Artifrin-Zdorovye solution for infection 1,7ml No. 10/1,7ml No. 10х5
Producer: LLC Pharmaceutical Company Zdorovye Ukraine
Code of automatic telephone exchange: N01B B58
Release form: Liquid dosage forms. Solution for injections.
General characteristics. Structure:
Main physical and chemical properties: transparent colourless or slightly yellowish-greenish solution; structure: 1 ml of solution contains an artikain of a hydrochloride in terms of 100% substance of 40 mg, Epinephrinum in terms of 100% substance (in the form of a hydrochloride) 0,006 mg; excipients: sodium metabisulphite, glycine (in terms of 100% substance), sodium chloride, 1M acid solution hydrochloric, water for injections.
Pharmacological properties:
Pharmacodynamics. The combined drug containing артикаин and Epinephrinum (adrenaline) intended for local anesthesia in stomatology.
Artikain – local anesthetic of amide group of a number of thiophenes. In fabrics is exposed to hydrolysis and releases the basis having high diffusion capacity and 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 neuron cell in a depolarization phase, prevents emergence and carrying out nervous impulse. Owing to high ability to contact blood proteins артикаин it is characterized by low system toxicity.
Epinephrinum has vasoconstrictive effect owing to what strengthens and prolongs action of an artikain. Epinephrinum interferes with system absorption of an artikain and development of its side effects.
At infiltration and conduction anesthesia in stomatology drug renders bystry (in 1 – 3 min.) and rather long (not less than 45 min.) mestnoanesteziruyushchy action, is characterized by reliable analgesic effect. Drug does not break healing of wounds that is caused by good fabric tolerance.
Causes weak surface anesthesia.
Pharmacokinetics. Artikain at submucosal introduction to an oral cavity has high diffusion capacity; contacts proteins of plasma for 95%, badly gets through a placental barrier. It Biotransformirutsya in a liver. An elimination half-life – near
25 min. It is removed generally by kidneys (about 60%).
Artikain through a placental barrier gets in very insignificant quantity; practically is not defined in breast milk.
Indications to use:
Infiltration and conduction anesthesia in stomatology, including during uncomplicated removal of one or several teeth, at treatment of caries and its complications, at preparation of teeth under crowns.
Route of administration and doses:
Dosing mode individual.
At an uncomplicated shchiptsovy exodontia of an upper jaw and lack of an inflammation usually enter in submucosal a transitional fold from the vestibular party of 0,5 - 1 ml of drug on each tooth. In some cases the additional vestibular injection (1 – 1,7 ml) for ensuring full anesthesia can be required. For anesthesia at palatal cuts or suture for the purpose of creation of palatal depot enter 0,1 – 0,2 ml of drug for one injection.
During uncomplicated shchiptsovy removal of premolar tooths of a mandible and lack of an inflammation enter in submucosal a transitional fold of 0,5 - 1,7 ml of drug on each tooth. In the absence of desirable effect carry out an additional vestibular injection
(1 – 1,7 ml of drug). In case of lack of full anesthesia it is necessary to carry out blockade of a mandibular nerve.
For processing of carious cavities or at preparation under a crown of any tooth (except for the lower painters) the drug is administered in a dose 0,5 – 1 ml on each tooth as an infiltration anesthesia from the vestibular party. The amount of drug depends on intervention volume.
For adults the maximum dose on one medical procedure makes 7 mg/kg of body weight, for children from 4 to 12 years – 5 mg/kg. Children with the body weight of 30 - 40 kg for one medical procedure can enter 0,5 – 2 ml of drug, but no more than 2 ml; with the body weight of 20 - 30 kg enter 0,25 – 1 ml, but no more than 1,5 ml.
To administration of drug it is always necessary to carry out trial aspiration for an exception of a possibility of intravascular introduction.
Features of use:
Drug is not intended for intravenous administration.
It is necessary to be the patient, extremely careful at purpose of drug, with deficit of cholinesterase (owing to probability of prolongation, and sometimes and strengthenings of effect of drug), with disturbances of respiratory and cordial activity.
If drug is used for this patient for the first time – conducting skin test is necessary: vnutrikozhno enter 0,02 ml of drug and within 15 min. observe local reaction. In the presence of the expressed hyperemia, an itch and other phenomena of intolerance drug is not used.
Owing to presence at Epinephrinum vasoconstrictor drug, Artifrin-Zdorovye with care appoint to patients with cardiovascular and endocrine diseases (heart diseases, arterial hypertension, a thyrotoxicosis, a diabetes mellitus, etc.), and also the receiving adrenoblockers, tricyclic antidepressants and monoamine oxidase inhibitors.
It is not necessary to apply the damaged karpula to an injection. Partially used karpula cannot be applied to treatment of other patients (for an exception of risk of infection with a viral hepatitis, etc.).
Meal is admissible only after sensitivity recovery.
Use during pregnancy and feeding by a breast. Use of drug during pregnancy and feeding by a breast since it gets through a placental barrier in smaller quantity, than other anesthetics is possible, and is not defined in breast milk in clinically significant concentration.
Influence on a possibility of control of vehicles and mechanisms. At assessment of opportunities of the patient to performance of potentially dangerous activity, including to control of vehicles, it is necessary to consider individual reaction to drug.
Side effects:
From the central and peripheral nervous system: headache, vision disorder, диспноэ, apnoea, tremor, twitchings of muscles; seldom – disturbance of consciousness, a spasm. These side effects are dozozavisimy. From an organ of sight: seldom – sight misting, a diplopia, a passing blindness. From system of digestion: nausea, vomiting, diarrhea. From cardiovascular system: seldom – increase in arterial pressure, tachycardia, bradycardia. Allergic reactions: seldom – hypostasis or an inflammation in the place of an injection, skin rash, an itch, conjunctivitis, rhinitis, a Quincke's disease, including hypostasis of an upper and/or under lip, cheeks, language, a glottis with difficulty of swallowing and breath, a small tortoiseshell, an acute anaphylaxis. Other: at an accidental intravascular injection in an injection site development of a zone of the ischemia sometimes progressing to degree of a fabric necrosis is possible.
Interaction with other medicines:
The vasoconstrictive effect of Epinephrinum which is a part of drug is strengthened by tricyclic antidepressants and monoamine oxidase inhibitors. At simultaneous use of drug and non-selective adrenoblockers raise risk of hypertensive crisis and the expressed bradycardia.
Contraindications:
The increased individual sensitivity to an artikain, Epinephrinum (adrenaline) or sulfites (especially at patients with bronchial asthma); Bouveret's disease and other tachyarrhythmias, dekompensirovanny heart failure, closed-angle glaucoma, deficit of cholinesterase.
It is necessary to avoid introduction to the inflamed fabrics.
Drug is not intended for use in all-surgical practice.
Overdose:
At development of initial signs of toxic action (symptoms – dizziness, motive concern, a stupor) it is necessary to stop administration of drug and to lay the patient. It is necessary to provide passability of respiratory tracts, to control the heart rate and arterial pressure. At disturbances of breath it is necessary to appoint an oxygenotherapy; if necessary – to apply an artificial respiration or an intubation of a trachea to carrying out controlled 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, registering effect, under constant control of cordial activity. Introduction of barbiturates has to be followed by liquid infusion.
At heavy disturbances of blood circulation, and also at shock of the patient transfer to horizontal position and slightly raise legs, control passability of respiratory tracts, carry out inhalation by oxygen, intravenous infusion of electrolytic and plasma substituting solutions, albumine; intravenous administration of glucocorticoids (equivalent of 250 - 1000 mg of Methylprednisolonum).
At the expressed lowering of arterial pressure and bradycardia intravenous administration of 0,025 - 0,1 mg of Epinephrinum (0,25 – 1 ml of solution of concentration of 0,1 mg/ml) is necessary. Introduction is carried out slowly, by no more than 0,1 mg for one introduction, controlling the heart rate and arterial pressure. If this dose is insufficient, it is necessary to add Epinephrinum to infusion solution.
At tachycardia or arterial hypotension it is usually enough to transfer the patient to horizontal position and to slightly raise legs. At the expressed tachycardia or a tachyarrhythmia administer intravenously antiarrhytmic drugs, but it is not necessary to apply non-selective blockers of adrenoceptors.
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 from 8 °C to 25 °C. Not to allow freezing.
To store in the place, unavailable to children.
Period of validity –2 years.
Issue conditions:
According to the recipe
Packaging:
Solution for injections on 1,7 ml in ampoules or karpula No. 10 in a pack. On 1,7 ml in karpula in blister strip packagings No. 10x5 in a pack.