FARMAIOD 10% SOLUZ CUT FL100ML

FARMAIOD 10% CUTANINE

active ingredients

100 g contain Active Principle: Iodopovidone (10% iodine available) 10,00 g. For the full list of excipients, see paragraph 6.1

Excellent

Hetoxyl alcohol, bibasic phosphate sodium, anidro citric acid, glycerin, hydroxide sodium, purified water.

Therapeutic indications

Disinfection of the skin in the presence of small superficial wounds; Skin disinfection integrates; Delimitation of the operating field.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Children under 6 months. Hyperthyroidism. Do not apply on mucous membranes, on severely injured skin and on large surfaces (see paragraph 4.4). Do not use for peritoneal washing in the treatment of purulent peritonite: in these situations can greatly increase concentrations of iodine in the blood and consequently in the urine.

Population

The product is to be used in such a way as to cover skin and skin (see paragraph 4.1). Tampon the skin with cotton abundantly soaked of solution. Repeat, if necessary, for a maximum of 3-4 times a day. DON'T OVERDO IT.

Conservation

Store at temperature not exceeding 30°C, in the original packaging to repair the product from light.

Warnings

The product is for exclusive external use. Don't swallow. Ingestion or inhalation may lead to serious, sometimes fatal consequences. Avoid contact with eyes. Do not use for prolonged treatments: the use, especially if prolonged, of products for local use, can give rise to phenomena of hypersensitivity, in this case interrupt the treatment and establish the appropriate symptomatic treatment. Avoid use on excessively extended surfaces and do not apply with occlusive bandage. Extensive absorption of iodine connected with the use of iodopovidone, which cannot be eliminated through renal, or metabolized, can cause systemic adverse effects (e.g. metabolic acidosis, neutropenia), including well-known ones on thyroid function, such as transient hypothyroidism, or, in the cases of latent hyperthyroidism, the danger of destabilization and thyrotoxic crisis. If a prolonged use or extended surface is required, it is appropriate to test thyroid function, especially in patients with thyroid dysfunction and younger subjects. Stop the treatment at least 10 days before making a spark with marked iodine. Iodine absorption can interfere with thyroid function tests or with those of occult blood research in feces and urine, for the strongly oxidative properties of iodine. In pediatric age use only in case of actual need. Cases of hypothyroidism have been highlighted as a result of the application of iodopovidone on infants. In newborns it has been observed that the application of topical iodine antiseptics, at term and preterm, could cause transitional thyroid dysfunction (see paragraph 4.3). The heating of the solution above the 43 °C causes release of toxic vapours of iodine, for a weakening of the bond between iodine and povidone. After a short period of treatment without appreciable results, medical evaluation is required.

Interactions

Avoid the contemporary use of other antiseptics and/or detergents. Do not simultaneously use the treated sapon or pomate containing mercury or benzoin compounds.

Effects

Unknown-frequency side effects (frequency cannot be evaluated by available data), as a result of which it is necessary to stop processing: • intolerance (burn or irritation); • allergic reactions (such as tuberous dermatitis, dermatitis, etc.); • iodism (see paragraphs 4.4 and 4.9); • delay in scarring the lexious tissues; • interference with thyroid function tests. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose syndromes have been found under normal conditions of use. The application on burns or on vast surfaces without epithelium can produce the systemic effects of iodine. In case of overcoming, voluntary or accidental doses, hypothyroidism or hyperthyroidism may occur. They may also appear metallic flavor, increased salivation, burning or pain of the oral cavity and throat, irritation or swelling of the eyes, rashes, gastrointestinal turbes and diarrhea, metabolic acidosis, hypernatremia, kidney function deficit, pulmonary edema. To establish symptomatic treatment and support with special attention to the electrolytic balance and the kidney function deficit.

Use only in case of actual need and under direct medical control.

Source: Farmadati