Storage and reconstitution

Storage and reconstitution

It is recommended that hyaluronidase should be stored at cool temperatures (2-8oC) as this guarantees the quality of the product over a long period. If storage is at room temperature (25oC), the stability is only guaranteed for 12 months.

Hyalase® may be reconstituted with either saline or water for injection. Reconstitution with saline tends to produce less stinging so is recommended. Although local anaesthetics may be used to reconstitute the product, as the enzymatic action of hyaluronidase can be affected by pH, care should be made with diluents. Hyaluronidase is indicated to improve permeation of subcutaneous products so the injection of local anaesthetic as a diluent may lead to wider spread and increased systemic absorption. For this reason, this guidance does not advocate the addition of local anaesthetic.

Reconstitution instructions: Open a 10ml ampoule of saline and add 1ml of saline to the opened ampoule of Hyalase®, ensure the powder is fully dissolved (draw up and expel the syringe a couple of times to ensure complete mixing). Aspirate the 1ml of saline with the reconstituted Hyalase® and re-introduce it into the ampoule of saline. Agitate the ampoule to ensure the Hyalase® is mixed throughout the whole volume of saline. This now gives a concentration of 150 Units/ml. The reconstituted solution can now be drawn up in a 0.3ml or 0.5ml syringe with a 27G or 30G needle. Each 0.01ml graduation represents 1.5 Units

 

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