LUAN GEL 100G 1% CHURCH

LUAN GEL

active ingredients

LUAN 2.5 % gel 100 g contain: Lidocaine hydrochloride g 2,5 Excipients: ethyl p–hydroxybenzoate, ethyl p–hydroxybenzoate, propile p–hydroxybenzoate, sodium benzoate For the full list of excipients, see paragraph 6.1 LUAN 1% gel 100 g contain: Lidocaine hydrochloride g 1 Excipients: ethyl p–hydroxybenzoate, ethyl p–hydroxybenzoate, propile p–hydroxybenzoate, sodium benzoate For the full list of excipients, see paragraph 6.1

Excellent

LUAN 2.5 % gel Excipients: sodium carmellose, glycerol, methyl p–hydroxybenzoate, ethyl p–hydroxybenzoate, propile p–hydroxybenzoate, sodium benzoate, purified water. LUAN 1% gel Excipients: sodium carmellose, glycerol, methyl p–hydroxybenzoate, ethyl p–hydroxybenzoate, propile p–hydroxybenzoate, sodium benzoate, purified water.

Therapeutic indications

• LUAN 2.5% gel: Facilitates endourethane maneuvers (introduction of catheters, expansions, cystoscopes, etc.) by combining the anesthetic lubricating action. • LUAN 1% gel: esophagoscopic intubazioni and anesthesia curarica, faringoscopie, tracheo–broncoscopie, gastroscopie and rettoscopie, and in all endoscopic indications with an exploratory and curative character. The product, combining the lubricating action with the anesthetic one, allows to avoid in endoscopic manoeuvres spastic reactions and reflections from the mucous membranes with which the instruments come in contact.

Contraindications

Hypersensitivity to local anaesthetics of amidic type or to any of the excipients.

Population

LUAN 2,5% gel Push the ointment directly into the urethra by crushing the tube and massaging at the same time the back urethra, applying a urethra caliper for 10 minutes, after which you can practice the desired endouretral maneuvers. The content of the tube is sufficient to fill the urethra completely. In order to facilitate the introduction of the medicine and to eliminate the pain that can be caused by the contact of the metal tip of the tube with particularly painful parts, the package is accompanied by a plastic extension to be screwed to the tube itself at the time of use. LUAN 1% gel Carefully smear a product layer on the tool before introducing it. The neutrality of the vehicle of both formulations of the product, its complete solubility in water and the absence of fatty substances cause, even with a continued use of LUAN, the lens of the instruments used for the various types of intubation and their rubber parts do not deteriorate. LUAN should be used with caution in patients who have severely damaged and sepsis mucosa in the region on which the application should be carried out. Pay attention to children, elderly people and seriously ill patients (see also paragraph 4.4 Special warnings and precautions of employment).

Conservation

This medicine does not require any special condition of conservation.

Warnings

The effectiveness and safety of lidocaine depend on a correct dosage and application technique. It is therefore necessary to use the minimum amount of the preparation sufficient to obtain the desired effect and to avoid the application for very long periods. The LUAN should be used with caution in patients with severely damaged mucous membranes or home to inflammatory or sepsis processes in the region in which the application should be carried out as it may have an excessive absorption of the active ingredient. High absorption of lidocaine can cause serious reactions to the load of S.N.C. and the cardiovascular apparatus in particular in children, elders and debilitated subjects (see paragraph 4.2). Products for topical application, especially if used for a protracted time or repeatedly, can give rise to awareness-raising phenomena. In this case it is necessary to stop the treatment and establish suitable therapy. Information about some excipients LUAN The medicine contains benzoate sodium: it can be slightly irritating to the skin, eyes and mucosa. The drug contains parahydroxybenzoates: it can cause allergic reactions, even delayed.

Interactions

Propionate prolongs the plasma half-life of lidocaine. The cimetidine can raise the plasma levels of lidocaine.

Effects

Locally there may be hypersensitivity reactions characterized by pain, burning, itching. Systemic reactions are generally rare. However, reactions from hypersensitivity to anaphylactic shock may occur. In the presence of irritated or injured skin, the risk of systemic absorption and toxicity increases. Treatment of vast areas and/or use of high dosages or increased body temperature, can increase the risk of systemic absorption and a potential increase in toxicity. 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.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Overdose symptoms (absolute or relative) are characterized by neuroeccitatory manifestations (tremors, convulsions followed by depression, respiratory failure and coma) and cardiovascular alterations with hypotension and bradycardia. Treatment is symptomatic. Any seizures may be controlled by short-acting barbituric or benzodiazepine administration.

Studies on rats and rabbits did not highlight risks to fetus. But his safety in man has not been established. This should be kept in mind before administration to pregnant women, especially in the early stages. Since lidocaine is distributed in breast milk, the use of topical preparations, especially when applied on the tracheobronchiale mucosa, must be used with caution in nursing women.

Source: Farmadati