HYALGAN 20MG\2ML №1(SYRINGE)

 

Dosage form

Solution for intra-articular administration, 20 mg/2 ml 2.0 ml

 

Compound

active substance – sodium hyaluronate 20.00 mg,

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

Description

Colorless, transparent viscous solution.

 

Pharmacotherapeutic group

Preparations for the treatment of diseases of the musculoskeletal system.

Other drugs for the treatment of diseases of the musculoskeletal system. Hyaluronic acid.

ATX code M09AX01

Pharmacological properties

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.
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 improved joint mobility
– as an aid in orthopedic surgery

Directions for use and doses

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®, 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

– moderate pain, swelling of the joint, 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 avian

proteins
– severe liver pathology
– presence of infection or damage to the skin in the injection area

Drug interactions

Gialgan® should not be prescribed concomitantly 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.

 

Use in pediatrics

Should not be used in children due to lack of clinical data.

Pregnancy and lactation

Should not be used during pregnancy or breastfeeding.

 

Use in pediatrics

Should not be used in children due to lack of clinical data.

Features of the 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.

Release form and packaging

Solution for intra-articular administration.

2.0 ml in colorless glass syringes type I, sealed with a rubber stopper.

1 syringe, along with instructions for use in the state and Russian languages, is placed in a cardboard pack.

Storage conditions

At temperatures not exceeding 25°C. Do not freeze.

Keep out of the reach of children!



Shelf life

3 years in original packaging

Do not use after the expiration date indicated on the package.

Conditions for dispensing from pharmacies

On prescription



Manufacturer/Packager

Fidia Pharmaceutisi S.P.A.

35031, Abano Terme, Via Ponte della

Fabbrica, Z/A, Italy




Registration Certificate Holder

Fidia Pharmaceutisi S.P.A.

35031, Abano Terme, Via Ponte della

Fabbrica, Z/A, Italy