Fermatron prosthesis of synovial fluid solution 1%, syringe No. 1
Expiration Date: 05/2027
Russian Pharmacy name:
Ферматрон протез синовиальной жидкости раствор 1%, №1 шприц
Intra-articular.
Injections should only be performed by a physician trained in the appropriate technique.
Before the introduction, the injection site must be treated with an antiseptic.
If there is articular effusion, it must be sucked off prior to injection.
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 once a week for 1-3 / 1-5 weeks.
The healthcare professional should clarify the dosing regimen for injections into the synovial space of the hip, ankle and shoulder joints.
It is recommended that injections be performed in the hip, ankle and shoulder joints under ultrasound or fluoroscopic guidance.
The duration of the effect in patients with mild to moderate knee osteoarthritis is up to 6 months.
The duration of the effect when injected into the hip, ankle and shoulder joints has not been established.
Synovial fluid prosthesis in 1 ml:
active substances:
sodium hyaluronate 9.75-11 mg,
sodium chloride 7.6-9.5 mg,
phosphates 0.15-0.25 mg;
auxiliary substances: water for injection - a sufficient amount
Do not administer if there is inflammation or signs of skin disease at the injection site.
Do not use in patients with known hypersensitivity to sodium hyaluronate.
Description
FermatronЃ synovial fluid prosthesis is a clear sterile solution of 1% sodium hyaluronate (20mg / 2.0ml) in phosphate buffered saline, placed in a pre-filled syringe for a single intra-articular injection into the synovial space of the joint.
The action of FermatronЃ-synovial fluid prosthesis is due to its biocompatibility and physicochemical properties.
Release form
Synovial fluid prosthesis. 2 ml of sterilized by filtration FermatronЃ Prosthesis of synovial fluid is placed in a glass disposable ready-to-use syringe. The syringe is packed in a blister pack and then in a cardboard box. The outer surface of the pre-filled syringe is sterilized with ethylene oxide.
Component properties
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 has been shown that this biopolymer, synthesized by the bacterium Streptococcus equi, is identical to sodium hyaluronate found in the human body. The hyaluronan contained in the composition complements the natural hyaluronan contained in the synovium, 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.
The FermatronЃ synovial fluid prosthesis has a pH similar to that of synovial fluid.
Requires 5 injections per course of treatment, one injection once a week.
Side effects
With intra-articular administration, temporary passing pain and swelling are possible.
In rare cases, an inflammatory reaction, septic arthritis or arthralgia may occur, which may or may not be associated with use.
Special conditions
Do not use if packaging is damaged.
The syringe included is a disposable device intended for one patient only. When used on a second patient, sterility will be compromised and there will be a risk of foreign body reaction or infection.
Cannot be re-sterilized as this may impair the function of the device.
A sterile needle must be used and discarded after a single use.
It is forbidden to use after the expiration date.
Sodium hyaluronate is obtained by fermentation of Streptococcus equi bacteria and is thoroughly purified. However, the physician should consider the immunological effects and potential risks associated with injecting any biological substances.
Not intended for children.
National and local rules and regulations must be followed for safe use and disposal of needles.