Hyalunronidase 1500 I.U. Powder For Solution For Injection/Infusion
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.
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SUMMARY OF PRODUCT CHARACTERISTICS
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. 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 Hyalase® dissolved directly in the solution to be injected.
With local anaesthetics: 1500iu Hyalase® is mixed with the quantity of local anaesthetic solution to be used. In ophthalmology, 15iu of Hyalase® per ml is recommended.
Extravasation: Where dispersal rather than localisation is indicated, 1500iu of Hyalase® 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 Hyalase® 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 Hyalase® is to be combined.
4.3 Contraindications
Hypersensitivity to hyaluronidase.
Not to be used for intravenous injections.
Not to be used to reduce the swelling of bites or stings or at sites where infection or malignancy is present.
Not to be used for anaesthetic procedures in cases of unexplained premature labour.
4.4 Special Warnings and Precautions for Use
Do not apply directly to the cornea.
Not to be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.
Solutions for subcutaneous administration should be isotonic with extracellular fluid.
Hyalase® is physically compatible with the commonly used infusion fluids. Use in hypodermoclysis has been reported with 0.9% sodium chloride, 0.18% sodium chloride with 4% glucose, 0.45% sodium chloride with 2.5% glucose and 5% glucose.
Potassium 34mmol/litre has been administered by hypodermoclysis in isotonic glucose or saline with 1500I.U/litre hyaluronidase.
Electrolyte-free fluids are less preferable than those containing electrolytes and should not be given too rapidly. Hyalase® has also been mixed with morphine, diamorphine, hydromorphone, chlorpromazine, metoclopramide, promazine, dexamethasone, local anaesthetics and adrenaline (see 6.2. Incompatibilities).
4.5 Interactions with Other Medicaments products and Other Forms of Interaction
None stated.
4.6 Pregnancy and Lactation
It is not known whether the drug enters breast milk although it is unlikely to harm the breast-fed infant. Caution should be exercised in administering it to nursing mothers.
There is no evidence on the drug’s safety in human pregnancy nor is there evidence from animal work that it is free from hazard. Avoid use in pregnancy unless there is no safer alternative.
4.7 Effects on Ability to Drive and to Use Machines
None known.
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 Malta:
ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3,
Rue D’Argens, GZR-1368 Gzira
Website: www.medicinesauthority.gov.mt; e-mail: postlicensing.medicinesauthority@gov.mt 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
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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: December 2014
104295-5 Twockhardt
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4.8 Undesirable Effects
Oedema has been reported in association with hypodermoclysis. Allergic reactions have included rare reports of periorbital oedema occurring with the use of hyaluronidase in conjunction with local anaesthetics in ophthalmology. Severe allergic reactions including anaphylaxis have been reported rarely. Local irritation, infection, bleeding and bruising occur rarely.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
United Kingdom:
Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard Malta:
ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3,
Rue D’Argens, GZR-1368 Gzira Website: www.medicinesauthority.gov.mt; e-mail: postlicensing.medicinesauthority@gov.mt
4.9 Overdose
No cases of overdose appear to have been reported.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Hyaluronidase is an enzyme that has a temporary and reversible depolymerising effect on the polysaccharide hyaluronic acid, which is present in the intercellular matrix of connective tissue.
5.2 Pharmacokinetic Properties
Not applicable
5.3 Preclinical Safety Data
There are no additional pre-clinical data of relevance to the prescriber.
6. Pharmaceutical Properties
6.1 List of Excipients
None.
6.2 Incompatibilities
Physical incompatibility has been reported with heparin and adrenaline, although in clinical practice very low concentrations of adrenaline are combined with hyaluronidase without problems. Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase.
6.3 Shelf Life
Unopened: 3 years.
Once opened use immediately and discard any unused contents.
6.4 Special Precautions for Storage
Do not store above 25oC.
6.5 Nature and Contents of Container
1ml neutral glass ampoule containing a plug of white freeze-dried powder.
Pack size: 10 ampoules.
6.6 Instructions for Use/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.
7. Marketing Authorisation Holder
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF
8. Marketing Authorisation Number
UK PL 29831/0113
Malta MA 154/01701
9. Date of First Authorisation/Renewal of Authorisation
April 2008
10. Date of Revision of Text
104295-5
^WOCKHARDT