BIALCOL MED SOL CUT300ML1MG/ML

BIALCOL MED 1 MG/ML EDUCATION

active ingredients

BIALCOL MED 1 mg/ml skin solution: 100 ml of solution contain: active ingredient benzoxonio chloride 100 mg. For the full list of excipients, see paragraph 6.1

Excellent

Isopropyl alcohol; acetone; acetate ethyl; glacial acetic acid; pine essence; diethylene ether monoethylene; octylphenol etoxylate; hydroxide sodium; purified water.

Therapeutic indications

Antisepsis and disinfection of the skin in the case of escoriations and superficial wounds of limited extension.

Contraindications

Hypersensitivity to the active ingredient benzoxonio chloride or to any of the excipients listed in paragraph 6.1 or to other quaternary ammonia compounds. Do not use on severely injured skin. Do not use it in the external acoustic meato. Do not use for mucous membrane disinfection. Do not use in body cavities or enteroclism. Do not use for disinfecting soft contact lenses.

Population

Population: For skin use. Method of administration: Apply a small amount locally, directly or using a sterile/cotton gauze, ensuring that the liquid does not accumulate in the skin folds of the patient, after cleaning the affected area with hot water and drying by touching slightly with a soft cloth. Repeat the application 4-5 times a day or as needed. Do not exceed recommended doses and use only for short periods of treatment (3 days).

Conservation

Keep the bottle closed. This medicine does not require any special storage temperature.

Warnings

Only for external use; it should not be ingested. Avoid contact with eyes, ears (auditive channel), mucous membranes (such as mouth and nose) and deep wounds. In case of accidental contact rinse well with plenty of water. It should not be used in body cavities or for enemaries. If the symptoms persist or the condition worsens (the wound is inflated, painful or accompanied by fever) or if a skin reaction occurs, stop use and consult your doctor. Do not use it frequently or for a long time without consulting your doctor. Do not apply on the breast during breastfeeding.

Interactions

No interaction studies have been carried out. However the potential for interaction with medicines is considered low as benzoxonio chloride is poorly absorbed after topical application. Avoid the contemporary use of other antiseptics or detergents.

Effects

Summary of Security Profile: In rare cases, skin irritation may occur which has no consequences and does not require a change of treatment. Prolonged and repeated application of the product on the skin is not recommended as it can occur urticaria, angioedema and anaphylactic reactions. Tabulate list of adverse reactions: Adverse reactions are listed below by classification for systems and organs and frequency. The frequencies are defined as: very common (≥1/10); common (≥1/100 a Organ Systems / Frequency Adverse reactions Immune system disorders   Very rare Anaphylactic reaction, angioedema, hives Pathologies of skin and subcutaneous tissue   Rare Skin irritation Notable Contact dermatitis 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 www.aifa.gov.it/content/segnalazionireazioni-avverse.

Overdosing

Synonyms Low systemic absorption of a topical application BIALCOL MED makes overdose very unlikely. While it is unlikely that accidental ingestion can cause systemic effects due to poor absorption of benzoxonio chloride, ingestion of high concentrations can cause esophageal damage and necrosis with symptoms such as nausea and vomiting. Symptoms of intoxication resulting in ingestion of significant amounts of quaternary ammonia compounds include: dispnea, cyanosis, asphyxia resulting from paralysis of respiratory muscles, depression of the Central Nervous System (SNC), hypotension and coma. In man the lethal dose is about 1-3 g. Treatment The treatment of poisoning is symptomatic. To administer, if necessary, emollient and diluent. Avoid vomiting and gastric lavender. Avoid alcohol as it promotes absorption. It is recommended that the immediate administration of milk or egg whites be thrown into the water. Active carbon can be considered if the patient is treated within an hour of ingestion. Corticosteroids can reduce oropharynxedema.

Pregnancy: There is no adequate data on the use of benzoxonio chloride in pregnant women. Studies of fetal toxicity in animals suggest no adverse effects (see paragraph 5.3). Potential risks for man are not known but are probably very low as benzoxonio chloride is poorly absorbed after topical application (see paragraph 5.2). BIALCOL MED can be used during pregnancy in small quantities (on small wounds). Nursing: It is not known whether benzoxonio chloride is excreted in breast milk. However it is unlikely that benzoxonio chloride can be present in breast milk in clinically significant quantities, as the product is poorly absorbed after topical application. BIALCOL MED can be used during breastfeeding in small quantities (on small wounds) except on breasts. Babies should not come into contact with treated skin. Fertility: No effect of benzoxonio chloride on fertility was seen in animal studies (see paragraph 5.3).

Source: Farmadati