Description
Medical device.
Intra-articular polynucleotide infiltration gel.
A transparent, colorless, viscoelastic solution: it comes as a pre-filled, sterile, pyrogen-free, single-use glass syringe containing 2 ml of solution. The polynucleotides are highly purified, of piscine origin, and have a concentration of 20 mg/ml.
It is characterized by viscoelasticity and a high ability to bind many water molecules, thus allowing it to lubricate and promote the normalization of synovial fluid viscosity.
Thanks to its viscoelastic and lubricating properties, Condrotide promotes the restoration of the rheological and physiological conditions of the joints. By improving the characteristics of the synovial fluid, it exerts a protective action on the joints and promotes the physiological repair mechanisms at the level of the articular cartilage. These properties contribute to both the improvement of joint function and the reduction of painful symptoms.

Instructions for use
Inject into the joint cavity using a sterile needle with a diameter between 18 G and 22 G, generally 20 G. As a guideline, unless otherwise advised by a doctor, infiltrate 2 ml of the product (40 mg of polynucleotides) intra-articularly once a week for 3-6 weeks.
Intra-articular infiltration must be performed by medical personnel, observing the technical and aseptic norms prescribed for these administration methods. Given the viscosity of the solution, to ensure a watertight seal and prevent product leakage between the needle and syringe during administration, firmly screw the needle onto the Luer-type locking collar of the syringe.

Components
Each pre-filled syringe contains: polynucleotides 20 mg/ml, water for injections, sodium chloride, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate.

Warnings
Condrotide is designed for single use.
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.
It is advisable to recommend to the patient, after intra-articular injection, to avoid strenuous physical activities for the joint and to resume normal activities after a couple of days.
Do not inject intravascularly, outside the joint cavity, into the synovial tissue or joint capsule.
Do not inject if impurities are noticed in the syringe.
The use of Condrotide is contraindicated in individuals with hypersensitivity to the product components or with a positive history of allergy to products of piscine origin.
Condrotide should not be injected in the presence of an infected or severely inflamed joint or if the patient has an infection near the infiltration site, to avoid the possibility of bacterial arthritis.
The efficacy and safety of Condrotide have not been established in patients with autoimmune diseases, pregnant or breastfeeding women, and children. Treatment in these cases is not recommended.
Possible adverse events associated with intra-articular injections include: pain, warmth, redness, or swelling. Such secondary manifestations can be mitigated by resting the joint and applying ice locally. These usually disappear after a short time. If symptoms persist, consult a doctor.
The doctor must ensure that patients inform them of any side effects that occurred 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 CONDROTIDE if the packaging is already open or damaged.
Once opened, Condrotide must be used immediately and disposed of after use.
Do not discard into the environment after use.
Condrotide must only be administered by authorized personnel in accordance with local legislation.

Storage
Store the container tightly closed, below 25 °C, away from light and heat. Do not freeze.
Shelf life when unopened: 36 months.

Format
2 ml syringe

Code. MD033VEU