Syner-KINASE 250,000unit powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Urokinase

Available from:

Syner-Med (Pharmaceutical Products) Ltd

ATC code:

B01AD04

INN (International Name):

Urokinase

Dosage:

250000unit

Pharmaceutical form:

Powder for solution for injection

Administration route:

Line lock; Intraarterial; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5060140340034

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYNER-KINASE® 10,000 IU POWDER FOR SOLUTION FOR INJECTION/INFUSION
SYNER-KINASE® 25,000 IU POWDER FOR SOLUTION FOR INJECTION/INFUSION
SYNER-KINASE® 100,000 IU POWDER FOR SOLUTION FOR INJECTION/INFUSION
SYNER-KINASE® 250,000 IU POWDER FOR SOLUTION FOR INJECTION/INFUSION
SYNER-KINASE® 500,000 IU POWDER FOR SOLUTION FOR INJECTION/INFUSION
urokinase
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Syner-KINASE is and what it is used for
2.
What you need to know before you use Syner-KINASE
3.
How to use Syner-KINASE
4.
Possible side effects
5.
How to store Syner-KINASE
6.
Contents of the pack and other information
1.
WHAT SYNER-KINASE IS AND WHAT IT IS USED FOR
The name of your medicine is Syner-KINASE. The active ingredient is
urokinase, an enzyme
extracted from human urine which acts as a thrombolytic. This means it
can help to dissolve blood
clots that may form in:
-
intravenous catheters or cannulae (surgical tubes used to withdraw
fluids from, or introduce
fluids into the body)
-
lungs
-
deep veins
-
peripheral arteries (blood vessels away from the heart, such as in the
leg)
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SYNER-KINASE
SYNER-KINASE WILL NOT BE GIVEN TO YOU IF YOU:
-
are allergic (hypersensitive) to urokinase or any of the other
ingredients of this medicine (listed
in section 6)
-
are currently bleeding or have been recently bleeding from the stomach
or intestines
-
have any cancer that has a risk of bleeding
-
had a major surgical operation or a stroke recently
-
had a recent trauma including cardiopulmonary resuscitation, chest or
brain surgery (for
example in the past 2 months)
-
have severe high bloo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Syner-KINASE® 10,000 IU powder for solution for injection/infusion
Syner-KINASE ® 25,000 IU powder for solution for injection/infusion
Syner-KINASE® 100,000 IU powder for solution for injection/infusion
Syner-KINASE® 250,000 IU powder for solution for injection/infusion
Syner-KINASE® 500,000 IU powder for solution for injection/infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 10,000, 25,000, 100,000, 250,000 or 500,000 IU of
urokinase
produced from human urine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White powder for solution for injection or infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Syner-KINASE® is indicated for the lysis of blood clots in the
following conditions:
-
thrombosed intravascular catheters and cannulae
-
extensive acute proximal deep vein thrombosis
-
acute massive pulmonary embolism
-
acute occlusive peripheral arterial disease with limb threatening
ischemia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Syner-KINASE® must be restricted to hospital use only. Adequate
diagnostic and
monitoring techniques should be available.
Posology
The dose of Syner-KINASE may be adjusted individually depending on the
clinical
condition and response to treatment.
THROMBOSED INTRAVASCULAR CATHETERS AND CANNULA
5,000 to 25,000 IU Syner- KINASE® should be dissolved in the volume
of solvent
required to completely fill the lumen of the catheter or cannula and
locked for a
duration of 20 to 60 minutes. The lysate is then aspirated and the
procedure repeated
if necessary.
Alternatively, an infusion of up to 250,000 IU Syner-KINASE® can be
administered
into the catheter or cannula over a period of 90 to 180 minutes using
a solution of
1,000 to 2,500 IU/ml in the solvent.
EXTENSIVE ACUTE PROXIMAL DEEP VEIN THROMBOSIS
An initial loading dose of 4,400 IU/kg body weight dissolved in 15 ml
solvent should
be infused in a peripheral vein over 10 minutes followed by 4,400
IU/kg/hour for 1