SportVisTM
For pain relief and optimization of ankle recovery after first or second degree sprains.
For the relief of chronic pain and movement restrictions of the elbow in lateral epicondylalgia.
For the relief of pain in patients with symptomatic rotator cuff tendinopathy.
Dosage form:
SportVisTM is a clear, sterile solution of 1% sodium hyaluronate in phosphate-buffered saline in a prefilled syringe for
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a series of two periarticular injections into the soft tissue of the ankle: a periarticular injection preferably within 48 hours after the injury and a second periarticular injection 2 to 3 days after the first injection.
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a periarticular injection in the area of the humeral epicondyle, if necessary, followed by a second injection one week after the first injection.
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a periarticular injection of SportVisTM into the subacromial space of the shoulder directly above the tendon, followed by a second periarticular injection 14 days after the first injection.
Sodium hyaluronate is a long-chain polysaccharide made of consists of repeating disaccharide units and naturally occurs in the body.
The pH value and osmolality of SportVisTM are biocompatible with soft tissue.
1.2 ml SportVisTM, sterilized by filtration, are contained in a ready-to-use single-use glass syringe. The syringe is packaged in a blister pack and an outer carton.
Dosage and administration:
The periarticular injection of SportVisTM should only be performed by a medical professional experienced in this technique.
Dosage:
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a periarticular injection preferably within 48 hours after a first or second degree ankle sprain and a second injection 2 to 3 days after the first injection. A 27 gauge injection needle is recommended.
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a periarticular injection in the area of the lateral epicondyle of the humerus, followed by a second injection at the same site one week after the first injection. A 27 gauge injection needle is recommended.
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a periarticular injection of SportVisTM into the subacromial space of the shoulder directly above the tendon, followed by a second periarticular injection 14 days after the first injection. A 22 gauge injection needle is recommended.
The syringe content is sterile and should be injected with a needle of a size suitable for the injection site.
The area to be treated should be disinfected before the injection.
Ankle sprains:
Periarticular injections should be applied using a single puncture along the anterior talofibular ligament using clinical landmarks. The injection is administered along 3 planes: anteroposterior, medial, and lateral to the proximal landmark on the ligament.
1.2 ml of SportVisTM is preferably injected within 48 hours after the injury, and a second injection of 1.2 ml is given 2 to 3 days after the first injection.
Lateral epicondylalgia:
Carefully palpate to locate the most painful point in the epicondyle area.
Position the needle at a 45-degree angle to the point of maximum pain in the area of the lateral epicondyle.
After piercing the skin, align the needle parallel to the skin and insert it towards the point of maximum pain at the lateral epicondyle. Inject half of the content while withdrawing the needle back towards the skin (but not out of the skin).
Rotate the needle 180 degrees (opposite direction) and insert the needle parallel to the skin towards the point of maximum pain at the lateral epicondyle. Inject the remaining content while withdrawing the needle outward.
Withdraw the needle from the skin.
Bend and straighten the elbow five times, then rotate it inward and outward five times.
Rotator cuff tendinopathy:
Have the patient sit upright, arm relaxed at the side and rotated outward. For guiding the injection, it is recommended to use an ultrasound probe positioned laterally on the shoulder, directed towards the plane of the supraspinatus tendon. Locate the acromion, greater tubercle, humeral head, and subacromial space. Insert the needle 1 cm posterior and 2 cm distal to the anterolateral acromial edge into the space. Advance the needle horizontally and slightly medially under the acromial process. If no resistance is felt on the plunger, inject SportVisTM over the humeral head into the subacromial space. Carefully avoid injecting into the tendon.
Dispose of syringe and needle after single use.
Application:
SportVisTM is intended for pain relief and optimization of regeneration of tendons and ligaments damaged by acute or chronic injuries.
SportVisTM sodium hyaluronate increases the naturally occurring sodium hyaluronate present in the soft tissue of damaged tendons and ligaments and supports lubrication and hydration of the affected area. This creates an ideal environment for healing the damaged tissue. SportVisTM has been shown to relieve ankle pain and optimize recovery after first or second-degree injuries and sprains. It relieved chronic pain and disabilities of the elbow with lateral epicondylalgia and the pain of patients with symptomatic rotator cuff tendinopathy.
Contraindications:
Patients with known hypersensitivity to sodium hyaluronate.
Warnings and precautions:
SportVisTM should only be injected by a medical professional trained in this technique.
The prefilled SportVisTM syringes are intended for single use only. The contents of the syringe should be used for one injection only. Any remaining sodium hyaluronate must be disposed of. If a syringe is stored for a later injection, there is a risk of contamination that may lead to patient infection and/or foreign body reaction.
SportVisTM should not be resterilized, as this may impair device performance and cause serious harm to the patient's health and safety.
SportVisTM must not be injected into blood vessels, as sodium hyaluronate may clog the vessels, potentially leading to embolism or infarction.
Direct injection into ligaments and tendons should be avoided as this can cause a rupture. Using an ultrasound probe to guide the injection minimizes this risk.
Do not inject into the soft tissue of patients if there is inflammation, infection, or signs of acute or chronic skin disease at the injection site. Sodium hyaluronate is produced by fermentation of Streptococcus equi Manufactured and carefully purified. Nevertheless, the medical professional should consider the immunological and other potential risks associated with the injection of any biological material.
As with any periarticular intervention, there is a risk of infection at the injection site.
There is no evidence of the safety of SportVisTM during pregnancy and breastfeeding in humans.
The safety and efficacy of SportVisTM in children under 18 years have not been studied.
SportVisTM must not be injected into a hematoma. Dispose of syringe and needle after single use.
National or local guidelines regarding the safe use and disposal of injection needles must be followed. In case of injury, consult a medical professional immediately.
Do not use if the packaging is damaged. Do not use after the expiration date.
Adverse reactions:
Mild erythema that fades over time. Temporary pain, swelling, inflammation, pustules, and discoloration may occur with periarticular injections. Rarely, fever, headache, nausea, edema, effusions, and skin itching may occur, which may or may not be associated with SportVisTM.
Incompatibilities:
The compatibility of SportVisTM with other substances for periarticular injection has not been tested. Therefore, mixing or simultaneous administration with other substances for periarticular injection is not recommended.
Storage:
Store at a temperature between 2 °C and 25 °C.
Do not freeze. Protect from light.
Do not use if the sterile packaging is damaged. Do not use after the expiration date.
Version code:
Z07
Date:
March 2020
Joint injections
Dermafiller
Supplements
