TISSEEL VH S/D fibrin sealant syringe

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

calcium chloride dihydrate, Quantity: 36 micromole/mL; human thrombin, Quantity: 400 IU/mL

Disponibil de la:

Baxter Healthcare Pty Ltd

INN (nume internaţional):

Aprotinin,calcium chloride dihydrate,Factor XIII,Fibrinogen,human thrombin

Forma farmaceutică:

Solution

Compoziție:

Excipient Ingredients: Albumin; sodium chloride; water for injections

Calea de administrare:

Topical

Unități în pachet:

10 mL ( 5 mL sealer protein solution + 5 mL thrombin solution), 2.0 mL (1mL sealer protein solution + 1mL thrombin solution), 4 mL (2 mL sealer protein solution + 2 mL thrombin solution)

Tip de prescriptie medicala:

Not Scheduled after consideration by Committee

Indicații terapeutice:

TISSEL is indicated: - as adjunct to haemostasis during surgical procedures, when control of bleeding by conventional surgical techniques is ineffective or impractical; and - as a sealant as an adjunct for closure of colostomies. - as a sealant and/or adhesive for use in autologous chrondrocyte implantation (ACI) or matrix-induced autologous chondrocyte implantation (MACI) procedures. - for mesh fixation in non-iatrogenic abdominal wall hernia repair, as an alternative to sutures, staples or tacks.

Rezumat produs:

Visual Identification: Tisseel is presented in a prefilled double-chamber syringe package with one set of sterile accessory devices (DUO SET), under deep-frozen state. The syringe is designed for simultaneous application of the Sealer protein Sol & Thrombin Sol; Container Type: Syringe; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below minus 18 degrees Celsius (deep freeze); Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2009-03-13

Prospect

TISSEEL ((frozen) fibrin sealant syringe)
Consumer Medicine Information
_ _
TISSEEL CMI 111107
Page 1 of 4
Baxter
TISSEEL
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about the TISSEEL Fibrin
Sealant, Two-
Component Fibrin Sealant, Deep-Frozen, Vapour Heated (VH) and Solvent
Detergent
(S/D) Treated [TISSEEL 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 of using TISSEEL.
It does not take the place of talking to your doctor or pharmacist. If
you have any
concerns about using this medicine, ask your doctor or pharmacist.
WHAT TISSEEL IS USED FOR?
TISSEEL is used to help stop excessive blood loss during surgery by
inducing clotting.
This clot has also sealing and fixation properties. Thus, it can also
be used as an aid to
help in the closure of colostomies and as an aid in some cartilage
repair procedures and
for use in hernia repair procedures.
HOW DOES TISSEEL WORK?
The blood coagulation factors in the composition of TISSEEL are the
same as those
found in normal healthy individuals. They are isolated from healthy
human plasma,
except aprotinin, which is a
synthetic component. The components are packed in a
double-chamber syringe. One of the chamber contains Sealer Protein
solution while the
other contains Thrombin solution. The double-chamber syringe is stored
in a deep frozen
state. It will be warmed up to 33
°
C - 37
°
C just prior to use.
BEFORE YOU ARE GIVEN TISSEEL
_TISSEEL SHOULD NOT BE GIVEN TO YOU IF: _
•
you have a tendency to allergic reactions or hypersensitivity to
aprotinin. Some of the
symptoms of an allergic reaction may include skin rash, swelling of
the face, lips or
tongue, which may cause difficulty swallowing or shortness of breath
•
the expiry date printed on the pack has passed
_YOU MUST TELL YOUR DOCTOR IF YOU:_
•
have any other illness
•
are taking any prescription medicine or any other medicines purchased
from a
pharmacy, health food

Caracteristicilor produsului

TISSEEL (aprotinin, factor XIII, fibrinogen, thrombin, calcium
chloride dihydrate)
Version 1.0
1 of 18
AUSTRALIAN PRODUCT INFORMATION – TISSEEL
(APROTININ, FACTOR XIII, FIBRINOGEN, THROMBIN,
CALCIUM CHLORIDE DIHYDRATE)
1
NAME OF THE MEDICINE
Aprotinin (synthetic), factor XIII, fibrinogen, thrombin and calcium
chloride dihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients of TISSEEL VH S/D are formulated as two
sterile, deep-frozen
solutions,
the Sealer
Protein
Solution
and
Thrombin
Solution
(see
Table
1
below
for
composition of TISSEEL). Each solution is presented in a separate
preloaded chamber of one
double-chamber syringe. The active ingredients are fractionated from
pooled human plasma.
TABLE 1: COMPOSITION OF TISSEEL
SEALER PROTEIN SOLUTION
THROMBIN SOLUTION
Active Ingredients
-Aprotinin (synthetic)
-Factor XIII
-Fibrinogen
-Thrombin (human)
-Calcium chloride dihydrate
Excipients
-Albumin (human)
-Histidine
-Nicotinamide
-Polysorbate 80
-Sodium citrate
-Water for Injections
-Albumin (human)
-Sodium chloride
-Water for Injections
TABLE 2: LIST OF ACTIVE INGREDIENTS AND ASSOCIATED QUANTITIES
SEALER PROTEIN
SOLUTION
QUANTITY
THROMBIN
SOLUTION
QUANTITY
Active
Ingredient
Aprotinin (synth)
Factor XIII
Fibrinogen
2250 - 3750
KIU/mL
1.2 - 10 IU/mL
72 - 110 mg/mL
Thrombin (human)
Calcium chloride
dihydrate
400 - 625 IU/mL
36 - 44 micromole/mL
The two deep frozen solutions comprising TISSEEL must be defrosted
prior to use. After
thawing and warming up to 37 ºC, the two solutions are mixed during
application (see
DOSE
AND METHOD OF ADMINISTRATION
section, heading
_Method of Application_
).
3
PHARMACEUTICAL FORM
Two-Component Fibrin Sealant, Deep-Frozen, Vapour Heated (VH) and
Solvent Detergent
(S/D) treated, TISSEEL VH S/D
1
. The 2 components of TISSEEL are colourless to pale
yellow, opalescent when frozen and clear to slightly turbid solutions
once defrosted.
1
The term ‘Vapour Heated (VH) and Solvent Detergent (S/D) treated’
is abbreviated as VH S/D
TISSEEL (aprotinin, factor XIII, fibr