Medicinal Products

DERMAL BETADINE 10%

Generic drug of the therapeutic class: Dermatology
active ingredients: Povidone iodine
laboratory: Meda Pharma

Solution for cutaneous application
Box of 10 single-dose containers of 5 ml
All forms

Indication

· Antisepsis of minor or superficial wounds or burns.

· Adjunctive treatment of diseases of the skin and mucosa originally bacterial or likely to be infected.

· Antisepsis of the skin of the operative field.

Note: antiseptic agents are not sterilizing. They temporarily reduce the number of microorganisms.

Dosage DERMAL BETADINE 10% Solution for cutaneous application Box of 10 Single-dose containers of 5 ml

Dermal.

Use pure or diluted.

· Pure: on the skin

· Diluted 1/10 with sterile water or saline for wound washing and 2% sterile saline for wound irrigation.

Against indications

This medicine MUST NOT BE USED in the following situations:

· History of allergy to one of the constituents, in particular povidone. There is no cross reaction with iodinated contrast media. Intolerance reactions (anaphylactoid reactions) to iodized contrast media or anaphylaxis to seafood are not a contraindication to the use of 10% DERMAL BETADINE,

· For the disinfection of medical and surgical equipment,

· In the newborn less than 1 month old.

· Prolonged during the 2nd and 3rd trimester of pregnancy.
Breastfeeding is contraindicated in case of prolonged treatment.

This medicine SHOULD NOT BE USED in combination with mercury-derived antiseptics (see section 4.5 ).

Betadine Dermal side effects

In the case of repeated and prolonged administration, iodine overload may occur which may cause thyroid dysfunction, especially in premature infants and fat burners.

Exceptionally hypersensitivity reactions: urticaria, angioedema, anaphylactic shock, anaphylactoid reaction have been described with products containing povidone including DERMAL BETADINE 10%.

When applied to large areas and burn victims, systemic effects have been observed: renal dysfunction with metabolic acidosis.

Local skin reactions may occur: caustic dermatitis with burns in the case of maceration and contact dermatitis.

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