SEPTANEST adrenaline solution 68 mg. 17 mcg. 50 pieces
Use medicament cautiously in patients suffering from hypertension or diabetes, because of the risk of local necrosis.
Risk of anesteziofagiya: rezlichni bite injuries (lips, cheek mucosa and tongue), patients should be warned to avoid chewing gum or food until no sensitivity.
SEPTANEST adrenaline solution 68 mg. / 17 mcg. 50 pieces
QUALITATIVE AND QUANTITATIVE COMPOSITION
Articaine hydrochloride 68.000 mg
Adrenaline tartrate 0.017 mg
1 cartridge of 1.7 ml
3 . PHARMACEUTICAL FORM
Solution for injection .
4 . CLINICAL DATA
4.1 Therapeutic indications
Local or loco- regional anesthesia in dentistry.
Dosage and method of administration
For adults and children over 4 years due to the inconvenience of applying
anesthetic technique under this age.
The amount which must be injected , for ^ ^ pZhzt amount of the transaction . As a general rule , use half to one patron of the session.
Do not exceed the equivalent of 7 t % articaine hydrochloride per kilogram of weight.
Children ( over 4 years)
The amount to be injected is determined by the child's age and the size of the operation.
The recommended dosage is an average of 5 mg articaine hydrochloride ( 0.125 ml of the anesthetic solution ) per kilogram of weight .
The maximum dose in t % of articaine hydrochloride, which is to be applied to a child is calculated as follows :
? the child's weight (in kilograms ) x 1.33
Patients over 65
Dose in the elderly should be halved
Method of administration
Local or regional intraoral submucosal injection.
You need to be sure that you will hit a blood vessel by performing repeated aspirations , especially in regional (block ) anesthesia.
The injection rate should not exceed 1 ml for 1 minute.
This product must be used in cases of hypersensitivity to local anesthetics or the components of the formulation and in the following situations:
• strong violation of atrioventrikularnta conductivity oez peismeikar
• history of epilepsy
Typically, this product should not be used in cases of treatment with other drugs, such as guanethidine and similar products (see " Interactions with other drugs ) .
Special precautions for use
THIS PRODUCT contains 1 /100, 000 Adrenalin
Use medicament cautiously in patients suffering from hypertension or diabetes , because of the risk of local necrosis.
Risk of anesteziofagiya : rezlichni bite injuries ( lips, cheek mucosa and tongue ), patients should be warned to avoid chewing gum or food until no sensitivity.
The product is not recommended for children under 4 years due to the inconvenience of the application of anesthetic technique at this age.
The effect of local anesthetics may be reduced , if injected into an inflamed or infected site.
Athletes should be aware that this medicine contains an active ingredient that is likely to induce a positive reaction in doping control tests .
Use of this product requires:
• preliminary inquiry regarding past or current illnesses or ongoing treatment
• in the case of a history of allergic reaction to be carried out with a test injection of 5 to 10 % of the dose
• be slowly , always after aspiration, to ensure that the product is injected strictly extravasated
• to maintain verbal contact with the patient
Caution should be exercised in patients taking anti- coagulants ( to monitor INR).
Because of the adrenaline , you should take precautionary measures in the following cases:
• each type of arrhythmia except bradycardia
• severe hypertension
• coronary disorders
In case of severe hepatocellular insufficiency may be necessary to reduce the dose of articaine as local anesthetics of the amide type are mainly processed by the liver.
Co-administration of this anesthetic with other drugs (see " Interactions with other medicines' ) requires continuous monitoring of the clinical and biologically condition of the patient .
Interaction with other medicaments and other forms of interaction
combinations not recommended
Due to the presence of adrenaline
? guanethidine and similar medicines (anti- glaucoma agents ):
Significant rise in blood pressure ( hyperreactivity associated with a decrease in tone and / or preventing the penetration of adrenaline in sympathetic fibers)
If it can not avoid such a combination , use carefully in a small amount of adrenaline.
Combinations requiring caution
Due to the presence of adrenaline
? Halogenated anesthetics
Severe ventricular arrhythmias (increased reactivity of the heart muscle ) .
Warnings to use : Limit the amount of the anesthetic , for example, less than 0.1 mg epinephrine for 10 min or 0.3 mg in 1 hour in adults.
? antidepressant Imipramine :
Paroxysmal hypertension with possible arrhythmia ( difficult access of adrenaline or noradrenaline at sympathetic fibers). Warnings to use : Limit the amount of the anesthetic , for example, less than 0.1 mg of epinephrine for 10 min or O , 3 mg per hour for adults.
? Serotonergic and noradrenergic antidepressants ( prescription minaltsipran and venlafaxine )
Proksizmalna hypertension with possible arrhythmia ( difficult access of adrenaline and noradrenaline in sympathetic fibers).
Warnings for use: Limited quantities eg less than 0.1 mg epinephrine for 10 min or 0.3 mg per hour in adults.
prompt measures to prevent any deterioration as a seizure followed by CNS depression ;
• respiratory symptoms : tachypnea , then bradypnea which can pass into the apnea ;
• cardiovascular signs : reduction of contractile force of the myocardium , slow heart rate and low blood pressure , tachycardia, cardiac arrhythmias ( ventricular premature complexes and ventricular fibrillation ) , conduction abnormalities ( atrioventricular block) ;
These symptoms can lead to cardiac arrest.
Toxic effects ( overdose of local anesthetic ) can occur in two ways:
• immediately, in case of accidental intravenous injection , as an expression of relative overdose
• or later , due to true after an overdose injection of a large quantity of anesthetic .
Manifestations of neurologic toxicity is treated by :
• placed in the supine position
• oxygen supply
If a myoclonus , administer oxygen and an injection of benzodiazepine.
Treatment may require endotracheal intubation with artificial respiration.
5 . Pharmacological Properties
5.1 Pharmacodynamic properties
Local anesthetic for injection for dental use / articaine
Articaine hydrochloride is a local anesthetic of the amide type , which blocks impulse conduction along nerve fibers located in the vicinity of the injection site.
Was added to a solution of epinephrine (1/100 , 000) reduces bleeding during surgery reduces passage of articaine in the general circulation , and thus provides long-term maintenance of actin tissue concentration
? Non-selective MAO inhibitors ( iproniazid )
Presivnoto increase adrenaline and nor adrenaline and more often moderate .
For use under strict medical supervision.
? A selective MAO inhibitors ( moclobemide, toloxatone ) with extrapolation of non-selective MAO inhibitors.
Risk of increasing presivnoto action. For use under strict medical supervision.
Pregnancy and lactation
Studies in animals have not shown evidence of teratogenicity. Absence of teratogenicity in animals means that they can not be expected malformations in humans.
Until now , no clinical data on the possibility of malformation or foetotoxic effects of articaine when administered during pregnancy .
Therefore articaine should be used during pregnancy in dentistry only if absolutely necessary.
Like any other local anesthetic articaine is excreted in breast milk in very small quantities. However, it is recommended that nursing be conducted after the slimming effect of the anesthetic .
Influence when driving or operating machinery
This medicinal product may alter the responsiveness when driving or operating machinery.
As with certain anesthetics, used in dentistry , it is possible
appear lipotomiya .
This product contains sodium metabisulphite , which may cause or aggravate anaphylaxis .
In the case of overdose or individual sensitivity possibly
observed the following reactions :
• symptoms of central nervous system: restlessness,
numbness , restlessness, nystagmus, logoreya , tremor , headache, nausea , noise
Anesthesia is obtained quickly - 2 to Zmin . The duration of anesthesia during the surgery was approximately 60 minutes. In pulpal anesthesia is 2 to 3 times shorter .
5.2 Pharmacokinetic properties
Artikainat when injected intra- oral mucosa , reaching peak plasma concentrations within 30 minutes after injection.
Half-life time of the anesthetic is about 110 minutes.
Articaine hydrochloride is metabolized by the liver , 5 to 10% of the dose is excreted unchanged in the urine.
5.3 Preclinical safety data
Studies conducted on animals showed that articaine is well tolerated by the body.
As with any type of local anesthetic amine type aktivnvta substance in large doses can cause toxic effects on the CNS and cardiovascular system (see " Undesirable effects").
6 . PHARMACEUTICAL PARTICULARS
Sodium chloride - 2,720 mg
Sodium metabisulfite - 0,850 mg
Sodium edetate - 0,425
Sodium hydroxide solution - pH = 5.3 0.2
Water for Injection - 1.7 ml
Not been established.