CONDROTIDE is a viscoelastic, transparent and colourless solution containing polynucleotides supplied in a sterile, non-pyrogenic pre-filled glass syringe for single use. Polynucleotides are highly purified substances of fish origin at a concentration of 20 mg/ml. Since CONDROTIDE is viscoelastic and capable of binding large numbers of water molecules, it acts as a lubricant and helps to normalize the viscosity of the synovial fluid.
Each pre-filled syringe contains: polynucleotides 20 mg/ml, water for injectable preparations, sodium chloride, sodium phosphate monobasic dihydrate, dibasic sodium phosphate dodecahydrate.
Painful joint diseases caused by degenerative or post-traumatic conditions or by modification of a joint. Thanks to its viscoelastic and lubricating properties, CONDROTIDE helps to restore the rheological and physiological conditions of joints. By enhancing the quality of the synovial fluid CONDROTIDE protects the joints and improves the physiological repair mechanisms of the articular cartilage.
These properties contribute to improve joint functionality and to reduce painful symptoms.
The recommended treatment consists of 3 injections of 2 ml in the joint to be treated. The time interval between each injection is 1-3 weeks.
The use of CONDROTIDE is contraindicated in patients who are hypersensitive to any of the product's components or with a history of allergy to products originating from fish.
To prevent the onset of bacterial arthritis avoid infiltrating CONDROTIDE if the joint is infected or seriously inflamed or in case of on-going infection at the site of injection.
Since the effectiveness and the safety of CONDROTIDE have not been proved in patients with autoimmune diseases, in pregnant or breastfeeding women or in children, treatment with CONDROTIDE is advised against in these cases.
CONDROTIDE is designed for single use only.
CONDROTIDE must be used with particular care in patients with lymphatic or venous stasis of the leg to be treated. In case of joint effusions, it is advisable to remove the fluid by aspiration before injecting the product. Patients receiving intra-articular injections should be advised to avoid any demanding forms of physical exercise for the joint and to resume their normal activities after a couple of days.
Do not inject via the intravenous route, outside the joint cavity, into the synovial tissue or into the joint capsule. Do not inject if any impurities are noted in the syringe.
Warnings: Intra-articular injections can be performed solely by medical personnel.
Check before use that the syringe packaging is intact: Do not use CONDROTIDE if the packaging is already open or damaged. Do not use the product after the expiry date indicated on the packaging. The expiry date refers to the intact and properly stored product.
Store the properly sealed packaging away from light and heat. Do not freeze. CONDROTIDE must be used immediately after opening and disposed of after use. Do not dispose of into the environment after use. CONDROTIDE must be administered only by personnel authorised in accordance with local legislation.
Adverse events associated with intra-articular injections such as pain, a burning sensation, reddening or swelling can occur when using CONDROTIDE. These secondary symptoms can be mitigated by resting the joint and applying ice locally. They normally disappear shortly after. Should these symptoms persist, refer to a physician.
The treating physician must make sure that the patient informs him/her of any undesirable effects occurring after the treatment.
Instructions for Use: CONDROTIDE is injected into the articular cavity using a sterile needle with a diameter ranging from 18 G to 22 G, usually a 20 G needle. This intra-articular injection must be performed by medical personnel strictly complying with the technical rules and the aseptic procedures required for this method of administration. In view of the viscosity of the solution, the needle must be firmly screwed onto the Luer-Lock fitting of the syringe to ensure that the connection is watertight, preventing any leakage between the needle and the syringe when administering the product.
Store below 25°C, in a closed place away from direct light and heat.
M09AX - Other drugs for disorders of the musculo-skeletal system ; Used in the treatment of musculo-skeletal disorders.
Condrotide inj 40 mg/2 mL
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