Instructions Proflex Intra gel for injection 12 mg/ml syringe 2.5 ml
Composition
Sterile gel for intra-articular injections:
1 ml of gel contains 12 mg of sodium hyaluronate.
Excipients: sodium dihydrogen phosphate dihydrate; sodium phosphate dodecahydrate; sodium chloride; water for injections.
Properties
proFLEX INTRA contains sodium hyaluronate, synthesized and structured by bioengineering methods from metabolites of streptococcal fermentation, which has high viscoelastic, lubricating ability, physical variability and high biocompatibility. proFLEX INTRA is sterile, free from pyrogens, allergens, genetic toxicity and does not have an irritating effect on the skin. proFLEX INTRA can be used as an orthopedic implant to improve joint function. When used as injections into the joint cavity, proFLEX INTRA volumetrically replaces synovial fluid, stimulates the synovial membrane to produce its own high-molecular hyaluronate, which increases joint mobility, acts as a shock absorber, relieves pain, reduces manifestations of synovitis, activates the processes of tissue regeneration of articular cartilage and slows down the progression of the disease.
The active ingredient of proFLEX INTRA - sodium hyaluronate is an important component of the extracellular matrix, restores physiological homeostasis and rheological properties of synovial fluid, normalizes the composition of synovial fluid, activating the biosynthesis of hyaluronic acid in the cells of the synovial membrane.
Recommendations for use
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 (osteoarthrosis of the knee and hip joints;
shoulder osteoarthritis with effusion (subject to prior aspiration of effusion) in the joint and without effusion;
traumatic injuries to joints with impaired cartilage integrity.
Method of application
The proFLEX INTRA medical device is intended for intra-articular injections.
The injection site must be treated with an antiseptic before administration and allowed to dry. If there is exudate, it is recommended to perform aspiration before administering proFLEX INTRA. Check the integrity of the individual sterile protective packaging. Take the syringe, observing the rules of asepsis. Screw the injection needle onto the Luer Lock syringe. Inject the required amount of proFLEX INTRA into the joint cavity. The injection should only be performed by a qualified specialist in a medical institution.
After administering the drug, the syringe and needle must be discarded.
Recommended dose
For a concentration of 12 mg/ml (2.5 ml), administer 1 injection once a week for up to 4-5 injections, depending on the severity of degenerative changes in the joint.
For a concentration of 20 mg/mL (3 mL), inject 1 syringe into 1 joint at a time.
If necessary, treatment with proFLEX INTRA may be continued as prescribed by a doctor.
The positive effect of the proFLEX INTRA treatment course can be observed within 9-12 months, depending on the initial severity of changes in the joints.
Reservation
Do not use the drug to treat patients with acute and chronic pyogenic arthritis, tuberculosis of the synovium and joints, hemorrhages, and hemophilia.
Do not use the drug in individuals with known hypersensitivity to the components of the medical device.
Do not use the drug in patients with infections or skin diseases at the injection site.
Special instructions
1. In order to prevent infection when inserting a medical device, the rules of asepsis should be strictly followed.
2. The pre-filled syringe is for single use only. The contents of the syringe should be used immediately after opening the package. Any gel remaining after injection should be discarded. Reuse may cause infection.
3. Do not use if sterile packaging is damaged.
4. The container of the sodium hyaluronate syringe is made of glass. Be careful when using it.
5. Do not administer simultaneously with drugs containing benzalkonium chloride.
6. Avoid using instruments sterilized with solutions of quaternary ammonium salts or disinfectants containing quaternary ammonium salts.
7. Do not use for intravenous injection.
8. Inject only into the joint cavity, do not inject into the synovium or ligaments.
9. Not intended for use in children under the age of 16. There is no evidence to support safe use in pregnant or breastfeeding women.
10. If there is joint effusion (intra-articular fluid), aspiration is recommended before injection.
11. Do not use after the expiry date stated on the packaging. The expiry date refers to the product stored in its original packaging at 2-25°C.
Side effects
When used at the injection site, reactions such as mild transient pain, swelling, redness, arthralgia and joint stiffness may occur. These symptoms disappear within a few days without medical intervention. If the symptoms do not disappear within this period, you should consult a doctor.
Storage conditions
In the original packaging at a temperature of 2-25 ° C and a relative humidity of no more than 80% in well-ventilated and clean rooms, in a place protected from light. Avoid exposure to aggressive gases. Do not freeze.
Release form
Gel for injection 12 mg/ml syringe 2.5 ml, No. 1.
