Synvisc One 1 6-ml syringe GENZYME
Synvisc One (Hylan G-F 20) is a viscoelastic solution recommended for relieving pain caused by osteoarthritis.
Sinovial 2 mg Hyaluronic Acid Intra-articular Injectable Solution, 3 vials
For warnings, precautions, and contraindications, please refer to the package insert.
Please include your prescription with your order.
Synvisc One (Hylan G-F 20) is a viscoelastichyaluronic acid solution recommended to relieve pain caused by osteoarthritis (a condition that causes “wear and tear” of the knee joint). Synvisc One (Hylan G-F 20) has been shown to be effective when administered at all stages of joint disease. Treatment with Synvisc One (Hylan G-F 20) helps reduce pain and discomfort, thereby increasing the joint’s range of motion.
Synvisc One (Hylan G-F 20) is a sterile, nonpyrogenic, elastoviscous fluid containing hylanes. Hylanes are derivatives of hyaluronan (sodium hyaluronate) and are composed of repeating units of N-acetylglucosamine and sodium glucuronate. Synvisc One (Hylan G-F 20) is biologically similar to hyaluronan. In vitro studies have shown that Synvisc One (Hylan G-F 20) protects cartilage cells against certain physical and chemical injuries. Pain relief may last up to 6 months.
Intra-articular administration. For adults only. The usual recommended dose is a single injection into the knee joint. It is important that this medical device be used in accordance with your doctor’s instructions. Synvisc One (Hylan G-F 20) must be administered only intra-articularly and by a doctor.
In cases of moderate osteoarthritis, it may be beneficial to use a natural glucosamine supplement to help relieve symptoms.
Viscoelastic solution, hyaluronic acid. Each mL of this viscoelastic, sterile, and pyrogen-free solution contains 8 mg of hylan. Excipients with known effects: disodium hydrogen phosphate, sodium chloride, sodium dihydrogen phosphate monohydrate, and water for injection.
Keep out of the reach of children. Never use Synvisc One (Hylan G-F 20) if you are allergic to any of its ingredients, if you have a skin condition at the injection site, or if the joint is infected or inflamed.
Box containing 1 6-mL syringe.
What is a joint made of?
A healthy joint consists of cartilage and synovial fluid, which protect the bones from impact and friction.
In a joint affected by osteoarthritis, the cartilage breaks down and the synovial fluid can no longer perform its protective role. This leads to friction between the bones, causing pain, joint stiffness, and swelling.
A Synvisc-One injection replaces the synovial fluid in an arthritic joint with a natural substance that forms a cushion to protect and lubricate the joint.
In a knee affected by osteoarthritis, the synovial fluid (also called “synovia”) may leak out. When this happens, the knee loses its protective and lubricating cushion.
Synvisc-One replaces the synovial fluid in the arthritic knee to relieve pain and improve the joint’s ability to act as a natural shock absorber.
Please note: This medication is not like other products. Read the medication guide carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.
Synvisc One (Hylan G-F 20) is a viscoelastic solution specifically designed to relieve pain caused by osteoarthritis.
Pain Relief: Osteoarthritis can cause debilitating joint pain. Synvisc One provides relief by reducing pain and discomfort.
Viscoelasticity: This viscoelastic solution acts as a lubricant and shock absorber for the joints, which can improve mobility and reduce pain.
Pre-filled Syringe: Synvisc One is available in a pre-filled syringe, making it convenient to use.
Medical Administration: Your healthcare provider can administer the solution directly into the affected joint.
Hylane GF 20 is available in two forms:
Synvisc, 2 ml: 2.25 ml glass syringe (boxes of 1 [ACL 34010 7848992 1 ] and 3 [ACL 34010 7647928 3 ]).
Synvisc-One, 6 ml: 10 ml glass syringe (ACL 34010 4864022 2 ).
Hylane GF 20 is a sterile, apyrogenic, viscoelastic liquid containing the hylane A and hylane B polymers produced from a highly purified avian extract. Hylans are derivatives of hyaluronan (sodium hyaluronate), and are composed of recurrent disaccharide units of N-acetylglucosamine and sodium glucuronate.
Hylane A has an average molecular weight of 6 000 000 daltons and hylane B is a hydrated gel. Hylane GF 20 contains hylan A and hylan B (8.0 mg ± 2.0 mg / ml) in buffered sodium chloride physiological solution (pH 7.2 ± 0.3).
For 1 ml (Hylane GF 20): hylane 8.0 mg, sodium chloride 8.5 mg, disodium phosphate 0.16 mg, sodium phosphate hydrate 0.04 mg, water for injections qs.
Synvisc contains 2 ml of Hylane GF 20. Synvisc-One contains 6 ml of Hylane GF 20.
Hylane GF 20 is biologically similar to hyaluronan. Hyaluronan is a constituent of the synovial fluid which gives it its viscoelasticity. However, the mechanical (viscoelastic) properties of Hylane GF 20 are superior to those of the synovial fluid and hyaluronan solutions of similar concentrations. Hylane GF 20 has an elasticity (storage coefficient G ') at 2.5 Hz of 111 ± 13 pascals (Pa) and a viscosity (loss coefficient G' ') of 25 ± 2 Pa. The elasticity and viscosity of knee synovial fluid of subjects aged 18-27 years measured with a method comparable to 2.5 Hz are G '= 117 ± 13 Pa; G '' = 45 ± 8 Pa. Hylans are metabolized in the body by the same route as hyaluronan and the products of their degradation are not toxic.
Hylane GF 20:
is a replacement agent and a temporary supplement for synovial fluid;
is effective when administered in all stages of joint disease;
is most effective when administered to patients whose regular physical activity mobilizes the affected joint;
exerts its therapeutic effects by acting as viscosupplement, restoring the physiological and rheological properties of the tissues of the joint affected by osteoarthritis.
The viscosupplementation with Hylane GF 20 is a treatment which reduces pain and discomfort and thus increases the range of motion of the joint. In vitro studies have demonstrated that Hylane GF protects cartilage cells against certain physical and chemical lesions.
Prior to injection, inform the patient that Synvisc and Synvisc-One are highly purified hyaluronic acid from an avian source.
Synvisc should only be administered intra-articularly and by a doctor to relieve the pain associated with osteoarthritis of the knee, hip, ankle and shoulder.
Synvisc-One should only be administered intra-articularly, and by a physician, to relieve the pain associated with osteoarthritis of the knee.
Do not use Hylane GF 20 if the packaging is opened or damaged.
The contents of the syringe must be used immediately after opening the package.
Aspiration of the synovial fluid or any effusion before each injection of Hylane GF 20.
Inject Synvisc at room temperature.
To remove the syringe from the thermoformed shell (or tray), grasp it by the body without touching the piston rod.
Inject Synvisc by applying strict aseptic methods and paying particular attention to the removal of the cap from the end of the syringe.
Unscrew the gray cap from the end of the syringe before removing it to minimize product leakage.
Use a suitable diameter needle:
Synvisc: 18 to 22 gauges;
Use a needle of adequate length, depending on the joint to be treated.
Synvisc-One: 18 to 20 gauges.
To ensure a leak-tight connection and prevent leakage during administration, tighten the needle securely to the syringe's Luer clamp.
Do not tighten or apply excessive pressure to secure the needle or remove the sheath, otherwise the end of the syringe may be broken.
Inject only into the synovial space, performing the operation, if necessary, under fluoroscopic guidance, especially in the case of treatment of hip and shoulder joints.
The contents of the syringe are for single use only. As indicated in the dosage recommendations, inject the entire volume of the syringe (2 ml for Synvisc and 6 ml for Synvisc-One). Discard the entire Synvisc / Synvisc-One product not used remaining.
When working under radioscopic control, an ionic or non-ionic contrast agent may be used. Do not use more than 1 ml of contrast medium per 2 ml of Hylane GF 20.
Do not sterilize Hylane GF 20 again.
The dosage of Hylane GF 20 depends on the joint to be treated.
It is recommended to administer Synvisc in a dosage regimen of 3 injections of 2 ml in the knee, one week apart each. To achieve optimal effect, it is essential to administer the 3 injections. The maximum recommended dose is 6 injections over a 6-month period, with an interval of at least 4 weeks between treatment cycles.
It is recommended to administer Synvisc-One according to a dosage regimen of a 6 ml injection into the knee. A second injection may be performed 6 months after the first injection, if the patient's symptoms warrant.
It is recommended that Synvisc be administered according to an initial dosage regimen of a single 2 ml injection. If, however, adequate symptomatic relief is not obtained after this injection, it is recommended to administer a second 2 ml injection. Clinical data showed that patients feel better the benefit of this second injection when administered between 1 and 3 months after the first injection.
Treatment with Hylane GF 20 only affects the treated joint; there is no systemic effect.
For patients who respond favorably to therapy, the duration of the therapeutic effect is generally 26 weeks maximum, although longer or shorter duration of efficacy has been observed. However, prospective clinical data revealed that patients with osteoarthritis of the knee had responded favorably to treatment up to 52 weeks after a single set of three injections of Synvisc.
Prospective clinical trial data in patients with osteoarthritis of the knee showed a reduction in pain up to 52 weeks following a single injection of Synvisc-One, as well as a decrease in stiffness and improved functionality.
Clinical data from a randomized controlled double-blind trial in patients with osteoarthritis of the knee showed a statistically and clinically significant reduction in pain compared with placebo. A total of 253 patients were treated (124 received Synvisc-One and 129 received placebo). Over 26 weeks, patients receiving Synvisc-One had an average pain reduction percentage relative to baseline values of 36%, while patients in the placebo group had an average percentage reduction in pain versus reference values of 29%.
Other prospective clinical data from two open-label multicentre studies in patients with knee osteoarthritis showed statistically significant improvements in pain relief over baseline values for up to 52 weeks administration of Synvisc-One.
In the first study, results obtained from 394 patients receiving Synvisc-One revealed a statistically significant change in the score obtained on the WOMAC A1 scale - walking pain scale - (28 ± 19.89 mm on a visual analog scale [EVA] of 100 mm) at week 26 compared to the reference values. In addition, statistically significant changes from the WOMAC A1 and WOMAC A, B and C scales were observed during the 6 observation periods between week 1 and week 52, confirming an improvement in the relief of (WOMAC A - 32.7 ± 19.95 mm; WOMAC A - 29.18 ± 19.158 mm); decreased stiffness (WOMAC B - 25.77 ± 22.047 mm); and an improvement in functionality (WOMAC C - 25.72 ± 19.449 mm) over 52 weeks.
In the second study, 571 patients receiving Synvisc-One showed a statistically significant improvement in pain over 26 weeks, as measured by the Verbal Pain Questionnaire (VPQ). The mean pain rating showed improvement in relief, with a baseline score of 3.20 during the baseline visit dropping to 2.24 at the 26-week visit, and 64.6% of patients reaching the pain relief. Secondary endpoints revealed statistically significant improvement in VPQ scores, regardless of the time points of observation, from week 1 to week 52, with mean VPQ scores decreasing by 3.20 at the baseline visit to 2.26 at the visit of week 52, and 61.5% of patients achieving pain relief.
In the presence of venous or lymphatic stasis in the corresponding limb, Hylane GF 20 should not be injected into the joint.
Hylane GF 20 should not be injected into an infected or severely inflamed joint or in patients with a skin condition or infection at the injection site.
Do not inject intravascularly.
Do not inject outside the joint cavity or into the synovial tissue or capsule. Undesirable effects, usually at the injection site, were observed after extra articular injection of Synvisc.
Do not use concomitantly with disinfectants containing quaternary ammonium salts for the preparation of the skin as hyaluronan can precipitate in their presence.
Do not administer Hylane GF 20 in the presence of significant joint effusion before injection.
As with any invasive procedure in the joint, the patient is advised to avoid intense physical activity after intra-articular injection and to resume normal activities after a few days.
Hylane GF 20 has not been evaluated in pregnant women or children under 18 years of age.
Hylane GF 20 contains a small amount of avian proteins and should not be administered to people who are hypersensitive to these proteins.
Intra-articular injections of Hylane GF 20 may cause temporary pain, edema and / or effusion. Cases of acute inflammation characterized by articular pain, edema, effusion and sometimes a sensation of heat and / or stiffness in the joint have been reported following an intra-articular injection of Synvisc or Synvisc-One . Synovial fluid analysis revealed an aseptic liquid without crystals. This reaction often responds to treatment with non-steroidal anti-inflammatory drugs (NSAIDs), steroids administered intra-articularly and / or arthrocentesis in a few days. A therapeutic benefit is always possible after reactions of this type.
No cases of intra-articular infection occurred in clinical trials with Synvisc / Synvisc-One; a few cases have been reported following the commercialization of Synvisc.
Hypersensitivity reactions including anaphylactic reaction, anaphylactoid reaction, anaphylactic shock and angioedema have also been reported.
Rare systemic reactions reported after administration of Synvisc include: erythema, urticaria, itching, fever, nausea, headache, dizziness, chills, muscle cramps, paresthesia, peripheral edema, malaise, difficulty breathing, hot flushes and facial edema. The controlled clinical trials with Synvisc did not reveal any significant statistical differences in the number or types of adverse systemic effects between the group of patients treated with Synvisc and the control group.
In the controlled trial with Synvisc-One, the frequency and types of adverse events were similar in the group receiving Synvisc-One and the placebo group.
The contents of each syringe are sterile and non-pyrogenic. Store between + 2 ° C and + 30 ° C. Do not freeze.
Class III medical device. CE marking 0086 (2003).
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