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METALYSE 8,000 UNITS (40 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION

METALYSE 8,000 UNITS (40 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Ask a doctor about a prescription for METALYSE 8,000 UNITS (40 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION

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Doctor

Tarek Agami

General medicine11 years of experience

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
  • Evaluation of symptoms and guidance on further diagnostic testing
  • Preventive check-ups and regular health monitoring
  • Medical support during travel or after relocation
  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Doctor

Nuno Tavares Lopes

Family medicine18 years of experience

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management
  • Travel medicine: pre-travel advice, vaccinations, fit-to-fly certificates, travel-related illnesses
  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment
  • Weight management and wellness: personalised weight loss programmes, lifestyle guidance
  • Skin and ENT issues: acne, eczema, allergies, rashes, sore throat, sinusitis
  • Pain management: acute and chronic pain, post-surgical care
  • Public health: prevention, health screenings, long-term monitoring
  • Sick leave (Baixa médica) connected to Segurança Social in Portugal
  • IMT medical certificates for driving licence exchange
Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use METALYSE 8,000 UNITS (40 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Metalyse 8,000 units (40 mg) powder and solvent for solution for injection

Metalyse 10,000 units (50 mg) powder and solvent 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 Metalyse is and what it is 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 Metalyse is and what it is used for

Metalyse is a powder and solvent 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 to treat heart attacks (myocardial infarction) within 6 hours of the start of symptoms and helps to dissolve blood clots that have formed in the heart's blood vessels. This helps to prevent damage caused by heart attacks and has been shown to save lives.

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 (hypersensitivity) 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
  • stroke (cerebrovascular accident)
  • very high blood pressure, not controlled
  • a head injury
  • severe liver disease
  • a stomach ulcer (peptic ulcer)
  • varices in the oesophagus (oesophageal varices)
  • blood vessel abnormalities (e.g. an aneurysm)
  • certain tumours
  • inflammation of the heart lining (pericarditis); inflammation or infection of the heart valves (endocarditis)
  • dementia;
  • if you are taking tablets/capsules to "thin" the blood, such as warfarin (anticoagulants);
  • if you have pancreatitis (inflammation of the pancreas);
  • if you have recently had major surgery, including brain or spinal surgery;
  • if you have had cardiopulmonary resuscitation (chest compressions) for more than 2 minutes in the last 2 weeks.

Warnings and precautions

Your doctor will take special care with Metalyse

  • if you have had any allergic reaction other than a severe allergic reaction (hypersensitivity) 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 high blood pressure;
  • if you have problems with blood circulation in the brain (cerebrovascular disease);
  • if you have had bleeding in the gut or urinary tract in the last 10 days (this could cause blood to appear in your stools or urine);
  • if you have a heart valve abnormality (e.g. mitral stenosis) with an irregular heartbeat (e.g. atrial fibrillation);
  • if you have had an intramuscular injection in the last 2 days;
  • if you are over 75 years old;
  • if you weigh less than 60 kg;
  • 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.

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

Over 90

Metalyse (U)

6,000

7,000

8,000

9,000

10,000

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

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 chest pain, as a single dose.

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 given 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
  • nosebleeds
  • genitourinary bleeding (you may see blood in your urine)
  • bruising
  • gastrointestinal bleeding (e.g. bleeding from the stomach or intestines)

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

  • irregular heartbeats (reperfusion arrhythmias), which occasionally lead to cardiac arrest. Cardiac arrest can be life-threatening.
  • internal bleeding in the abdomen (retroperitoneal bleeding)
  • bleeding in the brain (cerebral bleeding). After a brain bleed or other serious bleeding events, death or permanent disability can occur.
  • bleeding in the eyes (ocular bleeding)

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

  • low blood pressure (hypotension)
  • bleeding in the lungs (pulmonary bleeding)
  • allergic reactions (anaphylactoid reactions), e.g. rash, hives, 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

As with other thrombolytic agents, the following events have been reported as a consequence of myocardial infarction and/or thrombolytic administration:

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

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

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

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

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

  • cardiac arrest
  • problems with the heart valve or heart lining (mitral regurgitation, pericardial effusion)
  • blood clots in the veins (venous 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 1,000 people):

  • blood clots in the lungs (pulmonary embolism)

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

In the case of brain bleeding, effects related to the nervous system have been reported, e.g. drowsiness, speech disorders, paralysis of parts of the body (hemiparesis) and convulsions.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects 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 the pack in the outer carton to protect from light.

After reconstitution, 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. These measures will help to protect the environment.

6. Contents of the pack and other information

What Metalyse contains

  • The active substance 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 ingredients are arginine, phosphoric acid, and polysorbate 20.
  • The solvent is water for injections.
  • It contains gentamicin as a residual substance from the manufacturing process.

Appearance and pack contents

The pack contains:

  • a vial with 40 mg of tenecteplase as a lyophilised powder, a pre-filled syringe with 8 ml of solvent, and a vial adapter.

or

  • a vial with 50 mg of tenecteplase as a lyophilised powder, a pre-filled syringe with 10 ml of solvent, and a vial adapter.

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:

België/Belgique/Belgien

Lietuva

Boehringer Ingelheim SComm

Boehringer Ingelheim RCV GmbH & Co KG

Tél/Tel: +32 2 773 33 11

Lietuvos filialas

Tel: +370 5 2595942

България

Luxembourg/Luxemburg

Бохрингер Ингелхайм България ЕООД

Boehringer Ingelheim SComm

Tél/Tel: +32 2 773 33 11

Tел: +359 2 958 79 98

Ceská republika

Magyarország

Boehringer Ingelheim spol. s r.o.

Boehringer Ingelheim RCV GmbH & Co KG

Magyarországi Fióktelepe

Tel: +420 234 655 111

Tel: +36 1 299 89 00

Danmark

Malta

Boehringer Ingelheim Danmark A/S

Boehringer Ingelheim Ireland Ltd.

Tlf: +45 39 15 88 88

Tel: +353 1 295 9620

Deutschland

Nederland

Boehringer Ingelheim Pharma GmbH & Co. KG

Boehringer Ingelheim B.V.

Tel: +49 (0) 800 77 90 900

Tel: +31 (0) 800 22 55 889

Eesti

Norge

Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal

Boehringer Ingelheim Norway KS

Tel: +372 612 8000

Tlf: +47 66 76 13 00

Ελλάδα

Österreich

Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.

Boehringer Ingelheim RCV GmbH & Co KG

Τηλ: +30 2 10 89 06 300

Tel: +43 1 80 105-7870

España

Polska

Boehringer Ingelheim España, S.A.

Boehringer Ingelheim Sp. z o.o.

Tel: +34 93 404 51 00

Tel: +48 22 699 0 699

France

Portugal

Boehringer Ingelheim France S.A.S.

Boehringer Ingelheim Portugal, Lda.

Tél: +33 3 26 50 45 33

Tel: +351 21 313 53 00

Hrvatska

România

Boehringer Ingelheim Zagreb d.o.o.

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +385 1 2444 600

Viena - Sucursala Bucuresti

Tel: +40 21 302 28 00

Ireland

Slovenija

Boehringer Ingelheim Ireland Ltd.

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +353 1 295 9620

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Slovenská republika

Vistor hf.

Boehringer Ingelheim RCV GmbH & Co KG

Sími: +354 535 7000

organizacná zložka

Tel: +421 2 5810 1211

Italia

Suomi/Finland

Boehringer Ingelheim Italia S.p.A.

Boehringer Ingelheim Finland Ky

Tel: +39 02 5355 1

Puh/Tel: +358 10 3102 800

Κύπρος

Sverige

Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.

Boehringer Ingelheim AB

Τηλ: +30 2 10 89 06 300

Tel: +46 8 721 21 00

Latvija

United Kingdom (Northern Ireland)

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim Ireland Ltd.

Latvijas filiale

Tel: +353 1 295 9620

Tel: +371 67 240 011

Date of last revision of this leaflet:

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.

Alternatives to METALYSE 8,000 UNITS (40 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION in other countries

The best alternatives with the same active ingredient and therapeutic effect.

Alternative to METALYSE 8,000 UNITS (40 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION in Ukraine

Dosage form: lyophilizate, 10,000 IU (50 mg)
Active substance: tenecteplase
Prescription required
Dosage form: suppositories, 15000 IU + 1250 IU

Online doctors for METALYSE 8,000 UNITS (40 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Discuss dosage, side effects, interactions, contraindications, and prescription renewal for METALYSE 8,000 UNITS (40 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION – subject to medical assessment and local rules.

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Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
  • Evaluation of symptoms and guidance on further diagnostic testing
  • Preventive check-ups and regular health monitoring
  • Medical support during travel or after relocation
  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management
  • Travel medicine: pre-travel advice, vaccinations, fit-to-fly certificates, travel-related illnesses
  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment
  • Weight management and wellness: personalised weight loss programmes, lifestyle guidance
  • Skin and ENT issues: acne, eczema, allergies, rashes, sore throat, sinusitis
  • Pain management: acute and chronic pain, post-surgical care
  • Public health: prevention, health screenings, long-term monitoring
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  • IMT medical certificates for driving licence exchange
Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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His approach is friendly, clear, and focused on delivering practical medical advice tailored to each patient’s needs.

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Hocine Lokchiri

General medicine21 years of experience

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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