VeraSeal solutions for sealant 10 mL (Human fibrinogen 80 mg/mL syringe 5 ml / Human thrombin 500 IU/mL syringe 5 ml)

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

human thrombin, Quantity: 500 IU/mL

Dostopno od:

Grifols Australia Pty Ltd

Farmacevtska oblika:

Application

Sestava:

Excipient Ingredients:

Pot uporabe:

Epilesional Introduced onto or around a localised lesion

Enote v paketu:

The pack sizes are 2 mL, 4 mL, 6 mL, 10 mL (total volume)

Tip zastaranja:

exempt from scheduling - Appendix A; prescription medicine

Terapevtske indikacije:

VeraSeal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.

Povzetek izdelek:

Visual Identification: clear or slightly opalescent and colourless or pale yellow; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below minus 18 degrees Celsius (deep freeze)

Status dovoljenje:

Registered

Datum dovoljenje:

2021-11-03

Navodilo za uporabo

VeraSeal
TM
1
VERASEAL
TM
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING VERASEAL?
VeraSeal contains the active ingredients human fibrinogen and human
thrombin. VeraSeal is used as a sealant during surgical
operations in adults. It is applied to the surface of bleeding tissue
to reduce bleeding during and after the operation when
standard surgical techniques are not enough.
For more information, see Section 1. Why am I using VeraSeal? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM TREATED WITH VERASEAL?
Do not use if you have ever had an allergic reaction to VeraSeal or
any of the ingredients listed at the end of the CMI.
VeraSeal must not be applied inside blood vessels.
VeraSeal must not be used to treat severe or rapid bleeding from an
artery.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
treated with VeraSeal? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VeraSeal and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS VERASEAL USED?
•
Your surgeon will decide how much VeraSeal is needed. Your surgeon
will apply an amount of VeraSeal that is just enough
to form a thin, even layer.Detailed instruccions for your surgeon or
nurse on how to prepare VeraSeal are included in the
Product Information.
More instructions can be found in Section 4. How is VeraSeal used? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VERASEAL?
For more information, s

Lastnosti izdelka

1
▼
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
VERASEAL
™ SOLUTIONS FOR SEALANT (HUMAN FIBRINOGEN,
HUMAN THROMBIN)
WARNINGS
•
Life-threatening thromboembolic complications may occur if VeraSeal is
administered
intravascularly (see section 4.4.).
•
VeraSeal is made from pooled human plasma which may contain infectious
agents, such
as viruses, that can cause disease (see section 4.4.).
1
NAME OF THE MEDICINE
Human fibrinogen, Human thrombin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Component 1:
Human fibrinogen
80 mg/mL
Component 2:
Human thrombin
500 IU/mL
For the full list of excipients, see Section 6.1 List of excipients.
VeraSeal is a two-component fibrin sealant made of frozen sterile
solutions of human fibrinogen
and human thrombin produced from the plasma of human donors.
Cohn’s plasma fractionation method is used to obtain Fraction I,
which is the starting material
for the production of fibrinogen, and the prothrombin complex isolated
from supernatant of
Fraction I, which is the starting material for the production of
thrombin. The purification
process of fibrinogen includes solvent/detergent treatment, three
glycine precipitation steps,
and double nanofiltration using 35-nm and 20-nm filters. The
purification process of thrombin
includes solvent/detergent treatment, ion exchange chromatography, and
double nanofiltration
through 15-nm filters. After nanofiltration, the fibrinogen and
thrombin solutions are
formulated, sterile filtered, aseptically filled in syringes,
packaged, sterilized, and frozen.
2
3
PHARMACEUTICAL FORM
Solutions for sealant.
Frozen solutions. After thawing, the solutions are clear or slightly
opalescent and colourless or
pale yellow.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
VeraSeal is used as supportive treatment in adults where s