Betadona wound spray

Povidone-iodine has a comprehensive germicidal effect.

Application

1. What is Betadona and what is it used for?

Povidone-iodine has a comprehensive germicidal effect. It is effective against bacteria, fungi, spores, viruses and certain protozoa.
Reliable wound disinfection largely prevents infections and promotes rapid, problem-free healing.
Due to its mode of action, resistance of infectious agents to povidone-iodine is not to be feared.
By binding to povidone, the iodine largely loses the irritating properties of alcoholic iodine preparations and is well tolerated by the skin, mucous membranes and wounds.
The iodine discolours during the action process; the depth of the brown colouring therefore indicates its effectiveness. In case of discolouration, re-dosing is necessary.
Povidone-iodine is water-soluble and easily washable.

Applications
For repeated, time-limited use for
prevention and treatment of infections in burns, cuts and abrasions.
Preventive treatment of wounds at risk of infection, such as after the application of a suture for wound care or after surgical interventions.

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How is it applied?

What is Betadona and what is it used for?

Povidone-iodine has a comprehensive germicidal effect. It is effective against bacteria, fungi, spores, viruses and certain protozoa.
Reliable wound disinfection largely prevents infections and promotes rapid, problem-free healing.
Due to its mode of action, resistance of infectious agents (resistance) to povidone-iodine is not to be feared.
By binding to povidone, the iodine largely loses the irritating properties of alcoholic iodine preparations and is well tolerated by skin, mucous membranes and wounds.
During the action process, the iodine decolours, the depth of the brown colouring therefore indicates its effectiveness. In case of discolouration, re-dosing is necessary.
Povidone-iodine is water-soluble and easily washed off.

Applications
For repeated, time-limited use for

• Prevention and treatment of infections in burns, cuts and abrasions.

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• Preventive treatment of wounds at risk of infection, such as after applying a suture for wound care or after surgical operations.

What should you pay attention to before taking it?

What should you be aware of before using Betadona?

Betadona Wound Spray must NOT be used,

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• If you are allergic to povidone-iodine or any of the other ingredients of this medicine listed in section 6,
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• If you suffer from hyperthyroidism (signs: accelerated pulse, inner restlessness) or other thyroid diseases,
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• if you suffer from the rare chronic skin inflammation dermatitis herpetiformis Duhring,
• with simultaneous use of preparations containing mercury,
• with simultaneous use of octenidine-containing wound treatment products,
• before and after radiotherapy of the thyroid gland with iodine (radio-iodine therapy) until completion of the treatment,
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• before a thyroid examination (radio-iodine scintigraphy),
• before treatment for thyroid cancer (radio-iodine treatment).

Warnings and precautions.
Please talk to your doctor or pharmacist before using Betadona wound spray.

• Caution, do not inhale spray mist and do not spray in or near the eyes. The propellants are flammable. The spray mist can ignite. Therefore, be careful with open flames. Do not apply electrical devices (such as thermocautery) until the spray mist has completely evaporated.
• The accidental ingestion of Betadona Wound Spray by newborns, infants and young children must be avoided. See section Pregnancy and Lactation for safe use during this time.
• In newborns and infants up to the age of 6 months, Betadona Wound Spray should only be used after a strict risk/benefit assessment by the doctor and on an extremely limited basis. If necessary, thyroid function (e.g. T4 and TSH levels) should be monitored.
• With large-area burn treatment with povidone-iodine, the occurrence of electrolyte disturbances and an associated impairment of renal function may be favoured.
• Following thyroid disease (especially in elderly patients) or in the case of goitre, povidone-iodine should only be used over a long period of time or over a large area after a strict benefit/risk assessment by the doctor, as there is a risk of subsequent hyperthyroidism. Even after the end of treatment (up to 3 months), pay attention to early symptoms of hyperthyroidism and, if necessary, monitor thyroid function.
• Influence on diagnostic investigations:
  With the use of povidone-iodine, the iodine uptake of the thyroid gland may be reduced, this may lead to disturbances in various investigations of the thyroid gland and make a planned treatment impossible. An interval of at least 1 - 2 weeks after cessation of treatment with povidone-iodine should be observed.
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• Due to the oxidising effect of povidone-iodine, various laboratory tests may give false-positive results (including toluidine and guaiac resin for haemoglobin or glucose determination in stool or urine).
• Due to the oxidative property of povidone-iodine, metals can become rusty, plastics are generally povidone-iodine resistant. From case to case, a discolouration may occur that usually disappears again.
• Povidone-iodine is easily removed from textiles and other materials with warm water and soap, in stubborn cases with ammonia (ammonia solution) or sodium thiosulphate solution (fixing salt).
  Use Betadona Wound Spray with other medicines
  Inform your doctor or pharmacist if you are taking / using any other medicines recently or if you are going to take / use any other medicines.
  Do NOT use at the same time
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• Betadona Wound Spray and hydrogen peroxide, enzymatic or silver- as well as taurolidine-containing wound treatment agents or disinfectants, as there is a mutual weakening of effect,
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• Betadona wound spray and preparations containing mercury, as a corrosive compound (mercury iodide) may form,
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• Betadona wound spray and octenidine-containing wound treatment products, as dark discolouration may occur temporarily,
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Betadona Wound Spray and taurolidine, a chemotherapeutic agent against bacteria and fungi, as taurolidine can be converted to an acid (formic acid) which causes intense burning.
Protein, blood or pus components may affect the effectiveness of Betadona wound spray.
If you are receiving lithium therapy, you should only use Betadona wound spray for short periods and on small areas. Otherwise, larger amounts of iodine could be absorbed into the body.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Use in pregnant women and during breast-feeding may only be made according to the express instructions of the doctor, monitoring of thyroid function in the mother and infant respectively is indicated. A treatment should only last a short time. Iodine passes through the placenta (placenta) into the fetus (unborn child) and also passes into breast milk.
Accidental oral ingestion of Betadona Powder Spray by the infant through contact with the treated body part of the nursing mother must be avoided.
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Driving ability and ability to operate machinery
Betadona Wound Spray has no influence on the ability to drive and operate machinery.

How should the medicine be taken?

How to use Betadona?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Spray one to several times a day on the area to be treated until it is visibly covered with the golden brown povidone-iodine powder.
If discolouration occurs, re-dosing is necessary.

Use in children
In newborns and infants up to the age of 6 months, Betadona Wound Spray should only be used after a strict risk/benefit assessment by the doctor and on an extremely limited basis.

Betadona Wound Spray is intended for external use.

Shake the spray can vigorously before use, hold it vertically and spray onto the area to be treated at a distance of 15 cm. The propellant gas evaporates immediately and the cold stimulus produced during spraying disappears very quickly.
Betadona Wound Spray forms a dry film on the treated area and is easy to wash off. If necessary, a bandage can be applied over it.
Do not use Betadona Wound Spray together with wound treatment products other than Betadona (see also section Using Betadona Wound Spray with other medicines).

If you have used a larger amount of Betadona Wound Spray than you should have,read section 4. What side effects may occur?

If you forget to use Betadona Wound Spray, continue using it as directed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How should Betadona be stored?

Storage
Store this medicine out of the reach of children.
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Mildly flammable.
Keep away from sources of ignition (such as cigarettes).
Do not store above 25 °C.
Do not expose to temperatures higher than 50 °C (for example, do not leave in the sun, in a hot car or in the immediate vicinity of a radiator).
Shelf life
You must not use this medicine after the expiry date which is stated on the spray can and the carton "Use by: ...", you must not use this medicinal product after the expiry date stated on the spray can and the carton. The expiry date refers to the last day of the month indicated.
Do not dispose of this medicinal product in waste water or household waste. Only dispose of completely empty pressure containers. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. How to store Betadona?

Storage
Keep this medicine out of the reach of children.

Flammable.
Keep away from sources of ignition (such as cigarettes).
Do not store above 25 °C.
Do not expose to temperatures higher than 50 °C (for example, do not leave in the sun, in a hot car or in the immediate vicinity of a radiator).
Shelf life
Do not use this medicine after the expiry date which is stated on the spray can and the carton, "Use by: ...". The expiry date refers to the last day of the month indicated.
Do not dispose of this medicinal product in waste water or household waste. Only dispose of completely empty pressure vessels. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and further information
What Betadona Wound Spray contains
1 g contains 25 mg povidone-iodine complex, total content: 0.25% available iodine, isopropyl myristate, n-pentane, propane-butane/isobutane 25:75 suspended in liquefied propellant gas.

What Betadona Wound Spray looks like and contents of the pack
Spray for application to the skin, reddish-brown suspension
Aluminium pressurised container of 30 g and 80 g

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