Go-on 3 Pre-filled Syringes, 2.5 ml GOON

Sodium hyaluronate is a high-molecular-weight polysaccharide composed of a linear chain of disaccharide units made up of sodium glucuronate and N-acetylglucosamine. Sodium hyaluronate is widely distributed throughout the tissues of the human body and is present in high concentrations in synovial fluid, of which it is the main component. Sodium hyaluronate, which acts as a tissue lubricant, plays an important role in modulating the physical and mechanical interaction between adjacent tissues; furthermore, this viscoelastic substance maintains separation between tissues. While the molecular weight varies depending on the sodium hyaluronate preparation, the chemical structure is always identical. Go-On is a 1% sodium hyaluronate solution derived from the bacterium Streptococcus equi through fermentation and subsequent purification processes.

Synovial fluid, which owes its viscoelastic properties to its hyaluronic acid content, is present in all synovial joints, particularly in weight-bearing joints, where its lubricating and shock-absorbing properties enable normal, pain-free movement. It also supplies nutrients to the articular cartilage. Degenerative joint diseases such as osteoarthritis are associated with a significant decrease in the viscosity of synovial fluid, which consequently loses its lubricating and shock-absorbing functions. Mechanical stress on the joints then increases, and the articular cartilage thins to the point of causing pain and impairing the function of the affected joints.

It has been proven that an improvement in the quality of synovial fluid resulting from an intra-articular injection of sodium hyaluronate-based preparations enhances the viscoelastic properties of the synovial fluid. The lubricating and shock-absorbing effects increase, while mechanical stress on the joints decreases. Pain then subsides and joint mobility is restored. After a single course of treatment consisting of five intra-articular injections, this improvement lasts for at least six months.

Indications

• Viscosupplementation of the synovial fluid in the knee and shoulder joints.
• Viscosupplementation of other synovial joints.
• Suitable for treating the symptoms of osteoarthritis due to its lubricating and mechanical effects.

Contraindications

Go-On is contraindicated in patients with a history of hypersensitivity to any of the product’s components, and in cases of inflammatory joint diseases such as rheumatoid arthritis or ankylosing spondylitis.

Directions for Use: Go-On 3 Pre-filled Syringes, 2.5 mL GOON

Instructions for Use, Dosage

Go-On should be injected into the affected joint five times in total, at one-week intervals. It is possible to treat multiple joints simultaneously. Depending on the severity of the joint disease, the effects of a five-injection treatment course may last for more than six months. Treatment cycles may be repeated if necessary. In the event of joint effusion, it is recommended to perform a joint aspiration, immobilize the joint, apply an ice pack, and/or administer corticosteroids via intra-articular injection. Treatment with Go-On can be resumed two to three days later. As long as the sterile blister pack remains unopened, the contents and the surface of the pre-filled syringe are sterile.

Remove the syringe from the sterile blister pack, remove the rubber stopper, attach a suitable sterilized needle (e.g., 19 or 21 G), and secure it by turning it slightly. Do not tighten or apply excessive pressure to secure the needle or remove its sheath. If necessary, remove any air bubbles from the syringe before injection. GO-ON must be administered alone, without being mixed with any other substance prior to injection.

Precautions for Use

Long-term viscosupplementation with GO-ON in synovial joints other than the knee and shoulder is authorized only in patients eligible for arthroplasty.

Handling of this product is restricted to individuals familiar with its use. General precautions applicable to intra-articular injections must be followed, and the injection site must be thoroughly disinfected. The preparation must be discarded if the pre-filled syringe or sterile blister pack is damaged. Use of the product after the expiration date indicated on the packaging is not recommended. The product must be kept out of the reach of children.

This product may exacerbate local inflammation in patients with osteoarthritis who are experiencing joint inflammation. It is therefore recommended to wait until the local symptom has resolved before administering the product.

Administration of the product may, in rare cases, cause local pain. To prevent this pain, it is recommended to keep the affected area still after the injection. It is essential to inject the product into the intra-articular space; failure to follow this instruction may cause pain. It is not recommended to inject the product into a blood vessel or into surrounding tissues. Go-On should be administered with caution in patients with a history of drug hypersensitivity and in those with hepatic insufficiency or liver disorders.

Elderly patients: The product should be administered with caution in these patients, whose physiological functions are often impaired.

Children: Since the safety ofthis product has not been established in children, it should be administered with caution in these patients.

Pregnant or breastfeeding women: Although no teratogenic effects have been observed in animals, the safety of this product has not been established in pregnant women. It is therefore recommended to exercise caution when administering this product to pregnant women or in cases of suspected pregnancy. Sodium hyaluronate is excreted in the milk of treated animals; it is therefore advisable to discontinue breastfeeding during treatment.

Side Effects:

In rare cases, some patients may develop a skin rash, such as hives or itching. If this occurs, it is imperative to discontinue administration of the product and provide the patient with appropriate treatment. Pain (primarily transient pain following administration), swelling, and effusions, as well as infections at the injection site, have been reported on rare occasions. Patients may occasionally complain of redness, a sensation of warmth, and heaviness at the injection site. Shock has been reported very rarely. Anaphylactic reactions may occur. If this occurs, it is essential to discontinue administration of the product, closely monitor the patient, and provide appropriate treatment.

The injection of Go-On may be followed by local side effects at the treated joint, such as pain, a sensation of warmth, redness, and/or swelling, effusion, or infection. These adverse events can be relieved by applying an ice pack to the treated joint for 5 to 10 minutes.

Interactions with Other Agents:

Do not use concomitantly with disinfectants containing quaternary ammonium salts such as benzalkonium chloride, as there is a known incompatibility with hyaluronic acid. GO-ON must therefore not come into contact with such products, nor with medical and surgical equipment treated with these types of products, as sodium hyaluronate may precipitate in their presence.

To date, no incompatibility (interaction) between Go-On and other intra-articular solutions has been reported. Concomitant administration of oral analgesics and anti-inflammatory drugs may be beneficial for the patient during the first few days of treatment.

Composition: Go-On 3 pre-filled syringes, 2.5 mL GOON

Per syringe: 2.5 mL of 1% sodium hyaluronate solution, sodium chloride, disodium phosphate, monosodium phosphate, water for injection.

Sodium hyaluronate is a high-molecular-weight polysaccharide composed of a linear chain of disaccharide units made up of sodium glucuronate and N-acetylglucosamine. Sodium hyaluronate is widely distributed throughout the tissues of the human body and is present in high concentrations in synovial fluid, of which it is the main component. Sodium hyaluronate, which acts as a tissue lubricant, plays an important role in modulating the physical and mechanical interaction between adjacent tissues; furthermore, this viscoelastic substance maintains separation between tissues. While the molecular weight varies depending on the sodium hyaluronate preparation, the chemical structure is always identical. Go-On is a 1% sodium hyaluronate solution derived from the bacterium Streptococcus equi through fermentation and subsequent purification processes.

Synovial fluid, which owes its viscoelastic properties to its hyaluronic acid content, is present in all synovial joints, particularly in weight-bearing joints, where its lubricating and shock-absorbing properties enable normal, pain-free movement. It also supplies nutrients to the articular cartilage. Degenerative joint diseases such as osteoarthritis are associated with a significant decrease in the viscosity of synovial fluid, which consequently loses its lubricating and shock-absorbing functions. Mechanical stress on the joints then increases, and the articular cartilage thins to the point of causing pain and impairing the function of the affected joints.

It has been proven that an improvement in the quality of synovial fluid resulting from an intra-articular injection of sodium hyaluronate-based preparations enhances the viscoelastic properties of the synovial fluid. The lubricating and shock-absorbing effects increase, while mechanical stress on the joints decreases. Pain is then alleviated, and joint mobility is restored. After a single course of treatment consisting of five intra-articular injections, this improvement lasts for at least six months.

Indications

• Viscosupplementation of the synovial fluid in the knee and shoulder joints.
• Viscosupplementation of other synovial joints.
• Suitable for treating the symptoms of osteoarthritis due to its lubricating and mechanical effects.

Contraindications

Go-On is contraindicated in patients with a history of hypersensitivity to any of the product’s components, and in cases of inflammatory joint diseases such as rheumatoid arthritis or ankylosing spondylitis.

Directions for Use: Go-On 3 Pre-filled Syringes, 2.5 mL GOON

Instructions for Use, Dosage

Go-On should be injected into the affected joint five times in total, at one-week intervals. It is possible to treat multiple joints simultaneously. Depending on the severity of the joint disease, the effects of a five-injection treatment course may last for more than six months. Treatment cycles may be repeated if necessary. In the event of joint effusion, it is recommended to perform a joint aspiration, immobilize the joint, apply an ice pack, and/or administer corticosteroids via intra-articular injection. Treatment with Go-On can be resumed two to three days later. As long as the sterile blister pack remains unopened, the contents and the surface of the pre-filled syringe are sterile.

Remove the syringe from the sterile blister pack, remove the rubber stopper, attach a suitable sterilized needle (e.g., 19 or 21 G), and secure it by turning it slightly. Do not tighten or apply excessive pressure to secure the needle or remove its sheath. If necessary, remove any air bubbles from the syringe before injection. GO-ON must be administered alone, without being mixed with any other substance prior to injection.

Precautions for Use

Long-term viscosupplementation with GO-ON in synovial joints other than the knee and shoulder is authorized only in patients eligible for arthroplasty.

Handling of this product is restricted to individuals familiar with its use. General precautions applicable to intra-articular injections must be followed, and the injection site must be thoroughly disinfected. The preparation must be discarded if the pre-filled syringe or sterile blister pack is damaged. Use of the product after the expiration date indicated on the packaging is not recommended. The product must be kept out of the reach of children.

This product may exacerbate local inflammation in patients with osteoarthritis who are experiencing joint inflammation. It is therefore recommended to wait until the local symptom has resolved before administering the product.

Administration of the product may, in rare cases, cause local pain. To prevent this pain, it is recommended to keep the affected area still after the injection. It is essential to inject the product into the intra-articular space; failure to follow this instruction may cause pain. It is not recommended to inject the product into a blood vessel or into surrounding tissues. Go-On should be administered with caution in patients with a history of drug hypersensitivity and in those with hepatic insufficiency or liver disorders.

Elderly patients: The product should be administered with caution in these patients, whose physiological functions are often impaired.

Children: Since the safety ofthis product has not been established in children, it should be administered with caution in these patients.

Pregnant or breastfeeding women: Although no teratogenic effects have been observed in animals, the safety of this product has not been established in pregnant women. It is therefore recommended to exercise caution when administering this product to pregnant women or in cases of suspected pregnancy. Sodium hyaluronate is excreted in the milk of treated animals; it is therefore advisable to discontinue breastfeeding during treatment.

Side Effects:

In rare cases, some patients may develop a skin rash, such as hives or itching. If this occurs, it is imperative to discontinue administration of the product and provide the patient with appropriate treatment. Pain (primarily transient pain following administration), swelling, and effusions, as well as infections at the injection site, have been reported on rare occasions. Patients may occasionally complain of redness, a sensation of warmth, and heaviness at the injection site. Shock has been reported very rarely. Anaphylactic reactions may occur. If this occurs, it is essential to discontinue administration of the product, closely monitor the patient, and provide appropriate treatment.

The injection of Go-On may be followed by local side effects at the treated joint, such as pain, a sensation of warmth, redness, and/or swelling, effusion, or infection. These adverse events can be relieved by applying an ice pack to the treated joint for 5 to 10 minutes.

Interactions with Other Agents:

Do not use concomitantly with disinfectants containing quaternary ammonium salts, such as benzalkonium chloride, as there is a known incompatibility with hyaluronic acid. GO-ON must therefore not come into contact with such products, nor with medical and surgical equipment treated with these types of products, as sodium hyaluronate may precipitate in their presence.

To date, no incompatibility (interaction) between Go-On and other intra-articular solutions has been reported. Concomitant administration of oral analgesics and anti-inflammatory drugs may be beneficial for the patient during the first few days of treatment.

Composition: Go-On 3 pre-filled syringes, 2.5 mL GOON

Per syringe: 2.5 mL of 1% sodium hyaluronate solution, sodium chloride, disodium phosphate, monosodium phosphate, water for injection.

Sodium hyaluronate is a high-molecular-weight polysaccharide composed of a linear chain of disaccharide units made up of sodium glucuronate and N-acetylglucosamine. Sodium hyaluronate is widely distributed throughout the tissues of the human body and is present in high concentrations in synovial fluid, of which it is the main component. Sodium hyaluronate, which acts as a tissue lubricant, plays an important role in modulating the physical and mechanical interaction between adjacent tissues; furthermore, this viscoelastic substance maintains separation between tissues. While the molecular weight varies depending on the sodium hyaluronate preparation, the chemical structure is always identical. Go-On is a 1% sodium hyaluronate solution derived from the bacterium Streptococcus equi through fermentation and subsequent purification processes.

Synovial fluid, which owes its viscoelastic properties to its hyaluronic acid content, is present in all synovial joints, particularly in weight-bearing joints, where its lubricating and shock-absorbing properties enable normal, pain-free movement. It also supplies nutrients to the articular cartilage. Degenerative joint diseases such as osteoarthritis are associated with a significant decrease in the viscosity of synovial fluid, which consequently loses its lubricating and shock-absorbing functions. Mechanical stress on the joints then increases, and the articular cartilage thins to the point of causing pain and impairing the function of the affected joints.

It has been proven that an improvement in the quality of synovial fluid resulting from an intra-articular injection of sodium hyaluronate-based preparations enhances the viscoelastic properties of the synovial fluid. The lubricating and shock-absorbing effects increase, while mechanical stress on the joints decreases. Pain is then alleviated, and joint mobility is restored. After a single course of treatment consisting of five intra-articular injections, this improvement lasts for at least six months.

Indications

• Viscosupplementation of the synovial fluid in the knee and shoulder joints.
• Viscosupplementation of other synovial joints.
• Suitable for treating the symptoms of osteoarthritis due to its lubricating and mechanical effects.

Contraindications

Go-On is contraindicated in patients with a history of hypersensitivity to any of the product’s components, and in cases of inflammatory joint diseases such as rheumatoid arthritis or ankylosing spondylitis.

Directions for Use: Go-On 3 Pre-filled Syringes, 2.5 mL GOON

Instructions for Use, Dosage

Go-On should be injected into the affected joint five times in total, at one-week intervals. It is possible to treat multiple joints simultaneously. Depending on the severity of the joint disease, the effects of a five-injection treatment course may last for more than six months. Treatment cycles may be repeated if necessary. In the event of joint effusion, it is recommended to perform a joint aspiration, immobilize the joint, apply an ice pack, and/or administer corticosteroids via intra-articular injection. Treatment with Go-On can be resumed two to three days later. As long as the sterile blister pack remains unopened, the contents and the surface of the pre-filled syringe are sterile.

Remove the syringe from the sterile blister pack, remove the rubber stopper, attach a suitable sterilized needle (e.g., 19 or 21 G), and secure it by turning it slightly. Do not tighten or apply excessive pressure to secure the needle or remove its sheath. If necessary, remove any air bubbles from the syringe before injection. GO-ON must be administered alone, without being mixed with any other substance prior to injection.

Precautions for Use

Long-term viscosupplementation with GO-ON in synovial joints other than the knee and shoulder is authorized only in patients eligible for arthroplasty.

Handling of this product is restricted to individuals familiar with its use. General precautions applicable to intra-articular injections must be followed, and the injection site must be thoroughly disinfected. The preparation must be discarded if the pre-filled syringe or sterile blister pack is damaged. Use of the product after the expiration date indicated on the packaging is not recommended. The product must be kept out of the reach of children.

This product may exacerbate local inflammation in patients with osteoarthritis who are experiencing joint inflammation. It is therefore recommended to wait until the local symptoms have subsided before administering the product.

Administration of the product may, in rare cases, cause local pain. To prevent this pain, it is recommended to keep the affected area still after the injection. It is essential to inject the product into the intra-articular space; failure to follow this instruction may cause pain. It is not recommended to inject the product into a blood vessel or into surrounding tissues. Go-On should be administered with caution in patients with a history of drug hypersensitivity and in those with hepatic insufficiency or liver disorders.

Elderly patients: The product should be administered with caution in these patients, whose physiological functions are often impaired.

Children: Since the safety ofthis product has not been established in children, it should be administered with caution in these patients.

Pregnant or breastfeeding women: Although no teratogenic effects have been observed in animals, the safety of this product has not been established in pregnant women. It is therefore recommended to exercise caution when administering this product to pregnant women or in cases of suspected pregnancy. Sodium hyaluronate is excreted in the milk of treated animals; it is therefore advisable to discontinue breastfeeding during treatment.

Side Effects:

In rare cases, some patients may develop a skin rash, such as hives or itching. If this occurs, it is imperative to discontinue administration of the product and provide the patient with appropriate treatment. Pain (primarily transient pain following administration), swelling, and effusions, as well as infections at the injection site, have been reported on rare occasions. Patients may occasionally complain of redness, a sensation of warmth, and heaviness at the injection site. Shock has been reported very rarely. Anaphylactic reactions may occur. If this occurs, it is essential to discontinue administration of the product, closely monitor the patient, and provide appropriate treatment.

The injection of Go-On may be followed by local side effects at the treated joint, such as pain, a sensation of warmth, redness, and/or swelling, effusion, or infection. These adverse events can be relieved by applying an ice pack to the treated joint for 5 to 10 minutes.

Interactions with Other Agents:

Do not use concomitantly with disinfectants containing quaternary ammonium salts, such as benzalkonium chloride, as there is a known incompatibility with hyaluronic acid. GO-ON must therefore not come into contact with such products, nor with medical and surgical equipment treated with these types of products, as sodium hyaluronate may precipitate in their presence.

To date, no incompatibility (interaction) between Go-On and other intra-articular solutions has been reported. Concomitant administration of oral analgesics and anti-inflammatory drugs may be beneficial for the patient during the first few days of treatment.

Composition: Go-On 3 pre-filled syringes, 2.5 mL GOON

Per syringe: 2.5 mL of a solution containing 1% sodium hyaluronate, sodium chloride, disodium phosphate, monosodium phosphate, and water for injection.