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  • SYNVISC solution injectable (1x2ml)
SYNVISC solution injectable (1x2ml)
198.50 OleaPharma.fr

Marque: Genzyme


SYNVISC solution injectable (1x2ml)


198.50 €

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SYNVISC solution injectable (1x2ml)



F Hylan G- 20 is available in two forms :

Synvisc , 2 ml: glass syringe of 2.25 ml ( boxes 1 [ 3401078489921 ACL ] and 3 [ 3401076479283 ACL ] ) .

Synvisc -One , 6 ml: glass syringe 10 ml (ACL 3401048640222 ) .

Hylan GF 20 is a viscoelastic fluid , sterile and non-pyrogenic containing hylan . Hylans are derivatives of hyaluronan ( sodium hyaluronate ) , and they are composed of repeating disaccharide units of N- acetylglucosamine and sodium glucuronate .

The hylan A has an average molecular weight of 6 million daltons and hylan B gel is a hydrated . Hylan GF 20 contains hylan A and hylan B ( 8.0 mg ± 2.0 mg / ml ) solution in physiological buffered saline ( pH 7.2 ± 0.3 ) .

composition

To 1 mL ( 20 Hylan GF ) : hylan 8.0 mg , 8.5 mg sodium chloride , 0.16 mg disodium phosphate , sodium dihydrogen phosphate hydrate 0.04 mg Water for injection qs .

Synvisc contains 2 ml of Hylan G- F 20. Synvisc -One contains 6 ml of Hylan G- F 20.

properties

Hylan GF 20 is biologically similar to hyaluronan . Hyaluronan is a component of synovial fluid which provides its viscoelasticity . However, the mechanical properties ( viscoelastic ) of Hylan GF 20 are greater than those of synovial fluid and hyaluronan solutions similar concentration . Hylan GF 20 has an elasticity ( storage modulus G ') at 2.5 Hz 111 Pascals (Pa) ± 13 and a viscosity ( loss coefficient G '') of 25 ± 2 Pa . The elasticity and viscosity of the synovial fluid of the knee of subjects aged 18-27 years measured with a comparable method is 2.5 Hz G = 117 ± 13 Pa , 45 Pa G '' = ± 8. Hylans are metabolized in the body in the same way that hyaluronan and their degradation products are not toxic .

indications

Hylan G- 20 F :

is an agent of a temporary replacement and supplement the synovial fluid ;

is effective when administered in all stages of joint disease ;

proves most effective when administered to patients with regular physical activity mobilizes the affected joint ;

exerts its therapeutic effects by acting as viscosupplementation , restoring physiological and rheological properties of joint tissues affected by osteoarthritis .

Viscosupplementation with Hylan GF 20 is a treatment that reduces pain and discomfort , thereby increasing the range of motion of the joint. In vitro studies have shown that Hylan GF 20 protects cartilage cells against certain physical and chemical damage.

Instructions , Dosage

Synvisc should only be administered by intra -articular , and a doctor, to relieve pain associated with osteoarthritis of the knee , hip , ankle and shoulder .

Synvisc -One must only be administered by intra -articular , and a doctor, to relieve pain associated with osteoarthritis of the knee.

Aspirate synovial fluid or effusion before each injection of Hylan GF 20 .

Do not use Hylan GF 20 if package is opened or damaged.

Inject at room temperature .

To remove the syringe from the blister shell ( or tray ) , grasp the body without touching the piston rod.

The contents of the syringe should be used immediately after opening the package .

Injected using strict aseptic methods and paying particular attention to the removal of the cap at the end of the syringe.

Unscrew gray cap at the end of the syringe before removing to minimize spilling .

Using an appropriate diameter needle :

Synvisc : syringe 18 to 22 gauge ;

Synvisc -One syringe 18 to 20 gauge .

Use a needle of appropriate length , according to the joint to be treated .

To ensure a tight connection and prevent leakage during administration , fit securely in the needle clamp Luer syringe .

Do not tighten or apply excessive pressure to fix or remove the needle sheath under penalty of breaking the tip of the syringe .

Do not sterilize again Hylan G- F 20.

Inject only in the synovial space , by performing the operation , if necessary, under fluoroscopic guidance , in particular in the case of the treatment of the hip joints and the shoulder.

The contents of the syringe is for single use only .

As the dosing recommendations indicate, injecting the entire volume of the syringe .

When working under fluoroscopic control , a product of ionic or non-ionic contrast medium can be used .

Do not use more than 1 ml of contrast medium with 2 ml of Hylan GF 20 .

dosage

The dosage of Hylan GF-20 depends on the joint to be treated .
Osteoarthritis of the knee:
Synvisc :

It is recommended to administer Synvisc in a regimen of three injections, one week apart each. For optimal effect , it is essential to administer three injections. The maximum recommended dose is 6 injections over a period of six months , providing an interval of at least 4 weeks between treatment cycles.
Synvisc- One:

It is recommended to administer Synvisc -One in a regimen of one injection in the knee. A second injection can be given 6 months after the first, if the patient's symptoms warrant.
Osteoarthritis of the hip , ankle and shoulder :
Synvisc :

It is recommended to administer at an initial Synvisc one injection regimen . If, however , adequate symptomatic relief is not obtained after the injection, it is recommended to administer a second injection. Clinical data have shown that patients feel better benefit from this second injection when administered between 1 and 3 months after the first injection.
Duration of effects :

Treatment with Hylan GF 20 affects only the treated joint , it causes no systemic effect.
Synvisc :

For patients who respond favorably to treatment, the duration of the therapeutic effect is usually up to 26 weeks , although holdover longer or shorter were observed. However, prospective clinical data showed that patients with osteoarthritis of the knee had responded favorably to treatment up to 52 weeks after a single series of three injections of Synvisc .
Synvisc- One:

Prospective clinical data show an effect of treatment up to 26 weeks after a single injection of Synvisc- One.

Cons -indications

In the presence of venous or lymphatic stasis in the corresponding member , it should not inject Hylan GF 20 in the joint.

Should not inject Hylan GF 20 in an infected joint or severely inflamed or in patients with skin disease or infection at the site of injection.

Warnings:

Do not inject intravascularly.

Not injected outside the joint cavity or the synovial tissue or capsule . Adverse reactions , generally at the area of ??injection were observed after extra -articular injection of Synvisc .

Do not use concomitantly with disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence.

precautions:

Do not administer Hylan GF 20 in the presence of a large effusion in the joint before injecting.

As after any invasive procedure in the joint, it is recommended that the patient avoid any strenuous activity after intra-articular injection and resume normal activities after a few days .

Hylan GF 20 has not been studied in pregnant women or children under 18 years.

Hylan GF 20 contains a small amount of avian proteins and should not be administered to individuals with hypersensitivity to these proteins.

Side effects:

Intra-articular injections of Hylan GF 20 may cause pain , swelling and / or effusion passengers . Synvisc has shown that in some cases , effusion may be greater and result in greater pain , and it is essential to drain and then analyze this to remove a liquid or microcrystalline infectious cause. These reactions usually resolve in a few days . Therapeutic benefit is still possible after such reactions . No cases of intra -articular infection have occurred in clinical trials with Synvisc / Synvisc -One , rare cases have been reported post-marketing Synvisc .

Rare systemic reactions reported after administration of Synvisc , are: rash, hives , itching, fever, nausea, headache, dizziness , chills , muscle cramps, paresthesia, peripheral edema , malaise , shortness of breath , flushing and facial edema . Controlled clinical trials with Synvisc did not reveal any statistically significant difference in the number or types of adverse systemic effects between the group of patients treated with Synvisc and the control group.

In controlled with Synvisc -One, the test frequency and types of adverse events were similar in the group that received Synvisc -One and the group receiving placebo.

Storage conditions

Store between +2 ° C and +30 ° C.

Do not freeze.

Do not use if package is opened or damaged.


Réf. : 7848992003300

SYNVISC solution injectable (1x2ml)

Informations : Details :
Brands Genzyme

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