PRE-FILLED INTRA-ARTICULAR PERITENDINEAL SYRINGE TENDOGENIA PRO 2 ML

Description
Infiltrative device for the peritendinous 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 for relieving pain and improving the physical function of joints and soft tissues.
Proven to relieve pain and optimize recovery:
- in ligament and tendon injuries of the ankle;
- in ankle sprains;
- in lateral epicondylitis of the elbow;
- in ligament and tendon injuries of the shoulder capsule;
- in rotator cuff tendinopathies.

How to use
TENDOGENIAL PRO injection should only be performed by a healthcare professional trained in the specific injection technique. The contents of the syringe are sterile and should be injected with a sterile needle of appropriate size for the injection site. The area to be treated should be disinfected before injection.
Foot and ankle injuries
It is recommended that the first injection of TENDOGENIAL PRO be given preferably within 3 days of injury and a second injection 3 or 4 days after the first. Use a 27 gauge needle. Periarticular injections should be made in a single penetration along the anterior talofibular ligament using clinical landmarks. The injection should be performed in multiple planes.
Elbow injuries
A first injection of TENDOGENIAL PRO is recommended at the lateral epicondyle site, followed by a second injection, in the same area, 7 days after the first. Use a 27-gauge needle. Identify the most tender point of the epicondyle by gentle palpation; position the needle at 45 degrees to the point of maximum tenderness of the lateral epicondyle. After entering the subcutaneous tissue, the needle should be parallel to the skin and should be inserted toward the point of maximum tenderness in the region. Inject half of the volume while withdrawing the needle toward the entry point without exiting the skin. Rotate the needle 180 degrees. Inject the remaining volume while withdrawing the needle.
Shoulder injuries
A first injection of TENDOGENIAL PRO is recommended in the subacromial space of the shoulder joint, just above the tendon, followed by a second peri-articular injection two weeks later.

Components
Sodium hyaluronate (2%), phosphate buffered saline, L-proline (3%).

Warnings
Do not use in patients with known sensitivity to sodium hyaluronate and L-proline.
- TENDOGENIAL PRO must be injected only by a healthcare professional experienced in the procedure.
- TENDOGENIAL PRO pre-filled syringes are for single use only. The contents of the syringe must be used for a single injection.
- Residues must be discarded.
- TENDOGENIAL PRO must not be resterilized, as the performance of the device may be compromised and this could cause serious harm to the health and safety of the patient.
- TENDOGENIAL PRO must not be injected into blood vessels because sodium hyaluronate can occlude vessels, causing embolisms or infarctions.
- TENDOGENIAL PRO must not be injected into a haematoma.
- Direct injection into tendons should be avoided as it may cause tendon rupture.
- Do not inject into soft tissues of patients if the injection site area is infected or if there is evidence of acute or chronic skin disease.
- The healthcare professional must consider the immunological and other potential risks that may be associated with the injection of any biological material.
- There is no evidence of the safety of TENDOGENIAL PRO during pregnancy and breastfeeding. The safety and efficacy of TENDOGENIAL PRO have not been tested in children under 18 years of age.
- Do not use if package is damaged. Do not use after expiry date.
Adverse reactions: mild erythema and edema which should resolve with time.

Conservation
Store between 2°C and 25°C. Do not freeze. Protect from light.
Validity with intact packaging: 24 months.

Format
Pack containing 1 pre-filled syringe of 1 ml or 2 ml of TENDOGENIAL PROTM.

Code TD2