TACHOSIL human fibrinogen 5.5mg/square cm and human thrombin 2.0IU/square cm medicated sponge blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

human thrombin, Quantity: 2 IU/cm2; Fibrinogen, Quantity: 5.5 mg/cm2

Available from:

KSJ Pharmatech

INN (International Name):

Fibrinogen,human thrombin

Pharmaceutical form:

sponge, medicated

Composition:

Excipient Ingredients: sodium chloride; riboflavin; Collagen; sodium citrate dihydrate; arginine hydrochloride; Albumin

Administration route:

Topical

Units in package:

2 of 4.8cm x 4.8cm, 5 of 3.0cm x 2.5cm, 1 of 3.0cm x 2.5cm, 1 of 9.5cm x 4.8cm

Prescription type:

exempt from scheduling - Appendix A; prescription medicine

Therapeutic indications:

? TachoSil? is indicated as an adjunct to haemostasis during surgery when control of bleeding by standard surgical techniques is ineffective or impractical.

Product summary:

Visual Identification: off white patch marked by a yellow colour on the active side; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-03-22

Patient Information leaflet

TACHOSIL
®
MEDICATED
SPONGE
_fibrinogen and human thrombin_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TachoSil. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
this medicine.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having TachoSil
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TACHOSIL IS USED
FOR
This medicine is used during surgery
to stop local bleeding (haemostasis).
This medicine contains the two
active ingredients fibrinogen and
human thrombin, which are proteins
normally found in the blood.
When the sponge comes into contact
with fluids (such as blood, lymph or
saline solution) the fibrinogen and
the human thrombin are activated
and form a fibrin network.
This means that the sponge sticks to
the tissue surface, the blood
coagulates and the tissue is sealed.
In the body, TachoSil will dissolve
and disappear completely.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN RECOMMENDED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is not enough information to
recommend the use of this medicine
for children under the age of 18
years.
BEFORE YOU RECEIVE
TACHOSIL
_WHEN YOU MUST NOT HAVE IT_
DO NOT TAKE TACHOSIL IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
fibrinogen or human thrombin
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction includ

Summary of Product characteristics

TACHOSIL V6 (CCDS V3)
Page 1
AUSTRALIAN PRODUCT INFORMATION
TACHOSIL
® MEDICATED SPONGE
(FIBRINOGEN 5.5MG/ SQUARE CM AND HUMAN THROMBIN
2.0IU/SQUARE CM)
1.
NAME OF THE MEDICINE
fibrinogen and human thrombin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TachoSil sponge contains approximately 5.5 mg of fibrinogen and
2.0 IU of human
thrombin per cm
2
as the active ingredients.
Other inactive ingredients include riboflavine, collagen, albumin,
sodium chloride, sodium
citrate dihydrate and arginine hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
TachoSil is a biodegradable, highly flexible, hygroscopic surgical
medicated sponge. The
active side of the sponge, which is coated with fibrinogen and human
thrombin, is marked by
a yellow colour.
TachoSil is available in three presentations, which differ in the size
of the sponge, but not in
the composition of the sponge and the coating (see ‘Nature and
Contents of Container’).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TachoSil is indicated as an adjunct to haemostasis during surgery when
control of bleeding
by standard surgical techniques is ineffective or impractical.
4.2
DOSE AND METHOD OF ADMINISTRATION
The use of TachoSil is restricted to experienced surgeons.
TachoSil should not be used intravascularly (see
‘Contraindications’). For more information on
situations where TachoSil should not be used, see ‘Special Warnings
and Precautions for
use’.
The number of TachoSil sponges to be applied should always be
orientated towards the
underlying clinical need for the patient and should be governed by the
size of the wound area.
Application of TachoSil must be individualised by the treating
surgeon. In clinical trials, the
individual dosages have typically ranged from 1 to 2 sponges (9.5 cm x
4.8 cm), however
application of up to 7 sponges has been reported. For smaller wounds,
e.g. in minimal invasive
surgery, the smaller sized sponges (4.8 cm x 4.8 cm or 3.0 cm x 2.5
cm) are recommended.
Se