UNIA Oktaseptal Skin Aerosol 30ml,UNIA Oktaseptal Aerozol Na Skórę 30ml,Oktaseptal

“Product information
The active substances are: octenidine dihydrochloride and phenoxyethanol.
100 g of cutaneous spray contains 0.10 g of octenidine dihydrochloride and 2 g of phenoxyethanol.
Excipients: glycerol 85%, sodium D-gluconate, cocamidopropyl betaine 30%, sodium hydroxide, purified water.

Dosage
Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist.
Application is to the skin. Oktaseptal should be used undiluted.

Disinfection of the skin and mucous membranes:
Soak a sterile swab with Oktaseptal and thoroughly rinse the areas to be treated. After thoroughly moistening the skin or mucous membranes with the drug, wait at least 1 minute. After the doctor’s decision, Oktaseptal can be sprayed directly onto the skin or mucous membranes. The entire surface should be evenly moistened and left for at least 1 minute.

The drug has a disinfecting and anesthetic effect. It cleans wounds from dead tissues and secretions, stimulating the healing process. A sterile gauze pad should be soaked with Okaseptal and rinsed from the inside to the outside of the wound (not the other way around).

Attention
In order to avoid tissue damage and local swelling, the medicinal product should not be injected or introduced into the tissue under pressure. Always ensure adequate drainage from the wound (e.g. drain, suction). A sterile gauze pad soaked in Oktasepta l in the wound promotes the detachment of necrotic tissue, resulting in a faster wound healing.

Supportive in the treatment of mycoses of the skin, including tinea pedis of the feet:

The drug should be sprayed on the diseased areas of the skin in the morning and evening for 14 days.

Action
Oktaseptal is bactericidal, fungicidal and virucidal on the wound and skin surface.

Indications
It is intended for use on small wounds and for repeated short-term antiseptic treatment in the mucous membranes and adjacent tissues before diagnostic procedures
and before and after minor surgical procedures (e.g. in gynecology, urology, proctology, dermatology, geriatrics, venereology, obstetrics, dentistry) e.t.c.):

Warnings and Precautions
Oktaseptal must not be swallowed and must not be allowed to enter the bloodstream, especially in large amounts, e.g. as a result of accidental injection. As Oktasepta l is intended for limited-time adjuvant antiseptic treatment in interdigital mycosis only (in particular to prevent or reduce simultaneous bacterial superinfection), appropriate antifungal therapy should be administered. In such cases, patients should be informed in detail about the implemented treatment.

The use of an aqueous solution of octenidine (0.1%, with or without phenoxyethanol) for skin disinfection prior to invasive procedures has been associated with severe skin reactions in premature infants with low birth weight.

Any materials, covers or aprons soaked in the solution should be removed before proceeding with the next steps of the intervention. Do not use excessive amounts and do not allow the solution to accumulate in skin folds or under the patient, or to drip onto pads or other materials in direct contact with the patient. Before applying an occlusive dressing to previously treated areas with Oktaseptal, make sure that no excess product is left.

Pregnancy and breastfeeding
Pregnancy
Data obtained from a limited number of applications during pregnancy (300–1000 pregnant women, gestational age above 12 Hbd) do not indicate that the product containing octenidine dihydrochloride and phenoxyethanol causes malformations or is harmful to the fetus and / or the newborn.
Animal studies have shown no direct or indirect harmful effects on reproduction.
The use of Oktaseptal during pregnancy may be considered, if necessary.

Breast-feeding
Oktaseptal should not be applied to the breast area of ​​breast-feeding mothers.
There are insufficient data from animal studies and clinical trials on the use of the product containing octenidine dihydrochloride and phenoxyethanol during breastfeeding. Octenidine dihydrochloride is not or little absorbed, therefore it should be assumed that it does not pass into breast milk. Phenoxyethanol is rapidly and almost completely absorbed and is excreted almost entirely in oxidized form in the urine. Therefore, its presence in breast milk is unlikely

Fertility
The effect of Oktaseptal on fertility in humans has not been studied.
In animal studies, octenidine dihydrochloride had no adverse effects on fertility in rats. There are no data available on phenoxyethanol.

Driving and operating machinery
Oktaseptal has no influence on the ability to drive and use machines.”

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