Derderman Pure Solution, 1 L

Important notes (compulsory information):

Derderman pure. Applications: For hygienic and surgical hand disinfection.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.

LEAFLET: INFORMATION FOR THE USER.

Solution for hand disinfection
Active ingredients: 78.2 g of ethanol 96%, 0.1 g biphenyl-2-ol

1. What is Derderman Pure and what is it used for?
2. What do you need to pay pure before using Derderman?
3. How is Derderman to apply pure?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How is Derderman to keep pure?
6. ADDITIONAL INFORMATION

1. What is Derderman Pure and what is it used for?

DerDerman Pure is used for hygienic and surgical hand severance infection. The pharmaceutical constituents ethanol and biphenyl-2-ol act against bacteria (including Myconomists), mushrooms and many viruses. The effectiveness of Derderman Pure concludes the filled viruses (classification "limited virucid") * and rotaviruses.

*Checked against test viruses BVDV (surrogate viruses for hepatitis C virus) and vaccine virus. The results allow for current state of knowledge to the conclusion of the effectiveness against other tired viruses, e.g. Hepatitis B virus, HI virus.

2. What do you need to pay pure before using Derderman?

Derderman Pure must not be used if they are hypersensitive (allergic) to the active ingredients or any of the other ingredients.

Take special care with DEDERMAN PURE:
Warnings: Do not bring your eyes. In case of accidental eye contact with Derderman pure immediately rinse for several minutes with a lot of water when the eyelit is open.

Flash point according to DIN 51 755 16 ° C. Flammable. Do not bring into contact with open flames. After spilling the disinfectant, action against fire and explosion must be taken immediately. Suitable measures are e.g. absorbing spilled liquid and dilute with water, the ventilation of space as well as the elimination of ignition sources. Any transfer may only be carried out under aseptic conditions (sterile bank.

Pregnancy:
There are no experience on the application in pregnancy.

Latving:
There are no experience in man with the application of the medicine during breastfeeding.

Driveion and use of machines:
Derderman Pure has no influence on the ability to drive and use machines.

When using Derderman Pure with other medicines:
Please inform your doctor or pharmacist if you have applied other medicines or recently applied, even if it is non-prescription medicines.

3. How is Derderman to apply Pure?

Always use Derderman Pure exactly as your leaflet statement. Please ask your doctor or pharmacist if you are not sure.

Hygienic hand disinfection: 3 ml undiluted 30 seconds in the hands. Surgical Handedes infection: If necessary, sufficient amount of Derderman pure undiluted 90 seconds (1.5 Minutes) in the hands and forearms. Hands and forearms must be kept moist through the undiluted preparation throughout the application time.

If you have applied a larger amount of Derderman Pure than you should:
Findings on overdoses are not available. However, overdose is very unlikely in topical preparation.

4. Which side effects are possible?

Occasionally, there may be typical side effects such as skin irritation (e.g., redness, dryness) for alcoholic hand disinfectants. Despite further use, these disproportions already sound again after 8 - 10 days. Rarely can it come to contact alga reactions.

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also display side effects directly (see details below). By reporting side effects, you can help to provide more information about the security of this medicine.

Federal Institute for Pharmaceuticals and Medical Products
Dept. Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Website: www.bfarm.de

5. What is Derderman Storing Pure?

Store drug out of reach of children. The expiration date is printed on the container. Do not use this container after this date. After a breaking of the medicine, no longer than 8 months, but not beyond expiration date. No special storage conditions are required.

6. Further information

Derderman Pure contains in 100 g solution:

Active pharmaceutical ingredients:
78.2 g of ethanol 96%, 0.1 g biphenyl-2-ol

Other ingredients:
Povidone 30, isopropyl myristate (ph.eur.), (Hexadecyl / Octadecyl) (2-ethylhexanoate), sorbitol solution 70% (crystallizing) (pH. EUR.), 2-propanol (pH. EUR.), Purified water

Dosage form and content:
Derderman Pure is a clear, colorless solution and available in the packing sizes of 100 ml, 150 ml, 500 ml, 1 l and 5 l solution.

Pharmaceutical entrepreneur and manufacturer:
Schülke & Mayr GmbH
22840 Norderstedt
[email protected]
Tel.: +49 (0) 52100-0

Status of information: 08/2013

Source: Information of the leaflet
Status: 06/2015