ORTODERMIN CREMA 3G 5%

ORTODERMIN CREMA AT 5%

active ingredients

100 g cream contains 6.15 g Lidocaine hydrochloride, equal to Lidocaine base 5 g. Excipients with known effects: cetostearilic alcohol, methyl phydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Cetostearilic alcohol, Macrogol cetostearile ether, Vaseline oil, White spindle Vaseline, P-hydroxybenzoate of methyl, Purified water.

Therapeutic indications

Anesthetic of the accessible mucous membranes of the gold-pharyngeal cable, ano-rectal itching. Anesthetic in case of slight lesions of the skin.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Apply the cream on the smooth side appropriately; if the skin shows tears, it is recommended to spread the cream by a sterile gauze pad. In dentistry, in the anesthesia of the oral cavity mucosa dry the latter with a cotton ball and with a saliva ejector in order to minimize the dilution of the cream and promote the maximum absorption of lidocaine. When adapting a new teether, lay the cream on the surface in contact with the mucosa (Important: the setup period). In case of itching anus - rectal, to facilitate administration, it is possible to use the applicator cannula (included in 3 g packaging). The daily application should not exceed 35 g of cream.

Conservation

Not necessary.

Warnings

ORTODERMINA must be used with caution by those who present a particularly traumatized and sepsis mucosa in the region intended for the application of cream. In any case the safety of use depends on the dosage, correct application technique and the adoption of precautionary measures. The product should be used at the least effective dose, conveniently reducing the dose in relation to age and physical state in children, elderly and sick in acute form.

Interactions

There are no known interactions with other substances.

Effects

With the use of lidocaine, local and general allergic reactions may occur until anaphylactoid manifestations. The appearance of systemic signs is rare and is due to excessive dosage, rapid absorption, hypersensitivity or reduced tolerance. In these cases cardiovascular depression and nervous excitement can occur followed by sedation with drowsiness or loss of consciousness. In such cases, appropriate urgent measures must be taken. 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/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

The excessive dosage, rapid absorption and hypersensitivity or reduced tolerance cause the appearance of cardiovascular depression and nervous excitement followed by sedation with drowsiness or loss of consciousness. In such cases, appropriate urgent measures must be taken.

In pregnant women and early childhood the product should only be used in case of actual need and under direct control of the doctor.

Source: Farmadati