NexoBrid

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

proteolytic enzymes enriched in bromelain

Saatavilla:

MediWound Germany GmbH

ATC-koodi:

D03BA03

INN (Kansainvälinen yleisnimi):

concentrate of proteolytic enzymes enriched in bromelain

Terapeuttinen ryhmä:

Preparations for treatment of wounds and ulcers

Terapeuttinen alue:

Debridement

Käyttöaiheet:

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

Tuoteyhteenveto:

Revision: 15

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-12-18

Pakkausseloste

B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
NEXOBRID 2 G POWDER AND GEL FOR GEL
concentrate of proteolytic enzymes enriched in bromelain
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you or your child get any side effects, talk to your doctor. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What NexoBrid is and what it is used for
2.
What you need to know before NexoBrid is used
3.
How NexoBrid is used
4.
Possible side effects
5.
How NexoBrid is stored
6.
Contents of the pack and other information
1.
WHAT NEXOBRID IS AND WHAT IT IS USED FOR
WHAT NEXOBRID IS
NexoBrid contains a mixture of enzymes called “concentrate of
proteolytic enzymes enriched in
bromelain”, which is produced from an extract from the stem of the
pineapple plant.
WHAT NEXOBRID IS USED FOR
NexoBrid is used in adults, adolescents and children of all ages to
remove burnt tissue from deep or
partially deep burn wounds of the skin.
Using NexoBrid may reduce the need for, or the extent of, surgical
removal of burnt tissue and/or skin
transplantation.
2.
WHAT YOU NEED TO KNOW BEFORE NEXOBRID IS USED
_ _
NEXOBRID MUST NOT BE USED:
-
if you or your child are allergic to bromelain
-
if you or your child are allergic to pineapples
-
if you or your child are allergic to papaya/papain
-
if you or your child are allergic to any of the other ingredients of
the powder or gel (listed in section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before NexoBrid is used if:
-
you or your child have a heart disease;
-
you or your child have diabetes;
-
you or your child have an active peptic ulcer in the stomach,
-
you or your child have a vascular disease (with vascular occlusion);
-
you or your child have enlarged veins in the area close to the burn;
-
you or your child have implant

Valmisteyhteenveto

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
_ _
1
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 or 5g 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 or 5g/55g
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 in all age groups for removal of eschar in
patients 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
_Adults _
2 g powder in 20 g gel is applied to 1 % Total Body Surface Area
(TBSA) that corresponds to
approximately 180 cm
2
of an adult with a layer thickness of 1.5 to 3 mm.
5g powder in 50 g gel is applied to 2.5 %
TBSA that corresponds to approximately 450 cm
2
of an adult,
with a gel layer thickness of 1.5 to 3 mm.
NexoBrid
should not be applied to more than 15% TBSA (see also section 4.4,
Coagulopathy).
_Paediatric population _
_Children and adolescents (from birth to 18 years of age) _
For paediatric patients aged 4-18 years old NexoBrid should not be
applied to more than 15% TBSA.
For paediatric patients aged 0-3 years old this medicine should not be
applied to more than 10% TBSA.
It should be left in contact with the burn wound 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.
2
Special populations
_Renal impairment _
_ _
Ther