Intubeaze 20 mg/ml Laryngopharyngeal Spray, Solution for Cats

Composition

Each ml contains:

Active substances:

Lidocaine 16.2 mg

(equivalent to lidocaine hydrochloride monohydrate 20 mg)

Each actuation (0.14 ml) contains:

Lidocaine 2.27 mg

(equivalent to lidocaine hydrochloride monohydrate 2.8 mg)

Excipients:

Clear, colourless liquid.

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Pharmacological properties

4.1 ATCvet code: QR02AD02

4.2 Pharmacodynamics

Lidocaine acts by preventing the generation and conduction of nerve impulses. It prevents the increase in permeability of excitable membranes to sodium ions. Small, non-myelinated nerve fibres are more susceptible than are large fibres and the sensation of pain is the first modality to be lost. The veterinary medicinal product has a duration of action of approximately 15 minutes.

4.3 Pharmacokinetics

Lidocaine is metabolised mainly in the liver and excreted via the kidneys. Approximately 95% is excreted via the form of various metabolites while 5% is excreted unchanged.

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Target species

Cats.

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Indications

Local anaesthesia of the laryngeal mucosa of the cat in order to facilitate endotracheal intubation by preventing the stimulation of the laryngeal reflex.

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Dosage

Laryngopharyngeal use.

Give one or two sprays at the back of the throat.

Prior to use, prime the pump until liquid is released. Minimum of 4 sprays are recommended for priming the bottle before first use and at least 2 sprays are recommended for re-priming if unused for 7 days or longer.

Each spray (approximately 0.14 ml) contains approximately 2.8 mg of lidocaine hydrochloride monohydrate, which corresponds to 2.27 mg of lidocaine.

Allow 30-90 seconds before attempting intubation, so that the larynx is relaxed.

It should be noted that when removing the actuator from the spray pump it should be done vertically and not at an angle to ensure the pin does not get damaged.

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Contraindications

Do not use in animals which are hypovolaemic or show heart block.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Use with care in cases with hepatic and or cardiac insufficiency.

It is advisable to cold sterilise the nozzle between uses to avoid the spread of infection.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Lidocaine and chlorocresol may cause hypersensitivity (allergic) reactions. People with known hypersensitivity to these substances should avoid contact with the veterinary medicinal product.

Accidental exposure to the veterinary medicinal product may lead to local effects such as numbing, and systemic effects, such as dizziness or drowsiness. Accidental exposure, particularly oral, eye and inhalation exposure, should be avoided. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product. Wash any exposed areas after use. If accidental exposure to eyes occurs, rinse with water.

In cases of severe or extended reactions, seek medical advice immediately and show the package leaflet or the label to the physician.

Lidocaine can form genotoxic and mutagenic metabolites in humans. These metabolites can also induce, in long-term toxicology studies in rats, carcinogenic effects at high doses.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy.

Pregnancy and lactation:

Use only according to the benefit-risk assessment by the responsible veterinarian. Laboratory studies in mice have shown evidence of foetotoxic effects at high doses.

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Interactions

None known.

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Overdose

Maintain a patent airway and support ventilation with oxygen.

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Special warnings

Laryngeal spasm can also be stimulated by removal of the endotracheal tube. This should be carried out while the patient is still under anaesthesia.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

Clear type I glass vial of 10 ml with a polypropylene/polyethylene spray pump and actuator.

Pack sizes:

Cardboard box with 1 x 10 ml vial.

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Storage

Do not store above 25 °C.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 3 months.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 50406/5032 Vm 50406/3027

8 DATE OF FIRST AUTHORISATION

1 November 2018

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

May 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

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Registration holder

Dechra Regulatory B.V.

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