TachoSil sealant matrix 4.8cm x 9.5cm

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Human fibrinogen; Thrombin

Tersedia dari:

Takeda UK Ltd

INN (Nama Internasional):

Human fibrinogen; Thrombin

Dosis:

5.5mg/1square cm ; 2unit/1square cm

Bentuk farmasi:

Implant

Rute administrasi :

Epilesional

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF:

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TACHOSIL SEALANT MATRIX
Human fibrinogen/Human thrombin
READ ALL OF THIS LEAFLET CAREFULLY.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects talk to your doctor. This includes any
possible side effects not listed
in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What TachoSil is and what it is used for
2.
What you need to know before TachoSil is used.
3.
How to use TachoSil
4.
Possible side effects
5.
How to store TachoSil
6.
Contents of the pack and other information
1.
WHAT TACHOSIL IS AND WHAT IT IS USED FOR
How does TachoSil work?
The yellow side of TachoSil contains the active components: fibrinogen
and thrombin. The YELLOW
side of TachoSil is therefore the ACTIVE SIDE. When the active side
comes into contact with fluids
(such as blood, lymph or saline solution) the fibrinogen and the
thrombin are activated and form a
fibrin network. This means that the TachoSil sticks to the tissue
surface, the blood coagulates (local
haemostasis) and the tissue is sealed. In the body TachoSil will
dissolve and disappear completely.
What is TachoSil used for?
TachoSil is used during surgery to stop local bleeding (haemostasis)
and to seal tissue surfaces on
internal organs.
2.
WHAT YOU NEED TO KNOW BEFORE TACHOSIL IS USED
DO NOT USE TACHOSIL
-
if you are allergic (hypersensitive) to human fibrinogen, human
thrombin or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
TachoSil is for local use only and should not be applied inside a
blood vessel. Blood clots may occur if
TachoSil is unintentionally applied inside a blood vessel.
It is possible that you could suffer an allergic reaction after
TachoSil has been applied. You may suffer
hives, or a rash similar to nettle rash, chest discomfort or
tightness, wheezing or low blood pressure.
You should contact your doctor immediately if you discover any of
these symptoms.
After abdominal surgery and if TachoSil sti

Karakteristik produk

OBJECT 1
TACHOSIL SEALANT MATRIX
Summary of Product Characteristics Updated 11-Apr-2016 | Takeda UK Ltd
1. Name of the medicinal product
TachoSil sealant matrix
2. Qualitative and quantitative composition
TachoSil contains per cm
2
:
Human Fibrinogen
Human Thrombin
5.5 mg
2.0 IU
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Sealant matrix
TachoSil is an off-white sealant matrix. The active side of the
matrix, which is coated with fibrinogen and
thrombin, is marked by a yellow colour.
4. Clinical particulars
4.1 Therapeutic indications
TachoSil is indicated in adults for supportive treatment in surgery
for improvement of haemostasis, to
promote tissue sealing, for suture support in vascular surgery where
standard techniques are insufficient,
and for supportive sealing of the dura mater to prevent postoperative
cerebrospinal leakage following
neurological surgery (see section 5.1).
4.2 Posology and method of administration
_Posology_
The use of TachoSil is restricted to experienced surgeons.
The quantity of TachoSil to be applied should always be oriented
towards the underlying clinical need for
the patient. The quantity of TachoSil to be applied is 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 1-3 units (9.5 cm x 4.8 cm);
application of up to 10 units has been
reported. For smaller wounds, e.g. in minimally invasive surgery the
smaller size matrices (4.8 cm x 4.8
cm or 3.0 cm x 2.5 cm) or the pre-rolled matrix (based on a matrix of
4.8 cm x 4.8 cm) is recommended.
_Method and route of administration_
For epilesional use only. Do not use intravascularly.
See section 6.6 for more detailed instructions.
_Paediatric patients_
TachoSil is not recommended for use in children below age 18 years due
to insufficient data on safety and
efficacy.
4.3 Contraindications
TachoSil must not be applied intravascularly.
Hypersensitivity to the active substances or to any of