SEPTANEST . Adrenalin solution  68 mg. / 8.5 mcg.

Drugs - Qualitative and quantitative composition of 1.7 ml cartridge
Articaine HYDROCHLORIDE - 68.000mg;
Adrenalin TARTRATE - 0.0085mg.

Excipients
Sodium chloride ;
Sodium disulfide ;
Sodium edetate ;
Water for Injections.

formulation
Solution for injection in 1.7mg;
Cardboard box containing 50 rounds.

Pharmacotherapeutic group
local anesthetic

Name and address of the manufacturer and the holder of the marketing authorization
LABORATORIES SEPTODONT,
France

2 . Indications
Local and nerve anesthesia in dental surgery for adults and children over 4 years.

3 . ATTENTION
In what cases should not use this product .
Contraindications
This medicine should not be used in case of hypersensitivity ( allergy) to local anesthetics or to any component of the formulation in the following cases :
severe disturbances in atrioventricular conduction of the heart, uncontrolled with pacemakers ;
epileptic seizures, uncontrolled drug ;
porphyria .
Usually , this medicine should not be used in combination with other drugs , such as guanethidine and loved him products (eg anti- glaucoma drugs) unless prescribed by a doctor (see interaction with other drugs ) .

Special warnings and precautions for use
This product contains 1/200.000 adrenaline.
You should take into account the risk of causing local necrosis in allergic and diabetic patients.
Risk of anesteziofagiya : various small pursed ( lips, cheeks , mucosa , tongue ) ; Warn the patient to avoid chewing gum and nutrition to restore sensitivity .
This product is not recommended for use in children under 4 years due to the inconvenience of using anesthetic technique under this age.
Avoid injection of anesthetic into infected or inflamed tissues (reduce the
Effects of anesthesia ) .

Precautions:
Before using this medicine , you should :
medical history for common diseases of the patients using past and present therapy;
Testing can be done by pre- injection of 5 to 10% of the dose required for patients with allergies;
Inject slowly, repeatedly aspirated to make sure that the anesthetic does not penetrate directly into a blood vessel ;
maintain verbal contact with the patient .
Caution in patients on anti- coagulant therapy ( to monitor INR).

Due to the presence of epinephrine must be caution in the following cases:
any type of arrhythmia, except bradycardia ;
coronary lesions ;
hypertension.
In case of severe hepatic insufficiency may be necessary to reduce the dose of articaine as an amide -type local anesthetic is metabolized in the liver.
The amount of the anesthetic is to be reduced in the case of hypoxia, hyperkalemia or metabolic acidosis.
Co-administration of anesthetic with another medicine ( see: Interaction with other medicinal products ) requires close monitoring of clinical and biological state of the patient.

4 . Interaction with other medicinal products and other forms of interaction
To avoid interactions between different medicinal products should be aware of all drug used at present.
Absolute contraindications is applying SEPTANEST in combination with guanethidine and similar compounds to him ( antiglaucoma medications) . Apply only under strict medical supervision in combination with:
all classes of antidepressants (for example, Venlafaxine and Minaltsipran ): upon receipt of imipramine, and serotonolititsi noradrenalinolititsi , MAO inhibitors ( iproniazid , Moclobemide , toloxatone ) anesthetic should be reduced , e. : at least 0.1 mg epinephrine or 10 min 0.3 mg in 1 hour in adults ;
volatile anesthetics of the halogen -based (and promote cardiac reactivity ) - the amount of the anesthetic should also be reduced , e. at least about 0.1 mg epinephrine or 0.1 min 0.Z mg for 1 hour in adults.

5 . Pregnancy
This medicine should not be used during pregnancy unless absolutely necessary.
Like any other local anesthetic articaine is excreted in human breast milk in very small quantities. However, breastfeeding can continue after the anesthetic action pass.

6 . Driving and using machines
This product may have a minimal effect on ability to drive and use machines.

7 . Athletes
Athletes should be aware that this product contains an active substance which is likely to give a positive test for doping control.

8 . How to use this product
8.1. dosage
For adults and children over 4 years.

adults
The quantity to be injected depends on the size of the operative site . As a general rule , used by half to one carpoule routine manipulation. Do not exceed the equivalent of 7 mg articaine hydrochloride per kilogram of body weight .

Children ( over 4 years)
The amount to be injected is determined by the child's age , weight and the type of manipulation. The recommended maximum dose is 5mg articaine hydrochloride (0.125ml of anesthetic ) per kilogram body weight . The average dose articaine hydrochloride in mg which may be administered to children , is calculated as follows :
The child's weight (in kilograms ) x 1.33

Patients in the older age
Apply half of the adult dose .

8.2. Method and place of application
Local or regional intraoral submucosal INJECTION
Make sure you have not penetrated a blood vessel by repeated aspiration tests , especially in wire anesthesia. The amount of inputs solution should not exceed about 1 minute 1ml

9. Instructions for Use / Handling
Like other Kaprun , the diaphragm should be disinfected just before taking her Caution should be cleaned with a sponge :
or with 70% ethyl alcohol ;
or 90 % pure isopropyl alcohol;
Kaprun shall in no case be soaked in any solution ;
The anesthetic solution must be mixed with another product in the syringe ;
Not Opened cartridges of anesthetic solution can be used again.

10 . Duration of application
Once.

11 . Measures should be taken in overdose
The toxic effects may arise as a result of an overdose of anesthetic , can occur in two ways:
instant due to relative overdose due to inadvertent injection of anesthetic and get in a blood vessel , or ;
delayed due to the real overdose by introducing a large amount of anesthetic

12. Measures in case of emergency
As soon as these symptoms occur , the patient should breathe deeply and , if necessary, placed in the supine position. If they start myoclonic seizures, the patient ventilated with oxygen and inject the benzodiazepine. You may need endotracheal intubation with hardware breathing.

13.Nezhelani effects
As with all anesthetics used in dentistry , and the use of SEPTANEST 1/200.000 can be expected lipotomii . This product contains sodium metabisulphite , which may cause allergic reactions on the whole organism , and abnormal breathing .
In case of overdose or in predisposed patients may be observed following clinical manifestations :
Central Nervous System : Nervousness , anxiety , yawning, tremor, spasm of fear, nystagmus, logorea , headache, nausea , ringing in the ears. When these events are present , ask the patient to breathe deeply and begin to continuously monitor vital signs to avoid deterioration , such as convulsions, caused by CNS depression.
Respiratory SYSTEM : Rapid breathing followed by slow breathing and as a possible result of lack of breathing.
Cardio - vascular system: fast heartbeat , slow heartbeat, cardiovascular shock with hypotension can lead to collapse, cardiac arrhythmia ( ventricular fibrillation and ventricular ekstrasistuli ), disorder of the heart conduction ( atrioventricular block). These symptoms can lead to cardiac arrest .

Please report any unwanted or disturbing effects not listed in this BROCHURE authorized for the Office or the manufacturer of SEPTANEST 1/200.000.

DO NOT USE after the expiration date marked on the carton.

15 . Special precautions
Do not store above 25 ° C and protected from light.
Do not freeze .
Keep out of reach of children .