ANAURAN GTT OTO FL 25ML

ANAURAN AURICULAR GOODS, DEVELOPMENT

active ingredients

100 ml of solution contain: Active ingredients Polymyxin B sulphate U.I. 1.000.000; Neomycin sulphate 0.500 g (equal to neomycin base 0,375 g); Lidocaine hydrochloride 4 g. Excipients with known effects: benzalconio chloride and propylene glycol. For the full list of excipients, see paragraph 6.1.

Excellent

Benzalconio chloride, Propilene glycol, Glicerol, Purified Water.

Therapeutic indications

Acute and chronic otites.

Contraindications

ANAURAN is contraindicated: - in patients with hypersensitivity to polymixine B sulphate, neomycin sulphate and Lidocaine hydrochloride and compounds closely related to a chemical point of view or any excipient; - in patients presenting the perforated timpanic membrane, due to the risk of ototoxicity.

Population

- Adults 4-5 drops, 2-4 times a day. - Children 2-3 drops, 3-4 times a day. Instill, by means of the appropriate dropper, in the headset holding the head bent on the side for a few minutes. The treatment period is variable in relation to the rapidity of the therapeutic response, it is recommended not to use the medicine more than 10 consecutive days.

Conservation

No special precaution.

Warnings

The prolonged use of topical products can give rise to awareness-raising phenomena. In this case stop treatment and consult your doctor to establish suitable therapy. In the presence of deep or resistant infections it is appropriate to supplement the local dressing with appropriate antibiotic treatments by general. As with other antibiotic preparations, prolonged treatments can give rise to superinfections from resistant germs. Neomycin can induce permanent loss of neurosensory hearing due to the damage of the coclea, especially with the destruction of the ciliate cells of the organ of the Court. The risk of ototoxicity is greater in case of prolonged use, therefore, it is recommended to have a limited treatment period of 10 consecutive days. Crusade allergy and crusade resistance can be verified with other aminoglycosidic derivatives. ANAURAN should be used exclusively in the otological field; applications in other locations are inappropriate. Important information about some excipients: The drug contains in every drop 0.001 mg benzalconio chloride, which can irritate the skin. The medicine contains in every drop 11.6 mg of glycol propylene that can cause skin irritation.

Interactions

No known studies of interactions with the active ingredients present in the medicinal product.

Effects

Following the administration of Anauran, the following adverse reactions were reported. Frequency cannot be defined on the basis of available data.

Classification for systems and organs	Adverse reactions
Pathologies of skin and subcutaneous tissue	Allergic dermatitis, itching
Systemic pathologies and conditions for administration	Irritation in application
Traumatism, poisoning and procedure complications	Ototoxicity (see paragraph 4.4)

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 through the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported.

Pregnancy

: There are no adequate and well-controlled studies in pregnant women. The medicinal product must be used in pregnancy only in cases of actual need and under direct medical control.

Nursing:

It must be used caution when the medicine is used by nursing women.

Source: Farmadati