Metalyse 8,000 units. Powder and solvent for solution forinjection

METALYSE is a powder and solvent for solution for injection. This means that each pack contains:

• one vial of 8,000 units METALYSE powder and one pre-filled syringe containing 8 ml water for injections

Before use, the solvent (water for injections) is added to the powder to form a solution that is given by injection.

METALYSE belongs to a group of medicines called thrombolytic agents. These medicines help to dissolve blood clots. Tenecteplase is a recombinant fibrin-specific plasminogen activator.

METALYSE is used to treat myocardial infarctions (heart attacks) within 6 hours after the onset of symptoms and helps to dissolve the blood clots that have formed in the blood vessels of the heart. This helps to prevent the damage caused by heart attacks and has been shown to save lives.

METALYSE will not be prescribed and given by your doctor

• if you have previously had a sudden life-threatening allergic reaction (severe hypersensitivity) to the active ingredient tenecteplase, to gentamicin (a trace residue from the manufacturing process) or any of the other ingredients of METALYSE. If treatment with Metalyse is nevertheless considered to be necessary, facilities for reanimation should be immediately available in case of need;
• if you have, or have recently had, an illness that increases your risk of bleeding (haemorrhage), including:

a bleeding disorder or tendency to bleed (haemorrhage)
stroke (cerebrovascular event)
very high, uncontrolled blood pressure
a head injury
severe liver disease
a stomach ulcer (peptic ulcer)

varicose veins in the gullet (oesophageal varices)
abnormality of the blood vessels (e.g. an aneurysm)
certain tumours
inflammation of the lining around the heart (pericarditis); inflammation or infection of the heart valves (endocarditis);

• if you are taking tablets/capsules used to ?thin? the blood, such as warfarin or coumarin (anti-coagulants);
• if you have an inflamed pancreas (pancreatitis);
• if you have recently had major surgery including surgery to your brain or spine;
• if you have been given cardiopulmonary resuscitation (chest compressions) for more than 2 minutes duration, in the last two weeks.

Your doctor will take special care with METALYSE

• if you have had any allergic reaction other than a sudden life-threatening allergic reaction (severe hypersensitive) to the active substance tenecteplase, to gentamicin (a trace residue from the manufacturing process), or to any of the other ingredients of Metalyse (see section 6: ?Further information?);
• if you have high blood pressure;
• if you have problems with circulation of blood in the brain (cerebrovascular disease);
• if you have had gastrointestinal (gut) or genitourinary bleeding within the last ten days (this may cause blood in stools or urine);
• if you have a heart valve abnormality (e.g. mitral stenosis) with an abnormal heart rhythm (e.g. atrial fibrillation);
• if you have had an intramuscular injection in the last two days;
• if you are aged over 75 years;
• if you weigh less than 60 kg.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding
Ask your doctor for advice before you are given METALYSE.

The doctor calculates your dose of METALYSE according to your bodyweight, based on the following scheme:

Bodyweight kg less than 60 60 to 70 70 to 80 80 to 90 above 90 Metalyse U 6,000 7,000 8,000 9,000 10,000

Your doctor will give you medication to prevent blood clotting in addition to METALYSE, as soon as possible after your chest pain starts.

METALYSE is given by a single injection into a vein by a doctor who is experienced in the use of this type of drug.

Your doctor will give METALYSE as soon as possible after your chest pain starts as a single dose.

Repetition is not recommended.

Like all medicines, METALYSE can cause side effects, although not everybody gets them.

Evaluation of side effects is based on the following frequencies:

very common affects more than 1 user in 10 common affects 1 to 10 users in 100 uncommon affects 1 to 10 users in 1,000 rare affects 1 to 10 users in 10,000 very rare affects less than 1 user in 10,000 not known frequency cannot be estimated from the available data

The side effects described below have been experienced by people given METALYSE:

Very Common:

• bleeding

Common:

• bleeding at the injection or puncture site
• nosebleeds
• genitourinary bleeding (you may notice blood in your urine)
• bruising
• gastro-intestinal bleeding (e.g. bleeding from the stomach or bowel)

Uncommon:

• irregular heart beat (reperfusion arrhythmias), sometimes leading to cardiac arrest
• internal bleeding in the abdomen (retroperitoneal bleeding)
• bleeding in the brain (cerebral haemorrhage). Death or permanent disability may occur following bleeding in the brain or other serious bleeding events
• bleeding in the eyes (eye haemorrhage)

Rare:

• low blood pressure (hypotension)
• bleeding in the lungs (pulmonary haemorrhage)
• hypersensitivity (anaphylactoid reactions) e.g. rash, hives (urticaria), swelling of the throat
• bleeding into the area surrounding the heart (haemopericardium)
• blood clot in the lung (pulmonary embolism) and in the vessels of other organ systems (thrombotic embolisation)

Not known:

• fat embolism (clots consisting of fat)
• nausea
• vomiting
• body temperature increased (fever)
• blood transfusions as consequence of bleedings

As with other thrombolytic agents, the following events have been reported as sequelae of myocardial

infarction and/or thrombolytic administration:

Very common:

• Low blood pressure (hypotension)
• Irregular heart beat
• Chest pain (angina pectoris)

Common:

• Further heart attack (recurrent ischaemia)
• Heart failure
• Shock due to heart failure
• Inflammation of the lining around the heart
• Fluid in the lungs (pulmonary oedema)

Uncommon:

• Heart arrest
• Problem with the heart valve or heart lining (mitral valve incompetence, pericardial effusion)
• Blood clot in the veins (venous thrombosis)
• Fluid between the heart lining and the heart (cardiac tamponade)
• Rupture of the heart muscle (myocardial rupture)

Rare:

• Blood clot in the lung (pulmonary embolism)

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

In case of bleeding in the brain events related to the nervous system have been reported e.g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).

Tell your doctor immediately if you think you are experiencing any of these side effects.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not store above 30°C.
Keep the container in the outer carton in order to protect from light.

Once METALYSE has been reconstituted it may be stored for 24 hours at 2-8°C and 8 hours at 30°C. However, for microbiological reasons your doctor will normally use the reconstituted solution for injection immediately.

Do not use METALYSE after the expiry date which is stated on the label/carton.

What METALYSE contains

• The active substance is tenecteplase. One vial contains 8,000 units of tenecteplase. One pre-filled syringe contains 8 ml of water for injections.
• The other ingredients are L-arginine, phosphoric acid and polysorbate 20.
• The METALYSE solvent is water for injections.
• Gentamicin is contained as trace residue from the manufacturing process

What METALYSE looks like and contents of the pack

The folding box contains one vial with a lyophilised powder, one ready for use syringe with a solvent, one vial adapter and one needle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG
Birkendorfer Strasse 65
D-88397 Biberach/Riss
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgienSCS Boehringer Ingelheim Comm.V TélTel 32 2 773 33 11 LuxembourgLuxemburgSCS Boehringer Ingelheim Comm.V TélTel 32 2 773 33 1

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eská republika Boehringer Ingelheim spol. s r.o. Tel 420 234 655 111 MaltaBoehringer Ingelheim Ltd.Tel 44 1344 424 60

Danmark Boehringer Ingelheim Danmark AS Tlf 45 39158888 NederlandBoehringer Ingelheim b.v.Tel 31 0 800 22 55 88

Deutschland Boehringer Ingelheim Pharma GmbH Co. KGTel 49 0 800 77 90 900 NorgeBoehringer Ingelheim Norway KS Tlf 47 66 76 13 0

Eesti Boehringer Ingelheim RCV GmbH Co KGEesti filiaal Tel 372 60 80 940 ÖsterreichBoehringer Ingelheim RCV GmbH Co KGTel 43 1 80 105-

E Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 PolskaBoehringer Ingelheim Sp.zo.o. Tel. 48 22 699 0 69

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Lietuva

Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 37 473922

This leaflet was last approved in {MM/YYYY}.