HYALASE Powder for solution for injection/infusion Ref.[5073] Active ingredients: Hyaluronidase

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF

Therapeutic indications

Hyaluronidase 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.

Posology and method of administration

Adults, children and the elderly

With subcutaneous infusion (hypodermoclysis): 1500iu of Hyaluronidase 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. 1500iu 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.

With subcutaneous or intramuscular injections: 1500iu of Hyaluronidase dissolved directly in the solution to be injected.

With local anaesthetics: 1500iu Hyaluronidase is mixed with the quantity of local anaesthetic solution to be used. In ophthalmology, 15iu of Hyaluronidase per ml is recommended.

Extravasation: Where dispersal rather than localisation is indicated, 1500iu of Hyaluronidase in 1ml water for injections or normal saline infiltrated into the affected area as soon as possible after the extravasation is noted.

Haematoma: 1500iu of Hyaluronidase dissolved in 1ml water for injections or normal saline infiltrated into the affected area.

Immediately before use dissolve the freeze-dried powder in approximately 1ml of water for injections or directly in the solution with which Hyaluronidase is to be combined.

Overdose

No cases of overdose appear to have been reported.

Shelf life

Unopened: 3 years.

Once opened use immediately and discard any unused contents.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

1ml neutral glass ampoule containing a plug of white freeze-dried powder.

Pack size: 10 ampoules.

Special precautions for disposal and other handling

The solution should be used immediately after preparation. The appearance of the solution is clear and not more than faintly yellow.

For detailed instructions on preparation and administration, see section 4.2.

For single use only. Discard any unused contents.

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