BRAUNODERM alcoholic skin disinfectant recolored 1 l

Braunoderm tinted, solution. Indications: This is an alcoholic skin disinfectant for disinfecting the skin before surgical procedures, injections, punctures, catheterizations, blood draws, and vaccinations.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Braunoderm tinted, solution for cutaneous use
. Active ingredients: 50% 2-propanol (PH. Eur.) and 1% povidone-iodine.

Read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Braunoderm tinted must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If any of the listed side effects become serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains:

1. WHAT IS BRAUNODERM NACHGERÄRBT AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING BRAUNODERM RECOGNIC?
3. HOW IS BRAUNODERM TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD BRAUNODERM BE STORED WHEN RECOGNED?
6. MORE INFORMATION

1. WHAT IS BRAUNODERM RECOGNIZED AND WHAT IS IT USED FOR?

Braunoderm Recognised is an alcohol-based skin disinfectant used to disinfect the skin before surgical procedures, injections, punctures, catheterizations, blood draws, and vaccinations.

2. WHAT DO YOU NEED TO KNOW BEFORE USING BRAUNODERM RECOGNIZED?

Braunoderm Recognised must not be used in patients:

• who suffer from an overactive thyroid (hyperthyroidism) or another existing (manifest) thyroid disease,
• who suffer from dermatitis herpetiformis Duhring, a rare chronic skin inflammation with burning, itching and various skin symptoms, especially on the arms, legs, shoulders and buttocks.
• in whom radiation therapy of the thyroid with iodine (radioiodine therapy) is planned or has been carried out (until the end of the treatment),
• who are hypersensitive (allergic) to iodine (iodine allergy), 2&ndash%%%propanol or any of the other ingredients of Braunoderm.

Special care is required when using Braunoderm after coloring:

• After application, Braunoderm must be allowed to dry freely on the skin, as occlusive conditions (air exclusion) can lead to skin irritation due to the alcohol content. Therefore, during preoperative skin disinfection, pooling of the product under the patient should be avoided.
• Before using electrical devices, allow Braunoderm to dry on the skin after recoloring!
• Braunoderm is an eye and mucous membrane irritant. Do not get into the eyes, do not apply to broken skin or mucous membranes. In case of accidental contact with the eyes or mucous membranes, rinse immediately with plenty of water (including under the eyelids). If eye irritation persists, seek medical advice immediately.

Fire and explosion protection:
Braunoderm colorant is flammable (flash point 21-22°C). Above 21°C, Braunoderm colorant can be easily ignited by sparks, burning cigarettes, open flames, and other ignition sources. Therefore, if larger quantities are spilled, there is a risk of fire and explosion! In such cases, take immediate preventative measures: absorb the liquid, dilute with plenty of water, ventilate the room, and remove ignition sources.

Warnings according to the Hazardous Substances Ordinance and the German Social Accident Insurance (DGUV):
See label.

Interference with diagnostic tests:

• Due to the oxidizing effect of the active ingredient povidone-iodine, various diagnostic tests may produce false-positive results when using Braunoderm (e.g., toluidine and guaiac resin for hemoglobin or glucose determination in stool or urine).
• Povidone-iodine can affect iodine uptake by the thyroid gland. This can lead to interference with diagnostic thyroid examinations (thyroid scintigraphy, PBI determination, radioiodine diagnostics) after the use of Braunoderm post-staining and may render planned radioiodine therapy impossible. A period of at least 1-2 weeks should elapse between the application of Braunoderm post-staining and any new scintigram.

When using Braunoderm after coloring with other medicines:
Please inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

• Povidone-iodine reacts with mercury compounds to form highly corrosive mercury(l) iodide. Therefore, Braunoderm stained must not be used simultaneously with or shortly after mercury-containing wound treatment or disinfectant products.
• When Braunoderm is used concurrently with silver-containing disinfectants, hydrogen peroxide or taurolidine, there is a mutual reduction in effectiveness.

Other interactions:
The active ingredient povidone-iodine reacts with proteins and various other organic substances, such as blood and pus components, which can impair the effectiveness of Braunoderm.

Pregnancy and breastfeeding:
During pregnancy and breastfeeding, Braunoderm should only be used on the express instructions of a doctor and in extremely limited amounts. Accidental ingestion of Braunoderm by the infant through the breast of the breastfeeding mother must be strictly avoided.

What should be considered in children?
In newborns (especially premature infants) and infants up to 6 months of age, Braunoderm should only be used on the express instructions of a doctor and in extremely limited amounts, as 2-propanol and iodine can severely irritate and penetrate immature skin. In this case, the skin at the application site should be monitored for irritation, and thyroid function should be checked. Accidental ingestion of Braunoderm by the infant through the mouth must be avoided.

What should be considered in elderly people?
In elderly people, the risk of iodine-induced hyperthyroidism is increased. Therefore, Braunoderm Recoloring should only be used on the express instructions of a doctor.

Driving and operating machinery:
No special precautions are necessary.

3. HOW TO USE BRAUNODERM REColoring?

Always use Braunoderm Recoloring exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual application is: The skin is kept moist with the undiluted preparation for the entire prescribed application time. Braunoderm Recoloring is applied undiluted and rubbed in with a sterile swab. You must completely wet the area of skin to be treated and allow it to dry after the prescribed application time. Dab off any excess solution.

Application times:
for skin with low sebum production:

• Wait at least 15 seconds before injections and punctures,
• Apply for at least 1 minute before joint punctures, punctures of the cerebrospinal fluid space and before operations (reapply several times if necessary).

in skin rich in sebaceous glands (e.g. on the head, above the sternum, between the shoulder blades)

• Leave on for at least 10 minutes before all procedures (apply several times).

If you have used more Braunoderm Dye than you should:
Dab off excess product and allow skin to air dry. Absorb any puddles under the patient and allow to dry completely. Observe the flammability warning (see section 2).

First aid measures:
Braunoderm Dye is for external use only. In case of accidental ingestion, symptoms of poisoning similar to alcohol poisoning are possible, with the risk of respiratory arrest or unconsciousness (risk of suffocation from vomit). Seek medical advice immediately. Induce vomiting only on medical instructions.

4. POSSIBLE SIDE EFFECTS:

Like all medicines, Braunoderm Dye can cause side effects, although not everybody gets them. The following frequency data are used to describe side effects:

Important side effects or signs to watch out for, and what to do if you are affected:

• Very rare: Hypersensitivity reactions of the skin, e.g. delayed-type contact allergic reactions, which may manifest as itching, redness, blisters, etc.
• Very rare: Acute reactions of the immune system (anaphylactic reactions) involving other organs (e.g., skin, respiratory tract, circulatory system).

Discontinue use of Braunoderm after coloring and consult your doctor as soon as possible if you experience any of these side effects.

Other possible side effects:

• Occasionally: Local alcohol-related dryness and irritation of the skin (redness, tightness, itching).

Alcohol-based disinfectants can dry out the skin, especially in low humidity (e.g., in winter), and thus cause skin irritation. In such cases, it is recommended to use skin care creams.

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

5. HOW TO STORE BRAUNODERM RECOGNIZED?

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label. Braunoderm recolored can be used for 12 months after first opening the container, but not beyond the expiry date.

Storage conditions:
Do not store above 30°C.

Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

What Braunoderm coloring contains:
The active ingredients are: 2-propanol (Ph. Eur.) and povidone-iodine. 100 g of solution contains 50.0 g of 2-propanol (Ph. Eur.), 1.0 g of povidone-iodine with 10% available iodine (average molecular weight of povidone approximately 40,000). The other ingredients are: Purified water, potassium iodide (0.4 g, stabilizer), sodium dihydrogen phosphate, colorants E 110, E 124, E 151.

What Braunoderm looks like and contents of the pack:
Braunoderm is a clear, brown, alcohol-smelling solution for application to the skin, available in 250 ml, 1000 ml, and 5-liter containers. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
B. Braun Melsungen AG,
Carl-Braun-Str. 1,
34212 Melsungen, Germany.

alcoholic skin disinfectant BRAUNODERM recolored 1 l