Septodont Septanest 1:100,000

Indications

• Local or loco-regional dental anesthesia in patients of at least 4 years old

• Box containing 5 blisters of 10 x 1.7 ml glass cartridges

Pharmaceutical form

Solution for injection in 1.7 ml cartridges – carton box containing 50 units

Pharmaco-therapeutic class

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 :

• severe disorders of the atrio ventricular conduction non assisted by pace-maker
• epilepsy manifestations not controlled by any treatment,
• porphyria.

Usually, this medicinal product SHOULD NOT BE USED in case of treatment with guanethidine and related products (anti-glaucomatous agents), unless medically advised.

Special warnings

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 :

• a prior inquiry intended to know the patient's diathesis, current therapies and history,
• to perform a test injection of 5 to 10% of the dose in case of allergic reaction,
• to inject slowly, making repeated aspiration tests to check that the product is injected strictly out of the blood vessels,
• to keep verbal contact with the patient.

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:

• every type of arrhythmias except bradycardias
• coronary failure
• severe arterial hypertension

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

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

Sodium disulphite

HOW TO USE THIS MEDICINE

Posology

For adults and children over 4 years of age only.

Adults

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

Elderly patients

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

• As for any cartridge, the diaphragm should be disinfected just before use. It should be carefully swabbed:

. either with 70% ethyl alcohol,

. or with pure isopropyl alcohol (90%) for pharmaceutical use.

• Cartridges should not in any case be dipped into whatever solution
• The injectable solution should not be mixed with any other product into the same syringe.
• No open cartridge of anaesthetic solution should be reused.

Duration of treatment

Single use