8,000 units of powder and solvent for solution for injection
tenecteplase

What Metalyse is and what it is used for

Metalysis, powder, and solvent for solution for injection. Each package contains:

  • 1 vial containing 8,000 units of Metalyse powder and 1 pre-filled syringe containing 8 ml of water for injections

Before use, the liquid (water for injections) should be added to the powder to obtain a solution, which is given as an injection.

Metalysis belongs to a group of drugs called thrombolytic agents. These drugs facilitate the dissolution of blood clots. Tenecteplase is a recombinant fibrin-specific plasminogen activator.

Metalysis is used to treat a heart attack (heart attack) within 6 hours after the onset of symptoms and facilitates the dissolution of blood clots that form in the blood vessels of the heart. This counteracts damage caused by the heart attack and it has been shown that you can save lives.

What you need to know before using Metalyse

Do not use Metalyse

Your doctor will not give Metalyse:

  • if you have previously had a sudden, life-threatening allergic reaction (severe hypersensitivity) to the active substance tenecteplas, to gentamicin (a trace element remaining from the manufacturing process), or to any of the other ingredients of Metalyse. If treatment with Metalyse is still considered necessary, resuscitation equipment should be readily available if necessary;
  • if you have or have recently had a disease with an increased risk of bleeding, for example:

bleeding disorders or tendency to bleed

stroke ( cerebrovascular disease )

– very high, uncontrolled blood pressure

head injury

– severe liver disease

– stomach ulcer

varicose veins in the esophagus

– malformations in the blood vessels (eg aneurysm )

– some tumors you

– inflammation of the pericardium (pericarditis); inflammation or infection of the heart valves ( endocarditis )

– dementia;

  • if you are taking medicines to thin the blood, such as warfarin or coumarin ( anticoagulants );
  • if you have inflammation of the pancreas ( pancreatitis );
  • if you have recently undergone major surgery on your brain or spine;
  • if you have undergone cardiopulmonary resuscitation (compression of the chest) for more than 2 minutes, during the last two weeks;

Warnings and cautions

Your doctor will be especially careful with Metalyse

  • if you have had an allergic reaction other than a sudden, life-threatening allergic reaction (severe hypersensitivity) to the active substance tenecteplase, to gentamicin (a trace element remaining from the manufacturing process), or to any of the other ingredients of Metalyse (listed in section 6, Packaging) content and other information):
  • if you have high blood pressure;
  • if you have problems with blood circulation in the brain ( cerebrovascular disease);
  • if you have had bleeding from the gastrointestinal tract, reproductive organs or urinary tract in the last 10 days (this may cause blood in the stool or urine);
  • if you have malformations of the heart valves (eg mitral stenosis ) with abnormal heart rhythm (eg atrial fibrillation );
  • if you have had an intramuscular injection in the last two days;
  • if you are older than 75 years;
  • if you weigh less than 60 kg.
  • if you have received Metalyse before.

Children and young people

The use of Metalyse is not recommended for children and adolescents under 18 years of age.

Other drugs and Metalyse

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

How to use Metalyse

Your doctor will calculate the dose so that it is adapted to your body weight, based on the following table:

Body weight (kg) under 60 60 to 70 70 to 80 80 to 90 over 90
Metalyse (Units) 6,000 7,000 8,000 9,000 10,000
  • In addition to the treatment with Metalyse, your doctor will give you medicines that counteract coagulation of the blood as soon as possible after you feel chest pain.
  • Metalysis is given as a single injection into a vein by a doctor who has experience using this type of medicine.
  • Your doctor will give Metalyse as a single injection as soon as possible after you feel chest pain.

Possible side effects

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

The following side effects have been reported in people treated with Metalyse:

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

  • bleeding

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

  • bleeding at the injection site or sampling site
  • nosebleed
  • bleeding from the reproductive organs or urinary tract (you can see blood in the urine)
  • bruises
  • gastrointestinal bleeding (eg bleeding from the stomach or intestines)

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

  • irregular heartbeat (reperfusion arrhythmia) which sometimes leads to cardiac arrest. Cardiac arrest can be life-threatening.
  • internal bleeding in the abdomen (retroperitoneal bleeding)
  • bleeding in the brain (cerebral hemorrhage). Death or permanent disability can occur after bleeding in the brain and other severe bleeding
  • bleeding in the eye

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

  • low blood pressure ( hypotension )
  • pulmonary haemorrhage ( pulmonary haemorrhage)
  • hypersensitivity (anaphylactoid reaction) eg rash, hives ( urticaria ), difficulty breathing (bronchospasm)
  • hemorrhage (haemopericardium)
  • blood clots in the lung ( pulmonary embolism ) and in the blood vessels of other organ systems (thrombotic embolization)

No known frequency (frequency can not be calculated from available data): 

  • fat embolism (plugs consisting of fat)
  • nausea
  • vomiting
  • increased body temperature (fever)
  • blood transfusion due to bleeding

As with other anticoagulant drugs, the following events have been reported as a result of myocardial infarction and/or treatment with anticoagulants:

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

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

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

  • renewed chest pain / angina (reindeer infarction)
  • myocardial infarction
  • heart failure
  • shock due to heart failure
  • inflammation of the pericardium
  • fluid in the lungs ( pulmonary edema )

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

  • cardiac arrest
  • problems with heart valves or pericardium (mitral regurgitation, pericardial effusion)
  • blood clots in the veins ( venous thrombosis )
  • fluid between the heart and the pericardium ( cardiac tamponade )
  • myocardial rupture (myocardial rupture)

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

  • blood clot in the lung ( pulmonary embolism )

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

In patients with cerebral hemorrhage, side effects from the nervous system have been reported, such as drowsiness ( somnolence ), speech disorders, paralysis of parts of the body (hemiparesis), and convulsions (convulsions).

How to store 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 outer carton. Sensitive to light.

Once the liquid has been added to the Metalyse powder, the reconstituted liquid 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.

Contents of the pack and other information

Content declaration

  • The active substance is tenecteplase. Each vial contains 8,000 units (40 mg) of tenecteplase. Each pre-filled syringe contains 8 ml of liquid. After reconstitution with 8 ml of liquid, each milliliter contains 1,000 units of tenecteplase.
  • The other ingredients are L- arginine , phosphoric acid , polysorbate 20.
  • The liquid is water for injections.
  • Gentamicin is included as a trace residue that remains from the manufacturing process.

What the medicine looks like and contents of the pack

The carton contains a vial of lyophilized powder containing 40 mg tenecteplase, a pre-filled syringe containing 8 ml of liquid, an adapter for the vial,f and a needle.

Marketing Authorization Holder and Manufacturer

  • Boehringer Ingelheim International GmbH
  • Binger Strasse 173
  • D-55216 Ingelheim am RheinGermany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Birkendorfer Strasse 65

D-88397 Biberach / Riss

Germany

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

Contact the representative of the marketing authorization holder to find out more about this medicine:


Belgium / Belgique / BelgienSCS Boehringer Ingelheim Comm.V
Tel: +32 2 773 33 11

LithuaniaBoehringer Ingelheim RCV GmbH & Co KGLithuanian branchesTel: +370 5 2595942
BulgariaBoringer Inglehaim RIV Gemba and Co. KГ – clone of BulgariaTel: +359 2 958 79 98 Luxembourg / LuxemburgSCS Boehringer Ingelheim Comm.V
Tel: +32 2 773 33 11
Czech RepublicBoehringer Ingelheim spol. s roTel: +420 234 655 111 HungaryBoehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe
Tel: +36 1 299 89 00
DenmarkBoehringer Ingelheim Danmark A / STel: +45 39 15 88 88 MaltaBoehringer Ingelheim Ireland Ltd.Tel: +353 1 295 9620
GermanyBoehringer Ingelheim Pharma GmbH & Co. KGTel: +49 (0) 800 77 90 900 The NetherlandsBoehringer Ingelheim bvTel: +31 (0) 800 22 55 889
EestiBoehringer Ingelheim RCV GmbH & Co KGEesti subsidiaryTel: +372 612 8000 NorwayBoehringer Ingelheim Norway KSTel: +47 66 76 13 00
GreeceBoehringer Ingelheim Ellas AETηλ: +30 2 10 89 06 300 AustriaBoehringer Ingelheim RCV GmbH & Co KGTel: +43 1 80 105-7870
SpainBoehringer Ingelheim España, SATel: +34 93 404 51 00 PolandBoehringer Ingelheim Sp. z ooTel: +48 22 699 0 699
FranceBoehringer Ingelheim France SASTel: +33 3 26 50 45 33 PortugalBoehringer Ingelheim, Unipessoal, Lda.Tel: +351 21 313 53 00
CroatiaBoehringer Ingelheim Zagreb dooTel: +385 1 2444 600 RomaniaBoehringer Ingelheim RCV GmbH & Co KG Viena – Sucursala BucureştiTel: +40 21 302 28 00
IrelandBoehringer Ingelheim Ireland Ltd.Tel: +353 1 295 9620 SloveniaBoehringer Ingelheim RCV GmbH & Co KG Podružnica LjubljanaTel: +386 1 586 40 00
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicBoehringer Ingelheim RCV GmbH & Co. KG Organizing ServicesTel: +421 2 5810 1211
ItalyBoehringer Ingelheim Italia SpATel: +39 02 5355 1 Finland / FinlandBoehringer Ingelheim Finland KyPuh / Tel: +358 10 3102 800
.ΠροςBoehringer Ingelheim Ellas AETηλ: +30 2 10 89 06 300 SwedenBoehringer Ingelheim ABTel: +46 8 721 21 00
LatviaBoehringer Ingelheim RCV GmbH & Co KGLatvian branchTel: +371 67 240 011 United KingdomBoehringer Ingelheim Ltd.Tel: +44 1344 424 600

Muhammad Nadeem

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