ARTISS SOLUTIONS FOR SEALANT DEEP FROZEN

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

Aprotinin (synthetic) (for sealer protein solution); Calcium Chloride (for thrombin solution); Human Fibrinogen (Clottable protein) (for sealer protein solution); Human Thrombin (for thrombin solution)

제공처:

BAXTER HEALTHCARE (ASIA) PTE LTD

ATC 코드:

B02BC, V031K

약제 형태:

SOLUTION

구성:

Aprotinin (synthetic) (for sealer protein solution) 2250 – 3750 KIU/ml; Calcium Chloride (for thrombin solution) 36 – 44 μmol/ml; Human Fibrinogen (Clottable protein) (for sealer protein solution) 72 – 110 mg/ml; Human Thrombin (for thrombin solution) 3.2– 5.0 IU/ml

관리 경로:

TOPICAL

처방전 유형:

Prescription Only

Manufactured by:

Takeda Manufacturing Austria AG (Site: Industriestrasse 72)

승인 상태:

ACTIVE

승인 날짜:

2015-01-06

제품 특성 요약

Technical Info
Dieline
NA
NA
NA
CODE 3 OF 9
DATAMATRIX CODE
RSS / GS1-128 CODE
BODY TEXT SIZE
9.0 pt
760199
CODE ITF 2/5
NA
PHARMACODE
NA
GTIN / EAN-13 CODE
BACK
PANTONE 287 U
TECHNICAL SPECIFICATION:
ARTWORK DIMENSIONS/SIZE:
ITEM NUMBER:
FRONT
0760199
VERSION: 2
PROFILE: 0402551_1_PIL_Drwg
0402551_TSBP18
525 x 293 mm
GRAPHICS HOUSE:
SGK Redmond
DATE:
25JUL2023
OPTIONAL: Artwork Approver outside the Shire Management System:
ROLE:
NAME:
SIGNATURE:
DATE:
Swatch
Swatch
Swatch
PANTONE 287 U
Swatch
Swatch
Swatch
b
1.
NAME OF THE MEDICINAL PRODUCT
ARTISS Solutions for Sealant
Deep frozen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Component 1:
Sealer Protein Solution
Human Fibrinogen (as clottable protein)
91 mg/ml
1
produced from the plasma
of human donors
Aprotinin (synthetic)
3000 KIU/ml
2
Component 2:
Thrombin Solution
Human Thrombin
4 IU/ml
3
produced from the plasma
of human donors
Calcium Chloride
40 µmol/ml
1
Contained in a total protein concentration of 95 – 125 mg/ml
2
1 EPU (European Pharmacopeia Unit) corresponds to 1800 KIU
(Kallidinogenase Inactivator Unit)
3
Thrombin activity is calculated using the current WHO International
Standard for Thrombin
1 prefilled double chamber syringe which contains Sealer Protein
Solution
(with Aprotinin), deep frozen 1 ml, 2ml or 5 ml, in one chamber and
Thrombin
Solution (with Calcium Chloride), deep frozen 1ml, 2 ml, 5 ml, in the
other
chamber results in 2 ml, 4 ml or 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 μmol
4 IU
40 μmol
8 IU
80 μmol
20 IU
200 μmol
ARTISS contains Human Factor XIII co-purified with Human Fibrinogen in
a
range of 0.6 �