Description
Viscoelastic solution, transparent, colourless based on polynucleotides; is presented in the form of glass syringe, pre-filled, sterile, apirogenous, disposable, containing 2 ml of solution. Polynucleotides are highly purified, of ittic origin and have a concentration of 20 mg/ml. Condrotide is characterized by viscoelacity and a high power to bind numerous water molecules, therefore it allows to lubricate and promote the normalization of the viscosity of the synovial liquid.
Indicated in cases of painful joint pathologies ascribable to degenerative, post-traumatic fatigue or to alterations of joints. Condrotide thanks to its viscoelastic and lubricants properties favors the restoration of the rheological and physiological conditions of the joints. Condrotide, improving the characteristics of the synovial fluid, exercises a protective action of the joints and favors the physiological mechanisms of repair at the level of the joint cartilage. These properties contribute both to the improvement of joint functionality and to the reduction of painful symptoms.

Components
Each pre-filled syringe contains: polynucleotides 20 mg/ml, water for injectable preparations, sodium chloride, sodium phosphate monobasic dihydrate, sodium phosphate bibasic dodecaidrate.

Mode of use
Condrotide should be injected within the joint cavity using a sterile needle of diameter between 18G and 22G, generally 20 G. Intra-articular infiltration must be performed by medical personnel, observing the standards of technique and asepsis prescribed for this mode of administration. Given the viscosity of the solution, to ensure a stagnation and to prevent during administration the output of the product between needle and syringe, firmly screw the needle to the locking collar type Luer of the syringe.

Warnings
Condrotide is designed for disposable use. Condrotide should be used with particular attention in the presence of lymphatic or venous stasis in the leg to be treated. In the presence of joint pouring, we recommend the aspiration before injecting the product. It is recommended to recommend to the patient, after intra-articular injection, to avoid challenging physical activity for jointing and to resume normal activity after a couple of days. Do not use quaternary or chlorhexidine ammonium salt disinfectants. Do not inject vascularly, outside the joint cavity, in the synovial tissue or in the joint capsule. Do not inject if you notice impurities in the syringe.
The use of Condrotide is contraindicated in subjects with hypersensitivity to the components of the product or with positive anamnesi for allergy to the products of fish 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 place to infiltrate, in order to avoid the possibility of occurrence of bacterial artritis. Condrotide's effectiveness and safety were not established in patients with autoimmune diseases, pregnant or breastfeeding women and children, treatment with Condrotide in these cases is not recommended.
Adverse events associated with the practice of intra-articolar injections are possible with Condrotide: pain, feeling of warmth, redness or swelling. These secondary manifestations can be contained while maintaining the joint and applying locally ice. They usually disappear after a short time. If symptoms persist, contact a doctor. Your doctor must ensure that patients inform you of any side effects that have occurred after treatment.
Keep out of reach of children. Intra-articular injection can only be done by medical personnel. Check the integrity of syringe packaging before use: do not use Condrotide if the packaging is already open or damaged. Do not use after the expiration date indicated on the case. The expiry date refers to the intact product, properly preserved. Store the container well closed, sheltered from light and heat. Don't freeze. Once opened, Condrotide must be used immediately and eliminated after use. Do not disperse into the environment after use. Condrotide should only be administered by authorized personnel in accordance with local legislation.

Conservation
Store in closed place, sheltered from direct light and heat at room temperature (0-40°C).
Validity of whole packaging: 36 months.

Format
Cap containing a pre-assembled and pre-filled glass syringe with 2 ml solution, an illustration sheet. The solution contained in the syringe is sterile and apirogenous, the outer surface of the syringe is not sterile.

Cod. 810002B