斷血炎注射液10％

País: Taiwan

Língua: chinês

Origem: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Ingredientes ativos:

TRANEXAMIC ACID

Disponível em:

台灣第一三共股份有限公司 台北市中山區八德路二段308號7樓之1 (44884303)

Código ATC:

B02AA02

Forma farmacêutica:

注射劑

Composição:

TRANEXAMIC ACID (2012101300) 100MG

Unidades em pacote:

安瓿;;盒裝

Classe:

製　劑

Tipo de prescrição:

限由醫師使用

Fabricado por:

DAIICHI SANKYO PROPHARMA CO., LTD. TAKATSUKI PLANT 4-38, AKETACHO, TAKATSUKI,OSAKA,JAPAN JP

Área terapêutica:

tranexamic acid

Indicações terapêuticas:

紫斑病、再生不良性貧血、白血病等出血症、腎出血、手術等出血、血炎

Resumo do produto:

註銷日期: 2020/04/21; 註銷理由: 許可證已逾有效期; 有效日期: 2018/10/14; 英文品名: TRANSAMIN INJECTION 10％

Status de autorização:

已註銷

Data de autorização:

2008-07-29

Folheto informativo - Bula

20138 5
018189
®
10
TRANSAMIN
®
INJECTION 10%
()
1.
(Thrombin)
(
)
2.
Transamin
1
250mg
500mg
1
2
1
500mg
1,000mg500mg2,500mg
Transamin
1
2.5
5mL
1
2
1
5
10mL
5
25mL
1.
()
1)
2)
Heparin
3)
4)
2.
1) ()
2) ()
3.
2,972
0.07%
(2
)
0.17% (5
)
0.03% (1
)
0.07%
(2
)
0.03% (1
)
1)
(cardiac macro-vascular surgery)
Transamin
2)
4.
5.
1)
2)
2
2
pH
7.08.0
7.08.0
1Tranexamic
acid
250mg/2.5mL
(10w/v%)
1g/10mL
(10w/v%)
Transamin
®
10 %
(Fibrin)
(Plasmin)
Batroxobin
desA
(Hemocoagulase)
Batroxobin
(Eptacog Alfa)
()
0.11
0.1
(Thrombin)
DAIICHI SANKYO PROPHARMA CO., LTD., Takatsuki Plant
(O) 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
(P) 4-38, Aketacho, Takatsuki, Osaka, Japan
30871
[phone]
(1)
(2)
(3)
3)
6.
1.
1)
Tranexamic acid 500mg
1,000mg
Tranexamic acid
2.
14
C
Tranexamic acid
3.
1)
Tranexamic acid 500mg
1,000mg
Tranexamic acid
24
80% 76%
1.
709
83.8% (594)
2.
283
77.7% (220)
Tranexamic acid
t
1/2
(hr)
2.0
1.9
Vd
(L)
42.4
C
max
(μg/mL)
21.2
60.0
T
max
(hr)
0.5
500mg
1,000mg
15
Tranexamic acid
1.
2) 6)
Tranexamic acid
(Plasminogen)
(Lysine)
(LBS)
α2-macro-globuline
Tranexamic acid
2.
2)
Tranexamic acid
3.
7) 10)
Tranexamic acid
(plasmin)
Kinin
(peptide)
Tranexamic acid
trans-4-(Aminomethyl)cyclohexanecarboxylic acid
C
8
H
15
NO
2
157.21
(99.5)
36
2.510100
20134
1)
7
375 (1976)
2) Med.Pharm.
10
(1) 7 (1976)
3) Iwamoto, M.Thrombos.Diathes.Haemorrh.
33
573 (1975)
4) Markus, G.et al.J.Biol.Chem.
254
1211 (1979)
5) Abiko, Y.et al.Biochim.Biophys.Acta
185
424 (1969)
6) Abiko, Y.et al.Biochim.Biophys.Acta
214
411 (1970)
7)
14
364 (1974)
8)
15
(9) 755 (1966)
9)
6
36 (1966)
10) 63
(6) 560 (1967)