Betadine ointment, 20 g, Egis Pharmaceutical

Indications:
Betadine solution: disinfection of skin and mucous membranes before injections, punctures, biopsies, transfusions, infusions; preoperative disinfection of skin and mucous membranes; aseptic wound treatment; treatment of bacterial and fungal skin infections; preoperative total or partial body disinfection (disinfectant baths).
Betadine Ointment: treatment of burns, septic and aseptic wounds, trophic ulcers, bedsores and other skin infections and superinfected dermatoses.
Betadine solution is an antiseptic with a broad antimicrobial spectrum (bactericidal, fungicidal, virucidal, protozoicidal), recommended for disinfection of skin and mucous membranes. The preparation contains active iodine as an antimicrobial agent. Surgical soap is recommended both in preoperative asepsis of hands and for routine hygiene of medical personnel. Betadine ointment is a preparation with a broad antimicrobial spectrum.

Composition:
The solution contains 100 mg PVP-iodine/ml (corresponding to 10 mg active iodine per ml); the surgical soap contains 7.5 mg PVP-iodine/ml; the ointment contains 100 mg PVP-iodine/mg.

Method of administration:
The solution can be used as is, undiluted, or in a 1/10 dilution depending on the application; (in undiluted form when perfect asepsis is sought, with an exposure of 1-2 minutes). For the treatment of wounds, burns, skin and mucous membrane infections, in a 1/10 dilution; for preoperative baths in a 1/100 dilution (uniform exposure for at least 2 minutes, then washing with warm water). Betadine dilutions are prepared immediately before use and are not stored as such; Betadine can be removed with warm water, or, textile stains with sodium thiosulfate. Soap is used only in undiluted form; for current medical practice 5 ml are sufficient, with an exposure of at least 1 minute; hands are then rinsed abundantly with warm water; preoperatively 10 ml are used for 2.5 minutes; the operation is repeated after washing the hands abundantly with sterile water (so a total of 20 ml Betadine for 5 minutes). The ointment: is applied to clean and dry skin whenever deemed necessary.

Contraindications:
Iodine sensitivity; thyroid pathology, dermatitis herpetiformis, before radioactive iodine treatments; severe renal failure; treatment of premature babies and newborns, pregnant women after the third month of pregnancy and during lactation (possibly only after an individual medical evaluation and under continuous supervision).

Precautions:
The brown color of Betadine indicates its effectiveness; the diminution or disappearance of the color indicates a decrease in antimicrobial activity; Betadine decomposes under the influence of light or at temperatures above 40 degrees; the antimicrobial effect is exerted at a pH between 2 and 7; it is not used together with enzymatic or mercury-based topical preparations; the PVP-iodine complex of Betadine is incompatible with reducing agents, alkaline salts and acids. In the case of soap, due to certain cases of sensitivity, it is recommended to test the product beforehand; Betadine is not used together with other antiseptics; contact with the eyes should be avoided. In thyroid pathologies, especially in the elderly, the ointment is only used under strict medical supervision; the same precautions should be taken in the case of newborns, young children, pregnant women and during breastfeeding.

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, the use of povidone iodine during pregnancy and breastfeeding should be as low 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) with high TSH (thyroid stimulating hormone) values ​​in the fetus or newborn. It may be necessary to monitor the child's thyroid gland function. It is imperative
possible oral ingestion of the solution by the infant is avoided.

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

Presentation:
20g

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.