Biofactor Streptokinase 1.5million unit powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Streptokinase

Available from:

Beacon Pharmaceuticals Ltd

ATC code:

B01AD01

INN (International Name):

Streptokinase

Dosage:

1.5mega unit

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02100200; GTIN: 0793573976055

Patient Information leaflet

Biofactor GmbH
Streptokinase 1 500 000 – V3
Page 1
PATIENT INFORMATION LEAFLET
BIOFACTOR STREPTOKINASE 1 500 000
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 because you have
suffered a recent
heart attack, which was caused by a blood clot blocking the blood
supply to your heart.
Biofactor Streptokinase is being given to you to break down the blood
clot.
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)
-

Summary of Product characteristics

OBJECT 1
STREPTOKINASE 1,500,000 IU
Summary of Product Characteristics Updated 13-Aug-2015 | Beacon
Pharmaceuticals
1. Name of the medicinal product
Biofactor Streptokinase 1 500 000
2. Qualitative and quantitative composition
Biofactor Streptokinase 1 500 000 is presented as a powder for
solution in vials containing 1.5 million
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.
Acute myocardial infarction: within 12 hours of onset with persistent
ST-segment elevation or recent left
bundle-branch block. Note: No statement on therapy outcome can be made
for administration beyond the
time window indicated above.
4.2 Posology and method of administration
Posology
_Paediatric population_
The safety and efficacy of Biofactor Streptokinase have not been
sufficiently established in children. Due
to low levels of plasminogen in newborns and in children with acquired
plasminogen deficiency and due
to the potential of streptokinase for allergic/anaphylactic reactions,
it is not recommended in neonates,
infants and children.
_Adults_
Systemic administration: A single dose of 1.5 million IU streptokinase
should be infused intravenously
over one hour.
Local intracoronary administration: A bolus of 20,000 IU streptokinase
should be followed by a
maintenance infusion of 2,000 IU to 4,000 IU per minute over 30 to 90
minutes depending on the
achievement of coronary artery patency.
Method of Administration
The administration of streptokinase may be intravenous or
intracoronary.
For instructions on reconstitution of the medicinal product before
administration, see section 6.6.
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