Streptase

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Streptokinase 250000 [iU]

Available from:

Seqirus (NZ) Ltd

INN (International Name):

Streptokinase 250000 IU

Dosage:

250000 IU

Pharmaceutical form:

Powder for injection

Composition:

Active: Streptokinase 250000 [iU] Excipient: Albumin Monosodium glutamate Polygeline

Units in package:

Vial, single dose, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

CSL Behring GmbH

Product summary:

Package - Contents - Shelf Life: Vial, single dose, - 1 dose units - 48 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

1969-12-31

Patient Information leaflet

Page

1 
STREPTASE


(strep-tays)

streptokinase 
(strep-toe-kine-ays) 
Consumer Medicine Information (CMI) 

What is in this leaflet 
This leaflet answers some common questions about Streptase. 
It does not contain all the available
information. It does not take the place
of talking to your doctor or pharmacist. 
All medicines have risks and benefits. Your doctor has weighed the risks of you being
given Streptase against the benefits they 
expect it will have for you. 
If you have any concer ns about being
given this medicine, ask your  doctor  or  phar macist. 
Keep this leaflet with the medicine. You may need to read it again. 
What Streptase is used for 
The active ingredient of Streptase is streptokinase, an enzyme
produced by streptococcus bacteria. Streptase is used in 
hospitals to dissolve blood
clots, especially those in the heart and lungs. It is also
used on the clots formed in the tubing during 
kidney dialysis. 
Your doctor may have prescribed Streptase for another reason.  
Ask your  doctor  if you have any
questions about why Str eptase has been pr escr ibed
for  you. 
This medicine is available only with a doctor’s prescription. 
Streptase is not recommended for use in children.  
Before you are given it 
When you must not be given it 
You must not r eceive Str eptase if: 
•  you have a severe
allergy to Streptase or an allergy to any of the ingredients listed at
the end of this leaflet 
•  you are bleeding 
•  you have received streptokinase more than
5 days ago and less than 12 months ago 
•  any of the following apply to you: 
-  recent haemorrhage, biopsy or surgery of any kind 
-  peptic ulcer, ulcerative colitis (inflammation of the colon) or diverticulitis (inflammation
in the colon) 
-  

Summary of Product characteristics

DATA SHEET 
STREPTASE
®

_STREPTOKINASE _
DESCRIPTION 
Streptase is highly purified streptokinase obtained from the culture
filtrate of beta-
haemolytic streptococci of group C. 
The various strengths of Streptase contain the following amounts of
dry substance 
including pure lyophilised streptokinase and human albumin as
stabilising agent: 
250 000 IU streptokinase: 134 - 176 mg dried material 
750 000 IU streptokinase: 139 - 182 mg dried material 
1 500 000 IU streptokinase: 147 - 192 mg dried material 
PHARMACOLOGY 
Streptokinase acts with plasminogen to produce an 'activator complex'
that converts 
plasminogen to the proteolytic enzyme, plasmin. The more plasminogen
bound 
within this complex, the less plasminogen is left to be converted
into its enzymatically 
active form. Therefore, high doses of streptokinase are associated
with a lower 
bleeding risk and low doses of streptokinase are associated with a
higher bleeding 
risk. Due to the high degree of affinity and rapid reaction between
streptokinase and 
antistreptokinase-antibodies, which are possibly present in the
patient's blood, low 
quantities of streptokinase are eliminated from the blood with
a half-life of 18 
minutes. The elimination half-life of streptokinase based on activator
formation is 
about 80 minutes. The major part of streptokinase is degraded to
peptides and 
eliminated by the intestines and kidneys. Plasmin degrades fibrin
clots as well as 
fibrinogen and other plasma proteins. Plasmin is inactivated by
circulating inhibitors 
such as alpha-2-plasmin inhibitor or alpha-2-macroglobulin. These
inhibitors are 
rapidly consumed at high doses of streptokinase. 
Experimental studies have shown that Streptase induces lysis of the
thrombus both 
superficially and also from within the thrombus. 
Intravenous infusion of streptokinase is followed by increased
fibrinolytic activity, 
which decreases plasma fibrinogen levels for 24 to 36 hours. The
decrease in 
plasma fibrinogen is associated with decrease