Сингиал™

General characteristics. Structure:

Active ingredient: sodium hyalrunate – 10 mg/ml.

Excipients: sodium dihydrophosphate monohydrate, sodium hydrophosphate heptahydrate, sodium chloride, water for injections.

Pharmacological properties:

СИНГИАЛ®/SYNGYAL® – the immunobiological drug intended for substitution of synovial fluid which collects at degenerative inflammatory diseases of joints and for activation of processes of recovery of tissues of joint cartilages. Drug is the effective therapeutic remedy which is used for elimination of pain at degenerative and inflammatory diseases of joints. СИНГИАЛ®/SYNGYAL® has visco-elastic properties, works as the shock-absorber, the liquid recovering mobility of joints. Use of drug is especially recommended to the patients who is not gaining adequate medical effect of reception of analgeziruyushchy or antiinflammatory medical drugs, physiotherapeutic procedures and gymnastic exercises.

Active ingredient of the drug SINGIAL®/SYNGYAL® – hyalrunate of sodium is an important component of an extracellular matrix which recovers physiological homeostasis and rheological properties of synovial fluid, normalizes and contributes to normalization of composition of synovial fluid, activating biosynthesis of hyaluronic acid in cells of a synovial membrane.

The hyaluronic acid entered into a joint bag supports the initial molecular weight in synovial fluid of a joint bag. When filtering through tissues of joints in a peripheral blood stream the molecular mass of active ingredient of the drug SINGIAL®/SYNGYAL® considerably decreases. The period of its half-decay in a joint bag makes 20,6 hours; half-life in a blood plasma after its migration in blood makes 3 days of a joint bag.

СИНГИАЛ®/SYNGYAL® keeps in synovial fluid for 4-5 days. Metabolism, excretion and recirculation happen over 9 days after introduction. It was defined that about 83% of the hyaluronic acid entered into a joint bag are metabolized in a liver, its most part is excreted in the form of carbon dioxide and water, and about 17% are reused in the form of lipids, proteins and components of acid soluble fraction of an organism.

Indications to use:

Osteoarthritis and periarthritis of humeral and knee joints.

Route of administration and doses:

СИНГИАЛ®/SYNGYAL® about 2 ml are entered into a joint bag once a week, for three weeks consistently. Frequency of injections can korregirovatsya depending on symptoms and disease severity. Because СИНГИАЛ®/SYNGYAL® it is entered directly into a synovial cavity, use of medicine needs to be carried out with observance of strict aseptic conditions.

Features of use:

СИНГИАЛ®/SYNGYAL® patients should enter with care with the hypersensitivity recorded earlier to others medicinal to means, patients with liver diseases in the present or in the anamnesis (at patients who had liver diseases earlier, abnormal levels of nuclear heating plant and ALT were observed), to patients with diseases of skin or an infection into a joint.

In case of administration of drug СИНГИАЛ®/SYNGYAL® it is recommended to enter into the joints affected with a heavy inflammation only after disappearance of an inflammation as symptoms of a local inflammation can amplify.

The drug needs to be administered in a joint cavity with care as its effluence can cause pain.

After administration of drug local pain can be observed what it is necessary to inform the patient on and to recommend a local relaxation after the carried-out injection.

As pain can be caused by a drug effluence for injections from a joint cavity, it should be entered into a joint cavity with care.

In the absence of therapeutic effect the number of administrations of drug should be limited to three.

If there is an accumulation of joint liquid that, if necessary, its excess should be removed by a transfiction.

The drug cannot be administered in a system blood stream.

Drug is not intended for use in ophthalmologic practice.

Administration of medicine needs to be carried out in strictly aseptic conditions, using a needle 22 ~ 23 G (as drug is liquid with very high viscosity).

Elderly people need to carry out administration of drug with care as physiological functions at this category of patients have the features.

Introduction to children. As safety of drug for children is not established, СИНГИАЛ®/SYNGYAL® children should enter with care only if its use cannot be avoided.

Do not use drug if the rubber cap of a front part of the syringe is open.

Contents of the syringe are intended only for single application.

Use at pregnancy and feeding by a breast. Drug researches on animals revealed lack of its teratogenic influence, however safety of drug for pregnant women is not established. The drug should be administered with care to pregnant women only if, according to the doctor, the advantage exceeds risk.

As at preclinical trials it was established that drugs of hyaluronic acid are emitted with breast milk, it is necessary to stop feeding by a breast throughout drug use.

Side effects:

Shock: as patients can have shock symptoms (with an uncertain frequency), it is necessary to watch a condition of patients carefully. At emergence of any signs of shock it is necessary to stop use of drug and to take necessary measures.

Hypersensitivity: hypostasis (including persons, a century), a peristatic hyperemia of the person, in rare instances – rash, urticaria, an itch. At emergence of these symptoms it is necessary to stop use of drug and to take necessary measures.

Injection sites in a joint: can sometimes arise pain (generally short-term after an injection), a swelling, in rare instances – hypostasis, a peristatic hyperemia, feeling of heat and local pressure.

Others: nausea, vomiting and fever can be observed.

Interaction with other medicines:

СИНГИАЛ®/SYNGYAL® can cause sedimentation of quadribasic salts of ammonium (бензалкониум chloride), disinfectants and a hlorgeksidin.

Contraindications:

Hypersensitivity to sodium hyalrunate.

Overdose:

It is not known.

Storage conditions:

In the place protected from light at a temperature not over 25 ºС. Not to freeze. To store in the place, unavailable to children. Period of storage 3 years. Not to use after the termination of a period of validity.

Issue conditions:

According to the recipe

Packaging:

On 2 ml in previously filled syringe. On one previously filled syringe enclosed in the blister from polymeric material. On 1 or 3 previously filled syringes in the blisters enclosed in a pack from a cardboard together with the instruction about use.