Artifrin-Zdorovye Forte, (1:100000), carp. 1,7ml No. 10х5

General characteristics. Structure:

Main physical and chemical properties: transparent, colourless or slightly yellowish-greenish solution; structure: 1 ml contains an artikain of a hydrochloride (in recalculation for 100% substance) - 40 mg, Epinephrinum (in recalculation for 100% substance) - 10 mkg (in the form of a hydrochloride); excipients: sodium metabisulphite, glycine, sodium chloride, 1M acid solution hydrochloric, water for injections.

Pharmacological properties:

Pharmacodynamics. Artifrin-Zdorovye (1:100 000) is forte intended for local anesthesia in stomatology. Artikain – local anesthetic of amide type of thiafoehn group. In fabrics is exposed to hydrolysis and releases the basis having lipophilic properties and easily getting through a membrane in nerve fibril. It is ionized and transformed to a cation. Interacting with receptors, inhibits an entrance of ions of sodium to a cell in a phase of depolarization and blocks carrying out an impulse on nerve fibril. Epinephrinum (adrenaline) has vasoconstrictive effect thanks to what there is strengthening and prolongation of mestnoanesteziruyushchy effect of an artikain. Anesthesia after administration of drug develops in 1 - 3 minutes lasting effective surgical anesthesia not less than 75 minutes. Drug is characterized by good fabric tolerance and has no adverse effect on healing of a post-operational wound.

Pharmacokinetics. Artikain at submucosal introduction to an oral cavity shows high diffusion capacity. An elimination half-life – 25,3 minutes. Drug in the minimum degree gets through a placental barrier, is practically not emitted with breast milk.

Indications to use:

Infiltration and conduction anesthesia in stomatology at the following operations and manipulations:
- the mucous membrane or bone operations demanding the expressed effect of ischemia;
- operations on a tooth pulp (amputation and an extirpation of a pulp);
- removal of the broken tooth (osteotomy);
- an odontectomy, struck with an apical paradentit;
- Konduella-Luke's operation;
- transdermal osteosynthesis;
- kistektomiya;
- mukogingivalny operations;
- radectomy;
- preparation of carious cavities and teeth under a crown at patients with hypersensitivity of teeth. 

Route of administration and doses:

The drug dose Artifrin-Zdorovye forte is established individually, taking into account weight and duration of operational intervention.
At uncomplicated shchiptsovy extraction of an upper tooth in the absence of an inflammation of usually rather vestibular injection of 1,7 ml of drug on each tooth. In some cases the additional vestibular injection from 1 to 1,7 ml for ensuring full anesthesia can be required. For anesthesia at palatal cuts and at suture it is sufficient palatal depot injection in a dose of 0,1 ml. At multiple extractions by a number of the located teeth the quantity of vestibular injections usually manages to be limited.
At uncomplicated shchiptsovy extraction of the lower premolar tooths in the absence of an inflammation the injection as an infiltration anesthesia in a dose of 1,7 ml of drug on each tooth is usually sufficient. If it was not succeeded to reach full anesthesia, carry out an additional vestibular injection in a dose from 1 to 1,7 ml. In the absence of desirable effect it is necessary to carry out usual anesthesia by method of mandibular blockade.
For preparation of a cavity or preparation under a crown of any tooth, except for the lower painters, carry out a vestibular injection of drug in a dose of 0,5 - 1,7 ml on each tooth. The optimum dose depends on the desirable depth and duration of anesthesia.
The highest dose of an artikain for adults – 7 mg/kg (0,18 ml of solution/kg), for children – 5 mg/kg (0,13 ml/kg). Doses to 500 mg (12,5 ml of solution) are usually well transferred. To an injection it is always necessary to carry out trial aspiration for an exception of a possibility of intravascular introduction.

Features of use:

At use of drug carry for the first time out skin test: vnutrikozhno enter 0,02 ml of drug and within 15 minutes observe local reaction. In the presence of sharply expressed hyperemia, an itch and other phenomena of intolerance, use of drug for this patient is contraindicated.
The drug cannot be administered intravenously; before introduction trial aspiration for the purpose of an exception of a possibility of an intravascular injection has to be carried out always. It is impossible to carry out an injection in the field of an inflammation.
During pregnancy local anesthesia is a choice method at surgeries. Artikain gets through a placental barrier to a lesser extent, than other local anesthetics. In view of bystry metabolism and elimination артикаин is not defined in breast milk in clinically significant concentration, in this regard there is no need to interrupt breastfeeding at its use.
To patients with diseases of cardiovascular system (chronic heart failure, pathology of coronary vessels, stenocardia, disturbances of a rhythm, a myocardial infarction in the anamnesis, an arterial hypertension), cerebrovascular frustration, with existence of paralysis in the anamnesis, chronic bronchitis, emphysema, a diabetes mellitus, a hyperthyroidism, and also in the presence of the expressed concern it is reasonable to appoint Artikain with Epinephrinum (1:200 000) containing smaller quantity of Epinephrinum.
It is not necessary to use the damaged karpula for an injection. Partially used karpula cannot be applied to treatment of other patients (risk of infection with a viral hepatitis, etc.).
Meal is admissible only after sensitivity recovery.

Side effects:

Drug is usually well transferred by patients. However development of by-effects is possible.
From TsNS: depending on the applied dose consciousness disturbance chances, up to its loss; breath disturbances, up to its stop; the muscular tremor, involuntary twitchings of muscles sometimes progressing up to generalized spasms; nausea, vomiting.
From an organ of sight: occasionally - opacification in eyes, a passing blindness, a diplopia.
From cardiovascular system: moderately expressed disturbances of a hemodynamics which are shown a lowering of arterial pressure, tachycardia or bradycardia.
Allergic reactions: hypostasis or an inflammation in the place of an injection; erubescence, an itch, conjunctivitis, rhinitis, a Quincke's disease of various degree of manifestation, including hypostasis of an upper and/or under lip, cheeks, language, a glottis with difficulty of swallowing and breath; small tortoiseshell. These phenomena can progress before development of an acute anaphylaxis.
Others: the headache connected probably with existence in composition of drug of Epinephrinum.
At an accidental intravascular injection in an injection site the ischemia zones sometimes progressing to a fabric necrosis can develop.
At disturbance of the equipment of an injection – injuries of a nerve, up to development of paralysis of a facial nerve.

Interaction with other medicines:

The vasoconstrictive effect of Epinephrinum amplifies tricyclic antidepressants and monoamine oxidase inhibitors.
It is not necessary to appoint Artifrin-Zdorovye forte against the background of treatment non-selective beta adrenoblockers as at the same time there is a risk of development of hypertensive crisis and the expressed bradycardia.

Contraindications:

Hypersensitivity to an artikain, adrenaline, sulfites. Bouveret's disease and other tachyarrhythmias. Closed-angle glaucoma.
Drug should not be used to patients with deficit of cholinesterase as these patients have a probability of prolongation, and sometimes and strengthenings of effect of drug.

Overdose:

At development of initial signs of side reactions or toxic action (dizziness, motive concern, a stupor) it is necessary to stop administration of drug, to give to the patient horizontal position. To provide passability of respiratory tracts, to control the heart rate and arterial pressure. It is recommended to begin intravenous infusion of crystalloid solutions even if symptoms are not represented heavy, for further ensuring intravenous access. At disturbances of breath it is necessary to appoint oxygen depending on weight of a state; if necessary - to apply an artificial respiration or an intubation of a trachea to carrying out artificial ventilation of the lungs. Analeptics of the central action are contraindicated.
Involuntary muscular contractions or generalized spasms stop intravenous administration of barbiturates of short or ultrashort action. Their introduction should be carried out slowly, depending on effect, continuing at the same time inhalation of oxygen and monitoring of cordial activity. Introduction of barbiturates is accompanied with infusional delivery of liquid through earlier established cannula.
At tachycardia or arterial hypotension often it is enough to give to the patient horizontal position with slightly raised legs.
At heavy disturbances of blood circulation, including at shock, it is necessary to provide horizontal position of the patient with slightly raised legs, passability of respiratory tracts, administration of oxygen, intravenous infusion of the balanced electrolytic solution, plasma substituting solutions, albumine, intravenous administration of glucocorticoids (for example, 250 - 1000 mg of Methylprednisolonum).
At the expressed lowering of arterial pressure and the accruing bradycardia – intravenous administration of Epinephrinum: 1 ml dissolve 1:1 000 solutions in 10 ml of solvent and enter slowly 0,25 - 1 ml of solution (0,025 - 0,1 mg of Epinephrinum) under control of heart rate and arterial pressure. It is not necessary to enter more than 1 ml of solution
(0,1 mg of Epinephrinum) once. If this dose is insufficient, it is necessary to add Epinephrinum to infusion solution (speed of infusion is regulated taking into account heart rate and the level of arterial pressure).
At the expressed sinus tachycardia or a tachyarrhythmia intravenously enter blockers of beta adrenoceptors under control of parameters of blood circulation. At increase in arterial pressure at the patients having arterial hypertension appoint peripheral vazodilatator.

Storage conditions:

To store in the place protected from light at a temperature at above 25 °C. Not to allow freezing.

Period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

On 1,7 ml or 1,8 ml in karpula No. 10, No. 10х5 in blister strip packagings