HYALASE Powder for solution for injection/infusion Ref.[5073] Active ingredients: Hyaluronidase

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).

None stated.

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.

None known.

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.

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.