HIALUROM Tendon
Sodium hyaluronate 40 mg/2 ml, sterile solution for injection in a prefilled syringe
For peritendinous injection or injection into the tendon sheath.
Hialurom Tendon is a viscoelastic, isotonic solution containing 40 mg/2 ml sodium hyaluronate in a physiological buffer solution. It also contains sodium chloride and mannitol (pH 7-8). Sodium hyaluronate is obtained by bacterial fermentation of a Streptococcus strain and subsequently purified.
Sterile by moist heat.
Indications:
For pain relief and limited mobility in tendon disorders.
Contraindications:
Hialurom Tendon must not be used in:
- known hypersensitivity to any of the components of Hialurom Tendon, known allergies (hypersensitivity) to proteins from gram-positive bacteria, existing infections at the injection site if other medications have already been injected at or around the injection site.
Possible side effects:
Local side effects such as pain, warmth, bruising, redness, and swelling may occur after treatment with Hialurom Tendon.
Dosage and method of application:
Hialurom Tendon should only be administered by medical professionals trained in the specific injection techniques of peritendinous injection or injection into the tendon sheath.
Injection into the tendon sheath:
For tendons with a tendon sheath, Hialurom Tendon is injected directly into the tendon sheath in the affected area.
Peritendinous injection:
For tendons without a tendon sheath, the product is applied along the affected tendon but not into the tendon itself.
Inject Hialurom Tendon a total of 2 times at weekly intervals around the affected tendon or into the affected tendon sheath. Multiple tendons can be treated simultaneously. Repeat treatments are possible if needed.
The contents of the Hialurom Tendon prefilled syringe are sterile.
The prefilled syringe is taken out of the sterile packaging, the cap is removed, a suitable needle (e.g., 25 to 27G) is attached and secured with a slight twist.
Needle selection is the responsibility of the physician. Various factors influence the choice of the correct needle length and thickness, such as the anatomy of the treatment site, the distance of the tendon to be treated from the skin, and patient-specific factors like weight and age. Ultrasound monitoring of the treatment is recommended.
Remove any air bubbles before use.
Interactions:
No information is currently available on interactions of Hialurom Tendon with other drugs.
Precautions:
Caution in patients with known hypersensitivity to medications.
General precautions for peritendinous injections or injections into the tendon sheath must be observed.
Hialurom Tendon must be correctly injected into the tendon sheath or correctly applied around the affected tendon, if necessary under ultrasound guidance.
Avoid nerve injuries and injections into blood vessels.
The product should not be used in patients with known systemic bleeding disorders or a history of vasovagal reactions or syncope.
There is insufficient data to recommend the use of sodium hyaluronate in children, adolescents, pregnant or breastfeeding women. Treatment with Hialurom Tendon is not recommended in these cases.
Patients who develop complications in the days following the injection must see a doctor immediately.
Warnings:
Single-use product! The product Hialurom Tendon 40 mg/2 ml is intended for single use for one patient only.
Do not use the prefilled syringe if the seal or blister is damaged. Solution not used immediately after opening must be discarded and must not be used otherwise. After the first injection, the sterility of the solution can no longer be guaranteed.
Used needles and syringes must be disposed of after each injection and must not be kept for other administrations.
Do not reuse! Reusing used needles and syringes can lead to the transmission of infectious agents (including HIV and hepatitis).
The product must not be re-sterilized, as this can damage or alter the product.
General aseptic precautions must be observed to protect the patient from infections.
The injection site must be properly disinfected (70% alcohol or another disinfectant). Disinfectants containing quaternary ammonium salts should not be used for skin disinfection, as this can cause a breakdown reaction of the hyaluronic acid.
Use the product only if the liquid is clear and shows no cloudiness or discoloration.
Keep out of reach of children.
Hialurom Tendon is a medical device. To be used only by a doctor.
Properties and mode of action:
A tendon is a robust structure made of fibrous connective tissue, designed to transmit forces from muscles to bones to withstand tension during muscle contraction. Tendons can be surrounded by different structures: e.g., fibrous bands, synovial sheaths, tendon sheaths, bursae.
Overuse or incorrect loading can cause inflammation and/or degenerative changes of the tendon, leading to pain and loss of function. Lubricating the tendon could reduce pain, improve tendon function, and decrease the possibility of adhesions.
Due to its lubricating and viscoelastic properties, Hialurom Tendon supports the gliding ability of tendons as well as the physiological regeneration process. Additionally, Hialurom Tendon reduces the free passage of inflammation-promoting cells and molecules through the tendon sheath due to its macromolecular structure.
Hialurom Tendon is a clear solution of natural, highly pure sodium hyaluronate, obtained by fermentation and therefore free of animal proteins.
Hialurom Tendon is also stabilized by the addition of mannitol, a radical scavenger. In biocompatibility studies, Hialurom Tendon has proven to be particularly well tolerated.
Package of pitze Hialurom Tendon with 40 mg/2 ml in sterile packaging.
Storage:
Do not store in the refrigerator. The product should be stored in its original packaging. Storage temperature should not exceed 25°C.
Information status: June 2016
Joint injections
Dermafiller
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