- Approval Id
- 007689e879d86e6a
- Drug Name
- METALYSE FOR INJECTION 10,000 U/VIAL
- Product Name
- METALYSE FOR INJECTION 10,000 U/VIAL
- Approval Number
- SIN12015P
- Approval Date
- 2002-07-05
- Registrant
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Licence Holder
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Posology</p>
<p>METALYSE should be administered as early as possible after symptom onset on the basis of body weight, with a maximum dose of 10,000 units (50 mg tenecteplase). The volume required to administer the correct dose can be calculated from the following scheme (table 1):</p>
<img src="/TGIF/Metalyse-Table1_181224.png" alt="Metalyse Dosage Table 1" /><br><br>
<p><u><strong>Adjunctive therapy:</strong></u></p>
<p>Antithrombotic adjunctive therapy is recommended according to the current international guidelines for the management of patients with ST-elevation myocardial infarction.</p>
<p>For coronary intervention please refer to section 4.4 Special warnings and precautions – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><u>Method of administration</u></p>
<p>The reconstituted solution should be administered intravenously and is for immediate use.</p>
<p>The required dose should be administered as a <u>single</u> intravenous bolus over 5 to 10 seconds.</p>
<p><strong>HANDLING INSTRUCTIONS</strong></p>
<p>METALYSE should be reconstituted by adding the complete volume of water for injection from the pre-filled syringe to the vial containing the powder for injection.</p>
<ol>
<li><p>Ensure that the appropriate vial size is chosen according to the body weight of the patient. (see section 4.2 Dosage and Administration)</p></li>
<li><p>Check that the cap of the vial is still intact.</p></li>
<li><p>Remove the flip-off cap from the vial.</p></li>
<li><p>Remove the tip-cap from the syringe. Then immediately screw the pre-filled syringe on the vial adapter and penetrate the vial stopper in the middle with the spike of the vial adapter.</p></li>
<li><p>Add the water for injection into the vial by pushing the syringe plunger down slowly to avoid foaming.</p></li>
<li><p>Keep the syringe attached to the vial adapter and reconstitute by swirling gently.</p></li>
<li><p>The reconstituted preparation is a colourless to pale yellow, clear solution. Only clear solution without particles should be used.</p></li>
<li><p>Directly before the solution is administered, invert the vial with the syringe still attached, so that the syringe is below the vial.</p></li>
<li><p>Transfer the appropriate volume of reconstituted solution of METALYSE into the syringe, based on the patient’s weight.</p></li>
<li><p>Unscrew the syringe from the vial adapter.</p></li>
<li><p>A pre-existing intravenous line, which has been used for administration of 0.9% sodium chloride solution only, may be used for administration of METALYSE. METALYSE should not be mixed with other drugs, neither in the same infusion-vial nor the same venous line (not even with heparin).</p></li>
<li><p>METALYSE should be administered to the patient, intravenously over 5 to 10 seconds. It should not be administered into a line containing dextrose as METALYSE is incompatible with dextrose solution.</p></li>
<li><p>The line should be flushed after METALYSE injection for proper delivery.</p></li>
<li><p>Any unused solution should be discarded.</p></li>
<li><p>Alternatively the reconstitution can be performed with a needle instead of the included vial adapter.</p></li>
</ol>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>METALYSE is indicated for the thrombolytic treatment of acute myocardial infarction (AMI) with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>METALYSE is contraindicated in:</p>
<ul>
<li>patients with known hypersensitivity to the active substance tenecteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients</li>
<li>situations associated with a risk of bleeding such as:
<ul class="bullet">
<li>significant bleeding disorder at present or within the past 6 months, known haemorrhagic diathesis any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)</li>
<li>severe uncontrolled arterial hypertension (see section Special Warnings and Precautions for use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis</li>
<li>active ulcerative gastro-intestinal disease</li>
<li>known arterial aneurysm and.or arterial/venous malformation</li>
<li>neoplasm with increased bleeding risk</li>
<li>bacterial endocarditis, pericarditis</li>
<li>acute pancreatitis</li>
<li>haemorrhagic stroke or stroke of unknown origin at any time.</li>
<li>patients receiving effective oral anticoagulant treatment (e.g. vitamin K antagonists with INR > 1.3) (please see section 4.4 Special Warnings and Precautions for use, subsection “Bleeding” – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI), recent trauma to the head or cranium</li>
</ul></li>
</ul>
- Atc Code
- B01AD11
- Atc Item Name
- tenecteplase
- Pharma Manufacturer Name
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
