Prescribing Information:

SportVis™ is intended to relieve pain and optimise recovery of the ankle following first or second degree sprain and also to relieve chronic pain and disability of the elbow which is associated with epicondlyitis.

Presentation:

SportVis™ is a clear solution of sterile 1% sodium hyaluronate in a phosphate buffered saline contained in a pre-filled syringe for:

a series of two peri-articular injections into the soft tissue of the ankle - one peri-articular injection within 48 hours of the injury and a second peri-articular injection 2 to 3 days following the first injection

a peri-articular injection in the elbow epicondyle followed by a second injection as may be required one week after the first injection Sodium hyaluronate is a long chain polysaccharide made up of repeating disaccharide units, which occurs naturally in the body.  SportVis™ has a pH and osmolality biocompatible with the soft tissue.

Dosage and Administration:

1.2ml of SportVis™, sterilised by filtration, is enclosed within a glass, ready to use, disposable syringe. The syringe is packed within a blister pack and an outer cardboard carton.  Each pack contains 2 doses.

Peri-articular injection of SportVis™ should only be administered by a Healthcare Professional trained in the technique.

The dosage regimen is:

one peri-articular injection within 48 hours of the first or second degree ankle sprain injury and a second injection 2 to 3 days following the first injection
one peri-articular injection at the lateral elbow epicondyle site followed by a second injection at the same site one week after the first injection

The contents of the syringe are sterile and should be injected using a sterile needle of an appropriate size (20mm, 27 gauge needle is recommended).  The area to be treated should be disinfected before injection.

Ankle Sprains:  Peri-articular injections should be delivered during a single penetration along the anterior talofibular ligament using clinical landmarks.  The injection is delivered along 3 planes from antero-posterior, medial and lateral to the proximal ligamentous landmark.

1.2ml of SportVis™ is injected within 48 hours of the injury and a second injection of 1.2ml is given 2 to 3 days after the first injection.

Elbow: Peri-articular injections identify the tenderest point of the epicondyle by gentle palpation.  Insert the needle at 90 degrees to the point of maximal pain on the lateral epicondyle.  After insertion to the epicondyle, angle the needle at 45 degrees approximately and inject half the ontents as the needle is withdrawn to the skin (without exiting the skin).

Insert the needle to 45 degrees in the opposite direction to the epicondylar point of maximum pain and inject the remaining contents on withdrawing of the needle outward.  The needle is removed from the skin.  The elbow is flexed and extended five times and then internally and externally rotated five times.

Discard the syringe and needle after single use.

Contra-indications:

Patients with known sensitivity to sodium hyaluronate.

Warnings and Precautions:

SportVis™ should only be injected by a healthcare professional trained in the procedure.

SportVis™ must not be injected into blood vessels because Na-HA has the potential to occlude the vessels, which could result in embolism or infarction.
Do not inject into the soft tissue of patients if the area of the injection site is inflamed, infected or where there is evidence of acute or chronic skin disease.

Sodium hyaluronate is manufactured by fermentation of Streptococcus equi and rigorously purified. However, the healthcare professional should consider the immunological and other potential risks that can be associated with the injection of any biological material.

There is a risk of infection at the injection site as with any peri-articular procedure.

There is no evidence of the safety of SportVis™ in human pregnancy and lactation. Administration during pregnancy and lactation is at the discretion of the healthcare professional.

Needles should not be reused because SportVis™ may become turbid due to precipitation in the presence of cationic agents such as benzalkonium chloride or detergents residual in the needle following re-sterilisation.

Follow national or local guidelines for the safe use and disposal of needles. Obtain prompt medical attention if injury occurs.

Do not use if packaging has been damaged.

Adverse Reactions:

Mild erythema  should resolve with time.

Incompatibilities:

SportVis™ has not been tested for compatibility with other substances for peri-articular injection. Therefore the mixing or simultaneous administration with other peri-articular injectables is not recommended.

Storage:

Store between 2 degrees C and 25 degrees C.  Do not freeze.  Protect from light.
Do not use if sterile packaging has been damaged. 
Sterile product for single use only. 
Do not use after expiry date.