METALYSE 8,000 UNITS (40 MG) POWDER AND SOLVENT FOR INJECTABLE SOLUTION
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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
- What Metalyse is and what it is used for
- What you need to know before you are given Metalyse
- How Metalyse is given
- Possible side effects
- Storage of Metalyse
- 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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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