Descrizione Clinica
TENDIAL PRO
Description
Infiltrative device for peritendine and/or synovial sheath of hyaluronic acid (HA) and L-proline indicated to relieve pain and restore the functionality of damaged tendons and ligaments.
TENDOGENIAL PRO is a unique formulation of hyaluronic acid (20 mg/ml) and L-proline (30 mg/ml) useful to relieve pain and improve the physical function of joints and soft tissues.
He has proven to relieve pain and optimize recovery:
- in ligament lesions and ankle curtains;
- in ankle distortions;
- in the side epicondilytes of the elbow;
- in the ligament lesions and shoulder capsule curtains;
- in the curtains of the rotator head.
Mode of use
The injection of TENDOGENIAL PRO must be carried out only by a healthcare professional trained to the specific injection technique. The content of the syringe is sterile and must be injected with a sterile needle of adequate size to the injection site. The area to be treated must be disinfected before injection.
Foot and ankle injuries
It is recommended a first injection of TENDOGENIAL PRO preferably within 3 days from the injury and a second injection at 3 or 4 days from the first. Use a 27 gauge needle. Periarticular injections must be carried out during a single penetration along the front thiofibular ligament using clinical reference points. The injection must be performed on several floors.
Elbow injuries
A first injection of TENDOGENIAL PRO is recommended on the site of the lateral epichondyl, followed by a second injection, in the same area, 7 days after the first. Use a 27 gauge needle. Identify the softest point of the epichond it by a slight palpation; place the needle at 45 degrees compared to the maximum pain point of the lateral epichondyl. After entering the subcute, the needle must be parallel to the skin and should be inserted towards the maximum pain point of the region. Inject half of the volume while the needle is withdrawn to the entry point without leaving the skin. Rotate the needle 180 degrees. Inject the remaining volume by withdrawing the needle.
Shoulder injuries
A first injection of TENDOGENIAL PRO is recommended in the subacromial space of the shoulder joint, just above the curtain, followed by a second peri-articular injection after two weeks.
Components
Hyaluronate sodium (2%) saline phosphate pad, L-proline (3%).
Warnings
Do not use in patients with sensitivity known to sodium hyaluronate and L-proline.
- TENDOGENIAL PRO must be injected only by an experienced healthcare professional in the procedure.
- TENDOGENIAL PRO pre-filled syringes are disposable. The syringe content must be used for one injection.
- The residues must be discarded.
- TENDOGENIAL PRO should not be resterilized, since the performance of the device could be compromised and this could cause serious damage to the health and safety of the patient.
- TENDOGENIAL PRO should not be injected into blood vessels because sodium hyaluronate may obstruct vessels, causing embolism or heart attacks.
- TENDOGENIAL PRO should not be injected into a hematoma.
- The direct injection in the tendons must be avoided because it can cause the break.
- Do not inject in soft tissues of patients if the injection site area is infected or if there is evidence of acute or chronic skin disease.
- The healthcare provider must consider the immunological risks and other potential risks that may be associated with injection of any biological material.
- There's no evidence of TENDOGENIAL PRO's safety during pregnancy and nursing. The safety and effectiveness of TENDOGENIAL PRO have not been tested for children under 18 years.
- Do not use if the package is damaged. Do not use after the expiry date.
Adverse reactions: mild erythema and edema that should resolve with time.
Conservation
Store between 22°C and 25°C. Don't freeze. Protect from light.
Validity of whole packaging: 24 months.
Format
Pack containing 1 pre-filled syringe of 1 ml or 2 ml of TENDOGENIAL PROTM.
Cod. TD2
Infiltrative device for peritendine and/or synovial sheath of hyaluronic acid (HA) and L-proline indicated to relieve pain and restore the functionality of damaged tendons and ligaments.
TENDOGENIAL PRO is a unique formulation of hyaluronic acid (20 mg/ml) and L-proline (30 mg/ml) useful to relieve pain and improve the physical function of joints and soft tissues.
He has proven to relieve pain and optimize recovery:
- in ligament lesions and ankle curtains;
- in ankle distortions;
- in the side epicondilytes of the elbow;
- in the ligament lesions and shoulder capsule curtains;
- in the curtains of the rotator head.
Mode of use
The injection of TENDOGENIAL PRO must be carried out only by a healthcare professional trained to the specific injection technique. The content of the syringe is sterile and must be injected with a sterile needle of adequate size to the injection site. The area to be treated must be disinfected before injection.
Foot and ankle injuries
It is recommended a first injection of TENDOGENIAL PRO preferably within 3 days from the injury and a second injection at 3 or 4 days from the first. Use a 27 gauge needle. Periarticular injections must be carried out during a single penetration along the front thiofibular ligament using clinical reference points. The injection must be performed on several floors.
Elbow injuries
A first injection of TENDOGENIAL PRO is recommended on the site of the lateral epichondyl, followed by a second injection, in the same area, 7 days after the first. Use a 27 gauge needle. Identify the softest point of the epichond it by a slight palpation; place the needle at 45 degrees compared to the maximum pain point of the lateral epichondyl. After entering the subcute, the needle must be parallel to the skin and should be inserted towards the maximum pain point of the region. Inject half of the volume while the needle is withdrawn to the entry point without leaving the skin. Rotate the needle 180 degrees. Inject the remaining volume by withdrawing the needle.
Shoulder injuries
A first injection of TENDOGENIAL PRO is recommended in the subacromial space of the shoulder joint, just above the curtain, followed by a second peri-articular injection after two weeks.
Components
Hyaluronate sodium (2%) saline phosphate pad, L-proline (3%).
Warnings
Do not use in patients with sensitivity known to sodium hyaluronate and L-proline.
- TENDOGENIAL PRO must be injected only by an experienced healthcare professional in the procedure.
- TENDOGENIAL PRO pre-filled syringes are disposable. The syringe content must be used for one injection.
- The residues must be discarded.
- TENDOGENIAL PRO should not be resterilized, since the performance of the device could be compromised and this could cause serious damage to the health and safety of the patient.
- TENDOGENIAL PRO should not be injected into blood vessels because sodium hyaluronate may obstruct vessels, causing embolism or heart attacks.
- TENDOGENIAL PRO should not be injected into a hematoma.
- The direct injection in the tendons must be avoided because it can cause the break.
- Do not inject in soft tissues of patients if the injection site area is infected or if there is evidence of acute or chronic skin disease.
- The healthcare provider must consider the immunological risks and other potential risks that may be associated with injection of any biological material.
- There's no evidence of TENDOGENIAL PRO's safety during pregnancy and nursing. The safety and effectiveness of TENDOGENIAL PRO have not been tested for children under 18 years.
- Do not use if the package is damaged. Do not use after the expiry date.
Adverse reactions: mild erythema and edema that should resolve with time.
Conservation
Store between 22°C and 25°C. Don't freeze. Protect from light.
Validity of whole packaging: 24 months.
Format
Pack containing 1 pre-filled syringe of 1 ml or 2 ml of TENDOGENIAL PROTM.
Cod. TD2
