Instructions Hyalgan solution for injection 20 mg/2 ml syringe 2 ml No. 1
Composition
active ingredient: hyaluronic acid;
2 ml of solution contain 20 mg of sodium salt of hyaluronic acid;
Excipients: sodium chloride; sodium dihydrogen phosphate, dihydrate; sodium hydrogen phosphate, dodecahydrate; water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent, highly viscous aqueous solution.
Pharmacotherapeutic group
Means used in pathologies of the musculoskeletal system. ATX code M09A X01.
Pharmacological properties
Pharmacodynamics.
Hyaluronic acid is a component present in high concentrations in articular cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity of synovial fluid, and is also necessary for the formation of proteoglycans in articular cartilage. By normalizing the quality of synovial fluid and activating tissue renewal processes in articular cartilage, the drug improves joint function. Hyalgan has an anti-inflammatory effect on the joint epithelium, stimulates the natural formation of hyaluronic acid inside the joint.
Pharmacokinetics.
Hyaluronic acid is effectively metabolized in the body, is rapidly eliminated from the bloodstream and is rapidly destroyed in the liver. Metabolites are excreted mainly in the urine. Approximately 42% of the administered dose is detected in the liver 24 hours after administration. The drug is detected in synovial fluid within 2 hours, and in articular cartilage within 6 hours. Cartilage is the most stable site of hyaluronic acid localization. Hyaluronic acid is retained in synovial fluid for 4-5 days.
Indication
Mild to moderate arthritis of the knee joints.
Contraindication
Individual hypersensitivity to the components of the drug. History of allergy to poultry protein. Severe liver dysfunction.
Intra-articular injections are contraindicated in the presence of existing infection or skin disease at the injection site to reduce the potential for septic arthritis.
Interaction with other medicinal products and other types of interactions
Hyaluronic acid interacts with some local anesthetics, prolonging their analgesic effect.
Application features
It is not recommended to use disinfectants containing quaternary ammonium salts, as a precipitate may form upon contact with hyaluronic acid;
Intra-articular injection should be performed by competent healthcare professionals according to established procedures under aseptic conditions required for this route of administration;
Before performing an intra-articular injection, the patient should be examined for signs of acute inflammation. If such signs are present, the physician should assess the feasibility of performing the injection;
Some patients with inflammatory arthritis (rheumatoid arthritis or gouty arthritis) have experienced a transient increase in inflammation after injection of the drug;
if there is joint effusion, it is recommended to perform aspiration before administering Hyalgan;
It is recommended not to overload the joint for several hours after the injection.
Use during pregnancy or breastfeeding
Although no embryotoxic or teratogenic effects were observed in animal experiments, the use of the drug in pregnant and breastfeeding women should be limited, except in cases where the physician considers it absolutely necessary, and only after careful assessment of the risk/benefit ratio.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Application features
It is not recommended to use disinfectants containing quaternary ammonium salts, as a precipitate may form upon contact with hyaluronic acid;
Intra-articular injection should be performed by competent healthcare professionals according to established procedures under aseptic conditions required for this route of administration;
Before performing an intra-articular injection, the patient should be examined for signs of acute inflammation. If such signs are present, the physician should assess the feasibility of performing the injection;
Some patients with inflammatory arthritis (rheumatoid arthritis or gouty arthritis) have experienced a transient increase in inflammation after injection of the drug;
if there is joint effusion, it is recommended to perform aspiration before administering Hyalgan;
It is recommended not to overload the joint for several hours after the injection.
Method of administration and doses
Adults should be administered 2 ml of Hyalgan (20 mg) by intra-articular injection once a week for 5 weeks.
Children
Should not be prescribed to children.
Overdose
Phenomena associated with overdose cases have not been recorded at this time.
Adverse reactions
Injection site reactions including discomfort, pain, swelling, redness, irritation, rash, nodules, pustules, vesicles, hemorrhages, ecchymosis, itching, joint inflammation, synovitis, joint effusion, joint stiffness, and joint mobility impairment. These symptoms resolve within a few days with rest and ice application. Only in rare cases have these reactions been more prolonged and severe.
Hypersensitivity reactions, including anaphylactoid reactions, angioedema, skin reactions, including rash, itching, erythema, eczema, dermatitis, urticaria; very rarely - anaphylactic shock, but without fatal consequences; serum sickness; fever, feeling of heat, headache, paresthesia.
If the patient has a chronic inflammatory process in the acute stage, the use of hyaluronic acid in some individual cases worsened the patient's condition.
Cases of bacterial arthritis and reactive arthritis at the site of intra-articular injection have been observed (see section "Special warnings and precautions for use").
Expiration date
3 years.
Storage conditions
Store in the original packaging out of the reach of children at a temperature not exceeding 25 °C.
Incompatibility
Do not mix with other medicines in the same container.
Packaging
2 ml in a glass vial; 1 vial in a blister; 1 blister in a box.
2 ml in a pre-filled glass syringe; 1 syringe in a blister; 1 blister in a box.
Vacation category
According to the recipe.
Producer
Fidia Pharmaceuticals S.p.A., Italy.
Location of the manufacturer and address of its place of business.
Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD), Italy.
Address
Via Ponte della Fabrika, 3/A, 35031 Abano Terme (PD), Italy.
