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METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION

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About the medicine

How to use METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Metalyse 50,000 units (25 mg) powder for solution for injection

tenecteplase

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 pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Metalyse and what is it used for
  2. What you need to know before you are given Metalyse
  3. How Metalyse is given
  4. Possible side effects
  5. Storage of Metalyse
  6. Contents of the pack and other information

1. What is Metalyse and what is it used for

Metalyse is a powder for solution for injection.

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

Metalyse is used in adults for the treatment of stroke caused by a blood clot in an artery of the brain (acute ischaemic stroke) when it has been less than 4.5 hours since you last did not have the symptoms of your current stroke.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you are given Metalyse

Metalyse will not be prescribed or given to you by your doctor

  • if you have previously had a severe allergic reaction (anaphylaxis) to tenecteplase, to any of the other ingredients of this medicine (listed in section 6) or to gentamicin (a residual substance from the manufacturing process). If treatment with Metalyse is still considered necessary, resuscitation equipment must be available for immediate use if needed;
  • if you have, or have recently had, a condition that increases your risk of bleeding (haemorrhage), including:
  • a bleeding disorder or tendency to bleed;
  • very high blood pressure, which is not controlled;
  • a head trauma;
  • inflammation of the layer surrounding the heart (pericarditis); inflammation or infection of the heart valves (endocarditis);
  • severe liver disease;
  • varices of the oesophagus;
  • a stomach ulcer (peptic ulcer);
  • a blood vessel abnormality (e.g. an aneurysm);
  • certain tumours;
  • bleeding in the brain or skull;
  • if you are taking anticoagulant tablets/capsules, unless a suitable test has confirmed that the medicine is not clinically active;
  • if you have a very severe stroke;
  • if your stroke only causes mild symptoms;
  • if your symptoms improve quickly before you receive Metalyse;
  • if your stroke symptoms started more than 4.5 hours ago or if it is possible that your symptoms started more than 4.5 hours ago, because you do not know when they started;
  • if you had seizures at the start of your stroke;
  • if your thromboplastin time (a blood test to see how your blood clots) is abnormal. This test may be abnormal if you have received heparin (a medicine used to thin the blood) in the last 48 hours;
  • if you have diabetes and have previously had a stroke;
  • if you have had a stroke in the last three months;
  • if the number of platelets (thrombocytes) in your blood is very low;
  • if you have very high blood pressure (above 185/110 mmHg) that can only be lowered by injecting medicines;
  • if the amount of sugar (glucose) in your blood is very low (below 50 mg/dl) or very high (above 400 mg/dl);
  • if you have recently undergone major surgery, including brain or spinal surgery;
  • if you have recently had a biopsy (a procedure to obtain a tissue sample);
  • if you have had cardiopulmonary resuscitation (chest compressions) for more than 2 minutes in the last two weeks;
  • if you have pancreatitis.

Warnings and precautions

Your doctor will be particularly careful with Metalyse

  • if you have had any allergic reaction other than a severe allergic reaction (anaphylaxis) to tenecteplase, to any of the other ingredients of this medicine (listed in section 6) or to gentamicin (a residual substance from the manufacturing process);
  • if you have, or have recently had, any other condition that increases the risk of bleeding, for example:
  • an intramuscular injection
  • a minor injury such as a puncture of large vessels or external cardiac massage
  • if you weigh less than 60 kg;
  • if you are over 80 years old, you may have a worse outcome, regardless of treatment with Metalyse.

However, in general, the benefit/risk balance of Metalyse in patients over 80 years old is positive and age alone is not an obstacle to treatment with Metalyse;

  • if you have been given Metalyse before.

Children and adolescents

Metalyse is not recommended for use in children and adolescents under 18 years.

Other medicines and Metalyse

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are taking or have recently taken:

  • any medicine used to thin the blood;
  • certain medicines used to treat high blood pressure (ACE inhibitors).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

3. How Metalyse is given

Your doctor will calculate your dose of Metalyse according to your body weight, as follows:

Body weight (kg)

Less than 60

60 to 70

70 to 80

80 to 90

Above 90

Metalyse (U)

3,000

3,500

4,000

4,500

5,000

Metalyse is given as a single injection into a vein by a doctor with experience in the use of this type of medicine.

Your doctor will give you Metalyse as soon as possible after the start of your stroke, as a single dose.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

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

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

  • bleeding
  • bleeding in the brain (cerebral haemorrhage). After a brain haemorrhage or other serious bleeding events, death or permanent disability may occur.

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

  • bleeding at the injection or puncture site
  • nosebleeds
  • genitourinary bleeding (you may see blood in your urine)
  • bruising
  • gastrointestinal bleeding (e.g. bleeding from the stomach or intestine)

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

  • internal bleeding in the abdomen (retroperitoneal haemorrhage)
  • bleeding in the eyes (ocular haemorrhage)

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

  • low blood pressure (hypotension)
  • bleeding in the lungs (pulmonary haemorrhage)
  • hypersensitivity (anaphylactoid reactions), e.g. rash, urticaria, difficulty breathing (bronchospasm)
  • bleeding in the area surrounding the heart (haemopericardium)
  • blood clots in the lungs (pulmonary embolism) and in the blood vessels of other organ systems (thrombotic embolisms)

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Metalyse

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

Do not use this medicine after the expiry date which is stated on the label and carton after EXP.

Do not store above 30°C.

Store in the original package to protect from light.

Once reconstituted, Metalyse can 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 immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Metalyse contains

  • The active substance is tenecteplase.
  • Each vial contains 50,000 units (25 mg) of tenecteplase. Each ml contains 1,000 units of tenecteplase when reconstituted with 5 ml of water for injections.
  • The other ingredients are arginine, phosphoric acid concentrated and polysorbate 20.
  • It contains gentamicin as a residual substance from the manufacturing process.

Appearance and pack contents

The pack contains one vial with 25 mg of tenecteplase as a lyophilised powder.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

You can get more information about this medicine by contacting the local representative of the marketing authorisation holder:

Belgium

Boehringer Ingelheim SComm

Tel: +32 2 773 33 11

Lithuania

Boehringer Ingelheim RCV GmbH & Co KG

Lithuanian branch

Tel: +370 5 2595942

Bulgaria

Boehringer Ingelheim Bulgaria EOOD

Tel: +359 2 958 79 98

Luxembourg

Boehringer Ingelheim SComm

Tel: +32 2 773 33 11

Czech Republic

Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111

Hungary

Boehringer Ingelheim RCV GmbH & Co KG Hungarian branch

Tel: +36 1 299 89 00

Denmark

Boehringer Ingelheim Danmark A/S

Tel: +45 39 15 88 88

Malta

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Netherlands

Boehringer Ingelheim B.V.

Tel: +31 (0) 800 22 55 889

Estonia

Boehringer Ingelheim RCV GmbH & Co KG

Estonian branch

Tel: +372 612 8000

Norway

Boehringer Ingelheim Norway KS

Tel: +47 66 76 13 00

Greece

Boehringer Ingelheim Hellas Single Member S.A.

Tel: +30 2 10 89 06 300

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +43 1 80 105-7870

Spain

Boehringer Ingelheim España, S.A.

Tel: +34 93 404 51 00

Poland

Boehringer Ingelheim Sp. z o.o.

Tel: +48 22 699 0 699

France

Boehringer Ingelheim France S.A.S.

Tel: +33 3 26 50 45 33

Portugal

Boehringer Ingelheim Portugal, Lda.

Tel: +351 21 313 53 00

Croatia

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

Romania

Boehringer Ingelheim RCV GmbH & Co KG Vienna - Bucharest branch

Tel: +40 21 302 28 00

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Slovenia

Boehringer Ingelheim RCV GmbH & Co KG Ljubljana branch

Tel: +386 1 586 40 00

Iceland

Vistor hf.

Tel: +354 535 7000

Slovakia

Boehringer Ingelheim RCV GmbH & Co KG organizational unit

Tel: +421 2 5810 1211

Italy

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Finland

Boehringer Ingelheim Finland Ky

Tel: +358 10 3102 800

Cyprus

Boehringer Ingelheim Hellas Single Member S.A.

Tel: +30 2 10 89 06 300

Sweden

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

Latvia

Boehringer Ingelheim RCV GmbH & Co KG Latvian branch

Tel: +371 67 240 011

United Kingdom (Northern Ireland)

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Date of last revision of this leaflet:{MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

The leaflet can be found in all EU/EEA languages on the European Medicines Agency website.

Online doctors for METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION

Discuss questions about METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

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General medicine 15 years exp.

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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

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  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
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Doctor

Sviatoslav Chekhun

Oncology 13 years exp.

Dr. Sviatoslav Chekhun is a medical oncologist with international clinical and research experience, specializing in modern medical oncology and a personalized approach to cancer treatment.

Currently (since 2025), he works as a Medical Oncologist at Institut Català d’Oncologia (Girona, Spain). Previously, he completed his residency in Medical Oncology and was involved in clinical research at Hospital Universitari Germans Trias i Pujol.

Dr. Chekhun has a strong academic and scientific background. He served as a lecturer in Internal Medicine at O.O. Bohomolets National Medical University and conducted research in experimental oncology at the R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology.

Earlier in his career, he worked as a medical oncologist at the Kyiv City Clinical Oncological Center and contributed to regulatory evaluation of medicinal products at the State Expert Center of the Ministry of Health of Ukraine.

When to consult Dr. Chekhun:

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Dr. Chekhun provides online consultations, where you can receive:

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Prescription and monitoring of medications must be carried out by your treating physician in an in-person (offline) setting. An online consultation does not replace a face-to-face visit but helps you make more informed decisions about your treatment.

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Frequently Asked Questions

Is a prescription required for METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION?
METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION?
The active ingredient in METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION is tenecteplase. This information helps identify medicines with the same composition but different brand names.
Who manufactures METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION?
METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION is manufactured by Boehringer Ingelheim International Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to METALYSE 5,000 UNITS (25 MG) POWDER FOR INJECTABLE SOLUTION?
Other medicines with the same active substance (tenecteplase) include METALYSE 10,000 UNITS (50 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION, METALYSE 8,000 UNITS (40 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION, ACTILYSE powder and solvent for injectable solution and for infusion. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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