ARTISS fibrin sealant VH S/D 4 IU (frozen) solution for sealant syringe

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

human thrombin, Quantity: 3.2 IU/mL; calcium chloride dihydrate, Quantity: 36 micromole/mL

Disponible des:

Baxter Healthcare Pty Ltd

Designació comuna internacional (DCI):

Aprotinin,calcium chloride dihydrate,Factor XIII,Fibrinogen,Thrombin

formulario farmacéutico:

Solution

Composición:

Excipient Ingredients: sodium chloride; Albumin; water for injections

Vía de administración:

Topical

Unidades en paquete:

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

tipo de receta:

Not Scheduled after consideration by Committee

indicaciones terapéuticas:

ARTISS is indicated to adhere autologous skin grafts in burn patients. ARTISS is indicated to adhere tissue flaps during rhytidectomy (face-lift). Artiss is not indicated for haemostasis

Resumen del producto:

Visual Identification: ARTISS 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 Solution & Thrombin Solution.; 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

Estat d'Autorització:

Registered

Data d'autorització:

2010-08-19

Informació per a l'usuari

ARTISS ((frozen) fibrin sealant syringe)
Consumer Medicine Information
ARTISS CMI 130624
Page 1 of 4
Baxter
ARTISS
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about the
ARTISS FIBRIN SEALANT, TWO-
COMPONENT FIBRIN SEALANT, DEEP-FROZEN.
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 having ARTISS.
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.
WHAT ARTISS IS USED FOR?
ARTISS is used as a tissue glue to join skin surfaces in burns
surgery. ARTISS is also
used to join skin surfaces in face-lift surgery.
HOW DOES ARTISS WORK?
The blood coagulation factors in the composition of ARTISS are the
same as those found
in normal healthy individuals. They are isolated from healthy human
plasma, except
aprotinin, which is synthetically made. The components are packed in a
double-chamber
syringe. One of the chambers 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 between 33°C -37°C just prior to use.
BEFORE YOU ARE GIVEN ARTISS
_ARTISS SHOULD NOT BE GIVEN TO YOU IF: _

you have a tendency to allergic reactions or hypersensitivity to
aprotinin or any of the
ingredients in this medicine (listed under
_What is in ARTISS?)_
. 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 store or supermarket

have previously received aprotinin or fibrin sealant, whether you are
allergic or not to
it
_ _
_YOU MUST TELL YOUR DOCTOR IF YOU ARE PREGNANT, PLANNING TO

Fitxa tècnica

ARTISS (aprotinin, factor XIII, fibrinogen, thrombin, calcium chloride
dihydrate)
Version 1.0
1 of 16
AUSTRALIAN PRODUCT INFORMATION – ARTISS
(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
ARTISS is a two-component fibrin sealant made from pooled human
plasma. Each solution is
presented in a separate preloaded chamber of one double-chamber
syringe: chamber one [1]
contains Sealer Protein Solution (with aprotinin), deep frozen (1 mL,
2 mL or 5 mL), chamber
two [2] contains Thrombin Solution (with calcium chloride), deep
frozen (1 mL, 2 mL or
5 mL), resulting in 2 mL, 4 mL or 10 mL total volume of product ready
for use.
Composition of the active ingredients of ARTISS:
(1) SEALER PROTEIN SOLUTION:
1 mL of the solution contains:
ACTIVE INGREDIENTS
QUANTITY
As total protein
96 – 125 mg
Fibrinogen (Clottable Protein)
72 – 110 mg
Factor XIII (human)
1.2 – 10 IU
Aprotinin, synthetic (Fibrinolysis Inhibitor)
2250 – 3750 KIU
1
ARTISS contains Human Factor XIII co-purified with Human Fibrinogen in
a range of 1.2 -
10.0 IU/mL.
(2) THROMBIN SOLUTION:
1 mL of the solution contains:
ACTIVE INGREDIENTS
QUANTITY
Thrombin (human)
3.2 – 5 IU
2
Calcium chloride dihydrate
36 – 44 µmol
LIST OF EXCIPIENTS:
Composition of the excipients of ARTISS:
(1)
SEALER PROTEIN SOLUTION
: 1 mL of the solution contains human albumin (10 – 20 mg),
histidine (10 – 25 mg), sodium citrate (4.8 – 9.7 mg), polysorbate
80 (0.6 – 1.9 mg),
nicotinamide (3 – 9 mg) and Water for Injections q.s. to 1 mL.
(2)
THROMBIN SOLUTION
: 1 mL of the solution contains human albumin (45 – 55 mg), sodium
chloride (3.5 – 5.5 mg) and Water for Injections q.s to 1 mL.
1
KIU = Kallidinogenase Inactivator Unit
2
Thrombin activity is calculated using the current WHO International
Standard for thrombin.
ARTISS (aprotinin, factor XIII, fibrinogen, thrombin, calcium chloride