Synobial (Solution) Instructions for Use

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

ATC Code

M09AX01 (Hyaluronic acid)

Active Substance

Hyaluronic acid (BAN)

Dosage Form

Synobial

Solution for intra-articular administration 10 mg/ml: 2 ml syringes 1 pc.

Dosage Form, Packaging, and Composition

2 ml – syringes of colorless glass (1) – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Drug stimulating the process of regeneration of cartilage tissue

Pharmacotherapeutic Group

Tissue regeneration stimulant

Pharmacological Action

Pharmacological action – anti-inflammatory, analgesic, correcting the metabolism of bone and cartilage tissue.

Synobial is a sterile, apyrogenic, viscous buffered aqueous solution of a fraction of the sodium salt of highly purified hyaluronic acid with a molecular weight from 500 to 730 kDa.

Hyaluronic acid is an essential component of the extracellular matrix, present in high concentrations in the articular cartilage and synovial fluid. Endogenous hyaluronic acid provides the viscosity and elasticity of the synovial fluid, and it is also necessary for the formation of proteoglycans in the articular cartilage.

In osteoarthritis, there is a deficiency and qualitative changes in hyaluronic acid in the synovial fluid and cartilage. Intra-articular administration of hyaluronic acid against the background of degenerative changes in the surface of the synovial cartilage and pathology of the synovial fluid leads to an improvement in the functional state of the joint.

When using the drug Synobial, an improvement in the clinical course of osteoarthritis is noted for six months from the start of treatment, and an anti-inflammatory and analgesic effect is observed.

Pharmacokinetics

The sodium salt of hyaluronic acid, when administered intra-articularly, is eliminated from the synovial fluid within 2-3 days. Pharmacokinetic studies have shown rapid distribution of the substance in the synovial membrane.

The highest concentrations of labeled hyaluronic acid were found in the synovial fluid and joint capsule, with lower concentrations in the synovial membrane, ligaments, and adjacent muscles.

Hyaluronic acid in the synovial fluid does not undergo significant metabolic changes. In experimental models, the main metabolism occurs in the periarticular tissues and liver, and excretion is mainly carried out by the kidneys.

Indications

• Osteoarthritis and post-traumatic changes of the knee and hip joints;
• Relief of pain and improvement of joint mobility;
• As an auxiliary agent in orthopedic surgery.

ICD codes

Dosage Regimen

Intra-articularly.

Into the knee and hip joints, the contents of one filled syringe (20 mg/ 2 ml) should be administered once a week, as a course of 5 injections according to the standard technique described below.

Administration technique

Before administering Synobial, effusion should be removed from the joint capsule. The drug should be injected precisely into the joint cavity using standard techniques, taking into account anatomical features. The same needle, inserted once before aspiration, can be used to remove effusion and administer the drug. In this case, the syringe with the drug is connected to the needle freed from the syringe with aspirated fluid. To confirm the needle is in the joint cavity, aspirate the available amount of synovial fluid before slowly administering the drug. Aseptic and antiseptic rules must be observed during the procedure. Administration of the drug into the joint cavity should be stopped if pain occurs during the injection. Avoid getting air into the syringe with the drug.

Unused drug should not be stored.

Adverse Reactions

Moderate transient pain, swelling, increased temperature, and redness at the injection site, as well as an increase in exudate content in the joint cavity, may occur. The aforementioned symptoms are transient and usually disappear within 24 hours. If these symptoms occur, it is recommended to unload the affected joint and apply ice.

Cases of allergic reactions (itching, rash, urticaria) and anaphylactic reactions to the drug have been reported.

Contraindications

• Hypersensitivity to the active substance or auxiliary components of the drug;
• Severe liver pathology;
• Presence of infection or skin damage in the injection area;
• Children under 18 years of age (due to lack of clinical data).

Use in Pregnancy and Lactation

Should not be used during pregnancy and breastfeeding due to lack of clinical data.

Use in Hepatic Impairment

Contraindicated in severe liver pathology.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Within the first 2 days after the procedure, it is recommended not to overload the joint, especially avoiding prolonged stress. If aspiration fluid is obtained before drug administration, appropriate tests should be performed to rule out bacterial etiology of arthritis.

Do not use the drug Synobial with damaged or opened packaging.

Effect on the ability to drive vehicles and mechanisms

Synobial does not affect a person’s ability to drive vehicles, engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

No cases of overdose have been reported.

Drug Interactions

Synobial should not be prescribed simultaneously with other intra-articular injections, due to the lack of significant experience.

Do not use disinfectants containing quaternary ammonium compounds, as hyaluronic acid precipitates in the presence of these substances.

Storage Conditions

In a place protected from light at a temperature not exceeding 25°C (77°F). Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.