.Hyaluronidase (Ovine) Strength: 1500IU per vial
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
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 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 Hyaluronidase is administered.
Driving and using machines
Hyaluronidase has not been reported to affect ability to drive or operate machines. Hyaluronidase (Ovine) Strength: 1500IU per vial
3. HOW HYALURONIDASE SHOULD BE GIVEN
• The usual dose for Hyaluronidase is 1500 International Units (iu)
• Hyaluronidase 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 Hyaluronidase
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, Hyaluronidase may cause side-effects in some patients.
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of Proprietary Medicinal Product
Hyaluronidase 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
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 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.
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
Solutions for subcutaneous administration should be isotonic with extracellular fluid.
Hyaluronidase 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. Hyaluronidase 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
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
4.7 Effects on Ability to Drive and to Use Machines
Measure bar should be 150mm at 100% scale
Min. Point Size
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• Hyaluronidase (Ovine) Strength: 1500IU per vial