Hyalgan 20 mg/2 ml No. 1 solution for intra-articular administration in a syringe

Composition and release form

bottles: 2 ml in bottles of colorless borosilicate glass type I, sealed with rubber stoppers, varnished aluminum caps and removable plastic seals; 1 or 5 bottles with instructions for use are placed in a cardboard box.

syringes: 2 ml in sterile syringes of colorless borosilicate glass type I, with rubber stoppers on which polypropylene pistons are fixed; syringes are equipped with luer locks to protect the needle; 1 or 5 syringes, each of which is placed in a blister pack made of PVC and paper, placed in a cardboard box with instructions for use.

Pharmacodynamics

Hyalgan Fidia is a sterile, pyrogen-free, viscous buffered aqueous solution of a highly purified sodium salt fraction of hyaluronic acid with a molecular weight of 500 to 730 kDa. Hyaluronic acid is an essential component of the extracellular matrix and is present in high concentrations in articular cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity to synovial fluid, and is also necessary for the formation of proteoglycans in articular cartilage. With osteoarthritis, there is a deficiency and qualitative changes in hyaluronic acid in the composition of synovial fluid and cartilage. Intra-articular administration of hyaluronic acid against the background of degenerative changes in the surface of synovial cartilage and pathology of synovial fluid leads to an improvement in the functional state of the joint. When using Gialgan Fidia, there is an improvement in the clinical course of osteoarthritis within six months from the date of treatment, and an anti-inflammatory and analgesic effect is observed.

Gialgan Fidia (solution for intra-articular injection 20 mg/2 ml 2 ml syringe)

A country

Italy
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Compound

Syringe 2 ml
Sodium hyaluronate 20 mg. Excipients: sodium chloride - 17 mg, disodium hydrogen phosphate dodecahydrate - 1.2 mg, sodium dihydrogen phosphate dihydrate - 0.1 mg, water for injection - up to 2 ml. The solution for intra-articular administration is colorless, transparent, viscous.

pharmachologic effect

Stimulator of reparative processes. Hyalgan Fidia is a sterile, pyrogen-free, viscous buffered aqueous solution of a highly purified sodium salt fraction of hyaluronic acid with a molecular weight of 500 to 730 kDalton. Hyaluronic acid is an essential component of the extracellular matrix and is present in high concentrations in articular cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity to synovial fluid, and is also necessary for the formation of proteoglycans in articular cartilage. With osteoarthritis, there is a deficiency and qualitative changes in hyaluronic acid in the composition of synovial fluid and cartilage. Intra-articular administration of hyaluronic acid against the background of degenerative changes in the surface of synovial cartilage and pathology of synovial fluid leads to an improvement in the functional state of the joint. When using Gialgan Fidia, there is an improvement in the clinical course of osteoarthritis within 6 months from the date of treatment, and an anti-inflammatory and analgesic effect is observed.

Indications for use

— for relieving pain and improving the mobility of synovial joints, with osteoarthritis and post-traumatic changes; - as an aid in orthopedic surgery.

Mode of application

The drug is intended for intra-articular administration. The drug is administered into the knee and hip joints in a dose of 20 mg once a week (contents of 1 bottle 20 mg/2 ml or filled syringe). The course consists of 3-5 injections. Rules for administering the drug The rules of asepsis and antisepsis should be observed when performing the procedure. Before administering Gialgan Fidia, effusion from the joint capsule should be removed. The drug should be administered precisely into the joint cavity using standard methods, taking into account the anatomical features. To remove the effusion and administer the drug, you can use the same needle, inserted once before aspiration. In this case, the syringe with the drug should be attached to the needle, freed from the syringe with the aspirated liquid. To confirm that the needle is in the joint cavity, an available amount of synovial fluid should be aspirated before slowly injecting the drug. Injection of the drug into the joint cavity should be stopped if pain occurs during injection. Avoid getting air into the syringe with the drug. The drug remaining in the syringe cannot be stored.

Interaction

Gialgan Fidia should not be prescribed concomitantly with other drugs for intra-articular administration due to the lack of sufficient clinical experience. Disinfectants containing quaternary ammonium salts should not be used, since hyaluronic acid precipitates in the presence of these substances.

Side effect

Local reactions: possible - moderate transient pain, swelling, increased exudate in the joint cavity, increased temperature and redness in the injection area. These reactions are transient and usually disappear after 24 hours (if these symptoms occur, it is recommended to unload the affected joint and apply ice). Allergic reactions: in isolated cases - itching, rash, urticaria, anaphylactic reactions.

Contraindications

- severe liver diseases;
- infections or damage to the skin in the injection area; - hypersensitivity to the components of the drug; - increased sensitivity to avian proteins. Use during pregnancy and breastfeeding The drug should not be prescribed during pregnancy and lactation (breastfeeding) due to the lack of clinical data on use in this category of patients.

Use in children Due to the lack of clinical data on use in pediatrics, the drug should not be prescribed to children.

special instructions

During the first 2 days after the procedure, it is recommended not to overload the joint, especially prolonged activity should be avoided. When obtaining aspiration fluid, appropriate studies should be carried out before administering the drug to exclude a bacterial etiology of arthritis. Use in pediatrics Due to the lack of clinical data on use in pediatrics, the drug should not be prescribed to children. Effect on the ability to drive vehicles and operate machinery Gialgan Fidia does not affect the ability to drive vehicles and other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Dispensing conditions in pharmacies

On prescription

Pharmacokinetics

When administered intra-articularly, the sodium salt of hyaluronic acid 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, lower concentrations in the synovial membrane, ligaments and adjacent muscles.

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

Hyalgan fidia

Release form, composition and packaging

The solution for intra-articular administration is colorless, transparent, viscous.

1 ml 1 fl. sodium hyaluronate 10 mg 20 mg.

Excipients: sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injection.

The solution for intra-articular administration is colorless, transparent, viscous.

1 ml 1 syringe sodium hyaluronate 10 mg 20 mg.

Excipients: sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injection.

Clinical and pharmacological group

Synovial fluid substitute.

pharmachologic effect

Stimulator of reparative processes. Hyalgan Fidia is a sterile, pyrogen-free, viscous buffered aqueous solution of a highly purified sodium salt fraction of hyaluronic acid with a molecular weight of 500 to 730 kDalton. Hyaluronic acid is an essential component of the extracellular matrix and is present in high concentrations in articular cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity to synovial fluid, and is also necessary for the formation of proteoglycans in articular cartilage.

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

When using Gialgan Fidia, there is an improvement in the clinical course of osteoarthritis within 6 months from the moment of treatment, and an anti-inflammatory and analgesic effect develops.

Pharmacokinetics

Suction and distribution

When administered intra-articularly, the sodium salt of hyaluronic acid is eliminated from the synovial fluid within 2-3 days. Pharmacokinetic studies have shown rapid distribution of the substance in the synovial membrane. Cmax of labeled hyaluronic acid was found in synovial fluid and the joint capsule, lower concentrations were found in the synovial membrane, ligaments and adjacent muscles.

Metabolism and excretion

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

Indications for use of the drug

• for relieving pain and improving the mobility of synovial joints, with osteoarthritis and post-traumatic changes;
• as an aid in orthopedic surgery.

Dosage regimen

The drug is intended for intra-articular administration.

The drug is administered into the knee and hip joints in a dose of 20 mg once a week (contents of 1 bottle 20 mg/2 ml or filled syringe). The course consists of 3-5 injections.

Rules for administering the drug

The rules of asepsis and antisepsis should be observed when performing the procedure.

Before administering Gialgan Fidia, effusion from the joint capsule should be removed. The drug should be administered precisely into the joint cavity using standard methods, taking into account the anatomical features. To remove the effusion and administer the drug, you can use the same needle, inserted once before aspiration. In this case, the syringe with the drug should be attached to the needle, freed from the syringe with the aspirated liquid. To confirm that the needle is in the joint cavity, an available amount of synovial fluid should be aspirated before slowly injecting the drug. Injection of the drug into the joint cavity should be stopped if pain occurs during injection.

Avoid getting air into the syringe with the drug.

The drug remaining in the syringe cannot be stored.

Side effect

Local reactions: rarely - moderate pain, swelling, increased exudate in the joint cavity, increased temperature and redness in the injection area. These reactions are transient and usually disappear after 24 hours (if these symptoms occur, it is recommended to unload the affected joint and apply ice).

Allergic reactions: in isolated cases - itching, rash, urticaria, anaphylactic reactions.

Contraindications to the use of the drug

• severe liver disease;
• infections or damage to the skin in the injection area;
• hypersensitivity to the components of the drug;
• hypersensitivity to poultry proteins.

Pregnancy and lactation

The drug should not be prescribed during pregnancy and lactation (breastfeeding) due to the lack of clinical data on its use in this category of patients.

Use for liver dysfunction

The drug is contraindicated in severe liver diseases.

special instructions

During the first 2 days after the procedure, it is recommended not to overload the joint, especially prolonged activity should be avoided.

When obtaining aspiration fluid, appropriate studies should be carried out before administering the drug to exclude a bacterial etiology of arthritis.

Use in pediatrics

Due to the lack of clinical data on use in pediatrics, the drug should not be prescribed to children.

Impact on the ability to drive vehicles and operate machinery

Gialgan Fidia does not affect the ability to drive vehicles or perform other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Currently, there are no cases of overdose.

Drug interactions

Gialgan Fidia should not be prescribed concomitantly with other drugs for intra-articular administration due to the lack of sufficient clinical experience.

Disinfectants containing quaternary ammonium salts should not be used, since hyaluronic acid precipitates in the presence of these substances.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C; do not freeze. Shelf life: 3 years when stored in original packaging.

Do not use Gialgan Fidia with damaged or opened packaging.

Directions for use and doses

Intra-articular.

The contents of one bottle (20 mg/2 ml) or a filled syringe (20 mg/2 ml) should be administered into the knee and hip joints once a week, in a course of 5 injections according to the standard method.

Method of administration

Before administering Gialgan Fidia, effusion from the joint capsule should be removed. The drug should be administered precisely into the joint cavity using standard methods, taking into account the anatomical features. The same needle can be used to remove the effusion and administer the drug, inserted once before aspiration. In this case, the syringe with the drug is attached to the needle freed from the syringe with aspirated liquid. To confirm that the needle is in the joint cavity, an available amount of synovial fluid should be aspirated before slowly injecting the drug. The rules of asepsis and antisepsis should be observed when performing the procedure. Administration of the drug into the joint cavity should be stopped if pain occurs during injection. Avoid getting air into the syringe with the drug. The drug, which has not been completely used, cannot be stored.

Hyalgan 20 mg/2 ml No. 1 solution for intra-articular administration in a syringe

Instructions for medical use of the drug Gialgan® Trade name Gialgan® International nonproprietary name No Dosage form Solution for intra-articular administration, 20 mg/2 ml 2.0 ml Composition active substance - sodium hyaluronate 20.00 mg, excipients: sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate , water for injections. Description Colorless, transparent viscous solution. Pharmacotherapeutic group Drugs for the treatment of diseases of the musculoskeletal system. Other drugs for the treatment of diseases of the musculoskeletal system. Hyaluronic acid. ATC code M09AX01 Pharmacological properties 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, lower concentrations in the synovial membrane, ligaments and adjacent muscles. Hyaluronic acid in synovial fluid does not undergo significant metabolic changes. Experimental models have established that metabolism occurs mainly in the periarticular tissues and liver, excretion is mainly carried out by the kidneys. Pharmacodynamics Hyalgan® is a sterile, pyrogen-free, viscous buffered aqueous solution of a highly purified sodium salt fraction of hyaluronic acid with a molecular weight of 500 to 730 kDa. Hyaluronic acid is an essential component of the extracellular matrix and is present in high concentrations in articular cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity to synovial fluid, and is also necessary for the formation of proteoglycans in articular cartilage. With osteoarthritis, there is a deficiency and qualitative changes in hyaluronic acid in the composition of synovial fluid and cartilage. Intra-articular administration of hyaluronic acid against the background of degenerative changes in the surface of synovial cartilage and pathology of synovial fluid leads to an improvement in the functional state of the joint. When using Gialgan®, there is an improvement in the clinical course of osteoarthritis within six months from the date of treatment, and an anti-inflammatory and analgesic effect is observed. Indications for use - osteoarthritis and post-traumatic changes in joints - pain relief and improvement of joint mobility - as an adjuvant in orthopedic surgery. Method of administration and dosage: Intra-articular. The contents of one filled syringe (20 mg/2 ml) should be injected into the knee and hip joints once a week, in a course of 5 injections according to the standard method. Method of administration Before administering Gialgan®, the effusion from the joint capsule should be removed. The drug should be administered precisely into the joint cavity using standard methods, taking into account the anatomical features. The same needle can be used to remove the effusion and administer the drug, inserted once before aspiration. In this case, the syringe with the drug is attached to the needle freed from the syringe with aspirated liquid. To confirm that the needle is in the joint cavity, an available amount of synovial fluid should be aspirated before slowly injecting the drug. The rules of asepsis and antisepsis should be observed when performing the procedure. Administration of the drug into the joint cavity should be stopped if pain occurs during injection. Avoid getting air into the syringe with the drug. The drug, which has not been completely used, cannot be stored. Side effects Rarely - moderate pain, joint swelling, increased exudate in the joint cavity, increased temperature and redness in the injection area. The above symptoms are transient and usually disappear after 24 hours. If these symptoms occur, it is recommended to unload the affected joint and apply ice. In isolated cases - allergic (itching, skin rash, urticaria) and anaphylactic reactions Contraindications - hypersensitivity to the components of the drug or bird proteins - severe liver pathology - infection or damage to the skin in the injection area Drug interactions Gialgan® should not be prescribed simultaneously with other intra-articular injections, due to the lack of significant experience. Disinfectants containing quaternary ammonium salts should not be used, since hyaluronic acid precipitates in the presence of these substances. Special instructions During the first 2 days after the procedure, it is recommended not to overload the joint, especially prolonged loading should be avoided. When obtaining aspiration fluid, appropriate studies should be carried out before administering the drug to exclude a bacterial etiology of arthritis. Do not use Hyalgan® with damaged or opened packaging. Pregnancy and lactation should not be used during pregnancy or breastfeeding. Pediatric Use: Should not be used in children due to lack of clinical data. Peculiarities of influence on the ability to drive a vehicle or potentially dangerous mechanisms Gialgan® does not affect a person’s ability to engage in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. However, given the effect of the drug on the functions of the joints of the lower extremities, you should refrain from driving for the first 2 days after the injection. Overdose There have been no cases of overdose. RELEASE FORM AND PACKAGING SOLUTION FOR INTRA-ARTICULAR ADMINISTRATION. 2.0 ML IN CLEAR GLASS SYRINGES TYPE I, SEALED WITH A RUBBER CAP. 1 SYRINGE TOGETHER WITH INSTRUCTIONS FOR USE IN THE STATE AND RUSSIAN LANGUAGES IS PLACED IN A PACK OF CARDBOARD. STORAGE CONDITIONS AT TEMPERATURES NOT HIGHER THAN 25 °C. DO NOT FREEZE. KEEP OUT OF THE REACH OF CHILDREN! SHELF LIFE IS 3 YEARS IN ORIGINAL PACKAGING DO NOT USE AFTER THE EXPIRATION DATE STATED ON THE PACKAGING. CONDITIONS FOR DISCHARGING FROM PHARMACIES ACCORDING TO A PRESCRIPTION MANUFACTURER/PACKAGER FIDIA PHARMACEUTIS S.P.A. 35031, ABANO TERME, VIA PONTE DELLA FABBRICA, Z/A, ITALY REGISTRATION AUTHORITY HOLDER FIDIA PHARMACEUTISI S.P.A. 35031, ABANO TERME, VIA PONTE DELLA FABBRICCA, Z/A, ITALY ADDRESS OF THE ORGANIZATION RECEIVING CLAIMS FROM CONSUMERS ON THE QUALITY OF PRODUCTS (GOOD) LLP IN THE TERRITORY OF THE REPUBLIC OF KAZAKHSTAN FIDIA PHARMA KAZAKHSTAN REPUBLIC KAZAKHSTAN, ALMATY, Ave. AL-FARABI 7, NURLY-TAU ADMINISTRATIVE RESIDENTIAL COMPLEX, BLOCK 4A, OFF. 6 TEL/FAX, 311 02 53 EMAIL ADDRESS

special instructions

During the first 2 days after the procedure, it is recommended not to overload the joint, especially prolonged loading should be avoided. When obtaining aspiration fluid, appropriate studies should be carried out before administering the drug to exclude a bacterial etiology of arthritis.

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

Do not use Gialgan Fidia with damaged or opened packaging.

Synonyms of nosological groups

Category ICD-10 Synonyms of diseases according to ICD-10