Braunol skin solution/oropharyngeal solution, 10 x 1000 ml, B.Braun Melsungen AG

Indications:
Braunol skin solution/oropharyngeal solution is an antiseptic and disinfectant containing the active substance iodine (in the form of povidone iodine). It is used to prevent and treat infections of intact skin and mucous membranes in adults, adolescents, children and infants over 6 months of age.
Braunol cutaneous solution/oropharyngeal solution has bactericidal, yeasticidal, fungicidal, mycobactericidal and limited virucidal activity against certain viruses (enveloped viruses, including HBV, HCV, HIV, influenza virus).

For single use:
Disinfection of intact external skin, for example before injections (intramuscular, subcutaneous, peripheral intravenous or intradermal) and blood tests.
Disinfection of the oral mucosa (lining of the mouth) before a surgical intervention.

Repeated use, limited in time:
Hygienic and surgical hand disinfection.
Antiseptic washing and bathing during hygiene procedures.
Braunol cutaneous solution/oropharyngeal solution is indicated for adults, adolescents, children and infants over 6 months of age.

Composition:
- The active substance is iodine (in the form of povidone iodine).
Each ml of solution contains 7.7 mg available iodine (as povidone iodine).
100 ml of solution contains 0.77 g of available iodine (in the form of povidone iodine).
- The other ingredients are sodium dihydrogen phosphate dihydrate, sodium iodate, macrogol lauryl ether (9 ethylene oxide units), sodium hydroxide (for pH adjustment) and purified water.

Mode of administration:
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

For cutaneous or oropharyngeal administration.
Skin disinfection:
Apply Braunol cutaneous solution/oropharyngeal solution undiluted to the skin until it is completely wet, for example before injections (intramuscular, subcutaneous, peripheral intravenous or intradermal) and blood tests. The skin must remain moist throughout the procedure.

Mucous membrane antisepsis:
Apply Braunol skin solution/oropharyngeal solution undiluted.
As part of an antiseptic treatment of the oral mucosa (eg before surgery), rinse the mouth for 30 seconds without swallowing, using 10-15 ml of undiluted mouthwash.

Hand disinfection:
Apply undiluted Braunol skin solution/oropharyngeal solution:
- Hygienic hand disinfection: Rub at least 3 ml of Braunol skin solution/oropharyngeal solution on dry and visibly clean hands, keeping them moist for at least 1 minute.
Hands should not be washed after this preparation.
- Surgical hand disinfection: Rub at least 2 x 5 ml of undiluted Braunol skin solution/oropharyngeal solution on dry and visibly clean hands and forearms for 5 minutes. Keep hands wet with undiluted solution throughout.

Rinse and wash:
Braunol skin solution/oropharyngeal solution can be used diluted for rinsing, washing and antiseptic bathing. Washing and bathing only support hygienic procedures, they do not replace conventional preoperative skin disinfection.

Instructions:
To bathe the patient, first fill the tub with water, then add the required amount of Braunol skin solution/oropharyngeal solution. In this way, the release of iodine vapors that can cause yellowing of the surrounding materials is prevented.
The brown color of Braunol skin solution/oropharyngeal solution is a characteristic of the medicine. Although there is no direct correlation between the color of the solution and its effectiveness, the drug should not be used if the loss of the intensity of the brown color is observed.
The following dilutions using water, isotonic sodium chloride solution, Ringer's solution, or phosphate buffer solution (depending on the intended application) are given as recommendations:
- wash 1:2 to 1:25
- bath for one member, approximately 1:25
- full body bath, approximately 1:100
All dilutions should be prepared on site and used immediately.

Use in children:
Avoid regular use in newborns.
Do not use Braunol cutaneous solution/oropharyngeal solution in very low birth weight newborns (see section 2, "Do not use Braunol cutaneous solution/oropharyngeal solution").

Frequency and duration of application:
For repeated use of Braunol skin solution/oropharyngeal solution, the frequency and duration of applications will depend on the respective case.
Braunol skin solution/oropharyngeal solution can be applied once or several times a day.
If the condition has not improved after several days of regular treatment (2 to 5 days) or if the infection recurs after stopping treatment with Braunol skin solution/oropharyngeal solution, contact your doctor.

Contraindications:
Do not use Braunol skin solution/oropharyngeal solution:
- if you are allergic to povidone-iodine or any of the other components of this medicine.

Precautions:
Before using Braunol skin solution/oropharyngeal solution, talk to your doctor or pharmacist.

Pregnancy, breast-feeding and fertility:
Iodine may be absorbed after extensive application and may cross the placenta. Use of Braunol skin solution/oropharyngeal solution may cause temporary hypothyroidism in the fetus or newborn if administered during pregnancy. During pregnancy and breastfeeding, Braunol skin solution/oropharyngeal solution should be used only on the recommendation of the doctor, and its use should be extremely limited. If no alternative to Braunol cutaneous solution/oropharyngeal solution is available during pregnancy, thyroid function testing of the child is necessary, especially in geographic areas known for low dietary iodine intake and goitre propensity.
Caution is required to prevent accidental ingestion of Braunol cutaneous solution/oropharyngeal solution by infants through contact with treated parts of the mother's body during breastfeeding.
Prolonged use of povidone-iodine on mucous membranes can cause significant absorption of iodine, which can affect fertility.

Driving vehicles and using machines:
Braunol cutaneous solution/oropharyngeal solution has no or negligible influence on the ability to drive or use machines.

Presentation:
10 x 1000 ml

Warning:
Read the leaflet carefully and completely before you start using this medicine, because it contains important information for you. Always use this medicine as directed in this leaflet or as directed by your doctor or pharmacist.