Traumatic and degenerative joint pathologies.
Adjuvant in orthopaedic surgery.

Unless otherwise prescribed by a doctor, 2 ml of Hyalgan (20 mg) can be injected intra-articularly once a week for 5 weeks.

- Disinfectants based on quaternary ammonium salts are not recommended because the presence of hyaluronic acid causes the formation of precipitates.
- The intra-articular infiltration procedure must be performed by qualified medical operators, according to the technique and in the conditions of asepsis prescribed for this type of administration.
- Special precautions must be taken in the case of patients with ongoing infections near the injection site, in order to avoid the possible onset of bacterial arthritis.
- Before performing intra-articular injection, the patient should be thoroughly examined to ascertain any signs of acute inflammation. Should these be present, the physician must assess whether it is advisable to proceed with the injection or not.
- If joint effusion is present, it is advisable to aspirate it before injecting HYALGAN.
- It is advisable not to overload the joint for several hours after infiltration.

Hyaluronic acid interacts with some local anaesthetics, prolonging the anaesthesia time.

Pregnancy category B reproduction studies have been performed in
A series of 4 in vitro and one in vivo studies was performed to evaluate the mutagenic Potential of hyaluronic acid.

4.6.1 In vitro studies
Ames test, Mutagenic potential assessed in mammalian cells using the Chinese hamster
Ovary/HPRT locus assay, chromosomal aberration test and unscheduled DNA repair synthesis
Test) there was no evidence of cytotoxicity or induction of a mutagenic response in any of
These Studies at any dose level either in the presence or absence of metabolic activation.
4.6.2 In vivo study
Micronucleus test was performed in Swiss derived CD-l mice at a dose level of 400
mg/Kg, the maximum administrable dose) there were no deaths and no clinical signs
Following administration of hyaluronic acid at any time during the 72-hour post dose period.
There was no increase in the number of micronucleated polychromatic to normochromatic erythrocytes and thus it was concluded that hyaluronic acid had no genotoxic potential and did not induce bone marrow toxicity in this test.
The human dose and have revealed no evidence of impaired fertility or harm to the fetus due
To (HYALGAN 20mg/2ml solution for intra-articular injection). There are, however, no adequate and well-controlled studies in pregnant women.
Although no embryotoxic or teratogenic effects have emerged from experiments on animals,
The Use of the drug in pregnant or nursing mothers should be limited to cases judged by a
Doctor to be absolutely necessary, after careful assessment of the risk-benefit ratio. Because
animal reproduction studies are not always predictive of human response, this drug should be
used in pregnancy only if clearly needed.
Lactation statement
It is unknown whether (HYALGAN 20mg/2ml solution for intra-articular injection).is excreted in human breast milk. The excretion of (HYALGAN 20mg/2ml solution for intra-articular injection) in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with (HYALGAN 20mg/2ml solution for intra-articular injection) should be made taking into account the benefit of breast-feeding to the child and the benefit of (HYALGAN 20mg/2ml solution for intra-articular injection) therapy to the woman.

HYALGAN does not affect the ability to operate machinery or drive a motor vehicle.

There have been rare cases (> 1/10,000 and < 1/1000) of injection site reaction, such as pain, swelling/effusion, heat, reddening, itching and synovitis. These generally resolve spontaneously within a few days if the joint is rested and an ice pack applied. Only occasionally have such cases been of a longer-lasting and more severe nature.
In the presence of objective signs indicating flare of the chronic, underlying, inflammatory process, the administration of hyaluronic acid has, in some rare cases, aggravated the condition.
There have been extremely rare cases (>1/10,000) of infection at the intra-articular injection site (See Section 4.4.).

Very rare cases (<1/10,000) of fever, systemic hypersensitivity reactions have been reported (skin rashes, urticaria, itching) and even rarer cases of anaphylaxis, but none with a fatal outcome.

To report any sided effects
Saudi Arabia:

o The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000.
o E-mail: npc.drug@sfda.gov.sa.
o Website: www.sfda.gov.sa/npc.

Other GCC states:

Please contact the relevant competent authority.

No cases of overdose have ever been reported.

Pharmacotherapeutic group: “Other drugs for disorders of the musculoskeletal system” – ATC Code: M09AX01)
Hyaluronic acid, a natural polymer belonging to the glycosaminoglycan family (acidic mucopolysaccharides), is an important component of all extracellular matrices and is present in particularly high concentrations in the cartilage and synovial fluid. The active ingredient of the medicinal specialty HYALGAN is a high-molecular-weight hyaluronic acid fraction with a high degree of purity and molecular definition, and special biochemical, physico-chemical and pharmacological properties.
The administration of HYALGAN into arthritic joints leads to a normalisation of the viscoelasticity of the synovial fluid and to an activation of tissue repair processes in the joint cartilage.
Evidence has emerged from various experimental models that hyaluronic acid has an anti-inflammatory and analgesic activity. This property translates into an improvement in joint function and means that the objective and subjective symptomatology related to arthritis can be kept in check.

Exogenous hyaluronic acid, being widely present in the organism, is physiologically metabolised after parenteral administration through the usual hexose metabolic pathways.
The results of studies carried out in dogs and rabbits after single and repeated intra-articular administration have shown that hyaluronic acid is rapidly distributed in the joint tissues and persists for a long period of time. The labelled product can be found in the synovial membrane within 2 hours of administration and persists for 7 days; the maximum concentration of labelled product is seen in the synovial fluid and then in decreasing concentrations in the joint capsule, ligaments and adjacent muscle. With regard to distribution in the organs, radioactivity has been found in the liver, kidneys, bone marrow and lymph nodes; the product is excreted mainly through the kidneys.
A study carried out in pregnant rats, using i.v. administration, showed radioactivity in the placenta and in various organs of the foetus.

The results from conventional preclinical studies on pharmacological safety, toxicity after repeated administrations, genotoxicity, carcinogenic potential and reproductive toxicity revealed no risk to humans.

Sodium chloride - Sodium dihydrogen phosphate dihydrate - Disodium hydrogen phosphate dodecahydrate - Water for injections

Disinfectants based on quaternary ammonium salts may cause the formation of precipitates in the presence of hyaluronic acid.
There is no chemical-physical incompatibility with drugs such as corticosteroids commonly used in intra-articular therapy.

Store in original packaging (protected from light) below 30°C. Do not freeze.

Sterile, 2.25-ml syringe in type-1, colourless, borosilicate glass in compliance with Ph. Eur., sealed with a sterile elastomer (latex-free) stopper and Luer Lock Adaptor for safe use of the needle.
- 1 sterile, pre-filled, disposable syringe containing 20 mg/2 ml

No special requirements