EVICEL solutions for fibrin sealant 4mL (thrombin 2mL, fibrinogen 2mL)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

human thrombin, Quantity: 1600 IU

Available from:

Johnson & Johnson Medical Pty Ltd

INN (International Name):

Factor XIII,Fibrinogen,human thrombin

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: water for injections; mannitol; sodium acetate; Albumin; calcium chloride dihydrate; tributyl phosphate; octoxinol 9

Administration route:

Epilesional Introduced onto or around a localised lesion

Units in package:

4mL (2mL thrombin solution + 2 mL fibrinogen solution)

Prescription type:

exempt from scheduling - Appendix A; prescription medicine

Therapeutic indications:

? as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. ? as suture support for haemostasis in large vessel vascular surgery. ? for suture line sealing in dura mater closure.

Product summary:

Visual Identification: Clear or slightly opalescent solutions; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below minus 18 degrees Celsius (deep freeze)

Authorization status:

Registered

Authorization date:

2012-10-22

Patient Information leaflet

CONSUMER
MEDICINE INFORMATION
EVICEL
®
Solutions for Fibrin Sealant
(Human
Thrombin, Human Fibrinogen and Factor
XIII)
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about EVICEL® Solutions
for Fibrin Sealant. It does not contain
all of the available information. All
medicines have risks and benefits.
Your doctor has weighed the risks
against the benefits for you by using
EVICEL® Solutions for Fibrin Sealant.
It does not take the place of talking to
your doctor or pharmacist. If you have
any concerns about having this
medicine, ask your doctor or
pharmacist.
Read this leaflet carefully before you
start using this medicine
Keep this leaflet. You may need to
read it again.
WHAT IS EVICEL® AND WHAT IS IT
USED FOR?
EVICEL® is a Fibrin Sealant which is
supplied in Australia as a package
containing two separate vials, each
containing 1 mL, 2 mL or 5 mL of
solution Human Fibrinogen and
Human Thrombin, respectively.
An application device and appropriate
accessory tips are supplied separately.
EVICEL® is applied during surgical
operations to reduce bleeding and
oozing during and after the operation.
EVICEL® is also used to seal tissues
during neurosurgery. It is dripped or
sprayed onto cut tissue where it forms
a thin layer that seals the tissue and/or
stops bleeding.
EVICEL® can also be used in blood
vessel surgery, in surgery taking place
in the area between the bowels and
the posterior abdominal wall, and in
brain surgery.
HOW DOES EVICEL® WORK?
Fibrinogen is a concentrate of clottable
protein and thrombin is an enzyme that
causes clottable protein to coalesce.
Thus, when the two components are
mixed together they clot instantly.
BEFORE YOU ARE GIVEN THE EVICEL®
EVICEL® SHOULD NOT BE GIVEN TO
YOU IF
•
You are hypersensitive (allergic) to
products made from human blood
or to any of the other ingredients of
EVICEL®.
Signs of such reactions include
hives, rash, tightness of the chest,
wheezing, drop in blood pressure
and breathing difficulties. If these
symptoms occur, the administration

Summary of Product characteristics

1
20210317
AUSTRALIAN
PRODUCT
INFORMATION
–
EVICEL
®
SOLUTIONS
FOR
FIBRIN
SEALANT
(HUMAN
THROMBIN,
HUMAN
FIBRINOGEN
AND,
FACTOR XIII)
1
NAME OF THE MEDICINE
Human Thrombin, Human Fibrinogen and Factor XIII.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Fibrinogen Solution _– 1mL contains Fibrinogen 80 to 120 mg/mL
total protein (clottable protein
(human) 50 – 90 mg).
_Thrombin Solution_ – 1mL contains 800 to 1,200 IU Thrombin (human)
_ _
_Note._ 1 IU (international unit) Thrombin (human) is defined as the
activity contained in 0.0853mg
of the first international standard of human thrombin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solutions for fibrin sealant.
The Fibrinogen and Thrombin solutions appear as white to slightly
yellowish opaque masses
when frozen, and as clear to slightly opalescent and colourless to
slightly yellowish solutions
when thawed.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
EVICEL
®
is used as supportive treatment in surgery where standard surgical
techniques are
insufficient, for improvement of haemostasis.
EVICEL
®
is also indicated as suture support for haemostasis in large vessel
vascular surgery.
EVICEL
®
is indicated for suture line sealing in dura mater closure.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The volume of EVICEL
®
to be applied and the frequency of application should always be
oriented
towards 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.
2
20210317
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 dural sealing in
neurosurgery, doses of up to 8 mL were used, whereas in
retroperitoneal or intra-abdominal
surgery the individual dosage used was up to 10 mL. For some
procedures (