Chondrotide 2 ml

Description
Medical device.
Gel for intraarticular infiltration with polynucleotides.
Viscoelastic, clear, colorless solution: presented in a pre-filled, sterile, pyrogen-free, single-use glass syringe containing 2 ml of solution. The polynucleotides are highly purified, of fish origin and have a concentration of 20 mg/ml.
It is characterized by viscoelasticity and a high capacity to bind numerous water molecules, therefore allowing lubrication and promoting the normalization of the viscosity of the synovial fluid.
Due to its viscoelastic and lubricating properties, chondroitin promotes the restoration of rheological and physiological conditions of the joints. By improving the characteristics of the synovial fluid, it protects the joints and promotes the physiological mechanisms of repair of the articular cartilage. These properties contribute to both improving joint function and reducing pain.

How to use
It is injected into the joint cavity, using a sterile needle with a diameter between 18 G and 22 G, generally 20 G. As a general rule, unless your doctor recommends otherwise, infiltrate 2 ml of the product (40 mg of polynucleotides) intra-articularly once a week, for 3-6 weeks.
Intra-articular infiltration should be performed by medical personnel, observing the technical and aseptic standards prescribed for these methods of administration. Given the viscosity of the solution, to ensure a tight seal and prevent leakage of the product between the needle and the syringe during administration, screw the needle tightly onto the Luer collar of the syringe.

components
Each pre-filled syringe contains: polynucleotide 20 mg/ml, water for injections, sodium chloride, monosodium phosphate dihydrate, disodium phosphate dodecahydrate.

warnings
Chondrotide is intended for single use only.
It should be used with particular caution in the presence of lymphatic or venous stasis in the leg to be treated.
In the presence of joint effusion, aspiration is recommended before injecting the product.
After the intra-articular injection, it is recommended that the patient avoid physical activities that are demanding on the joint and resume normal activities after a few days.
Do not inject intravascularly, outside the joint cavity, into synovial tissue or into the joint capsule.
Do not inject if you notice impurities in the syringe.
The use of Chondrotide is contraindicated in subjects with hypersensitivity to the product components or with a positive history of allergy to fish products.
Chondrotide should not be injected if the joint is infected or severely inflamed, or if the patient has an infection near the injection site, to avoid the possibility of developing bacterial arthritis.
The efficacy and safety of Chondrotide have not been established in patients with autoimmune diseases, pregnant or lactating women, and children. Treatment in these cases is not recommended.
Side effects associated with intra-articular injections may include pain, warmth, redness, or swelling. These side effects can be minimized by resting the joint and applying ice. They usually go away after a short time. If symptoms persist, consult a doctor.
The doctor should ensure that patients inform him of any adverse reactions that occur after treatment.
Keep out of reach of children.
Intra-articular injection can only be performed by medical personnel.
Check the integrity of the syringe packaging before use: do not use CHONDROTIDE if the packaging is already open or damaged.
Once opened, Chondrotide should be used immediately and discarded after use.
Do not dispose of in the environment after use.
Chondrotide should only be administered by authorized personnel, in accordance with local legislation.

Conservation
Store tightly closed, below 25°C, away from light and heat. Do not freeze.
Shelf life in intact packaging: 36 months.

Format
2 ml syringe

Code: MD033VEU