Hyaluronidase 1500 I.U. Powder for Solution for Injection or Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hyaluronidase

Available from:

Pinewood Laboratories Ltd

ATC code:

B06AA; B06AA03

INN (International Name):

Hyaluronidase

Dosage:

1500 international unit(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

Enzymes; hyaluronidase

Authorization status:

Marketed

Authorization date:

1984-03-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYALURONIDASE 1500 I.U. POWDER FOR SOLUTION FOR INJECTION OR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again while you are
receiving your treatment.

If you have any further questions, please ask your doctor or nurse.

This medicine has been prescribed for you. The contents of your
ampoule of
Hyaluronidase should not be shared with other patients.
IN THIS LEAFLET:
1.
What Hyaluronidase is and what it is used for
2.
Before you are given Hyaluronidase
3.
How Hyaluronidase should be given
4.
Possible side-effects
5.
How to store Hyaluronidase
6.
Further information
1.
WHAT HYALURONIDASE IS AND WHAT IT IS USED FOR
The name of your medicine is Hyaluronidase 1500 I.U. Powder for
Solution for Injection or
Infusion. The active ingredient in Hyaluronidase 1500 I.U. Powder for
Solution for Injection
or Infusion is hyaluronidase.
Hyaluronidase is an enzyme, a natural substance that activates
processes in the body. It is
used to temporarily break down the natural barriers in the body
tissues so that injections or
fluids injected under the skin or into muscle are more easily spread
and absorbed.
Hyaluronidase is also used to enable excess fluids and blood in the
tissues to be more easily
reabsorbed.
2.
BEFORE YOU ARE GIVEN HYALURONIDASE
YOU SHOULD NOT BE GIVEN HYALURONIDASE:

if you are known to be allergic to hyaluronidase

to reduce the swelling of bites or stings

at sites where infection or malignancy (cancerous growth) is present

directly onto the front of the eye

if you are in premature labour for which there is no explanation.
HYALURONIDASE SHOULD NOT BE ADMINISTERED BY INTRAVENOUS INJECTION.
Hyaluronidase should not be used to enhance the absorption and
dispersion of dopamine
and/or alpha agonist drugs. If you are taking dopamine or clonidine,
or any other alpha
agonist drug, please tell your doctor or nurse before you are given
this medicine.
If you have any doubts a

Summary of Product characteristics

Health Products Regulatory Authority
04 January 2021
CRN009YVK
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hyaluronidase 1500 I.U. Powder for Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 1,500 international units of Hyaluronidase.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion
A white, sterile, freeze-dried powder for solution for injection for
infusion.
4 CLINICAL PARTICULARS
4.1 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.
4.2 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:
1500 IU of hyaluronidase dissolved directly in 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 f