Syner-KINASE 10,000unit powder for solution for injection vials

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Urokinase

可用日期:

Syner-Med (Pharmaceutical Products) Ltd

ATC代码:

B01AD04

INN（国际名称）:

Urokinase

剂量:

10000unit

药物剂型:

Powder for solution for injection

给药途径:

Line lock; Intraarterial; Intravenous

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: ; GTIN: 5060140340003

资料单张

PACKAGE LEAFLET
SYNER-KINASE
®
INFORMATION FOR THE USER
Syner-KINASE® 10,000 IU
Syner-KINASE® 25,000 IU
Syner-KINASE® 100,000 IU
Syner-KINASE® 250,000 IU
Syner-KINASE® 500,000 IU
Powder for solution for injection or infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING/USING THIS
MEDICINE. IT CONTAINS A
SUMMARY OF THE INFORMATION AVAILABLE ON SYNER-KINASE. THE INFORMATION
IN THIS LEAFLET
APPLIES ONLY TO YOUR MEDICINE.
• keep this leaflet. You may need to read it again
• if you have further questions, please ask your doctor or your
pharmacist
• this medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours
• if any of the side effects become serious, or if you notice any
side effects not listed in this leaflet,
please tell your doctor
THIS LEAFLET ANSWERS THE FOLLOWING QUESTIONS:
1. WHAT SYNER-KINASE IS AND WHAT IT IS USED FOR
2. BEFORE YOU ARE GIVEN SYNER-KINASE
3. HOW SYNER-KINASE IS GIVEN
4. POSSIBLE SIDE-EFFECTS
5. HOW TO STORE SYNER-KINASE
6. FURTHER 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, a thrombolytic
that 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. BEFORE YOU ARE GIVEN SYNER-KINASE:
SYNER-KINASE WILL NOT BE GIVEN TO YOU IF YOU:
• are allergic (hypersensitive) to urokinase or any of the other
ingredients of Syner-KINASE (See
Section 6)
• are currently bleeding
• had a major surgical operation or a stroke recently (in the past 2
months)
• have severe high blood pressure
• have abnormal blood clotting
• have abnormal blood vessels
• have cancer of the brain
• have infection of the pancreas or heart
• have severe liver or kidney disease
SPECIAL CARE WILL BE TAKEN WI

产品特点

OBJECT 1
SYNER-KINASE 10,000 IU
Summary of Product Characteristics Updated 10-Mar-2016 | Syner-Medica
Ltd
1. Name of the medicinal product
Syner-KINASE
®
10,000 IU
Syner-KINASE
®
25,000 IU
Syner-KINASE
®
100,000 IU
Syner-KINASE
®
250,000 IU
Syner-KINASE
®
500,000 IU
Powder for solution for injection or 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 a 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
®
should be restricted to hospital use only. Adequate diagnostic and
monitoring
techniques should be available.
The route of administration is by intravenous infusion, intra-arterial
injection or local instillation. It must
not be given as a subcutaneous or intramuscular injection.
Instructions on reconstitution with the recommended solvent are
provided in section 6.6.
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