Medicinal Products

DELTAZINE 40 mg / ml ADRENALINEE 1/200 000

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
Active ingredients: Articaine, Adrenaline
laboratory: Ato Zizine

Injectable solution for dental use
Case of 50 cartridges of 1 mL
All forms

Indication

Local or loco-regional anesthesia in odonto-stomatological practice.

Dosage DELTAZINE 40 mg / ml ADRENALINEE 1/200 000 Solution for injection for dental use Case of 50 cartridges of 1 mL

Reserved for adults and children from 4 years old due to the type of anesthesia not adapted before this age.

Dosage

Adult

The quantity to be injected will be adapted according to the importance of the intervention.

Typically, one half to one cartridge for routine surgery.

Do not exceed the dose of 7 mg articaine hydrochloride per kilogram of body weight.

Child (over 4 years old)

The quantity injected depends on the age, the weight of the child and the type of intervention to be performed.

The maximum dose is 5 mg of articaine hydrochloride (0.125 ml of anesthetic solution) per kilogram of body weight.

The average dose in mg of articaine hydrochloride, which can be administered in children, can be calculated as follows:

Weight of the child (in kilograms) × 1.33.

Elderly

Half of the dose reserved for adults.

Administration mode

LOCAL OR REGIONAL INJECTION IN SUB-MUCOSAL.

Verify that there is no vascular intrusion by repeated aspiration tests, especially during regional (truncular) anesthesia.

The injection speed must not exceed 1ml of solution per minute.

Against indications

This drug is contraindicated in case of hypersensitivity to local anesthetics or any of the components, and in the following situations:

· Severe and uncomplicated atrioventricular conduction disorders;

Epilepsy not controlled by treatment;

· Acute intermittent porphyria.

This drug is generally not recommended in combination with certain drugs such as guanethidine and related products (see section 4.5 ).

Adverse effects Deltazine 40 MG / ML Adrenalinee

As with all anesthetics used in odonto-stomatology, lipothymia can occur.

ADRENALINE-RELATED EFFECTS : Local necrosis (frequency unknown).

In case of overdose or in certain predisposed patients, the following clinical signs may be observed:

· On the central nervous system:

nervousness, agitation, yawning, trembling, apprehension, nystagmus, logorrhea, headache, nausea, tinnitus.

These signs of call require to ask the patient to hyperventilate, as well as a careful monitoring to prevent a possible aggravation with convulsions then depression of the CNS.

· On the respiratory system:

tachypnea then bradypnea can lead to apnea.

· On the cardiovascular system:

tachycardia, bradycardia, cardio-vascular depression with hypotension that may lead to collapse, rhythm disturbances (ventricular extrasystoles, ventricular fibrillation), conduction disturbance (atrioventricular block).

These cardiac manifestations can lead to cardiac arrest.

Other rare side effects due to articaine:

Alteration of nerve transmission (para, hypo and dysesthesia) may occur after administration of articaine. Recovery is usual but can be long, sometimes requiring more than two months.

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