Betaisodona solution standardised

Povidone-iodine is a broad-spectrum germicide.

Application

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

Povidone-iodine is a broad-spectrum germicide. It is effective against bacteria, fungi, spores, viruses and certain protozoa.
Reliable disinfection largely prevents infections and promotes rapid, problem-free healing.
The development of resistance of infectious agents (resistance) to povidone-iodine is not to be feared due to the mode of action.
By binding to povidone, iodine largely loses the irritating properties of alcoholic iodine preparations and is well tolerated by skin, mucous membranes and wounds.
During the action, the iodine discolours, so the depth of the brown colour indicates its effectiveness. If discoloured, a follow-up dose is required. Povidone-iodine is water-soluble and easily washable.

Areas of application
Skin and mucous membrane disinfection, such as before operations, gynaecological and obstetric measures, bladder catheterisation, tissue sampling (biopsies), injections, punctures (punctures) for fluid or blood collection, interventions on the eye. Antiseptic wound treatment, burns.
104-BL-16/07-GI-2

Hygienic and surgical hand disinfection.

How is it used?

What is Betaisodona and what is it used for?

Povidone-iodine is a broad-spectrum germicide. It is effective against bacteria, fungi, spores, viruses and certain protozoa.
Reliable disinfection largely prevents infections and promotes rapid, problem-free healing.
The development of resistance of infectious agents (resistance) to povidone-iodine is not to be feared due to the mode of action.
By binding to povidone, iodine largely loses the irritating properties of alcoholic iodine preparations and is well tolerated by skin, mucous membranes and wounds.
During the action, the iodine discolours, so the depth of the brown colour indicates its effectiveness. If discoloured, a follow-up dose is required. Povidone-iodine is water-soluble and easily washable.

Areas of application

• Skin and mucous membrane disinfection, such as before operations, gynaecological and obstetric measures, bladder catheterisation, tissue sampling (biopsies), injections, punctures (punctures) for fluid or blood collection, interventions on the eye
• Antiseptic wound treatment, burns
• Hygienic and surgical hand disinfection

If you do not feel better or even worse after a few days, contact your doctor.

What should you consider before taking it?

What should you consider before using Betaisodona?

Betaisodona solution standardised must NOT be used,

• if you are allergic to povidone-iodine or any of the other ingredients of this medicine listed in section 6,
• if you suffer from hyperthyroidism or other thyroid diseases,
• if you suffer from the rare chronic skin inflammation dermatitis herpetiformis Duhring,
• with simultaneous use of mercury-containing preparations,
• before, during and after radio-iodine scintigraphy or radiotherapy of the thyroid with iodine (radio-iodine therapy) until the end of treatment.

Warnings and precautions

Please talk to your doctor or pharmacist before using Betaisodona solution standardised.

• In newborns and infants up to the age of 6 months, Betaisodona solution standardised should only be used after strict benefit/risk assessment by the doctor and extremely limited. If necessary, thyroid function should be monitored.
• Accidental ingestion of Betaisodona solution standardised by newborns, infants and toddlers must be avoided. See section "Pregnancy, breastfeeding and
  Fertility" for safe use during this time.
• When using Betaisodona solution standardised in the throat area, care must be taken that the solution does not enter the windpipe. Otherwise, respiratory problems up to pneumonia may occur. This can occur especially in intubated patients.
• In the case of large-area burn treatment with povidone-iodine, the occurrence of
  Electrolyte disturbances and an associated impairment of kidney function can be promoted.
• After thyroid diseases (especially in elderly patients) or in the case of a goitre, povidone-iodine should only be used over a long period of time or over a large area after strict benefit/risk assessment by the doctor, as subsequent hyperthyroidism cannot be completely ruled out.
  Even after discontinuation of therapy (up to 3 months), these patients should be monitored for early symptoms of hyperthyroidism and, if necessary, thyroid function should be monitored.
• Influence on diagnostic tests:
  Under the use of povidone-iodine, the iodine uptake of the thyroid gland can be reduced, this can lead to disturbances in various examinations of the thyroid gland and make planned treatment (radio-iodine therapy) impossible. A period of 1 – 2 weeks after discontinuation of treatment with povidone-iodine should be observed.
  Due to the oxidising effect of povidone-iodine, various laboratory tests can 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 corrode, plastics are generally povidone-iodine-resistant. In individual cases, a usually transient discolouration may occur.
• For skin disinfection before operations, avoid accumulation of solution under the patient (due to possible skin irritation). Prolonged contact can lead to irritation or, rarely, hypersensitivity reactions of the skin. Furthermore, accumulation can lead to burns to the skin. If skin irritation, contact dermatitis or hypersensitivity occurs, the application should be discontinued. Do not heat before use. Keep out of reach of children.
• Povidone-iodine can be easily removed from textiles and other materials with warm water and soap, in stubborn cases with sal ammoniac (ammonia) or fixing salt (sodium thiosulphate solution).

Use of Betaisodona solution standardised together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.
Do NOT use

• Betaisodona solution standardised and hydrogen peroxide, enzymatic or silver-containing wound treatment agents or disinfectants, as this leads to mutual weakening of the effect,
• Betaisodona solution standardised and mercury-containing preparations, as a corrosive compound (mercury iodide) can form,
• Betaisodona solution standardised and octenidine-containing wound treatment agents, as temporary dark discolouration may occur,
• Betaisodona solution standardised and taurolidine, a chemotherapeutic agent against bacteria and fungi, as taurolidine can be converted into an acid (formic acid) that causes intense burning.

Protein, blood or pus components can impair the effectiveness of Betaisodona solution standardised.

If you are receiving lithium therapy, Betaisodona solution standardised should be used with caution and only for a short period of time. In this case, larger amounts of iodine can be absorbed through the skin.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, 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 breastfeeding should only be carried out on the express instructions of the doctor, monitoring of thyroid function in the mother or infant is indicated. Treatment should only be short-term. Iodine passes through the placenta (placenta) into the foetus (unborn child) and also passes into breast milk.
Accidental oral ingestion of Betaisodona solution by the infant through contact with the treated part of the body of the breastfeeding mother must be avoided.

Driving and operating machinery

Betaisodona solution standardised has no influence on the ability to drive and use machines.

How should the medicine be taken?

How to use Betaisodona?

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

Betaisodona solution standardised for external use only, undiluted or diluted (for application to the skin and eyes, for application to the wound or for local application).

Do not pour into hot water and do not heat!

The solution is not suitable for ingestion.

For wound treatment (burns and other wounds), hand disinfection and skin disinfection, before surgical procedures, bladder catheterisation, injections, tissue sampling (biopsies), injections, punctures (punctures) for fluid or blood collection, Betaisodona solution standardised should be used undiluted. Multiple daily applications are possible.

Skin disinfection before injections, punctures (punctures) and blood collection, for example:

apply undiluted, allow to dry

Skin disinfection before operations

rub in undiluted and keep skin moist with it for 5 minutes

Disinfection before operations of mucous membranes and the adjacent skin area:

rinse undiluted for at least 30 seconds or wet completely

Hygienic hand disinfection:

2 x 3 ml undiluted - each with 30 seconds exposure time

Surgical hand disinfection:

2 x 5 ml undiluted – each with 2.5 minutes exposure time

When preparing for an operation, avoid accumulation of Betaisodona solution standardised under the patient (due to possible skin irritation from prolonged contact). Furthermore, accumulation can lead to burns to the skin.

Betaisodona solution standardised can be used diluted with tap water, physiological saline solution or Ringer's solution for the following applications. A screw cap holds 5 ml (for pack sizes of 15 ml and 100 ml).

The following dilutions are recommended:

Application

Dilution

for example

Moist compresses	1 : 5 to 1 : 10	200 - 100 ml to 1 litre (water)
Sitz and immersion baths	1 : 25	40 ml to 1 litre (water)
Hygienic full bath	1 : 1000	10 ml to 10 litres
Preoperative bath (before an operation)	1 : 100	10 ml to 1 litre
Vaginal irrigation
1 : 25	4 ml to 100 ml
Insertion of the "coil" (IUP insertion)
Irrigation of the perineum (perineal area)
Urological irrigation
Irrigation in orthopaedics and
1 : 10	10 ml to 100 ml
Traumatology
Irrigation in maxillofacial surgery
Irrigations in the context of
1 : 2 to 1 : 20	50 ml to 5 ml to 100 ml
Wound treatment, for example of
chronic wounds
(pressure sores,
leg ulcers, burns) and
Surgical wounds

Interventions on the eye: The dilution is prepared as a sterile dilution by your doctor or pharmacist.
Diluted solutions should only be prepared immediately before use and used as soon as possible.
For wound treatment, Betadona wound gel is also available for application to the wound after using Betaisodona solution standardised.
Do not use Betaisodona solution standardised together with wound treatment agents other than Betaisodona.

Newborns and infants under 6 months

In newborns and infants up to the age of 6 months, Betaisodona solution standardised should only be used after strict benefit/risk assessment by the doctor and extremely limited.

If you have used more Betaisodona solution standardised than you should,

please read section 4. What side effects are possible?
Information for doctors or medical professionals on overdose therapy can be found at the end of the package leaflet.

If you have accidentally swallowed a large amount of Betaisodona solution standardised have,

please contact your doctor immediately.
After accidental ingestion of a very large amount of povidone-iodine (oral intoxication,
Ingestion of more than 10 g of povidone-iodine (equivalent to 100 ml of the solution)) the following symptoms may occur: abdominal pain and cramps, nausea, vomiting, diarrhoea, dehydration, drop in blood pressure, bleeding tendency, kidney damage, urinary retention, oxygen deficiency, circulatory collapse, nerve sensitivity disorder, laryngeal swelling, pulmonary oedema and fever. Note for the doctor: Information on overdose therapy can be found at the end of this package leaflet.

If you have forgotten to use Betaisodona solution standardised

Do not use double the amount if you have forgotten the previous application.

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

What side effects are possible?

How should Betaisodona solution standardised be stored?

Do not store above 25 °C.

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the plastic bottle and carton after "Usable until:". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special storage conditions

5. How should Betaisodona solution standardised be stored?

Do not store above 25 °C.

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the plastic bottle and carton after,,Usable until:" The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special notes on the content

Contents of the pack and further information

What Betaisodona solution standardised contains
The active ingredient is:

Povidone-iodine
100 ml Betaisodona solution standardised contains 10 g povidone-iodine complex with a content of 11 % available iodine.

The other ingredients are:

Glycerol, nonoxinol 9, anhydrous sodium monohydrogen phosphate, anhydrous citric acid, sodium hydroxide, potassium iodate, purified water

What Betaisodona solution standardised looks like and contents of the pack

Red-brown clear solution in 15 ml, 100 ml, 500 ml, 1000 ml and multipack of 5 x 1000 ml.