KODAN

KODAN Tincture forte colorless pump spray

Important notes (mandatory information)

kodan Tincture Forte colourless. Areas of application: for skin disinfection before surgical procedures, catheterisations, blood and cerebrospinal fluid extractions, injections, punctures, excisions, cannulations, biopsies, etc., for suture care, for hygienic hand disinfection and for supporting general hygiene measures in the context of preventing skin fungal diseases.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

kodan Tincture Forte colourless, alcoholic antiseptic for use on the skin
Active ingredients: 2-propanol (Ph.Eur.), 1-propanol (Ph.Eur.), biphenyl-2-ol

1. WHAT IS KODAN TINTURE FORTE COLOURLESS AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE USING KODAN TINTURE FORTE COLOURLESS?
3. HOW IS KODAN TINTURE FORTE COLOURLESS USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KODAN TINTURE FORTE COLOURLESS BE STORED?
6. FURTHER INFORMATION

1. WHAT IS KODAN TINTURE FORTE COLOURLESS AND WHAT IS IT USED FOR?

kodan Tincture forte colourless is used for skin disinfection before surgical procedures, catheterisations, blood and cerebrospinal fluid extractions, injections, punctures, excisions, cannulations, biopsies, etc., for suture care, for hygienic hand disinfection and for supporting general hygiene measures in the context of preventing skin fungal diseases. The active pharmaceutical ingredients 2-propanol, 1-propanol and biphenyl-2-ol are effective against bacteria (incl. mycobacteria), fungi and many viruses. The effectiveness of kodan Tincture forte colourless against viruses includes enveloped viruses* (classification "limited virucidal").
*Tested against test viruses BVDV (surrogate viruses for hepatitis C virus) and vaccinia virus. According to current knowledge, the results allow the conclusion that it is effective against other enveloped viruses, e.g. hepatitis B virus, HIV.

2. WHAT DO YOU NEED TO CONSIDER BEFORE USING KODAN TINTURE FORTE COLOURLESS?

kodan Tincture forte colourless must not be used if you are hypersensitive (allergic) to the active ingredients or any of the other ingredients. The medicinal product must not be used for surgical hand disinfection.

Special care must be taken when using kodan Tincture forte colourless

Warnings: The medicinal product is intended for external use only. Do not bring into contact with open flames or switched-on electrical heating sources. Allow the medicinal product to dry before applying dressings. Do not use a thermocautery until the disinfected areas of skin have dried. In the event of accidental eye contact with kodan Tincture forte colourless, rinse immediately with plenty of water for several minutes with the eyelid open.

Pregnancy

There is no experience with use during pregnancy.

Breastfeeding

There is no experience with use of the medicinal product during breastfeeding in humans.

Driving and using machines

No influence known.

Children

kodan Tincture forte colourless should not be used in premature babies and newborns with immature skin (e.g. impaired skin barrier function) due to the high alcohol content.

When using kodan Tincture forte colourless with other medicinal products

Please inform your doctor or pharmacist if you are using or have recently used other medicinal products, even if they are non-prescription medicinal products.

3. HOW IS KODAN TINTURE FORTE COLOURLESS USED?

Always use kodan Tincture colourless exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. For skin disinfection, apply or spray onto the skin until it is completely wet and, before punctures and injections, leave to act undiluted for at least 15 seconds; before punctures of joints, body cavities, hollow organs and before surgical procedures, leave to act undiluted for at least 1 minute. For procedures on skin with a high concentration of sebaceous glands (scalp, forehead, armpits, front and back sweat groove and in the genital area), apply repeatedly and leave to act for 2 minutes. For hygienic hand disinfection, rub 3 ml into the hands within 30 seconds. In the event of contamination with mycobacteria, use twice.

If you have used more kodan Tincture forte colourless than you should

There is no knowledge of overdosages. However, an overdose is very unlikely with a topical preparation.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Skin irritations such as redness, burning and dryness can occur, particularly with frequent use. In rare cases, contact allergic reactions are possible.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD KODAN TINTURE FORTE COLOURLESS BE STORED?

Keep out of the reach of children. Do not use the medicinal product for more than 12 months after opening, but not beyond the expiry date stated on the packaging. No special storage conditions are required.

6. FURTHER INFORMATION

kodan Tincture forte colourless contains the following in 100 g solution

Active pharmaceutical ingredients: 2-propanol (Ph.Eur.) 45.0 g, 1-propanol (Ph.Eur.) 10.0 g, biphenyl-2-ol 0.20 g. Other ingredients: hydrogen peroxide solution 30% (Ph. Eur.), purified water.

Pharmaceutical form and contents

kodan Tincture forte colourless is a clear, colourless solution and is available in the following pack sizes: 6 ml, 250 ml (spray pump), 1 l, 2 l, 10 l, AP 10 x 250 ml, AP 5 x 2 l and AP 10 x 1 l.

Pharmaceutical entrepreneur and manufacturer

Schülke & Mayr GmbH
22840 Norderstedt
info@schuelke.com
Tel.: +49 (0) 52100-0

This package leaflet was last revised in March 2016.

Source: Information from the package leaflet
Version: 10/2017
Areas of application: for skin disinfection before surgical procedures, catheterisations, blood and cerebrospinal fluid extractions, injections, punctures, excisions, cannulations, biopsies, etc., for suture care, for hygienic hand disinfection and for supporting general hygiene measures in the context of preventing skin fungal diseases.