Fermathron Plus prosthesis synovial fluid 1.5% syringe 2 ml
Condition: New product
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Active ingredients
Release form
Composition
Sodium hyaluronate 15 mg.
Auxiliary substances: sodium chloride Ph. Eur - 9 mg; sodium dihydrogen phosphate Ph. Eur. - 0.27 mg; sodium phosphate monobasic Ph. Eur. - 0,092 mg; water for injection Ph. Eur. - enough
Sodium hyaluronate in the composition is a biopolymer consisting of repeating disaccharide units of D-glucuronic acid and N-acetyl-D-glucosamine (long-chain polysaccharide). It is shown that this biopolymer synthesized by bacteriaStreptococcus equi, identical to sodium hyaluronate contained in humans. The hyaluronan contained in the composition complements the natural hyaluronan contained in the synovial membrane, the amount of which has decreased due to degenerative changes or traumatic injuries of the knee joint. Sodium hyaluronate is a natural component of the human body.
Fermathron Synovial Fluid and Fermathron Plus The synovial fluid has a pH similar to that of the synovial fluid.
Pharmacological effect
Action Fermathron Plus The synovial fluid prosthesis is caused by biocompatibility and physicochemical properties.
Fermathron Plus The synovial fluid prosthesis is a transparent sterile solution of 1.5% HMW sodium hyaluronate in saline phosphate buffer solution, placed in a pre-filled syringe for a single intra-articular injection into the synovial space of the joint.
Indications
To relieve pain and stiffness in the knee, hip, ankle joints of patients with mild to moderate osteoarthritis, resulting from degenerative and traumatic changes in the synovial joint.
Contraindications
Do not enter with inflammation or signs of skin disease at the injection site.
Do not use in patients with known hypersensitivity to sodium hyaluronate.
Use during pregnancy and lactation
Safety of use during pregnancy and lactation has not been established.
Dosage and administration
Intra-articular.
Injections should be performed only by a physician trained in the appropriate technique.
Before the introduction of the injection site must be treated with an antiseptic.
If there is an articular effusion, it must be sucked out before injection.
The contents of the syringe are sterile. The introduction should be made with a sterile needle of an appropriate size (from 18 to 21G / 19 to 20G is recommended) (for Fermathron Plus Prosthesis of synovial fluid, Fermathron C Prosthesis of synovial fluid / Fermathron Prosthesis of synovial fluid, respectively).
The syringe has a connectorLuer Lok ™ (6%) for reliable attachment of the needle to the syringe.
Dispose of the syringe and needle after a single use.
For patients with mild to moderate osteoarthritis of the knee joints, it is recommended to inject 2 ml of the drug into the synovial cavity of the knee joint 1 time per week for 1–3 / 1–5 weeks (for Fermathron Plus Prosthetic synovial fluid / Fermathron Prosthetic synovial fluid, respectively).
The health care professional should specify the dosage regimen for injection into the synovial space of the hip, ankle and shoulder joints.
It is recommended to perform injections in the hip, ankle and shoulder joints under ultrasound or fluoroscopic control.
The duration of the effect in patients with mild or moderate osteoarthritis of the knee joint is up to 6 months.
The duration of the effect with the introduction of the hip, ankle and shoulder joint has not been established.
Side effects
With intra-articular administration, temporary transient pain and swelling is possible.
In rare cases, an inflammatory reaction, septic arthritis or arthralgia may occur, which may or may not be associated with use.
Interaction with other drugs
The compatibility of simultaneous intra-articular administration with other substances has not been tested. Therefore, mixing or simultaneous administration of other intra-articular drugs is not recommended.
special instructions
Do not use if the packaging is damaged.
The syringe which is a part - the disposable device intended only for one patient. When used for the second patient, sterility will be impaired and there will be a risk of reaction to a foreign body or infection.
Not re-sterilized, as This may impair the function of the device.
You must use a sterile needle that should be thrown away after a single use.
It is forbidden to use after the expiration date.
Sodium hyaluronate obtained by fermentation of bacteriaStreptococcus equi and thoroughly cleaned. However, the physician must consider the immunological effects and the potential risk associated with the injection of any biological substances.
Not intended for children.
For safe use and disposal of needles, national and local rules and regulations must be observed.
Storage conditions
In the dark place at a temperature of 2-25 ° C. Do not freeze. The product is sterile. For single use only.
Keep out of the reach of children.