- Approval Id
- 34b5f81474dc33cb
- Drug Name
- PRAXBIND SOLUTION FOR INJECTION/INFUSION 50 MG/ML
- Product Name
- PRAXBIND SOLUTION FOR INJECTION/INFUSION 50 MG/ML
- Approval Number
- SIN15083P
- Approval Date
- 2016-08-31
- Registrant
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Licence Holder
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>4.2 POSOLOGY AND METHOD OF ADMINISTRATION</strong></p>
<p><strong>Posology</strong></p>
<p>The recommended dose of Praxbind is 5 g (2 x 2.5 g/50 ml)</p>
<p>Praxbind (2x2.5 g/50mL) is administered intravenously, as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.</p>
<p>In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests have occurred up to 24 hours after administration of idarucizumab (see Pharmacological properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Administration of a second 5 g dose of Praxbind may be considered in the following situations:</p>
<ul>
<li>recurrence of clinically relevant bleeding together with prolonged clotting times, or</li>
<li>if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or</li>
<li>patients require a second emergency surgery/urgent procedure and have prolonged clotting times.</li>
</ul>
<p>Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) (see Pharmacological properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>A maximum daily dose has not been investigated.</p>
<p><u>Restarting Antithrombotic Therapy</u><br>
Pradaxa treatment can be re-initiated 24 hours after administration of Praxbind, if the patient is clinically stable and adequate hemostasis has been achieved.</p>
<p>After administration of Praxbind, other antithrombotic therapy (e.g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate hemostasis has been achieved.</p>
<p>Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.</p>
<p><u>Patients with renal impairment</u><br>
No dose adjustment is required in renally impaired patients. Renal impairment did not impact the reversal effect of idarucizumab.</p>
<p><u>Patients with hepatic impairment</u><br>
No dose adjustment is required in hepatically impaired patients (see Pharmacokinetic – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
<p><u>Elderly</u><br>
No dose adjustment is required in elderly patients aged 65 years and above (see Pharmacokinetic – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Paediatric population</u><br>
The safety and efficacy of Praxbind in children below the age of 18 years have not yet been established. No data are available.</p>
<p><strong>Method of administration</strong></p>
<p><u>Instructions for use/ handling</u></p>
<p>Parenteral medicinal products such as Praxbind should be inspected visually for particulate matter and discoloration prior to administration.</p>
<p><strong>Praxbind must not be mixed with other medicinal products</strong>. A pre-existing intravenous line may be used for administration of Praxbind. The line must be flushed with sterile sodium chloride 9 mg/ml (0.9 %) solution prior to and at the end of infusion. <strong>No other infusion should be administered in parallel via the same intravenous access.</strong></p>
<p>Praxbind is for single-use only and does not contain preservatives (storage condition, see 6.3 Shelf Life – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
<p>No incompatibilities between Praxbind and polyvinyl chloride, polyethylene or polyurethane infusion sets or polypropylene syringes have been observed.</p>
<p><u>Traceability</u></p>
<p>In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 THERAPEUTIC INDICATIONS</strong></p>
<p>Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa when rapid reversal of the anticoagulant effects of dabigatran is required:</p>
<ul>
<li>For emergency surgery/urgent procedures</li>
<li>In life-threatening or uncontrolled bleeding</li>
</ul>
- Contraindications
- <p><strong>4.3 CONTRAINDICATIONS</strong></p>
<p>None.</p>
- Atc Code
- V03AB37
- Atc Item Name
- idarucizumab
- Pharma Manufacturer Name
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
