HYALASE

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

HYALURONIDASE

Mevcut itibaren:

PROPHARM LTD

ATC kodu:

B06AA03

Farmasötik formu:

POWDER FOR SOLUTION FOR INJECTION

Kompozisyon:

HYALURONIDASE 1500 IU/AMPOULE

Uygulama yolu:

I.M, S.C

Reçete türü:

Required

Tarafından üretildi:

CP PHARMACEUTICALS LTD, U.K.

Terapötik grubu:

HYALURONIDASE

Terapötik alanı:

HYALURONIDASE

Terapötik endikasyonlar:

To enhance permeation of subcutaneous or intramuscular injections, local anesthetics and subcutaneous infusions to promote resorption of excess fluids and blood in the tissues .

Yetkilendirme tarihi:

2023-06-30

Ürün özellikleri

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