Adant

General characteristics. Structure:

Active ingredient: 25 mg of sodium of hyalrunate.

Pharmacological properties:

Pharmacodynamics. Product of medical prescription. Gualuronovy acid has such physical properties which do possible to use this substance as substitute of the synovial fluid broken by inflammatory process. Thus, recovering physical characteristics of joint liquid, hyaluronic acid increases mobility and reduces morbidity of the joints affected with an osteoarthritis or a periarthritis.

Besides, drug induces synthesis of the high-molecular hyaluronic acid similar on structure to "usual" hyaluronic acid, in the synovial joints affected with chronic degenerative or inflammatory process. Without this incentive the molecular weight of a synthesizable sinoviotsitama of hyaluronic acid is lower than norm.

This mechanism of action combines the prolonged clinical effect of sodium of hyalrunate which by 10 times exceeds effect at the rate of intra joint clearance and metabolism.

Intra joint administration of drug of Adant improves functioning of joints, stops the pain caused by an osteoarthritis of knee and humeral joints. The Adant improves mobility of joints and normalizes composition of synovial fluid. Besides, drug of Adant is shown for introduction to a carpal and metacarpal joint at the patients suffering rizartrozy.

Preclinical data on safety. After single administration of drug to rats the size LD50 appeared 2014mg/kg at males and 1761mg/kg at females. After intraperitoneal administration of drug of Adant to males and females of rats within 28 days it was established that the dose which is not rendering toxic effect makes 30 mg/kg/days. During the research of reaction of ASA, intra joint reactions, intradermal reactions, corneal reactions, reaction of Schultz-Dale, reaction of RSA, diffusion in gel and reaction of RNA at the Guinea pigs receiving drug of Adant, antigenic properties of drug did not come to light. During the research of reverse mutation of bacteria mutagen properties of drug were not revealed. Single introduction of 0.1 ml had no undesirable effect on a cornea, an iris of the eye and a konjyuktivalny cover of rabbits. These data say that drug of Adant does not affect mucous membranes.

Pharmacokinetics. There are no data.

Indications to use:

— osteoarthritis of knee and humeral joints;

— osteoarthritis of a carpal and metacarpal joint of I, II and III degrees;

— pain and restrictions of mobility of other synovial joints, as a result of degenerative and posttraumatic changes.

Route of administration and doses:

Intra joint administration of drug once a week within 5 weeks in a row is generally recommended.

The drug should be administered directly in a cavity of a knee joint, in a shoulder joint (a joint cavity, a subacromial bag or a vagina of a sinew of a long head of a biceps), a carpal and metacarpal joint or in other affected synovial joints.

In a case with a carpal and metacarpal joint two ways of introduction depending on osteoarthritis degree of manifestation are recommended: lateral outside way (I degree of a rizartroz) and interdigital to a kommisur of the first finger (II and III degrees of a rizartroz). Nevertheless, the choice of this or that way of administration of drug depends on specific features of each patient; it is better to carry out administration of drug at endoscopic control. Anyway, the choice of a dose depends on symptomatology degree of manifestation.

Precautionary measures when carrying out an injection. Since the drug of Adant is administered in a joint cavity, process of administration of drug should be carried out with observance of all rules of an asepsis.

If within 5 weeks of treatment there does not come stopping of symptomatology, treatment should be stopped.

If signs of a delay of synovial fluid are observed, it is recommended to execute артроцентез.

Other recommendations. Administration of drug of Adant in a circulatory bed is not allowed.

Not to administer the drug in eye tissue. Considering high viscosity of drug, use of needles No. 21-23G is recommended

Before use it is necessary to warm drug to room temperature.

It is necessary to use drug once directly after packaging opening. Unused drug should be utilized with observance of necessary regulatory requirements.

Application instruction

1. To exempt the syringe from the blister packaging, to break off tips on an emphasis for fingers in the middle of the syringe. If drug was stored in the frozen look, then before use it is necessary to warm drug to room temperature within 20-30 min.

2. To remove a rubber cap.

3. To dress on the syringe an injection cannula 21G, 22gili 23G.

4. The syringe is ready to work:

* Before administration of drug to wipe with alcohol an injection site.

* After an injection to utilize the syringe and a needle with observance of necessary requirements.

Features of use:

Use at pregnancy and feeding by a breast. In spite of the fact that during preclinical trials teratogenic properties of drug are not found, its safety at appointment to pregnant women was not studied. Therefore to pregnant women, or at suspicion it is necessary to appoint to pregnancy, drug with care.

Sodium hyalrunate cosecretes with milk of animals therefore for the period of use of drug it is recommended to stop breastfeeding.

Use at abnormal liver functions. Patients should appoint drug of Adant with care with abnormal liver functions.

Use for children. Since safety of drug at appointment to children was not investigated, it should be applied with care.

Use for elderly patients. Appointment to elderly patients: it is necessary to appoint drug with care as at elderly people many physiological functions of an organism are reduced.

Special instructions. Drug can cause an aggravation of inflammatory process in patients with an osteoarthritis. In this case administration of drug is recommended to be carried out after stopping of inflammatory symptomatology.

In rare instances after administration of drug morbidity is noted. For prevention of development of pain after an injection of drug it is recommended to keep rest in the affected joint.

Administration of drug needs to be carried out directly in a joint cavity, otherwise local morbidity can develop. Patients should appoint drug of Adant with care with the burdened allergic anamnesis and the patient with abnormal liver functions.

Appointment to elderly patients: it is necessary to appoint drug with care as at elderly people many physiological functions of an organism are reduced.

Use in pediatrics. Since safety of drug at appointment to children was not investigated, it should be applied with care.

Influence on ability to driving of motor transport and to control of mechanisms. There are no data.

Side effects:

Development of local allergic reaction, such as urticaria and itch is in certain cases possible. In this case administration of drug it is necessary to stop and appoint the corresponding therapy.

There are separate messages on morbidity development (mainly, tranzitorny pains after an injection) and swellings.

Patients can show complaints to puffiness, reddening, a burning sensation and weights in the place of an injection.

Development of shock reactions is extremely seldom observed. In this case further administration of drug should be stopped, to establish observation of the patient and to appoint the corresponding therapy.

Interaction with other medicines:

Mixing of drug with quaternary ammonium salts is not allowed, including a benzalkoniya chloride, or with hlorgeksidiny, because of development of precipitation.

Contraindications:

— hypersensitivity to active ingredient.

Storage conditions:

To store at a temperature from 1 °C to 30 °C. Drug freezing is allowed. To protect from direct hit of light. A period of validity – 3 years.

Issue conditions:

According to the recipe

Packaging:

One syringe (2.5 ml) of drug of Adant.