ProFlex Intra gel for intra-articular injection 12 mg/ml. syringe 2.5 ml

Description

ProFlex Intra Ingredients
1 ml of gel contains 12 mg sodium hyaluronate.
Excipients: sodium dihydrogen phosphate dihydrate; sodium phosphate dodecahydrate; sodium chloride; water for injections.

Release form
Sterile gel for intra-articular injection.
gel for injection 12 mg / ml syringe 2.5 ml, № 1

Pharmacological properties
ProFlex Intra contains sodium hyaluronate, synthesized and structured by bioengineering methods from streptococcal fermentation metabolites, which has high viscoelasticity, lubricity, physical variability and high biocompatibility. ProFlex Intra is sterile, free from pyrogens, allergens, genetic toxicity and does not irritate the skin. Can be used as an orthopedic implant to improve joint function. When used in the form of injections into the joint cavity, it volumetric replaces the synovial fluid, stimulates the synovial membrane to produce its own high-molecular hyaluronate, which increases the mobility of the joint, acts as a shock absorber, relieves pain, reduces the manifestations of synovitis, activates the processes of tissue repair of the articular cartilage and slows the progression of the disease.
The active substance – sodium hyaluronate is an important component of the extracellular matrix, restores the physiological homeostasis and rheological properties of the synovial fluid, normalizes the composition of the synovial fluid, activating the biosynthesis of hyaluronic acid in the cells of the synovial membrane.

Indications
The ProFlex Intra medical device is intended for intra-articular injections.
ProFlex Intra as an orthopedic implant is used to facilitate joint mobility (as a shock absorber), protect articular cartilage and for symptomatic treatment:

• degenerative diseases (osteoarthritis of the knee and hip (hip) joints;
• osteoarthritis of the shoulder with effusion (subject to preliminary aspiration of the effusion) into the joint and without effusion;
• traumatic injuries of the joints in violation of the integrity of the cartilage.

Route of administration and doses
The injection site must be treated with an antiseptic and allowed to dry before administration. In the presence of exudate, it is recommended to perform aspiration before administration. Check that the individual sterile protective packaging is intact. Take the syringe aseptically. Screw the injection needle onto the Luer Lock syringe. Inject the required amount of INTRA profiles into the joint cavity. The introduction should only be carried out by a qualified specialist in a medical institution.
After the injection of the drug, the syringe and needle must be discarded.
Recommended dose                                                                                                                                                                 For a concentration of 12 mg / ml (2.5 ml), 1 injection is administered once a week for up to 4–5 injections, depending on the severity of degenerative changes in the joint.                                                                                       If necessary, according to the doctor’s prescription, the treatment can be extended.
The positive effect of the course of treatment can be observed within 9-12 months, depending on the initial severity of changes in the joints.

Contraindications
Do not use for the treatment of patients with acute and chronic pyogenic arthritis, tuberculosis of the synovial membrane and joints, hemorrhages and hemophilia.
Do not use on persons with known hypersensitivity to medical device components.
Do not use on patients with infections or skin conditions at the injection site.

Side effects
When used at the injection site, reactions are possible in the form of mild fleeting pain, swelling, redness, arthralgia and joint stiffness. These symptoms disappear within a few days without medical intervention. If symptoms persist during this period, you should consult your doctor.

Special instructions:

• In order to prevent infection during the introduction of a medical device, aseptic rules should be strictly observed.
• The pre-filled syringe is for single administration only. The contents of the syringe should be used immediately after opening the package. If the gel remains after injection, it must be disposed of. Reuse can lead to infection.
• Do not use if sterile packaging is damaged.
• The container of the sodium hyaluronate syringe is made of glass. Take care when using.
• Do not administer at the same time with medicinal products containing benzalkonium chloride.
• Avoid the use of instruments sterilized with solutions of quaternary ammonium salts or disinfectants containing quaternary ammonium salts.
• Do not use for intravenous injection.
• Inject only into the joint cavity, do not inject into the synovium or ligaments.
• Not intended for use in children under 16 years of age. There is no evidence to support safe use in pregnant and breastfeeding women.
• In the presence of joint effusion (intra-articular fluid), aspiration is recommended before injection.
• Do not use after the expiration date printed on the package. The expiry date refers to the product stored in its original packaging at a temperature of 2-25 ° C.

Storage conditions
In original packaging at a temperature of 2–25 ° C and a relative humidity of no more than 80% in well-ventilated and clean rooms, protected from light. Avoid exposure to corrosive gases. Do not freeze.