Medicinal Products

ALCOHOLIC BETADINE 5%

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

Solution for cutaneous application
Box of 40 Single-dose containers of 10 ml
All forms

Indication

· Antisepsis of healthy skin before minor surgery

· Surgical antisepsis: preparation of the operative field.
Antiseptic agents are not sterilizing: they temporarily reduce the number of microorganisms.

Dosage ALCOHOLIC BETADINE 5% Solution for cutaneous application Box of 40 Single-dose containers of 10 ml

DERMAL

About 5 ml of product should be applied to the skin surface with a sterile pad for at least 10 seconds and with a drying time of about 30 seconds before the minor surgery procedure.

Surgical antisepsis: preparation of the operative field

· Skin cleansing with Betadine Scrub

· Rinse with 10 ml of physiological saline

· Drying with sterile compress

· Skin antisepsis in 2 successive applications of one minute of 5% alcoholic Betadine separated by a spontaneous drying time of one minute in the air.

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 iodinated contrast media or anaphylaxis to seafood are not a contraindication to the use of Betadine.

· Child less than 1 month old

This medicine is generally not recommended:

· During the third trimester of pregnancy and during lactation (see section on Pregnancy and lactation ).

· In combination with mercurial antiseptics (see section Interactions with other medicinal products and other forms of interaction ).

Adverse effects Betadine Alcoholic

In case of repeated and prolonged administrations, iodized overload can occur which may cause thyroid dysfunction, especially in the premature infants.

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

When applied to large areas systemic effects have been observed: renal function disorder with metabolic acidosis.

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

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