NEXOBRID 5 G POWDER AND 50 G GEL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CONCENTRATE OF PROTEOLYTIC ENZYMES ENRICHED IN BROMELAIN

Available from:

MEDIWOUND LTD.

ATC code:

B06AA11

Pharmaceutical form:

POWDER AND GEL

Composition:

CONCENTRATE OF PROTEOLYTIC ENZYMES ENRICHED IN BROMELAIN 5 G

Administration route:

TOPICAL

Prescription type:

Required

Manufactured by:

MEDIWOUND LTD, ISRAEL

Therapeutic area:

BROMELAINS

Therapeutic indications:

NexoBrid is indicated for removal of eschar in adults with deep partial- andfull-thickness thermal burns.

Authorization date:

2019-06-30

Patient Information leaflet

MediWound Ltd. 42 Yarkon St.,Northern Industrial Area 81227 Yavne,
Israel
Tel: [phone] Web: www.mediwound.com Fax: [phone]
יראת
ך
:
05/06/2019
יאופרה תווצל העדוה
:ןודנה
ל"נה םירישכתה לש אפורל ןולעל ופסונש
תורמחה
:
םש
ה
רישכת
רפסמו
םושירה
:
NEXOBRID 2 G POWDER AND 20 G GEL דירבוסקנ
2
ו הקבא 'רג
20
ל'ג 'רג
152-30-33685-00
NEXOBRID 5 G POWDER AND 50 G GEL דירבוסקנ
5
ו הקבא 'רג
50
ל'ג 'רג
152-31-33686-00
:היוותה
NexoBrid is indicated for removal of eschar in adults with deep
partial- and
full-thickness thermal burns.
:בכרה
Concentrate of proteolytic enzymes enriched in Bromelain.
םש
לעב
םושירה :
MEDIWOUND LTD, ISRAEL
–
דנווידמ
מ"עב לארשי
MediWound Ltd. 42 Yarkon St.,Northern Industrial Area 81227 Yavne,
Israel
Tel: [phone] Web: www.mediwound.com Fax: [phone]
:םייונישה טוריפו תוהמ
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
POSOLOGY,
DOSAGE &
ADMINISTRATION
_Renal impairment _
There is no information on the use of
NexoBrid in patients with renal
impairment
_ _
_ _
_Hepatic impairment _
There is no information on the use of
NexoBrid in patients with hepatic
impairment.
_Preparation of patient and wound area_
To prevent possible irritation of abraded
skin by inadvertent contact with
NexoBrid, such areas can be protected
by a layer of a sterile fatty ointment.
_Renal impairment _
There is no information on the use of
NexoBrid in patients with renal impairment.
THESE PATIENTS SHOULD BE CAREFULLY
MONITORED.
_Hepatic impairment _
There is no information on the use of
NexoBrid in patients with hepatic
impairment.
THESE PATIENTS SHOULD BE
CAREFULLY MONITORED.
_Preparation of patient and wound area_
To prevent possible irritation of abraded skin
BY INADVERTENT CONTACT WITH NEXOBRID AND
POSSIBLE BLEEDING FROM THE WOUND BED,
ACUTE WOUND AREAS SUCH AS L
ACERATIONS OR
ESCHAROTOMY INCISIONS SHOULD BE PROTECTED
BY A LAYER OF

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
NexoBrid 2 g powder and gel for gel/ NexoBrid 5 g powder and
gel for gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 2 g of concentrate of proteolytic enzymes
enriched in bromelain, corresponding to 0.09 g/g concentrate of
proteolytic enzymes enriched in bromelain after mixing (or 2 g/22
g gel).
One vial contains 5 g of concentrate of proteolytic enzymes
enriched in bromelain, corresponding to 0.09 g/g concentrate of
proteolytic enzymes enriched in bromelain after mixing (or 5 g/55
g gel).
The proteolytic enzymes are a mixture of enzymes from the stem of
Ananas comosus (pineapple plant).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder and gel for gel.
The powder is off-white to light tan. The gel is clear and colourless.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NexoBrid is indicated for removal of eschar in adults with deep
partial- and full-thickness thermal burns.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should only be applied by trained healthcare
professionals in specialist burn centres.
POSOLOGY
2g powder in 20 g gel is applied to a burn wound area of 1 % Total
Body Surface Area (TBSA) of an adult, with a gel layer thickness
of 1.5 to 3 mm.
5g powder in 50 g gel is applied to a burn wound area of 2.5
% Total Body Surface Area (TBSA) of an adult, with a gel layer
thickness of 1.5 to 3 mm.
The gel should not be applied to more than 15% TBSA (see also
section 4.4, Coagulopathy).
It should be left in contact with the burn for a duration of 4 hours.
There is very limited information on the use of this medicinal
product on areas where eschar remained after the first application.
A second and subsequent application is not recommended.
SPECIAL POPULATIONS
RENAL IMPAIRMENT
There is no information on the use in patients with renal impairment.
These patients should be carefully monitored.
HEPATIC IMPAIRMENT
There is no information on the use in patients with hepatic
impairment. These patients should be