Hyalunronidase 1500 I.U. Powder For Solution For Injection/Infusion
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
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.
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.
Hyaluronidase should not 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. 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 Interaction with other medicinal 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 breastfed 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.
Effects on ability to drive and use machines
4.7
None known.
4.8 Undesirable effects
Oedema has been reported in association with hypodermoclysis. There have been rare reports of periorbital oedema occurring with the use of hyaluronidase in conjunction with local anaesthetics in ophthalmology; in most cases, the doses of hyaluronidase exceeded the licensed dose. Severe allergic reactions including anaphylaxis have been reported rarely. Local irritation, infection, bleeding and bruising occur rarely.
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 PARTICULARS
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. Furousemide, 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 an unused contents.
6.4 Special precautions for storage
Do not store above 25°C.
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 Special precautions for disposal
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(S)
Ireland PA 1339/11/1 UK PL 29831/0113 Malta MA 154/01701
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
April 2008
10 DATE OF REVISION OF THE TEXT
12/12/2014