Hyalase 1500 I.U. Powder for Solution for Injection Infusion
1. Name of Proprietary Medicinal Product
Hyalase 1500 I.U. Powder for Solution for Injection/Infusion.
2. Qualitative and Quantitative Composition
Each ampoule contains 1500 international units of Hyaluronidase.
For excipients see section 6.1
3. Pharmaceutical Form
Powder for solution for injection/infusion.
A white, sterile freeze-dried powder for solution for injection or infusion.
4. Clinical Particulars
4.1 Therapeutic Indications
Hyalase® can be used to enhance permeation of subcutaneous or intramuscular
injections, local anaesthetics and subcutaneous infusions and to promote resorption of
excess fluids and blood in the tissues.
4.2 Posology and Method of Administration
Adults, children and the elderly:
With subcutaneous infusion (hypodermoclysis): 1500iu of Hyalase dissolved in
1ml of water for injections or normal saline injected into the site, before the infusion is
set up, or injected into the tubing of the infusion set, about 2cm back from the needle,
at the start of the infusion.
Hyalase 1500 I.U. is sufficient for administration of 500-1000ml of most
fluids. Refer to Section 4.4 for information on solutions for hypodermoclysis. Care should
be taken in young children and the elderly to control the speed and total volume of fluid
administered and to avoid over-hydration, especially in renal impairment.