Description for Synvisc Classic
Hylan G-F 20 is available as
• Synvisc , 2-ml pack.
• Synvisc-One®, 6-ml pack.
Hylan G-F 20 is a sterile, pyrogen-free, elastoviscous fluid containing Hylan A and Hylan B polymers derived from a highly purified avian extract. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. The average molecular weight of Hylan A is approximately 6,000,000 Daltons, and Hylan B is a hydrated gel. Hylan G-F 20 contains Hylan A and Hylan B (8.0 mg ± 2.0 mg per ml) in a buffered physiological sodium chloride solution (pH 7.2 ± 0.3).
PROPERTIES
Hylan G-F 20 is biologically similar to hyaluronan. Hyaluronan is a component of synovial fluid and is responsible for its viscoelasticity. However, the mechanical (elasto-viscous) properties of Hylan G-F 20 exceed those of synovial fluid and hyaluronan solutions of comparable concentration. At a frequency of 2.5 Hertz, Hylan G-F 20 has an elasticity (G’: shock absorption factor) of 111 ± 13 Pascal (Pa) and a viscosity (G’’: shock dissipation factor) of 25 ± 2 Pa. At a frequency of 2.5 Hertz, the elasticity and viscosity of knee synovial fluid measured by a comparable method in 18- to 27-year-olds were G’ = 117 ± 13 Pa and G’’ = 45 ± 8 Pa. Hylans are broken down in the body in the same way as hyaluronan; the breakdown products are non-toxic.
INDICATIONS
Hylan G-F 20
• serves as a temporary replacement or supplement to synovial fluid.
• is indicated for patients at all stages of joint disease.
• shows the most effective results in patients who actively and regularly move the affected joints. move regularly.
• The therapeutic effect of Hylan G-F 20 is based on viscosupplementation, a process in which the physiological and rheological conditions of the arthritic joint tissue to be restored.
Viscosupplementation with Hylan G-F 20 is a therapy to relieve pain and physical discomfort, enabling improved joint mobility. In vitro-Studies have shown that Hylan G-F 20 protects cartilage cells from certain physical and chemical damage.
Synvisc is intended only for intra-articular use by the physician to treat pain associated with degenerative joint disease of the knee, hip, ankle, or shoulder.
Synvisc-One is intended only for intra-articular use by a physician to treat pain associated with degenerative joint disease of the knee.
CONTRAINDICATIONS
• If venous or lymphatic congestion occurs in the affected limb, Hylan G-F 20 should not be injected into the joint.
• Hylan G-F 20 must not be used in infected or severely inflamed joints or in patients with skin diseases or infections in the injection area.
• Hylan G-F-20 must not be used in patients with known hypersensitivity (allergy) used against hyaluronan (sodium hyaluronate).
WARNINGS
• Do not inject intravascularly.
• Do not inject extra-articularly and not into the synovial tissue or capsule. Side effects at the injection site may especially occur if the Injection of Synvisc not strictly intra-articular.
• Disinfectants containing quaternary ammonium salts can cause precipitation favor hyaluronan. Therefore, they should not be used simultaneously, for example, to prepare the skin for the procedure.
PRECAUTIONS
• If there is a large intra-articular effusion before injection, Hylan G-F 20 should not be used.
• As with any invasive procedure in the joint, patients are advised to avoid strenuous activities for a few days after the injection.
• Hylan G-F 20 has not been tested in pregnant women and children under 18 years of age.
• Hylan G-F 20 contains small amounts of bird protein and should be used with caution in patients who should not be used in patients who react hypersensitively to this.
SIDE EFFECTS
• Side effects affecting the joint injected: After injection of Hylan G-F 20 into the joint, temporary pain and/or swelling and/or effusions in the injection area may occur. Cases of acute inflammation characterized by joint pain, swelling, effusion, and occasionally warming or stiffness of the joint have been reported after intra-articular injection of Synvisc or Synvisc-One observed. Examination of the synovial fluid shows an aseptic fluid without crystals. This reaction often responds within a few days to treatment with a nonsteroidal anti-inflammatory drug (NSAID), intra-articular steroids, and/or arthrocentesis, whereby a clinical benefit of the treatment may still be present even after the reactions have occurred.
• Joint infections did not occur in any clinical study with Synvisc/Synvisc-One and were rarely used in therapeutic applications with Synvisc reported.
• Hypersensitivity reactions including anaphylactic reaction, anaphylactoid reaction, anaphylactic shock, and angioedema have also been observed.
• Since market introduction, the following systemic events have been reported, which are rare after administration of Synvisc may occur: rash, urticaria, itching, fever, nausea, headache, dizziness, chills, muscle cramps, paresthesia (abnormal sensations such as tingling), peripheral edema, malaise, breathing difficulties, flushing, and facial swelling.
• Controlled clinical studies showed no statistically significant differences in the number or type of systemic side effects between the patient group that Synvisc received, and the control group.
• The controlled clinical study with Synvisc-One showed a comparable number and type of side effects between the patient group that Synvisc-One received, and the control group that received a placebo.
DOSAGE AND ADMINISTRATION
• Do not use Hylan G-F 20 if the package has already been opened or damaged.
• The contents of the syringe must be used immediately after opening the package.
• Remove synovial fluid and effusions before injecting Hylan G-F 20.
• Inject at room temperature.
• Avoid touching the plunger when removing the syringe from the blister (or from the tray) want to take. Only touch the syringe body.
• Use strictly aseptic techniques during administration and proceed be especially careful when removing the protective cap.
• Twist the protective cap before removing it. This minimizes Product leakage.
• Use an appropriate needle size:
• Synvisc – 18 to 22 Gauge
Use an appropriate needle length according to the joint to be treated.
• Synvisc-One – 18 to 20 Gauge
• To achieve the best possible seal of the needle and thus prevent leakage during administration, hold the Luer-lock connection of the syringe vial firmly while screwing in the needle tightly.
• Avoid excessive twisting or applying leverage when attaching the needle to the syringe or removing the needle shield, as this could cause the needle tip to break.
• Inject strictly intra-articularly and, if necessary, perform under imaging guidance, especially for joints such as the hip and shoulder.
• The contents of one syringe are intended for single use only. The recommended dosage corresponds to the injection of the entire contents (2 ml for Synvisc and 6 ml for Synvisc-One) of a syringe. Unused Synvisc/Synvisc-One is to be disposed of.
• Syringes and/or needles must not be reused. Reusing syringes, needles, and/or product residues from already used syringes results in loss of sterility. This can lead to product contamination and/or incomplete treatment.
• When using fluoroscopy, ionic and non-ionic contrast agents may be used. A maximum of 1 ml contrast agent may be used per 2 ml of Hylan G-F 20.
• Do not re-sterilize Hylan G-F 20.
DOSAGE INSTRUCTIONS
The dosage of Hylan G-F 20 depends on the joint to be treated.
Osteoarthritis of the knee joint:
Synvisc
The recommended treatment consists of 3 weekly intra-articular injections of 2 ml each. To achieve maximum effect, it is necessary to complete all 3 injections. The recommended maximum dosage is 6 injections within six months, with at least four weeks between treatment series.
Synvisc-One
The recommended treatment consists of a 6 ml intra-articular injection. The injection can be repeated six months after the first injection if the patient's symptoms justify it.
Osteoarthritis of the hip joint/upper ankle joint/ Shoulder joint:
Synvisc
An initial treatment with a single 2 ml injection is recommended. However, if adequate relief of symptoms is not achieved after this injection, administration of a second 2 ml injection is recommended. Clinical data have shown that patients benefit from a second injection if it is given within one to three months after the first injection.
DURATION OF EFFECT
Treatment with Hylan G-F 20 acts only locally in the joint; it does not produce a general systemic effect.
Synvisc
It is reported that the effect in patients who respond to treatment generally lasts up to 26 weeks, although both shorter and longer durations of effect have been observed. Furthermore, prospective clinical data in patients with knee osteoarthritis have shown a treatment benefit lasting up to 52 weeks after a single treatment cycle with three Synvisc-injections were shown.
Synvisc-One
Prospective clinical study data in patients with gonarthrosis after a single injection of Synvisc-One a reduction in pain lasting up to 52 weeks, along with related improvements in mobility and function.
Clinical data from a double-blind, randomized, controlled study in patients with gonarthrosis showed a statistically significant and clinically meaningful reduction in pain compared to placebo. A total of 253 patients were treated (124 received Synvisc-One and 129 received placebo). Over 26 weeks, patients under Synvisc-One showed an average percentage change in pain from baseline of 36%, while patients in the placebo group showed an average percentage change in pain from baseline of 29%.
Additional prospective clinical data from two multicenter, open-label studies in patients with gonarthrosis after a single injection of Synvisc-One showed a statistically significant improvement in pain relief for up to 52 weeks compared to baseline.
In the first study, 394 patients who Synvisc-One received a statistically significant change in the WOMAC A1 - walking pain subscore (-28 ± 19.89 mm on a 100 mm VAS, Visual Analog Scale) from baseline to week 26. Additionally, statistically significant changes from baseline were observed in WOMAC A1 and WOMAC A, B, and C scores across all six observation periods between week 1 and week 52, demonstrating improvements in walking pain and pain (WOMAC A1 -32.7 ± 19.95 mm; WOMAC A -29.18 ± 19.158 mm), mobility (WOMAC B -25.77 ± 22.047 mm), and function (WOMAC C -25.72 ± 19.449 mm) over 52 weeks.
In the second study, 571 patients who Synvisc-One received a statistically significant improvement in pain over 26 weeks, measured by the Verbal Pain Questionnaire (VPQ). The average pain score improved from 3.20 at the start of treatment to 2.24 at the week 26 visit, with 64.6% of patients achieving pain relief. Secondary endpoints showed a statistically significant improvement in VPQ scores at all observation points from week 1 to week 52, with average VPQ scores decreasing from 3.20 at baseline to 2.26 at the week 52 visit, and 61.5% of patients achieving pain relief.
CONTENT PER ml (Hylan G-F 20)
1 ml contains: 8.0 mg Hylan, 8.5 mg sodium chloride, 0.16 mg disodium hydrogen phosphate, 0.04 mg sodium dihydrogen phosphate, water for injection q.s.
DOSAGE FORM
The contents of the syringes are sterile and pyrogen-free. Store between +2 °C and +30 °C.
Do not freeze.
Synvisc is supplied in a 2.25 ml glass syringe vial containing 2 ml of Hylan G-F 20. Synvisc-One is supplied in a 10 ml glass syringe vial containing 6 ml of Hylan G-F 20.
INFORMATION FOR PATIENTS
Inform the patient before the injection that Synvisc and Synvisc-One are made from highly purified avian-derived hyaluronic acid.
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