Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
HYALURONIDASE
PROPHARM LTD
B06AA03
POWDER FOR SOLUTION FOR INJECTION
HYALURONIDASE 1500 IU/AMPOULE
I.M, S.C
Required
CP PHARMACEUTICALS LTD, U.K.
HYALURONIDASE
HYALURONIDASE
To enhance permeation of subcutaneous or intramuscular injections, local anesthetics and subcutaneous infusions to promote resorption of excess fluids and blood in the tissues .
2023-06-30
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF PROPRIETARY MEDICINAL PRODUCT Hyalase ® powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule contains 1500 international units of Hyaluronidase. For excipients see section 6.1. 3. PHARMACEUTICAL FORM A white, sterile freeze-dried powder for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hyalase ® 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 Hyalase ® 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 Hyalase ® dissolved directly in the solution to be injected. WITH LOCAL ANAESTHETICS: 1500iu Hyalase ® is mixed with the quantity of local anaesthetic solution to be used. In ophthalmology, 15iu of Hyalase ® per ml is recommended. EXTRAVASATION: Where dispersal rather than localisation is indicated, 1500iu of Hyalase ® 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 Hyalase ® dissolved in 1ml water for injections or normal saline infiltrated into the affected area. Immediately before use dissolve the freeze-dried powder in approximately 1 ml of water for injections or directly Soma hati kamili