Fermathron containing 1% solution of sodium hyaluronate.
Synovial viscosupplement device versions are sterile, placed in prefilled syringes and developed for single injection of the solution. The syringe is sealed with a tip cap at one end and a plunger stopper at the other end. A Luer Lock adapter is provided at the syringe tip to ensure the secure attachment of the needle. A plunger rod and backstop are attached. The syringe is held within a blister tray with blister lid and packed in an outer cardboard carton, along with the implantation stickers and the instructions for use leaflet (IFU).
The prepared gel, which was sterilized by steam autoclave, is filled into syringes which are supplied sterile.
As the gel filling process is completed, Fermathron the syringe apparatuses backstop and plunger are attached to syringe. Then prepared syringes are placed in an empty PET package and closed by Tyvek paper via wrapping machine. PET package and Tyvek paper are sterilized with ethylene oxide beforehand.

Sodium hyaluronate, mg/ml 9,75–11,0
Sodium chloride, mg/ml 7,6–9,5
Phosphates, mg/ ml 0,15–0,25
Water for iniections Sufficient amount

Fermathron is a synovial sodium hyaluronate-based viscosupplementation medical device for the relief of pain and stiffness of knee, hip or ankle joints in patients with mild to moderate osteoarthritis induced by degenerative and traumatic changes in joints. Fermathron is also indicated for the shoulder injections.

For the relief of pain and stiffness of the knee, hip and ankle joints in patients with mild to moderate osteoarthrosis resulting from degenerative and traumatic changes in synovial joints..

The key component of the synovial viscosupplement device Fermathron is a sodium hyaluronate (also known as hyaluronic acid or hyaluronan), a long chain polysaccharide made up of repeating disaccharide units of D-glucuronic acid and N-acetyl-D-glucosamine which occur naturally in the body.
Fermathron buffered solutions are designed for providing sodium hyaluronate solution with characteristics similar to physiological conditions at the injection site.

Do not inject the synovial viscosupplement device if the area of the injection is infected or when there is an evidence of skin disease.
Do not use in patients with known hypersensitivity to sodium hyaluronate.

Do not use if the sterile package has been damaged.
Do not use after the date of expiry.
Sodium hyaluronate is manufactured by fermentation of Streptococcus equi and rigorously purified. However, the Healthcare Professional should consider the immunological and other potential risks that can be associated with the injection of any biological material.
Do not use for children.
There is no evidence concerning the safety of the synovial viscosupplement device in human pregnancy and lactation. Administration during pregnancy and lactation is at the discretion of the Orthopedic Surgeon / Healthcare Professional.
Follow national or local guidelines for the safe use and disposal of needles. Obtain prompt medical attention if injury occurs.
The synovial viscosupplement device is a single use device and is intended to be used for a single patient only. If the synovial viscosupplement device is used for a second patient the sterility will be compromised and there is a risk of foreign body reaction and/or infection. The synovial viscosupplement device should be used with a sterile needle that should be discarded after single use. The synovial viscosupplement device should not be re-sterilised as the device performance may be compromised.
An increase in injection pressure may indicate incorrect extra-articular placement of the needle or overfilling of the joint.

Intra-articular injection of the Viscosupplement device must only be made by a Healthcare Professional trained in the specific intra-articular injection procedure. Dosage regimen depends on the version:
- for Fermathron: it is recommended to inject 2.0 ml of the product into the synovial cavity of the knee joint once a week for 1–5 weeks. The dosage regimen should be adapted by the Healthcare Professional for injection into the synovial space of the hip, ankle, and shoulder joints.
Clean the skin around the injection site with antiseptic and allow to dry before the injection of the synovial viscosupplement device is given. If joint effusion is present, it should be aspirated before injection of the synovial viscosupplement device. Inject the synovial Viscosupplement device into the joint cavity only. When injecting the synovial viscosupplement device into the hip, ankle or shoulder joints (depending on device version) ensure accurate needle placement by using fluoroscopic or ultrasonic guidance. The contents of the syringe are sterile and should be injected using a sterile needle of an appropriate size. A 19-20G needle is recommended for Fermathron. The syringe is fitted with a Luer Lock adaptor (6%) to ensure secure attachment of the needle to the syringe. Discard the syringe and needle after use.

Transient pain and swelling may occur following intra-articular injections.
Rarely an inflammatory reaction, septic arthritis (infection), or arthralgia (joint pain usually lasting longer than transient) could occur which may or may not be associated with the Viscosupplement device use.

Incompatibilities

The synovial viscosupplement device has not been tested for compatibility with other substances for intra-articular injection. Therefore, the mixing or simultaneous administration with other intra-articular injectables is not recommended.

Environmental protection and disposal

The synovial viscosupplement device is single use only. Follow national or local guidelines for the safe use and disposal.
The contents of the syringe are not toxic or flammable.
Unused syringe can be disposed as normal waste. Glassware should be disposed of carefully.
Unused syringe contents before or after expired    shelf-life can be disposed as normal waste (flushed to waste with copious quantities of water).

Precautions for disposal of used syringes and needles:

Used syringes and needles shall be disposed of as epidemiological hazardous waste (infective and potentially infective waste, e.g. materials and tools contaminated by blood and/or other biological fluids). Comply with national or local regulations for safe use and disposal.

Store between 2°C and 25°C.
Do not freeze. Protect from light. Sterile product for single use only. Do not use after expiry date.
The product should be transported under the same conditions as the storage conditions.

Epiona AG, Bahnhofstrasse 21, 6300 Zug, Switzerland
Authorized representative in Russia
Limited liability company “MCNT Import” (“MCNT Import” LLC)
Address: 12, Ordzhonikidze st., bldg. 2
Moscow, 119071, Russian Federation
Ph.: +7 495 786-39-63
e-mail: info@mcnt.ru