Stoparthrosis
> Treatment methods
> The drug Gialgan
Orthopedist
Litvinenko A. S.
November 23, 2021 3357
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One of these medications is the Italian chondroprotector Hyalgan Fidia, which contains sodium hyaluronate. This substance helps improve the quality of synovial fluid. It improves its viscosity and elasticity and restores the shock-absorbing properties of the lubricant. The drug Gialgan is indicated for rapidly progressing arthrosis of large human joints, as well as as an adjuvant during surgery.
It is administered by intra-articular injection and promotes:
- improving lubrication of cartilage tissue;
- increasing joint mobility;
- relieving pain and reducing the dose of painkillers;
- slowing down degenerative processes.
Description:
Hyalgan Fidia is a product for intra-articular administration containing a solution of sodium hyaluronate.
The solution is injected by the doctor directly into the diseased joint and ensures the restoration of intra-articular fluid, thereby helping to cope with pain and impaired joint mobility due to osteoarthritis or after injury. In our pharmacy, the drug Gialgan Fidia is sold in an easy-to-use form - a filled syringe. The needle for administering the drug is selected by the doctor individually depending on the size of the joint and the patient’s build.
Pharmachologic effect:
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.
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
Directions for use and dosage:
The drug is intended for intra-articular administration.
The drug is administered to the knee and hip joints in a dose of 20 mg once a week (contents of 1 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.
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.
Hyalgan Fidia 2ml 20mg 5pcs - Instructions
Dosage form
Solution for injection, 5 syringes per package.
Compound
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 phosphate, dodecahydrate; water for injections.
Pharmacological group
Medicines used for pathology of the musculoskeletal system.
Pharmacological properties
Pharmacological.
Hyaluronic acid is a component found in high concentrations in articular cartilage and synovial fluid. Endogenous hyaluronic acid provides the viscosity and elasticity of synovial fluid, and it 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 and stimulates the natural formation of hyaluronic acid inside the joint.
Pharmacokinetics.
Hyaluronic acid is effectively metabolized in the body, quickly eliminated from the bloodstream and quickly destroyed in the liver. Metabolites are excreted primarily in the urine. Approximately 42% of the administered dose is determined in the liver 24 hours after administration. The drug is determined in synovial fluid within 2:00, and in articular cartilage - within 6:00. Cartilage is the most stable site of localization of hyaluronic acid. Hyaluronic acid is contained in synovial fluid for 4-5 days.
Indications for use
Arthritis of the knee joints of mild to moderate severity.
Directions for use and doses
Adults are prescribed 2 ml of Gialgan (20 mg) by intra-articular injection once a week for 5 weeks.
Contraindications
Hypersensitivity to the constituent components of the drug. A history of allergy to poultry proteins. Severe liver dysfunction.
Intra-articular injections are contraindicated in cases of existing infection or skin disease at the injection site in order to reduce the potential development of septic arthritis.
Interaction with other drugs and other types of interactions
Hyaluronic acid interacts with some local anesthetics, prolonging their analgesic effect.
Features of application
It is not recommended to use disinfectants containing quaternary ammonium salts, since upon contact with hyaluronic acid, sediment may form; intra-articular injection must be performed by competent healthcare professionals according to established procedures under aseptic conditions required for this method of administration; Before performing an intra-articular injection, the patient must be examined for signs of acute inflammation. If such signs are present, the doctor should evaluate the advisability of the injection; some patients with inflammatory arthritis (rheumatoid arthritis or gouty arthritis) experienced a transient increase in inflammation after injection of the drug; in the presence of joint effusion, it is recommended to perform aspiration before administering Gialgan; It is recommended not to overload the joint for several hours after the injection.
Use during pregnancy or breastfeeding
Although no fetal toxicity or teratogenic effects have been observed in experiments performed on animals, the drug should be limited to pregnant and breastfeeding patients unless, in the judgment of a physician, it is absolutely necessary, and only after a careful assessment of the risk/benefit ratio.
The ability to influence the reaction rate when driving vehicles or other mechanisms
Does not affect.
Children
Should not be given to children.
Overdose
Phenomena associated with cases of overdose have not been recorded at present.
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, impaired joint mobility. These symptoms disappear within a few days if you rest the joint and apply an ice pack. Only in rare cases have such reactions been 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, sensation of heat, headache, paresthesia.
If the patient had 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 “Peculiarities of Application”).
Best before 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 medications in the same container.
Vacation category
On prescription.