Solution for injection in 1.7 ml cartridges – carton box containing 50 units
INJECTABLE LOCAL ANAESTHETIC FOR DENTAL USE / ARTICAINE (ATC code: N01 BB 58)
Manufacturer's name and address
SEPTODONT 58, Rue du Pont de Créteil. 94100 Saint-Maur-des-Fossés, France
IN WHICH CASE SHOULD THIS MEDICINAL PRODUCT BE USED (Therapeutic indications)
This medicinal product is recommended in adults and children over 4 years of age for local or loco- regional anaesthesia in dental surgery.
WARNINGS In which cases should such a medicinal product not be used (Contraindications)
This medicinal product SHOULD NOT BE USED in case of hypersensitivity (allergy) to local anaesthetics or to any components of its formulation, and in the following situations :
Usually, this medicinal product SHOULD NOT BE USED in case of treatment with guanethidine and related products (anti-glaucomatous agents), unless medically advised.
THIS PRODUCT CONTAINS 1/100,000 ADRENALINE.
The risk of local necrosis in hypertensive or diabetic patients should be taken into account.
Risk of anesthesiophagia : various biting trauma (lips, cheeks, mucosae, tongue); the patient should be told to avoid chewing-gum or food as long as there is no sensitivity.
This product is not recommended in children under 4 years of age because of the unsuitability of the anaesthetic technique to this age.
Avoid injecting into infected or inflammatory tissues (it minimises the effectiveness of the local anaesthetic).
Precautions for use
The use of this product imperatively requires :
Monitoring should be increased in patients under anti-coagulants (monitoring of the INR).
Due to the presence of adrenaline, precautions and monitoring should be increased in the following cases:
In case of severe hepatic insufficiency, it may be necessary to reduce the dose of articaine since amide type local anaesthetics are mainly metabolised by the liver.
Posology should also be reduced in case of hypoxia, hyperkaliaemia or metabolic acidosis.
Concurrent administration of this anaesthetic with some other medicines (see “interactions with other medicaments”) requires a constant observation of the patient’s clinical and biological state.
Pregnancy - Lactation
This drug should only be used in pregnancy when absolutely necessary. Lactation may be carried on after a local anaesthesia in dentistry.
AS A GENERAL RULE, IT IS ADVISABLE, DURING PREGNANCY AND LACTATION TO ALWAYS REFER TO YOUR DOCTOR OR DENTIST BEFORE TAKING ANY MEDICATION.
Drivers and machine operators
This medicinal product can alter reaction abilities to drive and use machines.
Sportspeople should be warned that this medicinal product is likely to induce a positive reaction to tests undertaken in anti-doping controls.
List of excipients, the knowledge of which is required in order to be used safely in certain patients
HOW TO USE THIS MEDICINE
For adults and children over 4 years of age only.
The quantity to be injected will depend on the size of the operation. As a general rule, use half a cartridge to one cartridge per session.
Do not exceed the equivalent of 7 mg of articaine hydrochloride per kilogram of body weight.
Children (over 4 years of age)
The quantity to be injected should be determined by the age and weight of the child and by the type of operation to be performed.
The maximal dose is 5 mg articaine hydrochloride (0.125 ml of anaesthetic solution) per kilogram of body weight.
The recommended average dose in mg of articaine hydrochloride, which can be administered in
children, is calculated as follows: child’s weight (in kilograms) x 1.33
The dose used in adults should be reduced by half.
Method and route of administration
LOCAL OR REGIONAL SUB-MUCOUS INTRAORAL INJECTION.
Make sure that there is no insertion into a blood vessel by performing repeated aspiration tests, particularly for regional (block) anaesthesia.
Injection should not exceed 1 ml per minute. Directions, instructions for handling
. either with 70% ethyl alcohol,
. or with pure isopropyl alcohol (90%) for pharmaceutical use.
Duration of treatment
Out of Stock
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