Biofactor Streptokinase 750,000unit powder for solution for infusion vials

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Streptokinase

Beszerezhető a:

Beacon Pharmaceuticals Ltd

ATC-kód:

B01AD01

INN (nemzetközi neve):

Streptokinase

Adagolás:

750000unit

Gyógyszerészeti forma:

Powder for solution for infusion

Az alkalmazás módja:

Intravenous

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 02100200; GTIN: 0793573976048

Betegtájékoztató

Biofactor GmbH
Streptokinase 250 000 & 750 000 – V3
Page 1
PATIENT INFORMATION LEAFLET
BIOFACTOR STREPTOKINASE 250 000 AND 750 000
Powder for solution for infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET?
1. What Biofactor Streptokinase is and what it is used for.
2. What you need to know before you are given Biofactor Streptokinase.
3. How Biofactor Streptokinase is given to you.
4. Possible side effects.
5. How Biofactor Streptokinase is stored.
6. Contents of the pack and further information.
1. WHAT BIOFACTOR STREPTOKINASE IS AND WHAT IT IS USED FOR.
Biofactor Streptokinase contains a number of ingredients. The active
substance is a protein
called streptokinase, an antithrombotic agent which dissolves blood
clots.
You are being treated with Biofactor Streptokinase to break down blood
clots in blood
vessels.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BIOFACTOR STREPTOKINASE.
You should not be treated with Biofactor Streptokinase if you:
-
are allergic to streptokinase or any of the other ingredients in this
medicine (listed in
section 6)
-
are pregnant
-
are suffering from or have recently had internal bleeding
-
have recently suffered a stroke or a serious head injury
-
have recently had surgery, especially on your head (intracranial) or
spine (intraspinal)
-
have a brain tumour or a tumour with a risk of bleeding
-
have uncontrollable high blood pressure
-
have problems with your blood vessels (e.g. weakness in an artery)
-
have a clotting disorder or are taking drugs to prevent blood clotting
(anticoagulants)
-
have an unusual susceptibility to bleeding
-
have inflammation of the pancreas (acute pancreatitis) or inflammation
in or around
your he

Termékjellemzők

OBJECT 1
STREPTOKINASE 750,000 IU
Summary of Product Characteristics Updated 11-Aug-2015 | Beacon
Pharmaceuticals
1. Name of the medicinal product
Biofactor Streptokinase 250 000 and 750 000
2. Qualitative and quantitative composition
Biofactor Streptokinase 250 000 and 750 000 are presented as a powder
for solution in vials containing
250 000 and 750 000 International Units (IU) of purified streptokinase
as the active ingredient. For a full
list of excipients, see section 6.1.
Highly purified streptokinase is extracted from the culture filtrate
of certain strains of the streptococcus
group C. It is presented as a white to slightly yellow powder and
contains stabilisers.
3. Pharmaceutical form
Powder for solution for infusion.
White to slightly yellow powder.
4. Clinical particulars
4.1 Therapeutic indications
Biofactor Streptokinase is indicated in adults.
Biofactor Streptokinase is a fibrinolytic agent which may be used for
the intravascular dissolution of
thrombi and emboli in:
- acute massive pulmonary embolism
- acute, sub-acute or chronic (not older than 6 weeks) occlusion of
peripheral arteries
- extensive deep vein thrombosis
- central retinal venous or arterial thrombosis (arterial occlusions
not older than 8 hours, venous
occlusions not older than 10 days).
Note: No statement on therapy outcome can be made for administration
beyond the time windows
indicated above.
4.2 Posology and method of administration
Posology
_Adults_
Deep vein thrombosis
An initial dose of 250 000 IU streptokinase should be infused into a
peripheral vein over 30 minutes. A
maintenance infusion of 100 000 IU/hour for 72 hours should follow.
Pulmonary embolism
Infuse 1 500 000 IU streptokinase into a peripheral vein preferably
over a short time of 1-2 hours.
As an alternative, an initial dose of 250 000 IU streptokinase should
be infused into a peripheral vein over
30 minutes. A maintenance infusion of 100 000 IU/hour for 24 hours
should follow.
Occlusive peripheral arterial diseases
Administer streptokinase with a local intra-arte