Description
CHONDROTID
Description
Viscoelastic, transparent, colorless solution based on polynucleotides; it comes in the form of a glass syringe, pre-filled, sterile, apyrogenic, single-use, containing 2 ml of solution. The polynucleotides are highly purified, of fish origin and have a concentration of 20 mg/ml. Condrotide is characterized by viscoelasticity and a high power to bind numerous water molecules, therefore it allows to lubricate and promote the normalization of the viscosity of the synovial fluid.
Indicated in cases of painful joint pathologies attributable to degenerative conditions, post-traumatic conditions or joint alterations. Condrotide, thanks to its viscoelastic and lubricating properties, promotes the restoration of the rheological and physiological conditions of the joints. Condrotide, improving the characteristics of the synovial fluid, exerts a protective action on the joints and promotes the physiological repair mechanisms at the level of the articular 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 injections, sodium chloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dodecahydrate.
How to use
Condrotide should be injected into the joint cavity using a sterile needle with a diameter between 18G and 22G, generally 20G. Intra-articular infiltration must be performed by medical personnel, observing the technical and aseptic standards prescribed for this administration method. Given the viscosity of the solution, to ensure a watertight seal and prevent the product from leaking between the needle and syringe during administration, screw the needle tightly onto the Luer-type closure collar of the syringe.
Warnings
Condrotide is designed for single use. Condrotide 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, it is recommended to aspirate it before injecting the product. It is advisable to advise the patient, after the intra-articular injection, to avoid physical activities that are demanding for the joint and to resume normal activities after a couple of days. Do not use disinfectants based on quaternary ammonium salts or chlorhexidine. Do not inject vascularly, outside the joint cavity, into the synovial tissue or into the joint capsule. Do not inject if impurities are noted in the syringe.
The use of Condrotide is contraindicated in subjects with hypersensitivity to the components of the product or with a positive history of allergy to products of fish origin. Condrotide must not be injected in the presence of an infected or severely inflamed joint or if the patient has an infection near the site to be infiltrated, in order to avoid the possibility of bacterial arthritis. The efficacy and safety of Condrotide have not been established in patients with autoimmune diseases, in pregnant or breastfeeding women and in children; treatment with Condrotide in these cases is not recommended.
Adverse events associated with intra-articular injections such as pain, sensation of heat, redness or swelling are possible with Condrotide. These secondary manifestations can be contained by keeping the joint at rest and applying ice locally. They usually disappear after a short time. If symptoms persist, contact a doctor. The doctor must ensure that patients inform him of any undesirable effects that occur after treatment.
Keep out of reach of children. Intra-articular injection may only be performed by medical personnel. Check the integrity of the syringe packaging before use: do not use Condrotide if the packaging is already opened or damaged. Do not use after the expiry date indicated on the carton. The expiry date refers to the intact product, correctly stored. Keep the container tightly closed, protected from light and heat. Do not freeze. Once opened, Condrotide must be used immediately and discarded after use. Do not disperse in the environment after use. Condrotide must be administered only by authorized personnel in compliance with local legislation.
Conservation
Store in a closed place, away from direct light and heat at room temperature (0-40°C).
Validity with intact packaging: 36 months.
Format
Case containing a pre-assembled and pre-filled glass syringe with 2 ml of solution, an information leaflet. The solution contained in the syringe is sterile and apyrogenic, the external surface of the syringe is not sterile.
Cod. 810002B
Viscoelastic, transparent, colorless solution based on polynucleotides; it comes in the form of a glass syringe, pre-filled, sterile, apyrogenic, single-use, containing 2 ml of solution. The polynucleotides are highly purified, of fish origin and have a concentration of 20 mg/ml. Condrotide is characterized by viscoelasticity and a high power to bind numerous water molecules, therefore it allows to lubricate and promote the normalization of the viscosity of the synovial fluid.
Indicated in cases of painful joint pathologies attributable to degenerative conditions, post-traumatic conditions or joint alterations. Condrotide, thanks to its viscoelastic and lubricating properties, promotes the restoration of the rheological and physiological conditions of the joints. Condrotide, improving the characteristics of the synovial fluid, exerts a protective action on the joints and promotes the physiological repair mechanisms at the level of the articular 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 injections, sodium chloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dodecahydrate.
How to use
Condrotide should be injected into the joint cavity using a sterile needle with a diameter between 18G and 22G, generally 20G. Intra-articular infiltration must be performed by medical personnel, observing the technical and aseptic standards prescribed for this administration method. Given the viscosity of the solution, to ensure a watertight seal and prevent the product from leaking between the needle and syringe during administration, screw the needle tightly onto the Luer-type closure collar of the syringe.
Warnings
Condrotide is designed for single use. Condrotide 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, it is recommended to aspirate it before injecting the product. It is advisable to advise the patient, after the intra-articular injection, to avoid physical activities that are demanding for the joint and to resume normal activities after a couple of days. Do not use disinfectants based on quaternary ammonium salts or chlorhexidine. Do not inject vascularly, outside the joint cavity, into the synovial tissue or into the joint capsule. Do not inject if impurities are noted in the syringe.
The use of Condrotide is contraindicated in subjects with hypersensitivity to the components of the product or with a positive history of allergy to products of fish origin. Condrotide must not be injected in the presence of an infected or severely inflamed joint or if the patient has an infection near the site to be infiltrated, in order to avoid the possibility of bacterial arthritis. The efficacy and safety of Condrotide have not been established in patients with autoimmune diseases, in pregnant or breastfeeding women and in children; treatment with Condrotide in these cases is not recommended.
Adverse events associated with intra-articular injections such as pain, sensation of heat, redness or swelling are possible with Condrotide. These secondary manifestations can be contained by keeping the joint at rest and applying ice locally. They usually disappear after a short time. If symptoms persist, contact a doctor. The doctor must ensure that patients inform him of any undesirable effects that occur after treatment.
Keep out of reach of children. Intra-articular injection may only be performed by medical personnel. Check the integrity of the syringe packaging before use: do not use Condrotide if the packaging is already opened or damaged. Do not use after the expiry date indicated on the carton. The expiry date refers to the intact product, correctly stored. Keep the container tightly closed, protected from light and heat. Do not freeze. Once opened, Condrotide must be used immediately and discarded after use. Do not disperse in the environment after use. Condrotide must be administered only by authorized personnel in compliance with local legislation.
Conservation
Store in a closed place, away from direct light and heat at room temperature (0-40°C).
Validity with intact packaging: 36 months.
Format
Case containing a pre-assembled and pre-filled glass syringe with 2 ml of solution, an information leaflet. The solution contained in the syringe is sterile and apyrogenic, the external surface of the syringe is not sterile.
Cod. 810002B
