Prospect: information for the user

Metalyse 8000units (40 mg) powder and solvent for injectable solution

Metalyse 10000units (50 mg) powder and solvent for injectable solution

tenecteplasa

Read this prospect carefully before this medicine is administered to you,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Metalyse and for what it is used

2.What you need to know before Metalyse is administered to you

3.How Metalyse is administered

4.Possible adverse effects

5.Storage of Metalyse

6.Contents of the package and additional information

Metalyse is composed of powder and solvent for injectable solution.

Metalyse belongs to a group of medications called thrombolytics. These medications contribute to the dissolution of blood clots. Tenecteplase is a recombinant plasminogen activator specific for fibrin.

Metalyse is used for the treatment of myocardial infarctions (heart attacks) within 6 hours of symptom onset and contributes to the dissolution of blood clots that have formed in the coronary blood vessels. This helps to prevent damage caused by heart attacks and has been shown to save lives.

Metalyse will not be prescribed or administered by your doctor

• if you have previously experienced a sudden allergic reaction that put your life at risk (severe hypersensitivity) to tenecteplase,to any of the other components of this medication (listed in section6) orto gentamicin (a residual substance from the manufacturing process).If treatment with Metalyse is considered necessary, resuscitation resources must be immediately available for use in case of need;

-if you have, or have recently had, a condition that increases your risk of bleeding (hemorrhage), including:

• bleeding disorder or tendency to bleed
• stroke (cerebrovascular accident)
• very high, uncontrolled blood pressure
• head trauma
• severe liver disease
• stomach ulcer (peptic ulcer)
• varicose veins in the esophagus (esophageal varices)
• vascular anomaly (e.g., aneurysm)
• specific tumors
• inflammation of the heart's outer layer (pericarditis); inflammation or infection of the heart valves (endocarditis)
• dementia;

• if you are taking tablets/capsules to "thin" the blood, such as coumarin derivatives like warfarin (anticoagulants);
• if you have pancreatitis;
• if you have recently undergone major surgery, including cerebral or spinal surgery;
• if you have received cardiopulmonary resuscitation (chest compressions) for more than 2 minutes in the past two weeks.

Warnings and precautions

Your doctor will take special care with Metalyse

• if you have had any allergic reaction other than sudden allergic reactions that put your life at risk (severe hypersensitivity) to tenecteplase, to any of the other components of this medication (listed in section 6)or to gentamicin (a residual substance from the manufacturing process);
• if you have high blood pressure;
• if you have problems with cerebral blood circulation (cerebrovascular disease);
• if you have experienced gastrointestinal or genitourinary bleeding in the past ten days (this could cause the presence of blood in the stool or urine);
• if you have a heart valve anomaly (e.g., mitral stenosis) with an abnormal heart rhythm (e.g., atrial fibrillation);
• if you have received an intramuscular injection in the past two days;
• if you are over 75 years old;
• if you weigh less than 60kg;
• if you have been previously administered Metalyse.

Children and adolescents

Metalyse is not recommended for use in children and adolescents until the age of 18years.

Other medications and Metalyse

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before this medication is administered.

The doctor calculates your dose of Metalyse according to your body weight, as follows:

Your doctor will administer a medication to prevent blood coagulation, in addition to Metalyse, as soon as possible after the onset of chest pain.

Metalyse is administered via a single injection into a vein by an experienced doctor in the use of this type of medication.

Your doctor will administer Metalyse as soon as possible after the onset of your chest pain, in the form of a single dose.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects described below have been experienced by patients who have received Metalyse:

Very common (may affect more than 1 in 10 people):

• bleeding

Common (may affect up to 1 in 10 people):

• bleeding at the injection or puncture site
• nasal bleeding
• genitourinary bleeding (you may notice blood in your urine)
• bruising
• gastrointestinal bleeding (e.g., stomach or intestinal bleeding)

Rare (may affect up to 1 in 100 people):

• irregular heartbeats (arrhythmias due to reperfusion), which occasionally lead to cardiac arrest. Cardiac arrest (heart) may put your life at risk.
• internal bleeding in the abdomen (retroperitoneal bleeding)
• bleeding in the brain (cerebral hemorrhage). After a brain hemorrhage or other severe bleeding events, death or permanent disability may occur.

• bleeding in the eyes (ocular hemorrhage)

Frequency not known (cannot be estimated from available data):

• low blood pressure (hypotension)
• bleeding in the lungs (pulmonary hemorrhage)
• hypersensitivity (anaphylactoid reactions), e.g., rash, urticaria, difficulty breathing (bronchospasm)

• bleeding in the area around the heart (pericardial bleeding)
• blood clots in the lungs (pulmonary embolism) and in the vessels of other organ systems (thrombotic embolism)

Frequency not known (cannot be estimated from available data):

• fat embolism (clots formed by fat)
• nausea
• vomiting
• increased body temperature (fever)
• blood transfusions as a result of bleeding

Like other thrombolytic agents, the following events have been described as sequelae of myocardial infarction and/or administration of thrombolytics:

Very common (may affect more than 1 in 10 people):

• low blood pressure (hypotension)
• irregular heartbeats
• chest pain (angina pectoris)

Common (may affect up to 1 in 10 people):

• additional chest pain/angina (recurrent ischemia)
• heart attack
• heart failure
• cardiac shock due to heart failure
• inflammation of the heart lining
• fluid in the lungs (pulmonary edema)

Rare (may affect up to 1 in 100 people):

• cardiac arrest
• problems with the heart valve or heart lining (mitral valve regurgitation, pericardial effusion)
• blood clots in the veins (thrombosis)
• fluid between the heart lining and the heart (cardiac tamponade)
• rupture of the heart muscle (myocardial rupture)

Rare (may affect up to 1 in 10,000 people):

• blood clots in the lungs (pulmonary embolism)

These cardiovascular events may be potentially fatal and may lead to death.

In the case of cerebral hemorrhages, the following effects related to the nervous system have been described, e.g., drowsiness, speech disorders, paralysis of parts of the body (hemiparesis), and convulsions.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or nurse, even if it ispossibleside effects that do not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and the box after CAD.

Do not store at a temperature above 86°F.

Store the container in the outer packaging to protect it from light.

Once reconstituted, Metalyse can be stored for 24 hours at 39‑58°F and 8 hours at 86°F. However, for microbiological reasons, your doctor will usually use the reconstituted injectable solution immediately.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose ofthe containers and medications that you no longerneed.This will help protect the environment.

Composition of Metalyse

• The active principle is tenecteplase.
• Each vial contains 8,000 units (40 mg) of tenecteplase. Each pre-filled syringe contains 8 ml of solvent. Each ml contains 1,000 units of tenecteplase when reconstituted with 8 ml of solvent.

or

• Each vial contains 10,000 units (50 mg) of tenecteplase. Each pre-filled syringe contains 10 ml of solvent. Each ml contains 1,000 units of tenecteplase when reconstituted with 10 ml of solvent.
• The other components are arginine, concentrated phosphoric acid, and polisorbate 20.
• The solvent is water for injection.
• It contains gentamicin as a residual substance from the manufacturing process.

Appearance of the product and contents of the pack

The box contains:

• one vial with a lyophilized powder containing 40 mg of tenecteplase, a pre-filled syringe prepared for use with 8 ml of solvent, and a vial adapter.

or

• one vial with a lyophilized powder containing 50 mg of tenecteplase, a pre-filled syringe prepared for use with 10 ml of solvent, and a vial adapter.

Marketing authorization holder and manufacturer

Marketing authorization holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Birkendorfer Strasse 65

88397 Biberach/Riss

Germany

Boehringer Ingelheim France

100-104 avenue de France

75013 Paris

France

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.