Descrizione Clinica
Medical devices - medical devices Synvisc one sir intraderm 6ml
SYNVISC
H Y L A N G - F 2 0
H Y L A N G - F 2 0
COMPOSITION
Hylan G-F 20 is available as
• Synvisc-One, prefilled syringe 6 ml
Hylan G-F 20 is a sterile viscoelastic liquid, apirogen, containing hylan. Hylans are derivatives of hyaluronate (sodium salt of hyaluronic acid) and are constituted by repetitive disaccharide units of N-acetylglucosamine and sodium glucuronate. Hylan A has an average molecular weight of about 6.000.000 by Dalton and hylan B is a hydrogel. Hylan G-F 20 contains hylan A and B (8.0 mg ± 2.0 mg per ml) in buffered physiological solution of sodium chloride (pH 7.2 ± 0.3).
FEATURES
Hylan G-F 20 is biologically similar to hyaluronate. Hyaluronate is one of the components of the synovial liquid and determines the characteristics of viscoelacity. The mechanical properties (viscoelastic) of Hylan G-F 20 are, however, higher than those of the synovial liquid and those of solutions based on hyaluronate of similar concentration. Hylan G-F 20 has an elasticity (storage modulus G ') to 2.5 Hz equal to 111 ± 13 Pascal (Pa) and a viscosity (loss modulus G') of 25 ± 2 Pa. The elasticity and viscosity of the synovial fluid of the knee in subjects of age between 18 and 27, measured with a superimposable technique, at 2,5 Hz are respectively G ' = 117 ± 13 Pa and G' = 45 ± 8 Pa. Hylans are metabolized physiologically through the same process of hyaluronates and decomposition products are not toxic.
INDICATIONS AND USE
Hylan G-F 20
• temporarily restores the viscoelasticity of the synovial fluid.
• provides clinical benefits to patients in all stages of joint arthrosis.
• is more effective in patients who actively and regularly use jointing affected by pathology.
• achieves its therapeutic effect through viscosupplementation, a process through which the physiological state and the rheological characteristics of the synovial fluid of arthrosic articulation are reintegrated.
Viscosupplementation with Hylan G-F 20 is suitable for relieving pain and functional limitations, allowing a wider movement of jointing. In vitro studies have shown that Hylan G-F 20 protects cartilage cells from damage due to physical and chemical agents.
Synvisc-One is indicated only for intra-articular use by a doctor in the treatment of pain associated with knee arthrosis.
CONTRACTS
• Hylan G-F 20 should not be injected into the joint in the presence of venous or lymphatic stasis in the limb affected by pathology.
• Hylan G-F 20 should not be used in the presence of infections or severe inflammations or dermopathy or skin infections in the injection area.
WARNING
• Do not inject endovascularly.
• Do not inject extra-articular or tissue or synovial capsule. In general, complications in the injection area were determined by an extra-articular spread of Synvisc.
• Do not use in conjunction with disinfectants containing quaternary ammonium salts for the preparation of the skin, as in their presence the hyaluronate could precipitate.
PRECAUTIONS
• Hylan G-F 20 should not be used if a substantial intra-articular deposit occurred before injection.
• As with all invasive joint procedures, it is recommended that the patient avoid any excessive motor activity after intra-articular injection, and resume full activity within a few days.
• Hylan G-F 20 has not been experienced in pregnant women or children/children under the age of 18.
• Hylan G-F 20 contains small amounts of avian protein and should not be used in patients with hypersensitivity to such protein.
INDESIDER EFFECTS
• Undesirable effects that may affect the articulation in which the injection was performed: transitional pain and/or swelling and/or pouring into the injected joint may occur as a result of intra-articocular injections of Hylan G-F 20 Synvisc-One. The analysis of the synovial liquid reveals aseptic liquid without crystals. Often this reaction responds in a few days to the treatment with non-steroidal anti-inflammatory drugs (NSAIDs), intra-articocular steroids and/or arthrocentesis. The clinical benefit from treatment can still be evident after such reactions.
• During clinical trial on Synvisc-One intra-arthic infections have not been recorded, and are rarely found during clinical use Synvisc.
• Hypersensitivity reactions including anaphylactic reaction, anaphylactic reaction, anaphylactic shock and angioedema have also been reported.
• In the clinical trial controlled with Synvisc-One, frequency and type of side effects were similar to the group of patients treated with Synvisc-One and the group of patients who had received placebo treatments.
DOSAGE AND ADMINISTRATION
• Do not use Hylan G-F 20 if the package is open or damaged.
• The syringe content must be used immediately after the packaging is opened.
• Remove the synovial liquid or pour before each injection of Hylan G-F 20.
• Inject at room temperature.
• To extract the syringe from the blister (or from the container), hold it tight for the body without touching the stem of the plunger.
• Administer using strictly aseptic procedures, paying particular attention to the removal of the bucket.
• Unscrew the grit before extracting it, to minimize the output of the product.
• Use appropriate size needles:
• Synvisc-One – 18 to 20 caliber
• To ensure a perfect seal and avoid leakage during administration, make sure the needle is firmly inserted on the syringe.
• Do not tighten or exert excessive pressure during application of the needle or removal of the needle protection, as you could break the tip of the syringe.
• Inject only in the synovial space by performing the operation if necessary under instrumental guidance, such as fluoroscopy, especially in case of hip and shoulder treatment.
• The syringe content is disposable. The guidelines for the recommended dosage indicate to inject the entire volume (6 ml per Synvisc-One) syringe. Throwing the Synvisc-One not used.
• Do not reuse the syringe and/or needle. Reuse of syringes, needles and/or a product of a used syringe can lead to loss of sterility, contamination of the product and/or incomplete treatment.
• Under fluoroscopic guide, an ionic or non-ionic contrast medium can be used. Do not use more than 1 ml of contrast medium for 2 ml of Hylan G-F 20.
• Do not resterilize Hylan G-F 20.
POSOLOGY
The posological scheme of Hylan G-F 20 depends on the joint to be treated.
Knee arthrosis:
Synvisc-One
The treatment regime recommended for Synvisc-One is of only one injection of 6 ml in the knee, which can be repeated after six months if justified by the symptoms of the patient.
EFFECT DURATION
The treatment with Hylan G-F 20 only affects the joint injection site and does not produce a general systemic effect.
Synvisc-One
Data from a prospetic clinical study in patients with knee osteoarthritis have evidenced a pain reduction for a period of up to 52 weeks after a single injection Synvisc-One, and improvements related to stiffness and joint function.
Clinical data of a double-blind, randomized, and controlled study in patients with OA of the knee have evidenced in clinical terms a statistically significant reduction and pain compared to the placebo group. 253 patients were treated in total (124 received Synvisc-One and 129 received placebo). Over 26 weeks, in patients treated with Synvisc-One an average percentage change of pain compared to the initial figure of 36%, while patients in the placebo group showed an average percentage change of pain compared to the initial figure of 29%.
Further prospective clinical data of two open multicentric studies in patients with knee OA showed statistically significant improvement of pain relief compared to the initial data for a period of up to 52 weeks after a single administration of Synvisc-One.
In the first study, 394 patients treated with Synvisc-One showed a statistically significant variation in the WOMAC A1 subscale pain score (-28 ±19.89 mm on a 100 mm VAS) at Week 26 compared to the initial figure. In addition, statistically significant variations have been observed with respect to the initial data in the WOMAC A1 and WOMAC A, B and C scores for all six periods of observation between week 1 and week 52, demonstrating an improvement of the pain in the walking and resting pain (WOMAC A1 -32,7 ±19.95 mm; WOMAC A -29,18 ±19.158 mm), of stiffness (W.
CONTENT PER ml (Hylan G-F 20)
Each ml contains: hylan 8.0 mg, sodium chloride 8,5 mg, disodium phosphate hydrogen 0.16 mg, sodium phosphate hydrogen phosphate 0.04 mg, water for injectable preparations enough.
CONFECT
The content of each syringe is sterile and apirogen. Store at a temperature between +2° C and +30°C. Don't freeze.
Synvisc-One comes in a pre-filled 10 ml glass syringe with 6 ml Hylan G-F 20.
Cod.002420
Hylan G-F 20 is available as
• Synvisc-One, prefilled syringe 6 ml
Hylan G-F 20 is a sterile viscoelastic liquid, apirogen, containing hylan. Hylans are derivatives of hyaluronate (sodium salt of hyaluronic acid) and are constituted by repetitive disaccharide units of N-acetylglucosamine and sodium glucuronate. Hylan A has an average molecular weight of about 6.000.000 by Dalton and hylan B is a hydrogel. Hylan G-F 20 contains hylan A and B (8.0 mg ± 2.0 mg per ml) in buffered physiological solution of sodium chloride (pH 7.2 ± 0.3).
FEATURES
Hylan G-F 20 is biologically similar to hyaluronate. Hyaluronate is one of the components of the synovial liquid and determines the characteristics of viscoelacity. The mechanical properties (viscoelastic) of Hylan G-F 20 are, however, higher than those of the synovial liquid and those of solutions based on hyaluronate of similar concentration. Hylan G-F 20 has an elasticity (storage modulus G ') to 2.5 Hz equal to 111 ± 13 Pascal (Pa) and a viscosity (loss modulus G') of 25 ± 2 Pa. The elasticity and viscosity of the synovial fluid of the knee in subjects of age between 18 and 27, measured with a superimposable technique, at 2,5 Hz are respectively G ' = 117 ± 13 Pa and G' = 45 ± 8 Pa. Hylans are metabolized physiologically through the same process of hyaluronates and decomposition products are not toxic.
INDICATIONS AND USE
Hylan G-F 20
• temporarily restores the viscoelasticity of the synovial fluid.
• provides clinical benefits to patients in all stages of joint arthrosis.
• is more effective in patients who actively and regularly use jointing affected by pathology.
• achieves its therapeutic effect through viscosupplementation, a process through which the physiological state and the rheological characteristics of the synovial fluid of arthrosic articulation are reintegrated.
Viscosupplementation with Hylan G-F 20 is suitable for relieving pain and functional limitations, allowing a wider movement of jointing. In vitro studies have shown that Hylan G-F 20 protects cartilage cells from damage due to physical and chemical agents.
Synvisc-One is indicated only for intra-articular use by a doctor in the treatment of pain associated with knee arthrosis.
CONTRACTS
• Hylan G-F 20 should not be injected into the joint in the presence of venous or lymphatic stasis in the limb affected by pathology.
• Hylan G-F 20 should not be used in the presence of infections or severe inflammations or dermopathy or skin infections in the injection area.
WARNING
• Do not inject endovascularly.
• Do not inject extra-articular or tissue or synovial capsule. In general, complications in the injection area were determined by an extra-articular spread of Synvisc.
• Do not use in conjunction with disinfectants containing quaternary ammonium salts for the preparation of the skin, as in their presence the hyaluronate could precipitate.
PRECAUTIONS
• Hylan G-F 20 should not be used if a substantial intra-articular deposit occurred before injection.
• As with all invasive joint procedures, it is recommended that the patient avoid any excessive motor activity after intra-articular injection, and resume full activity within a few days.
• Hylan G-F 20 has not been experienced in pregnant women or children/children under the age of 18.
• Hylan G-F 20 contains small amounts of avian protein and should not be used in patients with hypersensitivity to such protein.
INDESIDER EFFECTS
• Undesirable effects that may affect the articulation in which the injection was performed: transitional pain and/or swelling and/or pouring into the injected joint may occur as a result of intra-articocular injections of Hylan G-F 20 Synvisc-One. The analysis of the synovial liquid reveals aseptic liquid without crystals. Often this reaction responds in a few days to the treatment with non-steroidal anti-inflammatory drugs (NSAIDs), intra-articocular steroids and/or arthrocentesis. The clinical benefit from treatment can still be evident after such reactions.
• During clinical trial on Synvisc-One intra-arthic infections have not been recorded, and are rarely found during clinical use Synvisc.
• Hypersensitivity reactions including anaphylactic reaction, anaphylactic reaction, anaphylactic shock and angioedema have also been reported.
• In the clinical trial controlled with Synvisc-One, frequency and type of side effects were similar to the group of patients treated with Synvisc-One and the group of patients who had received placebo treatments.
DOSAGE AND ADMINISTRATION
• Do not use Hylan G-F 20 if the package is open or damaged.
• The syringe content must be used immediately after the packaging is opened.
• Remove the synovial liquid or pour before each injection of Hylan G-F 20.
• Inject at room temperature.
• To extract the syringe from the blister (or from the container), hold it tight for the body without touching the stem of the plunger.
• Administer using strictly aseptic procedures, paying particular attention to the removal of the bucket.
• Unscrew the grit before extracting it, to minimize the output of the product.
• Use appropriate size needles:
• Synvisc-One – 18 to 20 caliber
• To ensure a perfect seal and avoid leakage during administration, make sure the needle is firmly inserted on the syringe.
• Do not tighten or exert excessive pressure during application of the needle or removal of the needle protection, as you could break the tip of the syringe.
• Inject only in the synovial space by performing the operation if necessary under instrumental guidance, such as fluoroscopy, especially in case of hip and shoulder treatment.
• The syringe content is disposable. The guidelines for the recommended dosage indicate to inject the entire volume (6 ml per Synvisc-One) syringe. Throwing the Synvisc-One not used.
• Do not reuse the syringe and/or needle. Reuse of syringes, needles and/or a product of a used syringe can lead to loss of sterility, contamination of the product and/or incomplete treatment.
• Under fluoroscopic guide, an ionic or non-ionic contrast medium can be used. Do not use more than 1 ml of contrast medium for 2 ml of Hylan G-F 20.
• Do not resterilize Hylan G-F 20.
POSOLOGY
The posological scheme of Hylan G-F 20 depends on the joint to be treated.
Knee arthrosis:
Synvisc-One
The treatment regime recommended for Synvisc-One is of only one injection of 6 ml in the knee, which can be repeated after six months if justified by the symptoms of the patient.
EFFECT DURATION
The treatment with Hylan G-F 20 only affects the joint injection site and does not produce a general systemic effect.
Synvisc-One
Data from a prospetic clinical study in patients with knee osteoarthritis have evidenced a pain reduction for a period of up to 52 weeks after a single injection Synvisc-One, and improvements related to stiffness and joint function.
Clinical data of a double-blind, randomized, and controlled study in patients with OA of the knee have evidenced in clinical terms a statistically significant reduction and pain compared to the placebo group. 253 patients were treated in total (124 received Synvisc-One and 129 received placebo). Over 26 weeks, in patients treated with Synvisc-One an average percentage change of pain compared to the initial figure of 36%, while patients in the placebo group showed an average percentage change of pain compared to the initial figure of 29%.
Further prospective clinical data of two open multicentric studies in patients with knee OA showed statistically significant improvement of pain relief compared to the initial data for a period of up to 52 weeks after a single administration of Synvisc-One.
In the first study, 394 patients treated with Synvisc-One showed a statistically significant variation in the WOMAC A1 subscale pain score (-28 ±19.89 mm on a 100 mm VAS) at Week 26 compared to the initial figure. In addition, statistically significant variations have been observed with respect to the initial data in the WOMAC A1 and WOMAC A, B and C scores for all six periods of observation between week 1 and week 52, demonstrating an improvement of the pain in the walking and resting pain (WOMAC A1 -32,7 ±19.95 mm; WOMAC A -29,18 ±19.158 mm), of stiffness (W.
CONTENT PER ml (Hylan G-F 20)
Each ml contains: hylan 8.0 mg, sodium chloride 8,5 mg, disodium phosphate hydrogen 0.16 mg, sodium phosphate hydrogen phosphate 0.04 mg, water for injectable preparations enough.
CONFECT
The content of each syringe is sterile and apirogen. Store at a temperature between +2° C and +30°C. Don't freeze.
Synvisc-One comes in a pre-filled 10 ml glass syringe with 6 ml Hylan G-F 20.
Cod.002420
