Betadine solution, 30 ml, Egis Pharmaceuticals

Indications :
Betadine solution is a broad-spectrum antiseptic agent, acting against bacteria, viruses, fungi and protozoa.
It is used for disinfection of the skin before injections, transfusions, infusions, blood sampling, biopsies; for asepsis of wounds, skin burns, preoperative disinfection of the skin and mucous membranes. It can also be used for preoperative baths (total or partial disinfection of patients).

Composition:
One ml of solution contains 10 mg of active iodine as a disinfectant agent and excipients: glycerin, nonoxynol 9, anhydrous disodium hydrogen phosphate, anhydrous citric acid, sodium hydroxide, purified water.

Method of administration:
Betadine solution is applied either as is or as a 10% or 1% dilution, depending on the indication and the area to which it is applied:
- application of Betadine solution as such, for disinfection of intact skin before injections, transfusions, infusions, blood sampling, punctures, biopsies. The exposure period should not be shorter than 1-2 minutes.
- application of Betadine 10% aqueous solution (diluted 1:10 with water) for wound cleaning and treatment of skin burns, for disinfection of mucous membranes and in bacterial or fungal skin infections.
- application of Betadine 1% aqueous solution (diluted 1:100 with water) for preoperative baths. The patient should be washed evenly over the entire body surface and after 2 minutes of exposure, rinse with warm water.
Betadine solution should always be diluted immediately before use; unused diluted solutions should not be stored. Betadine solution stains can be removed from clothes by washing with warm water, and for persistent stains, sodium thiosulfate solution should be used.

Contraindications:
Treatment with Betadine solution should not be used in case of hypersensitivity (allergy) to povidone, iodine or any of the product's excipients, thyroid conditions (hyperthyroidism, thyroid adenoma), newborns, during pregnancy and breastfeeding.
Treatment with Betadine solution should be avoided in cases of dermatitis herpetiformis Duhring, renal failure, during treatment with thyroid hormones and before radioactive iodine therapy. It should also be avoided in infants and children under 30 months.

Tell your doctor before starting treatment if:
- you have had an unpleasant reaction to any of the ingredients listed in the 'What your medicine contains?' section.
- you suffer from a thyroid condition
- you are pregnant or breastfeeding
- you suffer from a vesicular skin disease (Dermatitis herpetiformis Duhring)
- you suffer from kidney failure
In infants and children under 30 months, the product can only be used on the advice of a doctor, after a functional examination of the thyroid gland.

Pregnancy, lactation and fertility:
During pregnancy and breastfeeding, povidone iodine should only be used if strictly indicated and for the shortest possible period of time.
Since iodine crosses the placenta and is excreted in breast milk and because of the increased sensitivity of the fetus or newborn to iodine, during pregnancy and breastfeeding the use of povidone iodine should be done in as small quantities as possible. Furthermore, the concentration of iodine is higher in breast milk compared to the concentration in serum. The use of povidone iodine may induce transient hypothyroidism (reduced thyroid gland activity) in the fetus or newborn. It may be necessary to monitor the thyroid gland function of the child. Possible oral ingestion of the solution by the infant must be avoided.

Driving and using machines:
Betadine does not affect the ability to drive or use machines.

Presentation:
30 ml

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.