Fermathron^® (Prosthesis) Instructions for Use

Therapeutic Category

Medical device for the treatment of musculoskeletal system diseases

Properties

The Fermathron^® Plus synovial fluid prosthesis is a clear, sterile solution of 1.5% high molecular weight sodium hyaluronate in phosphate-buffered saline, supplied in a pre-filled syringe for a single intra-articular injection into the synovial space of the joint. Its action is due to its biocompatibility and physicochemical properties.

The high molecular weight Sodium Hyaluronate in Fermathron^® Plus is a biopolymer consisting of repeating disaccharide units of D-glucuronic acid and N-acetyl-D-glucosamine. This biopolymer, synthesized by the bacterium Streptococcus equi, has been shown to be identical to the sodium hyaluronate contained in the human body. The hyaluronan in Fermathron^® Plus supplements 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.

The Fermathron^® Plus synovial fluid prosthesis has a pH similar to that of synovial fluid.

Scope of Application

Of the Fermathron^® Plus product

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

ICD codes

Dosage Regimen

Prosthesis

Intra-articular. Injections should be performed only by a healthcare professional trained in the appropriate technique.

For patients with mild to moderate osteoarthritis of the knee joints, it is recommended to administer 2 ml of the product into the synovial cavity of the knee joint once a week for 1-5 weeks.

The healthcare professional should clarify the dosing regimen for injections into the synovial space of the hip, ankle, and shoulder joints. Injections into the hip, ankle, and shoulder joints are recommended to be performed under ultrasound or fluoroscopic guidance.

Before administration, the injection site must be treated with an antiseptic and allowed to dry.

The contents of the syringe are sterile. Administration should be performed using a sterile needle of appropriate gauge (it is recommended to use a 19 to 20 G needle). The syringe is equipped with a Luer Lok^® (6%) connector for secure attachment of the needle to the syringe. The syringe and needle should be disposed of after single use.

If joint effusion is present, it must be removed prior to the administration of the Fermathron^® synovial fluid prosthesis.

The duration of effect in patients with mild to moderate knee osteoarthritis is up to 6 months. The duration of effect in the hip, ankle, and shoulder joints has not been established.

Side Effects

Possible – transient, temporary pain and swelling upon intra-articular injection.

Rarely – inflammatory reaction, septic arthritis, or arthralgia, which may or may not be associated with the use of Fermathron^®.

Contraindications

• Hypersensitivity to sodium hyaluronate;
• Inflammation or skin diseases at the injection site;
• Childhood.

Use During Pregnancy and Lactation

Safety during pregnancy and lactation has not been established. Prescription during pregnancy and lactation is at the discretion of the orthopedic surgeon.

Special Instructions

Do not use if the sterile packaging is damaged. Do not use after the expiration date.

Sodium hyaluronate is obtained by fermentation of Streptococcus equi bacteria and is thoroughly purified. Nevertheless, the physician should consider the immunological impact and potential risk associated with the injectable administration of any biological substances.

The Fermathron^® syringe is a single-use device intended for one patient only. Use on a second patient will compromise sterility and pose a risk of foreign body reaction or infection. The Fermathron^® syringe should not be re-sterilized, as this may impair the device’s function. The Fermathron^® syringe must be used with a sterile needle, which should be disposed of after single use.

National and local rules and regulations for the safe use and disposal of used needles must be observed. In case of injury, consult a doctor immediately.

Not intended for children.

Environmental Protection and Disposal

The contents of the syringe are not toxic or flammable. Unused syringes may be disposed of as household waste. Glass should be disposed of with care. Unused syringe contents before or after the expiration date may be disposed of as household waste (dilute with plenty of water).

Precautions for Disposal of Used Syringes and Needles

Used syringes and needles must be disposed of as epidemiologically hazardous waste (infected and potentially infected waste, such as: materials and instruments, items contaminated with blood and/or other biological fluids). National or local legislation for safe use and disposal must be followed.

Drug Interactions

Compatibility of simultaneous intra-articular administration of Fermathron^® Plus with other substances has not been tested. Therefore, mixing or simultaneous administration of other intra-articular drugs is not recommended.

Storage Conditions

The device should be stored and transported protected from light at a temperature between 2°C (35.6°F) and 25°C (77°F). Do not freeze.

Shelf Life

Shelf life is 36 months from the date of manufacture. Do not use after the expiration date.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.