This medical device is a sterile, elastophistochemical solution intended for direct injection into a joint by a physician. It serves as a temporary replacement and supplement for the natural joint fluid (synovial fluid). It thus helps to support the physiological lubricating and shock-absorbing properties of the joint, while relieving pain and limiting movement. The treatment is designed for patients with joint conditions at various stages and is particularly beneficial when the affected joint is used regularly and actively.

Scope and mechanism of action
The solution is administered by intra-articular injection into the affected joints, such as the knee, hip, ankle, shoulder or other suitable joints. Through a process known as viscosupplementation, the joint fluid is temporarily supplemented to improve the mechanical properties of the joint. The aim is to reduce pain and discomfort, as well as facilitate mobility in everyday life. Laboratory studies have shown that the substances contained in the solution can protect cartilage cells against certain physical and chemical stressors.

Administration
The injection should be performed exclusively by a physician and administered directly into the joint space (intraarticular). Before injection, the joint is clinically assessed; if necessary, any existing joint fluid or effusion is removed, after which the injection is performed under strict aseptic conditions. Depending on the specific joint and the treatment regimen, the procedure may consist of a single injection or a series of injections administered at set intervals. After treatment, the affected joint should be left to rest for several days, avoiding strenuous physical activity, before gradually resuming normal activities. Important warnings
This preparation is intended for intra-articular use only and should not be injected into blood vessels (intravascular), into surrounding tissues or outside the joint space. It should not be used if the joint is infected or severely inflamed, or if there are skin conditions or infections in the area where the injection is to be given. The product should not be used in cases where there is significant joint effusion. It has not been tested for use in pregnant women, children or adolescents under 18 years of age. As the product contains small amounts of avian protein (from birds), it should not be used by people with known hypersensitivity to such components or to preparations containing hyaluronan.

Possible side effects
After injection, temporary pain, swelling or an effusion (fluid collection) may occur in the treated joint, sometimes accompanied by a feeling of warmth or stiffness. In rare cases, more severe inflammatory reactions in the joint have been reported, usually without evidence of pathogens in the synovial fluid. Very rarely, hypersensitivity reactions - including severe allergic reactions - may occur. Since the product has been marketed, systemic symptoms such as rash, itching, fever, nausea, headache or chills have been observed rarely. If you experience unusually intense discomfort, signs of infection or an allergic reaction, seek medical attention immediately. If you have any questions, please consult your doctor or pharmacist.

Handling and safety
The pre-filled syringe is sterile, pyrogen-free and intended for single use only. It should only be used if the original packaging is intact and unopened; do not use if the packaging has been opened or damaged. The contents of the syringe should be used immediately after opening; any remaining product should not be reused. The product should be injected at room temperature and stored between +2°C and +30°C; do not freeze. The components of the outer packaging are recyclable and can be disposed of in accordance with local regulations.

Intended for intra-articular use by physicians only; not suitable for self-injection.
Intended for temporary replacement and supplementation of synovial fluid to relieve pain and improve mobility.
Do not use in case of joint infection, severe inflammation, skin infections at the injection site or in case of known allergy to hyaluronan/avian proteins.
Sterile, single-use syringe; use only if the package is intact and unopened. Do not reuse any remaining product. Active substances
1 syringe = 6 ml solution
Hylan GF 20 (derived from avian source) 48 mg

Excipients
1 syringe = 6 ml solution

• Sodium dihydrogen phosphate 0.24 mg
• Disodium hydrogen phosphate 0.96 mg
• Sodium chloride 51 mg
• Water for injections