BRAUNODERM disinfectant spray Bottle Solution 250 ml

Braunoderm, solution for cutaneous use. Indications: 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, 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 must be used correctly.

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

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

Braunoderm is an alcoholic 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?

Braunoderm should not be used on patients who

• 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 application, Braunoderm must be allowed to dry freely on the skin, as occlusive conditions (air exclusion) can lead to skin irritation due to its alcohol content. Therefore, during preoperative skin disinfection, pooling of the product under the patient should be avoided.
• Allow Braunoderm to dry on the skin before using electrical devices!
• 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 is flammable (flash point 21-22°C). Above 21°C, Braunoderm 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.

Warning information 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 (including toluidine and guaiac resin for determining hemoglobin or glucose in stool or urine).
• Povidone-iodine can affect the thyroid gland's iodine uptake. This can interfere with diagnostic thyroid examinations (thyroid scintigraphy, PBI determination, radioiodine diagnostics) during the use of Braunoderm and may make planned radioiodine therapy impossible. A minimum of 1-2 weeks should elapse between Braunoderm administration and any new scintigram.

When using Braunoderm 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(I) iodide. Therefore, Braunoderm must not be used simultaneously with or shortly after using mercury-containing wound treatment or disinfectant products. The simultaneous use of Braunoderm and silver-containing disinfectants, hydrogen peroxide, or taurolidine will result in 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 may 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 via the breast of the breastfeeding mother must be strictly avoided.

What should be considered when using Braunoderm on 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 must be avoided.

What should be considered in elderly people?
In elderly people, the risk of iodine-induced hyperthyroidism is increased. Therefore, Braunoderm 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?

Always use Braunoderm 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 as follows: The skin is kept moist with the undiluted preparation for the entire prescribed application time. Braunoderm 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. Excess solution is dabbed off.

Application times:
for skin with low sebum production:

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

For 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 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 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 can cause side effects, although not everybody gets them. The following frequency categories 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).

Stop using Braunoderm 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 notice any side effects, contact your doctor or pharmacist. This also applies to 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?

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 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 medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Due to the water solubility of povidone-iodine, stains can be easily removed from textiles with soap and water; in stubborn cases, ammonia or thiosulfate solution can be used.

6. FURTHER INFORMATION

What Braunoderm contains:
The active ingredients are: 2-propanol (Ph. Eur.) and povidone-iodine. 100 g of solution contain 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.

What Braunoderm looks like and contents of the pack:
Braunoderm is a clear, brown, alcohol-smelling solution for cutaneous use in containers of 100 ml, 250 ml, 1000 ml and 5 liters. Not all pack sizes may be marketed.

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

disinfectant spray BRAUNODERM 250 ml