive bacteria (staphylococci, including MRSA; streptococci, including vancomycin-resistant enterococci) ,Gram-negative bacteria (including Escherichia coli, Pseudomonas aeruginosa, Proteus vulgaris, Proteus mirabilis, Helicobacter
pyloriand Listeria monocytogenes) and mycobacteria (including Mycobacterium tuberculosis).
Desderman N medicine has fungicidal effects, including on yeast (including Candida albicans).
The medicine has virucidal effects on, among others, hepatitis B virus, rotaviruses, adenoviruses,
herpes simplex(HSV) and poliovirus .
Desderman N medicine also contains moisturizing and emollient excipients that prevent dryness of the hands and maintain skin elasticity.

Indications:

Desderman N is an alcoholic liquid for hygienic and surgical disinfection of the skin of the hands.

When not to use Desderman N medicine

Do not use in case of hypersensitivity to ethanol, biphenylol, or any excipient of the medicine.

Method of use:

Hygienic disinfection of the skin of thehands:
3 ml of Desderman N medicine should be rubbed into dry hands in portions for 30 seconds.
Disinfection of the skin of thehands before surgical procedures:
In washed, dry hands and forearms, 10 ml of Desderman N medicine should be rubbed in portions for 90 seconds, ensuring constant moistening of the skin with the medicine.
Wait until the hands are completely dry before putting on gloves.

Warnings and precautions:

Before starting to use Desderman N medicine, consult a doctor or pharmacist.
Avoid contact of the medicine with eyes and mucous membranes.
In case of using the medicine not in accordance with the indications and method of use, the alcohols contained in the product may cause irritation or be absorbed through the skin, especially damaged skin, and cause systemic effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine .

Desderman N medicine and other medicines

Tell your doctor about all medicines that the patient is currently taking or has recently taken, as well as medicines that the patient plans to take.

Driving vehicles and operating machines

No studies have been conducted on the effect of the medicine on the ability to drive vehicles and operate machines.

Using a larger dose of Desderman N medicine than recommended:

In case of using a larger amount of medicine than recommended or ingesting the medicine, contact a doctor immediately.

Possible side effects

Like any medicine, this medicine may cause side effects, although not everybody gets them.
Dryness and irritation of the skin may occur. Rarely, allergic contact dermatitis or contact urticaria may occur.
Reporting side effects
If any side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of 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. (22) 49 21 301, fax (22) 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Thanks to the reporting of side effects, more information can be collected on the safety of the use of the medicine.
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Schulke Polska Sp. z o.o.
02-305 Warsaw
Al. Jerozolimskie 132
tel. 022-11-60-700, fax: 022-11-60-701

Date of last text update:

16. INFORMATION PROVIDED IN BRAILLE

desderman N

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable.

INFORMATION PLACED ON OUTER PACKAGING (label-leaflet)

CANISTER

1. NAME OF THE MEDICINAL PRODUCT

desderman N, (79 g + 0.10 g)/100 g, liquid for the skin
(Ethanolum + 2-Biphenylol)

2. CONTENT OF ACTIVE SUBSTANCES

Composition:

100 g of liquid for the skin contains:

• active substances: ethanol 96%, 79 g, contaminated with 1% methyl ethyl ketone, 2-biphenylol, 0.10g;

3. LIST OF EXCIPIENTS

• excipients: isopropyl myristate, hexadecyl/octadecyl [(RS)-2-ethylhexanoate, povidone 30, liquid sorbitol, isopropyl alcohol, purified water

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

Liquid for the skin

5000 ml Code: 5909990425501

5. METHOD AND ROUTE OF ADMINISTRATION

For skin use only.

Read the leaflet carefully before using the medicine.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

Store in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

The medicine is flammable.

8. EXPIRY DATE

Expiry date:

Do not use this medicine after the expiry date.

9. SPECIAL STORAGE CONDITIONS

Storage conditions:

Store at a temperature below 25°C. Due to the low flash point (16°C), special safety precautions should be taken during use and storage.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Marketing authorization holder and manufacturer

Schülke & Mayr GmbH
Robert Koch Strasse 2
22851 Norderstedt
Germany

12. MARKETING AUTHORIZATION NUMBER

Marketing authorization number 13058

13. BATCH NUMBER

Batch number:

14. GENERAL CATEGORY OF AVAILABILITY

OTC - Medicine available without a prescription.

15. INSTRUCTIONS FOR USE

Description of action:

Desderman N medicine has bactericidal, fungicidal, and virucidal effects.
Desderman N medicine acts on microorganisms such as Gram-positive bacteria (staphylococci, including MRSA; streptococci, including vancomycin-resistant enterococci) ,Gram-negative bacteria (including Escherichia coli, Pseudomonas aeruginosa, Proteus vulgaris, Proteus mirabilis, Helicobacter
pyloriand Listeria monocytogenes) and mycobacteria (including Mycobacterium tuberculosis).
Desderman N medicine has fungicidal effects, including on yeast (including Candida albicans).
The medicine has virucidal effects on, among others, hepatitis B virus, rotaviruses, adenoviruses,
herpes simplex(HSV) and poliovirus .
Desderman N medicine also contains moisturizing and emollient excipients that prevent dryness of the hands and maintain skin elasticity.

Indications:

Desderman N is an alcoholic liquid for hygienic and surgical disinfection of the skin of the hands.

When not to use Desderman N medicine

Do not use in case of hypersensitivity to ethanol, biphenylol, or any excipient of the medicine.

Method of use:

Hygienic disinfection of the skin of thehands:
3 ml of Desderman N medicine should be rubbed into dry hands in portions for 30 seconds.
Disinfection of the skin of thehands before surgical procedures:
In washed, dry hands and forearms, 10 ml of Desderman N medicine should be rubbed in portions for 90 seconds, ensuring constant moistening of the skin with the medicine.
Wait until the hands are completely dry before putting on gloves.

Warnings and precautions:

Before starting to use Desderman N medicine, consult a doctor or pharmacist.
Avoid contact of the medicine with eyes and mucous membranes.
In case of using the medicine not in accordance with the indications and method of use, the alcohols contained in the product may cause irritation or be absorbed through the skin, especially damaged skin, and cause systemic effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine .

Desderman N medicine and other medicines

Tell your doctor about all medicines that the patient is currently taking or has recently taken, as well as medicines that the patient plans to take.

Driving vehicles and operating machines

No studies have been conducted on the effect of the medicine on the ability to drive vehicles and operate machines.

Using a larger dose of Desderman N medicine than recommended:

In case of using a larger amount of medicine than recommended or ingesting the medicine, contact a doctor immediately.

Możliwe działania niepożądane

Possible side effects

Jak każdy lek, lek ten może powodować działania niepożądane, chociaż nie u każdego one wystąpią.
Może wystąpić suchość i podrażnienie skóry. Rzadko występuje uczuleniowe kontaktowe zapalenie
skóry lub pokrzywka kontaktowa.
Zgłaszanie działań niepożądanych
Jeśli wystąpią jakiekolwiek objawy niepożądane, w tym wszelkie objawy niepożądane niewymienione
w tej ulotce, należy powiedzieć o tym lekarzowi lub farmaceucie, lub pielęgniarce. Działania
niepożądane można zgłaszać bezpośrednio do Departamentu Monitorowania Niepożądanych Działań
Produktów Leczniczych Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i
Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel. (22) 49 21 301, fax (22) 49
21 309,
strona internetowa: https://smz.ezdrowie.gov.pl.
Działania niepożądane można zgłaszać również podmiotowi odpowiedzialnemu.
Dzięki zgłaszaniu działań niepożądanych można będzie zgromadzić więcej informacji na temat
bezpieczeństwa stosowania leku.
W celu uzyskania bardziej szczegółowych informacji należy zwrócić się do miejscowego
przedstawiciela podmiotu odpowiedzialnego:
Schulke Polska Sp. z o.o.
02-305 Warszawa
Al. Jerozolimskie 132
tel. 022-11-60-700, fax: 022-11-60-701

Data ostatniej aktualizacji tekstu:

Date of last text update:

16. INFORMATION PROVIDED IN BRAILLE

desderman N

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable.