Fermathron solution 20mg/2ml #1

Instruction for Fermathron

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pharmachologic effect

Pharmacological action - compensating for the lack of synovial fluid.

Action on the body

Fermathron synovial fluid prosthesis is a transparent sterile solution of 1% 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.

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 is shown that this biopolymer, synthesized by the bacterium Streptococcus equi, is identical to sodium hyaluronate contained in the human body. 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 synovial joint. Sodium hyaluronate is a natural component of the human body.
Fermathron prosthetic synovial fluid and Fermathron Plus prosthetic synovial fluid have a pH similar to that of synovial fluid.

Recommended

To alleviate pain and stiffness in the knee, hip, ankle and shoulder 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.

Side effects of Fermathron

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

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.

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 aspirated prior to 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 synovial fluid prosthesis, Fermathron C synovial fluid prosthesis / Fermathron synovial fluid prosthesis, respectively).
The syringe has a Luer Lok ™ connector (6%) for secure attachment of the needle to the syringe.
Dispose of the syringe and needle after a single use.
For patients with mild to moderate osteoarthrosis, it is recommended to inject 2 ml of the drug into the synovial cavity of the knee joint once a week for 1-3 weeks for Fermathron Plus synovial fluid prosthesis, 1-5 weeks for Fermathron synovial fluid prosthesis.
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.

special instructions for Fermathron

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 is obtained by fermentation of bacteria Streptococcus 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.

Release form

Prosthesis of synovial fluid. On 2 ml filtered by Fermathron sterilized by filtration the synovial fluid prosthesis is placed in a glass disposable syringe ready to use. The syringe is packed in a blister pack, and then in a cardboard box. The outer surface of a pre-filled syringe is sterilized with ethylene oxide.

Storage conditions Fermathron synovial fluid prosthesis

In the dark place at a temperature of 2-25 ° C. Do not freeze. The product is sterile. For single use only.

Terms of sell

You don't need a prescription to buy Fermathron.