BETADINA disinfecting powder spray
BETADINA desinfizierendes Puderspray
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Not availableAnalogues of the product based on the Anatomical Therapeutic Chemical (ATC) Classification - D08AG02
Description - BETADINA disinfecting powder spray
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 the mode of action, there is no reason to fear that infectious pathogens will become resistant to povidone-iodine. 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. During the process of action, the iodine discolors, so the depth of the brown color indicates its effectiveness. In the event of discoloration, additional dosing is required. Povidone iodine is water soluble and easily washable.
Areas of application
For repeated, temporary use for
- Prevention and treatment of infections in burns, cuts and abrasions.
- Preventive treatment of wounds at risk of infection, such as after suturing to treat wounds or after surgery.
Swissmedic-approved patient information
BETADINA? disinfectant powder spray
The effectiveness and safety of BETADINA disinfectant powder spray were only summarized by Swissmedic. The approval of BETADINA disinfecting powder spray is based on Betadona Wound Spray as of January 2018, which contains the same active ingredient and is approved in Austria.
What is BETADINA disinfecting powder spray and when is it used?
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 the mode of action, there is no reason to fear that infectious pathogens will become resistant to povidone-iodine. 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. During the process of action, the iodine discolors, so the depth of the brown color indicates its effectiveness. In the event of discoloration, additional dosing is required. Povidone iodine is water soluble and easily washable.
Areas of application
For repeated, temporary use for
- Prevention and treatment of infections in burns, cuts and abrasions.Preventive treatment of wounds at risk of infection, such as after suturing to treat wounds or after surgery.
When must BETADINA disinfecting powder spray not be used?
BETADINA disinfecting powder spray must NOT be used,
- if you are allergic to povidone-iodine or any of the other ingredients of this medicine listed in the section «What does BETADINA Disinfectant Powder Spray contain»,if you have an overactive thyroid gland (hyperthyroidism; signs: pulse acceleration, inner restlessness) or suffer from other thyroid diseases,if you suffer from the rare chronic skin inflammation dermatitis herpetiformis Duhring,when using preparations containing mercury at the same time,with the simultaneous use of wound treatment agents containing octenidine,before and after radiation therapy of the thyroid gland with iodine (radio-iodine therapy) until the end of the treatment,before a thyroid gland examination (radio-iodine therapy) iodine scintigraphy),before treatment for thyroid cancer (radio-iodine treatment).
When is when using BETADINA disinfecting powder spray Caution required?
Please talk to your doctor or pharmacist before using BETADINA disinfecting powder spray.
- Caution, do not breathe spray and do not spray in or near eyes. The propellants are flammable. The spray can ignite. So be careful with open flames. Only use electrical devices (such as thermal cautery) after the spray mist has evaporated completely.Accidental ingestion of BETADINA disinfectant powder spray by newborns, infants and small children must be avoided. See the section "Can BETADINA disinfecting powder spray be used during pregnancy or breastfeeding" for safe use during this time.BETADINA disinfecting powder spray is only to be used in newborns and infants up to the age of 6 months after strict use/ Risk assessment by the doctor and extremely limited to use. If necessary, the thyroid function (e.g. T4- and TSH values) should be monitored.In the case of large-scale burn treatment with povidone-iodine, the occurrence of electrolyte disturbances and an associated impairment of the kidney function are promoted.After thyroid diseases (especially in older patients) or in the case of a goiter, povidone-iodine should only be used over a longer period of time or on a large scale after a strict benefit/risk assessment by the doctor, since the risk of a subsequent there is hyperthyroidism. Even after the end of treatment (up to 3 months) one should pay attention to early symptoms of hyperthyroidism and monitor thyroid function if necessary.
Influence on diagnostic tests
- The uptake of iodine by the thyroid gland may be reduced with the use of povidone-iodine; this can interfere with various thyroid tests and make planned treatment impossible. An interval of at least 1-2 weeks should be observed after stopping treatment with povidone-iodine.Because of the oxidizing effect of povidone-iodine, various laboratory tests can provide false-positive results (including toluidine and guaiac resin for determining hemoglobin or glucose in stool or urine).Due to the oxidative properties of povidone iodine, metals can become rusty, plastics are generally resistant to povidone iodine. From case to case, a discoloration that usually disappears again can occur.Povidone-iodine can be removed from textiles and other materials with warm water and soap, in stubborn cases with ammonia (aqueous ammonia) or sodium thiosulphate solution (fixing salt), easily removable.
Use of BETADINA disinfecting powder spray together with other medicines
Inform your doctor or pharmacist if you are taking other medicines/ are using, have recently taken/used other medicines or intend to take/use other medicines.
DO NOT use
at the same time- BETADINA disinfecting powder spray and hydrogen peroxide, enzymatic or silver- and taurolidine-containing wound treatment agents or disinfectants, since there is a mutual weakening of the effect,BETADINA disinfecting powder spray and mercury-containing preparations, since a caustic compound (mercury iodide ) can form,BETADINA disinfecting powder spray and octenidine-containing wound treatment agents, as dark discoloration can temporarily occur,BETADINA disinfecting powder spray, a chemotherapeutic agent against bacteria and fungi, since taurolidine is an acid (formic acid), which causes intense burning.
Protein, blood or pus components can impair the effectiveness of BETADINA disinfecting powder spray. If you are receiving lithium therapy, you should only use BETADINA disinfecting powder spray for a short time and on small areas. Otherwise larger amounts of iodine could be absorbed into the body. This medicine has negligible influence on the ability to drive and use machines. Tell your doctor, pharmacist or druggist if you
- suffer from other diseases,have allergies ortake other medicines (including those you bought yourself!) or use them externally!
Can BETADINA disinfecting powder spray be used while pregnant or breastfeeding?
If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant ask your doctor or pharmacist for advice before using this medicine. Pregnant women and breastfeeding women may only be used on the express instructions of a doctor; monitoring of thyroid function in the mother or infant is indicated. A treatment should only last a short time. Iodine enters the fetus (unborn child) via the placenta (placenta) and also passes into breast milk. Accidental oral ingestion of BETADINA disinfectant powder spray by the infant through contact with the treated part of the nursing mother's body must be avoided.
How do you use BETADINA Disinfectant Powder Spray?
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 onto the area to be treated once or several times a day until it is visibly covered with the golden-brown povidone-iodine powder. In the event of discoloration, additional dosing is required.
Use in children
BETADINA disinfecting powder spray is only to be used in newborns and infants up to the age of 6 months after a strict benefit/risk assessment by the doctor and is extremely limited. BETADINA disinfecting powder spray is intended for external use. Shake the spray can vigorously before use, hold it vertically and spray onto the area to be treated from a distance of 15 cm. The propellant evaporates immediately and the cold stimulus caused by spraying disappears very quickly. BETADINA disinfecting powder 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 BETADINA disinfecting powder spray together with wound treatment products other than Betadine (see also the section «When is caution required when using BETADINA disinfecting powder spray»). If you use more BETADINA disinfectant powder spray than you should, please read the section "What are the possible side effects of BETADINA disinfectant powder spray"? If you forget to use BETADINA disinfecting powder spray, continue using it as intended. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Stick to the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.
What side effects can BETADINA disinfecting powder spray have?
Like all medicines, this medicine can also have side effects, although not everyone gets them.
Rare (affects 1 to 10 users in 10,000)
Hypersensitivity, hypersensitivity reactions of the skin, which can manifest themselves in the form of itching, redness, blisters or similar.
Very rare (affects less than 1 in 10,000 users)
Acute general allergic reactions (anaphylactic reactions) often accompanied by a drop in blood pressure, dizziness, nausea and possibly shortness of breath, hyperthyroidism in patients who tend to (signs: increased heart rate, inner restlessness) 1), allergic, painful swelling of the skin and mucous membranes (angioedema).
Not known
Frequency cannot be estimated from the available data: Underactive thyroid 2), disturbances in the electrolyte balance 3), metabolically induced hyperacidity of the blood and body 3), acute kidney failure 3 ), number of dissolved substances in the blood too high or too low 3). 1) In patients with a history of thyroid dysfunction (see the section "When should caution be exercised when using BETADINA disinfectant powder spray") after ingestion of a large amount of iodine, for example in the course of a extensive use of povidone-iodine in the treatment of wounds and burns over a long period of time 2) Hypothyroidism after long-term or excessive use of povidone-iodine 3) May occur after ingestion of large amounts of povidone-iodine (e.g. treatment of burns).
Reporting of side effects
By reporting side effects, you can help provide more information on the safety of this medicine. If you get any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.
What else needs to be considered?
The medicinal product may only be used up to the date marked «EXP» on the container.
Storage instructions
Do not store above 25°C. Keep out of the reach of children. Highly flammable. Keep away from sources of ignition (such as cigarettes). Do not expose to temperatures higher than 50°C (e.g. do not leave in the sun, in a hot car or in the immediate vicinity of a radiator).
Further information
You must not use this medicine after the expiry date stated on the spray can and the «EXP» carton. The expiry date refers to the last day of that month. Do not throw away this medicine via wastewater or household waste. Only dispose of completely empty pressure containers. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment. Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.
What does BETADINA disinfecting powder spray contain?
BETADINA disinfecting powder spray is a red-brown suspension for use on the skin.
Active ingredients
1 g wound spray contains 2.5 mg iodine as povidone iodine.
Excipients
Isopropyl myristate, n-pentane, propane-butane, isobutane suspended in liquefied propellant.
Approval number
67515 (Swissmedic)
Where can you get BETADINA disinfecting powder spray? What packs are available?
In pharmacies and drugstores, without a doctor's prescription. 30 g and 80 g aluminum pressurized containers
Authorization holder
Mundipharma Medical Company, Hamilton/Bermuda, Basel branchThis leaflet was last checked by the foreign reference authority in January 2018. Without safety-related supplements from Swissmedic: March 2020