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

Patient Leaflet Updated 30-Mar-2023 | Wockhardt UK Ltd

PACKAGE LEAFLET: INFORMATION FOR THE USER

HYALASE® 1500 I.U. Powder for Solution for Injection/Infusion

Hyaluronidase

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 Hyalase® should not be shared with other patients.

In this leaflet:

1. What Hyalase® is and what it is used for
2. Before you are given Hyalase®
3. How Hyalase® should be given
4. Possible side-effects
5. How to store Hyalase®
6. Further information

1. WHAT HYALASE® IS AND WHAT IT IS USED FOR

The name of your medicine is Hyalase®. The active ingredient in Hyalase® is hyaluronidase.

Hyalase® 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.

Hyalase® is also used to enable excess fluids and blood in the tissues to be more easily reabsorbed.

2. BEFORE YOU ARE GIVEN HYALASE®

You should not be given Hyalase®:

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.

Hyalase® should not be administered by Intravenous Injection.

Hyalase® 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 whether this medicine should be administered then talk to your doctor or nurse before it is given to you.

Pregnancy and breast-feeding

You should let your doctor know if you are pregnant, wish to become pregnant, or are breast-feeding before Hyalase® is administered.

Driving and using machines

Hyalase® has not been reported to affect ability to drive or operate machines.

3. HOW HYALASE® SHOULD BE GIVEN

The usual dose for Hyalase® is 1500 International Units (iu)
Hyalase® for injection is dissolved in water for injections, normal saline or the solution to be injected
Your doctor or nurse will give the injection either into a muscle (intramuscular) or under the skin (subcutaneous)
For an injection given continuously under the skin (subcutaneous infusion), the injection is injected into the infusion tubing.

Your doctor will decide the dose and route of administration that is best for you. If you do not understand what you are being given, or are in any doubt, ask your doctor or nurse.

If you think you have been given too much Hyalase®

Your doctor will decide which dose is best for you. If you think too much medicine has been given to you contact your doctor or nurse.

If you think you have missed a dose

If you think that an injection has been missed, speak to you doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Hyalase® may cause side-effects in some patients.

Very rarely, severe allergic reactions to Hyalase® may occur, with difficulty breathing, rapid pulse and profuse sweating. If you develop any of these symptoms, contact your doctor or nurse immediately
Hyalase® has on rare occasions caused allergic reactions (rash, itching, swelling around the eyes) or soreness, bleeding or bruising at the injection site
Local swelling may occur when Hyalase® is used with subcutaneous infusions.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below:

United Kingdom:

Yellow Card Scheme

Website: http://www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE HYALASE®

Keep out of the sight and reach of children

Hyalase® should not be stored above 25°C. Store the ampoules in the package container in which they were dispensed
The injection must be used immediately after preparation. Any portion of the contents not used at once should be discarded
Hyalase® should not be given if the powder shows signs of discolouration (it should be white)
Hyalase® should not be used after the expiry date on the label. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

What Hyalase® looks like and contents of the pack

Hyalase® is a sterile, freeze-dried powder in 1 ml neutral glass ampoule, containing 1500 international units of the active ingredient (hyaluronidase).

The registered pack size is 10 x 1ml glass ampoules.

Other formats

To listen to or request a copy of this information in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product Name Reference Number

Hyalase® for Injection/Infusion 1500iu/ml PL 29831/0113

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:

CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Leaflet prepared: January 2022

104295/6

Company Contact Details

Wockhardt UK Ltd

Address

Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF

Fax

+44 (0)1978 661 702

Medical Information e-mail

[email protected]

Telephone

+44 (0)1978 661 261

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