Qualitative and quantitative composition
Each dose of Intermed XYLOJELL® Spray contains 10 mg of lidocaine in base form.
Excipient(s) with known action:
Propylene glycol (as a component of Banana flavor excipient).
Ethanol.
Pharmaceutical form
Spray
Intermed XYLOJELL® Spray is a clear or almost clear liquid with an ethanol, menthol and banana odor.
The active substance is dissolved in a mixture of water, ethanol and polyethylene glycol 400.
Therapeutic indications
Nasal procedures, e.g. puncture of the maxillary cavity.
Oral and dental procedures, e.g. before injection.
Operations on the oropharynx, e.g. esophagogastroscopy.
Interventions in the respiratory tract eg, insertion of tubes and other medical instruments.
Operations on the larynx, trachea and bronchi.
Interventions in obstetrics and gynecology, e.g. normal delivery, suturing after mucosal tear and cervical biopsies.
Intermed XYLOJELL® spray is indicated for adults and children ≥ 3 years of age
Dosage and method of administration
Intermed XYLOJELL® Spray is intended for use on mucous membranes and provides sufficient surface anesthesia, which lasts for approximately 10-15 minutes. The anesthetic effect is usually achieved within 1-3 minutes, depending on the area of application.
As with any local anesthetic, lidocaine's safety and effectiveness depend on proper dosage, proper technique, adequate
precautions for use and emergency preparedness.
The recommended lower dosage regimen should be considered as a guide.
The physician's clinical experience and knowledge of the patient's physical condition are of great importance when calculating the required dose.
Each actuation of the dosing valve releases 10 mg of lidocaine in base form.
There is no need to dry the spot before spraying.
Contraindications
Hypersensitivity to the active substance or to any of the excipients mentioned in paragraph 6.1
Hypersensitivity to local anesthetics of the amide type.
Special warnings and precautions for use
An overdose of lidocaine or short intervals between doses can lead to high plasma levels and serious side effects. Absorption from mucous membranes varies, but is particularly high from the bronchial tree.
Such sprays are therefore likely to cause rapid increases or excessive plasma concentrations, with an increased risk of toxic symptoms such as convulsions.
Lidocaine spray should be used with caution in patients with wounds or injured mucosa at the application site. The injured mucosa allows for increased systemic absorption.
Treatment of serious adverse reactions may require the use of resuscitation equipment, oxygen, and others.
List of executors
Ethanol (96%), Polyethylene glycol 400, Banana flavor, Levomenthol, Saccharin sodium, Water purified.
Lifetime
30 months at a temperature less than or equal to 25 ºC
Special precautions when storing the product
Do not store at a temperature above 25 °C. When stored at a temperature less than or equal to 8 °C, turbidity may appear.
Nature and ingredients of the container
Glass bottle of 50 ml with a mechanical spray pump with a dosing valve and a plastic spray nozzle. The vial is further packaged in a cardboard box along with a User Instruction Sheet.
Special precautions for disposal and other handling
The spray nozzle is ready in its final form and does not need any operation before use.
The nozzle should not be cut, otherwise the spray mechanism of the nebulizer will be damaged.
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