Hyalase 1500 I.U. powder for solution for injection infusion

Hyalase 1500 I.U. powder for solution for injection infusion

HYALASE 1500 I.U. POWDER SOLUTION FOR INJECTION/INFUSION . Hyalase 1500A white, sterile freeze-dried powder for solution for injection or infusion. Local anaesthetics and subcutaneous infusions and to promote resorption of excess fluids and blood in the tissues.Hyalase 1500 I.U. powder 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.

Posology and method of administration

Posology and method of administration

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.

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.

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 1500 I.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).

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard