ORTHOFLEX ONE 2% 60MG/3ML

ORTHOFLEX ONE 3ML is a sterile viscous elastic solution containing two highly purified biological polymers, sodium hyaluronate and sodium chondroitin sulfate. ORTHOFLEX ONE consists of sodium hyaluronate derived from the bacterial fermentation of the Streptococcus strain and chondroitin sulphate produced from bovine cartilage.

ORTHOFLEX ONE is a sterile viscoelastic solution processed using aseptic technique and supplied in a disposable glass syringe, i.e. 3 ml solution.

COMPOSITION:
Each pre-filled syringe contains 60 mg sodium hyaluronate, 90 mg chondroitin sulfate, sodium chloride, sodium phosphate monohydrate monohydrate, disodium phosphate dodecahydrate, sodium hydroxide and/or hydrochloric acid (for pH adjustment), water for injections

INDICATIONS:
ORTHOFLEX ONE is indicated as a viscoelastic additive or a substitute for the synovial fluid of human joints, e.g. knee, hip, ankle, shoulder, elbow, wrist, fingers, feet, temporomandibular and joint joints).

ORTHOFLEX ONE is intended for use in the symptoms of degenerative diseases and joint pain, such as mild or severe arthritis.

ORTHOFLEX ONE’s actions are “lubrication and mechanical support”.

CONTRAINDICATIONS:
ORTHOFLEX ONE is contraindicated in patients with: allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulphate or any of the ingredients in ORTHOFLEX ONE, existing infections or skin conditions at the intended injection site, known infection, bleeding or bleeding tendency. ORTHOFLEX ONE should not be used in patients with known hypersensitivity to material of bovine origin.

SIDE EFFECTS: Swelling and transient pain may occur after injection. These reactions usually subside within 72 hours.

DOSAGE AND ADMINISTRATION: Not for intravenous injection. The product is strictly administered by intra-joint injection. Do not inject the product too often. Strict aseptic technique must be followed. The injection site must be properly disinfected (70% alcohol or other disinfectant).

PRECAUTIONS:
Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risk associated with the use of any biological material. ORTHOFLEX ONE should only be administered into the joint space by medical professionals trained in intra-articular administration techniques.

WARNINGS:
Check the expiration date and integrity of the package before use. Do not use ORTHOFLEX ONE after the “use by” date on the package. Do not use the syringe if its package is opened or damaged. The product is administered only when the solution is clear. Once opened, the contents of the syringe should be used immediately.

The ORTHOFLEX ONE product is intended for single use only! Do not reuse. Each ORTHOFLEX ONE pre-filled syringe is to be used only once per patient.

CHARACTERISTICS AND HOW TO OPERATE:
ORTHOFLEX ONE is a safe, effective and well-established product supporting the treatment of osteoarthritis by injecting a hyaluronic acid solution into the painful joint. ORTHOFLEX ONE acts as a temporary replacement and supplement for synovial fluid. ORTHOFLEX ONE relieves joint pain, improves joint mobility and protects cartilage.

Hyaluronic acid is the main component of synovial fluid and cartilage, and its viscoelastic and rheological properties are responsible for the lubrication and cushioning of joints. It reduces friction between the surfaces of the joint and protects the soft tissue from injury by acting as a shock absorber. The quantity and quality of hyaluronic acid in the synovial fluid is reduced in patients with osteoarthritis because its synthesis by synovial and cartilage cells is disrupted.

The protection of the articular surfaces is therefore strongly altered, the cartilage becomes vulnerable and exposed to structural degradation caused by friction and compression forces. Chondroitin sulfate, a glycosaminoglycan sulfate, is an important structural component of cartilage extracellular matrix.

The role of chondroitin sulfate is to optimize the rheological behavior of hyaluronic acid due to specific interactions. In addition, in in vitro studies, chondroitin sulfate inhibits the main enzymes involved in the destruction of the cartilage matrix: metalloproteinases and aggrecenases. Chondroitin sulfate also inhibits the secretion of pro-inflammatory factors. These data support the observed clinical activity as symptomatic slow action for osteoarthritis with improvement and improvement in pain.

ORTHOFLEX ONE, given as a single injection, restores good lubrication and shock absorption to the joint and will provide a significant improvement in symptoms.

MAINTENANCE AND STORAGE:
Keep in these below 25°C in the original packaging in order to protect from light. Do not freeze.