EVICEL solutions for fibrin sealant 10mL (thrombin 5mL, fibrinogen 5mL) vials

Main information

  • Trade name:
  • EVICEL solutions for fibrin sealant 10mL (thrombin 5mL, fibrinogen 5mL) vials
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EVICEL solutions for fibrin sealant 10mL (thrombin 5mL, fibrinogen 5mL) vials
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 181319
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

181319

EVICEL solutions for fibrin sealant 10mL (thrombin 5mL, fibrinogen 5mL) vials

ARTG entry for

Medicine Registered

Sponsor

Johnson & Johnson Medical Pty Ltd

Postal Address

PO Box 134,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

22/10/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. EVICEL solutions for fibrin sealant 10mL (thrombin 5mL, fibrinogen 5mL) vials

Product Type

Composite Pack

Effective date

9/05/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific 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.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store below minus 18

degrees Celsius (deep

freeze)

Not recorded

Store Upright

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

10mL (5mL thrombin solution + 5 mL fibrinogen solution)

exempt from scheduling - Appendix A; prescription medicine

Components

1. Fibrinogen

Dosage Form

Solution

Route of Administration

Epilesional Introduced onto or around a localised lesion

Visual Identification

Vial containing frozen solution, which is colourless or yellow when thawed

Active Ingredients

Factor XIII

10 IU

Fibrinogen

250 mg

2. Thrombin - human

Dosage Form

Solution

Route of Administration

Epilesional Introduced onto or around a localised lesion

Public Summary

Page 1 of

Produced at 22.05.2019 at 08:15:13 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Visual Identification

Clear or slightly opalescent solutions

Active Ingredients

human thrombin

4000 IU

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 22.05.2019 at 08:15:13 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

CONSUMER

MEDICINE INFORMATION

EVICEL

Solutions for Fibrin Sealant (human)

Fibrinogen, Thrombin (human)

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

has to be discontinued immediately.

The expiry date printed on the pack has

passed.

Take special care with EVICEL

When EVICEL

is applied during surgery, the

surgeon must ensure that it is only applied

onto the surface of tissue. EVICEL

must

not be injected into tissue or blood vessels

because it would cause clots which could

be fatal.

The use of EVICEL

has not been studied

in the following procedures, and there is

therefore no information to show that it

would be effective in these procedures:

- controlling bleeding in the stomach or

intestines by applying the product through

an endoscope (tube) - sealing the stomach

or the bowel in order to avoid leakage of

their contents after they have been sutured

- and in spinal procedures.

Life threatening air or gas embolism has

occurred with the use of spray devices

employing a pressure regulator to

administer EVICEL

. This event appears to

be related to the use of the spray device at

higher than recommended pressures and/or

in close proximity to the tissue surface. To

avoid the risk of potentially life threatening

air embolism EVICEL

should be sprayed

using pressurised CO2 gas only.

Nearby areas should be protected to make

sure that EVICEL

is only applied onto the

surface which is to be treated.

As with any product containing

proteins, allergic type hypersensitivity

reactions are possible. Signs of such

reactions include hives, rash, tightness of

the chest, wheezing, drop in blood pressure

and anaphylaxis. If these symptoms

occur, the administration has to be

discontinued immediately.

When medicines are made from human

blood or plasma, certain measures are

put into place to prevent infections being

passed on to patients. These include careful

selection of blood and plasma donors

to make sure those at risk of carrying

infections are excluded, and the testing

of each donation and pools of plasma for

signs of viruses/infections. Manufacturers

of these products also include steps in the

processing of the blood and plasma that can

inactivate or remove viruses. Despite these

measures, when medicines prepared from

human blood or plasma are administered,

the possibility of passing on infection

cannot be totally excluded. This also applies

to any unknown or emerging viruses, or

other types of infections. The measures

taken in the manufacture of Fibrinogen

and Thrombin are considered effective

for lipid coated viruses such as human

immunodeficiency virus (HIV), hepatitis B

virus and hepatitis C virus, and the non-

enveloped virus, hepatitis A. The measures

taken may be of limited value against

parvovirus B19. Parvovirus B19 infection

may be serious for pregnant women (foetal

infection) and for individuals whose immune

system is depressed or who have some

types of anaemia (e.g. sickle cell disease or

haemolytic anaemia).

The healthcare professionals will record

the name and batch number(s) of EVICEL

used in order to trace any possible infection

source.

You must tell your doctor if you

are taking or have recently taken any other

medicines, even those not prescribed.

You must tell your doctor, if you are

pregnant, planning to become pregnant or

breast feeding.

There is not enough information

available to know whether any particular

risks are associated with the use of

EVICEL

during pregnancy or whilst

breast-feeding. However, since EVICEL

is used during a surgical operation, if you

are pregnant or breast-feeding you should

discuss the overall risks of the operation

with your doctor.

Use in Children

Safety of use in children has not

been established.

How EVICEL

is given

The doctor treating you will administer

EVICEL

during surgery.

During your operation, your doctor will drip

or spray EVICEL

onto raw tissue, using an

application device. This device allows equal

amounts of the two components of EVICEL

to be administered at the same time, and

ensures that they mix evenly, which is

important for the sealant to have its

optimal effect.

The amount of EVICEL

that will be applied

depends on the surface area of tissue to be

treated during the operation. It will be dripped

onto the tissue in short bursts or sprayed in

very small amounts (0.1-0.2 ml), to produce

a thin, even layer. If application of a single

layer of EVICEL

does not completely stop the

bleeding, a second layer may be applied.

Case of overdose

EVICEL

is used only for local application and

thus the case of overdose is unlikely to occur.

Side effects

Like all medicines, EVICEL

can have side

effects, although not everybody gets them.

Art n°: 80FZ00MV-1

©Johnson & Johnson Limited 2016

Manufacturer:

Omrix Biopharmaceuticals Ltd.

MDA Blood Bank, Sheba Hospital, Ramat Gan, POB

888, Kiryat Ono 5510801, ISRAEL

This leaflet was last revised on

5 December 2016

Name and Address of Sponsor:

Australian Sponsor

Johnson & Johnson Medical Pty Ltd.

1-5 Khartoum Rd, North Ryde

NSW 2113, AUSTRALIA

New Zealand Sponsor

Johnson & Johnson (New Zealand) Ltd.

507 Mt Wellington Highway

Mt Wellington 1060

Auckland, NEW ZEALAND

Poison schedule of the medicine

Exempt from scheduling

Date of approval

22 October 2012

EVICEL

is a fibrin sealant. Fibrin sealants in

general may, in rare cases (1 to 10 patients

in 10,000), cause an allergic reaction. If you

experience an allergic reaction you might

have one or more of the following symptoms:

skin rash, hives or wheals (nettle-rash),

tightness of the chest, chills, flushing,

headache, low blood pressure, lethargy,

nausea, restlessness, increased heart rate,

tingling, vomiting, or wheezing. No allergic

reactions have so far been reported in

patients treated with EVICEL

There is also a theoretical possibility that you

could develop antibodies to the proteins in

EVICEL

, which could potentially interfere with

blood clotting.

If you feel unwell tell your doctor

immediately, even if your symptoms are

different from those just described.

If you notice any side effects not

mentioned in this leaflet, please inform

your doctor or pharmacist.

In clinical studies with EVICEL

some

undesired events occurred for which a

causal relation to the application of EVICEL

could not be excluded. After abdominal

surgery, some patients presented with an

abscess, and in vascular surgery, some cases

of an occluded graft occurred which had to

be reoperated.

Product Description

What is in EVICEL

The active ingredients are as follows:

Component 1: Fibrinogen

(50 - 90 mg/ml clottable protein)

Component 2: Thrombin - human

(800 - 1200 IU/ml)

Other ingredients are:

Component 1: arginine hydrochloride,

glycine, sodium chloride, sodium citrate,

calcium chloride and water for injections.

Component 2: calcium chloride, human

albumin, mannitol, sodium acetate and

water for injections.

EVICEL

in Australia is available in the

following sizes: 2 ml (2 x 1 ml vials), 4 ml (2 x

2 ml vials) and 10 ml (2 x 5 ml).

What EVICEL

looks like and contents

of the pack

EVICEL

is a Human Fibrin Sealant which is

supplied in Australia as a package containing

two separate vials, each containing 1 ml, 2

ml or 5 ml solution of Human Fibrinogen and

Human Thrombin, respectively.

An application device and appropriate

accessory tips are supplied separately.

Fibrinogen and Thrombin are packaged

together as two vials each containing the

same volume (1 ml, 2 ml or 5 ml in Australia)

of frozen, sterile solution, which is colourless

or yellowish when thawed. 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.

How to store EVICEL

Keep out of the reach and sight of children.

The vials must be stored in an upright

position. Store in freezer at or below - 18°C.

Do not use EVICEL

after the expiry date

which is stated on the label as well as on the

carton after EXP. The expiry date refers to the

last day of that month.

Keep the vials in the outer carton in order to

protect from light. After thawing, unopened

vials can be stored at 2-8°C and protected

from light, for up to 30 days. Do not refreeze.

The Fibrinogen and Thrombin components are

stable at room temperature for up to 24 hours

but once drawn up into the application device,

they must be used immediately.

Where can you get more

information?

You can get more information from your

doctor or pharmacist.