Hyalase 1500 I.U. Powder for Solution for Injection / Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYALURONIDASE

Available from:

Wockhardt UK Limited

ATC code:

B06AA03

INN (International Name):

HYALURONIDASE

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

HYALURONIDASE 1500 international unit(s)/millilitre

Prescription type:

POM

Therapeutic area:

OTHER HEMATOLOGICAL AGENTS

Authorization status:

Authorised

Authorization date:

2006-08-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYALURONIDASE 1500 I.U. POWDER FOR SOLUTION FOR INJECTION/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 about whethe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hyalase®
1500
I.U.
Powder
for
Solution
for
Injection
/
Infusion
or
Hyaluronidase 1500 I.U. Powder for Solution for Injection / Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 1,500 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
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:
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