HYALASE Powder for solution for injection/infusion (2015)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | Wockhardt UK Ltd |
---|---|
Διεύθυνση | Ash Road North, Wrexham, LL13 9UF, UK |
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Περιεχόμενα
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
Qualitative and quantitative composition
Each ampoule contains 1,500 international units of Hyaluronidase. For excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection/infusion. A white, sterile freeze-dried powder for solution for injection or infusion.
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. ...
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 ...
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 ...
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 ...
Interaction with other medicinal products and other forms of interaction
None stated.
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 ...
Effects on ability to drive and use machines
None known.
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 ...
Overdose
No cases of overdose appear to have been reported.
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.
Pharmacokinetic properties
Not applicable.
Preclinical safety data
There are no additional pre-clinical data of relevance to the prescriber.
List of excipients
None.
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, ...
Shelf life
Unopened: 3 years. Once opened use immediately and discard any unused contents.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
1ml neutral glass ampoule containing a plug of white freeze-dried powder. Pack size: 10 ampoules.
Special precautions for disposal and other 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 ...
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF
Marketing authorization number(s)
UK: PL 29831/0113 Malta: MA 154/01701
Date of first authorization / renewal of the authorization
5<sup>th</sup> February 1993
Date of revision of the text
19<sup>th</sup> February 2015
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