Hyalotend
Hyalotend
Hyalotend is a pre-filled syringe containing a hyaluronic acid sodium salt solution for peritendinous use. It consists of a viscous solution of hyaluronic acid sodium salt (500-730 kDa), derived through bacterial fermentation, and suspended in a buffered physiological solution for peritendinous injection. The solution (20 mg/2 ml) is provided in a sterile, pre-filled syringe. Hyaluronic acid, a key component of synovial fluid, is naturally produced in the tendon sheath and forms a significant part of the tendon’s extracellular matrix. Administering exogenous hyaluronic acid sodium salt into the peritendinous space helps reduce superficial tendon friction, enhances sliding efficiency, alleviates pain, and improves tendon function in cases of tendinopathy, thereby facilitating a quicker return to normal activities and sports. HYALOTEND is indicated for pain relief and improved elasticity in tendinopathies of both upper and lower extremities.
Composition
- Hyaluronic acid sodium salt
- Sodium chloride
- Dibasic sodium phosphate dodecahydrate
- Monobasic sodium phosphate dihydrate
- Water for injection
Instructions for Use
The product must be administered exclusively by qualified medical personnel. Use an ultrasound probe to guide the injection if necessary. Strict aseptic technique rules must be followed. Avoid using disinfectants containing quaternary ammonium salts as they may degrade hyaluronic acid. Utilize an appropriate sterile needle (21-25 G) as advised by a physician. Dispose of the syringe and needle after a single use. Administer three peritendinous injections at weekly intervals based on medical advice. Multiple tendons can be treated simultaneously if needed, and repeated treatments may be performed.
**Warnings**
- Do not administer HYALOTEND to patients with known hypersensitivity to its components.
- Contraindicated in cases of infections or skin conditions at the injection site.
- Not tested on pregnant women, the elderly, or individuals under 18; therefore, it is contraindicated for these groups.
- Do not use the product after the expiration date or if the packaging is open or damaged.
- The syringe is disposable and intended for single use only.
- Reuse or reprocessing of the syringe can lead to contamination, posing serious health risks.
- Dispose of the syringe immediately after use, in accordance with regulations.
- Post-injection, avoid overloading the joint.
- Keep out of reach of children.
- Possible local reactions include pain, warmth, redness, swelling, or bruising at the injection site, which are typically transient.
- Sporadic local or systemic allergic reactions to hyaluronic acid have been observed.
Storage
Store the product at temperatures not exceeding 25 °C in its original packaging, protected from light. Do not freeze.
Format
- Carton with 1 pre-filled syringe sealed in a blister pack.
- Box with 3 pre-filled syringes, each sealed in a blister pack.
The 20 mg/2 ml hyaluronic acid sodium salt solution in the pre-filled syringe is steam sterilized.
Code: 10000122, 10000123
