EVICEL HUMAN SURGICAL SEALANT

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

CALCIUM CHLORIDE; PROTEIN CLOTTABLE; THROMBIN

Доступна з:

OMRIX BIOPHARMACEUTICALS LTD, ISRAEL

Код атс:

B05BA10

Фармацевтична форма:

SOLUTION

Склад:

THROMBIN 800 - 1200 IU / 1 ML; CALCIUM CHLORIDE 5.6 - 6.20 MG / 1 ML; PROTEIN CLOTTABLE 50 - 90 MG / 1 ML

Адміністрація маршрут:

TOPICAL IN SURGERY

Тип рецепту:

Required

Виробник:

OMRIX BOPHARMACEUTICALS LTD, ISRAEL

Терапевтична група:

COMBINATIONS

Терапевтична области:

COMBINATIONS

Терапевтичні свідчення:

General haemostasis : Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. Efficacy has been demonstrated in liver surgery and orthopaedic surgery.Evicel ® is also indicated as suture support for haemostasis for suture line sealing in dura mater closure.

Дата Авторизація:

2023-01-31

інформаційний буклет

העדוה
העדוה
לע
לע
הרמחה
הרמחה
עדימ (
עדימ (
ןולעב )תוחיטב
ןולעב )תוחיטב
אפורל
אפורל
יראת
ך
24.2 .201 5
םש
רישכת
תילגנאב
רפסמו
םושירה
EVICEL HUMAN SURGICAL SEALANT 118 61 298 95
02
םש
לעב
םושירה
OMRIX BIOPHARMACEUTICALS LTD
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
NR
EVICEL
®
is also indicated as
suture
support
for
haemostasis for suture line
sealing in dura mater closure.
CONTRAINDICATI
ONS

EVICEL
®
must not be applied
intravascularly.

Hypersensitivity to the active
substances or any of the excipients

Spray application of EVICEL should
not be used in endoscopic
procedures. For laparoscopy, see
Section 4.4.

EVICEL
®
must
not
be
applied
intravascularly.

Hypersensitivity
to
the
active
substances or any of the excipients
listed in section 6.1.

Spray application of EVICEL should
not
be
used
in
endoscopic
procedures. For laparoscopy, see
Section 4.4.

EVICEL must not be used for sealing
the suture line in dura mater if there
are gaps of greater than 2 mm after
suturing.

EVICEL must not be used as a glue
for the fixation of dural patches.

EVICEL must not be used as a sealant
when the dura mater cannot be
sutured
POSOLOGY,
DOSAGE &
ADMINISTRATION
NR
….for suture line sealing in dura mater closure,
doses of up to 8 ml were used….
SPECIAL
WARNINGS AND
SPECIAL
PRECAUTIONS
FOR USE
……

Adequate data are not
available to support the use of this
product
in
tissue
gluing,
neurosurgery, application through
……

Adequate data are not
available to support the use of this
product
in
tissue
gluing,
neurosurgery, application through
an endoscope for treatment of
bleeding
or
in
gastrointestinal
anastomoses.
6.6
INSTRUCTIONS SPECIAL
PRECAUTIONS FOR USE, DISPOSAL AND
OTHER HANDLING AND DISPOSAL
SUR
GERY
SPR
AY
SET
TO
BE
USED
APP
LICAT
OR
TIPS
TO
BE
USED
PRES
SURE
R

Характеристики продукта

1
PHYSICIAN'S LEAFLET
EVICEL
HUMAN SURGICAL SEALANT
1.
NAME OF THE MEDICINAL PRODUCT
EVICEL
Human Surgical Sealant
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients are as follows:
1 ML VIAL
2 ML VIAL
5 ML VIAL
COMPONENT 1 (BAC2)
Human
clottable protein containing mainly
fibrinogen and fibronectin*
50 – 90 mg
100 – 180 mg
250 – 450 mg
COMPONENT 2 (THROMBIN)
Human Thrombin
800 – 1,200 IU
1,600 – 2,400 IU
4,000 – 6,000 IU
Calcium Chloride
5.6 – 6.2 mg
11.2 – 12.4 mg
28 – 31 mg
* Total quantity of protein is 80 - 120 mg/ml.
For a full list of excipients see Section 6.1.
3.
PHARMACEUTICAL FORM
Solutions for sealant.
Clear and colourless to slightly yellowish solutions.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
General haemostasis: EVICEL is used as supportive treatment in surgery
where standard
surgical techniques are insufficient, for improvement of haemostasis.
Efficacy has been demonstrated in liver surgery and orthopaedic
surgery (see Section 5.1).
EVICEL is also indicated as suture support for haemostasis for suture
line sealing in dura
mater closure.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
2
The use of EVICEL is restricted to experienced surgeons who have been
trained in the use of
EVICEL.
Posology
The volume of EVICEL to be applied and the frequency of application
should always be
oriented toward the underlying clinical needs of the patient.
The dose to be applied is governed by variables including, but not
limited to, the type of
surgical intervention, the size of the area and the mode of intended
application and the
number of applications.
Application of the product must be individualised by the treating
physician. In controlled
clinical trials in vascular surgery, the individual dosage used was up
to 4 ml; for suture line
sealing in dura mater closure, doses of up to 8 ml were used, whereas
in retroperitoneal or
intra-abdominal surgery the individual dosage used was up to 10 ml.
However, for some
procedures (e.g.,liver trauma) larger volumes may be required.