ARTISS

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Aprotinin 2250 kIU/mL - 3750 kIU/mL; Factor XIII 1.2 IU/mL - 10 IU/mL; Fibrinogen 72 mg/mL - 110 mg/mL; Calcium chloride dihydrate 0.036 mmol/mL - 0.044 mmol/mL; Thrombin 3.2 IU/mL - 5 IU/mL

から入手可能:

Baxter Healthcare Ltd

INN（国際名）:

Aprotinin 2250 kIU/mL - 3750 kIU/mL

投薬量:

4 IU

医薬品形態:

Topical solution

構図:

Active: Aprotinin 2250 kIU/mL - 3750 kIU/mL Factor XIII 1.2 IU/mL - 10 IU/mL Fibrinogen 72 mg/mL - 110 mg/mL Excipient: Albumin Histidine Nicotinamide Polysorbate 80 Sodium citrate dihydrate Water for injection Active: Calcium chloride dihydrate 0.036 mmol/mL - 0.044 mmol/mL Thrombin 3.2 IU/mL - 5 IU/mL Excipient: Albumin Sodium chloride Water for injection

パッケージ内のユニット:

Combination pack, AST double-chamber pre-filled syringes x 2mL, 2 mL

クラス:

Prescription

処方タイプ:

Prescription

製:

Bachem AG

適応症:

ARTISS is indicated for use in adhering autologous skin grafts in burn patients. ARTISS is not indicated for haemostasis.

製品概要:

Package - Contents - Shelf Life: Combination pack, Double-chamber pre-filled syringes x 2mL - 2 mL - 24 months from date of manufacture stored at or below -18°C (Deep freeze) 14 days unopened stored at or below 25°C. controlled room temperature 4 hours unopened stored once quick thawed to 33-37 degrees C - Combination pack, Double-chamber pre-filled syringes x 4mL - 4 mL - 24 months from date of manufacture stored at or below -18°C (Deep freeze) 14 days unopened stored at or below 25°C. controlled room temperature 4 hours unopened stored once quick thawed to 33-37 degrees C - Combination pack, Double-chamber pre-filled syringes x 10mL - 10 mL - 24 months from date of manufacture stored at or below -18°C (Deep freeze) 14 days unopened stored at or below 25°C. controlled room temperature 4 hours unopened stored once quick thawed to 33-37°C

承認日:

2009-12-07

製品の特徴

NEW ZEALAND DATA SHEET
ARTISS Data Sheet 13 July 2021
Page 1 of 15
Baxter Healthcare Ltd
1 ARTISS (4IU topical solution)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aprotinin (synthetic), factor XIII, fibrinogen, thrombin and calcium
chloride dihydrate.
ARTISS is a two‐component fibrin sealant made from pooled human
plasma. The two components
of ARTISS are formulated as two sterile, deep‐frozen solutions. 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 (1mL, 2mL or 5mL),
chamber two [2] contains Thrombin Solution (with calcium chloride),
deep frozen (1mL, 2mL or
5mL), resulting in 2mL, 4mL or 10mL total volume of product ready for
use.
_Biological origin of active substance _
Produced from pooled human plasma.
_Composition of the active ingredients of ARTISS _
(1) SEALER PROTEIN SOLUTION: 1mL of the solution contains
Active Ingredients
Quantity
As total protein
96 – 125mg
Fibrinogen (Clottable Protein)
72 – 110mg
Factor XIII (human)
1.2 – 10IU
Aprotinin, Synthetic (Fibrinolysis Inhibitor)
2250 – 3750KIU
1
ARTISS contains Human Factor XIII co‐purified with Human Fibrinogen
in a range of 1.2

10.0IU/mL.
(2) THROMBIN SOLUTION: 1mL of the solution contains
Active Ingredients
Quantity
Thrombin (human)
3.2 – 5IU
2
Calcium Chloride dihydrate (2 H
2
O)
36 – 44µmol
For the full list of excipients see Section 6.1
3 PHARMACEUTICAL FORM
Topical solution.
The two components of ARTISS are colourless to pale yellow, opalescent
when frozen and clear to
slightly turbid solutions once defrosted.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
ARTISS is indicated to adhere:

autologous skin grafts in burn patients.

tissue flaps during facial rhytidectomy surgery (face‐lift).
ARTISS is not indicated for haemostasis.
1
KIU = Kallidinogenase Inactivator Unit.
2
Thrombin activity is calculated using the current WHO International
Standard for thrombin.
NEW ZEALAND DATA SHEET
ARTISS D