STREPTASE 750000 I.U.

Israel - English - Ministry of Health

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Active ingredient:
STREPTOKINASE
Available from:
GENMEDIX , ISRAEL
ATC code:
B01AD01
Pharmaceutical form:
POWDER FOR SOLUTION FOR INFUSION
Composition:
STREPTOKINASE 750000 IU/VIAL
Administration route:
I.V, INTRA-ARTERIAL
Prescription type:
Required
Manufactured by:
CSL BEHRING GmbH, GERMANY
Therapeutic group:
STREPTOKINASE
Therapeutic area:
STREPTOKINASE
Therapeutic indications:
Acute myocardial infarction, deep vein thrombosis, pulmonary embolism, acute or subacute thrombosis of peripheral arteries and chronic occlusive arterial diseases, occlusion of central retinal artery or vein.
Authorization number:
028 86 21258 00
Authorization date:
2012-11-30

Streptase 750 000:

Streptase

®

Active ingredient: Stabilized pure streptokinase, derived from the culture filtrate of beta-

haemolytic streptococci of Lancefield group C. It is presented as a white powder and contains

stabilizers.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients

Streptase 1 500 000:

1 injection vial with 147 to 192 mg dried substance contains 1 500 000 IU streptokinase.

1 injection vial with 139 to 182 mg dried substance contains 750 000 IU streptokinase.

Other ingredients

Human albumin, Sodium-L-hydrogen glutamate monohydrate, Sodium dihydrogenphosphate

dihydrate, Disodium hydrogenphosphate dihydrate.

PHARMACEUTICAL FORM AND PRESENTATIONS

Pharmaceutical form

Powder for intravenous or intraarterial administration after reconstitution with physiological saline.

Presentations

Streptase 1 500 000

1 vial of 1 500 000 IU streptokinase

Streptase 750 000

1 vial of 750 000 IU streptokinase

PHARMACOTHERAPEUTIC GROUP

Streptokinase (antithrombotic agents, enzymes).

ATC-code: B01A D01

THERAPEUTIC INDICATIONS

Streptase 750,000 IU: Acute myocardial infarction, deep vein thrombosis, pulmonary embolism,

acute or subacute thrombosis of peripheral arteries and chronic occlusive arterial diseases,

occlusion of central retinal artery or vein.

Streptase 1,500,000 IU:

Systemic administration: in deep vein thromboses, lung embolism, acute myocardial infarction for re-

opening of coronary vessels. In acute and subacute thromboses of peripheral arteries and chronic

occlusive arterial diseases, occlusion of central retinal artery or vein.

Local administration: in acute myocardial infarction for re-opening of coronary vessels, in acute,

subacute and chronic thromboses as well as embolisms of peripheral arteries.

CONTRAINDICATIONS

Streptase must not be used in case of severe allergic reactions to the product.

Because of the increased risk of haemorrhage under thrombolytic therapy, Streptase must not be

given in the following situations:

existing or recent internal haemorrhages

all forms of reduced blood coagulability, in particular spontaneous fibrinolysis and extensive

clotting disorders

recent cerebrovascular insultus, intracranial or intraspinal surgery

intracranial neoplasm

recent head trauma

arteriovenous malformation or aneurysm

known neoplasm with risk of haemorrhage

acute pancreatitis

uncontrollable hypertension with systolic values above 200 mmHg and/or diastolic values

above 100 mmHg or hypertensive retinal changes grades III/IV

recent implantation of a vessel prothesis

simultaneous treatment with oral anticoagulants (drugs which inhibit the coagulation) (INR>1.3)

severe liver or kidney damages

endocarditis or pericarditis. Isolated cases of a pericarditis, misdiagnosed as acute

myocardial infarction and treated with Streptase, have resulted in pericardial effusions

including tamponade.

known bleeding tendency

recent major operations (6

to 10

postoperative day, depending on the severity of surgical

intervention)

invasive operations, e.g. recent organ biopsy, long-term closed-chest cardiac massage.

Local administration

Also in local administration a systemic effect is possible. Therefore, the contraindications

mentioned above should also be considered for local administration.

Pregnancy and lactation

Due to the risk for the fetus, Streptase should only be given during pregnancy after careful

benefit-risk consideration. In the first 18 weeks of pregnancy, the use of streptokinase must be

restricted to vital indications only.

Information on the use of Streptase during breast-feeding is not available.

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Individual benefit/risk assessment

The risk of therapy in case of life-threatening thromboembolic events, in particular that of

haemorrhages, must be weighed against the anticipated benefit in cases such as:

recent severe gastrointestinal bleeding, e.g. active peptic ulcer

risk of severe local haemorrhage, e.g. in case of aortography by lumbar route (angiography of

principal artery of the lumbar vertebrae section)

recent trauma and cardiopulmonary resuscitation

invasive operations, e.g. recent intubation

puncture of non-compressible vessels, intramuscular injections

recent delivery, abortion (including miscarriage)

diseases of the urogenital tract with existing or potential sources of bleeding (implanted

bladder catheter)

known septic thrombotic disease

severe atherosclerotic vessel degeneration, cerebrovascular diseases

cavernous diseases (e.g. open tuberculosis)

mitral valve defects or atrial fibrillation.

Local administration

A systemic effect is also possible during local administration. Therefore, the special warnings

mentioned above should also be considered for local administration.

Antistreptokinase antibodies

Because of the increased likelihood of resistance due to antistreptokinase antibodies, re-treatment

with Streptase or streptokinase-containing products may not be effective if administered more

than 5 days, particularly between 5 days and 12 months, after initial treatment.

Likewise, the therapeutic effect may be reduced in patients with recent streptococcal infections

such as streptococcal pharyngitis, acute rheumatic fever, acute glomerulonephritis.

Infusion rate and corticosteroid prophylaxis

At the beginning of therapy, fall in blood pressure, increase in heart rate or decrease in heart

rate (in individual cases reaching as far as shock) are commonly observed. Therefore, at the

beginning of therapy the infusion should be performed slowly. Furthermore, corticosteroids can

be administered prophylactically.

Pre-treatment with heparin or coumarin derivatives

If the patient is under active heparinization, it should be neutralized by the administration of

protamine sulphate before the start of the thrombolytic therapy. The thrombin time should not

be more than twice the normal control value before thrombolytic therapy is started. In patients

previously treated with coumarin derivatives, the INR (International Normalized Ratio) must be

less than 1.3 before starting the streptokinase infusion.

Simultaneous treatment with acetylsalicylic acid

A positive, mutually reinforcing effect of acetylsalicylic acid and streptokinase on the life-expectancy

of patients with suspected myocardial infarction has been observed. The administration of

acetylsalicylic acid should commence prior to the streptokinase therapy and be continued for at

least one month.

Arterial puncture

Should an arterial puncture be necessary during intravenous therapy, upper extremity vessels are

preferable. After the puncture, pressure should be applied for at least 30 minutes by a compression

bandage, and the puncture site should be checked frequently for evidence of bleeding.

INTERACTIONS

WITH

OTHER

MEDICINAL

PRODUCTS

AND

OTHER

FORMS

OF

INTERACTIONS

Simultaneous or previous treatment with anticoagulants or substances which inhibit the platelet

formation or function (e.g. platelet aggregation inhibitors, dextrans) may increase the danger of

haemorrhage.

Before starting long-term systemic lysis of deep vein thromboses and arterial occlusions with

streptokinase, the effects of drugs which act upon platelet formation or function should be allowed

to subside (see “Special warnings and precautions for use”).

Incompatibilities

Not known.

For further dilution of the reconstituted solution special infusion solutions are recommended (see

also “Administration”).

DOSAGE AND ADMINISTRATION

Dosage

Note:

When

thrombolytic

therapy

necessary

high

antibody

concentration

against

streptokinase is present, or recent streptokinase therapy has been given (more than 5 days

and less than one year previously), homologous fibrinolytics should be used (see also “Special

warnings and precautions for use”).

Acute transmural myocardial infarction with persistent ST-segment elevation or recent left bundle-

branch block:

Systemic administration

In short-term lysis for the treatment of acute myocardial infarction 1.5 Mio IU Streptase are given

within 60 min.

Local administration

In acute myocardial infarction patients are given an intracoronary bolus of 20 000 IU Streptase on

average and a maintenance dose of 2000 IU to 4000 IU per min over 30 to 90 min.

Acute, subacute and chronic thromboses/embolisms of peripheral venous and arterial vessels

and chronic occlusive arterial diseases:

Systemic administration

In short-term thrombolysis, adults with peripheral venous and arterial vessel occlusions/ embolism,

receive an initial dose of 250 000 IU Streptase within 30 min, followed by a maintenance dose

of 1.5 Mio IU per hour over a maximum of six hours. The six-hour Streptase infusion can be

repeated on the following day, depending on the therapeutic success of lysis. However, repetition

of treatment must on no account be conducted later than 5 days after the first course.

As an alternative to short-term lysis, a long-term lysis for the treatment of peripheral occlusions

may be considered. An initial dose of 250 000 IU Streptase is given within 30 min, followed by

a maintenance dose of 100 000 IU per hour. The duration of therapy depends on the extension

and localisation of the vessel occlusion. In peripheral vessel occlusion the maximum duration is

5 days.

Local administration

Patients with acute, subacute and chronic peripheral thromboses and embolisms receive 1000 IU

to 2000 IU Streptase in intervals of 3 to 5 min. The duration of administration depends on the

length and localisation of the vessel occlusion and amounts up to 3 hours at a total dose of max.

120 000 IU Streptase.

A percutaneous transluminal angioplasty can be performed simultaneously, if necessary.

Occlusions of central retinal artery or vein:

Systemic administration

In case of thromboses of the central retinal vessels, lysis of arterial occlusions should be limited

to max. 24 hours and in venous occlusions to max. 72 hours. If continuation of thrombolysis

is indicated due to extensive thrombotic occlusions, therapy should be interrupted for one day,

followed by administration of a homologous fibrinolytic.

Dosage for neonates, infants and children:

Sufficient experience with Streptase therapy in children is not yet available. The benefit of

treatment has to be evaluated against the potential risks which may aggravate an acute life-

threatening situation.

Control of therapy

Systemic administration

In case of short-term lysis over six hours heparin should be administered during or following

Streptase infusion when the thrombin time (TT) or partial thromboplastin time (aPTT) have

reached less than twice or 1.5 times the normal control value, respectively. The TT and aPTT

should be prolonged to 2 to 4 fold and 1.5 to 2.5 fold the normal value, respectively, in order to

ensure sufficient protection against rethrombosis.

If the Streptase infusion is not repeated the heparin therapy is instituted simultaneously with the

administration of oral anticoagulants (see Follow-up treatment).

The long-term lysis is controlled with the thrombin time (TT). A 2 to 4 fold prolongation of the TT

which is considered as a sufficient anticoagulant protection has to be aimed at. Therefore, a

simultaneous administration of heparin may become necessary from the 16

hour of treatment.

If the TT after the 16

hour is still prolonged to more than 4 fold the normal control value, the

maintenance dose of Streptase has to be doubled for several hours until the TT recedes.

Local administration

As is usual with angiographies (x-ray of the vessels with the help of contrast media), heparin is

administered, if necessary, prior to the angiography as a safeguard against catheter-induced

thromboses. The success of therapy can be determined by the angiography. With a sufficient blood

flow of more than 15 minutes the therapy can be considered successful and then terminated.

Follow-up treatment

After every course of streptokinase therapy a follow-up treatment with anticoagulants or platelet

aggregation inhibitors can be instituted as a prevention of rethromboses. With heparin therapy,

in particular, an increased risk of haemorrhage must be considered. The heparin therapy is

controlled individually with the TT or aPTT. A 2 to 4 fold prolongation of the TT and 1.5 to 2.5 fold

coumarin derivatives or platelet aggregation inhibitors can be applied.

Administration

Streptase is administered intravenously or intraarterially. The duration of therapy depends on

the nature and extension of the vessel occlusion and differs according to the indication (see

“Dosage”).

Streptase is presented as a white lyophilisate. Upon reconstitution with physiological saline, a

colourless to yellowish, clear solution is obtained.

To ensure that the contents of the vial are rapidly and completely reconstituted, 5 ml of

physiological saline should be injected into the Streptase vacuum vial, and the residual vacuum

abolished by briefly loosening the needle from the syringe.

For administration with an infusion pump, physiological saline, Ringer-lactate solution, 5%

glucose or laevulose solution can be used as diluent. For higher dilutions, especially when good

stability is required over longer periods, polygeline can be used as diluent.

UNDESIRABLE EFFECTS

If you experience reactions, especially those which are not mentioned in this package insert,

please inform your doctor or pharmacist.

The following adverse reactions are based on experience from clinical trials and on postmarketing

experience. The following standard categories of frequency are used:

Very common

>

1/10

Common

>

1/100 and < 1/10

Uncommon

>

1/1,000 and < 1/100

Rare

>

1/10,000 and < 1/1,000

Very rare

<

1/10,000 (including reported single cases)

Blood disorders

Common

: Haemorrhages at the injection site and ecchymoses. Gastrointestinal or urogenital

bleedings, epistaxis.

Uncommon: Cerebral haemorrhages with their complications and possible fatal outcome, retinal

haemorrhages, severe haemorrhages (also with fatal outcome) including liver haemorrhages,

retroperitoneal bleedings, splenic rupture. Blood transfusions are rarely required.

Very rare: Haemorrhages into the pericardium including myocardial rupture during thrombolytic

treatment of acute myocardial infarction.

In severe haemorrhagic complications the Streptase therapy is discontinued and a proteinase

inhibitor, e.g. aprotinin, administered in the following dosage: Initially 500 000 KIU , if necessary

up to 1 million KIU, followed by 50 000 KIU per hour by intravenous drip until the bleeding

stops. In addition, combination with synthetic antifibrinolytics is recommended. If necessary,

coagulation factors can be administered. Additional administration of synthetic antifibrinolytics

was reported to be efficient in single cases of bleeding episodes.

Immune system disorders

Very common: Development of antistreptokinase antibodies (see also “Special warnings and

special precautions for use”).

Common: Allergic-anaphylactic reactions with rash, flushing, itching, urticaria, angioneurotic

edema, dyspnoea, bronchospasm or fall in blood pressure.

Very rare: Delayed allergic reactions, such as serum sickness, arthritis, vasculitis, nephritis

and neuroallergic symptoms, polyneuropathy,( e.g. Guillain Barré syndrome), severe allergic

reactions up to shock including respiratory arrest.

Mild or moderate allergic reactions may be managed with concomitant antihistamine and/or

corticosteroid therapy. If a severe allergic/anaphylactic reaction occurs the administration of

Streptase has to be discontinued immediately and an appropriate treatment should be initiated.

The current medical standards for shock treatment should be observed. Lysis therapy should be

continued with homologous fibrinolytics.

Nervous system disorders

Rare: Neurologic symptoms (e.g. dizziness, confusion, paralysis, hemiparesis, restlessness

or convulsions in the context of cerebral haemorrhages or cardiovascular disorders with

hypoperfusion of the brain.

Cardiac complication and vascular disorders

Common: At the beginning of therapy fall in blood pressure, tachycardia or bradycardia (see also

“Special warnings and special precautions for use”, subheading “Infusion rate and corticosteroid

prophylaxis”).

Very rare: Crystal cholesterol embolism.

In the setting of fibrinolytic therapy with Streptase in patients with myocardial infarction the

following events have been reported as complications of myocardial infarction and/or symptoms

of reperfusion:

Very common: Fall in blood pressure, heart rate and rhythm disorders, angina pectoris

Common: Recurrent ischaemia (depletion of blood), heart failure, reinfarction, cardiogenic

shock, pericarditis, pulmonary oedema.

These cardiovascular complications can be life-threatening and may lead to death.

During local lysis of peripheral arteries, distal embolization cannot be excluded.

Respiratory disorders

Very rare: Non-cardiogenic pulmonary edema after intracoronary thrombolytic therapy in

patients with extensive myocardial infarction.

Gastrointestinal disorders

Common: Nausea, diarrhoea, epigastric pain and vomiting.

General disorders

Common: Headache and back pain, muscle pain, chills and/or rise in temperature as well as

faintness/ weariness.

Investigations

Common: Transient elevations of serum transaminases (liver function parameters) as well as

of bilirubin.

STORAGE AND STABILITY

Streptase is to be stored at +2 to +25 °C.

Once reconstituted with physiological saline, the physico-chemical stability has been demonstrated

for 24 hours at +2 to +8 °C. From a microbiological point of view and as Streptase contains

no preservative, the reconstituted product should be used immediately. If it is not administered

immediately, storage shall not exceed 24 hours at +2 to +8 °C.

Streptase must not be used after the expiry date given on the pack and container.

Keep out of the reach of children!

Manufacturer:

CSL Behring GmbH, Germany

Emil-von-Behring-Str.76

D-35041 Marburg

Germany

Genmedix, 12 Beit Harishonim St. Emek-Hefer 38777

The format of this leaflet has been determined by the Ministry of Health and its content has been

examined and approved in November 2012.

Registration holder:

SH Z550051009999B/STR OCT14

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