ACIDO BORIDO SELLA 3% 500ML

ACIDO BORIDO SELLA 3% CUTANEA DEVELOPMENT

active ingredients

100 ml of solution contain Active ingredient: boric acid 3 g Excipient with known effects: benzalconio chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Benzalconio chloride Purified water

Therapeutic indications

Antiseptic for disinfection of minor burns and irritated or screpolated skin areas. The solution is also used in the form of decongestant action local buffers. Boric acid is indicated as an antibacterial for acne treatment.

Contraindications

4.3 Contraindications Boric acid is contraindicated in case of: - hypersensitivity to the active ingredient or any of the excipients; - extensive skin lesions; - children under 3 years of age.

Population

External use: apply to the need on the affected area. Adults Boric acid can be applied directly one or two times a day on inflamed areas in case of skin cracked, irritated or dry, abrasions, mild burns, sunburns, windburns or insect bites. Children over 3 years Boric acid can be applied directly one or two times a day on the inflamed areas associated with screpolated, irritated or dry skin, diaper dermatitis, mild burns, sunburns, windburns or insect bites.

Conservation

Keep the container well closed to protect the medicine from light.

Warnings

Excessive and prolonged application on extended areas or on loose skin can cause accumulation toxicity. Keep away from the reach of children, as deaths occurred as a result of accidental ingestion. The medicinal product should not be used for ophthalmic use. Important information about some excipients: 50 ml of this medicine contain 0.1 mg of benzalconium chloride. Benzalconio chloride can irritate the skin. If you are breastfeeding do not apply this medicine on the breast because the child could ingest them with his milk.

Interactions

There are no known interactions between boric acid for external use and other medicines.

Effects

The absorption of boric acid through the skin is less than 0.5%; however it may increase if administered accidentally by systemic or applied on wounds or injuries. Below are the undesirable effects of boric acid verified in case of accumulation toxicity, after prolonged exposure and following systemic absorption. These effects are organized according to the organic systemic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Pathologies of skin and subcutaneous tissue Dermatitis, rashes, alopecia. Gastrointestinal diseases Gastro-intestinal disorders: nausea, vomiting, diarrhea. Disorders of metabolism and nutrition Anorexia. Endocrine diseases Menstrual disorders. Emolinfopoietic system pathologies Anemia. Diseases of musculoskeletal system and connective tissue Boldness. Psychiatric disorders Confusion. Diseases of the nervous system Convulsions. 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

The risk of acute intoxication by skin appears a negligible event given its low transcutaneous absorption index. Boric acid can be absorbed in toxic quantities through the gastrointestinal tract, by inhalation or through skin lesions. Synonyms Following the use of large amounts of boric acid on wounds or wounds, especially in children, cases of poisoning and death occurred. The mechanism of toxic action is unknown and numerous are the organs and systems affected in particular the skin, kidney and digestive tube. The toxic effects also affect the SNC and the lung with lesions, mainly hemorrhagic, of dark genesis. The main symptoms of boric acid poisoning are vomiting, diarrhea, visceral pain, skin erythema followed by desquamation, stimulation of the SNC followed by depression, restlessness, headache. Frequent are also metabolic acidosis and serious hydrosaline imbalances. Moreover, boric acid in these situations can cause seizures, changes in body temperature and kidney damage that can be highlighted with oliguria. Death, following circular collapse and untreated shock, can occur within 3-5 days. Cyanosis, delirium, seizures and coma (HSDB) can also be checked. Cases of severe intoxication occurred with gastrointestinal disorders (73%), central nervous system (67%) and skin injuries (76%). Chronic poisoning symptoms include anorexia, confusion, debilitation, dermatitis, menstrual disorders, anemia, seizures and alopecia (see paragraph 4.8). Treatment No treatment is necessary if the dose taken is less than 50 mg/kg. For ingestion of higher doses, gastric lavender with suspension of activated charcoal and saline purgante. If the absorbed amount exceeds 100 mg/kg, even if the patient is still asymptomatic, a forced diuresis must be established immediately, in order to accelerate the elimination and protect the kidney from toxic effects; the first signs of kidney failure and overdose of water must be replaced by forced diuresis with peritoneal or hemodialysis. The remaining therapy is symptomatic and reanimation.

Pregnancy Clinical data relating to exposed pregnancy are not available. Animal studies are insufficient to highlight the effects on embryo/fetal development (see paragraph 5.3). The potential risk for man is not known, however, if the medicinal product is used in accordance with the methods of use, absorption is poor and therefore the risk of systemic effects is minimal. Food Data on the use of the medicinal product during breastfeeding are not available and is not known if this active ingredient passes into breast milk. However, since the absorption of the drug can be considered negligible, it is very unlikely that relevant quantities reach breast milk.

Source: Farmadati