溶栓　凍晶注射劑１，５００，０００單位

País: Taiwan

Idioma: xinès

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

ingredients actius:

STREPTOKINASE

Disponible des:

吉發企業股份有限公司 台北市愛國西路９號２Ｆ之９ (03178418)

Codi ATC:

B01AD01

formulario farmacéutico:

凍晶注射劑

Composición:

STREPTOKINASE (2040000100) 1500000IU (I

Unidades en paquete:

小瓶;;盒裝

clase:

製　劑

tipo de receta:

限由醫師使用

Fabricat per:

CSL BEHRING GMBH EMIL-VON-BEHRING STRASSE 76,35041 MARBURG GERMANY DE

Área terapéutica:

streptokinase

indicaciones terapéuticas:

血栓及栓塞之纖維溶解劑

Resumen del producto:

註銷日期: 2015/06/29; 註銷理由: 自請註銷; 有效日期: 2015/10/30; 英文品名: STREPTASE 1500000I.U.LYOPSILIZED FOR INJECTION

Estat d'Autorització:

已註銷

Data d'autorització:

1997-10-15

Informació per a l'usuari

STREPTASE
®
1 500 000
ACTIVE INGREDIENT: Stabilized pure streptokinase, derived from the
culture filtrate of beta
haemolytic streptococci of Lancefield group C. It is presented as a
white powder and contains
stabilizers.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
1 injection vial contains 1 500 000 IU streptokinase.
OTHER INGREDIENTS
Human albumin, sodiumLhydrogen glutamate monohydrate, sodium
dihydrogenphosphate
dihydrate, disodium hydrogenphosphate dihydrate
PHARMACEUTICAL FORM AND PRESENTATIONS
PHARMACEUTICAL FORM
Powder for intravenous or intraarterial administration after
reconstitution with physiological
saline.
PRESENTATIONS
Streptase 1 500 000
1 vial of 1 500 000 IU streptokinase
PHARMACOTHERAPEUTIC GROUP
Streptokinase (antithrombotic agents, enzymes)
ATCcode: B01A D01
NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER
CSL Behring GmbH
EmilvonBehringStr. 76, 35041 Marburg, Germany
THERAPEUTIC INDICATIONS
SYSTEMIC ADMINISTRATION
– acute transmural myocardial infarction (not older than 12 hours),
with persistent STsegment
elevation or recent left bundlebranch block
– deep vein thromboses (not older than 14 days)
– acute massive pulmonary embolism
– acute and subacute thromboses of peripheral arteries
– chronic occlusive arterial diseases (not older than 6 weeks),
– occlusion of central retinal artery or vein (arterial occlusions
not older than 6 to 8 hours,
venous occlusions not older than 10 days).
LOCAL ADMINISTRATION
– acute myocardial infarction for reopening of coronary vessels
(not older than 12 hours)
– acute, subacute and chronic thromboses as well as embolisms of
peripheral venous and
arterial vessels.
Note: No statement on therapy outcome can be made for administration
beyond the time
windows indicated above.
CONTRAINDICATIONS
Streptase 1 500 000 must not be used in case of severe allergic
reactions to the product.
Because of the increased risk of haemorrhage (bleeding) under
thrombolytic therapy Streptase
1 500 000 must not be given in the following