Artiss Solutions for Sealant Deep Frozen

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

HUMAN FIBRINOGEN; APROTININ; THROMBIN; CALCIUM CHLORIDE

Dostępny od:

BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.

INN (International Nazwa):

HUMAN FIBRINOGEN; APROTININ; THROMBIN; CALCIUM CHLORIDE

Sztuk w opakowaniu:

2ml mL; 4ml mL; 10ml mL

Wyprodukowano przez:

Takeda Manufacturing Austria AG

Charakterystyka produktu

BAXTER
1.
NAME OF THE MEDICINAL PRODUCT
ARTISS Solutions for Sealant
Deep frozen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Component 1:
Sealer Protein Solution
Human Fibrinogen
91 mg
1
/ml (as clottable protein) produced from the plasma of
human donors
Aprotinin (synthetic)
3000 KIU
3
/ml
Component 2:
Thrombin Solution
Human Thrombin
4 IU
3
/ml produced from the plasma of human donors
Calcium Chloride
40

mol/ml
1 prefilled double chamber syringe which contains Sealer Protein
Solution (with
Aprotinin), deep frozen 1 ml, 2 ml, 5 ml, in one chamber and Thrombin
Solution
(with Calcium Chloride), deep frozen 1 ml, 2 ml, 5 ml, in the other
chamber results in
2 ml, 4 ml, 10 ml, total volume of product ready for use.
After mixing
1 ml
2 ml
4 ml
10 ml
Component 1: Sealer protein solution
Human Fibrinogen
(as clottable protein)
Aprotinin (synthetic)
45.5 mg
1,500 KIU
91 mg
3,000 KIU
182 mg
6,000 KIU
455 mg
15,000 KIU
Component 2: Thrombin Solution
Human Thrombin
Calcium Chloride
2 IU
20

mol
4 IU
40

mol
8 IU
80

mol
20 IU
200

mol
ARTISS contains Human Factor XIII co-purified with Human Fibrinogen in
a range
of 0.6 – 5 IU/ml.
For the full list of excipients, see section 6.1.
1
Contained in a total protein concentration of 96 - 125 mg/ml
2
1 EPU (European Pharmacopoeia Unit) corresponds to 1800 KIU
(Kallidinogenase Inactivator Unit)
3
Thrombin activity is calculated using the current WHO International
Standard for Thrombin.
3.
PHARMACEUTICAL FORM
Solutions for Sealant
Deep frozen
Colourless to pale yellow and clear to slightly turbid solutions.
Component 1, Sealer Protein Solution: pH 6.5 – 8.0
Component 2, Thrombin Solution: pH 6.0 – 8.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARTISS is indicated as a tissue glue to adhere/seal subcutaneous
tissue in plastic,
reconstructive and burn surgery, as a replacement or an adjunct to
sutures or staples
(see 5.1). ARTISS is not indicated for hemostasis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ARTISS is intended for hospital use only. The use of